“Innovation is not just about creating something new; it’s about embracing failure, staying lean, and persevering through challenges. Every setback is a lesson in disguise, and resilience is the key to success in the journey of entrepreneurship. Success in innovation isn’t about what you do; it’s about why you do it. Your passion and belief in your mission inspire others to join you on the journey to change the world.” – Akshay Bhuva

Our Smart Home series dives deep into the brains behind the innovations, exploring how biometric data, wireless powerless technology, and AI are shaping the homes of tomorrow. Tune in and get ready to reimagine how you live!

“The thing that is very important for me as the lead founder of AI Wover is bringing equity to the hand of everybody, every household with an infant on their day watch. This baby monitoring system, without extra cost, can be equipped with advanced AI and watch out if the babies are going through every milestone on time. And if not, then that concern that they have can be brought up to the pediatrician, and then hopefully the chain of action could happen on time.”                                                                                                                      – Sarah Ostadabbas

Our Smart Home series dives deep into the brains behind the innovations, exploring how biometric data, wireless powerless technology, and AI are shaping the homes of tomorrow. Tune in and get ready to reimagine how you live!

“In my dream world of, like, a smart home, I want Rosie the robot. I don’t want to do chores at all. And we’re getting there. I think we’re getting there. I think a lot of the pieces are there. But whether we’ll actually see it all come to fruition in a way that everybody’s really happy about in five to ten years, you know, I don’t know. Fingers crossed.” – Andrew Gebhart

Our Smart Home series dives deep into the brains behind the innovations, exploring how biometric data, wireless powerless technology, and AI are shaping the homes of tomorrow. Tune in and get ready to reimagine how you live!

The conversations with our amazing guests were informative, inspiring and fun. If you like what you hear, we encourage you to go back and listen to the full episodes for some great stories, tips, and tricks from our guests. 

Be on the lookout for our upcoming smart home series where we talk about what a smart home is and what its future looks like. Join us as we chat with innovators and enthusiasts who are developing smart home technology that is safer, easier to use, and kinder to our world. 

“People come away with smiles. I mean, I can tell you some very impactful stories. I was there. I saw it happen. It gives you chills just thinking about it. But at the same time, I needed to know if there was anything real to it. And that’s what got me started doing this research all those years ago. And it’s real.” — Dr. Nancy Gee 

Beyond the Collar is an exploration of animal research and innovations that are making waves in the animal health industry. Listen as our hosts and guests dive into the impact our pet relationships have on us, obstacles and triumphs in pet medicine, and tools for ensuring the safety of our pets. 

About Nancy Nancy R. Gee, PhD, is Professor of Psychiatry, Bill Balaban Chair in Human Animal Interaction, and the Director of the Center for Human Animal Interaction at Virginia Commonwealth University in Richmond, Virginia, USA. The Center is uniquely situated in the School of Medicine and in addition to research and educational activities it also houses the “Dogs on Call” therapy dog program, which includes 90+ dog/handler teams who visit patients and staff throughout the VCU health system. 

Dr. Gee, President of the International Society for Anthrozoology, has extensive research and teaching experience and has specialized in the area of Human Animal Interaction (HAI) for the past 18 years. She served for five years as the HAI Research Manager for the Waltham Petcare Science Institute, located in Leicestershire, UK. In this role she managed a large portfolio of collaborative university-based research projects spanning multiple countries and topics, including; how companion animals impact the lives of older adults, or help students learn, or reduce the impact of PTSD symptoms in military veterans. Dr. Gee’s own program of research has focused primarily on the impact of dogs on aspects of human cognition, including working memory, executive functioning and physiological responses such as heart rate variability to interactions with dogs. Currently she is the primary investigator on three grant funded clinical trials examining the impact of a hospital-based therapy dog visitation program on loneliness, depression and anxiety in vulnerable patient populations such as children, older adults, and people with mental illness. 

A recipient of multiple grants and awards, Dr. Gee has 70 peer reviewed publications and has edited and contributed to numerous books. Dr. Gee regularly delivers international presentations on a variety of HAI topics, serves on the editorial review boards of several peer reviewed journals and has actively promoted the field of HAI through participation on the boards of several HAI organizations including the International Society for Anthrozoology and currently as the Chair of Pet Partners’ Human-Animal Bond Advisory Board. 

With the amazing guests that joined us the conversations were informative, inspiring and fun. So while we could only pick one highlight, there is so much more to learn in the full episodes and we encourage you to go back and listen. Hope you enjoy. 

Be sure to be on the lookout this year as we bring you series built around smart homes, automotive innovations and, of course, told through the lens of Inventivity!

Join host James Di Virgilio and guest Katherine O’Fallon, Executive Director of the Marine Research Hub, as they kick off the first episode of our Blue Economy Series!   

Listen as Katherine gives an educational overview of the Blue Economy, the Marine Research Hub’s impact on it, and how anyone can be a steward for our oceans.    

Our Blue Economy series is a look at what the Blue Economy is, who’s involved, and what the future is going to look like thanks to dedicated innovators. Listen as our hosts and guests cover topic areas of renewable energy, fisheries, maritime transport, tourism, climate change, and waste management.

With the amazing guests that joined us the conversations were informative, inspiring and fun. So while we could only pick one highlight, there is so much more to learn in the full episodes and we encourage you to go back and listen. Hope you enjoy. 

Join us next time for the beginning of our Blue Economy series!

To celebrate the release of the new book Secrets of Successful Women Inventors by Edith G. Tolchin, from Square One Publishers, the Inventivity Pod has welcomed Edith G. Tolchin, Kenya Adams, and Angelique N. Warner to the show!  

Listen as the author and two inventor contributors discuss with host, Richard Miles, their inspiration and journeys. Obstacles like patents, funding and support. And learn what to do when what you want doesn’t exist. Create it.  

Be sure to purchase Secrets of Successful Women Inventors available now! 

Listen as host Richard Miles and Rodrigo Griesi have an engrossing, encompassing conversation. From how winning the 2022 Cade Prize impacted Rodrigo’s business, NEPTUNYA, to insights into different business cultures, and what we can do with failure. Join us for the final episode in our Hope for the Future series.  

The Hope For the Future series is an innovative look at sustainability. For this limited series, we talk to inventors contributing to the sustainability movement. Listen and see why they provide, Hope for the Future. 

The Cade Museum for Creativity and Invention hosts the annual Cade Prize for Innovation. Which, since 2010 has been Florida’s premier Innovation prize. And this year, 2023, has become a national prize with an overall purse of $100,000.   

Join us next time for the continuation of our Hope for the Future series!  

Join host James Di Virgilio and guest Dr. John Cotter, of Cotter Research and Development, as they delve into the creation of John’s lumber alternative. A concrete that has nailability! In the continuation of our Hope for the Future series.  

Listen as they discuss how John discovered the importance of customer discovery and the different avenues you can take to get your innovation out into the world.  

The Hope For the Future series is an innovative look at sustainability. For this limited series, we talk to inventors contributing to the sustainability movement. Listen and see why they provide, Hope for the Future. 

Join host Richard Miles and guest Dr. Anthony Engler, of Polymer Solutions, as they kick off the first episode of the newly branded Inventivity Pod, with the first episode of our Hope for the Future Series!  

Listen as they discuss Anthony’s journey from an inquisitive student to CTO of a company he co-founded! The company develops polymers and is focused on energy and material sustainability.  

The Hope For the Future series is an innovative look at sustainability. For this limited series, we talk to inventors contributing to the sustainability movement. Listen and see why they provide, Hope for the Future.  

Join hosts Richard Miles and James Di Virgilio as they discuss the future of the podcast! What was once known and loved as Radio Cade will now be known and loved as the Inventivity Pod! Want to find out more? Give this minisode a listen! And stay tuned for all new episodes of, The Inventivity Pod! Brought to you by the Cade Museum for Creativity and Invention, in Gainesville, Florida.  

DJ Schmitt and Michael Finkelstein founded Neuro20 Efficient Health, a company that manufactures washable and wearable electrical muscle stimulation suits. Neuro20’s mission is to be the leading provider of advanced wearable technology that specializes in the use of Electro Muscle Stimulation (EMS) training and rehabilitation.  

This series was made possible in partnership with the Cade Museum, Florida House on Capitol Hill, and the Florida Inventors Hall of Fame.

Dr. Sylvia Wilson Thomas leads the University of South Florida research enterprise and is the first African American female to lead an R1 university research program in Florida. Dr. Thomas also serves as President of the Institute of Electrical and Electronics Engineers Engineering in Medicine and Biology Florida West Coast Section, advisor for Society of Women Engineers and National Society of Black Engineers, and member of the Board of Directors for Black Girls Code and Florida Senate Appointee to the Florida Education Fund Board of Directors.

This series was made possible in partnership with the Cade Museum, Florida House on Capitol Hill, and the Florida Inventors Hall of Fame.

Paul Sohl is the CEO of the Florida High Tech Corridor Council, an economic development initiative of the University of Central Florida, the University of South Florida, and the University of Florida.

This series was made possible in partnership with the Cade Museum, Florida House on Capitol Hill, and the Florida Inventors Hall of Fame.

“So, the fuel that we’re using to power our generators is really where our patent is around, which is the way that we convert the biomass into a powderized fuel that is very uniform and it behaves in a very predictable way. So, what has been a challenge in the industry is really to be able to overcome the different types of biomass that are available and be able to find the system where you can create a uniform output out of this mixed biomass waste. And that’s exactly what our patent focuses on and what our expertise really lies in.”

Stefano Alva is Chief Financial Officer of Farm to Flame Energy. Farm to Flame Energy was a Fibonacci Finalists in the 2021 Cade Prize Competition for Innovation. 

To learn more about Farm to Flame Energy visit their website at ftfenergy.com or visit Wefunder.com/farmtoflameenergy2 

Sathya and his company are in the process of developing hydrogen powered, modular, autonomous air and road mobility electric vehicles with vertical takeoff and landing: “A lot of people have to travel hundreds of miles to go to a large commercial airport to take an overseas trip or take a long-distance flight. So, what we are doing is promoting an alternative for those people to fly from their little hometowns, from the rural areas, from small cities to these bigger commercial airports and both those sides”. 

In this episode, Sathya discusses how the movies he saw in his childhood inspired him to find a solution to the problems many face regarding regional transportation—only about 28% of the American population has access to air travel, because it is too tedious or expensive, but Sathya believes it does not have to continue to be this way. He believes inventors should collaborate and solve similar problems together.

Dr. Christine Schmidt is the Chair of the J. Crayton Pruitt Family Department of Biomedical Engineering at the University of Florida. She is known for her work in biomaterials science and cellular tissue engineering. In 2020, Dr. Schmidt was inducted into the Florida Inventors Hall of Fame.

In this episode, Patil and Shah share the inspiration behind their ideas with host Richard Miles and recommend always having patience, especially when starting a new business.

Abilitare Products 

Disability Technology TEDxLSSC by Jeff Paradee

Susann Keohane is the IBM Watson Health Innovation Leader for Healthy Aging and Longevity. Her induction into the Florida Inventor’s Hall of Fame in 2021 is amongst one of her achievements; another includes having 137 U.S. patents. She has become an expert in enabling human ability through emerging technologies with a focus on accessibility research, aging-in-place Internet of Things (IoT) technology, and cognitive systems to deliver personalized insights and adaptive interfaces.

In this episode, Keohane shares with host Richard Miles the importance of building more intuitive design solutions for the aging population, alongside having them feel comfortable with the technology.

Craig Bandes is the CEO and co-founder of Pixelligent Technologies. He has over 25 years of experience serving as a CEO, entrepreneur, and angel investor. Additionally, he is a member of the NanoBusiness Alliance Advisory Board.

In this episode, Bandes shares with host James Di Virgilio the importance of having a business background before entering the business world, how he’s saved a company from bankruptcy, and the next steps for said company in terms of workplace diversity, globalization, and sustainability.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade — a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. Starting in running your own company — it’s not for everyone. For those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. We decided to go out and talk to some of those people and find out what they’ve learned, what they’d repeat, what they’ll never do again, or hear stories from their first year, then from the period when they realized they’re going to survive and how they intend to position their companies for the future. We’ll find out what a CEO’s normal day is like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is it time to move on? Join us for CEO101 — a limited series of deep looks at people who are their own boss — for better or for worse.

James Di Virgilio: 0:54

We’re talking with Craig Bandes, the president and CEO of Pixelligent Technologies. It’s a nanotechnology company that does a whole lot of fascinating things that Craig is going to tell us all about. But first, Craig, tell us about your background as a leader. You’ve done a lot of things — both co-founding companies, as well as being brought in to be a CEO.

Craig Bandes: 1:14

Yeah. Well, great. Thanks for inviting me to join today. So, you know , I think it’s , it’s nothing that I think you can prepare for without being in the role. There’s so much of it that you figure out as you go. There’s definitely taking advantage of books on leadership or being mentored by others that have come before you, but there’s nothing like being in it to really make all the mistakes, hopefully learn from them, and start to formulate what you think is a, a good compilation of strategies, right? There’s not just one that I think makes a leader, or a CEO, successful.

James Di Virgilio: 1:45

Give us a little bit about your, just, biography, sort of the companies that you’ve led. Give us a CV here.

Craig Bandes: 1:51

So, very different companies, very different industries. The first company I co-founded with a partner was in IT staffing and consulting — and that was an area where he had slightly more experience than I did in it. And we were big users of those, sort of resources and vendors when we’re both working together as executives in a telecom company, which [inaudible] many back around the uh, circa 2000, didn’t work out after raising lots and lots of money — which was my main job when I was there. And so we started it together, and it was not my lifelong dream to do it, but I had more entrepreneurial background than he did, so it was more, helping get started. I did that for a couple of years, and I’m still running more of a lifestyle type of business today, and decided that really was not what I was looking for, so [I] moved on from that and got recruited to go join a — very early stages — a company that was being formed in the Homeland Security sector, not too long after 9/11. So this would have been in, like, early 2003 when the Department of Homeland Security was just really coming together; and there was a huge need for companies that could come in and provide services to this [inaudible] organization to try and find all kinds of ways to make sure we were better prepared for all kinds of things and acts of terrorism, for sure, but just generally, even natural disasters. It’s not something that was well-integrated in state and local and federal governments. And so I was brought in [inaudible] Global Secure as the president. I wound up taking over the CEO title about a year later and grew that company to, from really three of us, to about 300 people with operations in five states that span software development and training services, and many batches of protective gear and raised about $25 million, maybe closer to $30 million, had nationwide distribution channels we set up… And then ultimately, after trying to go public, but not hitting the window at the right time, when I’m selling off the business at the end of 2007, into early 2008. And that’s about the time that I was approached by a friend, who’s a corporate attorney in D.C., to try and take a look at this company called Pixeligent, which was a very early-stage, non-material company at the time, but also happened to find themselves in a bad spot of bankruptcy and litigation against a large public company. So I was really brought in to see if it was salvageable, and brought in some experts that knew IP portfolios much better than I did, said there was good IP here, and decided to get involved and see if I could at least get it turned upright, and then see what happened. Appointed by the bankruptcy court, the chief restructuring officer wound up restructuring the company, ending the litigation, getting back control of the IP. And then we had to raise money for a pre-revenue, recently bankrupt, [inaudible] technology company in January of 2009 — which could not have been worse timing. So we got out by the skin of our teeth, for myself and a bunch of local investors that I know and started the process of rebuilding Pixelligent.

James Di Virgilio: 4:38

That’s a fascinating story that we could spend an entire podcast on, for sure. I also started my wealth management firm in February of 2009. So I know, I know exactly what kind of time that was. All right, Greg, take us back to what you would consider to be your early formative years as either a CEO or a co-founder. What was it like for you to take on that kind of role?

Craig Bandes: 5:02

So, we went in with — on the first one, at least — called Focus Technology, we went in saying, “hey, we’re going to start this company.” The telecom company had ended. And there were a bunch of really good people that we thought we could bring on quickly. First time I wrote a big check to get something started as did my partner. And it was just dark right, and very entrepreneurial, not a lot of great planning. It was just, “we think there’s a good opportunity and let’s, let’s go.” And the first big lessons for me there were, one: we hired a lot of people too quickly. And all of a sudden we had a burn that put a lot of pressure on us to go close business in a way that was really not organic. We figured it out, but it wasn’t without a lot more pressure [ inaudible] that we really needed to put ourselves under, and we should have started much more cautiously with a handful of people, including ourselves, and built it a little more brick by brick. I think the timing was, around when we started the business, was when things were contracting in the world of telecos. And we thought that meant it would be a good opportunity to go after short-term staffing, as these companies were cutting fixed overhead and we realized that that was not the right premise, that the consultants were the first to go. And so there , there is a lot of things that we jumped out of the gate on, and I put a lot more faith than my partner, who felt he knew that business better than I did. And within about six months, we were digging ourselves out, as opposed to growing the company. That first lesson, or basket of lessons, was: when you’re starting, start more carefully — really understand the markets better, the timing of what’s happening in those markets better. Figure out what is the right number of employees you need to really just get things started — and even if it means you’re going to lose some really terrific talent that you may not be able to get back, it’s a safer, better bet to do that and then go find other team members as you grow. Those were the main lessons on that. And we learned them righting the ship. We wound up, you know, growing a lot more carefully after that, but those were some early missteps that, in hindsight, seem obvious, but at the time we were just excited to take off.

James Di Virgilio: 6:58

Yeah. Why take on a project like this? You come out of school, you’re starting to do whatever it is you want to do. Why take on an entrepreneurial project in the first place?

Craig Bandes: 7:07

I wouldn’t advise it, actually. In fact , if I look at some of the issues that led to pretty serious circumstances that Pixelligent found themselves in, it was started by three PhDs that just got through their postdoctorates and started this company without ever having worked in a business, and then really understanding what all the facets are. And sometimes for folks that are sort of, deep buried in the technology, they think the technology is the hard part in business and growing is the easy part, which obviously is not the case. There’s tens of billions of pieces of paper, of patents, out there that will never see the light of day. Most of the time — and there are the Mark Zuckerbergs and the Bill Gateses of the world — for every one of those there’s millions more that maybe try too early. And so I would say the first thing is, that it’s better to go out and just get some level of experience before you start. I think once you have that, and you have an idea of that you think is a service or a product that’s missing in , in whatever market that you’re in, or you’re aware of. And you get to a point where you just realize that, “if I don’t try it, I’ll never know, and I’ll always regret it.” And then you jump into it . But jumping in with more experience, I think, really increases the odds of surviving .

James Di Virgilio: 8:14

This is a lot of good information. Let’s probe this a little bit further. You talked about funding early on, and obviously that’s the lifeline of any company that’s trying to go anywhere. You have to fund your ideas, be able to get your product or service to market. It’s much different obtaining funding in your current role at your current stage, I’m sure than it was in the beginning, in the early stages. What was it like for you to take on a project and then have to go out and get funding in the early stages, given that you had probably never generated funding for something before?

Craig Bandes: 8:42

So my background was a little different. I came out of investment banking and venture cap. And so, so I was very comfortable with the capital markets. Back — growing up, my family had an over-the-counter trading firm when I got my [inaudible] seven right after high school. So I was deeply enmeshed in the financial markets and was very comfortable in the language, and the way things worked . So, for me, jumping into raising capital was something that was a skill set that I just already had, so I think on that front, I definitely had an advantage. I did a lot of capital raising at the telecom company where it was $275 million of equity and debt capital for that company, and then filed to go public with that company as well, and ran that process. So I had a lot of really good background . So when I jumped into, even with Focus — the first company — we raised a little bit of money, like a million and a half or $2 million, maybe. Beyond that we put into it ourselves, it wasn’t that difficult. I think as you start to go into companies that have a much bigger appetite for cash, like this one — Pixelligent — today, we raised over $50 million of equity so far, and we’re not done yet. But what I learned along the way here is that there’s many different types of capital. And I think a lot of entrepreneurs get focused on venture, and very few of them get it. And so you can spend a lot of time , especially at the early stage of launching, trying to go chase that capital with a very low likelihood of success. And so I think about it of: there’s many pockets of capital , right? There’s the initial friends and family round, then there’s the angel round, then there’s a super angel round, family offices. And then there’s different flavors of different stages of venture capitalists. There’s corporate venturing — and that helps bring in some strategic capital that may help you scale your business faster, open up markets faster than you could on your own. And so when I tell friends, or , or when I mentor for classes, that you really want to understand, what type of capital do you need, how much do you really need to get to the next one or two milestones to start to show real progress? And you can point to success that will help you go raise additional and greater sums of capital and really know the audience who you’re talking to well — in terms of the type of investor you’re talking to because each one of those that I mentioned will have a very different set of criteria they’re looking at and a different set of objectives that they’re looking for. And so sometimes I see, especially first-time money-raisers , kind of put together a deck and think it’s a one size-fits-all. And it’s not. I have probably put together, even with Pixelligent, hundreds of different decks, targeting different types of investors, depending on really understanding what their objectives were and why they would want to write a check.

James Di Virgilio: 11:13

Yeah, that’s really good information, especially on the funding side, which you mentioned a little bit already about. Especially if they’re inventors on the technology side or the ones that created the innovation, the business side tends to be foreign to them — and the funding side tends to be very, very foreign. What were some challenges that you faced or found particularly difficult during the early stages of your career? Again, as a CEO and co-founder.

Craig Bandes: 11:37

I think some of the challenges or the key lessons learned, well we covered a little bit of this already, which is: start more slowly and build into it so that you don’t put too much pressure on capital raised and just control the burn until you really start to get real revenue traction with your customers. I think the understanding of all kinds of different stakeholders that can help you be successful, right ? So we talked just now about raising capital — that’s one area you need to know — but I had great success in bringing on awesome advisory board members along the way who bring skill sets from a technical perspective, a financial perspective, maybe more of a strategic or a market entrepreneurial perspective. And having them on the team not only makes the team overall smarter, we can leverage their experience. We can leverage their networks in terms of capital raising, customers, or just an understanding of how markets work. And I think the other key piece of it is: when you’re out there building the company, you’ve really got to focus on bringing on the right employees, right? And every time I settled for anybody, you’re bringing on the wrong body. You have to, even though you might be under a great deal of pressure, you know you need more people, you really have to focus and t ake the time to bring on the right people. And the right people will be the ones that you have to sell. It’s just not a matter of you’re going to give them a job and pay them a salary a nd g etting t hem m ix equity. B ut people that I brought on that have been the best, h ave really been the ones that have put me through the pieces the most a nd t urned o ut to be the most productive and most loyal employees. And so, really understanding as t he CEO, it’s your job to basically convince and sell all your stakeholders. I t’s not just t hat in this case, a, uh, an investor stakeholder, but really everybody that you need to be on the team to help you be successful.

James Di Virgilio: 13:21

So true when it comes to people being what moves these things forward, right? The wrong team and the best ideas — not going to get it done. You have to have both of those things. Let’s move from, let’s call it, your rookie years, your early years to your middle years. You’re a veteran now. You’re established, you’ve done some things already. You’ve learned some of these lessons, which you’ve already shared, thus far. How did that change how you were able to lead as a CEO, having some of that experience under your belt already?

Craig Bandes: 13:46

So I think part of it is you , you learn to be a little more thoughtful before you make decisions, in terms of people over investment. Once you’ve gone through some of those painful processes in the past that you were maybe moving too quickly, I think you start to realize how important the CEO is in setting the tone for the organization and understanding really the impact you have on the organization. Sometimes we’re so focused on the objective of just getting it done and charging hard to go after, especially after you raise some capital and you’ve got investors over your shoulder. It’s really important that you make sure that the team really understands where you’re headed, and why that’s hard, in an entrepreneurial venture, is that that changes, right? The classic word, pivot — there’s many pivots. I can’t count them [inaudible] here. And when you do that, it’s really important to make sure everyone understands what the new objectives and goals are and to spend the time with everybody. And I think some of the mistakes I’ve made was: I thought it was clear after one meeting and “we got to go do this.” And it wasn’t. And sometimes that would make people frustrated. Sometimes it would make them feel alienated . Sometimes they would leave, because they didn’t understand the direction . And so really making sure that as we’re moving forward, everyone that’s in the huddle really has a good understanding of where we’re going, why we’re going there, what the play is that we’ve called. And so when we go execute, we don’t have a problem . And I think that’s something that I did not really take into account or grasp as much as I needed to early on. And now I spend a lot more time communicating with the team, making sure we all understand where we’re moving forward. I think you can’t over-communicate — you can have too many meetings — but you can’t over-communicate to make sure everybody understands really where we’re at.

James Di Virgilio: 15:21

That’s a great one. Oftentimes as a leader, you can have a lot of thoughts in your head and you live with those thoughts every single day. And you spit out a few sentences, a paragraph, some moments at a meeting where you think the direction is clearly understood, but other people are not necessarily living in your head all day, knowing all the thoughts you have, and it comes out to them as some passing thoughts. So that’s a great key takeaway there. During the veteran’s stage, if you will, the middle stage of your, your CEO life, how did you handle growing and expanding rapidly, really starting with X number of people and then very quickly you find yourself with growing resources, growing staff — how are you able to navigate that successfully?

Craig Bandes: 15:56

I think it’s been different with different companies that I’ve been a part of. With Global Secure, we were a buy-and-build strategy, so we acquired three companies and another one, but it was more like a foreclosure and we got the product line and some people. So that one, we were able to scale very quickly because we had the cash and we were able to make some good acquisitions. And then that was more around an integration of the company. Now, each of these companies that we acquired were meant to be in separate areas and talked about. So it was software, it was training, it was product manufacturing. So it wasn’t meant to make them work together, but still finding a way to keep, thematically, why we did what we did, and scaling that. So it was more, each one of those was very much like scaling three individual companies, which had its own set of challenges, but I also had very competent executives running those divisions. And so we were able to, as a team, move that one along pretty quickly and scale pretty quickly based off of the infrastructure that was already there when we acquired this company, but Pixelligent’s different — Pixelligent was seven PhDs, and then me, and this is a chemical manufacturing company — it’s around novel technology and nanotech , and I had never taken chemistry. I’d taken some physics. So it really was an amazingly steep learning curve for me across everything that we did. And so for this one, it was more really getting my head around, “okay, what are we doing?” And what the initial path was didn’t work. So what capabilities do we have? And I think we can go sell to the market that differentiates us, and really kind of start here one step at a time and build it brick by brick, as we start to get some level of customer interest in them, and then start to build up a brand, initially here. And then we started going to Asia very early to build up our reputation there because that’s a big market for us — still spent a lot of time there, you know, non-COVID time. So it was a much more methodical approach of how we build and scale a team. But even here, we scaled very quickly. Around 2015 or 2017, we got our first big market –it was going to be in the area of solid-state lighting and LEDs. And ultimately, we missed the timing on that and we had to scale back and cut the company [inaudible] very quickly just to kind of give ourselves time to pivot, and now we’ve been in a rebuilding mode again, really since 2019. But in this situation, I was able to read much more quickly what was happening, make the change — as painful as it was — very fast, early on to give us time to recover and redirect ourselves. And had I not had the prior experiences, I think it would have made the decision [inaudible] .

James Di Virgilio: 18:20

So the prior experience obviously helps you as a leader to make better decisions. You have an algorithm in your mind that says, “I’ve tried that, that’s not going to work in this situation. That’s going to more efficiently get you to the right answer.” How does your own personal brand help you? Obviously, if you’re in the middle stage, you’re a veteran, right? You basically have a resume that people can look at where it says, “hey, Craig has been successful doing this and that.” And at the table, that gives you a little bit more credibility, right? When you’re having these discussions during those years, what you say has a little more weight than if you’re in the beginning where you’re , you’re sort of fighting tooth-and-nail, just to get some respect.

Craig Bandes: 18:54

I think that’s right. But beyond the credibility that may be on a piece of paper, your experience just comes out, right? In conversations with potential employees, with investors, with board members, you’re trying to recruit budget board members, customers, you just have more confidence because you’ve just been through so many battles; you’ve made, and hopefully learned from, a number of big and small mistakes along the way. And like anything else, you just feel better prepared. Whether you’re looking to recruit a junior marketing person who has 10 offers and you really want her and her business, or you’re in front of the CEO of a multi-billion dollar company, trying to convince them to write a check to invest in you. You just have the confidence to be able to have those conversations. You prepare for them obviously, but then there’s just a certain level of understanding and background, and reading a room or a person that you just get with experience, right? So I think for me, that’s the biggest part of it is just having lived through so much of it. I’m sure, you know, having a good background and people see you and check you out on LinkedIn — that all helps, like, establish your credibility maybe before you get in the room. But I think we’ve all met people who are a lot better on paper than they are in person. And so being able to, when you’re in that situation, in person, with whoever it is you’re trying to talk to, having that experience and confidence and being able to understand what their objectives are, what yours are, and trying to find the right way to get to the result you want is really just experience.

James Di Virgilio: 20:13

And you’ve touched on this now, at least you’ve touched on the now throughout this conversation, which has been great. Let’s bring you into the now in this moment right now — here we are in 2021 — you are the Pixelligent CEO; you have this wealth of experience behind you. The first question I want to ask is: in your opinion, is being a CEO today — is it different than it was 15 or 20 years ago? Is it harder? Is it easier?

Craig Bandes: 20:36

I don’t think it’s ever easy — it’s different, right? I think it’s a much more global environment. I mean, even for the size we are today — which is not big — in terms of employees, I have a team, small team in Korea and Taiwan. Prior to COVID, I would be in Asia once a quarter, visiting three or four countries, talking to customers and partners; we have distributors in Japan and China and Korea, Taiwan. You got to keep on top of those guys. So I just think everything is more spread out. Everything is global. And you have to think about your business and today probably on a much more global way than you ever have, and it’s not going to go backwards. I think having the mindset that what you make is important, but also how you make it, and the people you have onboard your team that are responsible for delivering it is really important. So I think diversity should have always been important. I think now it has obviously a lot more of a spotlight on it. We worked and had a very diverse workforce across everything and everyone that’s here. And I say everything. I mean, everything that we do, we have manufacturing, we have our research and development, we have formulation technology, I mean finance, and we have diversity really throughout the organization. And I think that adds to it. And I think there’s thankfully been a lot more focus on that, but you know , I’m reading more and more articles of how that is really in this ESG movement, more and more how CEOs are being judged. And I think that’s right. I think having a more sustainability and environmentally conscious mindset is critical. What we do as a materials company — it’s super important. What we make makes everything we go into a lot more efficient. So we’re directly in line with that. But we also think a lot about how are we making it? And what kind of footprint are we leaving? So I think from that perspective, it’s a lot more today about, broadly, what are you delivering and how are you delivering it ? Can it be more efficient, maybe less impactful? I think that’s different than what you probably had 15, 20 years ago, which creates opportunities, but for sure, a lot more moving pieces.

James Di Virgilio: 22:25

So how do you handle the pressure of the media, public opinion, these goals, these directives, the globalization of being a CEO, how is all of that handled?

Craig Bandes: 22:34

I think it’s different for every leader in how they internalize that process and use it. For me, it’s really about — doesn’t matter the size of the organization — we all have an impact on making sure that we create environments that are creating good opportunities for our employees to grow and to learn and to contribute. I think when you read some of these stories out there of CEOs who’ve gone astray that have made some pretty poor choices. You read some of these crazy pay packages that CEOs of large companies are getting paid, even when they don’t do a great job, and they have these massive payouts. I think it’s harder when you’re talking to other media folks sometimes and saying, “not all CEOs go about their business the same way.” And so I do think there is a little bit of extra thought you have to put into, to make sure that you are understood by your stakeholders and the media in a way that you want to be portrayed, which is being a thoughtful leader, that you understand the responsibilities we have as leaders; it’s not only about making a lot of money for your shareholders or for your top people at the company, but it really is trying to make sure you share that as much as you can along the way. And you have equal balance on your overall responsibility along the way. So I think some of what’s happened has been an important wake-up call. I think it’s good. I think holding the senior executive leadership of companies, large and small, more accountable is really important. And again, I think it’s a difference from what you saw 15 or 20 years ago, but I think it’s a good difference.

James Di Virgilio: 24:04

Craig, I can tell through all of your answers that you’re someone who’s constantly trying to improve, and you’re taking lessons from the past and you’re applying them to today. So with that lens, what are you thinking about and focusing on now, as it pertains to you improving as a leader?

Craig Bandes: 24:20

A lot of my focus now is on how do we, as still a relatively small company, have ultimately the impact that we believe we can have, and then how do we attract more like-minded people like us to our mission here to continue to grow the company? I’m spending a lot more time — we touched on this a little while ago — I’m really just thinking about: where are the critical roles we need to bring on? What do those people look like; if they have a similar mindset; and to make sure we maintain that, as things continue to progress for us… Because as you grow and, we are about to hit another, I believe, pretty serious rapid growth spurt in the next 12 to 24 months, how do you not lose hold of that? In terms of really focusing on these critical issues of impact, footprint, bringing on the right people along the way, making sure we continue to maintain the diverse workforce that we have, and just making sure that we continue to really live up to the credo that we have and the ideals that we have as we grow the company through this next level here. I think that’s probably the thing I focus the most on right now. We have the ability now with what we’ve accomplished to go, you know, access different sources of capital. We know our products that we have are impactful and the customers are telling us that. And we’re, we’re actually in a great position where we, in some ways, almost have more business than we can keep up with right now. So now it’s a matter of: how do we continue to keep the right focus here as we grow the company along the lines that we just mentioned?

James Di Virgilio: 25:46

Craig, let’s talk about strategy. Obviously, you had mentioned right in the opening that when you came onboard with Pixelligent, there was a very interesting landscape, all sorts of things going on — legally, a bankruptcy, et cetera. How did you decide first that you were going to take on this project, that it was worthy of taking it on; and secondarily, how did you go about deciding what strategy to take to be able to take the IP that was obviously good, as you said, and bring it actually to market in a way that was going to work?

Craig Bandes: 26:14

With Pixelligent, I had just finished with Global Secure and was joining some boards and doing some angel investing. As I said, a friend of mine in the D.C. area, his lawyer said, “hey, there’s this company that’s doing some work for the University of Maryland. They’re saying they have some of the most important technology they’ve seen come out of their incubator program, but they need to be helped. Can you go talk to them?” And so I sat down and I got with the team and then some of the advisors, and they had some pretty good folks. And the more I understood how they found themselves in that terrible bind, it was just a lot of really bad decisions, right? The technology was good. They actually had a financial backer who was really strong, who was still a supporter of the company. It was just a series of bad decisions. And then a lot of that driven by the inexperience, because they hadn’t been in the business environment before — they just started it right after their PhD programs — I felt this company shouldn’t die because of financially inexperienced decisions. So I decided to get involved. I had some time, of course it was on my time. Rolled up my sleeves, figure out what’s going on. I’ve gone through the restructuring processes before. So I was able to jump into that and go talk to the bankruptcy judge and buy some time, and then just start to untangle the mess. And so I brought in these IP lawyers who said, “there’s really important, valuable patents here around this brave new world of nanotechnology. And so there’s value here if you can figure out a way to make the mess go away.” So part of this job was at the end of the day, if we could get out of bankruptcy and the litigation, we might just sell off the patents and have a return and move on. Or we were trying to actually build something. At that point, I had taken a deep dive in “why had so many nanotechnology companies failed?” And at that point, most of them had — about $4 [billion] or $5 billion of venture money went into a nanotech company circa 2000, about $12 billion of government funding had gone into supporting growing nanotechnology initiatives and universities and companies, and then another $4 [billion] or $5 [billion] or $10 billion [inaudible] these days went in with corporate, and very little came out. And what I realized was, taking a deep dive, is that a lot of the first round of nanotech companies looked a lot like Pixelligent — brilliant scientists , nobody from a manufacturing perspective or a business perspective. And so really what I decided is that, if we could get in and find a way to make these products, these materials at scale and manufacture them, then there’s potential here, because at some point there would be a billion dollar company here. In the world of nanotech, it just has to happen with as much money and talent and energy was going into it. And so if we could crack the manufacturing scale-up code, where almost everyone else failed, then we would have a shot at becoming a meaningful company. And so as part of that, we went after a very large government program just after getting out of bankruptcy, and it was a hail Mary, and it was one of the first programs focused on the manufacturability of a nanoparticle versus the invention of one [inaudible] . And that really launched the company. And since then, manufacturability is deep in our DNA as the invention of human service . And that’s really what sets us apart. So when we have fortune 500 companies, can’t talk about most of them, but one of them was [inaudible] and that many others come and visit us and kick our tires. They see that we’re different because they can see our manufacturing lines right next to our R&D labs. And so part of it was, I felt that there was the potential to build something meaningful that could have a big impact, would help in the world of sustainability because of the way we make the materials and the efficiencies that they bring, and, ultimately, there were going to be some really big successful companies in the space. And if we can get the manufacturing down, that we would have as good a shot as anyone.

James Di Virgilio: 29:48

So, you build out this broad strategy, which was very well laid out right there. How does it go from that to something more narrow — strategy into actual tactics, as you moved along through the curve of progression with Pixelligent?

Craig Bandes: 30:01

So you start with, “okay, we have to know that we can manufacture whatever, right?” So the first thing is to hire the right people. So I brought on, pretty early on, a great senior executive and a manufacturing group , understanding of our business. And I told them when you join, “look, here’s the deal: walk down to the scientists , see what they’re doing. And if there’s anything that they’re doing that you think won’t scale, we’re going to tell them to stop.” And they came back and said, “there are a number things that they’re doing that won’t scale. They are using materials that are [inaudible] … or they’re so toxic, you can’t put more than a gallon of them in the building, or you can be shut down by the fire marshal, or downstage processing, and environmental and safety and health issues that no large company will let you go into their building, from a manufacturing perspective. So very early on the tactics were, “okay, we’re only going to make things in the lab that we have a 75% chance that we believe can be scaled, and not violate those issues of safety and scalability that are required to be in fortune 500 supply chains .” So I think that was the key first step around manufacturing, tactically. And then it was okay, how do we build a new manufacturing line that has never existed before that makes these nanoparticles at scale? At that point, we’ve made them like a beaker [ inaudible] , right? How do you start to put these in large, 30, 50, 100, 200-gallon reactors that are making tons of material and still keep the same quality — which is really what set us apart from everyone else in the world, with the quality of the particle? And so we spent a lot of time and cracked that code, and a lot of money to crack that code, both from that program we got from the government, and then more equity that we raised around it. And so, tactically, it was just really spending time stage-by-stage. And from the scale-up perspective, there are steps you have to take so that you don’t just start with a coffee cup and go to a 200-gallon reactor. You start with a coffee cup, you go to a Crock-Pot , you go to a pressure cooker, all along the way to make sure that as you scale, you are able to control what’s happening. And we did that very methodically. So from that perspective, I think tactically is what we did there. Then the other side of it was to get out there into the market, and really just explain that what our technology can do, because we didn’t really know yet which customers in which markets were going to care most. But we started going out to conferences very early on; in generally the area of advanced materials and electronics, and slowly started to figure out after many, many of these trade shares and conferences, which areas that we were seeing the most pull from, and then we would focus our energy and capital around those. And we’ve kind of followed that same methodology throughout. And then we started seeing pull from Asia and, “okay, let’s go over there and start meeting with central customers and partners.” And then from there, “okay, we need a distributor because we need someone that can import this for us.” And , and then if you start with one and then you’ve got two, and then you get five , right? And so you start with what is the big problem that we need to solve, or prove that we can solve, to get the credibility? And then what’s the next one? And then what’s the next one, and what’s the next one? And then, tactically, bring in the right people to execute out all those plans.

James Di Virgilio: 33:03

Really well said. That’s a nice curve of progression through strategy, down to tactics being flexible and nimble, but then really making sure that you solve, solve the code-breaking problem that either breaks you or breaks for you. And scalability is certainly one of those things that affects a lot of companies and it’s often too late by the time they realize it. So lastly, now we’re standing today where you are, you’ve built Pixelligent to where it is, of course you and your team and everyone working there, you’ve utilized all of the strategies and tactics. You’ve mentioned you have this wealth of experience in front of you and behind you. What are you looking at for Pixelligent into the future?

Craig Bandes: 33:36

I think we have a really unique opportunity over the next three to five years to become one of those first companies to really break out in a market that has been waiting for somebody for 20 years. We have the right combination of the right technology at the right time. When I say “at the right time,” you know, the materials that we make, to get geeky for a second, they’re referred to as “high index materials.” It’s a way for us to get more light into or out of the system or bend light in a way that makes something work better. And that was a(n) interesting concept. And that’s kind of cool when we first started doing it in 2013, and now we have to have that in these next generation displays, augmented and mixed reality devices that we’re all going to be wearing in the sensors that are moving into really becoming part of everything from self-driving cars and drones, and everywhere you touch there’s a sensor… That all of these products now require the materials, the types of materials that we make, in a proprietary way. And so we’re having some of the best companies in the world approach us about integrating that into their technology. Our challenge now is that we’re supporting some of the biggest technology companies in the world with a very small, relatively small team, less than 50 people. And we have to scale that quickly now to not lose these opportunities, because they’re now expecting us to look like the companies we compete against, which are massive companies: Dow, DuPont, Merck, and others at that scale in electronic material space. And so we now have to prove to them that we can deliver at that same level. Now they’re saying they’re bought in on the technology. Now they have to buy in on our capability to really deliver, to give them the customer support that they need, the quality metrics that they demand, and then the ability to supply them wherever they are around the world. So now it’s a matter of, back to your question about strategy and tactics, and we have the strategy of where we want to go. We have the customers, and now tactically, how do we start to go do this? So, I was in Korea. I first shipped out of the country in a long time, three weeks ago, and was able to get an expedited quarantine time. And we closed a partnership with a large Korean partner who is going to be a manufacturing partner for us in Asia. Critical staff . We started that 18 months ago and worked through a number of them before we found the right one and had to go there to meet the CEO. And he had to meet me, and make sure that it was the right thing — thank goodness it was. And so we’re putting in place the infrastructure also on a global basis to be able to go do that and not entirely on our own, even if you have all the resources, all the cash you need, it still makes sense to partner , especially if you’re going into new markets and new regions that you’ve never built anything in before. And so it’s continuing to execute on what I think I have a pretty good handle on, of expanding the types of partners and stakeholders that can really help us execute a pretty big strategy on a global basis and realizing that you can’t, and you shouldn’t, do it alone. And just making sure you’re picking the right partners and the right people to help you get there along the way.

James Di Virgilio: 36:26

And perfect. That’s a wrap. Great job, Craig, great answers, really insightful stuff, really logical linear thinking, which makes sense from a finance guy. That’s , that’s how we tend to do things. And from Radio Cade, I’m James Di Virgilio.

Outro: 36:39

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episode’s host was James Di Virgilio, and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeek. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

Gaines has served as the CEO of Evren Technologies, OBMedical Company and Ixion Biotechnology. Additionally he has been the chairman of several companies and non-profits, and is a member of the Keck Graduate Institute’s Corporate Relations Board.

In this episode, Weaver shares with host Richard Miles the importance of a CEO’s role to encourage teamwork, foster trust in a company, and grow — in a way that’s not just about the money. 

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. Starting in running your own company — It’s not for everyone. For those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. We decided to go out and talk to some of those people and find out what they’ve learned, what they’d repeat, what they’ll never do again, or hear stories from their first year, then from the period when they realized they’re going to survive and how they intend to position their companies for the future. We’ll find out what a CEO’s normal day is like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is it time to move on? Join us for CEO 101, a limited series of deep looks at people who are their own boss — for better or for worse. Welcome to another episode of CEO 101, a series of special episodes in which we talk to and about CEOs of startup companies. I’m your host, Richard Miles. Today my guest is Weaver Gaines , the CEO of several companies, including Evren Technologies, OBMedical, both of those are medical device companies, as well as Ixion Biotechnology. He’s also served as a chairman of numerous companies and non-profits, among other things. Welcome to the show, Weaver.

Weaver Gaines: 1:18

“Well, thank you for having me here,” I think is the formulaic response to–

Richard Miles: 1:22

That’s right, there’s only one right answer. You’re not going to be here. Weaver, you’ve done a lot of stuff in your life and your career. So why don’t we just start with a short overview of your career?

Weaver Gaines: 1:31

Okay. Well, one way of thinking about my career is, “here’s a guy who obviously can’t keep a job.” I went to law school primarily because even though I was an ROTC commissioned officer, everybody else was trying to avoid being drafted into the war in Vietnam. And they were all going to law school and they were on the debate team at Dartmouth, so I went to law school too , with about that much forethought about it. And when I graduated from law school, I went on active duty and I spent two years in the army — one year in Europe, in Heidelberg and Berlin. And one year in long been Vietnam — an experience for which I will be always grateful. The whole experience was extraordinary. I’m glad I did it. I can’t talk anybody into doing it now, but I think it’s really one of the formative experiences of my life. And I’m glad I got involved in it.

Richard Miles: 2:17

This is being in the military or being in Vietnam, or both?

Weaver Gaines: 2:19

Both. Well, the military itself is an extraordinary experience, and being in a world at war where there are people who are actually trying to kill you every day, although you could argue that that was like being in New York, and , um , it was a different circumstance and I’m glad I did it.

Richard Miles: 2:35

And you were in an infantry unit in Vietnam, correct?

Weaver Gaines: 2:37

No, I was not in an infantry unit in Vietnam. I was a company commander in Berlin, but when I got to Vietnam, the army had just invoked the update to the military justice system, in which for the first time, if the defendant asked for a lawyer, he got a lawyer. Before then, he only got a lawyer if the trial counsel , the army’s prosecutor was a lawyer. Otherwise officers served in that role and the army and its usual degree of incredible forward thinking came up on the day where they had to supply a lawyer to everybody without any lawyers . So a lot of non-JAG lawyers got JAG positions — Judge Advocate General positions.

Richard Miles: 3:14

You had a law degree.

Weaver Gaines: 3:15

I had a law degree, and by the way, it made the judge advocate guys really mad because they had signed on for four years in order to avoid combat. And here were all these combat arms like me. I only had two years and also avoided combat, but we didn’t avoid people shooting at us or setting–

Richard Miles: 3:34

You were in a combat zone.

Weaver Gaines: 3:35

We were in a combat zone. And then I went to work for the law firm that I had intended to go to work for. And I worked for them for a bunch of years and decided that being in a law firm wasn’t that interesting. So I went to a corporation and in the middle of that gig, I realized that, really, I wanted to do it more than I wanted to give people advice about how to do it. So I now call myself a recovering lawyer. And while I provided legal services to the companies that I’ve founded, mostly I’m being an executive and mostly in financial or life science businesses. So to get to the crux of CEO 101, I came to Gainesville after I had spent a year on the national reelection campaign for Bush-Quayle in 1992 . And since Bush didn’t get reelected, clearly doing something in Washington, D.C. was not in the cards. I came down to Gainesville where I had a weekend place and a friend said, “Let’s start a biotech company.” And so that’s how I started my first entrepreneurial biotech company.

Richard Miles: 4:34

So, Weaver, I’ve got to say that the first parts of our lives eerily track one another. Of course I was in the army as well, got out of the army. And if things had gone right, I’d be in the Jeb Bush administration right now. But things apparently didn’t go that way. So I moved to Gainesville too , but I didn’t start any successful biotech company. So apart from that small asterisk, essentially we’ve lived the same life.

Weaver Gaines: 4:55

Well, I can’t say the first one was a successful biotech company. It was named Ixion Biotechnology and I picked its name, a Greek name, very common in science to use Greek. Ixion sounded good. It said that Ixion had been condemned by Zeus to be bound to a burning wheel for eternity. And since the product we were thinking about was going to be used to treat recurrent kidney stones, I thought, well, that sounds like being bound to a burning wheel, that’s not bad. And after the company had been going for two or three years, I asked my very first associate, the first person who joined me, I said, you know, I don’t know anything about this guy, Ixion, whose name, by the way was pronounced ex-eye-on, but I gave up. Everybody called it Ixion. And he comes back to me and he says, “well, do you want to know why he was condemned by Zeus to be bound to a burning wheel for eternity ?” “No. Why?” “Because he attempted to rape Hera. That’s why.” So I named my first company after an attempted rapist.

Richard Miles: 5:50

So marketing was not really your strong suit–

Weaver Gaines: 5:51

Absolutely not . Nobody knew that except us. And so we never told anybody, and I think this is the first time I’ve ever broadcasted it, for that matter.

Richard Miles: 5:58

Anyone owning Ixion stock out there, maybe now’s the time to sell.

Weaver Gaines: 6:02

Now’s the time to sell or to put it on 4Chan or something like that, but that was an enlightening experience, Richard. I made, I literally made every mistake a startup entrepreneur could make, although there were some mistakes I couldn’t make because an earlier mistake had sorta foreclosed the possibility of–

Richard Miles: 6:19

So we’re going to get into that. But before that, I wanted to ask you. So you get out of the army. This must have been what? Early 70s-ish?

Weaver Gaines: 6:25

Yeah, 70s, basically.

Richard Miles: 6:26

And you’re an army brat. So what brought you to Gainesville? Did you have a family connection here?

Weaver Gaines: 6:32

Okay. So my dad was a graduate at the University of Florida, ROTC graduate — World War II, Korea, Vietnam vet himself, and my sister had gone to the University of Florida, one of my sisters had gone to the University of Florida and her best friend here was my current wife, Mary True. And my sister — I’d been married once before — and she said to me, “Look here, Weaver every time you pick out a girl for yourself, you do a poor job.” That’s not exactly what she said, but that’s what she meant, right ? Yes. “I’d like to pick out your next girl for you.” And I said, “well, I can’t do any worse than that.” So, she was from Gainesville. Mary was from Gainesville. So I got to know her and I got to date her, and then we got married and I told her if she would just keep her apartment in Gainesville and not bring her car to New York for less than the cost of parking the car in New York, we could keep the Gainesville apartment . So that’s how I ended up with a place in Gainesville.

Richard Miles: 7:27

This was planned from the very beginning,

Weaver Gaines: 7:28

Yes, everything thought out carefully in advance with the primary reason for changing directions, being that I had cracked my shins on something and it hurt. And so I would stop to see where I was going. That wasn’t it. So that’s how I got to Gainesville. And that was in late 1992 after the election with the Bush-Quayle campaign.

Richard Miles: 7:46

Okay. Prior to that, you were living in New York?

Weaver Gaines: 7:50

Prior to that, I was living in Manhattan, New York, except for one year in Philadelphia, where all I could think of was how to get back to Manhattan. Philadelphia is — sorry, Phillies . So I started the first company, as I said, being completely ignorant. And that’s probably the only reason why anybody would start his first company.

Richard Miles: 8:10

Take us back to the first few weeks, even of what that was like, first of all, start with what was the core idea or the core business model insight? And then what were your first steps? Did you just sort of file the papers and rent a space somewhere? Or what was–

Weaver Gaines: 8:23

Yeah, basically well, sort of that. I got the idea of starting it from a fellow I’d hired at one of my previous jobs who said, “look, let’s start this biotech company. I have a brother who’s a research scientist, the University of Florida, very smart guy.” And he was a very smart guy. And he’s got some technology, which is really exciting. And he had two completely distinct technologies. One was a stem cell treatment for type 1 diabetes. And the other was a probiotic treatment using a bug called Oxalobacter formigenes, you know how that rolls off the tongue. So the very first thing was to learn to pronounce Oxalobacter formigenes.

Richard Miles: 8:59

Now I see why Ixion was a more attractive alternative–

Weaver Gaines: 9:01

Yes, right, than “Oxalobacter Formigenes Company.” And so the first thing I told him was, “well, I can get the company started, but really, I don’t know anything about biotech.” And he said, “well, you don’t need to, my brother knows about biotech. You need to know about starting companies.” That turned out to be wrong, by the way. And so I said, “well, the very first thing to do is to kind of get our arms around the intellectual property.” Y ou got nothing if you don’t have that. And the intellectual property was resident at the University of Florida, and the University of Florida had an officer in charge of licensing technology. And on a good year, they would license two or three. They license 90 or 100 now. And on a bad year, they didn’t get much done at all. And so it took about a year to negotiate the license for the technology, but you really couldn’t do much else. I mean, I was running it out o f my house because you really couldn’t do much else, right? Because you didn’t have anything to do i t with.

Richard Miles: 9:54

Right.

Weaver Gaines: 9:55

And in those days you couldn’t be sure you would live long enough to license it from the university.

Richard Miles: 10:00

So there was no point in continuing research or things like that or making an investment because you don’t own anything.

Weaver Gaines: 10:05

You don’t own anything. And the research has continued and a guy who’s the research side and he’s going on, doing the research at the university. And there was a fellow named Shelley Schuster who, at that time, was the head of the biotech program here at the University of Florida. He’s now at the Keck Graduate Institute. He’s the president of the Keck Graduate Institute in Claremont, California. And he said, “I have some space in the Progress Center. Why don’t you come out there and have an office in my space while you’re trying to license the technology? And I won’t charge you anything for it.” So yes, I did arrange for an office, but I didn’t pay anything for it. And I went out there and got the office in Progress One, which was, at that time, owned by the university and set up my first computer to demonstrate, yes, we were a company because we had an office–

Richard Miles: 10:48

It was a physical, awaiting a computer?

Weaver Gaines: 10:50

No, no, it was an IBM. It was an IBM. It had like, I don’t know, 250 bytes of board memory, or so, it’d use the big four-and-a-half-inch floppy disks. But then we got the license. Now you’re going to actually start trying to do something.

Richard Miles: 11:06

So after you got done with your bottle of champagne, from getting the license–

Weaver Gaines: 11:09

We couldn’t afford champagne. It was a bottle of cold dock , but , um , yeah, we got the license and now we were actually in a position to try and do something. So there’s a whole bunch of things you try and do to get ready to do the thing that you most need to do. So what you most need to do is find money because you can’t do anything without it in the startup world, but you can’t just go say, “give me money; I have an appealing face,” — even worse if you have my face. And so you have to do things like come up with a business plan, think through how exactly you’re going to exploit this technology. What’s feasible? What isn’t? What kinds of research needs to be done? Where are you going to get money to do the research? How far do you have to go in the research before you can make a plausible claim for the money? One of the big mistakes I made was if it’s a really brilliant idea in a magnificent market, they’re going to give you money. No, they’re not. And in this case, it was two, basically, pharmaceutical preparations. And I took a long time to learn that those are decade-long projects — and that’s if they’re ready to be taken out of the university, if they’re developed enough to be taken out of the university, which they said not — another one of my mistakes. And I also didn’t know then, like I know now, that about 90%+ of them will fail. They will not, in fact, ever reach the market — and that’s assuming you can finance it. I’m just talking about the ones that go through the process of bringing a biotechnology, pharmaceutical entity to the point where somebody will buy it or at least be willing to support it to the point where it can be sold, mostly fails.

Richard Miles: 12:40

It’s one of those statistics you really don’t need to hear early on.

Weaver Gaines: 12:42

No no, well, actually I said, “if you knew, if you knew when you started what you will learn along the way you would go into another line of work,” like, I don’t know, bicycle repair.

Richard Miles: 12:50

Something more lucrative, right ?

Weaver Gaines: 12:52

Right, plumbing.

Richard Miles: 12:53

Plumbing. Yeah .

Weaver Gaines: 12:53

So you have to develop a business plan. A lot of people think that you can get somebody to develop a business plan for you, but you can’t. You really have to do it yourself because that’s going to be where you learn about the things you need, but don’t have, and think through how you’re going to get them and then make some guesses about what it’s going to cost you to get from here to there, and with your business plan, and your intellectual property, and some sense of people you might be able to get involved with you that you can talk into working for nothing or nearly nothing, because you’re likely to be working for, not very much money, particularly at the beginning. Quite common for you to go without pay for months at a time, which by the way, Richard, means that if you want to do this sort of game, you can’t be in it for the money because t hat’ll never be good enough. You have to be in it because you think you’re trying to do something that’s worth making some kind of sacrifice for. So when I left the campaign, when Bush lost in 1992, the first thing that happened was I got a job to go to work for a financial service company. And I thought to myself, “well, if we get to the end of the day and they say, ‘okay, Weaver, w hat did you do with your life?’ Say w hat — made a lot of money?” That just didn’t seem very satisfying to me because you can make a lot of money a nd people don’t do that, and there’s nothing wrong with making a lot of money. Good for the people who do. But for me, I thought, you know, my father was a s ervice m an. He spent his life in service and that’s w here I felt a little … smarmy. If that’s all I was going to be able to say, “he made a lot of money,” but if you could say, “well, I tried to cure type 1 diabetes.” Even if it didn’t work, I tried to deal with people who a re suffering from recurrent kidney stones. You ever had a kidney stone?

Richard Miles: 14:33

I have not. I’ve seen people who’ve had.

Weaver Gaines: 14:35

You don’t want them.

Richard Miles: 14:36

Not something I want to do.

Weaver Gaines: 14:37

And it turned out, by the way that, that, wasn’t what we ended up trying to get that probiotic to do, because that costs too much money, a long shot, too much money. It ended up being a treatment for a condition called primary hyperoxaluria, which is a genetic condition in which half of the people who have it will die before they’re one year old and the rest will die by the time they’re 12, and there’s no cure. There’s nothing you can do except a kidney-liver transplant.

Richard Miles: 15:01

Well, good point that you made there about doing something that you feel makes a difference, and David Brooks, the author, talks about the difference between resume virtues and eulogy virtues, which I think is a nice way of encapsulating ’cause a lot of what we do, certainly as early adults, what we focus on is resume virtues.

Weaver Gaines: 15:15

Sure!

Richard Miles: 15:16

What’s going to get me my next job? What’s going to get me promoted? What’s going to make me look really good? But if you think about it, when you’re dead and gone, and they’re saying, “Weaver Gaines…” And they just rattle off your qualifications and degrees…

Weaver Gaines: 15:29

It’s the same sort of dissatisfaction. And Richard, you and Phoebe have achieved this in your lives with the Cade Museum, and what it represents in terms of contribution to, not just our local community, but to the country and to the world.

Richard Miles: 15:42

Well, thank you.

Weaver Gaines: 15:44

So you know what I’m talking about. You can only put up with some of this stuff if you’re motivated by something besides the money.

Richard Miles: 15:50

But let’s talk about those first few days, because as you well know, from your first few days, it looks really daunting because you wake up and every day your to-do list has a hundred things on it. And all of them are objectively urgent. They all have to be done first, right? Because you get an office. Well, great. Well, your office needs a phone. Well, does it have a phone in it? Maybe it doesn’t. Well, you get a phone and you have to have someone to answer the phone and get the mail, and all of those things were sort of “must-do,” but yet you’ve also got to raise money. So one of the most crucial decisions early on is your first hire, your first couple of hires. Did you have any help in making that decision or was it the first person who walked through the door and needed a job? You said, “go get a phone, go get the mail.” ‘Cause that’s sometimes how it happens, right?

Weaver Gaines: 16:30

Well actually I would say what happened in this case was that, because Mary had lived here for a long time, she knew a whole bunch of people: college graduates. Master’s degree in history and he’s helping his wife run a deli, and he became a friend, and he came to me and he said, “either you have to give me a job or I’m going to kill my wife and go to jail. Those are my options. I can’t afford to pay a fine, just as long as I have a job.” And it turned out that one of the critical things, on those first few days, is that there be somebody else there. So while you may have to do everything yourself, sometimes you just can’t do it all today. And even if you could do it tomorrow, even if you could do it tomorrow better than the person that’s working with you, you just can’t bring yourself to do one more thing today after you’ve gotten the mail arranged for the phone, and arrange for the post office to deliver the mail to you the way they said they would, when you put the post office box down and all that sort of stuff … It helps to have somebody there. And somebody you can go in and say, “could you get the phone? Will you answer the phone?” And all that sort of stuff.

Richard Miles: 17:33

Right.

Weaver Gaines: 17:33

So the very first hire actually was critically important, but did not functionally supply one of the nominal things that we needed, a person who could oversee the science and a person who could handle the legal stuff and all the things that you think of go into a company. But if you’re the only guy on the ground, there’s one person you want to have there that you can turn to and say, “I just, I can’t face this today.” And they’ll do it for you. So that was the very first hire. He was terrific in that role. He later worked for me one other time. In between times, he worked for another one of our local companies that got acquired by SmithKline .

Richard Miles: 18:10

And what was his background?

Weaver Gaines: 18:11

History major — master’s degree in history. Bright guy, competent, and totally competent and enthusiastic and got caught up in what we were doing. And [he] later took over a lot of things just because he was there, and he was smart, and he could do stuff. And not because he had any background in science or engineering or anything else.

Richard Miles: 18:30

This is what we tell people from our limited experience with tech companies is that, people make this assumption, “well, a tech company is just full of engineers and people like that.” It’s like, well, no, every company needs a fairly broad array of talents to just make it to that first milestone.

Weaver Gaines: 18:44

Absolutely.

Richard Miles: 18:44

Because again, if you don’t have somebody who can help you do all the mundane things that need doing — a room full of 10 engineers that don’t answer the phone or answer the mail is not going to make it.

Weaver Gaines: 18:53

And also if you have a company of all engineers and you aren’t, you think you’re speaking their language — it sounds like English — but it’s not. It’s “engineer’s speak.” And it’s hard to communicate with 10 engineers without a translator.

Richard Miles: 19:06

So let’s fast forward a little bit, maybe if we’re talking about Ixion or it could be any of the, one of the companies that you started, and I don’t know what the timeline for these companies was, but let’s say you’ve hit your first, maybe, good milestone — whatever that is, and whenever that is. But inevitably, almost every company that succeeds has had at least one, maybe two or more big setbacks. What was, if you’d like to share the details without triggering any lawsuits, what was maybe one of your first big setbacks and how did you recover?

Weaver Gaines: 19:32

Okay. Well, I would say that the setbacks tend to come in categories. The one that you’re most conscious of most of the time. So if you’re the CEO of a startup company, you have several jobs and they’re all full-time jobs. And one of them is actually making sure the entity will function, and that it does have telephones and so forth. You don’t have to do it, but you have to make sure of it. And one of them is to make sure that the science is moving forward because it’s never fully developed when you get it. And one of them is raising money. And so basically you’re always raising money. The biggest science setback came when we could not replicate in the company’s labs, the results that were taking place in the scientists’ labs at the university. It was critical that we be able to do the cell culture that he was doing in order to have a product that we could show off to get some more money, right? We couldn’t get it to work. And this is going on for a long time. Now, competent scientists working hand in glove with the people at the university, we can’t get the cells to reproduce? Same refrigerators, same T75 flasks. They won’t grow. “Why not?” A scientist is rolling his eyes. You know, Jesus, he comes out, he can’t get them to grow out there , at the Progress Center either. So the answer to that one was that it turns out that there are two manufacturers of T75 cell culture flasks: Cornell Glass and Phillips . And he was using one and we were using the other — their nominal specifications were identical, but it grew in one, it didn’t grow in the other. And you tell this to people who are cell culture experts, and they say, “Well, yeah, everybody knew that.” I wish they would say, “That’s not possible.” What they say is, “Everybody knows that.” Yeah. Right. No, it made a difference, but that set us back by months. Well, when you’re burning cash every day, whether you’re being set back or not, any one of those kinds of scheduled delays will eventually turn into a financial problem. And the setback comes when you go to people and you say, “We’re not going to be able to make payroll next month. There’s not enough money. We got maybe some coming in, but we’re going to all be working with no money or very little money…” Because some people can’t work with no money. They can’t.

Richard Miles: 21:44

Yeah.

Weaver Gaines: 21:45

And so you say, “Well, okay,” and one of the ones, this guy I was telling you about, Teddy, said, “Well, I can defer income.” So that was one of them. One of them was, as sometimes happen, you’d get an agreement to make an investment from an angel group or a high-net-worth individual, for example. And you’re very close to closing the agreement, and it falls out of bed for some reason or another. And you’ve made the mistake — one of the many mistakes — you’ve made the mistake of thinking it’s going to close around this day. And then it doesn’t. And now you don’t even know if it’s going to, because the problem that came up is one that isn’t immediately obvious how you’re going to settle it, because it’s a fundamental issue in the deal itself. And those are grim.

Richard Miles: 22:25

It’s not in some little insignificant detail.

Weaver Gaines: 22:28

No, they’ve thought it over and they need 45% of the company instead of 20% — something major like that, and you can say no, and they say, “Fine, I’ll pack up my bags and wish you the best of luck.” Or you can see if rolling over on your back and exhibiting your unprotected belly will work, or if there’s some other option that might help out. And then there’s the one where you have the fight with the big investor. He’s already invested. He now basically could control the company. He hasn’t yet. You’ve had this conversation that goes, “Well, I invested in you because I believe in the management of this company and I’m going to sit on the board, but I’m going to be influencing as a board member and not as a big investor.” And then you come to a point where you don’t agree with the big investor. And he says, “Well, have you forgotten who owns this amount of money in your company?” And you say, “No, have you forgotten that you said, when you invested, that you were going to rely on the management?” And he says, “No, and I stopped relying on you because I have the money and you’ll either do what I say, or you’re going to quit or get fired.” And “get fired” appeared to be one of the alternatives that turned out was the one that happened. But , uh, all kinds of grace, of course.

Richard Miles: 23:35

Right.

Weaver Gaines: 23:35

He took over and put one of his young proteges, the Swede — he was a Swedish guy. In fact, he was the only Swedish multi- millionaire I know who was an actual member of the Communist Party. Really interesting, very interesting, cultured man. So that’s an example of an actual death experience. Yeah. Right.

Richard Miles: 23:52

Weaver, earlier , we were talking about institutional culture, and it kind of fascinates me and I think it does you as well. And one of the ways in which institutional culture changes is related to the size of the company. And so you’ve been in companies literally where there are a couple of people — that’s the way it starts, two or three people — and you hesitate to even call it a company, right? It seems more like a family or a frat party or something, right? Not an actual company, but then there’s a certain point at which you do have to start resembling an actual company with titles and sort of clear responsibilities and divisions. What does it do from a managerial standpoint? If you’re the leader, what things do you have to consciously do differently? Because you now, instead of two employees, you’ve got 20 or 200 employees.

Weaver Gaines: 24:33

Yeah, well first I think, organically, there’s a theory of “span of control.” I’m sure you’ve heard of “span of control.” And some people say, “The most people you can really have usefully reporting to you is somewhere between five and seven, maybe 10.” So early on in a company — when there’s five or seven or eight or nine people in the company — one of the things that’s true is you pretty much all know what the other person’s strengths and weaknesses are. You don’t give a person with a weakness a task that you know plays to the weakness, and you don’t keep a person whose strength from doing that. But you all know what it is. And you, the CEO, can really have a material, substantive effect on all of the major decisions made by your company. And then it goes over that number. And two things happen when it goes over that number — up to about 25 in my experience — one of them is: it’s no longer the case that you really can do everything. And you mustn’t, you have to start relying on people. And sometimes that’s a different person. So the person who could handle lab operations, when there was one person in the lab, can’t handle lab operations when there are 10. It went outside their “Peter principle.” They’re not competent at lab management, as opposed to–

Richard Miles: 25:40

Working in the lab.

Weaver Gaines: 25:40

Working well in a lab with some scientists. The second thing is: you no longer know all of the strengths and weaknesses of all of the people in your company, although you should still know who’s good and who’s not, and the people who are reporting to you. And as a CEO, you must resist the temptation to meddle in the operations of the people who are now responsible for operations of their own. This is one thing that’s really disabling to people. It’s the sense that two things happen — they’re both bad. One is: you tend to make decisions where you don’t know what’s happening on the ground, like they do. And perhaps the worst aspect is: they start thinking, “Well, he’s going to be the one staying up at night, not me, because he’ll double-check my decisions. And if he doesn’t agree, he’ll tell me to change it.” And if you want a comfortable-running company, you can’t let people think they can move hard decisions to you that is within their area. So I tell people, “Look, there’s three kinds of decisions that affect you,” — and this starts at around 20 people — “One is the kind of decision I expect you to make. And I don’t expect you to tell me, because it’s the kind of decision you should make. And I don’t want to be bothered by being told you did it because it’s your decision. And the second is the kind of decision that I expect you to make, but I do expect you to tell me. It’s something I need to know, but I don’t need to prove it. And I’m not going to disapprove it. And the third: this is the one where you’re about to make a decision that could result in a hole below the water line,” — for all you Navy guys out there — “that one you have to consult with me in advance.” And inevitably, these people say, “Well, how will I know which one’s which?” And I say, “Well, you have to use your judgment.” And by the way, if you get it consistently wrong, you’re in the wrong job. So you have to get this sort of thing right. But I don’t want you to bring Category Two decisions, the kind you need to be making, to me for prior approval. I’ve got all the hard decisions already. You have those. Then, when a company gets to be about 100 or so, you need a lot more bureaucratic structure than you had before. You can get along with a lot of informal arrangements — doesn’t have to all be written down. Yeah, it’s useful to have an organization chart and so forth, but you don’t need it. It’s a bleak day in a company’s existence when it needs a Human Resources department, because that means there will be human resources — people there who are basically spiders or vampires, you pick the name, and that company is a completely different company. And the way you nurture some kind of camaraderie and corporate culture has to come from the top-down and it has to filter through the CEO — so there is no escape from this — to see if you can inculcate that with the janitor in the lab, who’s working for you and whose job is important too , but not at the level that you’re going to go in and pat him on the back and say, “Nice job, Junior, you know, I really appreciate your mopping.” ‘Cause, you know, it’s not gonna work.

Richard Miles: 28:26

Right.

Weaver Gaines: 28:26

And the other thing you have to do, in my opinion as a CEO, is you cannot rely for your information entirely on the people who are reporting to you. So you actually have to get up and walk down into the lab and say, “So how are things going here?” “We’re completely out of beakers.” “You’re out of beakers! Is that right? Well, does Joe know that?” “I’ve told him several times and we’re still out of beakers.” “Well that’s interesting. Okay. Thank you.” I mean, people will talk to you. Ross Perot, you’ve heard of Ross Perot–

Richard Miles: 28:52

Yes, yes.

Weaver Gaines: 28:52

Ross Perot ran a company and his cafeteria, you sat at the next seat at whatever table was open — they’re trestle tables — and he would sit down with whoever was at the table and say, “Talk to me.” This did two things. One: he learned what was going on. And the second thing is: the people who reported to him knew he would learn what was going on, which is also useful. So I think you can inculcate a culture from the top, from the beginning, that says, “We don’t lie. We don’t cheat. We don’t steal. And we’re not going to tolerate people who do those things.” You can make that happen throughout your company, regardless of its size. But the other stuff, the commitment to the task, the belief in what you’re doing, all of that stuff, has to be established when the company is small and then you hope it will permeate the company as it grows.

Richard Miles: 29:37

Weaver, we were talking about this earlier in a different context: Contrary to popular belief, CEOs are not superhuman.

Weaver Gaines: 29:43

Really? That explains a lot.

Richard Miles: 29:46

I know, I’m bursting your bubble.

Weaver Gaines: 29:47

That explains a great deal.

Richard Miles: 29:49

And certainly when you start out and you founded your own company, as we’ve already talked about, there’s no shortage of things and worries to occupy your day. From the minute you get up to the minute you go to bed, you can be working in the company and often you do. At a certain point, that’s not a great personal-life-work-life-balance strategy — particularly if you’re married or you have children and so on. What are some of the things that you have seen, both good and bad? How should CEOs think about their commitments to their company, but then the commitments to the rest of their life? Because they’re just not probably gonna make it very far or, we’ll put it this way, they may have a successful company and ruin the rest of their life. What have you seen, in terms of successful strategies, to avoid that? And then, are there any horror stories you can relate in which people did the exactly wrong thing? Let’s leave out, say, the first 30 days in which, okay, you’re just going to be working 24/7. Everyone gets that. But let’s say you’re a little bit further along. You’ve got some employees, maybe even some revenue, but yet that feeling hasn’t gone away, that you gotta be Johnny-on-the-spot all the time.

Weaver Gaines: 30:49

Let me start by saying when I started my career, it was as an associate lawyer at a big law firm on Wall Street. And there was no work-life balance. It was just work. And I think maybe half of the people who started in that law firm with me, including myself, were divorced in the course of six or seven or eight years. You basically communicated through notes on the refrigerator ’cause you were working till 10:00 many nights and almost every weekend. When you’re in a startup company, it’s more than 30 days that it’s like that. And you’re really asking the people who are around you — I don’t have children, so I didn’t have that particular problem, but I do have a wife that I cherish — and you’re basically saying, “Look, you’re signing onto this with me. Are you okay with that? You know what you’re signing on for? Because I can get a job that’s 9:00-5:00 or 9:00-7:30, if it’s a bigger job than that.” But it reminds me of when I was growing up, army wives — they knew what they had signed up for. Foreign service wives knew what they’d signed up for. They’re going to make a sacrifice too, and, in some cases it’ll be a big one, and you can’t do it alone, I don’t think. I mean, maybe for a bachelor, you can, but if you’re married, you have an intimate relationship with somebody or you have a close, personal relationship with somebody. They have to be on board with you too . Or you won’t be able to do what I think needs to be done to be a success in the first couple or three years of a startup company, because it’s going to be that long before you get to the place where you can take a breath and, “Where’s the dog?” “The dog died last month.” You know, I mean it didn’t, you know, we never had a dog.

Richard Miles: 32:18

Right.

Weaver Gaines: 32:20

I think that the thing that probably engenders more work-life balance is increasing exhaustion in age than it is any kind of conscious stratagem that I know of. And when I look around at the people who are successful CEOs, they may not have dark shadows under their eyes now, but they all went through it. And as I said, you need that team at home who’s willing to back your play and understands what’s involved. I don’t know any other answer to give you, Richard. I mean–

Richard Miles: 32:48

No, it’s a good one. I found, just in my very limited experiences, there’s a step of humility and trust, once you start seriously delegating your responsibilities, right? Where when you first start out, you just think, “I’m the only one that really understands this company, this technology. And it’s so important — my understanding of it — that I really can’t ask somebody else to do it.” But at a certain point, you realize you’ve got to make that step. You’ve got to hire that person, mentor them, teach them, because otherwise you are a prisoner of your own creation, right? You will never break free–

Weaver Gaines: 33:19

Never.

Richard Miles: 33:19

… Until you are able to find and train–

Weaver Gaines: 33:23

Community service.

Richard Miles: 33:23

… Those people. What I find in many instances, and this is what’s really gratifying, is you find people who can not only do it, they can do it better. And that’s when you realize like, wow, if I really want to build something, first it’s a trust issue because you don’t think they can do it better. And then it turns out they’re really good at it — not always, obviously, there , there are some misfires. And I think that, to me, from what I’ve seen is the secret to building — as we said earlier today — something built to last is a recognition there are talented people out there that can do this job. I’ve got to find them, I’ve got to train them, and so on. And then you’re off to the races.

Weaver Gaines: 33:55

All true with this corollary. It took me a while to realize that just because it was different, didn’t mean it was worse. So somebody who did something different from the way I would’ve done it, didn’t mean they were doing it worse. And in fact, my goal in hiring people was to hire people I thought could do it better. But the very first thing I had to get used to doing was the judgment that that was good enough. And then after a while , I got to thinking, “Well, maybe it’s not only good enough. Maybe it’s actually better than the way I would have done it.” But that first step, in which it gets done differently and you think, “Oh my God, you know, we’re doomed! This is not going to — I got to step back in here.” So good enough was the first thing to do.

Richard Miles: 34:34

Yeah.

Weaver Gaines: 34:35

But sometimes you can’t find somebody that you think is going to be better. You’re happy with somebody fogging a mirror because you have to fill this position. You need a quality person because otherwise you can’t pass the FDA audit. And this is the quality person you could get in Gainesville. This one. And the one thing you know for sure is he knows more about quality than you do, but that’s all you know, and not looking good, right? And recalls are going to be bad — that sort of thing. But even as people take up a bigger share of the burden, the burden itself is growing. So the company is getting bigger. And if you’re lucky enough to actually have a product, which has now been approved by the FDA, well, somebody has to be the manufacturing manager because you got to make sure it’s made. And then somebody else has to be the quality manager to make sure it’s made right. And if you’re dealing with a distributor , somebody has to be in charge of the distribution program in the marketing and sales operation. And you, the CEO, are responsible for all of those things, whereas before you had only the scientists and you and there’s still — notwithstanding Einstein and quantum mechanics — there’s still only 24 hours in the calendar day and you have to spend some of them sleeping, and you really do need to spend some time with the other person or persons in your life, even if they’re taking the short end of the stick for a while. And so sometimes it’s not possible to assemble the dream team right away, as you have to do with what you got.

Richard Miles: 36:06

Weaver, one final question and that is: In any of your CEO experiences or leadership positions, have you ever gone in with sort of a personal exit plan? Do you say, “Okay, I’m going to do this, but I’m leaving after 10 years,” or “I’m leaving after we hit this certain milestone,” or is it more, “I’ll play it by ear. I’ll see how it goes. And if it turns out well, I stay.” How has that sorted itself out for you?

Weaver Gaines: 36:26

I have never gone in with a personal exit plan, but you remember my planning skills are … defective. Um , more often than not, the exit has been attributed to an exogenous circumstance. Something happens, and it’s appropriate now for you to leave. So, in the first company, Ixion Biotechnology, when the Swedish investor took one of the two technologies and left the other one behind, left the stem cell one behind, and getting together with all of the scientists and everybody, we determined that it was going to take five more years and maybe $20 million to see if it would work. We decided that was not a good play, that we couldn’t justify taking $20 million of somebody’s money, knowing what we now knew. And by the way, that technology has never worked, although, other people have tried it. We could do the stem cell magic — we just couldn’t do it in commercial quantities, couldn’t make enough to sell. So that resulted in leaving. I mean, that’s what we did. In OBMedical Company, the failure of an investment involving one of our local Florida investment groups, — whose name I won’t mention over the air because I can’t mention it without running the risk of a lawsuit…

Richard Miles: 37:33

We’re a lawsuit-free podcast here.

Weaver Gaines: 37:35

Right . When that was over and it was necessary to go out and now solicit people who had already contributed when you told them, “Okay, we have a term sheet and we’re ready to move forward.” And now you’re going to have to go back and say, “We had a term sheet and we’re not ready to move forward because the other guy’s a jerk.” And everybody’s going to think, “Yeah, well, was he the only jerk in the room?” And my sister was dying of a glioblastoma. I said, “It’s time for a new person to come in — a fresh voice. You’ll put up with what CEOs put up with, which is the new CEO, can blame everything on you for a while ” . And in fact, that’s what happened: A really good guy came in that I recruited, and who pushed the company over the finish line till it was sold. I stayed on as an advisor, so that wasn’t planned. And this current company that we’re doing, I did deliberately promise Blythe Karow, who’s the CEO right now, who’s taken over — I’m the executive chairman, because she’s not quite the complete CEO, and I’m not quite the board chairman, but it’s gradually getting to the point where she’s going to be the standalone CEO. When that happens, when the board says, “Okay, she’s ready. Are you ready?” I’ll be ready. But that will be more planning than I’ve ever done before. And I think she’s probably ready now, but we need to get through this next round of financing and then we’ll see what happens. So, I don’t know, ambiguous answer to that question.

Richard Miles: 38:52

Good answer, and well thought out. It’s been a great conversation, Weaver, and I feel charged up and ready to go. I’m going to go out and acquire a company.

Weaver Gaines: 38:59

There you go.

Richard Miles: 38:59

Now I’m sure that the job offers will flood in, I said —

Weaver Gaines: 39:02

Any moment.

Richard Miles: 39:03

And that ends our conversation, Weaver Gaines, so you’re ready to go, but I appreciate you coming on the show and look forward to seeing what’s next for you.

Weaver Gaines: 39:09

Thank you, Richard. I appreciated being here. It was a lot of fun.

Richard Miles: 39:12

Great. Thank you.

Outro: 39:14

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak . The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

Olmstead is the Co-Founder, Managing Director, and Partner at Vocap Investment Partners based in Vero Beach, Florida. Prior to Vocap, Olmstead was CEO of Bridgevine, an advertising technology company focused on customer acquisition.

In this episode, Olmstead talks with host James Di Virgilio about his experience as a CEO and investor, and to share his advice for entrepreneurs that are trying to rise above the crowd to get funding. 

TRANSCRIPT:

Intro : 0:01

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. Starting and running your own company. It’s not for everyone for those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. We decided to go out and talk to some of those people and find out what they’ve learned, what they’d repeat, what they’ll never do again. We’ll hear stories from their first year, then from the period, when they realize they’re going to survive and how they intend to position their companies for the future, we’ll find out what a CEO’s normal day days like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is the time to move on, join us for CEO 101, a limited series of deep looks at people who are their own boss for better or for worse. This episode of Radio Cade, CEO101 features and interview Vinny Olmstead, Managing Director of the Florida based venture capital firm, Vocap Partners.

James Di Virgilio: 0:59

Vinny, take me back to a time that was a first time for you, either as a company, founder, CEO, whatever you feel like was kind of that first experience. And describe for me what it was like to start something.

Vinny Olmstead: 1:13

The one word I would use is just excitement. If you were taking a picture, I think you would see wide eyes and a smile on my face. And if you peel back the onion on that a little bit, in my early days, as I was looking at opportunities, I was hyper focused on solving some type of problem and spending a good amount of time trying to figure out what the solution would be for that type of problem. And I’m sure at one point it will get into learnings and how that evolves. But early on it’s a lot of them spend time doing some research. I came up through the finance rings . So a lot of times finance people think about businesses through the lens of Excel and spreadsheets, a little different than engineers do sometimes a little different than sales folks do at times, but me personally, came up through the finance route. So a lot of what I did was think through business model think through pricing, think through the market and those types of things, and try to think about how that solution could grow into something very large. And without knowing it , trying to take a look at competition and find to look at where the needs here . So I answered the question in a couple of ways, which is facial expression. And then a little bit of experience probably on and through the prism of CEO, that has a finance background, which is sometimes good. And sometimes it needs to be complimented.

James Di Virgilio: 2:31

So you had mentioned very early on, I know you started some companies in your teens, let’s go back and visit that. Why start something then like what attracted you to a certain project at that stage of your life?

Vinny Olmstead: 2:42

One of the businesses I’ve started in my teams was an events business. So I grew up in a small town in upstate New York called Binghamton, and I chartered buses and charged people. And we’d go to sporting events in New York or Buffalo or Pennsylvania or whatever. And it was pretty lucrative. So comically enough, simultaneously I had typical hourly jobs at McDonald’s and things like that. And all of a sudden I realized, wait, I can, A) have fun and B) charged people some okay money and C) make a lot more than minimum wage, which I think was $3.25 and so that blended a little bit of fun passion in a way to make money.

James Di Virgilio: 3:19

Did that strike you at that age is something that was, I don’t want to say abnormal, but like how many of your friends were thinking the same way you were at that time?

Vinny Olmstead: 3:27

I don’t think a ton. And I did a lot of the typical stuff, pre college of different types of whether it be mowing lawn business and hiring three other people through business and hiring five other people somewhere along the way. I got the leverage thing early on, which is good. Right? You can work hard at yourself and make an hourly wage early on. I realized either charging, not based on hour or leveraging other resources in order to make money made a bunch of sense. And that was sort of one thing that I saw early on you’re right. You don’t see it a bunch, but I also have a 18 year old son who’s about to graduate college and he’s got sort of the entrepreneurial bug also. And as I look at his peer group, a majority of them are willing to take that hourly rate and he’s taking a lot more risks and he’s sort of following that path a little bit, but back then, and now people like the idea of entrepreneurial-ism, but sometimes they don’t get the scale. And some of those important things that may make you at least outsize your profits and or outsize your business, those types of things.

James Di Virgilio: 4:26

That’s really interesting. If you look at entrepreneurship through that lens is a way to view the world. And at the Cade Museum, we spend a decent amount of time creating a culture of innovation, which is to flip some of those hourly mindsets. If you will, into a, Hey, you also can create these things . And some people are born with it. I think a curiosity about how to improve things, but it also can be cultured. And so failure, something you mentioned is obviously a direct thing that many people, especially people that don’t want to dive into creating something, feel a question I get a lot also as an entrepreneur is , well , aren’t you afraid that the things you’ll do will fail. So for you, did you feel that, I mean, you started early, you started earlier than most people was failure ever, something that entered into your mind, or you just saw an opportunity to improve something.

Vinny Olmstead: 5:10

Its funny. I don’t think I ever thought of it as failure per se, right. Things didn’t work. And I just went to the next thing and didn’t really worry about it early on. That didn’t matter. I wasn’t taking other people’s money. When you take other people’s money. It’s a little different, a little different situation. I didn’t really think about it as failure. I thought about it as an experiment and then I’m moving on. And again, early on it wasn’t about building the unicorn. It’s about building a cool business that made some money. Also early on it was a lot about where I was passionate or where the ecosystem is. I failed a bunch. Don’t get me wrong in a bunch of businesses that fail, but I never thought about it as failure. I thought about it as a stage. And then just move on and don’t worry about it.

James Di Virgilio: 5:45

You had mentioned hiring some people in these early ventures. How did you go about hiring people back then? Was there a rubric? Was it a feeling what led you to make a decision on who to hire?

Vinny Olmstead: 5:55

I don’t know if this happenstance or not happenstance. I’ll give you my early, I was 12 years old and I had a paper route. And so delivering newspapers as second route became open. And I said, Hey, I’m going to take that route and hire a couple of folks who filled in when I was on vacation, I can do the whole thing if I need to. And if not, I will have some folks help. And then I got another one after that. And so I think that was where I started learning. Holy cow , I can make a bunch more money. These folks think we’re making pretty good money, but I make more than I’m making some off of them. And then coupled with that, it’s not avant garde now, and I’m dating myself, but you used, it deliver newspapers every Monday night and you have to go collect for a week’s worth of newspapers. And back in those days, I pioneered the, I would just have people put the money in the envelope underneath their front doormat and I’d pick it up every Saturday morning and not have to talk with them. But as I delivered the papers, I would pick them up or I would have the employees pick them up. So two things you learn there is leverage people and then improve process wise. And a lot of people liked it because coming to their door at six o’clock at night, and then Monday when their little dinner wasn’t the most perfect time. And it just seemed to be easier for them process side, serendipitously hiring a few people. And I did that for, I think, four or five years subsequent to that also . So it wasn’t like one week it kept me going until I sorta hit my 16 or 17 year old age, newspapers were done for me at that point.

James Di Virgilio: 7:12

Now, were your parents entrepreneurs, or did they view you as like a total anomaly?

Vinny Olmstead: 7:16

A completed anomaly. My father was an elevator mechanic and my mother worked in the home health field in the payments area, but they weren’t entrepreneurial and they weren’t risk takers . And maybe that’s why I ended up as a little bit more of a risk-taker , but they were not at all.

James Di Virgilio: 7:31

Did they have conversations with you? Vinny, what are you doing all this stuff for? You should be getting educated this way or focusing on these things or were they supportive?

Vinny Olmstead: 7:39

They were actually pretty supportive like back into the newspaper days when I lived in New York and it was degrees below zero, and my father would take the minivan . And as opposed to me trying to bike or push a shopping cart around newspapers , and then he would drive me around. They were , they were very supportive in anything that I did. They sometimes wonder whose kid I was, because it wasn’t what their typical path was, but they were supportive the entire time.

James Di Virgilio: 8:00

That’s great. It’s always great to hear that. Especially like you mentioned, you just sort of come out totally different and I can imagine as parents, they’re truly wondering where did Vinny come from? So, so you then obviously go on to a higher level of CEO ship. We’ll call it. Now, we’re calling a CEO in this case, really anything where you’re going to be running something, as you mentioned, either for other people there’s other investment or it’s yourself, and now it’s a much larger and full scale operations . So we’re still gonna focus on the early stages and what you would consider to be your first CEO role with that definition. So with that, how different was your first year as a CEO from those early years of startups?

Vinny Olmstead: 8:36

It’s a good question. And it’s sort of the step two and sort of the path. So in the earlier days, it was sort of from the hip, solutions that revolved around things that I had worked passionate about in the early ages, in your teens and in your early twenties, it’s more about things that are going to the sporting events and chartering buses and all that of stuff. It was sort of a pastime and a passion, and it was more viewed as a opportunity for a period of time, but not for a long period of time. Whereas when you get into your twenties and your thirties, you’re more thinking about it from a career perspective and the mentality then was grow it and own it forever or own it for a long time. The mentality is changing a lot in the last 20 years in regards to wanting to grow it and sell it after seven years and becoming a unicorn and all that fun stuff. But at that point in my life, it was more about grow something sustainable. So that’s one, is your looking to grow something in perpetuity. And then there was just, I guess, that next iteration of polish around the PowerPoint presentations and the Excel spreadsheets and putting something down on paper versus just doing it, right. Which by the way, now that I’m in the VC world is very interesting. And seeing in that stage is that you often see doers and then you see folks who like to put things in Excel and PowerPoint, and they’re not as much doers. And so I would say my second phase was adopting not only the Excel and some of the skillset that I got through college and my early days as a CPA and accountant, it was the actual combining that with the doing mentality. And so again, so I think the themes there are, you look for something that’s sustainable in perpetuity. You look a little more institutional per se, and combining the doing with a little bit of the planning, I would characterize it that way.

James Di Virgilio: 10:17

And if you’re looking at your time in this early CEO stage, this early venture stage, and obviously now you have a whole different set of experiences, which we will get to later as a VC now, but at that time, the biggest question on most people’s minds is how do you get funding? How does anyone get funding nowadays? How do people get funded? How did you get funded for the projects you were working on?

Vinny Olmstead: 10:39

The way you get funded is evolved. And there’s a much more of an ecosystem, but I don’t think that the actual channels of getting funded have changed. Although funding has become much more ubiquitous. I would say, you’d go to the friends and family. And I put as much as my own money and my own salary as possible, which became easier later in life was much harder earlier in life. So you go out to those friends and family and at first, you’re a little bit nervous about asking and you should be, if you take it serious, but even then it was go to the friends and family and then ultimately go to that next institutional role. And then you start working up toward your C) and or your A) or your B) the most important thing to all of that is you gotta be networking every single minute. You have to be fundraising and networking every single second. Even if you’re talking about a solution, you have to excite people. And that took me a little while. It’s not that I mind asking for money, but it was a little bit uncomfortable and there’s nothing wrong with asking for funding for something that you really believe in. And you’re really passionate about. So it was the same sort of ecosystem back then, the friends and family seed and starting into A) and B). The problem then there was just wasn’t as much money the world didn’t watch shark tank and understand all this entrepreneurial-ism and stuff. So it was harder to find outlets. There wasn’t really much online, back then and all that. So it was there and it was sort of similar. It just wasn’t as easy to get to nor was there as plentiful amount of money out there as there is today.

James Di Virgilio: 12:02

Yeah, the brand awareness of entrepreneurship was obviously much lower. And as you mentioned, the tools to access, it was much smaller. If you could go back in time to these stages you’re discussing right now. And this is, I think a good one for really anything that pops into your mind. First kind of the first thing that pops into your mind, what wisdom would you give yourself at that stage? Learning everything you’ve learned now.

Vinny Olmstead: 12:22

These are all things that are somewhat standard that you would think through, but don’t be afraid to hire great people and try to understand what great means. And don’t be afraid to hire people that make more money than you, or have a lot more experience. And that’s the thing we never with a lot of entrepreneurs, they really struggle with that, acknowledging that you don’t have deep experience around repeatable sales processes or deep knowledge around product requirements. There’s nothing wrong with that. Don’t have the pride to think that as CEO, you need to know everything and that you need to have the experience in every single verticalized aspect of your business. Go get the right people. And on the heels of that real quickly, one of my mistakes with one of the companies that did well with and sold. I had the opportunity to take a lot more money. And I didn’t, and it definitely inhibited the growth of my company, and I wish I would raise more capital. So get the right people. And I was very prudent with the money, and I was very in tune to my investors, but I should have taken more.

James Di Virgilio: 13:17

Yeah its interesting, we’re going to talk a lot about funding as we get towards the end of this. And I have so many questions on that, myself being a finance person and investor, and we will get to that one. So save, that for further probing, let’s talk about the middle years, and this can be the middle for you as you think of your own career and experience in life, but the middle years as a leader, how did your normal day to day change from these earlier years?

Vinny Olmstead: 13:38

Yes. So the most interesting part in all of that, the theme there was how to let go, because it’s sort of this interesting thing. It’s not as though I couldn’t do a bunch of this stuff better than select employees, but you have to let go and let the leverage down. For example, back to when I was on the paper , boy , you have to let them go, let them deliver the route , make sure it’s on time. You can’t walk with every single person or ride with every single person. And it’s the same theory when you’re running a business, it was a little bit harder to let certain things go. I was pretty good at Excel and financial modeling. I could do the Excel, but it was dumb for me to do the Excel because I had other people that could, you have to let go. So the middle years is about where are your priorities and allocation of time are best spent in order to create the greatest value. And that’s easy to say, but it’s really not hard to do personally. And for the CEOs that we see, even in our investments today.

James Di Virgilio: 14:29

Optimization with your time, your own focuses, right? You recognize when you reach a certain age that no matter how smart you are, you just cannot do everything. And on top of that, there’s certain things you should do that will yield more, not obviously just for yourself, but also for your team, for the project you’re working on. How do you begin to trim away? Some of those margins, some of those things like how do you create a funnel to say this is priority one task? And this one I should probably think about delegating.

Vinny Olmstead: 14:54

It goes back to my point around hiring some of the right people, but it’s not always about hiring the right people. It’s also about the mentality of that. There’s a lot of different ways to do it. One thing I see that works pretty well and worked for me, there’s this thing called the entrepreneurial operating system. It’s basically a management system where you meet with your team quarterly and you review your mission, vision, values, all that fun stuff once a year, but you go through what priorities are. And it’s sort of a healthy way with no titles to get into a room with your top management team and to help prioritize. It was fairly enlightening for me to hear people say, you shouldn’t be doing this. You should be doing that. And you can still do ELS, or you can bring in a facilitator either way. It was a good way to prioritize . And then it was a good way for folks not to feel uncomfortable, to say, you need to not allocate your time to doing all that Excel spreadsheet or drawing out the HTML for the buy flow of a commerce and things that you shouldn’t be doing. It’s okay for people to interview you and say, where are you thinking about interviewing? You are having conversations about where you want it to go, but you have to let go. So that’s just one example of ways to sort of take care of that. And the second one was I, I didn’t accept which I wished that I did it. Must’ve been a seed investor with the company bridgevine, which is a Florida company. We were, I think 500, I think seven times fastest growing 57, the highest. But one of the things he kept telling me to do is hire sort of a chief of staff to keep you organized. And I don’t know why I just was stubborn and didn’t do it. And now, whereas what we tell our CEO is, Hey, you know , hire a chief of staff to help you organize. So when you go to these meetings and you have follow up , they can really make it happen. Or if you need a quick project done or research on competitor or market, you have somebody to do it. So you’re not sitting there doing that. So two things I think helped facilitated one, which I adopted. One of which I refused was the EO’s system. And then also the chief of staff and chief of staff starts getting pertinent when companies sort of are starting up into the 5 million and above in revenue, because that’s also a time where it starts getting complex to scale.

James Di Virgilio: 16:50

Yeah. And that’s great. You segwayed perfectly to my next question, which is during these middle years, how do you go about handling, growing and expanding? Oftentimes it happens rapidly and oftentimes the CEOs may or may not have had a lot of experience with handling something that’s growing that quickly or scaling that fast.

Vinny Olmstead: 17:07

Its a good point. And when our CEO Bridgevine, it went from a million to six to 11 to 18 million in revenue, over five years, growing from nothing to one and going up, and it was good because a software company, but it also leveraged the early days, early days, the mid days of the web and online demand generation and all of that, but not easy. And then the hardest part about it was the people part of it. And it wasn’t only that you’re hiring t he r ight people. It’s that people that had generalist jobs t hat had five jobs, they may have had five different responsibilities. And as you get larger, you need to be able to motivate them, to be excited about taking a more narrow role that does more, as opposed to running HR and p roduct. Now you have to put p roduct in a separate bucket o nto itself. So I think managing people A) are they capable of scaling? If they’re not, they may have a VP level, but should be a director. Can you put them into a director role and then how to narrow what their responsibilities. That was the hardest part. I think about the scale, getting the infrastructure in place for f our data centers and all that was fine. There’s a lot of other things that were they’re hard, but they’re not that hard. A nd the people part is by far the hardest part.

James Di Virgilio: 18:16

What was the most rewarding experience or set of experiences when you reflect back on your middle years?

Vinny Olmstead: 18:20

The fun part of all of this is creating a culture that is great to work in and creating a culture. When I described earlier, my eyes getting open in a smile on my face is trying to create an environment where it may not be because you’re running the company, but it may be because you’re running products that you have the big eyes and smile on your face because you’re really creating something. I think that’s probably the best illustration.

James Di Virgilio: 18:46

That is the joy, right? This idea of creating, improving . There’s nothing like it. And I think even people that wouldn’t say they’re entrepreneurial, if you can kind of get granular and say, well, let’s talk about a time in your life. You created something. There’s always this different level of passion and connectivity to it. All right, let’s move to now, we’re going to call it now so that you can call these your mature years. Of course, maturation never stops. Let’s just go with now, how is your role now different than it was in the middle years in the early years?

Vinny Olmstead: 19:12

So a couple of things there. So in my later years, I went from operator to a venture capitalist and this was about nine years ago. And when I started, I actually was CEO and started the fund at the same time with the blessing of the board. But I would call that some of my more mature years versus earlier. And so how is it different? One of the things that was very different in my middle years and now mature years, and this is for the whole industry is there’s a lot of ways to grow businesses fast because of all of the different plugins solutions out there. And so when I coach CEOs, or when I look at businesses as an example, I don’t want them to create a new commerce platform. They can go plug in Shopify. And so one of the things I think I thought about earlier on is you take everything under solvers and you have to do everything yourself. In my later years, I adopted more to, Hey, I can plug stuff in and the value is more speed to market than it is sometimes proprietary type items, like a commerce platform as an example. So whenever they agreed in the Lunchables, which was like Oscar Meyer and an Oreo cookie from Dole , the Lunchables is a great idea. You don’t have to own every component of it in order to get to market faster and perform better. And as life goes on, both with technology evolving and adoptability, it’s , it’s more of a norm now, but it wasn’t in 2011. It is becoming that right now. But it’s the embracement of that aspect of solutions that can plug into your solutions.

James Di Virgilio: 20:39

And you are just like nailing every segue. So here’s another one. What are some of the new challenges CEOs face today that perhaps they were not facing 20 or 25 years ago?

Vinny Olmstead: 20:50

That’s a great question. When I look across my portfolio and we back great CEOs and they sort of bifurcated into two buckets, which is some with less experience and some with more experience. And I think one of the hardest parts of the ones with less experience is the true accountability and expecting people to work as hard as you’re expected to work. It’s a little bit millennialism is a little bit of a challenge. And so I think that’s the number one difference that I don’t know if I didn’t tolerate it, or if the norms were different, but now it’s often tough to get to that accountability and to have people and accountability states. That’s a lot of where we spend our time. A lot of management teams, these CEOs make 50, to hundred thousand bucks and all of a sudden they need to bring in somebody who runs XYZ. That makes $225,000. There is a lot of concern and consternation about bringing in people who make more than you and have more experience. And we spent enormous amount of time having those types of conversations and say, you need to balance your equity with what your overall goal is and your priorities. And so that’s the second part. This challenge was challenge to me too . And it’s a challenge when I worked with our CEOs now.

James Di Virgilio: 22:01

We could do an entire podcast on team building and culture and pay and meritocracy. And that exact principle of does there need to be this triangle hierarchy where the person X , Y , Z makes more than someone else, or is there room, as you’re mentioning to have a more market-based or creative, or just what’s best for the venture mindset. So how do you handle the pressure of the media of public opinion of your own employees? How is that handled as you become a notable CEO with prestige?

Vinny Olmstead: 22:29

So one is you’re going to have to face the fact that the accountability is on your shoulders and it’s human nature for your employees, whomever, they report up to whether you’re one of the greatest CEO or whether you’re Elon Musk or others. People are still going to have fun with you a little bit. And sometimes you have to have some pretty thick skin just don’t let that part of it bother you. It’s just part of it. The other part, which follows you as being early to middle to late stages is it’s great to be friends with everybody, but you have to be cognizant of how you handle employees and people inside the workforce. It’s human nature to have certain things in common with people inside your organization, but it may look like you’re favoring them just because you both like Florida Gators and whatnot. So there’s those aspects that you have to be very cognizant of. And you have to separate yourself a little bit. You may not be able to cope with certain people and not other people. And so types of that hierarchy. So it doesn’t create imbalance or odd things inside and thick skin because they are going to have fun here especially they like to have fun.

James Di Virgilio: 23:24

Yeah, it definitely really important for leaders to have thick skin . That seems to be perhaps a quality. I’m sure you’re spending more time with your CEOs today that you’re working with and maybe you would have in years past.

Vinny Olmstead: 23:33

Yes. There’s a good example. There’s a product that I created at Bridgevine. And I think 80% of the company disagreed with me on wanting to roll it out. I knew it was the right thing to do, and it ended up being the valuable aspect of the business, but it was a turbulent time. It wasn’t like a all out civil war, but it was, I don’t understand that we shouldn’t be doing this. We should be focused over here. And I just said, and this is my decision going to the board. This is my decision. This is what I think is right. There is dissent . And it ended up paying off, staying true and staying part in what you believe it was tough, but ended up being a good outcome.

James Di Virgilio: 24:10

Yeah and that is the role obviously of a leader is to go out there at times. And if you really believe in what you’re doing and you think it is best that you have to put yourself out there with it, otherwise, nothing great is going to get done. So what was one of the most challenging experiences that you’ve had rather recently, it’s really just been a difficult spot.

Vinny Olmstead: 24:29

We’ve had a shutdown on business and that’s never fun or stop supporting a business, which is never fun because you’d go and you back these entrepreneurs, like even in COVID times, there are two different outcomes for our companies. One was they thrive because everything’s coming satisfied. And another instance COVID, wasn’t good for the market. And I don’t want to tip off with the company is but sitting down and saying, I can’t fund you anymore. If the business is going to take two to three more years to come back and you’re going to have to either cut back your salary. People salaries, certain things, but I also invest on behalf of other investors as a fund. I have limited partners who invest in me. I can’t support you . I think you’re great. Your business model was good. Last year. Your business model has become less good this year and I have to move forward, I’ll support you, two need to be on the board, but financially I can’t throw good money after that. And that’s a hard conversation.

James Di Virgilio: 25:24

Yeah, thats an excellent example of a very real world . And sometimes out of our control, right, as entrepreneurs scenario. So now let’s launch into this fourth piece, which is a strategy phase. So this can encompass any part of your time in life. I think obviously as a VC, a lot of this stuff is going to apply to the questions I’ll ask because there’s so many interesting things happening. And of course you’re based in Florida, which a lot of people would describe as a pioneering very early VC world, where perhaps 20 years from now, the state looks very different. So when it comes to strategy, you launch your VC firm a decade ago, essentially, or almost a decade ago, and you have to create a strategy, VCs, have different strategies, different niches, they work in, how did you create yours?

Vinny Olmstead: 26:05

And that’s a great question because even when I was on the other side of receiving capital, I never thought there was like a strategy behind venture capital. And now I’m realizing that there is very much so a strategy behind venture capital and like our portfolio companies, that strategy has to really evolve. So I’m on my third fund. And if I go back to the first bond versus the third fund, our strategy has evolved fairly significantly. So when the first bond that was sort of more of a reactive fund, it was sort of doing it fun , sort of doing it reactively. Didn’t have the infrastructure of the relationship because it was coming hot off the heels of many years as an operator, as opposed to an investor. And I was investing in seed A and B stage companies and they’re around technology. So at a high level, and my strategy was a pretty big umbrella technology. So fast forward into phase two, I started really narrowing that down, which is I could provide the best value for folks are in the one to $10 million range, had a couple of good employees, had some product markets fit . And so it started really focusing around A stage investing. And although I had done some B to C stuff, the B2B SAS type of some things seem to be the companies that were doing better. So went to that next level of, okay, I’m going to invest in Baystate businesses that are doing SAS and or repeatable revenue. And then we get into three and I’m like very similar to other companies. My fun one was sort of by myself , my current CFO and partner, Wendy Coya and a junior person, fun too I had brought on another managing director who also was an operator and sold his company. So we were like-minded in that regard. And he was thinking about going out and doing the angel round funding. And he decided to come in and I said, look, I went through that, don’t do it. Jump on board, with me. We have very similar mindsets, but it caused us to have a lot more interrupt in strategic conversations, adding that second very experienced person. And so if you fast forward to fund three, our team goes off campus quarterly, and it’s all around strategy . So we went from sort of haphazard to somebody structured . So now it’s very clear A stage enterprise software around the future of work around transforming healthcare and around the science of selling. And we are disciplined along those three. And I imagine when we got to fund four , it’s going to be the same thing. So the common theme is that even VCs have to continue on the strategy, not just similar to the portfolio companies that I have, and they have to evolve with the times and it comes through with the I’m sure we can talk a little bit about funding, but even the world , the funding has changed series A used to be 3 to 6 million. Now it’s sort of seven to 12. And so our strategy has to be smart on that side.

James Di Virgilio: 28:42

That was perfect in fact, you answered multiple other questions by telling me the story of how the model and strategy changed over the years, which is really the goal and how it will change in the future. And I think that is a key mark, obviously, of someone who is still highly in tune with innovation and not stagnation. And recognizing that professionalization of something is a constant refinement. You never reach your end goal, but you should always be getting better and more refined, more processed. And not as obviously what you described, speaking of funding, there’s two questions I want to ask here. One are VCs this big, bad, evil empire that is spitting good ideas and entrepreneurs out of it, or is it a necessary nurturing, useful, helpful tool?

Vinny Olmstead: 29:22

So I was on both sides of that and I agree venture capitalists behind me. And I was savvy enough to know, I think when they were helping, when they weren’t helping. And when I had my VC board, I had one guy who was always cognizant of balance sheet, another guy who was very good at sales, another guy who was thinking strategy, but I sort of leverage them and use them that way. I didn’t use them all the same way. And so I had a very positive experience on that. There are a lot of nightmare scenarios with VCs , and I think it’s a quasi healthy tension, right? Because as a VC , you want to be friends with the CEO , but you have to push them a little bit. And there’s always tension with pushing them, hire that chief operating officer, because you need it. And well, I don’t want them to , I only want a director of operations. I get that. But one year from now, you understand that six months for that CEO to even understand your business. And you’re going to be a scale on a size where you’re going to grow into this particular, he or she in order to move forward. So if you went out and did a survey of my CEOs, I think they would all be pretty favorable, but also state that there are times of tension and disagreement. And it’s how you handle that tension and disagreement. And then the obvious is when companies aren’t doing well, VCs plan management management, blames the VCs and how you handle that, which is sometimes potentially switching out a CEO and sometimes selling a company and at sometimes putting some more, million dollars in to let them fulfill their strategy. And so it’s like everything in life, it’s communication and how you communicate. And there is definitely a healthy tension. There there’s been bad actors out there in the marketplace. And look , there is dissension. Sometimes you told me you were going to hit this amount of revenue. Now you’re going to spend twice as much and get paid half amount of revenue. We do have an issue here because this is what you supported. And so there are those moments also.

James Di Virgilio: 31:08

Let’s talk about philosophically yourself, your VC venture, how you view things, of course, because we can’t reductively say what all VCs do. But in your case, when you’re taking on a new project, are you thinking more along the lines of I’m taking on this project? Because I believe in it, I want to be able to help this entrepreneur funding as a part of that. I want them to grow because growing will help the world around me. Or are you looking at it straight numerically saying, I think this company is going to make a ton of money if they do X, Y, Z, and I’m in it to make sure that the money is made.

Vinny Olmstead: 31:36

I think it’s somewhere in between, right? So I know it’s a huge and growing market, but there are a lot of huge and growing markets that we won’t go into because philosophically we don’t agree with them. So I want to believe in the company’s missions and visions. Otherwise, even if it’s a great opportunity, I won’t invest there. So I wouldn’t go through and say, I have a hard rule of I’m not investing in X, Y, Z, but when it really comes down to it, you have to believe in the mission and the vision of the company. It’s not pure economics . It truly isn’t . I was invested in a great company called your cause, which was basically a payments platform for social good. And they did things like integrating the HR systems of AT&T and enabling the employees of AT&T tens and tens and tens of thousands of them to give whether it be to their favorite not-for-profit or when Katrina hit or whatnot. And I loved the mission, the CEO and I who’s a great guy. He went and believed in his passion, we sometimes hit clash heads a little bit, but I loved his mission, vision and the purity of it. And healthcare ones we invest in are all around chronic care. And as a matter of fact, one of the recommendations made to the CEO there at a company called Time Doc that I invested in on the board is they’re helping people with chronic diseases, through a software platform, enabling physicians. And they also have caregivers that help somewhat. And I’m like, I want to hear how you’re helping people. I want to hear how you’re helping the person, that they didn’t realize that they were deaf or couldn’t get to the doctor or couldn’t get food and you guys facilitated it. So I think for us, at least at Vocap, yes, we are capitalists . And we are sort of trying to make somewhere between five and 10 times off of each investment, knowing that 30% to 40% of them might fail. But I do think that if they were not within our value system, we would not be interested in the business.

James Di Virgilio: 33:18

And it’s really interesting. And again, it could be another podcast for a different day, just talking about freedom, capitalism, private property funding, ideas, this idea that obviously, if somebody makes a gazillion dollars, it’s not a zero sum game. It’s not a fixed pie. They’re not taking money from someone else to get there. And the only way for that to happen is for people to use whatever they’ve created. So there is a level obviously of marketability and market growing that if you believe in what you’re doing, and of course you’re doing things ethically in the right way, the larger you become, the more people you can help theoretically. So a lot of that stuff, again, different discussion for a different podcast.

Vinny Olmstead: 33:50

Thats a long podcast .

James Di Virgilio: 33:51

Yeah. That’s a long one. That’s a big one that I love that kind of high level stuff. But for now let’s get granular and talk about funding here in Gainesville, Florida, the University of Florida obviously now leads really the country with incubator companies. And so it has not quite had the success of turning some of these incubator companies into the huge names we know yet, perhaps one day that will happen. But funding is on everyone’s mind, especially in the state of Florida, where there are tons of patents being had every single year. Obviously again, we talked about at the top of the show, Florida, as an emerging VC area, you’re here, you’ve been working in it. How hard is it to get an idea funded? It seems like if you were to panel a lot of young startup companies, they would feel like it’s almost impossible to get their idea funded. How hard is it really to get an idea funded?

Vinny Olmstead: 34:35

That’s another long fun conversation. When I raised capital here for my Bridgevine company, back in early 2000’s, I couldn’t get anybody in the state of Florida or the Southeast interested at all. I had to go to the Northeast in order to raise capital, fast forward several years. And there are a good number of whether it be Vocap or Los Olas or [inaudible] is on like fund number five or six or whatever they’re on. And there’s a lot more ecosystems in Florida and in the Southeast. So there is more capital than 20 years ago when I was out raising money in the state of Florida before I was in Florida, I was in Seattle, we raised two and a half million dollars. And that was sort of a startup on steroids. You wouldn’t find public on that. And then I came to Florida and it was really, really tough. I mean, I couldn’t even get on the state of Florida venture I’m on the board and have been for 10 years and love it. It was hard on the state of Florida. There wasn’t as much money. I still think we’re not quite there yet. Right. So I think we’re still five years away from having the capital in place that other places have. And so it is hard. I live in Vero Beach, Florida. I had an open office in Atlanta group talent reasons. And because it’s easier later on to sell the company and find companies or investors to invest Florida sort of a distributed place, right? There’s no clear ecosystem. And geography is a big deal. New York, Austin , San Francisco, Austin, very, very concentrated. Whereas Florida’s ecosystem on entrepreneurs are spread out and VCs are inherently lazy and they don’t want to go to Gainesville and they don’t want to go to a Ocala. Steve Case is doing a wonderful job of trying to illuminate, all the great ideas of the secondary cities. And I think we’re getting there on that front. And I think geography is a little bit of a disadvantage. And again, I’m skewed toward thinking about tech versus broader ideas. I look at the biotech space personally, and look at stuff like that, but geography has an implication . So I think we’ve come a long way. And we still have a lot of opportunities over the next five years. And then you’ll relay this umbrella of holy cow. There are a lot of financial people coming to the state of Florida and that is going to be nothing but hell . So I’m in this town called Vero Beach, Florida. And we happened to have, I think the number one place of Ex CEOs of fortune 500 companies, a lot of them happen to have okay amount of money. And that’s how I raised both my early seed money for my company and then also my venture money. So the more you get some of these folks relocating to Florida, which seems to be happening in a rapid fashion, I think the money will continue to follow, especially for the seed side of things. As more family offices are down here and more intellectually curious people who understand the finance world are down here. So I have a lot of optimism now and going forward. And the only other point I’d make also is the hard part is there are so many new companies coming out. It’s hard to get through the noise right? Years ago, a few people wanted to be entrepreneurs. Now everybody wants to be an entrepreneur. So there’s increasing supply. The problem is there’s also increasing demand and you need to truly innovative and you need to figure out ways to really show your differentiation.

James Di Virgilio: 37:19

Another great segue. Before I ask you the last question, my grandparents live in Johns Island I’m my grandfather was an entrepreneur and he was super proud of the fact that Johns Island had zillion Ex CEOs and whatever the case was.

Vinny Olmstead: 37:32

Oh so awesome. Yeah. I can clearly see it from my window right here.

James Di Virgilio: 37:36

Yeah I figured. Yeah. Every Christmas actually my family, we drive across the state from Sarasota to Vero Beach and spend an evening. So that was my Christmas time. But , um, the last question and this one is going to be the one you just, again, segues perfectly into is all right. There’s a lot of people starting companies. There are a lot of good ideas out there. What is your advice for entrepreneurs to get funded? What are some things they can do to rise above the crowd?

Vinny Olmstead: 37:57

Yeah. So a couple of things on that front one, there’s a lot of great companies and a lot of new to companies. You’ve got to look yourself in the mirror and not be a me too . Go look at the competitive space and identify what your differentiation is. As I mentioned earlier, never stop networking. You are always raising capital and you don’t want to go to every single social event with your friends and just talk about your own business. You have to have some EQ to understand you have to have an EQ piece of it, but always be thinking about how you can network through to people. And when all of this noise, you have to be going after a big market with a unique product. Otherwise we don’t care. The reality is we want a large market and you can have a large niche, right? We have a supply chain company that does primarily around cold goods. That’s growing very quickly. And the whole market’s huge niche market. That’s perfectly fine. One of my board members, this guy by the name of Ted Leonsis who sold his company, to the first sale to all these partners, with Steve Case, he owns the Capitals and the Wizards and is just the greatest entrepreneur in the world. But he sat me down and said, you need to have your ten second pitch, your one minute pitch and your three minute pitch and you need to have it so crisp and so clear. And he seems like it’s easy, but it wasn’t as easy stated. And he’s abused need to have all of those incredible cadence and you need to convince me you’re passionate about it. And it was a great piece of advice for me. It’s one of the few things that I tell my CEOs, give me bad news as fast as you possibly can. I don’t care when I get the good news and have that cadence down, but how you talk about your company and the 30 sec, minute, five minute version. And so that would be my advice. Also, it sounds simple, but if I’m going to get a long complex story and what you’re trying to do, you cut off a lot of people.

James Di Virgilio: 39:35

That’s often stated. And as you said, because of that, it almost becomes like a trope , but the reality it’s so true. Robert Einstein once said that you make something as simple as possible and no simpler. And I think that’s also completely true with a pitch for your idea or your company for a million different reasons. So that’s great advice and low-hanging fruit and something. I’m sure that you see all the time. I see all the time here in Gainesville, is this not often done? And it’s not done well and not surprisingly, most of the companies that tend to go places are very good at that for a variety of reasons. Well, Vinny, I appreciate you spending an hour with us. I think we got a lot of great stuff in this segment, for sure. Lots of good insights. I certainly enjoyed talking with you.

Vinny Olmstead: 40:10

Likewise. I look forward to visiting the Cade Museum and visiting you all up there. So I appreciate the time.

Outro: 40:16

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida . This podcast episodes host was James Di Virgilio and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak . The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

Tarro is the former CEO of a telecommunications software and management services company founded in Boca Raton, Florida. His own experience of developing a startup led him to becoming the Vice President of the Board of Directors at New World Angels, a group of 78 accredited, private investors, operators and entrepreneurs dedicated to providing equity capital and guidance to early-stage entrepreneurial companies with a strong presence in Florida. 

In this episode, Tarro sits down with host Richard Miles to talk about his own trials of creating a startup, as well as discussing the importance of intellectualizing business as one forges their own path within the marketplace.

TRANSCRIPT:

Intro (00:01):

Starting and running your own company. It’s not for everyone, but for those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. So we decided to go on and talk to some of those people and find out what they’ve learned, what they’d repeat and what they’ll never do again. We’ll hear stories from their first year, then from the period when they realized they’re going to survive and how they intend to position their companies for the future. We’ll find out what a CEO’s normal day is like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is it time to move on? Join us for CEO 101, a limited series of deep looks at people who are their own boss, for better or for worse.

Richard Miles (00:38):

Welcome to another episode of CEO 101, a series of special episodes in which we talk to, and about, CEOs of startup companies. I’m your host Richard Miles today. My guest is Ron Tarro, CEO of a number of companies, as well as an advisor and investor in many more. Welcome to the show, Ron.

Ron Tarro (00:55):

It’s very nice to be here. Thanks for having me.

Richard Miles (00:57):

So why don’t we start with an overview of your career. You’ve done a lot of things. We just were talking about your role in a number of companies at various stages and levels. So why don’t you give a brief summary of where you started and what you’re doing now?

Ron Tarro (01:09):

Yeah, so I started as a nerd, software engineer, and I really came through a technical track. My background was in mathematics and the sciences. I ended up getting hired by IBM in IBM labs and so was on product teams, software engineering teams. Went through product marketing and product management jobs there, where I began to focus, not just on making the product, but deciding what should be in the product. I jumped out like a crazy person, one day went I into consulting and joined the industry young, ended up in a leadership position in the management consulting group, which focused on technology companies. So it was basically back to, what should we make? Why should we make it? Who should we sell it to? Those types of things. Did that for a bunch of years. In the meantime, a couple of my pals had started a software company here in Florida, and I was based in Minnesota at the time. I did work at IBM in Boca Raton, if you’re into Florida-centered conversation, and then started a company, I started advising it. I married one of them. My wife was one of the founders of this company and that company is telecommunication software platform. And we took that company, bootstrapping it, with no investment actually, and ended up putting it out into, I think 30, 40 countries. By the time we left, its largest market segment was in hotels and resorts, so we had a pretty big market share. We ultimately sold that company to what is now part of Cisco WebEx actually. And it’s gone through usual chopping up, getting acquired by a public company, where I was a public company, vice president for several years, as part of the arrangement, they went along with the desks and the pencils and that. So since the exiting, all of that, I’ve been an advisor in the incubators here in the state with the university system, in the leadership of a longest standing angel syndicate for investment in startups, so I do a lot of that. And that’s about it. Now, I’ve been a personal angel investor along with my wife, Dana, around the state. So that’s basically it, I mean, nerd turned business person, but still likes to do macros on spreadsheets or something.

Richard Miles (03:00):

Right, yeah. Nerd turned management consultant turned investor.

Ron Tarro (03:03):

Yeah, something like that. *laughter*.

Richard Miles (03:05):

You’re perfect for our show, Ron, perfect. You’ve a great experience in that you are able to both be an outsider and an insider and watching this process unfold of companies starting and then growing and then getting sold from a number of different angles. Why don’t we start with, what’s the biggest difference between watching it from the outside, like as an advisor or something, and actually doing it yourself? When you actually did that yourself with your wife, that company, were there things that you thought like, wow, I thought I knew what this process is like, but this is something nobody told me about?

Ron Tarro (03:35):

I guess I would look at it this way: in running an early stage company, in whatever form, you are absolutely single-minded. And I would say that what I know today that I didn’t know then is probably, I have more context in seeing some of the moves that we made. So we may have turned left, we should have turned right. And seeing lots of companies making left and right turns, you begin to look at it and say, “hmm, we could have thought about that problem very differently.” Now I would say this, that in our case, I think we made most of the fundamentally right decisions. And we can kind of walk through the life cycle of a company: when to get out of the company and sell it, all that stuff was being driven by stuff. But when you run a company, the thing that you need to be particularly careful, especially as an early one, is you are single-minded in your vision. And as a practical matter, what you don’t know can kill you. And so, I think once you’ve been through this a couple of times, you step back, you begin to see all of those other dangerous–there’s a counter argument, by the way, which would be your ignorance and optimism is the reason you’ll succeed. But I guess I’m a little bit more hardened by some of that.

Richard Miles (04:36):

Let’s get granular here and talk about the very, very beginning, but from your own experience in companies that you’ve helped start or advise. The first, maybe 30 to 60 days, where you’ve got a founder or a couple of founders, they’re very excited, they’ve got a lot of energy. Why don’t we start with the mistakes? The mistakes are always fun to talk about, right? What are some common mistakes that people make in the first few weeks, did they really come to regret later on? And maybe they don’t even know that they’re mistakes when they’re making them in that first 30 or 60 days? What have you seen?

Ron Tarro (05:02):

Yeah, no, I’ll start with the very basic one. Should you even bother? Is this a good idea? Because I think one of the things, when you see a founder, is they’re going to walk into this and they believe what they believe. And I’ll actually use the test with New World Angels, which is the angel group that I’m part of and leadership of, is this idea you have is derivative. It’s not better enough from anything else out there. It’s not enough to dislodge the current state. The way to look at that would be: I have a new idea for electronic banking, but can I get everybody to take everything out of this bank, including electronic banking, and move it to that bank? There’s a speed bump. There’s something here: you’re 10% better, but it’s 20% too much hassle to do it. And so one of the big challenges is you see a lot of folks coming into incubators and applying or coming to me for advisory. It is, I don’t know, has this been done before? And if it has, you better have some sort of transformative argument. It was Clayton Christiansen; he’s one of the Harvard guys that wrote a book. Is this sustaining innovation, meaning it’s incrementally improving stuff up, or is it disruptive? It restructures how something’s done fundamentally. Obviously you want a big success, it has to be fundamentally different, not just a flavor. It’s sort of like, there’s Uber and then there’s Uber for pizzas. It’s like, okay, you can make a living at that, and by the way, don’t want to discourage you, but it may not be an investible company, and it may be a company that’s only going to get to be this big because just by the nature of how you defined it in the first place. So part one is, is it even an idea that’s going to be able to, in effect, dislodge what’s already there? And if there is something there or is it clear sailing? And the other is, is it disruptive? Is it just incrementally improving something that already exists? I mean, obviously we want to be disruptive and there’s another great book out there, The Blue Ocean Strategies book that I always talk about, which is as a startup, this whole idea of derivative ideas will repeat. So it’s like, well, if Uber gets into pizzas, you’re dead. You’re, you’re not sailing in open ocean. You’re sailing in the shipping lanes. And so you better have a pretty good argument for why you think you’re gonna be able to stay afloat, new captains, smaller boat, limited gas (meaning financing). So you end up being in a little bit of a challenging spot. So really before you imagine a company, you have to sort of hack your insight, if you will, and say, yeah, I really believe that there’s insight here. There’s an engineer’s disease, and I can make fun of engineers because I used to be one, which is: because I can build it, I should. And that’s not the case. When you look at a lot of products, you see a lot of technology is built by a technical person that is logically and intellectually interesting, and economically kind of is around. For me, it’s like very first thing. Are you onto something here, something transformative? Can we go back a little bit about how you might evaluate that? That’s definitely the very first thing I look at. Yeah.

Richard Miles (07:34):

So you’ve been, I’m sure pitched a bunch of times. You’ve been to a lot of these pitch competitions, so on. You’ve seen probably thousands of presentations by typically a young-ish or very excited team and probably a bunch of engineers and they’re onto something, they’ve proved it somewhat, and it’s withstood a few proofs of concept. Have you developed, sixth sense is not really what I’m getting at here, but do you have like rules of thumb, five or six things that for you either, you’ll say like, nope, I’m done next? You see right away, apart from what you just talked about, say, is it a derivative idea? And then the other side, when a same team that if they say something, you go, okay, I’m going to go get that guy’s business card or I’m going to call them back because there’s something about their structure. Do you have like a mental checklist or is every presentation sui generis? You just figure it out after you’ve heard the presentation?

Ron Tarro (08:22):

So actually not only do I have opinions here, actually I’ve written a blog post. If you go to the newworldangels.com blog, there’s a post up there called Back-Testing, why we said no, essentially. So you just layered it right into a whole set of things that could take an hour. So clearly it’s the idea, you haven’t differentiated the idea in the marketplace and that’s a big deal. But at the other one that I look very quickly towards is the structure of the team. Again, I should put some context here. I’m a tech guy, right? So if we’re talking about opening a restaurant and marketing shoelaces, boy, am I the wrong person, right? It’s all a mystery to me, I’m a straight up core software person. But when I look at a team that’s bringing a technology product, if not out of the university, maybe even just an open market, I’m going to go, who are the founders? My favorite founders are one business person that knows the market space, where they think it’s going to apply, and one technology person who can make stuff. Period. If you have a business person who’s hiring out disinterested parties to make stuff, it’s a risk. It doesn’t mean no, but I’m going to worry that if the money runs out, all the cash is running out the door to the consulting firm or wherever it’s going to be. So very much, I look at what that team looks like and what their direct to main knowledge happens to be inside of it. So you have a team that seems logical. I begin to look at the market size, it’s called TAM, people talk about Total Addressable Market or serviceable market. And I always do this in dollars. It’s like, all right, this is great. This is really cool, and there’s 27 people in the world who would use this. So in order for it to be exciting, they each need to pay a hundred million dollars, right? (I’m making numbers up by the way). But it’s this idea that you have a market size that’s way too narrow, and so I’m going to worry about that as an investor. Now, again, you may look at this and you may say, yeah, this is a good product. And it deserves to be in the world. But from an investor standpoint, you’re going to have a ton of uphill battle with what’s being examined. Forming a company is a team sport. I’ll use Florida analogy here, but if the founder gets eaten by an alligator, what happens? And the answer should be well, there’s three more to carry on the journey, right?

Richard Miles (10:18):

Pre morph the alligator to snack.

Ron Tarro (10:20):

*Laughter* That’s right, so this whole idea of that is a big deal. And so all of this is back to the design of your company, right? What are you trying to do? Where are you focused? Does it matter? Is it big? Those sorts of things? And by the way, this is the theme you’ll see over and over again with investors, especially. But there’s a reason it’s not just because investors want to make a lot of money. It’s actually very rational. If I go back to running our company, we had lessons learned, but we had a total addressable market for our company, in that we dominated this total addressable market pretty successfully. We made a choice to not change industries, but to go global across one industry, those types of decisions. So in essence, when you look at our company, you would have said, okay, it’s a nichey product except globally, it’s a big niche, right? That kind of idea. And so those are the kind of decisions that you’re forced to make with left and right turns. We think we made the right one because it made us a pure play to be acquired one day.

Richard Miles (11:14):

I want to follow up on something you said in your ideal team is that you’ve got an inventor and a business person, but I’m sure you’ve seen–we’ve seen it in the Cade Prize competition–particularly coming out of research universities, you have the professor, right? Or you have the scientist or whatever. And they’ve got some grad students with them or whatnot. They love their idea. They’re smart people. and they figure how hard can it be to start and run a company, right? And your heart kind of aches for them because you want to say, you need to stay in the lab. Who has that tough conversation? Is that your job when they bring you along as an advisor or as an investor, for instance? Is one of the first conversations you have and say, look, professor, you need to stick to the, and the development of the idea and the product, and you need somebody who knows how to do this. I’m guessing the successful ones listened to you, and the ones that don’t listen to you, what happens to them?

Ron Tarro (12:02):

I’ll give you the losing argument, which is, “Hey professor, do you want a hundred percent of zero? Or do you want 50% of a lot?” There’s a question here. It’s hard to succeed in most of these companies; never say never, but aspirationally, there’s always this idea that being the CEO might be cool. However, if you look at the pain in the neck that that job can be, even as a college professor, I’ve been on both sides of the technology versus business fence. Some days I really missed the corny technology story. The reality is that you’re not going to get momentum unaccompanied very easily by being a part-timer, especially a professor. And you see it again and again, where they don’t get funded. The best thing you could do as a college professor would be back to my one maker, one business person that can carry and coordinate. And if you’re a member of the academy of arts and sciences or whatever the case might be, why would you check out of that? Where’s your next idea? What’s your next core research? It’d be better as a professor to have a portfolio of companies that you have a significant interest in that, where you were the founding insight, right? The technology, whatever the case might be. And you let those things grow and nurture because the attention required, you have to choose, you can’t be both. And there are a lot of PhDs who jumped out of academia to run companies, but that’s the choice you must make, I think at the end of the day. So you can rationalize it for a little while, but I know personally a number of folks that just have not been funded because they insist on being CEO as a professor or as a doctor or something like that. And so the funding dries up because nobody wants to fund a hobby, right? Or a side hustle. My money’s at risk and you’re part-timing me, not going to happen. Now maybe again, if you can make it all work without any money up from outside or whatever. But basically go find your best friend’s CEO and found it together, and then you can be chief science officer and you can contribute intellectual property into the business in really interesting ways. You get all the benefit, none of the work, you stay to your passions. And so I think you have to be honest with yourself too. Do you want to be a professor? If that’s where you want, you want the intellectual rigor to an effect, break down new territory. If that’s what energizes you, great. If you have that one idea, you think it’s it, then you got to go all the way in.

Richard Miles (14:03):

The counter-argument you hear from these researchers is they say, yeah, I recognize I need somebody with a business background, but these people really need to understand the core idea and a core principle here. And sometimes the core principles are fairly sophisticated, like, particularly in the healthcare field or in tech field. So if a business person doesn’t really get the technology, you understand it, right? They’re probably of limited use because they may have trouble visualizing or imagining the applications of that technology, if they don’t really understand how the technology works.

Ron Tarro (14:33):

Okay, I would argue a little bit differently. All you described was your requirements in recruiting for a CEO. You’re not going to get a CEO who did real estate management, no offense to real estate managers. That’s an entire industry that has a focus. If indeed, and we’ve done a series of investments in med tech, so basically what you need is somebody who understands the marketplace for these technologies. Here’s the problem with investing in research. Science is not the thing that adds value, it’s the application of the science in the marketplace. So you need somebody who knows the marketplace. So you have to go to a professor and you have to say, “Hey, you know the science, now you need somebody who needs to know the application space for the science.” And that’s different. They don’t have to be you, but they have to be somebody who is in effect, creating value through the application of the technology. That’s a different thought process. That’s a quite different thought process, because at some point it has to be commercialized. Now, if you’re just busy selling patents, if you will, you can do that. But then hire a patent troll, they’ll know how to do all that stuff too. So you still have somebody who’s going to spend all their time thinking about that. So there’s an intellectual foundation for a business and there’s an application foundation, if you want to think of it that way, maybe. So you still really haven’t defeated the argument. My two-person model is still the best model and that’s what should be pursued to create value. You know, I’ve been in the consulting world, which is sort of the intellectualization of business, right, which is all about strategies and frameworks and methods. And I worked at a think tank, for a number of years, doing this kind of published work. I get the academic-business divide. The reality is, is putting something in the marketplace takes balls. Period. Yeah.

Richard Miles (16:05):

So it sounds like important advice. Number one is it’s not enough to get somebody with a generic business background or business skills. You really need to have somebody who understands that particular market in which you’re trying to enter with your technology.

Ron Tarro (16:17):

And came out of networks, and networks and telecommunication. And there’s some young motivated types that can come up those learning curves, and that’s all great. But listen, if you want a CEO, you probably want somebody who knows how telecom works. All the better, right? We’re going to get back to, what you don’t know can kill you, right? So they bring actually wisdom that an academic probably wouldn’t bring to the business.

Richard Miles (16:36):

So let’s talk about the strategy and the frameworks. Now let’s imagine a company and I’m sure you’ve got real-world examples of, let’s say they’ve gone through their first year. They’ve launched, they’re getting revenue. They’re doing pretty well. They’re starting to grow, but then they face some serious choices, right? Do we grow in this direction or that direction? You start having to make significant trade-offs in terms of hires or just start hiring like crazy. What are some of the pitfalls, let’s say after a successful year one, that companies make in terms of a strategic direction after that first 365 days?

Ron Tarro (17:05):

So I’ll change your 365 days, cause I’ll let that flex, and I’m going to look for certain milestones. So I carve up a company lifestyle this way, is somebody is in the phase of hacking value. It’s the idea that I have a technology and I am busy refining potential uses for it and testing that. A good program in that startup type of stuff, iCore, I think most of the academic world has seen the iCore program. If you want NSF funding, et cetera, there’s iCore, is certainly a help to that process. But this is the idea of, before I build it, should I, right? Or, and what should it do? So this is the idea of hacking your insight, right? Getting that really polished, such a way that you have an insight and you know how it’s going to be applied, then build a prototype. So I’m gonna look at a company first and say, where are you at with that, and have you established that as a phase? Second thing I’m gonna look at is, okay, let’s hack product market fit. Product market fit is this idea that somehow it’s the right set of features and it’s the right price, and you’ve demonstrated that by a bunch of things like, maybe selling it to a few people. And so hacking product market fit to me is you’re done with that based on basically a quick check. Are you having to force customers to take this product or are they excited to take it? And we can talk about how to do that. And you’re going to test your different ways to sell it and your messages and stuff like that. And then third, you’re going to hack growth, and hack growth is another way of saying, you’re going to hire more salespeople and you’re going to begin to accelerate because things start to get repeatable, right? Here’s the problem, if you haven’t properly hacked your product market fit, and now you start hiring salespeople, guess what happens? They work really, really hard and they don’t sell a lot. Or worse yet, they do sell something, customer doesn’t like it and is always yelling at you, and maybe they stop using it. So what’s going on? The ones who went through and did this in steps. It’s not a calendar step. It’s sort of like a testing thing almost to say, I have insight. I have fit. Now I’m going to chase growth. And then you start hiring salespeople and evolving your messages, and you decide whether you’re going to use in-house people or whatever, and that lots of different things can go on. But that’s how I look at it. And you can see more often than not, that’s how companies get stuck, is they actually didn’t do the first two steps. The other interesting thing that you see with companies is you can look at the marketplace, crossing the chasm, that guy, this idea that you’ve got innovators and early adopters. And when you’re a new company, brand new product, and this idea that you have, these innovators and early adopters, and when you’re first starting a company, you have a brand new product. The tendency is to take the product out there and convince everybody how great it is. And if you did your insight right, what you really want to do is just look for all the people who are desperate to have it.

Ron Tarro (19:40):

There are certain people that a narrow range of people who will be fast adopters to this; it could be people with a huge problem and they don’t care about the wrong or risk it takes on a new company, somebody who’s the perfect fit for the product. So you’re looking for people with perfect fit, not trying to convince the rest of the world that you have the next big thing. You’ll see a lot of folks doing a lot of presenting, and what they haven’t done is they haven’t narrowed everything down into a nice tight message to a very tight group of people. And so they burn weeks and months, even a year or two, break their picking because they’re tackling the wrong folks. The other side of that is you want the risk takers, the people who have such a big problem that take a risk on you, right? And what you’re going to have is the big corporates. Everyone says, I want to sell this. I want so-and-so to buy it, big NASDAQ, New York stock exchange company. The reality is is those folks more often than not are managing risk of technology acquisition, along with innovation. You need somebody who needs the innovation because they’re desperate for it. So, I watch where people are on the cycle of early stage, and what you find is that some people rush it and fail late, after they’ve collected a lot of money by the way, from investors or worse yet, from their mom. So now you’re sitting there going, well, what happened here? Well, you weren’t quite defined in what your product was. It’s interesting, the story of our company really was similar to this, which was, we built a piece of software that was essentially a middleware, to use software terms. And we put that software into very select companies that were very innovative and had very sophisticated requirements that only we could do. And so we’ve found that one and then this one and picked our way individually through the group until we said, okay, this is a story that’s turning out to be repeatable with everybody else, and we refined it. So it happens that way in real life. If you try to circumvent that, you lose.

Richard Miles (21:26):

Let’s talk some about CEO’s as managers. You referred earlier to the life cycle of an early stage company, and you start out say with four or five people on your team, and it’s more like a family or a basketball team than it is a company, right? Because everyone knows each other. It’s very close. And then you get a little bit bigger. Maybe now you’re 25 or 30 employees. And then one day you’re 150 to 200 employees, and that obviously requires a different management structure, a different management style as you start growing the company in size and scope. How many CEOs are able to successfully make that transition from five people working for them to 200 people working for them? And how often is the case where somebody says, you know, “All I ever want to do is manage startups, I don’t want to manage a big company. It’s not fun. It’s too bureaucratic. Blah, blah, blah.” What is the range of outcomes that you’ve seen?

Ron Tarro (22:13):

Well, actually you described it. Let me just put it this way, maybe. Let’s just talk about growth of a CEO. So I started a company, it’s getting bigger. How do I have to change personally, right? Now I came into a small company from a large, so I had some visibility on what it’s like to manage a more complex environment, I suppose. You go as a founder and a CEO to, in effect, managing a product and customers, right, and building a product, if you will, to, in effect, building an organization. So it’s almost better to view what you’re building as a machine. It’s a machine where, if you actually step back from it, the machine keeps running, right? So you see a lot of CEOs who, and they’re right in the short term, they could probably do everybody’s job better than the person they hired. This becomes untrue as time goes on or less true, anyway. It’s probably even untrue. And so, they hold on to stuff too long. If you show me an overwhelmed manager, the first thing I look for is a delegation problem where they’re not viewing your organization as an organism that care and feeding, if you will, and they haven’t spread things out. And the real telling thing happens when you become a manager of managers, that’s the break point where it forces you down this road. So if you’re reaching into your managers or over your managers, then you’re just in the wrong head space. So to me, the growth thing is you have to then begin to say, okay, “how do I set up structures and communication so that everybody knows what I know believes, what I believe is seeking what I seek, KPIs to use fancy terms, Key Performance Indicators, to design the organization a little bit, so everybody’s a believer?”

Ron Tarro (23:38):

Listen, Elon Musk is great. He knows how to do this intuitively, which is our mission is to get to the moon, right? Who believes that we should be on the moon? So he’s got a whole organization, absolutely energized to this big idea and lining everything up to it. Here’s all the steps. And that’s the big thing is that basic transition away from being the best at everything and the person who’s best at moving the chess pieces around, if you want to think of it that way or best at designing ways that everybody can get stuff done faster. You don’t give up everything, you know, you choose. So for me, an example of how we sold early on; I sold, because we’re not venture backed, so I was selling the product, if you will. Ended up then having a sales group. In the sales group, they would in effect do some selling, but I would focus on various strategic things like this customer right over here has to be the one that we get next, Marriott or something. And so, I’m actively involved in that, because it had a material impact. But once we got Marriott corporate on board, getting every Marriott hotel to in effect use our product, an entire team that could drive that. So you begin to move yourself into something and then back out. You look at the messaging, all your positioning. So in our case, it was strategic impact sales, and then also the product roadmap. What are we making and why? One of the most telling things, cause I obsess on Musk probably too much is he’s not the CEO he was. But if you look at where he spent his time, he spent it as chief product officer, chief engineers. He’s very focused, because the product is what makes the business as a foundation and then its application and alignment to the marketplace the second. Those are the two things. If you have a CFO, the CFO makes sure that the mine is not running out the door wrong or something, but those are not the core things for a CEO. The CEO is what do we make and who are we making it for and why does it matter, et cetera. And that’s until you go public. And even then, still that.

Richard Miles (25:24):

Do you see that often where a founder, the idea person says, I just want to stick with product, developing products because that’s what I love? Is that fairly common?

Ron Tarro (25:33):

One of the reasons I came into our company was our CTO and COO were like, “we really don’t want to run this,” our CTO just really wanted to stay on the product side, it’s all he wanted to do. And by the way, that’s a very honest self-assessment, just to say this is not something I want to do. You can still own a huge percentage equity of a company and do profoundly well, but you just don’t want to go through the brain damage to that other job over there. And by the way, since you are a founder, is you get to pick your job. So why shouldn’t you? I actually have a lot of respect for that. The idea that, especially with technical co-founders is I say, “I want to be on the technical track. I don’t want to be a CEO. I don’t want to be dealing with every HR issue and financial and market, this and blah, blah, blah. I want to design and make products.” That’s hugely valid and maybe even desirable if I were to go back.

Richard Miles (26:17):

Ron, why don’t we conclude with something you said at the very beginning. You mentioned, if you could give yourself advice, young Ron Tarro advice from the older Ron Tarro, what would it be in terms of lessons learned? Let’s say you’ve got the young idealistic tech guy at 22, 23, or tech woman, and they’re going to go conquer the world, start the next Facebook, whatever. What do you think their older selves would be telling them in 20 years?

Ron Tarro (26:40):

At the end of the day, I end up getting rather tactical. I’ve been asked this before and I end up getting, “I would’ve made this decision differently,” but in general, if I were looking at all of it, I would have much more peripheral vision than I did. In some sense, we were pretty good at this, but not good enough. So the idea that we could have gone into other verticals faster, that we could have accelerated faster, that we were a little bit too conservative in what we were up to. Now, the reality is it turned out okay. But I would say that there’s an element of luck to that, that is significantly large, so we beat the odds. In some sense it was our success, but it was also probably a limiting factor of the company. So in a lot of ways, there’s a tendency to try to make what you’re doing today better, more efficient, more whatever. And sometimes there’s a breakout idea that you should be focused on to really grow the company. You could reasonably argue that we didn’t have enough peripheral vision to make a bunch of decisions or even see the decisions to be made. And so the advice to myself would be to get wider faster on what’s going on with mega trends, et cetera. I’m like 75% convinced of what I just told you. Now we pivoted different products in different markets. And the other was a strictly technical one and maybe more tactical too. It was really fundamental. There’s this thing called technical debt in software, and technical debt is this idea that you designed a product that has an architecture, but as you grow, your architecture is not so cool. It doesn’t support the growth or better yet, it sort of turns into a hair ball and you’d be adding this and adding that. Customer A wants this and customer B, and you lose control of the core product, and I would say that you suffered from a technical debt issue, because as an early company in our segment, we said yes to everybody. Sure, we’ll do that. Sure, we’ll do that. And we did not take a step back and abstract, what we’re doing, get back to peripheral vision, why are we doing this, right? What’s the larger context. And so we literally had to take a year pause on our product to say, it’s time to remodel the house. We should have been remodeling the hallway and then also abstracting. And so this is very much a software technology CEO problem, very specific to my world, but this idea that you sort of lost control of your code base. And so now every time you wanted to do an update, it took you 47 horses and a mule to get a new release out, when it should’ve just been a horse. You end up with a slower and slower product cycle. And so, one of the big lessons on the technical side was to really approach, I think, the software engineering story differently, but we survived.

Richard Miles (28:58):

I actually have one final question, both from your personal experience and what you’ve seen. What does being a CEO do to somebody’s personal life? Because everyone thinks like I want to be my own boss, that’s the best thing in the world. But then once you are, you realize that you’ve exchanged some freedom for responsibility, right? Part of being your own boss is you have to worry literally for a time, at least, about just about everything. You don’t really get to go home at 5:00 PM or 6:00 PM and check out and then show up at work the next day. You are the person. What was that like for you? And what has it been like for others that you’ve seen in that position?

Ron Tarro (29:28):

Well, I thought about my business every day of the week and pretty much all day. So let me give you the motivation. There’s a moral case for a CEO, especially startups, with deep respect to startups. What you have is you’re changing the world in a positive way. You’re creating something that will improve something for somebody somewhere. And so, if you have a passion for that, that’s pretty cool. And that is a motivation. I find that CEOs that care about money, it’s a crappy and soul-deadening way to approach life. Money’s a by-product of changing the world in a cool way. And so if you’re chasing money, then you’re just chasing money, and there’s no excitement. Then work is work, a slave to a dollar rather than a slave to change. I think one of the things I heard, I always sort of kept in the back of my mind is if you’re a CEO in these companies, what you’re trying to do is, it’s not about you making a product. It’s about you solving a problem in the world for somebody. And so, stay focused on the product or the problem. And with that focus, everything else takes care of itself. It’s its own joy. You made this industry better. You made this customer better. You made the world better. Something to that effect. That’s a huge personal motivation and something worth chasing. Back to, are you in the business of making profitable rockets or are we trying to get to Mars? And what’s the big calling here? And so I think as a CEO, if you have that, then everything else kind of gets easy, and you start blending work, play, and purpose all together in one thing. And that’s much better than being a slave to a dollar.

Richard Miles (30:47):

Ron, thank you very much for joining me today on CEO 101. Lots of good advice. I hope all of your clients and your companies are doing well and do well, and look forward to having you back on the show at some point.

Ron Tarro (30:58):

Cool. Hey, it was very nice meeting you.

Outro (31:01):

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood, Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

In this episode, Dickey remembers the quick and drastic shift into the digital realm, a time when somebody like Steve Jobs showed up to Stanford University with his latest Apple products and showed them to eager students, including Dickey, who took inspiration from those moments—as well his own father’s history in broadcasting—to create his own company.

TRANSCRIPT:

Intro: (00:01)Starting and running your own company. It’s not for everyone, but for those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. So we decided to go on and talk to some of those people and find out what they’ve learned, what they’d repeat and what they’ll never do again. We’ll hear stories from their first year, then from the period when they realized they’re going to survive and how they intend to position their companies for the future. We’ll find out what a CEO’s normal day is like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is it time to move on? Joining us for CEO 101, a limited series of deep looks at people who are their own boss, for better or for worse.

Intro: (00:40)Today’s guest CEO, Lew Dickey came to prominence as co-founder and CEO of Atlanta-based Cumulus Media, the nation’s second largest radio company. He is also the co-founder and chairman of DM Luxury, America’s largest regional magazine company.

James Di Virgilio: (00:56)Lew, take us back to your first year, starting your venture. How did it feel to take on such a role and how did that necessitate some changes in your life?  Lew Dickey: (01:05)It’s interesting because I had a market research business that I was running and had started that when I got out of school back in 1985, and that business I was working for all the major television groups and radio groups across the country doing market research and strategy consulting. My sort of purview was nationwide. I was operating in dozens and dozens of markets from the largest to the smallest providing consulting services and market research, consumer insights. So I understood the landscape and I knew a lot of the owners and managers across the country. And I was doing some work for early stage venture capitalists that own some stations in the Caribbean, and they were a mess and I was down there helping this person try to get them figured out. And I was talking about the telco act, which had just passed. This was in 1996, the telco act that had passed beginning of that year and it was revolutionary. And it’s actually still the statute that governs telecommunications today. And I felt that there was an anomaly in the rules that made for an arbitrage where the mid-size and smaller markets actually could benefit from greater concentration based on the rules than the largest markets that may have 50 signals in them. And I said, look, the capital is sort of chasing the largest markets, and that was Infinity back in the day and Evergreen and a few others. And I said, they’re chasing the largest markets or is it a little more uncontested in the midsize and smaller markets?

Lew Dickey: (02:24)So I was explaining this to the VC and his response was, I don’t know anything about radio, clearly based on what you’re seeing with this mess, we’ve got in the islands here, but I do have some connections and we could raise some capital, it sounds like an interesting idea. And so we had that discussion on a long flight back from Barbados. And at that stage, we put it into action and we went out and put together a business plan to do this, to be a consolidator and midsize and smaller markets. Obviously we didn’t have any radio stations. We started with zero at the time. Now my father had some stations in Toledo, Ohio, and then we had as a family, some stations in Atlanta, Georgia. And then I had purchased earlier in 96, a station in Nashville with my brothers. And so we had three markets going into this, but they were in Atlanta, Nashville or larger than the markets we were going to go after, but Toledo would definitely fit, which was my father’s stations that he had had since 1965. So we launched the business, raised about $60 million from some insurance companies and state pensions and a private equity group out of Nations Bank, which is now obviously B of A and got started. But you start, you don’t have any stations. So you have to buy radio stations. You can’t start them from scratch, they’re licensed. So we went out and because of my knowledge and relationships across the country, that’s what I was tasked to do. And so I was on the road nonstop in essence, meeting people and reacquainting myself with others and leveraging relationships with some capital to buy radio stations. And so we bought a number of markets and continued to roll this up. And also keep in mind that to take everybody back to those days, you had top line growing like crazy. You had consolidation happening, and there was no digital competition to speak of here. See, you had a business that was growing nicely on the top line, you had great operating leverage and multiples were increasing.

Lew Dickey: (04:08)And so we started this thing in May of 97 after the capital was raised, started doing transactions in 97, and obviously it was at a breakneck pace in 98-99. We took the business public regular way IPO in July of 98, and then did a follow on offering in 99. We were rolling assets up pretty quickly. And so we were scaling this business fast. And then by the end of 99, we had enough critical mass that we now had to shift from sort of purely acquiring mode, just a deal machine, to really an operating business. And so I then shifted my role and became the chairman CEO of the business in early 2000, January of 2000. And we didn’t think about the early years of this. So I was 39 and was a first time CEO, first time public CEO. And we had a ton of radio stations that posed a set of challenges in that we had acquired dozens and dozens and dozens of assets from disparate owners, disparate cultures, competing factions inside of a market. And so the challenges for integration enormous. I remember on the IPO going around and we were meeting with prospective investors and they would ask about integration challenges. And it was somewhat lost on me, obviously, having not been through that. And everybody was learning real time, by the way. There was no handbook on this because the flood gates just opened in 1996, before that you could own 1:00 AM on FM in a market. So there was no consolidation. And so everybody was learning real time and, and as they say, sort of drinking through a fire hose. And so the integration risks or challenges were enormous and could not be foreseen. At least we weren’t smart enough to understand that. And so that was really job once I took over, which was to in essence, create a homogenous operating culture and take all of these sometimes warring factions within a market.

Lew Dickey: (05:58)You might buy five radio stations in a market from five different owners, and everyone had a different idea of how they wanted to do things, how they kept their books, what they thought of the other people who was going to survive, who would the manager be. And so these were a lot of challenges; now magnify that by 30, 40 times because of the number of markets that we were in, and it was an enormous amount of work. So on top of that, you also had to run the public company. So I was told early on by one of my mentors, Lowry Mays, who was enormously successful and had Clear Channel back then, now called iHeart. He told me early on, he says, “you’ve really got two jobs here; you’ve got to run the company and you got to run the stock, and sometimes they’re two entirely different jobs and you’ve got to make sure that you’re focused on both of them at all times. And I thought that was good advice. And so I did my best to heed it. And we had to effectively write the rule book in terms of how to bring all of these back to the operation side, how to bring all of these disparate radio stations and cultures and management styles, as they say in systems, and try to homogenize them and try to create a best practices approach to create something that we could scale with as we were going to continue to grow. And oftentimes it was very unpopular and people don’t like change particularly in a mature industry. And so we had to navigate those challenges and a lot of people, in essence, like to design their own jobs and you can’t do something like that when you have to have a smart division of labor, if you’re going to really operate the business as efficiently as possible, which is what the street was looking for.

Lew Dickey: (07:27)The other side of the job, to make sure that you had the operating margins that they were looking for in the operating leverage, which is just a fancy way of saying, as you grow a dollar of revenue, you grow a greater percentage of that in cash flow or EBITDA, which is the principal metric that the business was valued on. And so that was the challenge. And that’s what we were very focused on doing in the early days. And again, this was in the very early days in terms of software and how the business was managed and then taking a step back for a second. Prior to my research company that I started after school, I had started a software company in school with my freshmen dorm mate, and we created software for traffic and billing and for music scheduling and callout music research. So my background, the first company I actually started was a company called OmniSoft, was a software company for radio stations. So with that background, I actually brought him in as CTO, and we worked to understanding that the software was sort of a cottage industry broadcast software. And none of it was really very good, and so we wanted to create a really an integrated technology platform, sort of ERP, that would help run the business and would do so and enable us to, as they say, systemize, the approach to running radio stations, particularly the back office and the SGNA function. And so that’s what we did. But again, same sort of thing. You meet with resistance because a program director who was used to their music scheduling system that they had used for a long time, just like viewer on word, perfect. And somebody said, you want to go to Microsoft Word, met with resistance there. And so these are the sort of the things that we had to navigate through. So there were a lot of challenges. The good news is the economy was chugging along and the broadcast business was doing very, very well. So that sort of brings us up to the spring of 2000 before the.com crash. And then that created a whole separate set of challenges that we had to navigate. I can take a pause there if you’d like to ask any other questions.

James Di Virgilio: (09:25)So describe the beginning, the feeling, what some of the experiences might have been. And in fact, it might even be instructive to start with your time at Stanford, with a very first company you started. What stands out to you, putting yourself back in that mindset, starting a new venture, looking around and saying, here’s what we’re going to do. Here’s why we’re doing it. What is fresh in your mind about that sort of experience as a leader or a founder of a new venture?

Lew Dickey: (09:52)Sanford was a pretty fertile ground for it and you’d see it all around you. So it was easy to get caught up in it. And I can remember being at the undergraduate library and when Apple brought in the early Macintoshes and there was a big table in Meyer library, and a number of us were there and we were asked to use this mouse. And you remember the original Macs and look at this. And Steve jobs was in there walking around, talking to all of us. “What do you think of this? How does this work?” And doing a little focus group with half a dozen of us sitting around a table doing this, and obviously he was already a very big deal and a celebrity in his own right. And enormously successful. And so those were sort of the formative years and you were around that. And so it was easy to embrace that and want to participate and want to do something like that. And I knew the broadcast business because of my father’s stations in Toledo, having grown up in them. I never actually worked there, but I certainly was around it and understood the business. And so they were doing everything manually from music scheduling and tracking and billing. And he was looking to automate that and had proposals. I was out schooling and he said, you’re out there. Tell me what you want, what I should look at, and that’s how it started. I took a look at all these brochures and grabbed my buddy Alford, who was a computer science wizard and said, what do you think of all this stuff? And cocky freshmen. He’s like, hell, I could write that much better. And so that’s when we looked at it and said, all right, well, this is a business. It’s a good industry. Let’s do it. And that’s how we started it. And that was it. You didn’t know what you didn’t know. And at that stage of life, there’s so much success coming out of the young, smart kids that are out there and all around the country now. It’s great because you don’t know what you don’t know. And sometimes you need that blissful ignorance and self-assuredness to just go forward and do it. And that’s what we had. And it didn’t work that well.

James Di Virgilio: (11:30)And you mentioned sort of a blissful ignorance, perhaps hubris, right? There’s a lot of benefit to that when starting a new venture. Was there a time in any of your early years at these various ventures that you started, that you were perhaps afraid of failing, or you had a fear that this won’t work or what happens if this doesn’t work?

Lew Dickey: (11:47)No, there really wasn’t, I’ve never been afraid of failing. And I’ve always sort of thought when I went into something that I was going to succeed, and I think that that never really entered my mind. I think, you know, later in life, when you have a lot of responsibility, it’s difficult to walk away from something. Then I think it’s just common sense. People are much more risk averse, and it’s very hard to do that. And you have to really think about failure and consequences. Particularly you have real responsibilities, which is why that’s the perfect time to do it when you don’t and you can sort of let it fly and throw caution to the wind and just go and you have a good idea, chase it. And I think it’s the greatest feeling in the world. And I would encourage anybody who’s in a position to do so to do it. And I think as we all go through life and you have more responsibilities as you get older, that’s why, if you think about it and you want to do it as a young person without all of the responsibilities that could potentially weigh you down, do it. But to answer your question, no, I never really thought about failure or what, I was just sure that it was going to work out and it just scoped full speed ahead.

James Di Virgilio: (12:41)And looking back now, obviously here you are, right? Lots of experience, all the things you’ve done in your life. Looking back now to any one of those early stage moments, what is some wisdom you would have given to yourself? You’re in a time machine, you go back and you say, “Hey, young Lew, here’s some things at this stage that now I know that you should either not worry about or focus more on.” What are some of those things?

Lew Dickey: (13:01)I always try to do this, but you never really do it in the moment – you think about it in retrospect. But I always told myself to pay attention to people that had gone before me and try to absorb as much knowledge as you can from people who have had that experience, lived through it, had the school of hard knocks, paid for it, and trying to benefit from their experience. And even though I told myself that, and I think to an extent I did, and I was very fortunate enough to have some key mentors in the industry who were very helpful to me, in addition to my father, who was my number one mentor and blessed with an enormous amount of common sense and was in his own right, very successful. I just think that I could have done more in that respect, but I think about mistakes that you make, maybe it’s inevitable, but I think if possible, really hone in on and go the extra mile in terms of trying to learn from people who have walked there before you, because it really can provide a shortcut. You don’t have to learn everything. You don’t hear yourself or relearn it. And if some people have trodden that ground before you don’t be a dummy and learn from them. So I think I probably could have done a better job there.

James Di Virgilio: (14:01)Wise words there for sure. All right. Let’s take a look at the, we’ll call these the middle years, but really this is going to be anything in your mindset that sits out as middle to you. So you finished the startup years. You finished your early seed years. Now, you’re obviously a CEO you’re established to some degree. How did your normal day change compared to the early years?

Lew Dickey: (14:22)It’s less frenetic. You’re more on top of it. You understand the game, if you will. That comes with experience and seasoning. And was, I said, you have two jobs, you have to run the stock and you have to run the company and you just get better at both. And we were very aggressive, you know, continued to push and continued to grow and innovate wherever we could, whether it be new structures, deal structures, or continued to work on the technology platform. So I would just say that you get more comfortable, you know your way around, you’re known to the other people in the industry and in the investment community and Wall Street. And so I just think that it’s pretty much common sense. I just think the longer you’ve been doing it, the better you get. You’re just more productive. You’re not putting out fires to that extent. And you’re building a good team and all that as a prerequisite to building a lasting enterprise.

James Di Virgilio: (15:09)You’ve got a foundation set, and now you’re beginning the optimization period, and you mentioned the team. Did your original team change just a little bit or significantly from the early years to more of the middle years?

Lew Dickey: (15:20)Yes it did, but that’s inevitable in business. So you think about the C-suite yes. We changed CFO, we changed some of the key operating people, and then obviously you’re constantly having change, which is just the nature of business within business units. And it’s a very distributed business, which is very different from a tech company or a large software company where everything tends to be in one area. Even though you’re doing business around the world. In the radio business, you don’t have a large corporate staff; at the Heights, we had 7,000 employees and we may have had 75 at corporate. And so you’re talking about 1-2% of your employees are at corporate and everybody else’s out in the field and you’ve got business units that run their own P and L’s and they report up. So that’s the way to think about it. James Di Virgilio: (16:01)So you have this obviously changing, as you’ve mentioned, responsibility landscape. Your roles become not more defined, but certainly you take the lessons that you’ve learned and you know some things you want to apply. What were some of the focus points that shifted from the early years to the middle years? What were some of the priorities that perhaps changed as the business grew and there were different challenges that needed to be addressed?

Lew Dickey: (16:22)Well, all businesses go through challenges. I think we had early on the need to, I called it professionalize the business from a lot of the mom and pops that sort of ran it out of their checkbook and didn’t have what normal industry practices would be away from the broadcast industry. Something like CRM or an ERP system, the various checks and balances that you would need for timely reporting sales training. These are things that were really done ad hoc. Some of them didn’t do it at all. And so in essence, to professionalize and try to create standards and best practices and drive those through the organization. So you could effectively scale it and leverage your management structure and create something where you could have upward mobility within the company, which I thought was an extremely important part. And if you had a very small market, if you were in Macon, Georgia, or Albany, Georgia, and you wanted somebody to be in a position to be able to run Atlanta, the skillset required to do it is essentially the same. It’s the same business. It’s this question of, if you have the right standardization and processes that are consistent or homogenous throughout the organization, you can really create upward mobility. And there really wasn’t a lot of that, I think in the industry. The people who ascended to roles in markets were generally people who came up in those markets rather than people who came from a smaller market or a hub market and moved up. And so there wasn’t a lot of that in the industry. So I wanted to create something that would give people the opportunity to do that and move if they so desire, it wouldn’t just have to be running the market. Could be a sales manager, could be a key account manager, program, director, music, director, chief engineer, whatever role you would think of within a radio station, marketing promotions director. So those are the things that we wanted to create.

Lew Dickey: (17:59)And as I mentioned, it caused an awful lot of consternation to get folks to buy into that. And just simply because people are very, very, very resistant to change. And so that was the bane of my existence in trying to do that. But over time, people self-selected. And we actually went outside the business because we were systematized to that extent, we were able to then hire outside of the business and bring some people in from other industries, from hospitality, from other business services industries, into the broadcast business, which also I think was helpful in growing the talent base. So I think that all of that was very necessary and it was just a lot of hard knocks and scars to get it there, but that started to change over time. And then a lot of industries, particularly as we see now, more prevalent than ever, particularly through the pandemic, the broadcasting business, as well as traditional media, beginning with the newspaper industry, started to experience serious disruption by digital technology. And it happened to them first and they obviously missed the boat by allowing their content to be shared for free. And so in doing so, they devalued their content and consumers really began to believe that information was free. And I talked about this in my book, only a couple of newspapers really, successfully, have survived this; the New York times, Wall Street Journal, Financial Times, and others are working hard to do it. Most did not, and the reason is they let their information out for free, very early on and consumers came to expect it and didn’t value it. And then when they tried to erect a paywall consumers just moved on and there were plenty of others places they can find free information.

Lew Dickey: (19:43)So in my judgment, had the newspaper industry adopted the paywall approach early on…they never handed out New York times or Atlanta Constitution Journals free on the street corner. You had to buy them. And now that the information was available digitally on your personal computer, (which was back in the day, now obviously everything’s mobile) they were able to access that for free. And so I think they should have been much more careful about that early on. And clearly I think the motion picture industry was, and to a great extent television and the sports leagues, they understood the value of their content. Newspaper people didn’t. So as a result, newsrooms have been gutted, they’re off 70% in terms of staffing and hundreds of papers have closed and stopped printing, and others will do the same going forward. So it’s a very challenged industry simply because they didn’t get on it early enough. And on the broadcast side, it was really the competition for digital advertising. It wasn’t so much which that they were getting our product for free because in broadcasting, you already got the product for free. Our model was obviously distribute free to consumers and the advertisers pay for it. And there really was no digital competition for local radio per se. You had music services, but you always had record players and cassette players and CDs in the cars. So your music collection already had a separate outlet anyway that competed with broadcast. The difference was it was local advertisers, and national, but local advertisers which always represented about 85% of the business weighted average. They now had another choice and that was search and obviously social, which is why those behemoths now between the two of them, Google and Facebook, now have multiples probably 10 times, if not more, it could be as much as 15 times, the entire size of the radio industry, just in those two companies. So that dollar started moving in that direction. And obviously in a fixed inventory business, I started putting real pressure on rates because these businesses were growing at 20, 30% a year.

Lew Dickey: (21:23)And ad dollars tend to grow with nominal GDP, which we know is low single. And so as a result that you were seeing a real share shift away, and that’s why it crushed newspapers. It really began with Craigslist and the classifieds, which represented half of the newspapers’ profits and for a service, it was essentially free that started to decimate them. And then as people wouldn’t pay for their news, that sort of was the nail in the coffin then. And so you saw dollars go there, that business was gutted. And then it started to pick up steam, the shift in dollars away from local media into digital. And that’s what’s caused a great deal of problems today. So the radio industry was, I think at its height, 21-22 billion, and now it’s probably honing in on half that post pandemic. And we’ll see whether or not there is a rebound. I’m highly doubtful that there will be a significant rebound from here. X political, which was sort of supercharged in 2020, but I’m highly skeptical that in broadcast radio there’ll be a significant rebound and in television reruns, which they refer to as their subscription revenue, which obviously is coming from the MVPD now represents between that and political represents half the business. And obviously that never used to be the case. So they’re straight local ad dollars spot advertising is off dramatically as well.

James Di Virgilio: (22:34)This is a nice segue from what you just talked about, but now looking as a mature CEO facing a lot of the challenges you just mentioned, you’re in this stage, you’re no longer a disruptive startup force. You’re obviously steering a much larger ship. It’s harder to be as nimble as the college kids who are taking one idea and trying to improve upon it. So how do you handle the pressure as a CEO with all of these different changes that occur in your industry? How do you handle the pressure of the media of public opinion, your own employees when making these decisions?

Lew Dickey: (23:04)Well, it’s a good question and there’s no real single answer, I think, that can encapsulate that. You have to look at each of the constituents independently and you have a plan and then obviously you’re going to make mistakes and you’ve got to course correct, and you’ve got to do so as quickly as you possibly can. Some of these things, you have to take them as they come. The landscape is changing. You might be able to see a little bit around the corner, but nobody has perfect vision into the future. I certainly did not at the time predict the speed with which the shift would go to digital, the acceleration and the rate of it, that it would go. And I think that they would inform everybody in terms of balance sheet management, if anybody had that idea, you know, nobody’s downside cases had, I think, much of a shift or this rapid over shift taking place. And anybody who says they did would be fooling you because if that was the case, if anybody knew, then everybody would have put their companies up for sale five years earlier and been on top of it. So you don’t know at the time. And sometimes it’s hard when you’re in the forest to actually see the proverbial trees and understand that because you’re a cheerleader for your own book and what you’re doing, and sometimes it’s hard to have perfect objective information on this. And again, when there’s no precedent for it, it makes it even that much more difficult. So I think we worked very hard to innovate and saw some things coming to our credit. And we looked very hard at commerce and we had a commerce initiative, which was to in essence, look for a different revenue model from the reach. Radio always had great reach and still does have great reach. It’s just got a very challenged ad-based business model because it doesn’t have pricing power. And so you have to look for incremental ways to monetize an audience, which as I mentioned earlier, and as everybody knows, gets it for free.

Lew Dickey: (24:42)And so you have to look for smart ways to monetize. And commerce is a very interesting way to do that. We sell our ad units to help other people make money with their businesses. And is there a way to participate in that and have a revenue stream other than just selling commercial announcements? And so we had a commerce initiative. I definitely saw the need for, or the shift with digital, and that everybody sort of gets into everybody’s business because it’s all bits. And so the need for more of a multi-platform brand or approach to entertainment and media. And so we were looking at that. We had a good presence in country, so we created our Nash brand to do just that. Obviously at radio, we had a record label that we put together with Scott Porshanna. We bought country weekly magazine and converted that to Nash magazine that we bought from American media. And we’re looking for a cable channel TV outlet, to create this virtuous circle of content distribution monetization under a brand that could in essence attract a large and loyal audience. And so we were doing that, had a streaming proposal that we were doing with Yannis Frieze, who started Skype and sold it. And so we had some interesting things that we were doing. This is back in 20 13, 14, 15, so long time ago, I think a tad ahead of our time, these things would all be necessary today to evolve immediate business, but broadcast radio company into a modern media business.

James Di Virgilio: (26:03)Looking at the various stages that you were in: early, middle, mature, now. You always had to make decisions strategically with how you were going to run the business or compete. What informed those decisions, what was the playbook or the rubric, like how do you go about deciding how you’re going to compete or solve a problem, or basically move the industry forward?

Lew Dickey: (26:26)You’ve always got the constraint of your balance sheet, your capital structure. And so you have to weigh everything. So it’s easier to see what needs to be done. At least I always felt this way. It’s easier to understand what needs to be done and where you need to go than it is to actually go and do it based on the constraints that you have with your existing capital structure. So I don’t know if that answers your question, but I think you constantly have to understand sort of leverage liquidity and risk in anything that you do. And I always try to size up problems through that prism. And then in terms of moving the industry, like that was the other part of your question, it’s very difficult to do that. And because you have a lot of headstrong people that run their own businesses and more power to them, and they’re going to run their business as they see fit. And ultimately you compete against them. And if you can show a better way, perhaps they move and adopt your vision, or just try to copy you or emulate you. And so it’s very difficult to try to lead an industry. And I think that a lot of my colleagues, if they were trying to create a consortium to do something, and even if it was an incredibly noble effort and well thought out, my experience was that it was always really difficult to succeed there. And so sort of observing that, I always thought that there’s a better use of time than trying to get a bunch of people who have their own balance sheets and worries and concerns to try to do what you want them to do. And sometimes reflexively people are stubborn just because it’s coming from a competitor. And so those are the kinds of things that industry leadership in that respect, I always looked at as the best way to do that is to just chart your own course and lead by example. And if you’re successful, what you’re doing makes sense from an industrial logic perspective and the results are there, then people will follow. That’s sort of the best way to do it is you just have to lead by example, if you’re really trying to move an industry, there isn’t time for the brain damage that it takes to try and herd cats and get a bunch of disparate folks with disparate agendas to try to coalesce. Very, very, very difficult to do and in my judgment, not necessarily the best use of time.

James Di Virgilio: (28:29)Lew, wonderful stuff. Thank you for being with us here on the Radio Cade podcast, for spending a considerable amount of time with us today. And for Radio Cade, I’m James di Virgilio.

Outro: (28:36)Radio Cade is produced by the Cade Museum for Creativity and Invention, located in Gainesville, Florida. This podcast episode’s host was James di Virgilio and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

TRANSCRIPT:

Intro (00:01):

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace. Starting and running your own company: it’s not for everyone, but for those who have done it, it can be exhilarating, exhausting, and easily the hardest thing they’ve ever done. So we decided to go out and talk to some of those people and find out what they’ve learned, what they’d repeat, and what they’ll never do again. We’ll hear stories from their first year, then from the period when they realized they’re going to survive, and how they intend to position their companies for the future. We’ll find out what a CEO’s normal day’s like, how they build and manage their teams, what it’s done to their personal lives. And finally, when is the time to move on? Join us for CEO 101, a limited series of deep looks at people who are their own boss for better or for worse. This episode’s guest is Rick Carlson, CEO of SharpSpring, a comprehensive sales and marketing automation platform.

Richard Miles (01:25):

Rick, welcome to the show. Glad to have you on to get your experiences as CEO of SharpSpring. We’re going to start by talking about the very beginning. So if you could take us back literally to your first year, really your first few days as CEO, and let’s get a snapshot for people who’ve never done this before, what that is like. And obviously, you put in work before you probably became a CEO into the company, the idea, but let’s start with the first 30 days. You’ve got your company, it started, maybe it’s just you, maybe you have a handful of employees. What was that experience like?

Rick Carlson (01:56):

First off, thanks so much for having me, appreciate the opportunity and I’m glad to be here. So when I heard you pose the question, your first day as CEO, actually what immediately came to mind is during that first year or even two years, or maybe three years, I certainly did not think of myself as a CEO. CEO is what I am now managing a very large team with managers and a couple of hundred people. When I think about that first year, I think about struggling with a fledgling team where I am just another team member, and that’s exactly what it was like. I was a founder of a business, much more than a CEO, what somebody thinks of as a CEO today, and that means everything that you think it means. My co-founder and I, Travis, who was really the technical side (he remains our CTO today), we’re doing anything and everything that it took to survive, from raising money to making the coffee, to go buying the office supplies fortuitously. Just a week ago, Travis celebrated his ninth year with us and dug up one of his first emails to me about buying office supplies as he moved over from his previous company to start things. So very literally in that first year, it’s about being a team member and forming a team and doing whatever it takes to survive.

Richard Miles (03:17):

So at this stage, you can afford to tell great anecdotes about the early days, including maybe some early failures or things that didn’t work out, right? Do you have any stories–again, go back, limit yourself to maybe the first month or first few weeks–of something that you look back and smile now, but at the time you considered it a disaster or failure, or just a really bad day?

Rick Carlson (03:37):

Depending on which lens you think about SharpSpring, my business, in some senses, it feels like we had a straight line to success. Like we did not have to pivot our business model. Once we got to market, we started selling and I think it’s even more common that a business pivots once or twice before it really finds its footing. Through that lens, SharpSpring was pretty straightforward, but being more on track to the question that you asked, there are so many failures that it’s too hard to name one in every sort of micro way. There are more failures than you can count. It’s a winding road. So I have put our development teams and the early days through so many useless development features projects that never took off and meant anything to any one of our customers. And over the years, we think we’ve gotten a little bit smarter about how we make those decisions, but an immense amount of wasted effort on this sort of winding road to figure out what customers want and how our business is supposed to work. Again, though, if you backed up, it would look like a straight line for us. So I hope that paradox makes sense to your listeners.

Richard Miles (04:51):

So all the management books, or most of them, focus on one of the most important things you do as a founder, CEO, is who you hire. So again, going back to this first few weeks, did you have sort of a template in mind already of like, this is the person that my co-founder and I want to work at this company? Did you have, literally, a list of qualifications, or did you just sort of figure it out as you went along? What constituted a good employee for SharpSpring and a bad employee for SharpSpring?

Rick Carlson (05:18):

Yeah, great question. Like everything in a startup, my vision of what I wanted was almost immediately thrown out the window, and we were left with reality. But the specific story there is that I left a great job in internet security to start SharpSpring and intended to found it with somebody different than the person I ended up founding it with. So I quit the job. I moved back to Gainesville, I’m in it, up to my neck, and I get a call from the original co-founder who said, “Guess what? I can’t do this. My wife is having twins and I just can’t take the risk with you. I’m so sorry, Rick.” So yeah, I had exactly the right guy in mind and before we could even really get started, the best laid plans as they were, right? I think that there’s a lesson there though, which is press forward, and I found a lot of luck involved in this. So pressing forward is not always enough to be very clear, but it is required. And so I press forward and was lucky enough to find Travis Whitten, who founded the company with me ultimately. And we found a third person in the early days. And between the three of us, we had a super complimentary skillset. Travis backend architecture, fantastic developer, could really build anything we imagined. I sort of brought the business model and product vision to the company. And then we had another gentleman, Joe Kelly, who came from Grooveshark. Some of your listeners probably are very familiar with Grooveshark. Between the three of us, we were able to build a product and get to market. And so it was a super powerful team. And I’ve read a lot about this, a lot of companies are founded with three. That’s, sort of a magic number. It feels rare that two people can cover all the ground to make things work out of the gates, and four starts to become a crowd if you will, and in essence, three doesn’t appear to be a crowd when it comes to starting a business.

Richard Miles (07:16):

Good answer. Okay, final question on the early days: I’m sure you’re at the stage in your career, having succeeded as you are, that you’re probably asked for advice a lot by people wanting to do something similar. What sort of advice do you give to people who say, “Okay, I’m ready to jump out the window. I’m quitting my good job, and I’m going to go out on my own, start my company.” Or what wisdom would you have given yourself now, looking back, talking about everything from the completely mundane to the inspirational. So like, “hey, make sure you buy a fire extinguisher” or “believe in yourself,” whatever. What are a key piece of advice you would give to somebody, let’s say tomorrow, that was about to start their own company?

Rick Carlson (07:52):

Yeah, so, I think that answer depends on the experience of the person who’s wanting to start the business. So yes, you’re right. I do get people, different experience levels, asking, “Hey, I’m thinking about doing this.” In my mind, there’s a magic window, and that window is bigger for some people than others. That the magic window I’m talking about is where you have enough experience. You have enough knowledge of the market that you’re trying to get into, or problem that you’re trying to solve for your customers, that’s a whole other conversation. Incidentally, being able to solve a customer’s problem is not enough to start a business. But, anyway, you’ve got enough experience, and yet at the same time, you haven’t gotten bogged down with life, family, children, mortgages, all the things that mean you’ve got to find security and so forth. And so there’s a window there that it feels like gives you the best chance to succeed with the experience, and yet allows you to take the risks that you need to take. And sometimes, people wait too long and they realize it’s just impractical to start a business. I mentioned my original co-founder all of a sudden having twins. It’s a perfect example of that. And then I see people who are maybe starting a business a little bit too early, before they’ve gotten into the market that they’re trying to attack and participate in. It’s not to say that they can’t succeed. People succeed all the time, but we’re talking about giving yourself the best chance and having that experience to put to bare, I think is a really important thing. So that’s the framework I like to think about these things. Also, you should have a fire extinguisher.

Richard Miles (09:26):

No, it was good advice, right? So Rick, I’m literally going to go off script here. I’m going to ask you a question we hadn’t thought about, but something you said triggered it when you decided, okay, I’m going to do this. I’m going to go try to start my own company. What was the most common reaction from friends and family? Did they go, “All right, Rick, go get them!” Or were they like, “Whoa, uh, what are you doing?” What sort of reactions did you get from those who knew you best?

Rick Carlson (09:50):

For most people, it wasn’t a surprise at all. For me, and anybody who is listening to this that knows me, knows this to be true, very difficult for me to work underneath somebody else. It was almost a requirement that I go and start my own thing, because working for 40 years for somebody else, with my personality, probably not going to work.

Richard Miles (10:10):

So this sounds like it was part of a plea deal, right?

Rick Carlson (10:14):

[Laughter] Well put, well put, exactly right. I think it was just a foregone conclusion. But even before I figured that out, when I was a teen, I knew that I had no idea what business–I mean, it could have been a restaurant at the time, but I just knew I wanted to start my own business. And so, I don’t think it surprised anybody. I still think people, parents and so forth, it’s not to say they weren’t worried. They weren’t surprised, but not to say they weren’t worried at the same time.

Richard Miles (10:43):

I’m sure you did no complaining whatsoever, so they probably didn’t even know if you’d had a bad day, right?

Rick Carlson (10:48):

Yeah, that’s right. Well, just in terms of generational changes, my father was somebody who worked for an electric company for his entire career. And what you sought at the time was security and a pension. And so even before I started a business, what’s commonplace today, switching jobs every couple years and trying different things was just foreign to them. And so, yeah, there was a complete lack of understanding. And it’s only just in the last few years where people go, “okay, you knew what you were doing,” so.

Richard Miles (11:20):

Let’s talk a little bit about the middle years, and I know that’s a relative term, depending on what company we’re talking about, but let’s start as a discussion point. Let’s say a year or two. So you’ve been doing this for a year, and presumably at that point you had more than three employees, your personal priorities in terms of how you spent your day as the founder slash CEO were probably starting to change. Maybe the original team was starting to change. You’re beyond the, “okay, we may fail tomorrow stage,” but you haven’t quite hit the big time yet either. Was it a surprise in terms of the new challenges or did it just seem like this is day 366, it’s not really any different than day five?

Rick Carlson (11:54):

There are absolutely stages to the thing, where everything felt different. For me, again, I was the guy that the first year and a half, two years, pretty fantastic for me. I raised some money. I knew how to do that–again, I had some experience–and so I was able to raise some money, and a lot of the burden was on Travis and the dev team to actually build the product. And I remember distinctly, it took us a couple of years, even though we were building an MVP product and trying to get to market quickly, because our product category in many ways had already been defined by the market, took us a while to build our version of it and the layering on the new things. And I remember distinctly, after two years of hard work from my teammates, not to say that I wasn’t working hard during that time doing my thing, but the burden shifted over to me. I promised these guys we can sell, I promised these guys we could market, and all of a sudden we had to go and do that. And I remember the first month we went to market, we sold exactly nothing, and that was because we had unrealistic expectations of the sales cycle. And thankfully in the second month we started to do some things, but I definitely remember a stressful period during that time. Then I remember a third phase, in what I would call those middle or teenage years, where all of a sudden we had enough customers and gosh, it became even harder. So first it was like raising money, which is actually sort of the easy part, then it’s your initial sales, and then you’ve got this customer base. Now you’ve got to keep selling, you probably have to keep raising money, and now you’ve got to support customers. So it just layers on these incremental obligations and complexities and difficulties as time goes on, which doesn’t paint a very beautiful picture. But I think running a business can be pretty messy. It’s not to say it’s also not fun and rewarding and that you learn things, but that’s how I remember the years, two and three and those earlier years.

Richard Miles (13:55):

It’s almost more of a challenge to grow and succeed, right, than to decline and fail because decline and fail, your world keeps getting smaller, but the growing and succeeding you’re now, like you said, adding layers of complexity that somebody’s got to manage, and somebody’s got to think about it.

Rick Carlson (14:10):

That’s a fantastic way to put it. I think that’s exactly right. Mentally, clearly the opposite is true when you’re not succeeding. And sometimes even when you are and when you’re marginally successful, it can take a real mental toll on you. It’s really tough to work that hard and not succeed, which is the case with a lot of businesses. And if you’re in that situation, you have to remember that that’s okay, and that’s part of the thing and that most businesses don’t succeed. But I think that’s exactly right on the operational side of things; you get to the next level, and there’s a whole new set of complexity that you’ve got to figure out how to manage. And I could keep going into stage four and five. I think I described three of them so far, but I’ll stop there.

Richard Miles (14:48):

That’s a perfect segue into the next topic. Now, we’re bringing you up to the present day. So if this were a movie, the flashback would be over, the characters back in the present day. So I can only imagine that your duties may be significantly different than they were when you first started. Maybe you’re further detached from the actual production of the product, so to speak and even sales. So what are you spending most of your time on now in the company? And then, describe some of those additional challenges that you have to take on at this level. I imagine dealing with the media, dealing with public opinion, dealing with a lot more employees is a bit more of a challenge. So what is that like today?

Rick Carlson (15:27):

I think I left off where we’re all of a sudden, we were selling and then we had all these customers to manage and so forth. Along the way you hire a bunch of people, and there’s a phase when we first started our conversation today, I said, I didn’t feel like a CEO. I felt like a member of a team, a founder, a part of a team. Somewhere along the line, you become a CEO, and there’s a difference, and what was striking to me was when people started to treat me–when we had enough employees–where people started to treat me as a CEO, and I struggled with it, actually. There were things that I could say to a teammate in even an abrasive way, because that person knew that we were on the same team and they knew what I meant, and they knew we were all going in the same direction. And it was no big deal because, you know, we’re just onto the next thing, and we’re all pressured. But as a CEO, saying exactly the same thing to somebody who doesn’t know you as well, who thinks of you as a, not a teammate or a founder, but as a CEO, even the smallest things you say could really ruin someone’s day. So there’s this transition that takes place. I can’t pinpoint it, but it’s part of the detachment that you mentioned. You’re right. Like I used to know everybody on the team, and I used to be able to spot talent personally and see somebody who’s making a mark. And now, you are separated by a layer or sometimes even two layers of management, and you’re not intimately involved in really any process. You try to dabble in everything, but you’re not as deep in any process. And I think you know this, but we’re actually public, and so there’s a strange story to how we became public, but we’re a public company. So a lot of my time now is dealing with analysts and banks in New York and everywhere, and key investors, and new potential investors, and our public company board. And that carves out a big chunk of time that would, in the early days, be a hundred percent focused on the business. So it’s a pyramid with your customers sort of at the bottom of the pyramid, and the bigger the organization gets, the taller the pyramid, the further you are away from those customers and what’s happening sort of at the ground level, if you will. I think I just described a multilevel marketing company. I hope, I hope I didn’t do that.

Richard Miles (17:47):

That’s what, that’s how I will describe in the show notes, exactly [laughter]. I think the transition comes when everyone starts laughing at all your jokes and you win all your golf games, then you know, you’re really the CEO, right?

Rick Carlson (17:57):

That is required from day one, Richard, that was day one where we just, everybody knew that about me. You got to laugh at the jokes. It’s the uncomfortable laugh.

Richard Miles (18:06):

And they laugh when you know the joke wasn’t funny. But it’s interesting what you say, just the limited experience I’ve had with running the Cade Museum and starting it, is in a way, you have to keep reinventing yourself, right? Because you keep having to redefine, how do I add value? And it’s not the same way as you did in week one or year one, when, as you said, you may be down there with the floor level programmers and workers and you no longer really add value to the company doing that anymore. You’ve got to do, like you said, talk to the Wall Street analysts and talk to the media and that’s how you add value. But in a sense, it’s a shifting target, right? As a company gets bigger and bigger, and as you said, you have other layers of management, even those things, eventually, maybe somebody else will do, right?

Rick Carlson (18:46):

Yeah, you are a hundred percent spot on, that you have to reinvent yourself. You can cause more harm than good actually by, by not doing that, not evolving, which isn’t to say as I sit here and proudly declare that I’ve figured that out. It’s not to say. I know it to be true, and yet it’s a work in progress for me, constantly trying to evolve and figure out how I can be the least disruptive and add the most value, right? I would actually go further since we’re on the topic, that is true of every person in the company and every process, every process in the company. So one of the things that I’ve talked about with the nucleus of people that have worked together 5, 6, 7 years now, and we have constantly built up processes, they’ve worked and then somehow 12 or 18 months later, because of the size of the company, because of other changes in the company, they no longer work. So there’s a process of tearing down the processes that worked yesterday and rebuilding them. The obvious examples, when you’re 20 employees and you need to communicate something, you yell it out because you’re all in the same room, right? There’s that sort of thing. When all of a sudden you’ve got departments, it’s a totally different communication style. When you’ve got enough departments of enough size where the interaction between departments and coordinating two, three departments, almost like they’re people. Each department has a personality, it has their own needs and goals and ambitions, and trying to coordinate that, it requires different processes. And so going back to the original question you posed, it’s absolutely, as a CEO, tearing down my idea of the value that I create and rebuilding it, but it’s also true of, I think every process in the business, by my estimation.

Richard Miles (20:44):

I like the way you put it. It almost gives you a sneaking sympathy for large bureaucracies, right? Because you can understand how bureaucratic processes get put in place to coordinate ever larger and larger companies or government agencies and so on. But then of course, you’ve got to be careful because that also tends to sort of throttle creativity and make people risk averse and all those things. So it’s a real challenge, right? How to get bigger, stay coordinated yet without killing the dream with all your employees, so to speak.

Rick Carlson (21:09):

Yeah, that’s exactly right. I could talk about that one point for a while, frankly. I remember with a certain amount of hubris and this is true today, by the way we, this is part of our corporate culture. We’re extremely proud of how nimble we are versus our competition. But I remember almost laughing about it and thinking about these much larger companies and how slow and cumbersome they were. In reality, we’ve taken a couple steps closer to those companies out of necessity. And guess what? Turns out when you’ve got 10,000 businesses using your software, you darn sure better have better QA than you had in the early days, right? And so there are definitely things that necessitate slowing down and communication and so many things. So it’s just one of the many things that, that changes over time with a business

Richard Miles (21:57):

Yeah, and when you’re publicly traded, best not to talk to the press after three martinis, right?

Rick Carlson (22:01):

Ah, a lesson, I’m still trying to learn [laughter]. No, that’s not true.

Richard Miles (22:04):

So let’s talk about, a little bit philosophical here, and I understand since you’re publicly traded, you can’t give me any secrets, and we don’t want any of our listeners to be indicted for insider trading here. But tell us a little bit about the model and strategy that maybe you had from day one or maybe you developed it. What was your strategic true north? Did you know, from the very beginning, okay, this model, this strategy we think is going to position us so that we beat our competitors. And if so, has that model and strategy changed or you just had to maybe tweak it? Is it still essentially, the model and business strategy that you have, is essentially the same as when you began with modifications?

Rick Carlson (22:41):

So, what I would say is the mission has been consistent, and the strategy has shifted once. And now we’re at an interesting stage forth with our business where the strategy isn’t shifting, but we’re layering on other concepts. So let me bring some of that to life. For our business, we’ve always had a mission of bringing what we call today, a revenue growth platform. Our product is traditionally known as marketing automation, but has grown well beyond that set of functionality now to basically being anything in, an SMB needs to manage their sales and marketing processes, s,o CRM and social media management and marketing automation and email. So that was always our mission to bring an affordable, easy to use solution to SMBs, of which there are millions of them. And as we spent all that time building our first version of the product, when we started the business, we saw it as greenfields because everything was up at the enterprise. Large businesses were using this and maybe medium-sized businesses, but SMBs were not. And over those years that we were feverously building, we saw other competition enter that space, and they were better brands with at the time better products and more well-funded, and by the way, really sophisticated marketers. So one of the strategic decisions we made and it’s less important to think about the decision itself and more about the impetus for the decision we had to figure out a way not to compete. And so often you hear people talk about figuring out ways to compete. Well, the thing to do is to figure out how not to compete. If you can find a place not to compete, it’s a much easier path to go down. And so early on, we decided to work with digital marketing agencies because we found that they were the path to get to these SMB businesses. And when we looked around, nobody was focused on them, and so that has been something we’ve done since we launched the business six years ago. Now we’ve got a brand that is becoming nationally known, that people are aware of. And we can potentially, in addition to working with agencies, approach businesses directly and so forth as we move forward. But I think for the listeners, for us, it was staying true to our mission of going after SMBs while figuring out that space in which we could avoid competition for as long as possible. That’s what I think we did successfully.

Richard Miles (25:14):

I read or heard, or maybe I just made it up, this idea of embrace your weaknesses in so far as the earlier, you understand what you’re not good at–and I’m not saying that your company wasn’t good at theirs–but it allows you to focus on their strengths and reach out and find somebody else to help you do this stuff that maybe you’re not as good at or interested in or whatnot. And I’ve always thought that’s pretty good advice, that the people or the companies that decide they’re going to be everything a to Z soup to nuts. Usually they’re just a can’t be, right. There are going to be certain aspects that they do better than others. And sometimes it just makes sense to think, like you said, choose not to compete in a certain area.

Rick Carlson (25:47):

Yeah, no, I think that’s right. Look, at least metaphorically, companies are a lot like people, and they’re going to have their strengths and weaknesses in their products and their people. I’m never going to be a weightlifter.

Richard Miles (25:58):

That was my next question, Rick.

Rick Carlson (26:01):

Yeah [laughter]. Anyway, there are things I’m not going to do. And there are things that our business is not going to do and being realistic about those things and working with what you have, applying your skills efficiently, is the key to everything.

Richard Miles (26:14):

So Rick, one final question, and I know you may have to plead the fifth amendment on this one, but coming back to you as a CEO, Rick Carlson, do you have an internal endpoint where you think, or, you know, you’ve accomplished pretty much everything you set out to do with this company and you know, it’s time to move on or have you not even thought about that?

Rick Carlson (26:31):

Well, the question is a multi-part question. First off, when you’re starting a business, like I was, which is hard to believe, but nine years ago now, we’ve been in the market roughly seven, but nine years ago, we chose to start the business. I’ve far surpassed what I set out to do back then. We thought we’d build something with a few million dollars of revenue and sell. It was the idea, and that would be the end of it. Maybe we go to another startup, that sort of thing. So by that measure, I have far surpassed it, but what I would say is still a lot of fun, still a lot of challenges. We’re lucky to be in a market that there’s no ticking time bomb in terms of we’re missing a wave or something where the market’s going to disappear. And it’s constantly, there’s new things that are coming out of the product to make it even more valuable to customers. And there’s new lessons to learn with how to manage an ever growing business. And so our folks know I’m prone to say, I’m always going to keep it interesting. Being in SharpSpring is always interesting. Sometimes it’s fun. Sometimes it’s not fun. Sometimes it’s challenging, but always interesting. And that I think has got me amped up for the next couple of years, for sure.

Richard Miles (27:39):

Isn’t that what Don Corleone said in the Godfather too, right? The mafia is always interesting, right?

Rick Carlson (27:44):

I actually don’t remember that quote. I think it keeps sucking me back in, right, or something like that. That’s exactly right,

Richard Miles (27:51):

Rick, that was great. I really appreciate having you on the show. You’re doing tremendous work, keep doing it. It’s inspirational on all sorts of different levels and wish you the best.

Rick Carlson (27:59):

Thanks so much for having me.

Outro (28:00):

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood, soundstage and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

TRANSCRIPT:

Intro (00:01): 

Inventors and their inventions Radio Cade, and podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida, the museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace. 

James Di Virgilio (00:40): 

Medicine that talks to you, or at least talks to your smartphone. That’s no longer the stuff of science fiction. It will soon be available for patients everywhere. Welcome to another episode of Radio Cade, I’m your host, James Di Virgilio. And today my guests are Eric Buffkin and Susan Baumgartner the developers of a system called ID Cap and the co-founder of a company called eTectRx. Welcome to the show, Eric and Susan. 

Eric Buffkin (01:03): 

Thanks very much. 

James Di Virgilio (01:04): 

So let’s dive right into your story. I spent a lot of time pre-show talking with you, Eric, about what you developed. It’s very fascinating. I’m sitting here looking at it right now, in its simplest form you developed a medical breakthrough, this something that doesn’t exist in its form. Tell us about what you’ve done, what you’ve created. 

Eric Buffkin (01:19): 

Probably the most important thing we invented James, is a way to communicate in an edible radio. And when you get right down to it, it’s a tiny little radio that’s small enough that you can swallow it and it can take power off of the chemicals in your stomach. And so you don’t need a battery. You don’t need much of anything. You can see it there it’s really tiny. And once you swallow it, it essentially starts transmitting. There are a lot of folks that have tried to do different things like this. You can get ingestible cameras for doing endoscopy’s and different things, but they’re typically fairly large, fairly expensive and not something you want to use to track when somebody takes every dose of their medication, which is what we’re trying to do. 

James Di Virgilio (01:56): 

Now, Susan, as a pharmacist, I have friends who are pharmacists, I know that one of the most important things is for patients to actually take their drugs. How often is it that patients are not taking their drugs on time or even taking them at all during a course of drug therapy? 

Susan Baumgartner (02:11): 

In terms of long term therapy, the numbers about 50%. So 50% of medicine is not taken as it’s prescribed or as it’s needed in patients. So that’s pretty big number and that’s the one that we’re trying to help solve for. 

James Di Virgilio (02:24): 

And that’s what creates a significant need, is if I’m the physician and I prescribe the medication, it’s not taken, my patient may not get better. And I can’t for sure say why I might prescribe another medication, which may be the wrong course of therapy. So in comes this solution, we understood and learned, you know, really recently that you’ve gotten FDA approval. Tell us about the process of getting FDA approval, because it’s not simple and for what you’re doing, it was essential. 

Eric Buffkin (02:47): 

So that would be Susan’s core area of expertise. She is the one responsible for wrestling the FDA to the ground and making them cry uncle. And in that regard. 

Susan Baumgartner (02:56): 

So we have extensively tested the product. So after Eric and his team developed an incredible product with amazing technology, we had to put it into a usable form so that patients could use it on a day to day basis. And physicians could take that and other healthcare professionals could take that information and really use that to improve health outcomes. And so the process for getting clearance takes several years. It actually was a period of about four to five years that we did the required testing for the product and that included putting it into humans and seeing how long it took for the battery to send a signal and how long it took for the reader that’s worn to detect that signal. And also how the communication flowed from the body to the patient, to the healthcare provider who might be using that information. So we did clinical testing. We did a series of making sure that what was swallowed was actually very safe and it moved through the system the way it was supposed to move through and did a number of bench tests that also made sure that it worked the way it needed to, and it produced the results that it needed to. 

James Di Virgilio (04:04): 

So I’m looking at the pill here in front of me, it’s a normal capsule size. The drug manufacturer would be able to put their drug into this, along with the ID cap. Right? I take that. And then within 30 minutes, a signal is sent to a reader which is going to collect the data of the medication that I’ve taken. So therefore the physician, myself, maybe even the drug company, potentially I can know that I’ve taken this drug. Now that’s the base level thought of what’s going on. Right? 

Eric Buffkin (04:29): 

Right. Exactly. It’s really a measuring stick so that you can measure how often and how frequently and how regularly somebody takes their medicine. And the big difference between this approach. You didn’t notice a confirmed ingestion. There are hundreds of other products out on the market. You can go on to the app store for iOS and probably find 20 different medication reminder apps. All of those will allow you to separate minders to remind you to take your medicine, but not one of those or confirm anything, same thing with little pill bottles or other organizers, you can get reminded, but there’s no way for the physician to know other than the report by the patient saying, doc, I took my medicine and there’s many cases where that’s simply not sufficient for the care or for the patient’s wellbeing. 

James Di Virgilio (05:11): 

Now, as you mentioned, Eric, this problem has been around for a long time. We’ve talked about this, right? 50% of patients are not taking their drugs or taking them correctly. This idea that you had was not a brand new one, it’s been attempted to have been solved before we understood. There’s a competitor that exists, that does something similar and you yourself and this company has been around for more than 10 years. It’s obviously been a journey. Oh yes. And with any entrepreneurial story, there’s some conflict points where we would call it. Maybe some drama points in a movie. Tell us about a few of those experiences that got you to where you were today, but were maybe unknown as you walk through them. 

Eric Buffkin (05:44): 

Oh jeepers, how long we have? 

James Di Virgilio (05:46): 

Hours. 

Eric Buffkin (05:47): 

Okay. We’ll try and narrow it down. So first of all, I was one of the co-founders of the company. I had Dr. Neil Yoliana a local PhD, brilliant man who was actually the aha guy, the guy who originally thought of the, hey why don’t we put a radio on a pill and be able to detect when somebody takes their medicine. And he and I met several years ago, I had some chip and radio background and he has a lot of biomedical engineering background. And so we started exploring this. He had actually had some funding from the NSF to work with some UF professors to do some early development. And so we took that development, started the company we’re moving down the path a couple of years into it. We were getting interesting experimental results thing. Wasn’t quite behave in the way we wanted it to behave. And we ended up hiring a new engineer out of St. Pete named Judd Sheets. Brilliant guy. Also, one of the things I have discovered is make sure all the guys you hire are a lot smarter than you are. That’s certainly the case in our company. And one of the first days Judd came in and he started looking at this system and say, wow, this is really cool stuff, but you know, it’ll never work the way you’ve got it designed. And that was kind of one of those aha moments of are you serious? And to his credit, he was absolutely right. And to his further credit, he allowed us to fix it, which is a big part of it. So that was a big drama point, especially for being about three years into the company. At that time, James, enough of your background in the investment community, you’ve dealt with a lot of folks that are entrepreneurs and startups. They say, you can tell you’re a pioneer by the arrows in your back. We had a few of those three or four years ago. We actually had to shut the company down for a period of time. The short story is we weren’t able to raise the investment we needed. We had to shut it down, tell everybody go home. And we were fortunate in that. We around it up a new set of investors who basically said, okay, everybody come back and recapitalize and we got restarted and we’ve been better capitalized and resourced since that time. And that’s, what’s really allowed us to get over the hump of this FDA clearance. So that near death experience will give you a few gray hairs. 

James Di Virgilio (07:38): 

You’ve mentioned so much in your story that resonates with so many other success stories, which wouldn’t feel like a success. If you stop that a lot of points along the way, what kept you believing in your vision of this idea, becoming a reality, despite financial issues, a decade of time going through having to deal with FDA approval, you had a lot of hurdles. What kept you going? Why didn’t you just pull the plug and say, you know what? This isn’t worth it. 

Eric Buffkin (08:02): 

And we still thought it was the right thing to do. I want to play off one thing Susan said, and also want Susan to share one of the other interesting conflict points, but drama points, maybe. The problem’s not going away. 50% of people are still not taking the medicine for all you hear and in the press about how high drug prices are pharmaceuticals are still one of the least expensive ways to treat somebody, compare it, to go into emergency room or go into the hospital. Still much less expensive. And 50% of people that don’t take their medicine results in hundreds of billions of dollars of completely avoidable costs to the healthcare system here in the U.S. that’s money that our taxes have to pay and that we have to pay and drives our insurance premiums and drives a lot of stuff. So the problem was still there. The need was still there. We felt like the opportunity was still there. So we kept kicking the can down the road, kept trying to move ahead. 

James Di Virgilio (08:47): 

Now, Susan, tell us about this drama points that Eric’s mentioning. 

Susan Baumgartner (08:50): 

I was just in a play off one thing that you said in terms of the adherence side of things, the current way that adherence is measured is through a self report by the patient. The patient tells their provider how they’ve been taking the medicine, and that’s not as objective as it needs to be when you’re looking at high cost therapy or you’re looking at the outcomes that you’re really trying to drive in a patient and in a care situation. And so our device ends up giving real time, look at medication use that has not been seen before. It gives the time that they’ve taken the medication. It gives medication patterns, really essential information when someone’s being discharged from a hospital or when they’re starting on a new therapy or they have a complex regimen or a very expensive regimen that is designed to produce a certain outcome in that patient. And so it helps to inform that and provide evidence to be able to make the best decisions for that patient and their care. 

James Di Virgilio (09:46): 

Yeah, you’re hitting the nail on the head. I follow nutrition very closely, and it’s almost impossible to do a really good academic study in nutrition because it’s all self-reported and you get all sorts of weird results because people say why this many calories this week, or this much protein, and certainly in medicine, it’s the same thing. Only. It’s a lot more serious when it comes to drug therapy. And so when you were telling your story about it, because it’s important because it needed to be done. I think that’s the neatest thing. I think in our modern times, there’s oftentimes a misconception about why entrepreneurs start businesses, why creativity maybe even occurs in almost every time it’s to solve a real problem that exists. And that’s what I’m hearing in your stories. There’s a real problem that patients are not taking their drugs correctly, which is leading to a lower result for their own health. And this is an elegant solution that can hopefully improve the outcomes for patients. 

Susan Baumgartner (10:34): 

Yes. You asked about the persistence of this idea and the company over time. And as Eric said, we were fortunate to have an infusion of funding and people who trusted that this was the right solution. And there was a large market opportunity. And fortunately at each of those critical pivot points where we could have said, it’s not going to work, or it’s going to be too long of a road, or the regulatory hurdles are just too much for a small company like ours, the team that developed it, the group that was working on implementing it, and the investors all stood behind and said, we’ve got to bring this to the market to improve care and to improve adherence monitoring. And that’s one of the points that I think Eric was bringing up was when we stood at the end of a very long, very expensive clinical trial and had results that didn’t look quite what we expected them to be. And it took a large and laborious investigation from all of our technical folks and the entire team to dissect that and try to figure out why is it that we know this product can deliver at this high level? And why did we not achieve that in this study? And fortunately through the hard work of the engineers and the development team, we were able to pinpoint exactly what it was correct it very quickly and move forward with additional clinical studies, to be able to demonstrate that we were performing at that high level. Just one of many examples of the incredible persistence of a team and the investment group to make things happen. 

James Di Virgilio (12:01): 

And today we’re sitting here and there’s a bottle of champagne on the table in front of the three of us. And Eric You were the first to do the living adventure series at the Cade Museum, and you are now the first recipient of the Cade’s gift to you and to your company for receiving FDA approval. So we go through these dramatic points in your story, you survive some tumultuous points. Now you have FDA approval. What’s next. 

Eric Buffkin (12:23): 

Boy, that’s a good question. Sell like crazy. The FDA clearance is essentially the permission by the regulatory authority to go take money for this thing. We’ve been developing for a long time and it is now of something we are going to do with great enthusiasm. We’re working on building collaborations with a lot of people in the ecosystem around how pharmaceuticals are delivered to patients. There’s a lot of important partnerships delivery for development, data flow reimbursement. So one thing that was another kind of, one of these ahas, I come out of the chip business, primary building microchips for consumer electronics and, and that business, once you get at work, you go sell it. And the person who buys it is the person who uses it. The healthcare market’s not quite so simple because the person who uses it, it’s not the person who’s paying for it. And the person who’s prescribing it. It’s a lot of intertwined things that have to be sorted out. And the whole machine has to be running before the business starts to ramp up. So, um, we’re hopefully going to be taking advantage of this clearance to help get that ramp going. 

James Di Virgilio (13:22): 

And so taking what you said into consideration, how long do you think it will be before I could take a capsule like this one and have data transmitted to it? Are we months away, years away, maybe? Hard to say? 

Eric Buffkin (13:33): 

I’m going to give you two answers. The first one I’m gonna give you the second one. I’m give Susan to answer. If you’re willing to sign up for one of the clinical studies, we have run in with multiple people around the country, you can do it tomorrow. It’s a matter of fact, I may have some informed consent forms in that truck, James, so we can walk you out there and sign you up. But on the commercial side, do you want to talk about the commercial a little bit better as to what the companies have to go through to actually introduce a commercial product? 

Susan Baumgartner (13:54): 

Yes, the product will actually be available by prescription only. So as Eric said, there are clinical studies right now in place where the product is being used and you could get access to it. If you are eligible for those studies in terms of bringing a product to market within our capsule and with the ingestible sensor in it, there is a pathway that is allowed for that through the FDA. And so we can provide a combination drug device product very soon, but more than likely in partnership with other companies and other payers and pharmaceutical companies will be able to take approved products, combine them with that sensor that’s available and have those available for clinical applications and clinical use very soon. 

Eric Buffkin (14:36): 

One thing probably should clarify, James is that eTectRx does not handle drugs. We don’t make drugs. We don’t distribute drugs. We’re not a pharmacy. We created this device to help feed into that chain of pharmaceutical manufacturers, our pharmacies, to do exactly what described there. So we’re providing an enabling component to make that happen. 

James Di Virgilio (14:55): 

Well, Eric and Susan, this has been wonderful. We definitely need to bring you back for a second session so we can dive further into there’s so much more we can talk about including your own backgrounds, which I know oftentimes play into our stories as entrepreneurs. I know Eric, you like the beach. I know there’s other things you’d like to fishing, boating, right? I see that you have, in fact, a fishing shirt, I feel like it’s Friday. Maybe you’re going to head out and hit the open water this weekend, but regardless, there’s so much to cover. This is so exciting. I think it’s really neat whenever you get to look at a solution that doesn’t exist, there’s nothing right now that exists like what you have. And it’s been great to talk about it. We should dive further into it. And for James Di Virgilio and Radio Cade, thanks for joining us. 

Eric Buffkin (15:33): 

Thanks very much for having us James. 

Outro (15:35): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist, Jacob Lawson. 

TRANSCRIPT:

Intro (00:01): 

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. 

Richard Miles (00:40): 

An EKG for the eye is helping people with diabetes to keep their eyesight. Welcome to radio Cade, I’m your host, Richard Miles. And today I’m talking to Dr. Lloyd Hildebrand and ophthalmologist and founder of two startup companies. Welcome to Radio Cade, Lloyd. 

Dr. Lloyd Hildebrand (00:53): 

Thank you very much. It’s good to be here. 

Richard Miles (00:55): 

So Lloyd, I got to say you’re the second Canadian I’ve interviewed in the last three days. And our listeners may begin to think I’ve fled to Manitoba, Saskatchewan or somewhere, but I promise from the beginning, no hockey jokes, no references to Molson or any of that nonsense. 

Dr. Lloyd Hildebrand (01:08): 

Okay. At least it’s not February and 40 below zero. 

Richard Miles (01:12): 

Exactly. But I did want to comment on that. Actually, you were born in Canada and you grew up in Brazil. You came back to Canada for medical school, you practice in Iowa for a few years as a physician, then some training in Oklahoma, you worked in Portland, Oregon for a while. And now you’re either in New York or Las Vegas. I can’t remember where you are at the moment. 

Dr. Lloyd Hildebrand (01:30): 

I’m in Las Vegas now. 

Richard Miles (01:31): 

So the obvious question is, are you on the run from the law or sort of what explains your trajectory, give us a snapshot of Lloyd Hildebrand and why it is you in so many different places? 

Dr. Lloyd Hildebrand (01:39): 

Sure. I was born in Canada and at age four, my family moved to Brazil, Southern Brazil. All my parents were missionaries there. And I lived there till I was age 16. I came back to Canada and finished high school and went to do my undergraduate work in my medical school in Winnipeg at the University of Manitoba. I then went into primary care and was a primary care physician for almost a decade one year in Canada, and then move to council Bluffs, Iowa, where I joined two of the Canadian physicians there in a primary care setting, doing family medicine there, obstetrics. I then went back to training in ophthalmology at the University of Oklahoma in Oklahoma city at the Dean McGee eye Institute, which is a large regional well known academic center and did a fellowship at a family plastic and reconstructive surgery in Portland, Oregon. That was a one year program. And I was recruited back to the University of Oklahoma at that time. And I spent 22 years there on faculty and went through the full academic career there. I retired in 2016 to go to New York and work on an artificial intelligence project. I worked a couple of companies that were working with IBM Watson at the time. And after that project is completed, now I’ve decided to come to Las Vegas, Nevada and I start work on Monday, two days from now. 

Richard Miles (02:55): 

You’re quite the traveler. I did note that you’ve actually hit both coasts and the dead center of the United States, Canada and Brazil. So you’ve got the hemisphere pretty well covered. Lloyd, let’s talk about your core idea that you’ve been working on for a while, but I think is fascinating. I think that what we’d like to spend most of our time today talking about, and then later the company or the companies that you have founded to spread those ideas. So let’s start talking about diabetes, which isn’t obviously connected to eyesight for a lot of people, but tell us what is the connection to vision? And then what is the problem that you are trying to solve? 

Dr. Lloyd Hildebrand (03:29): 

Sure, well, diabetes is the largest growing problem and growing very rapidly at epidemic proportions, diabetes really does a lot of its damage in terms of damaging the end organs, The eye being one of them, the kidney, the heart, and the brain are also organs that can be damaged. It’s usually damaged to the small blood vessel of the eye and that’s called diabetic retinopathy and diabetic retinopathy is actually the leading cause of preventable blindness in working aged Americans. So it’s a major cause of vision loss. The real challenge in diabetic retinopathy is that it’s easily treated. They’re very effective treatments and there’s very, very good research, probably one of the best research diseases in our scientific literature. And yet at the same time, it’s best treated when patients are asymptomatic. So therefore patients with diabetes, there’s a guideline recommendations for them to have an annual examination or evaluation of their retina to see if they have treatable disease. And if you treat the disease, you can prevent the blindness. If they start having symptoms, you can prevent the progression, but it’s very difficult to reverse the vision that they’ve already lost. So therefore the real challenge becomes how do you treat people in a timely way? And the way to do that is to evaluate them regularly and have a reliable test for doing that. The result of the healthcare system though is that only about 40 to 50% of people have that test done on a regular basis. And as a result, a lot of disease go detected until it becomes symptomatic. And they’re behind the eight ball in terms of treatment at that point in time. 

Richard Miles (05:05): 

Can you give us a sense of the magnitude of the problem and do you know, what is the percentage say of people who are going to develop diabetic retinopathy? If they’re not checked? I mean, reminds me a little bit of skin cancer or certain forms of skin cancer, right? Where if you detected easy to treat, if you don’t detect it, it’s highly lethal. What are we talking about in terms of those folks who don’t get checked? Are they in big, big trouble? 

Dr. Lloyd Hildebrand (05:27): 

80% of people will develop diabetic retinopathy at some point in their lifetime of the disease. And there are certain risk factors that are associated with it. How long you’ve had diabetes, how poorly controlled it is. So the hemoglobin a one C level or the level of blood sugar that you have also it’s associated with a higher risk of patients with high blood pressure and high cholesterol and triglyceride levels. So high lipid levels. So all three of those states combined to increase the risk of the patient in doing this. So the relative risk of people developing vision from this, there were about 40,000 people a year that go blind from diabetic retinopathy. So it’s significant and there’s a much larger group of people that then have what we call moderate vision loss and moderate vision loss. Wouldn’t be so moderate to you and I. It’s the loss of the ability to read newsprint and loss of the ability to drive. So they’re very, very significant impacts in terms of people’s lifestyle and activities of daily living. 

Richard Miles (06:24): 

It sounds like if you have diabetes or if one has diabetes, you should at least be aware of the problem. But if I understand it correctly, from what I’ve read, the key is you may get this recommendation from your primary care physician and then you get a referral to a specialist and it’s in that scene, right? That a lot of people just don’t get around to doing it, or they don’t want to do it or whatnot. And so a lot of people who are actually told are aware that this may be a problem, don’t do the critical follow-up and there for, they go largely undiagnosed. Do I have that right? 

Dr. Lloyd Hildebrand (06:53): 

That’s correct. So the big challenge in the healthcare system is what I call people falling off the wagon. And you fall off the wagon from the primary care setting to the eye care environment where the eye exam needs to be done. Part of that is because it’s asymptomatic people, don’t perceive the importance of it. Part of it is it takes time. It costs money to do that. Part of it is that there’s some resistance on the eyecare environment in terms of getting appointments in a timely way. So there’s some inconvenience factor in that as well. And some of it is just that people aren’t even referred for it because again, it’s the asymptomatic disease. 

Richard Miles (07:27): 

So tell me then about the technology that you’ve developed to make this more efficient. I assume a primary care physician can do this in his or her office or pretty rapidly, so you no longer have to refer them to a specialist. 

Dr. Lloyd Hildebrand (07:40): 

Yes. So again, drawing back from my experience as a primary care physician, diabetes has exploded since I last practiced as a primary care physician, but nonetheless, it was an important part of our treatment as well. And so one of the things that primary care physicians do very well is tests people find out when they hit a threshold of disease that needs a specialist and then send them onto a specialist. So our idea is if we could provide a test for a primary care physician to do that was reliable and accurate and convenient for them to do. And generally you have to consider also the economic aspects of it so that they can actually make some revenue from doing this. But that would be something that could help us address this issue because it would avoid patients having to move from the primary care setting to the eye care setting until they had what we call threshold disease or disease severe enough to need treatment. So the initial application that we did is we use the photographic technique to do this. There was a photographic technique developed by the national institutes of health that was used for all clinical trials that were done for the FDA, for the new treatments, for new therapies and for epidemiologic studies. And that technique was developed on film, very similar to the view master film reels of cartoons that we used to watch as kids, little view masters. And it used that ability to create stereo by creating these two different views, our initial solution for doing that in the first company, I started took photographs and converted that process from a film based process to a digital process, created a reading center. So the photographs could be done in the primary care setting sent to the reading center and a report sent back to the primary care physician with a red and green label on it, a lot more detail if they wanted to, but they knew that if it was ramped, they needed to send the patient onto the ophthalmologist for treatments. So what we’re using now instead of imaging technology is we’re using a different form of imaging electrophysiologic imaging, where we actually measure the electrical activity of the eye to determine whether or not there is disease present there. And so that’s where the EKG of the eye analogy comes from. So it’s simpler to do doesn’t require the challenges of imaging, particularly in patients with cataract, because it doesn’t require us to image through the eye to get the data and it can be done much quicker and the reimbursement model is better. So there are several different advantages to the techniques of doing that currently. So part of that then was developing the service in such a way so that it could be delivered in the primary care setting. The workflow would not interfere with how the primary care physician does his or her work, and then setting up a reading center to be able to interpret the data and then report it back and doing this all through a cloud based architecture for doing it, and then important to the primary care physicians that we be able to integrate this into their existing healthcare infrastructure, their EMR systems, and that isn’t such a trivial thing to do either. So once we got all of that established, we were actually rolling out our pilot site and then our pilot site was very successful. And once we were successful with that, we were really working on commercial deployment and that’s when COVID hit. So we have to shut down for awhile. And now we’re reopening at this point and time. 

Richard Miles (10:42): 

So that makes it sound like this idea should spread like wildfire, right? Because it sounds like a quite superior way of handling it. And probably it’s going to save if not lives, at least people’s vision. Let’s talk now about the companies that you founded, not just the origin story, sort of like the day, but also a little bit about the experience of doing so, because you’re not the first one that we’ve had on the show. They come from primarily an academic background. They hit upon a great idea through their research, or they are collaborators on somebody else’s original insight. And most of them find it a very challenging transition to go from the academic world in which you do research and you publish and you then move on to the next research and you don’t have to worry about who’s paying for the little lights over your head or air conditioning or any of that. When they go into this world, in which your idea doesn’t sell itself, it has to be developed it has to be tested. It has to be marketed, it has to be distributed. How did you get, first of all, the idea that you wanted to do this to be involved yourself, right? Cause there’s another path and simply you could license the technology. And a lot of people do that and you move on to whatever else you want to do in life, but you decided to take the hard road and actually get involved in not one but two companies. So tell us what was the impetus for doing that? And describe for us maybe your first, I dunno, six months, what was it like and what did you learn in those early days? 

Dr. Lloyd Hildebrand (12:01): 

A little bit of this is the story of necessity is the mother of invention. So a lot of this was stimulated by a need. I had to do something to do that, to keep the idea alive. We developed the technology in our labs and we had actually continued to grow and develop the idea. We’re validating the idea through research grants and doing it through the traditional academic settings. We had a very large national trial that was going to be done, which is going to be the largest clinical trial ever done through the VA system. It was funded. We got the highest scores ever granted the program. And then for some unknown reason, it was rescinded. Again, I’m still not clear on why that happened. It was an almost $10 million grant, which at the time was the largest grant ever granted the University of Oklahoma health sciences center. So when that happened, the university said, look, either you have to abandon the idea or what you need to do is commercialize this idea and license it out. So we said, fine, we’ll do that. And we had obtained a patent for it at the time. So we thought we had some very tangible intellectual property license it out, but again, those things are a little bit challenging to do. And it was hard to get somebody that understood what we were doing to fund the company and then to run the company as well. There were two other co-inventors with me and they asked one of us to step out. And so I actually took the short straw and stepped out of the academic environment on a leave of absence from the university, just as I was about to hit tenure, my tenure promotion. It was a bit of a challenge and it was something that I hadn’t done before. And I remember the driving force behind my initial business plan was the Ernst & Young book, How to Write a Business Plan. And I literally followed that line by line chapter by chapter and develop a business plan for doing that. And I started marketing the business plan locally in Oklahoma, at the time it was hard to do that because a lot of people didn’t really understand what we were doing and the.com was booming at the time. So I packed everything up and I went to California and I started cold calling people on Sandhill Road. 

Richard Miles (13:59): 

Did you have any mentors at all that you turned to, or that offered you advice or was it just the Ernst & Young book and trial and error? You know, their whole bunch of small steps when you start a company that you don’t even think about filing for registration and finding an office and getting office furniture, all those sort of things that in other circumstances just appear out of nowhere as you do your work, did you have a roadmap or did you just day by day figure out, well, I guess I’ve got to do this and I guess I got to do that. 

Dr. Lloyd Hildebrand (14:25): 

So it’s not that there weren’t mentors, but at that point in time, especially in our academic environment, we were fairly immature at this concept of commercializing technology. So I was a little bit of a pioneer in all of that. And I think I suffered a lot of the arrows that pioneers have in their backs as a result of that as well, but still I did have good mentorship from some business people in the community, some people inside the university and then some of foundations that supported research at the university and these people were early investors in the idea, if nothing else, they provided me with encouragement. But much of what I had to do is really learn on the job OJT for sure, on the job training for the largest part of it. And the most frustrating part about it was that we really had an investor community in the Southwest in Oklahoma and in the region that really didn’t understand the digital world and the digital technology. And that changed dramatically when I went to California, didn’t move there. But when I went there to visit with investors there. 

Richard Miles (15:23): 

Primary care physicians are your principle market. I take it right. I mean, they’re the ones who you really expect this, or at least their hospitals will buy it for them. Once you had the product up and going or something to offer, was it a struggle at all? Or was it difficult to sell them on this idea? I mean, having been one yourself, you knew the language, at least that wasn’t a hurdle, but were there cost considerations or ease of use consideration? Did they said like, yeah. Okay. It looks great, but you know, we’re just going to stick with what we do and that’s fine with us. What did you encounter that at all? Or was it an easy sell? 

Dr. Lloyd Hildebrand (15:52): 

It was not an easy sell, as you can imagine. Medical systems are very resistant to change. First of all. So innovation is difficult to get implemented in medical systems. And there’s plenty of doors in terms of how long that takes somewhere between 7 to 14 years to really get that kind of adopted change. That was one of the points of resistance. So one of the main concerns that they had is the reimbursement issues and the reimbursement issues were complex because of the regulatory events around reimbursement. So Medicare and CMS had certain regulations that we had to follow. There were anti kickback rules that had to be followed as well because of self referral issues. And there were some telemedicine laws that were also pretty antiquated at that point of time, particularly anything that was done out of state. And when that happened, then we also have to follow other new rules in terms of licensure to be able to do this in other States. So there were significant complications to doing that. And then there was the natural resistance of the medical system to changing anything that they’re doing. There was some resistance from organized ophthalmology as well, which seemed to think that this was a threat because the ophthalmologist perspective of the problem is I see every diabetic that comes in and I examine them. What they don’t realize is that 60% of them aren’t making it in. Right? And so that was also one of the burdens that we had to overcome in order to do this. 

Richard Miles (17:13): 

I think you pointed out an under-appreciated problem or problems in the medical device or healthcare industry, and that this is classic third payer problem, right? Where even if the physicians themselves love the product or love the technology very often, they’re not the ones paying for it, nor do they have to deal with the regulatory hurdles necessarily in getting to use it. So did you find yourself having to spend a lot of time at Medicare offices in Washington or with regulators and insurance companies convincing them, this was a good thing for the field? Or how did you negotiate those hurdles? 

Dr. Lloyd Hildebrand (17:48): 

So we actually had to develop a strategy who we call coverage and reimbursement. So first of all, we had to change the policies and make this acceptable in order to do that, we went to the accreditation body. First of all, MCQA that this would meet the quality regulations that were part of the heat it’s report card, which is the report card, measuring the quality of a health plan performance on all of this. So that’s the first thing we had to do. Then we had to go to individual payers in each marketplace in order to get them to provide coverage and the reimbursement for this. So part of that is that we did a technical assessment. There are these organizations that the Hayes group does technical assessments of new technologies that come out, get that done. They review the literature and then provide a judgment on whether or not this is a qualified test to be done. We then went into individual marketplaces and we, first of all, tried to get Medicare coverage for that region. And we did that by visiting with people at CMS central office in Baltimore first, and then with the local carriers and the local carriers each made their own decisions. There’s an interesting story about our initial visit to CMS. It was actually on 9/11 and it was at nine o’clock on 9/11. So you can imagine what that was like. As I was walking into the building, the building was streaming out and we were meeting with the director of CMS at the time Dr. Sean Tunis. And he asked us and said, do you want to stay for the meeting or not? And we said, well, if you’re willing to meet, we’ll still meet, but we understand if you don’t want to do that. And we met and then lights were all grounded by them. And so we rented the last car at the airport and drove 24 hours, back to Oklahoma city. So it’s a very memorable day when we got that, but it was also a very good meeting with Dr. Tunis. 

Richard Miles (19:29): 

Wow. You probably carried out one of the only previously scheduled meetings and actually finished it on 9/11. I was in Washington at the state department and it was quite chaotic and, um, yeah. 

Dr. Lloyd Hildebrand (19:38): 

It was very, very tense and we had just driven from DC to Baltimore. So during that time, it was a very interesting time and very chaotic time. 

Richard Miles (19:47): 

Let’s go back a bit now about the company. So you have two companies, right? The current one is Trinoveon did I pronounce that correctly or how you did, but then the first one was called Inoveon, right? Correct. Okay. What’s the meaning behind those words? And what’s the difference between the two companies? 

Dr. Lloyd Hildebrand (20:02): 

Well, Inoveon was the initial company that we did and really the name was an aggregation of the word innovation and eon, the age of innovation. And so that was really the concept behind it. And our mission really was the prevention of diabetic blindness, because that was our whole mission in doing that. And so we set that up and we developed the technology. We developed all of the protocols with the protocols, the workflow, the business model, the regulatory model, and then the competency reimbursement and coverage decisions with all the health plans. We went through some ups and downs. We had several investors cycles and all of that. And ultimately, we sold that company to a German company that was a health IT company based in Germany, focused in, on the ophthalmology space and the largest provider of EMR systems for ophthalmology in the world. That company was then acquired in the sharks and minnows game by Topcon, which is a large Japanese ophthalmic company. And they were very interested because they were developing the devices that we were using to do the imaging. And so this was a natural fit for what they wanted to do. However, they also had an internal team that was working on their own solution for this. And so when they acquired the company, they basically mothballed the company. But the residual of all of that was that we had one of the largest datasets for annotated data that had very high quality data and evaluations in it that were commensurate with the research quality data that the NIH trials had done. So we had about 3 million images in that dataset. So as a result that became valuable to some of the artificial intelligence groups that were out there, the Googles of the world, and some of the large pharmaceutical companies that were developing and some of them are device companies. And so that data set has become the core of some of the big data analytics that has gone into some of the automated image reading systems that are out there. The challenge with imaging system and reading is that there are some significant operational challenges doing that. Diabetics have a large incidence of cataract. So when you have a cataract, it’s difficult to get a good image. And when you don’t get a good image, you can’t get a good test result. There are other workflow issues and the cost of the equipment and the operation of the equipment is also complex. So we thought that might be a better way to do this. So after that company was sold and spun out and was doing all of those things, we continued to work on other new innovative technologies to solve the same problem. And that’s the origin of trying to Trinoveon. 

Richard Miles (22:26): 

So the difference in, let me see if I have this straight part of what the challenge was. You’ve got all this data, but the ability to interpret the data and is that where the AI comes in, it just makes it more efficient and more accurate. Is that correct? 

Dr. Lloyd Hildebrand (22:37): 

That’s part of it. We still haven’t validated that it’s more accurate. We had human readers doing it. We had a very, very high quality system doing it. In fact, in daily routine operations, we actually matched or out performed research, trial quality data in our reading centers. So that was still difficult to do. The second part of it is that what’s happened in the retinal imaging. It’s become more of a screening technology rather than a diagnostic technology. And so what they’ve done is dummy down some of the questions that they have, and trying to just basically find people that have some disease and just get those people over. And so they can eliminate about 50% of the population that way. 

Richard Miles (23:15): 

I see. I hadn’t thought about that key difference between screening and diagnostic. One is just kind of bare minimum to do with a triage sort. Right. And then the other one is to really try to understand the disease Lloyd, tell me, how do you spend your days now in terms of the life cycle of the company? Are you still primarily on the research and development end or strategic management or.. 

Dr. Lloyd Hildebrand (23:36): 

So the answer is yes, to all of those as you do at small companies, there is a difference with Trinoveon, so first of all, the technology is different instead of technology we’re using electrophysiologic imaging. 

Richard Miles (23:49): 

So it’s the electrical activity, not actual photos that makes this so much simpler or relatively less complicated than the systems that are in place now. 

Dr. Lloyd Hildebrand (23:58): 

Yeah. So the technology of the device is actually quite complex, but what we’re trying to do is we’re trying to simplify all of the workflow for the primary care physician. So it can be done simply by a medical technician and can be done in less than five minutes. That was really the goal of what we were trying to do. So we’ve systematically operationalized all of those aspects with a device that used to be a desktop device that you put your head into now its a handheld device, much like an ice cream scooper has a little cup on it like that, that you put over the eye and the electrode that goes onto the lower eyelid and attaches to the device. And then a series of flashing lights that trigger the electrical activity in the eye and auto correct any errors in it, getting a valid test. And once a valid test is done, it notifies the user of that. And they put it into a little holster and that holster sends it over the internet to our reading center. And then we send the report back to them. 

Richard Miles (24:52): 

Is something that if you went to your doctor, it would only be done if you were diabetic or is this potentially something you would do as a normal battery things that physician’s assistant will do before you see your primary care physician or is that over kill? 

Dr. Lloyd Hildebrand (25:05): 

So one of the critical elements of everything that we do is we try and make sure that there’s a very solid, scientific and clinical foundation behind it. So what we’ve done is we’ve only validated this approach for diabetic retinopathy at this point, electrophysiology of the eye is done for other conditions, such as glaucoma. Hypertension can also make some changes in the eye, but we haven’t validated that clinically, but those are some future applications that we had anticipated will happen. 

Richard Miles (25:31): 

Wow that sounds exciting. So usually what I’d like to do is give everyone on the show, a chance to dispense the many nuggets of wisdom that they’ve accumulated in their scientific and entrepreneurial journeys. And so I’m guessing that from time to time, you were asked for advice maybe from other startups or even other physicians who might be thinking of something similar, have you accumulated a short list of things that you wouldn’t do again, knowing what you know now or pitfalls you definitely stay away from if you were say, asked to serve as a consultant to somebody else’s business. 

Dr. Lloyd Hildebrand (26:00): 

Yeah. I think one of the real lessons that I’ve learned is that perseverance is probably as important as brilliance or intelligence in this game. Is that really persevering with the idea believing in it? And then when the naysayers come, it’s much easier to say no to something than to say, Oh yes, that’s wonderful. That was work. So I think you have to have perseverance and you have to be a little bit immune to some of the critique and criticism that are out there. Even from environments like the academic environment. Some of the harshest critique we took was actually from our research and development group at the university that was supposed to be supporting us for doing this. We had to work through constitutional amendment to the state constitution, which prohibited faculty from participating in equity positions in company. And so we have to work through a lot of these different issues in order to be able to even achieve it. Now, fortunately, we paved the path for other people to do it, and it’s a leisure to doing it, but they’re facing other challenges as a result. But I think perseverance is one of the key things. And I think the other one is really having a solid foundation for what you’re doing. That’s based in scientific merit, particularly in medical applications that has the validation to it always gives you the high road. And so when you face those challenges, knowing that you have that behind you, I think it’s a very, very powerful tool. Ultimately, sometimes it’s harder to sell people on that because they don’t believe you can do it, but once you can prove that you can do it, then I think it becomes a real selling point. 

Richard Miles (27:29): 

Right, because there’s nothing like confidence in your product. If you know it works, then it’s that much easier to go out and tell other people, I guess in many cases it’s a chicken and egg thing, right. You know that a certain trial probably will confirm or make confirm, but you need money to do that trial. And so how do you split the difference? Like, you know, I’m very, very confident, but I’m not certain and get somebody to fund that. 

Dr. Lloyd Hildebrand (27:49): 

The other lesson that you learn is that leadership in a company like this is lonely, it’s lonely at the top because ultimately somebody has to make the call. What’s your priority and spending, are you doing it on marketing? Are you doing it on research? Research people are pulling for more data, the marketing people just want more money, so they can go out and tell the message, right? And so you have to make all of these decisions, how much to invest in technology. And so when you’re making that final decision, I think you really have to think about what are the basic principles that you’re going for. What are the metrics that you’re using to assure that your decision is a good decision, then how do you implement that decision and not lose your organization. 

Richard Miles (28:25): 

The other comment I was going to make Lloyd is when you said that you didn’t get the support, maybe you’re expecting from the academic community. I was gonna say, I’m shocked, shocked to hear that that would take place pettiness in academia. And it reminds me of that famous. I think it’s a Henry Kitchener quote in which he said the fights in academia are so vicious because the stakes are so small. 

Dr. Lloyd Hildebrand (28:43): 

Well, that’s right in academics. And in a lot of ways is a very individual sport too, right? It’s a lot about how do I develop my own career and how do I prosper in that career? And so each individual achievement has to be allocated to somebody. And so that is one of the challenges. The second one is that entrepreneurship wasn’t typically viewed as part of the academic journey. And now I think a lot of those things have changed in some of the academic settings and entrepreneurship actually does count for some of that. So I think those are good changes. 

Richard Miles (29:13): 

Yes. And you’ve made a very impressive and rare transition, most academics. In fact, most academic adventures at some point say, you know, this is just not worth it. And I’m going to either get bought or let this go to somebody else. Although I guess you had the best of both worlds you got bought and you kept going, so that’s even better, but I commend you for sticking with it Because it is a tough road, lots of very bright, energetic, committed people who don’t ultimately succeed through a combination of circumstances. So congratulate you on doing it. Not once, but twice. 

Dr. Lloyd Hildebrand (29:40): 

I tell my children find something you do in life that makes it easy to get up in the morning. And usually that means that you find something significant. And when you experience a blind person and particularly somebody that’s blinded from something that was avoidable preventable or treatable, then you really realize the pain and suffering that you can prevent by doing something significant is really relevant to the world. And it’s meaningful. And I think that’s the main thing that drives me. I work in other blindness prevention programs internationally as well, cataract blindness that’s for example, and all of these activities I think are centered on this focus that I’ve tried to put into my career, which is how do we leverage information technology to give us better clinical tool. We have a lot of administrative tools in medicine that really encumber us more than they help us. So I’m really focused much more on the clinical side. It’s how do we get good tool to help us do this? And that was part of the work in AI that I’m very interested in continuing to foster as well. 

Richard Miles (30:35): 

Lloyd, thank you very much. These have been very inspiring, encouraging words. My takeaway from this is I need to start booking more Canadians clearly. 

Dr. Lloyd Hildebrand (30:43): 

That’s probably a good thing to do.

Richard Miles (30:46): 

Right, thanks very much for being on Radio Cade and hope to have you back at some point. 

Dr. Lloyd Hildebrand (30:49): 

Absolutely. Thank you very much for the opportunity. It was a pleasure. 

Outro (30:53): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews, podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson. 

TRANSCRIPT:

Intro (00:01): 

Inventors and their inventions. Welcome to Radio Cade the podcast from The Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them. We’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. 

Richard Miles (00:40): 

A neural enabled prosthesis. That is a hand that actually feels like a hand for people who have lost them. Welcome to Radio Cade, I’m your host Richard Miles. Today I’ll be talking to Dr. Ranu Jung professor and chair of the biomedical engineering department at Florida International University. The holder of multiple patents and a finalist for this year’s Cade Prize for Innovation. Congratulations and welcome to Radio Cade, Dr. Jung. 

Dr. Ranu Jung (01:04): 

Thank you, Richard, for giving me this opportunity to be on Radio Cade. I’m excited about talking to you. 

Richard Miles (01:10): 

So Ranu, if it’s okay. If I call you Ranu, you’ve been at Florida International University for about 10 years now, but you’ve also spent time at Arizona State University, University of Kentucky and Case Western University in Cleveland. But you started life in New Delhi, India and came to the United States in 1983. So the first thing I’d like to ask, you’ve had a very illustrious career in academia, but I’m very curious about what was your first impression of the United States? What did you think when you stepped off the plane, were you excited to, do you think you’d made a really big mistake? 

Dr. Ranu Jung (01:42): 

That’s a long time ago, but I was excited because I was going to be able to follow a dream and I had come specifically to follow biomedical engineering. So I came into New York and I actually drove with a family friend from New York to Cleveland. And so what a way to get welcomed to the United States going across the whole of the East coast to the Midwest. It was just absolutely, absolutely fantastic. The whole, the whole beginning, as, as I recollect, it’s been a long time ago now. And the other thing in Cleveland was the welcoming nature of us Americans, because another graduate student who was starting in the program had already reached out to me and sent a letter to me saying, would you be interested in being my roommate? So I was really looking forward to meet Ruth tan Bracey who was going to be this new roommate for me. So it was a very, very exciting trip. 

Richard Miles (02:35): 

That’s a great experience. And you probably know this by now, but that is exact route. A lot of early settlers took as we sort of open up the frontier is going from New York through Ohio and further. And that was the frontier at the time. So what a great way to get introduced to the United States? 

Dr. Ranu Jung (02:50): 

Absolutely. 

Richard Miles (02:51): 

Let’s talk about your current work and this is what you are in the finalist for the Cade Prize for Innovation, but it’s obviously you’ve been doing this for awhile and I understand it correctly. You and your team at FIU, Florida International University have developed a prosthetic hand that can actually transmit neural signals to the brain so that a person without a hand can actually feel and control the prosthetic far better than a normal one. That sounds really complicated to me. I don’t know if I described it correctly, but tell us how it works and how did you come up with the idea? 

Dr. Ranu Jung (03:20): 

Yeah. So think about when you touch something, right? You’re, you’re what you feel, or you’ve touched somebody’s face. How do you feel about it? Or you grasp something you don’t really think about it much, right? You just pick up and you automatically know it’s hard, it’s soft, you don’t crush it. And if you touch somebody, you have all the sensations associated with it. Now, if somebody loses their hand for many reasons, often it’s because of trauma. Then what are their choices? The choices for them are to get a prosthetic hand. And currently there are prosthetic hands that are available, to, what we call upper limb amputees. Who have lost their hand, that the person can already control. So the way it works is that when we use our own hand, the muscles in our forearms contract and relax, and when they contract and relax, your hand opens or closes, or your fingers will open and close into the whole mechanism that happens. When you have an amputation, the muscles that are above the level of the amputation, that person can still control them. So if you can record the activity of those muscles and that is done with electrodes that are placed on the skin, one of the examples that’s the most common is like an EKG system, right? So putting the sensor is on there, those signals are picked up and they can be used to drive motors in the prosthetic hand. This is commercially available and there are different levels of prosthetic hands that are available that are simple to close, or there may be now new better prosthetic hands. So there are many that are available like that, but what is missing is how do you get sensation back. So there has been some attempt of saying, let’s take some information back and put a vibratory signal on this pin. So there’s approaches like that, that have been done. But what we went about saying is how could we give a better sensorial experience that would interface this information when somebody is touching something or grasping? So basically what our system is, it’s not designing the prosthetic hand. It is designing this whole interface with the nervous system to restore, hopefully this whole sensory experience. So in this case, what we have done is we have said, all right, let’s look at the prosthetic hand. If the prosthetic hand had sensors in it, can we tap into the sensory information? We process this sensor information to make sense of what is coming out from different parts of the sensors. And then we take that information and pass it on as commands through a wireless link, to a small neurostimulator that is implanted under the skin in the upper arm of the amputee. So what do I mean by a wireless link? You know, when you listen to the radio, there is somewhere a radio station that is sending out radio waves. So there’s a transmitting and an antenna and in your radio, and you’re now in your phone, there is some kind of receiving antenna. So these radio waves are going back, taking the information and passing it from the transmitting system, long distance into this antenna embedded inside some radio or a device, and it’s picking it up and it’s being coded. And you do hear the sound now, step into our system. You’re not sending radio waves all along very far distance, but we have a transmitting antenna that’s connected to the outside of the skin. And that’s what is connected to a little box that is inside the prosthetic, where all the processing has happened. And the receiving antenna is right underneath the skin below. There are no wires going back and forth. So it’s a wireless connection. Now this receiving antenna is connected to a neurostimulator. What’s a neurostimulator is like a pacemaker, but now your similator is connected to very, very fine wires like human hair. And these fine wires are threaded through the nerves in the upper arm. So again, reminding you, it’s an amputee who has a forearm that is gone, the hand is gone. They can control their muscles in the leftover arm, open and close the prosthesis as they close, the prosthesis back and forth. Signals are going to come back in. We are going to process them. We you’re going to communicate those through this wireless link to the implanted antenna. And that implanted antenna connected to a stimulator connected to fine wires inside nerves. So we give little charges of electrical pulses. When these pulses are delivered, the nerves get activated more precisely the nerve fibers that are inside the nerves get activated. And these nerve fibers would have originally carried sensor information from your hand or some of the nerve fibers are going the other way and are controlling the muscles. So when these nerve fibers get activated, then now this biological neural signal goes into the spinal cord and from the spinal cord to the brain and right there in the brain, there is where a person perceives. So the whole point here is, as we do a task, as you reach out, as you touched something with your prosthetic hand, you hold it, you squeeze something, but you’re not looking at it and your eyes are closed. Or maybe you can’t even hear it. You get a sense of touch or you understand what you’re grasping and how strong you are grasping it. So with this ability, we can do this. It might even embody that prosthetic hand into the person’s body. And if that happens, then perhaps this will become really much more a part of the person with the sensory loop factor. They may improve their control and that’s one aspect, but the richer sensorial experience may also embody the prosthetic hand better. And that might make people use the prosthetic hands more. And that has many other benefits. For example, they may be compensating with their other hand to do things, but now they may use this prosthetic hand, for example, or a plastic bottle with water in it. If you don’t know how much you’re squeezing out the water. So usually you would not use that prosthetic hand to do it. You’ll use your other hand. You would use compensatory methods. So our system is to restore the sensation through this neural interface. 

Richard Miles (09:23): 

That’s a great explanation. And this happens to me every year when we run the Cade Prize. I read the application. I think I understand the technology, but it’s not until talking to the inventor that I finally understand what the real breakthrough is, because it sounds like, as you said, the current state of the art is essentially one way communication only, right? You’re sending to the hand, the hand can open, close and so on, but it’s that feedback loop that is missing. And because there’s no feedback loop, you have somebody who doesn’t really feel like this is a part of them and not really delivering what they want it to and they end up not using it. 

Dr. Ranu Jung (09:56): 

Yeah. So we are really closing the loop. There is some feedback, obviously, if you have models in the system and people are very adapt, we are very, very good at doing things and they learn how much I open and close my hand. So they have learned a lot of that aspect they have learned. So it’s not like there is zero feedback and vision is a huge feedback. So if you’re looking at things that you can do a lot of stuff just by looking at it and seeing how much repetitive training you can do that, but it’s paying attention, not having to second guess yourself. It is having the confidence to reach out to things. All of those things are not there when the loop is not closed. 

Richard Miles (10:34): 

So a couple of questions come to mind, would this, in theory, at least as you develop the technology and improve, it, would it enable people who’ve lost a hand for instance, to engage in finer motor skills because they have the feedback or does that not really make a difference? 

Dr. Ranu Jung (10:47): 

Well, we hope that that is going to make a difference to be able to do finer motor skills. There’ll be many things to take into account how dextrous is the prosthetic camp. That will be one of the things, but that’s the technology that then, and that’s part of the scientific question. What is that information? That one can process when it’s coming from this effectively, to some extent an artificial sensor system, right? Do we really need a lot, or do we only need a few things about the cochlear system for hearing, right? They’re not people who have lost hearing. It’s not like every single sound and every single nerve is being stimulated, but they are interpreting sound. They are reading music. It is become part of the life. When you read, you don’t read each letter, you read words, you fill the gap, you put the whole thing together. We don’t know how many gaps you could effectively have in the sensor information and the person we are fantastic brains. So what we will do to put all of that together, but yes, it might help us with finer motor control. It might also help with things like picking up lighter weight objects. If it’s a heavy thing, something heavy, you are picking up, you know, rest of your arm is going to feel heavy and you will get information back. But what if people are picking up small things, like a towel at home, and you are pulling it, folding that light towel and pulling it. Yeah. The person would contract their muscles really hard and squeeze it really hard and pull it. But if they have the courage, they will know I already touched it. I already have it. I don’t have to squeeze. My muscles really had to clamp system. So over time fatigue, short term to make a difference. Long term use will impact the muscles. So all of these will be questions to ask. So you need the system first, you need the technology first. And then you can start to ask these questions and start to ask just pure science questions. How does our brain interpret information? What happens when you have, for a long time use of compensatory strategies, things have changed in the brain, perhaps. How do you pull all of this stuff together? So it opens up Pandora’s box. 

Richard Miles (12:48): 

I imagine, as soon as you solve one question, it just raises probably five more questions. In theory, could this also be applied to feet into legs? Or is there something about this technology that lends itself only to doing hands 

Dr. Ranu Jung (13:00): 

You are absolutely right. This can be extended to many different levels. So right now our indication is for somebody who has lost their forearm and their hand, but you wouldn’t think of it first portions of the upper arm, right? Then you can think about it as people who have lost their lower limbs. Actually what we have, what our technology is, is really think. We can take a signal and based on the signals, we can do targeted, focused stimulation inside the nerves. That’s what the technology is. This application is sensor information to go to our nerves that are going to communicate with the brain to give some information for prosthetic hand, but that’s not necessarily the only application. So in the very long run, you could think about saying, Oh, I’m going to stimulate another nerve. That’s a control system, right? And now are based on a signal that I’m going to get that says, there’s a problem with the stomach or the spleen. For example, in the diabetes situation, I will use that signal to stimulate those nerves because we are inside the nerve. We can do very focused stimulation. And so maybe that would be the application that is going to be the killer application. So to speak that you can do a very targeted stimulation of nerves going to organs within the body that would move us into the bioelectronic medicine, right? So pure thinking comes up at the bigger expanse in which the system could work. There are many pathways could be there, but our first application, our focus right now is to restore sensation to people who have lost their hands. 

Richard Miles (14:36): 

That’s really exciting. That would be huge. If that could be developed for other areas of the body. This targeted neurostimulation. Tell us where you are in terms of testing. I know that in the case of the hand, the prosthetic, you want to test this sort of in as much of a real world environment as possible. Tell how that’s going. And then what sort of path to market does it look like for you? Are we talking about years away from something that could be widely available for amputees? Or is this something that we’re going to see fairly soon? 

Dr. Ranu Jung (15:03): 

So this is what is called a class, it would fall under, what’s called a class three medical device. It’s because of the implanted neurostimulator that that is there. So the first step that we had to do was to go to the FDA to get approval for what is called an investigational device exemption in order to be able to run a clinical trial. So we did that. Not many academic labs will take technology such as this all the way through the pathway, to the FDA while companies often do it. And of course, large companies are doing the Medtronic and Boston Scientific is doing this all the time, but it’s not usual for an academic lab to have taken it from the scratch, something to the FDA. So we got the investigational device exemption. And so now we are in the process of running a feasibility clinical trial. And what that means is that we will be doing a small sample size of people who have a translatable amputation at first. And putting them through use of the system the way we have it. This is a longterm take home study. So you would do things for about three months in the lab. So after you get the implant, you would come into the lab, it’s a person I speak to you. So we would make sure you’re fit. And of course we want to collect additional data about how you are doing control of things. You will find some for a large, bigger control. Can you close your eyes and say it’s soft or hard or big or small things like that? What do you feel like when you open zip things up or squeeze water bottles? So we do that in the lab and then after three months, the person will take it home and then they will come back for the next three months, a little more often. And then they’ll come back for some data collection in the lab for up to two years. So we want to collect the data, but the system is then there’s to keep. You know, the implant is hopefully the way we have designed it, it’s for life. So the internal part doesn’t change. There’s no battery inside. So you don’t have to undergo another surgery to replace depleted batteries, all the powers with both from outside. And as we’re coming up with new algorithms outside, we have smarter prosthetic hands that may come in place. Then the outside can all be upgrade. So that’s also a throught through modular design aspect of it. So we are currently in this clinical trial. One person has completed 28 months of use more than 24 at home. And we are currently recruiting people. Once we recruit these people for one site, we also have received funding from the Army to move it to a second site, which would be the Walter Reed National Military Medical Center. We have to go back to their VA and we’ll back to the IRB to get approvals for increasing the number of people in the disability file and for the second site. And in case we will also try to see approvals for somebody who has amputations on both sides of bilateral amputee. We believe that this sensory feedback step is going to be really much more important for people who have lost both hands, even more so than somebody who has lost one of them. So once that happens, then we can go to the next step. We have just been accepted, absolutely delighted that we have just been accepted by the NIH in a program, which is called clinic to commercialization CPI program. And that program, our team was just accepted into that part. And that will take us for about 24 months to put a whole business framework in place. So we are expecting that by next year, we will have transcends, we have ideas of how we are thinking about our business framework, but we would start to strengthen that and we’ll start putting that in place. And while the feasibility trial is going on, and of course the feasibility trial has to go well for all of that to put it together. And so probably the first place we would have people in the Army, that’s where we would probably look to think the first deployment, but the clinical trial is funded by the National Institutes of Health and then new, additional monies from the US Army. So it would be open to all the civilians and it will be opened later to also people through the world to reach. So in a few years, we hope that this is going to be getting ready to be real commercialized. 

Richard Miles (19:17): 

So Ranu, I have to ask you, how do you spend your average day? Cause what you just listed in terms of your, to do list, I think would require about five or six people. So I’m guessing you’re not the one that’s doing all of this. You have people around you helping you, giving you advice. What do you focus on? Are you continuing to do a line share of the actual research? Or are you thinking about how do we actually get this into the hands of the people that need it? 

Dr. Ranu Jung (19:40): 

This is a partnership, as you said, this is not a one person job. This is a partnership. It’s an epidemic in this preclinical partnership. A lot of it has been so far in academia. I have the best team I can talk about. It is a long term partnership. It’s not two years. One year, three years. It’s about 10 years or more. I was talking to James Abbas at Arizona State who has been from the initial concept is research scientists who came same time. I came here, who used to be here. He was my doctoral student, but decided to become an engineer. And then now he’s actually going back to do his PhD another one, my old, old grad students have come back as well. I recently graduated grad student who works on the project is spending doing a post doc and is actually taking this commercialization pathway for what it’s a team. So what do I do in this team? Because we have cross-training so it’s not one person for one thing, but we do the regulatory work in high school. The implant was done right here in Miami, by doctor Aaron Burglar from the Nicholas Children’s Hospital. And obviously we have industry partners to make the implants. If we can make them think of like the computer manufacturers who have to buy things from different places, right. We can tell them the design, but it has to be somebody who can make medical products to be able to put an implant in there. And bof course we partnered with prosthetic manufacturers for making the prosthetic hand. So what do I do? I am like the orchestra manager for all of it, but I am officially the sponsor of the trial and the principal investigator of the trial. So I take the responsibility for all of that, all of the negotiations, the legal negotiations and all of that part. I discuss those, all the FDA submissions. I will read them and I will update them and I will review them, but I’m not writing from scratch. And it’s over years that has happened. I’m also not writing the program level details. The research scientists are doing, we will discuss, this is what we need to do. This is what we need support, but they are the ones writing the framework and putting all of that code in there. So to speak, what algorithms, what should they capture? So you can think of it as I’m putting the book in place, the chapter organization in place. But the exact words of how you are going to put in that paragraph are written by the engineers and scientists and graduate students that are involved and undergraduate students are involved, 

Richard Miles (22:03): 

Ranu, one of the questions we asked normally if inventors and entrepreneurs and we’re fascinated by it at the Cade Museum is well, what was the inspiration behind their story? And you’ve said that you were inspired by your parents and their can do spirit. Your father was a metallurgical engineer. Your mother was a school teacher taught English in India. How did they influence your decision to go into engineering? 

Dr. Ranu Jung (22:23): 

Not in a direct manner to say you should go into engineering because they themselves were doing what they wanted to do. They were pursuing new things. So right from early childhood, it was, you can do whatever you want to do. So it wasn’t that, Oh, you should do this or you should do that. So I think them taking that risk, and as I mentioned earlier to you, this was post India independence and a new industrialization happening to be coming in place. So my father who is going to be close to 19 and one of the first engineers and they were all doing this every day and you watch them do it. So you saw him come back and say, we broke this record of the blast furnaces. We melted this much iron ore today. So you saw that kind of atmosphere, you know, this allowed you to think and say, Oh yeah, what could I do? What would I want to do? And so that was the inspiration. And it was an interesting time to be in India. At that time in Indira Gandhi was the prime minister. I still remember going to a rally and listening to this woman, giving a speech. And I think that whole ecosystem was encouraging the children to dream and no boundaries that you need to stay here. You need to stay with the family. So they left their parents and their families to go to this new city and build that up. And for their children, they said, you have the world. You can go wherever you want to go to a very special time in history and a special city be raised in with a group of young entrepreneurial parents we were like a cohort, but then that’s what it was. You know, 

Richard Miles (23:52): 

What I find fascinating too is I know is that you actually consider going into medicine instead of engineering, and then you chose engineering, but now sort of the peak of your career, you’re in bioengineering, right? And ultimately you’ve got to have both things you wanted. 

Dr. Ranu Jung (24:04): 

And I have to say, undergraduate students going into research lab, they really should explore. And that’s how I found out about that. There is a potential possibility. There was a professor who had a lab called problem oriented research lab. And he had actually just spent maybe a semester in the US I don’t know exactly how long and come back. And he started this lab where they would bring medical instrumentation for an electronic blood pressure cuff. Oh, I could have a combination of all this electronic stuff. My major was electronics and communications and things. I could have been doing radar. And instead I said, Oh, there’s a place I could combine it. But there was nothing in biomedical engineering in India. I even interviewed to sell x-ray machines for a company, so I could get into the medical field, but then getting this opportunity to do grad school at Case Western it really, really a fantastic graduate program. That was the opportunity that helped me solidify my passion and this, I found a place that would be good. 

Richard Miles (25:03): 

I asked you earlier about what would your advice be to other researchers and entrepreneurs? And you wrote that one piece of advice would be don’t cross out ideas too fast because ideas are too early. So why don’t we explore that a little bit? How do you keep a good idea alive? Let’s say as a researcher, for which there may not be funding right away, or there may not be a commercial application right away, but you know, it’s a good idea. How do you keep those going? 

Dr. Ranu Jung (25:28): 

So let me tell you this idea of interfacing with the nervous system and think of it as out what we call a bio hybrid system, a bionic system, and this together, this idea of pulling this together and interfacing was way back when I was just graduated from my postdoc. And I worked with a professor named Davis Cohain and we were studying lamprey eels. They are like eels. And we looked at the spinal cord and how the spinal cord works and what helps to do the movement and was like, what if we could do a combination of a electronic circuit that mimics part of the spinal cord and interface it with this, I could do the simulations. I could do the experimental prep. I could not make the actual chip hardware, because that was not my background. I went to a summer course. I learned about it. And I came back and said, I gotta find it. Electrical engineering friend who is faculty member who will be willing to put this into hardware, found one practice with her for a few years. She went and did the course came back and we actually then put it into a physical thing. And we interfaced it with this grant. We’ve got a grant from NIH, which was called the a21. A futuristic grant to say, we can take an electronic chip and you’re hearing the word neuro morphic. Now this is now in there talking about in early 1990s, pick up the spinal cord from the lamprey. You can put it into a fluid bag and you can maintain it. And the spinal cord will be activated. We then connected it to this chip and close the loop. And we could show that the electronic chip and the spinal cord activity can go next to each other. I had a very tough time position that who would ever interface these pains, but the living system, what a crazy idea. Okay. So we got into a journal. I was thinking, this should go into science. It never did, but we did get there 10, 15 years later, somebody in the Army saw this paper. This was in the Iraq war. So I founded a small company because who needed a company for this. And we got funding where we basically said, if you’re focused injured, you will be stabilized in a false boot underneath it. We will put a small fall spot this spot would we be controlled with a circuit? Hey, what was that stuff like? The spinal cord circuits that we had done way back there. And this spinal cord circuit will be driven by sensors that pick up when the person starts to move. So if your upper leg is okay, as you start to move, there is make movement that will drive that file for circuit, that electronics that moves the food, that is the boot. And so the person can stick their foot into the stabilized park, the false foot, and you can wear this boot and you could walk out of there. And we actually demonstrated that on a person in the lab. So what forward even further, a few years, and this happened around the same time as I got funding for this neural interface thing to me. So I’m thinking all of this and saying, how are we combining electronic interfaces? So it has changed pace, but I idea has moved that you can link artificial systems with living systems and close the loop so that you’ve got, this merger, this bio hybrid system, where one is impacting the other, where will we go. Will we have adaptive engineered systems because our engineered systems that’s feeling not adapted enough. Where will it go? I think they will. Now you’d hear about neuromorphic word. Major companies are doing it, everybody’s doing it. So who knows where this is going to go? Where will this organic inorganic link happen? I’m talking about early 1990s. And we were the first people to show that you can interface an electronic circuit in a living spinal cord. It isn’t a bat. It’s not in the person walking or animal walking per se, but it was a living system. And today we are looking at saying, how can we interface? What are we doing with interfacing in electronic system with a real person and putting them into this room and hoping that this is going to actually improve their whole self, their ability to do different tasks. But most importantly to have is some [inaudible]. 

Richard Miles (29:35): 

I’m pretty sure I never heard the term neuromorphic until probably 2012, 2013, right around there. And I’d never heard of the term before. I thought it was brand new. I had no idea. It had been around since early nineties. 

Dr. Ranu Jung (29:47): 

Our paper is published with saying your morphic army grant is neuromorphic something. So it was way in the infancy of when that stuff was being talked about. Carver Mead from Caltech had been talking about it. I was very, very fortunate to have is Cohen and worked with her. I met her at the summer course at Woods Hole, Massachusetts on competition neuroscience. You never know where it can get you. So my PhD advisor, Peter Catona who I call him my academic father, who always gave me this type of saying, explore, explore. There was no idea, too crazy to be taken up. There was not this whole, we don’t do this, or you can’t do this. 

Richard Miles (30:25): 

Ranu, clearly our judges have done a great job in advancing you to our finals this year. I’m very excited to learn about what you’re doing. I hope it succeeds. I hope we can have you back at some point on the show to talk about updates. Again, want to congratulate you on making finals, but also just more broadly on the work that you have done currently at Florida International University, really enjoyed talking to you. So thank you for coming on the show today. 

Dr. Ranu Jung (30:46): 

Thank you Richard look forward to returning. 

Outro (30:49): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson. 

TRANSCRIPT:

Intro (00:01): 

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. 

James Di Virgilio (00:39): 

Innovation. Does it follow a specific path? Is it spontaneous? Is it something that we can plan for ahead of time? My guest today is Gary Miller, the co founder, and executive VP of research and development at Exactech. Gary, you’ve done so many things in your career. Your first let’s call official, right? Patented innovation was called the cemented hip. Yes? 

Gary Miller (01:05): 

No. 

James Di Virgilio (01:06): 

Not your first? 

Gary Miller (01:07): 

No, no. That was years later, but it did involve cement. My first invention, I was actually, by that time on the faculty, in the college of medicine, I was a researcher there as an engineer working in orthopedics and at the time, and still today, they have a very active bone tumor group. It’s really one of the foundational elements of that department. And we treated a lot of folks with metastatic disease. And when you have tumors in your bone, it’s very, very painful. And one of the things that we were trying to figure out is how to reduce the pain. And it turns out if you could reinforce that bone, it didn’t hurt as much. And my first invention was taking a metal rod, which was used for trauma or fractures and perforating the sides of that rod and using it as a long cannula to inject cement through. And that’s cement. So very liquidy viscous kind of material that hardens inside the body and leave the rod with the cement there, take the nozzle off and remove it. And that was the first foray for me into seeking an invention. I hadn’t even thought about patenting it and somebody suggested that’s a good idea. Why don’t you think about patenting it? And that led to that first patent for me. 

James Di Virgilio (02:21): 

Now, patents are often talked about, but are also very confusing. Did you find that to be true? The first patent you had to apply for like, what’s it like, how long does this take, what am I even patenting? 

Gary Miller (02:31): 

Absolutely. That patent world, the words, the phrases all mean something. And I think for an inventor, you know what the picture of it looks like, but in the patent world, it’s about the written claims. In fact, the pictures don’t matter. So that was very much new for me in my career. I was new in what I was doing and had that the good news was the university had patent attorneys on call that helped us do all that. And I really enjoyed that of the engineering and the law and continue to spend a lot of time to this day. I still do a lot of that kind of work because it’s a lot of fun to do. It can be very disappointing for the creative person. Oh, this is great. Nobody could have ever thought about that. Again. It used to be hard to find out whether it had ever been done because it was before the internet. Now in seconds you can find out by searching the internet and the US patent and trademark office, all the international offices now have online services. You can do basically a Google search. There’s Google patent is actually one of their products and get right into it very quickly. And you’ll find out well, half a dozen people have variations on this theme. And then if you do really want to pursue that patent, you’ve got to figure out what is in fact, new and inventive that somebody that skilled in the art of what you’re doing, wouldn’t have thought of it. And there’s an obviousness test that you have to perform. I’m not an attorney, but it’s a lot of fun being there because it really does help. You fine tune what you’re doing. Find out what’s really important about it. 

James Di Virgilio (04:04): 

Imagining that we’re in an operating room and we’ve got a surgeon and we have a patient, and then we have you. And then there’s me as an observer. And you’re watching the surgeon work. You’re seeing a medical device go in, it’s a hip or a knee, or it’s something that’s going to help the patient. You have two people you’re really serving there. You’re serving both the surgeon and the patient. And if it just works for the surgeon, but the patient’s like, Hey doctor, this is really painful. This is not working. I’m not feeling good and the surgeon thinking, but this is wonderful. Like how efficient this is. I can put this right in. It’s not successful. So you have two, and what you’re doing in this example, you have two end users two people that this matters the most to you, and you have to find a solution that works for both. That seems incredibly sensical. However, I think what you said is true. Oftentimes if you look at businesses or service models that don’t work, there’s so many layers between the person creating the solution and the person using the solution that the solution no longer works. How is it that you learn, as you’ve talked about off air to speak the language of the surgeon and the patient to find the proper solution, that’s an art and a science. I feel like. 

Gary Miller (05:08): 

It is. It’s an art and the sciences that takes a long time. And I liked the way you couched it. I don’t know that I was as efficient at it. Then as I like to think, I have become as you as an interview or no there’s good ways and not so good ways of trying to elicit responses, answers from people, being able to be conversant talking their language helps a lot. And I remember very distinctly first years of my career, attending orthopedic conferences, just listening to the surgeons, talking to each other, you build a vocabulary, you build an understanding of what they’re talking about. They use a different lingo than the engineer uses. The most effective teams are an engineer working with a surgeon who has a background or has learned the lingo of the engineer. So when I give out an engineering term, I don’t have to translate it for that person. So we can be talking about a design and a solution. And I’ll say, well, the stresses are going to be too high here. And they know what a stress is. And it doesn’t mean that you’re nervous about something. We’re talking about an engineering principle that resonates with them. So you get rid of the translator in the middle, if you will. So it can be very rapid fire. Most of the inventive work that I’ve done, I’ve always been surprised how, again, a little bit serendipitous, you’ll be working on a problem, working on a problem. All of a sudden this answer pops out for me. It’s usually not a solitary event. You’ll notice on my patents. I may have one or two that are just my invention, but I’ve shared ideas with people. Who’ve shared their ideas with me. And so I’m a co-inventor with folks and that’s the way patents are. That’s the way it should be. That all the people that created that inventive step should be included in the patent application and the eventual patent that efficiency can bubble. And they’re good folks to work with. And that’s so good folks to work with. And you’ll find that some people are very dogged in the solution that they brought to you. So what they’re really looking for is somebody to render their idea. That’s a very different kind of concept for me. I’ve been very lucky in my career that I haven’t been faced with that very often or when faced with it. I’ve usually been able to walk the person back to, I understand you have this answer, but could we talk about the question for a minute? Can we look at what the need is? And either work with me as a helper and translator to work with some of the brilliant minds that I’ve been able to work with. They’re people that design, that’s what they do. Engineering design in specific areas like medical devices. I’ve been really lucky and enjoyed immensely working with those kinds of creative minds. But when we talk to each other about, well, when did you finally figure that out? It’s the old adage? Oh, well I was taking out the garbage or I was in the shower. It’s when you stop thinking about something that you sometimes come up with your most creative ideas, I’d never been good at saying, okay, I’ve got this problem to solve. I’m going to sit down this morning and I’m going to spend the next hour. I blocked out the time to be creative or to be invented for me that doesn’t work. My mind doesn’t work that way. I have a bunch of stuff rumbling around in it. And every once in awhile at births an idea, and sometimes you could go for a long time. It’s the equivalent, I guess, to writer’s block when it just, it’s not there. It’s not there. 

James Di Virgilio (08:34): 

Is there pressure once you’ve innovated and created at a certain level to have to keep creating new things, you get to five, six, seven, eight patents, and it’s sort of like, Hey, Gary’s the guy. He can create stuff. He’s a visionary, he’s a creative. Do you feel that pressure build as you do more and more? Or is it just a thought where, Hey, if I have a good idea, I’m going to do it. And if I don’t, I don’t feel any pressure. 

Gary Miller (08:56): 

Two answers to your question. I don’t judge a person’s creativity or ability to solve unmet needs. I keep going back to that theme because I really believe in it to improve patient outcomes is another way to say it. It doesn’t have to result in a patent. Being the first in the market could be very valuable. Let’s just get it out there. Let’s just do it. If you look at the number of things that I’ve had, the opportunity to work on, the patents, don’t speak for the number of different things that we’ve done on the teams that I’ve worked on over the years, that’s sort of icing on the cake for me. I would be not telling you the truth. If I said that, getting that first one, which I still have, it’s all coffee spilled on it and everything else, but getting that first one and seeing it and seeing your name on it, it’s a validation of your inventiveness, if you will. But for me, it’s really about in the area I work in it’s about improving patient outcomes. There’ve been a lot of ideas that I and my colleagues have come up with that I would call me to, or people will come to you and say, well, three other companies had this, we need this one. We should make it. In some cases, you need to have that full bag. I go kicking and screaming in that direction sometimes. But finding that thing that hasn’t been solved out of that myriad of stuff and be able to come up with an answer to it that advances the art or the science that you’re in is what makes me tick. It’s what I love to do. So it’s a long way of answering your question, but there’s always stuff that I think we can improve. You know, I’ve been in this area of medical devices for over 40 years. Now that I think about it and still working on hips, one of the first implants that I developed, you mentioned it earlier, when I corrected it was a cemented hip and there were a lot of them on the market at the time. And working with an orthopedic surgeon who became my partner, Bill Petty, working together, the idea was, well, there’s all this stuff about cemented hips that work, but they don’t last for the lifetime of a patient. Could you get just one and be done those kinds of things. And we’re still advancing that art. And there are improvements it’s much faster to put them in, the instrumentation has improved, all of those kind of innovations contribute to that improvement in the patient outcome, because we all know it’s pretty obvious to a lot of people, the faster and better you can do something with the least amount of insult. In this case to the body, usually the better the outcome is going to be. And thinking back historically, when we used to judge, whether an implant was going to work very well, we thought about the 65 to 70 year old person that weighed 157 pounds. That was the standard that the first Food Drug Administration standards, had, imagine that today we all know people that are in their fifties or sixties that have arthritis that would benefit from a total joint replacement, for whatever reason. Sure. It would be better to get it later in life, but wouldn’t it be great if you then have a solution to that that lasts the patient’s lifetime and they’re in and out of the hospital the same day, it used to be a seven day hospital, stay in a very old population of folks. Now you hear about it and you see it on the news. You see it in your friends and family around a person. Well, I had my surgery one day and I was out the next day or two days later, walking around. Think about those improvements in four decades. Those are the kinds of things that you hear. That that’s what gets me excited. That’s, what’s nice about what we do. And I think there’s still a lot out there to improve and improve the experience for the patients and for the surgeons. It’s a lot of work doing a lot of these cases, standing there all day long and here, again, improving the instrumentation, working with surgeons to do what they think will work best. And time is a measure of that. Used to be years ago, you did two cases or three cases in a day, and now you could do five or six or more. And I say that primarily because you can double the number of patients that you can treat with the same resources for all intents and purposes, which is something that we as baby boomers get out there. We need to be able to do more cases. 

James Di Virgilio (13:14): 

What kind of environment do you need to be able to create and improve the world around you? We’ve talked on previous podcasts that the United States is significantly the leader in medical, technological improvements. It’s not even remotely close. It’s the US way ahead of Germany and everyone else. Why it’s a question that gets asked a lot you’re directly working in it? Why or what is the environment that allows companies like yours brains like yours and the US to innovate at a way higher level than what we see across the world? 

Gary Miller (13:45): 

Well, I think if I knew that that’s the $64,000 question, I don’t know that I have a great answer for you. I think one answer is we want, and in some ways, demand being healthy. And I put healthy in quotes, short on pain threshold, want to be able at age 55 to be able to play singles tennis and all those kinds of things. You don’t want to see yourself degrading if you will, and all those things you want to do. And I always joke if you lived your life backwards, you finally get the time when you can be out there playing and doing whatever and traveling, and you find your body giving out on you before you can do it. But back to your question, I’ve traveled to a lot of places outside the world had been really lucky to be able to lecture and be in those environments around the world. You know, it’s not fair to generalize probably, but you see people that have more deformity, they endure more pain before they get treatment, whether it’s because it’s not available. And it’s a vicious cycle. In some ways in the United States, we apply a lot of resources to creating an environment so that we can solve those problems as you were talking about. But I think that’s one of the answers. I don’t have a perfect answer for you. There are a lot of countries that do have niches though, within what we would now call the medical community, whether it’s drug development, the pharma industry, a lot of that happens outside of the United States, as you know, and a lot of computer assisted kinds of stuff happen in various places around the world as well. One of our divisions is in France that we’re works a lot on our computer assisted surgery happens to be an area in the South of France that does a lot of that kind of stuff. And it breeds itself. You have people that are working together, I think to do it well. It is a team sport and the United States creates a good playing field to use that analogy for engineers to both be trained and to be able to create careers in this area and do well at it. 

James Di Virgilio (15:48): 

Do you have a favorite project that you’ve worked on or creation or innovation, something that sticks out as like that one was really special. 

Gary Miller (15:57): 

You know I really don’t. I talk about that rod that I worked on at the very beginning, that was very, very rewarding for me. Let me twist it a little bit for you. One of the nicest things that I see, one of the most rewarding things for me as an engineer working in medicine is you get that feedback of how you’ve done. It was amazing to me with that first experience as a person that was debilitated on heavy drugs, couldn’t really walk. And it’s an end of life experience. It’s metastatic bone cancer, but their quality of life was really awful because of pain. And after doing the procedure that we had created, the orthopedic surgeons and I at the hospital would get up the next day, even though they had had a surgical procedure and say, Oh, wow, this is great. They were ready to go. Similarly, a person with really bad arthritis. They can’t get in and out of a chair to have to use the arms of a chair. One of the things I always kid around with some people is try getting up from a chair with no use of your hands. You have to have good knees to do that. And your hips have to be functioning really well. One of the nice things that we get to do in biomechanics in the field that I’ve spent my career in is seeing that patient walk out of the hospital or getting up that first day and say, well, I know it hurts because I had surgery, but it doesn’t hurt like it did before my surgery. That’s the measure that we have. There’s other areas of engineering that it’s much harder to get a read on the success of what you’ve done. I think that one of the things I’ve enjoyed so much working in medical devices and working in biomechanics over the years and being in a clinical situation, their research areas are all those things and not to dismiss those that I need as a person, you need the tools and the toolbox to be able to do all the things that we do. We need the materials. We need some of the understanding of design that are done in a laboratory setting. I’ve worked my career in applied biomechanics, if you will, or applied biomaterials where I get to use some of those early inventive steps to create a product or a device, if you will, that goes into a patient or is used to put something in a patient. And it’s been tremendously rewarding for me because as I said, if we can give a surgeon the opportunity to do that extra case, that’s one more patient. That’s gonna not have to endure pain for an extra day. It’s all about that patient outcome thing resonates with me. And I’ve been lucky to be able to spend so many years just being in that sandbox. 

James Di Virgilio (18:29): 

I’m hearing so much passion and excitement and joy for what you do. And I’m wondering after a full career of doing all these things, when you wake up each day, are you just as excited about solving problems today as you were 10, 15, 20, 30 years ago? 

Gary Miller (18:44): 

Yeah. I am. I don’t know if I can get there as fast and do it as quickly, but yes, it’s a terrifically rewarding area to be, and it’s what keeps me going for sure. 

James Di Virgilio (18:55): 

I think that’s true of people in general. You know, my belief and philosophy in life is that we’re here. We’re created to be here. We’re created to attempt to improve the world around us and your energy. As I’m sitting 10 feet away from you is palpable. You can feel the satisfaction and the drive that you have to improve the world around you. And that’s what creativity and innovation does. Let’s bring this down to the listener, whether they’re 15 or they’re 50, and talk about this idea of problem solving, how do you teach somebody to have not the same passion you do? Cause we’re all created differently in that regard, but to maybe view the world that way, Hey, maybe you too can see some problems and begin to think about solving them. Can this be taught? Are you born with this? What is this? Like? 

Gary Miller (19:35): 

Yes. And yes, the folks that are successful, I do think bring that intellectual curiosity with them. They don’t take things for granted about how’s it working, what it’s doing. And so I think that is innate. I think because there are people that are frustrated that they can’t sometimes I wish it was totally teachable because we could use more people inventing, right? If you use my basic thesis of improving life, however, to answer your question more specifically, very structured ways of looking at things that if you learn those techniques, that you can be better at it. I’ve been asked this by students before when I lecture. And one of the things I love to do is mentor at this stage. If somebody is willing to listen to you about your experiences and how you solved it, you end up transferring both the passion and the technique. So yours is a very good question. There’s structured ways of doing it and being creative there’s skills that you can learn. You look at a solution and say, what happens if you turn it upside down? What happens if it’s backwards? They’re ways of brainstorming is a catch phrase that some people use where you put every which way, think you could do it down on paper without judging whether it would work or not. And then manipulating those images of what you thought about. It works really good in a group setting that people throw stuff out on the table, if you will, and you’re not allowed to critique whether it would work or not. The whole idea is to generate the most ideas. So there are techniques. There have been a lot of books written about it. There have been a lot of books written about a lot of things. And how many books have been written about how to become a millionaire? How many people read the book and become a millionaire? I think the same applies here. I have been impressed though that the tools have gotten more powerful for us. I remember 40 years ago, it was a drafting table and a pencil and scale and compass and drawing stuff. And if you wanted to make four sizes, you had to make four different drawings and you sat there with your slide rule and or a tablet of paper and added all the numbers up fast forward to today. When there’s three D rendering of computer assisted design, and you can look at it on the screen and you can make it larger and smaller and you can take four pieces like their fourth five pieces in a given joint replacement, put them all together, see how they move together. Those are incredibly powerful tools. And then you decide, well, I want the smallest one to be this size and I want the largest one to be this size. And then you can do the scaling if you will. And the system, the computer helps you. I have to tell you, I have yet to be able to be good at computer assisted design, but I work with people that are just, they blow your mind away. You’ll say something about this idea you have, and they’ll walk in and say, how about looking at this on my tablet used to be a desk size computer. Now it’s on a tablet if you will. So we’ve gotten really good and powerful tools. Testing has matured dramatically. We can’t use the person as the experiment here, and you’ve gotta be able to do a lot of simulation testing. A lot of those kinds of things, which were very hard to do in the past now because of the computing power we have, we’re able to make simulators that run an implant for 50 million, 20 million to look for the endurance. How’s it behaving all those kinds of things. And you can do a lot of things simultaneously. So between CAD simulation and all those things, it’s a far cry from what it was many years ago, when you had to build a prototype and try to test it in some way in a laboratory. And then honestly, in those days, once we thought we had it pretty close, we’d start using it. And it would be used in patients that needed it the most so that the risk reward was there. Now we can do a lot more and we can do it much more quickly. We talked about earlier about the length of time that it takes to do a design when everything works well, 18 months is not out of the question sometimes because of the regulatory overhead that we have. It takes longer than that. But in years past, it could take five years, seven, eight years, and then you weren’t anywhere near as sure about what the outcome was going to be. As I think we are now, they’re less small steps, 

James Di Virgilio (24:01): 

Words of wisdom. So here you are decades of experience. I want you to imagine going back in time and having a conversation with your 20 something self, what are two things you would tell yourself back then? Here’s what I want you to anchor to. As you go forward and you have this career doing all these things, remember these two things, 

Gary Miller (24:20): 

Be sure to listen and to watch what’s going on. That would be number one for me. And number two would be, I know you’re going to be asked to learn a lot of things that you don’t think you’re going to need to learn. And all I can tell you is I’ve used almost everything that I was taught, except for super higher math. I’ve never liked partial differential equations, and I’ve never had to use them, but I’d mentioned the tools in the toolbox to you earlier. I would tell a person earlier in their career, learn as much as you can keep learning it, keep learning new things, because you’ll never know when you might need to use it. And I could cite examples over and over again of things. I never thought I would be in business. That engineering economics class looked like a waste of time to me. And it’s helped me those on the finance side that say, I still don’t know how to read a balance sheet. What can I tell you, James? But at least I know what I don’t know. And sometimes you need to know what you don’t know. 

James Di Virgilio (25:22): 

There’s a lot of wisdom there, especially if you look at being a lifelong learner, having no idea where your life will take you. And then as you mentioned, maybe one of the most important things that I hope listeners pull from. This is what we’ve talked about. Indirectly sometimes directly about this concept of communication language, if you will, and if you’ve traveled at all, you can relate to what it’s like to drop yourself. I went to Asia many years back and you drop in the middle of China or Japan, and no one speaks a word of your language and you don’t speak a word of their language and you both could be brilliant people. And you’re reduced to hand signals, right? And as you mentioned, you want to go from hand signals to fluency in whatever language you have, and you have no idea what language is you’ll pick up throughout your time, whether yours is a mixture of engineering and finance and classes you’ve taken or life experiences you have and how they will cross over down the road. That’s very wise. 

Gary Miller (26:13): 

Yeah. I have examples of that in my own life and career. What I love to tell traveling in Spain, I speak minimal Spanish. And at the time I spoke absolutely no Spanish and went to dinner with one of those creative orthopedic surgeons like I was telling you about. And both of us were so frustrated trying to speak through the one person at the table who spoke English and Spanish. And after about 10 minutes, we both had our pens out and you’re going to laugh at me, but we kept moving the glasses and the plates out of the way. And we started drawing on the tablecloth. And so the visual became our medium for communication. And you were teasing me about cemented hips there earlier. We went through his idea of a hip design on that tablecloth and two napkins, as I recall, and we got to the end and we understood what each of us was trying to say. And it came to a pretty nice solution in design that we were able to move forward on. The only embarrassing thing was in this very nice restaurant in Spain, we had to have them take the tablecloth and the napkins off the table and wrap them up and give them to us because it was before cell phones and the only way to transport all this work we had done for two and a half hours at a classic Spanish dinner was to take the table with us. So it’s a fond memory. Obviously for me, I bet a wonderful group of people all over the world. And it comes down yes to hand signals and drawing, drawing. The visual is really without language usually. 

James Di Virgilio (27:45): 

And that’s one of the greatest things about doing this podcast, talking with you today is that it’s people, it’s people like you. If you’re listening and it’s people like Gary, it’s people that have ideas and get together with other people that have ideas and those ideas become a reality, right? The things you’ve created, those were humans, creating the ideas and putting them into play. It wasn’t some magical process. It didn’t happen on its own. What you’ve learned what’s in your brain is valuable. Working with others valuable. One of my favorite economic examples is Milton Friedman. You can find this on the internet does like a two minute video on the pencil, the humble pencil, but the pencil comes from so many different places all over the world, which is what allows it to be so cheap nowadays. Right? But at one point in time, it wasn’t so cheap, even just getting led was difficult. And we’ve talked a lot about a lot of these things today. I always find it very encouraging when we’re talking to someone who’s created as many things as you have to hear that it really does come back to what do you know, what do other people know? How can you get together, work together, find solutions to problems that exist. It’s been absolutely great to have you. My guest today, Gary Miller, the co founder of Exactech, also a man of many other things. We can’t just label you as that. And also on the board for the Cade Museum. I would remiss, if I didn’t say that. So thank you for all of your support and also for your time today, we certainly loved having you on Radio Cade. 

Gary Miller (28:55): 

Well, thank you. It’s been an absolute pleasure. 

James Di Virgilio (28:58): 

For Radio Cade, I’m James Di Virgilio. 

Outro (29:01): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson. 

In this episode, host Richard Miles sits down with Yarina to learn more about Sisu Global and more specifically, Hemafuse, the company’s handheld, mechanical device for intraoperative autotransfusions, designed to replace or augment donor blood in emergency situations.

TRANSCRIPT:

Intro (00:01): 

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. 

James Di Virgilio (00:39): 

Innovation. Does it follow a specific path? Is it spontaneous? Is it something that we can plan for ahead of time? My guest today is Gary Miller, the co founder, and executive VP of research and development at Exactech. Gary, you’ve done so many things in your career. Your first let’s call official, right? Patented innovation was called the cemented hip. Yes? 

Gary Miller (01:05): 

No. 

James Di Virgilio (01:06): 

Not your first? 

Gary Miller (01:07): 

No, no. That was years later, but it did involve cement. My first invention, I was actually, by that time on the faculty, in the college of medicine, I was a researcher there as an engineer working in orthopedics and at the time, and still today, they have a very active bone tumor group. It’s really one of the foundational elements of that department. And we treated a lot of folks with metastatic disease. And when you have tumors in your bone, it’s very, very painful. And one of the things that we were trying to figure out is how to reduce the pain. And it turns out if you could reinforce that bone, it didn’t hurt as much. And my first invention was taking a metal rod, which was used for trauma or fractures and perforating the sides of that rod and using it as a long cannula to inject cement through. And that’s cement. So very liquidy viscous kind of material that hardens inside the body and leave the rod with the cement there, take the nozzle off and remove it. And that was the first foray for me into seeking an invention. I hadn’t even thought about patenting it and somebody suggested that’s a good idea. Why don’t you think about patenting it? And that led to that first patent for me. 

James Di Virgilio (02:21): 

Now, patents are often talked about, but are also very confusing. Did you find that to be true? The first patent you had to apply for like, what’s it like, how long does this take, what am I even patenting? 

Gary Miller (02:31): 

Absolutely. That patent world, the words, the phrases all mean something. And I think for an inventor, you know what the picture of it looks like, but in the patent world, it’s about the written claims. In fact, the pictures don’t matter. So that was very much new for me in my career. I was new in what I was doing and had that the good news was the university had patent attorneys on call that helped us do all that. And I really enjoyed that of the engineering and the law and continue to spend a lot of time to this day. I still do a lot of that kind of work because it’s a lot of fun to do. It can be very disappointing for the creative person. Oh, this is great. Nobody could have ever thought about that. Again. It used to be hard to find out whether it had ever been done because it was before the internet. Now in seconds you can find out by searching the internet and the US patent and trademark office, all the international offices now have online services. You can do basically a Google search. There’s Google patent is actually one of their products and get right into it very quickly. And you’ll find out well, half a dozen people have variations on this theme. And then if you do really want to pursue that patent, you’ve got to figure out what is in fact, new and inventive that somebody that skilled in the art of what you’re doing, wouldn’t have thought of it. And there’s an obviousness test that you have to perform. I’m not an attorney, but it’s a lot of fun being there because it really does help. You fine tune what you’re doing. Find out what’s really important about it. 

James Di Virgilio (04:04): 

Imagining that we’re in an operating room and we’ve got a surgeon and we have a patient, and then we have you. And then there’s me as an observer. And you’re watching the surgeon work. You’re seeing a medical device go in, it’s a hip or a knee, or it’s something that’s going to help the patient. You have two people you’re really serving there. You’re serving both the surgeon and the patient. And if it just works for the surgeon, but the patient’s like, Hey doctor, this is really painful. This is not working. I’m not feeling good and the surgeon thinking, but this is wonderful. Like how efficient this is. I can put this right in. It’s not successful. So you have two, and what you’re doing in this example, you have two end users two people that this matters the most to you, and you have to find a solution that works for both. That seems incredibly sensical. However, I think what you said is true. Oftentimes if you look at businesses or service models that don’t work, there’s so many layers between the person creating the solution and the person using the solution that the solution no longer works. How is it that you learn, as you’ve talked about off air to speak the language of the surgeon and the patient to find the proper solution, that’s an art and a science. I feel like. 

Gary Miller (05:08): 

It is. It’s an art and the sciences that takes a long time. And I liked the way you couched it. I don’t know that I was as efficient at it. Then as I like to think, I have become as you as an interview or no there’s good ways and not so good ways of trying to elicit responses, answers from people, being able to be conversant talking their language helps a lot. And I remember very distinctly first years of my career, attending orthopedic conferences, just listening to the surgeons, talking to each other, you build a vocabulary, you build an understanding of what they’re talking about. They use a different lingo than the engineer uses. The most effective teams are an engineer working with a surgeon who has a background or has learned the lingo of the engineer. So when I give out an engineering term, I don’t have to translate it for that person. So we can be talking about a design and a solution. And I’ll say, well, the stresses are going to be too high here. And they know what a stress is. And it doesn’t mean that you’re nervous about something. We’re talking about an engineering principle that resonates with them. So you get rid of the translator in the middle, if you will. So it can be very rapid fire. Most of the inventive work that I’ve done, I’ve always been surprised how, again, a little bit serendipitous, you’ll be working on a problem, working on a problem. All of a sudden this answer pops out for me. It’s usually not a solitary event. You’ll notice on my patents. I may have one or two that are just my invention, but I’ve shared ideas with people. Who’ve shared their ideas with me. And so I’m a co-inventor with folks and that’s the way patents are. That’s the way it should be. That all the people that created that inventive step should be included in the patent application and the eventual patent that efficiency can bubble. And they’re good folks to work with. And that’s so good folks to work with. And you’ll find that some people are very dogged in the solution that they brought to you. So what they’re really looking for is somebody to render their idea. That’s a very different kind of concept for me. I’ve been very lucky in my career that I haven’t been faced with that very often or when faced with it. I’ve usually been able to walk the person back to, I understand you have this answer, but could we talk about the question for a minute? Can we look at what the need is? And either work with me as a helper and translator to work with some of the brilliant minds that I’ve been able to work with. They’re people that design, that’s what they do. Engineering design in specific areas like medical devices. I’ve been really lucky and enjoyed immensely working with those kinds of creative minds. But when we talk to each other about, well, when did you finally figure that out? It’s the old adage? Oh, well I was taking out the garbage or I was in the shower. It’s when you stop thinking about something that you sometimes come up with your most creative ideas, I’d never been good at saying, okay, I’ve got this problem to solve. I’m going to sit down this morning and I’m going to spend the next hour. I blocked out the time to be creative or to be invented for me that doesn’t work. My mind doesn’t work that way. I have a bunch of stuff rumbling around in it. And every once in awhile at births an idea, and sometimes you could go for a long time. It’s the equivalent, I guess, to writer’s block when it just, it’s not there. It’s not there. 

James Di Virgilio (08:34): 

Is there pressure once you’ve innovated and created at a certain level to have to keep creating new things, you get to five, six, seven, eight patents, and it’s sort of like, Hey, Gary’s the guy. He can create stuff. He’s a visionary, he’s a creative. Do you feel that pressure build as you do more and more? Or is it just a thought where, Hey, if I have a good idea, I’m going to do it. And if I don’t, I don’t feel any pressure. 

Gary Miller (08:56): 

Two answers to your question. I don’t judge a person’s creativity or ability to solve unmet needs. I keep going back to that theme because I really believe in it to improve patient outcomes is another way to say it. It doesn’t have to result in a patent. Being the first in the market could be very valuable. Let’s just get it out there. Let’s just do it. If you look at the number of things that I’ve had, the opportunity to work on, the patents, don’t speak for the number of different things that we’ve done on the teams that I’ve worked on over the years, that’s sort of icing on the cake for me. I would be not telling you the truth. If I said that, getting that first one, which I still have, it’s all coffee spilled on it and everything else, but getting that first one and seeing it and seeing your name on it, it’s a validation of your inventiveness, if you will. But for me, it’s really about in the area I work in it’s about improving patient outcomes. There’ve been a lot of ideas that I and my colleagues have come up with that I would call me to, or people will come to you and say, well, three other companies had this, we need this one. We should make it. In some cases, you need to have that full bag. I go kicking and screaming in that direction sometimes. But finding that thing that hasn’t been solved out of that myriad of stuff and be able to come up with an answer to it that advances the art or the science that you’re in is what makes me tick. It’s what I love to do. So it’s a long way of answering your question, but there’s always stuff that I think we can improve. You know, I’ve been in this area of medical devices for over 40 years. Now that I think about it and still working on hips, one of the first implants that I developed, you mentioned it earlier, when I corrected it was a cemented hip and there were a lot of them on the market at the time. And working with an orthopedic surgeon who became my partner, Bill Petty, working together, the idea was, well, there’s all this stuff about cemented hips that work, but they don’t last for the lifetime of a patient. Could you get just one and be done those kinds of things. And we’re still advancing that art. And there are improvements it’s much faster to put them in, the instrumentation has improved, all of those kind of innovations contribute to that improvement in the patient outcome, because we all know it’s pretty obvious to a lot of people, the faster and better you can do something with the least amount of insult. In this case to the body, usually the better the outcome is going to be. And thinking back historically, when we used to judge, whether an implant was going to work very well, we thought about the 65 to 70 year old person that weighed 157 pounds. That was the standard that the first Food Drug Administration standards, had, imagine that today we all know people that are in their fifties or sixties that have arthritis that would benefit from a total joint replacement, for whatever reason. Sure. It would be better to get it later in life, but wouldn’t it be great if you then have a solution to that that lasts the patient’s lifetime and they’re in and out of the hospital the same day, it used to be a seven day hospital, stay in a very old population of folks. Now you hear about it and you see it on the news. You see it in your friends and family around a person. Well, I had my surgery one day and I was out the next day or two days later, walking around. Think about those improvements in four decades. Those are the kinds of things that you hear. That that’s what gets me excited. That’s, what’s nice about what we do. And I think there’s still a lot out there to improve and improve the experience for the patients and for the surgeons. It’s a lot of work doing a lot of these cases, standing there all day long and here, again, improving the instrumentation, working with surgeons to do what they think will work best. And time is a measure of that. Used to be years ago, you did two cases or three cases in a day, and now you could do five or six or more. And I say that primarily because you can double the number of patients that you can treat with the same resources for all intents and purposes, which is something that we as baby boomers get out there. We need to be able to do more cases. 

James Di Virgilio (13:14): 

What kind of environment do you need to be able to create and improve the world around you? We’ve talked on previous podcasts that the United States is significantly the leader in medical, technological improvements. It’s not even remotely close. It’s the US way ahead of Germany and everyone else. Why it’s a question that gets asked a lot you’re directly working in it? Why or what is the environment that allows companies like yours brains like yours and the US to innovate at a way higher level than what we see across the world? 

Gary Miller (13:45): 

Well, I think if I knew that that’s the $64,000 question, I don’t know that I have a great answer for you. I think one answer is we want, and in some ways, demand being healthy. And I put healthy in quotes, short on pain threshold, want to be able at age 55 to be able to play singles tennis and all those kinds of things. You don’t want to see yourself degrading if you will, and all those things you want to do. And I always joke if you lived your life backwards, you finally get the time when you can be out there playing and doing whatever and traveling, and you find your body giving out on you before you can do it. But back to your question, I’ve traveled to a lot of places outside the world had been really lucky to be able to lecture and be in those environments around the world. You know, it’s not fair to generalize probably, but you see people that have more deformity, they endure more pain before they get treatment, whether it’s because it’s not available. And it’s a vicious cycle. In some ways in the United States, we apply a lot of resources to creating an environment so that we can solve those problems as you were talking about. But I think that’s one of the answers. I don’t have a perfect answer for you. There are a lot of countries that do have niches though, within what we would now call the medical community, whether it’s drug development, the pharma industry, a lot of that happens outside of the United States, as you know, and a lot of computer assisted kinds of stuff happen in various places around the world as well. One of our divisions is in France that we’re works a lot on our computer assisted surgery happens to be an area in the South of France that does a lot of that kind of stuff. And it breeds itself. You have people that are working together, I think to do it well. It is a team sport and the United States creates a good playing field to use that analogy for engineers to both be trained and to be able to create careers in this area and do well at it. 

James Di Virgilio (15:48): 

Do you have a favorite project that you’ve worked on or creation or innovation, something that sticks out as like that one was really special. 

Gary Miller (15:57): 

You know I really don’t. I talk about that rod that I worked on at the very beginning, that was very, very rewarding for me. Let me twist it a little bit for you. One of the nicest things that I see, one of the most rewarding things for me as an engineer working in medicine is you get that feedback of how you’ve done. It was amazing to me with that first experience as a person that was debilitated on heavy drugs, couldn’t really walk. And it’s an end of life experience. It’s metastatic bone cancer, but their quality of life was really awful because of pain. And after doing the procedure that we had created, the orthopedic surgeons and I at the hospital would get up the next day, even though they had had a surgical procedure and say, Oh, wow, this is great. They were ready to go. Similarly, a person with really bad arthritis. They can’t get in and out of a chair to have to use the arms of a chair. One of the things I always kid around with some people is try getting up from a chair with no use of your hands. You have to have good knees to do that. And your hips have to be functioning really well. One of the nice things that we get to do in biomechanics in the field that I’ve spent my career in is seeing that patient walk out of the hospital or getting up that first day and say, well, I know it hurts because I had surgery, but it doesn’t hurt like it did before my surgery. That’s the measure that we have. There’s other areas of engineering that it’s much harder to get a read on the success of what you’ve done. I think that one of the things I’ve enjoyed so much working in medical devices and working in biomechanics over the years and being in a clinical situation, their research areas are all those things and not to dismiss those that I need as a person, you need the tools and the toolbox to be able to do all the things that we do. We need the materials. We need some of the understanding of design that are done in a laboratory setting. I’ve worked my career in applied biomechanics, if you will, or applied biomaterials where I get to use some of those early inventive steps to create a product or a device, if you will, that goes into a patient or is used to put something in a patient. And it’s been tremendously rewarding for me because as I said, if we can give a surgeon the opportunity to do that extra case, that’s one more patient. That’s gonna not have to endure pain for an extra day. It’s all about that patient outcome thing resonates with me. And I’ve been lucky to be able to spend so many years just being in that sandbox. 

James Di Virgilio (18:29): 

I’m hearing so much passion and excitement and joy for what you do. And I’m wondering after a full career of doing all these things, when you wake up each day, are you just as excited about solving problems today as you were 10, 15, 20, 30 years ago? 

Gary Miller (18:44): 

Yeah. I am. I don’t know if I can get there as fast and do it as quickly, but yes, it’s a terrifically rewarding area to be, and it’s what keeps me going for sure. 

James Di Virgilio (18:55): 

I think that’s true of people in general. You know, my belief and philosophy in life is that we’re here. We’re created to be here. We’re created to attempt to improve the world around us and your energy. As I’m sitting 10 feet away from you is palpable. You can feel the satisfaction and the drive that you have to improve the world around you. And that’s what creativity and innovation does. Let’s bring this down to the listener, whether they’re 15 or they’re 50, and talk about this idea of problem solving, how do you teach somebody to have not the same passion you do? Cause we’re all created differently in that regard, but to maybe view the world that way, Hey, maybe you too can see some problems and begin to think about solving them. Can this be taught? Are you born with this? What is this? Like? 

Gary Miller (19:35): 

Yes. And yes, the folks that are successful, I do think bring that intellectual curiosity with them. They don’t take things for granted about how’s it working, what it’s doing. And so I think that is innate. I think because there are people that are frustrated that they can’t sometimes I wish it was totally teachable because we could use more people inventing, right? If you use my basic thesis of improving life, however, to answer your question more specifically, very structured ways of looking at things that if you learn those techniques, that you can be better at it. I’ve been asked this by students before when I lecture. And one of the things I love to do is mentor at this stage. If somebody is willing to listen to you about your experiences and how you solved it, you end up transferring both the passion and the technique. So yours is a very good question. There’s structured ways of doing it and being creative there’s skills that you can learn. You look at a solution and say, what happens if you turn it upside down? What happens if it’s backwards? They’re ways of brainstorming is a catch phrase that some people use where you put every which way, think you could do it down on paper without judging whether it would work or not. And then manipulating those images of what you thought about. It works really good in a group setting that people throw stuff out on the table, if you will, and you’re not allowed to critique whether it would work or not. The whole idea is to generate the most ideas. So there are techniques. There have been a lot of books written about it. There have been a lot of books written about a lot of things. And how many books have been written about how to become a millionaire? How many people read the book and become a millionaire? I think the same applies here. I have been impressed though that the tools have gotten more powerful for us. I remember 40 years ago, it was a drafting table and a pencil and scale and compass and drawing stuff. And if you wanted to make four sizes, you had to make four different drawings and you sat there with your slide rule and or a tablet of paper and added all the numbers up fast forward to today. When there’s three D rendering of computer assisted design, and you can look at it on the screen and you can make it larger and smaller and you can take four pieces like their fourth five pieces in a given joint replacement, put them all together, see how they move together. Those are incredibly powerful tools. And then you decide, well, I want the smallest one to be this size and I want the largest one to be this size. And then you can do the scaling if you will. And the system, the computer helps you. I have to tell you, I have yet to be able to be good at computer assisted design, but I work with people that are just, they blow your mind away. You’ll say something about this idea you have, and they’ll walk in and say, how about looking at this on my tablet used to be a desk size computer. Now it’s on a tablet if you will. So we’ve gotten really good and powerful tools. Testing has matured dramatically. We can’t use the person as the experiment here, and you’ve gotta be able to do a lot of simulation testing. A lot of those kinds of things, which were very hard to do in the past now because of the computing power we have, we’re able to make simulators that run an implant for 50 million, 20 million to look for the endurance. How’s it behaving all those kinds of things. And you can do a lot of things simultaneously. So between CAD simulation and all those things, it’s a far cry from what it was many years ago, when you had to build a prototype and try to test it in some way in a laboratory. And then honestly, in those days, once we thought we had it pretty close, we’d start using it. And it would be used in patients that needed it the most so that the risk reward was there. Now we can do a lot more and we can do it much more quickly. We talked about earlier about the length of time that it takes to do a design when everything works well, 18 months is not out of the question sometimes because of the regulatory overhead that we have. It takes longer than that. But in years past, it could take five years, seven, eight years, and then you weren’t anywhere near as sure about what the outcome was going to be. As I think we are now, they’re less small steps, 

James Di Virgilio (24:01): 

Words of wisdom. So here you are decades of experience. I want you to imagine going back in time and having a conversation with your 20 something self, what are two things you would tell yourself back then? Here’s what I want you to anchor to. As you go forward and you have this career doing all these things, remember these two things, 

Gary Miller (24:20): 

Be sure to listen and to watch what’s going on. That would be number one for me. And number two would be, I know you’re going to be asked to learn a lot of things that you don’t think you’re going to need to learn. And all I can tell you is I’ve used almost everything that I was taught, except for super higher math. I’ve never liked partial differential equations, and I’ve never had to use them, but I’d mentioned the tools in the toolbox to you earlier. I would tell a person earlier in their career, learn as much as you can keep learning it, keep learning new things, because you’ll never know when you might need to use it. And I could cite examples over and over again of things. I never thought I would be in business. That engineering economics class looked like a waste of time to me. And it’s helped me those on the finance side that say, I still don’t know how to read a balance sheet. What can I tell you, James? But at least I know what I don’t know. And sometimes you need to know what you don’t know. 

James Di Virgilio (25:22): 

There’s a lot of wisdom there, especially if you look at being a lifelong learner, having no idea where your life will take you. And then as you mentioned, maybe one of the most important things that I hope listeners pull from. This is what we’ve talked about. Indirectly sometimes directly about this concept of communication language, if you will, and if you’ve traveled at all, you can relate to what it’s like to drop yourself. I went to Asia many years back and you drop in the middle of China or Japan, and no one speaks a word of your language and you don’t speak a word of their language and you both could be brilliant people. And you’re reduced to hand signals, right? And as you mentioned, you want to go from hand signals to fluency in whatever language you have, and you have no idea what language is you’ll pick up throughout your time, whether yours is a mixture of engineering and finance and classes you’ve taken or life experiences you have and how they will cross over down the road. That’s very wise. 

Gary Miller (26:13): 

Yeah. I have examples of that in my own life and career. What I love to tell traveling in Spain, I speak minimal Spanish. And at the time I spoke absolutely no Spanish and went to dinner with one of those creative orthopedic surgeons like I was telling you about. And both of us were so frustrated trying to speak through the one person at the table who spoke English and Spanish. And after about 10 minutes, we both had our pens out and you’re going to laugh at me, but we kept moving the glasses and the plates out of the way. And we started drawing on the tablecloth. And so the visual became our medium for communication. And you were teasing me about cemented hips there earlier. We went through his idea of a hip design on that tablecloth and two napkins, as I recall, and we got to the end and we understood what each of us was trying to say. And it came to a pretty nice solution in design that we were able to move forward on. The only embarrassing thing was in this very nice restaurant in Spain, we had to have them take the tablecloth and the napkins off the table and wrap them up and give them to us because it was before cell phones and the only way to transport all this work we had done for two and a half hours at a classic Spanish dinner was to take the table with us. So it’s a fond memory. Obviously for me, I bet a wonderful group of people all over the world. And it comes down yes to hand signals and drawing, drawing. The visual is really without language usually. 

James Di Virgilio (27:45): 

And that’s one of the greatest things about doing this podcast, talking with you today is that it’s people, it’s people like you. If you’re listening and it’s people like Gary, it’s people that have ideas and get together with other people that have ideas and those ideas become a reality, right? The things you’ve created, those were humans, creating the ideas and putting them into play. It wasn’t some magical process. It didn’t happen on its own. What you’ve learned what’s in your brain is valuable. Working with others valuable. One of my favorite economic examples is Milton Friedman. You can find this on the internet does like a two minute video on the pencil, the humble pencil, but the pencil comes from so many different places all over the world, which is what allows it to be so cheap nowadays. Right? But at one point in time, it wasn’t so cheap, even just getting led was difficult. And we’ve talked a lot about a lot of these things today. I always find it very encouraging when we’re talking to someone who’s created as many things as you have to hear that it really does come back to what do you know, what do other people know? How can you get together, work together, find solutions to problems that exist. It’s been absolutely great to have you. My guest today, Gary Miller, the co founder of Exactech, also a man of many other things. We can’t just label you as that. And also on the board for the Cade Museum. I would remiss, if I didn’t say that. So thank you for all of your support and also for your time today, we certainly loved having you on Radio Cade. 

Gary Miller (28:55): 

Well, thank you. It’s been an absolute pleasure. 

James Di Virgilio (28:58): 

For Radio Cade, I’m James Di Virgilio. 

Outro (29:01): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson. 

Here, Dr. Okun dispels myths surrounding Parkinson’s, talks about his research and clinical work, and discusses his involvement with several non-profits raising awareness on other conditions and diseases.  “Every day that I practice medicine, I know less,” says Dr. Okun.  “It’s a profession where you have to have a lot of humility. You have to have an open mind and things change over time.” 

TRANSCRIPT:

Intro (00:01):

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace. Parkinson’s Disease. What do we know about it? Why does it seem to be more common and how do we treat it? Welcome to Radio Cade. I’m your host Richard Miles today. I’m pleased to welcome Dr. Michael Okun the Chair of Neurology and Professor and Executive Director of the Norman Fixel Institute for Neurological Diseases at the University of Florida College of Medicine. Dr. Okun’s also an expert on deep brain stimulation and author of over 400 peer-reviewed articles, as well as the book “Parkinson’s Treatment: 10 Secrets to a Happier Life.” Welcome to Radio Cade, Dr. Okun.

Dr. Michael Okun (01:11):

My pleasure to be here, Richard.

Richard Miles (01:12):

So before we start, I have to mention you’re also a poet and that caught my eye mostly because I find myself in middle age becoming very interested in poetry, but only as a reader, not an actual poet. So I have to start, is this something you’ve always done or is it because being a brain doctor wasn’t challenging enough for you? What got you into poetry?

Dr. Michael Okun (01:28):

My original bent was in humanities, and I have a degree in history. And so, I love to write, and I love to try to express myself in different ways. I love poetry, because there’s a new precision towards, and I think that through poetry, you can express concepts using emotions and other modalities to reach your readers. And so, over the years I’ve done a number of poems, and I have an old book called “Lessons From the Bedside” and have done some writings in said time as well.

Richard Miles (02:01):

I love that analogy too, to the work that you do. Cause one of the things I have noticed in my very limited foray into studying poetry is precisely what you said, that the precision of the use of certain words versus not other words. And that reveals a lot of the thinking and so on. And I imagine studying medicine, there is some similarities there.

Dr. Michael Okun (02:18):

That’s right, and really keeping an open mind. And I am also a neurologist by training. And so I practice medicine and I say often that every day that I practice medicine, I know less. It’s a profession where you have to have a lot of humility. You have to have an open mind and things change over time. And we’re really like cabinet advisors to people. We’re here to help with the best information that we can, but we really shouldn’t be so prescriptive, and so sure of ourselves. And I think anybody, whether you’re an inventor, you’re a scientist, you’re a clinician or all of the above, will look back and say what I did five years ago, versus what I’m doing now, is different. And it might seem subtle because you lived it, but if you think in those terms, that’s, I think what I would term as wisdom and you realize that practice of medicine and the understanding of diseases evolves and that there’s not one solution for everyone.

Richard Miles (03:15):

That’s a great way of looking at it. And that really helps, I think, for what we’re about to talk about now, and that is you have developed, or you’re known as really one of the world’s experts on a technique to treat Parkinson’s. But before we get into the details of what that is and how it works, I’d like to talk more broadly about Parkinson’s itself, which is a disease that most people probably have heard of or know somebody with Parkinson’s, but they may not know exactly how it works and what are some of the underlying causes. And I noticed that a few years ago, you wrote a paper called “The Emerging Evidence of the Parkinson Pandemic,” which caught my eye, obviously because we’re in the midst of another pandemic. And so pandemics in general, I think are of higher interest to everyone. But in that paper, you said that neurological disorders are now the leading source of disability globally, and the fastest growing neurological disorder in the world is Parkinson’s disease. And you said that from 1990 to 2015, so about a quarter century time period, the number of people with Parkinson’s disease doubled to over 6 million. And finally your quote, “for most of human history, Parkinson has been a rare disorder, but various factors have now created” what you call Parkinson’s pandemic. There’s a lot there, but why don’t we start by briefly describing for listeners who are maybe not exactly sure how Parkinson’s differs from other types of neurological diseases. Define it for us. And then why don’t we spend some time talking about those various factors that have caused it apparently to go from a rare condition to pandemic-level proportions.

Dr. Michael Okun (04:40):

So first Parkinson’s Disease, it’s a neurological syndrome, and it comes with symptoms that people can readily detect. Oftentimes when you’re in a crowd, you see somebody might be shaking, they might be shuffling their feet, their handwriting might be small when they’re at the bank, and they may be struggling with some of these, what we call motor features and also what we call non-motor features. So it’s a brain disease that affect depression, anxiety, and quality of life. And it turns out that Parkinson’s Disease is not just a disease of dopamine. And so a lot of people believe that you lose dopamine in the brain and you get Parkinson’s, it’s actually degeneration of multiple circuits. I’ve spent my career studying the circuits and Parkinson and in other diseases. And when we think of Parkinson, I remember when I was at the White House in 2015, I was quoted as saying, “Parkinson is,” and I’m not the first person that said this and won’t be the last, “the most complex medical disorder period,” because there’s over 20 motor features and non-motor features. So tremor, stiffness, slowness, (and not everybody gets tremors and not everybody gets stiff necessarily, it could be different varieties) in depression, anxiety, sexual dysfunction, other issues too. And then you throw in dopamine replacement therapies, you throw in deep brain stimulation ,what you mentioned, and it’s something that we’ve been researching now for a few decades here at University of Florida with one of my partners, Kelly Foote, and Mendez and many other people in the laboratory. And so Parkinson’s Disease is a neurological disorder. It is rapidly expanding. And about eight years ago in the book, 10 Secrets to a Happier Life, in the prologue, I said: “Parkinson has all the same characteristics of a pandemic.” And that was very controversial at the time. That’s eight years ago. And our most recent book that just came out from Hatchette publishing, “Ending Parkinson’s Disease,” it was originally titled the Parkinson’s pandemic. The publisher changed the title, and they wished they could have that back because it came out in March, 2020. So, “pan” means “all” in Greek, “demos” means “people.” And when you apply the concepts of a pandemic, they can apply to other diseases. Although, I was just on a call with the World Health Organization last week, and I think it’s fair to keep the term pandemic reserved for infectious diseases. Although people should know that the rapid expansion, the geography, the people not being immune to it, it all applies to other diseases like Parkinson’s.

Richard Miles (07:06):

So tell us, what are some of the factors that researchers have uncovered, or maybe that you hypothesized are at work here that are causing it to grow, I’m guessing, dramatically on a per capita basis? Are there geographic differences, for instance, in range between different countries or different demographic groups? What is going on here, and what do you think is behind it?

Dr. Michael Okun (07:25):

So we just had a conference with our colleagues in Geneva, Switzerland at the World Health Organization that have taken this on. And there’s a working group of us from all different countries, from rich countries, from poor countries, from countries somewhere in the middle…Parkinson occurs in all of the above. Now, one of the myths of Parkinson is that it’s all due to aging. And so as you get older, you get a higher prevalence of Parkinson and that’s true. Now, many people might be surprised when I tell you in our waiting room, I see people in their teens, and twenties and thirties with Parkinson’s, and it becomes more of a common as you get older, but it doesn’t mean it can’t occur in young people, as well as people–I don’t say old people–I say more seasoned people. And it turns out that age, it’s a myth. Age is not the only thing that’s driving this increase. There is going to be a doubling of Parkinson between 1990 and 2015. That’s already happened. It’s going to double again from 2015 to 2040 and could collapse healthcare systems, cause lots of suffering if we don’t get out in front of it. And so there are other factors that are driving this. And one of the ones that we talked about in the latest book is about pesticides and chemicals and environmental factors, and how those factors and the industrialization of society and how that’s changed the game.

Richard Miles (08:47):

That’s fascinating. So let’s move on to, what are some of the treatments that are available? You mentioned deep brain stimulation that you and Dr. Foote and others have been working on for a couple of decades. What led you to that I guess, and tell us how it works and what sort of improvements that you see?

Dr. Michael Okun (09:02):

Back in the 1930s and 40s, there weren’t treatments for Parkinson’s and for other diseases of movement. Some of the early attempts were actually making holes in people’s minds and disrupting these abnormal conversations. So if we think of the brain as a group of islands and the islands are all talking to each other, if you disrupt the conversation, people discovered that this is a potential way to treat specific symptoms, depending on which circuit you disrupt that conversation. And as time evolved, we were able to modulate conversations by using medicines. And the first major medicine was introduced by George Cotzias in the 1960s, and that was dopamine replacement therapy. And that actually modulates, it changes the way the brain’s oscillations are moving, and everybody, whether you’re awake or you’re asleep, your brain is always oscillating. And when you have a disease, particularly in neurological disease, that oscillates in different ways. So surgeries came back; when we have better technology to get to very specific sub millimeter zones of the brain, we started burning out pieces of the brain and that’s what I did during my training. And then as we moved along, we began to understand how the different areas were talking to each other, and we develop what’s called neuromodulation, so sticking straws in, introducing electricity into those circuits, I’m trying to change the way that they would talk to each other. And so my mentor and one of Kelly Foote’s mentors who I work with is a man named Mahlon DeLong at Emory University. He’s retired now, but a tremendous human being, and he was the one that really spent years and years at the National Institute of Health, and then at Hopkins, and at Emory decoding what the circuits are. And in 2015, he received the Lasker Award, which is one of the highest awards in medicine, just under the Nobel, for this work.

Richard Miles (10:50):

Doctor, now that this is becoming more common and will become more common, walk us through what happens when, let’s say someone’s parent they’re 60, 65, 70 years old, they’re brought in to a doctor like you or a clinic somewhere, and they’re diagnosed with Parkinson’s. What are some of the first steps of treatment? And coming back to deep brain stimulation, is this a one and done type of treatment, or is this a continuous regimen of treatments over time? And then what does the outcome look like for, say, someone in their mid-fifties or early sixties?

Dr. Michael Okun (11:20):

So when we think about Parkinson’s Disease, the first thing we think about is when somebody comes in, we need to understand when you say those words, “you have Parkinson’s Disease,” it’s not the end of the world. Okay? There are a lot of different forms of Parkinson’s Disease. And I have folks in my practice I’ve taken care of for 20, 30, 40 years. Okay? So it’s important for us to dispel that myth. And as we dispel the myth and begin to deliver treatment, we recently wrote in the Lancer last week, a seminar on Parkinson’s Disease, 20 page-seminars, get your coffee if you want to read it. But we talk about, in that seminar, there’s a picture of when we started here at University of Florida, we had this concept of model for caring for the Parkinson person. And we said, the person’s the sun, and we should all orbit around the person and the family, because this is such a complex condition. And there are so many, you know, specialists; you need an archeologist, a neurosurgeon, neuropsychologist, PT, OT, and speech, or maybe you need a nutritionist, access to clinical trials… We have over a hundred clinical trials, it becomes confusing. And so, we need to integrate the care, and if we integrate the care into what we call a multidisciplinary team, we’ve learned that it isn’t just–I call myself the drug dealer as a neurologist. It isn’t just the drug dealer or the device dealer, where we take people to the operating room and put a device in that provides the best possible care. It’s this model of interdisciplinary care, and it continuously changes over time, and you have to actually listen to the people, so it’s a different specialty, and to actually listen to the clues that they give you on how they’re living in order to change timing and change doses. There’s over a dozen different medications, there’s all sorts of infusions, there’s deep brain stimulation. And I like to teach, and we have fellows here who, after they’re done with their neurology residency, spend two years with us to train in this, and we’ve trained about 70 of these were all over the world. And what I like to tell people is Parkinson is like a lifetime disease. Think of all these different therapies, and you need to understand how the disease evolves and when is the right window to apply each one. So deep brain stimulation isn’t for everyone at all times, but there are points in the treatment where it can provide extremely beneficial effects on things like just suppressing tremor or movements we call dyskinesia. And so knowing the disease and knowing the person, and then creating the right multidisciplinary plan is important. And the last point is, we wrote something for the Journal of the American Medical Association last year with Melissa Armstrong here at UF. And we, as experts said, a first-line therapy now is exercise. We now recognize that exercise is so beneficial for this disease, that it’s now considered a first-line therapy, right along with the medications. And so that should tell you something about the humility of treating this disease for so many years and us understanding what’s good for folks and what’s not.

Richard Miles (14:18):

If we compare this to a disease like cancer, is Parkinson’s something that could actually be put into remission, or is this a steadily degenerative disease? All the treatments are just slowing down or resting that trajectory, but essentially it’s going down, or can you stabilize somebody for a decade, for instance, with no decline? How does that compare to something like cancer?

Dr. Michael Okun (14:37):

Parkinson’s is a progressive neurodegenerative disorder. Now there are multiple what we call phenotypes. So we have what some people call benign Parkinson, because it progresses so slowly. And then there are other forms that progress faster. We’re just beginning–it’s like Genesis of the Bible–we’re just the in first couple of days in understanding actually the differences between some of these entities, but it is progressive. Now people might say, well, tell me, how did Pope John Paul get anointed as a Saint, right? Didn’t he cure a nun of Parkinson disease, and that’s how he achieved sainthood. Well, we’d like to leave that story alone because it turns out that many people who are presumed to have Parkinson’s disease do not. And so if you get better then you may not have Parkinson’s, and then there’s a group of people who have tremors and other symptoms that look like Parkinson’s. About 10%, about one in 10, very early on, when you first see them, then never progress. And a lot of times people don’t go back and realize, wait, this person’s not progressing at all — hey actually don’t have Parkinson, they have something else that’s more benign. And we realized that, and we gave this crazy name to that called scans without evidence of dopaminergic denervation. I would never call a person a sweat, that’s what it stands for. But, if you’re not progressing, you may not have Parkinson’s. And sometimes early on the diagnosis can be made in the wrong direction as well. And so it’s very important, but when you do have Parkinson right now, it’s progressive. Now we are searching for things that will slow the disease down and, or provide precision medicine or other treatments for it, but we haven’t gotten there yet.

Richard Miles (16:15):

So let me come back to something you just said about perhaps a faulty diagnosis. It sounds like the ideal treatment or regimen of treatment is this interdisciplinary approach, which you’ve got multiple people looking at it and working on it from different angles for a patient, but I’m guessing that that level of complexity of care is not available to everyone. Do you have to be next to, say a major research hospital, like University of Florida, or some major metropolitan area to get that kind of care? And if you’re not, and you’re in a rural area or in a very poor country, for instance, what is the outlook for somebody in their mid-sixties?

Dr. Michael Okun (16:44):

So in general, if you can get access to one of these multidisciplinary teams, it’s better. We know from Medicare data done by Allison Willis, who is at the University of Pennsylvania, that if you have access to even a neurologist, and most people don’t actually see a neurologist, if you have access to a neurologist, your morbidity and mortality, your nursing home placement, all of those things that are super important, those numbers get better. Just having access. If you have access to multidisciplinary care, the data is beginning to point that this is also better. There are centers of excellence that have been set up through foundations, ike I work as a medical advisor and former medical director for the Parkinson Foundation. We have 47 centers all over the globe, but these aren’t widely available to people. What we do at the University of Florida is we see people from all over the world, we always have, and we try to construct plans for them, so these plans can be carried out by people within local zip codes, whether your local zip code is in Australia or Asia, or you have flown in to be seen, you know, from there where we set the plans, and then we ask the therapists to follow them out. Beause a lot of therapists and other members of a multidisciplinary team, they may be giving you the wrong therapy. And sometimes the wrong therapy, Richard, is worse than no therapy in a disease like this. And so setting the right plans, communicating and creating public health value is important. And one of the three things, we just had a campaign it’s still ongoing called the Give a Dime for Parkinson’s Disease campaign, and our first goal was to get to 10,000 red cards to the White House. We’ve now reached 25,000. One of the three points, while we asked for three things– because if you ask for too many people get distracted–we’re asking the White House and congressional members to consider as one of the three things is to maintain telehealth access for people in the United States. That didn’t happen before COVID-19, and many people don’t realize that that’s not permanent. That has to be made permanent, and then we have to develop these types of interdisciplinary models, so that people who don’t have access or don’t live right next door can still get access and the right advice, and then put the right team together, so they can have the best outcomes. The best outcomes mean less falls, less fractures, billions of dollars in healthcare savings, happier people. And so I think it’s in everybody’s best interest, particularly as the disease has exploded.

Richard Miles (19:06):

And Dr. Okun, In addition to your research and your clinical work, I know you are involved in at least several nonprofits that I know of, probably more. Tell us a little bit about what you’re doing in those areas, like Tyler’s Hope and so on, and what has been the response as you’re trying to raise awareness on some of these conditions or diseases that are not as well known.

Dr. Michael Okun (19:23):

Yeah. So I think when you look at other diseases and what they’ve done to change the trajectory, the story of polio, the story of HIV, and in HIV, it took what we call four pillars to do that. So you have to develop a system with any of these nonprofits for any of these really important diseases that are going to affect society. P is for prevent, A is for advocate, C is for care, and T is for developing new treatments through research. We call it the PACT. So when we went and we researched, we said, what do you need to do? So we need to get all of our non-for-profits together and we need to organize and sum our voices, and reach that inflection point where we can become loud enough. We can advocate with enough force to actually push change. And that’s what happened in HIV. For example, they went from a few hundred million in funding to 3 billion, a year in funding. And now HIV, when I was an intern, my first year out of medical school, 25 years ago, this was a bad word to be on. If you have HIV, it was kind of the death word, and it was really not great. And now, it’s a chronic livable condition, the trajectory has changed for literally tens of thousands, if not more people, worldwide. And there’s a reason why that happened: prevent, advocate, care, and treat them. And advocacy was huge. And so I’m a big believer in non-for-profits and even more than opening the checkbook and writing the check, getting involved. And I’m a believer that when you sum voices together, if you can get to a certain level–and nobody knows exactly what that is, maybe we can ask them out loud while our tipping point lives through these things. But there is a moment where things tip. And so one of the things in Perkinson, for example, we’re trying to tip, one of the three things we’re asking for us increase the funding from 200 million to 2 billion a year, by 10 times, because we know that if you increase it by two times, you’re going to get twice as much research, twice as many young researchers. And so this is going to have a multiplicative effect. When it comes for Tyler’s Hope for just only a cure, here, this is a disease where we know the deletion. We know where it lives. We know quite a bit about it. We have a lot of technology, we just need to, sum our voices, push more money into this, and that’s what Tyler’s Hope is doing, push the advocacy, and we can create a precision medicine treatment. And I think we’re on our way and that disease as well, there’s still a way to go, but the same for Tourette. So I’ve been in the tourette world with a non-for-profit called the Tourette Association of America. So I think the story is the same, but I think part of the formula to reach impact is you have to bring together globally voices. And when we were speaking with World Health Organization, there were representatives from all countries talking about Parkinson and creating that grassroots movement. And we have a grassroots movement called the PD Avengers on Twitter. Now there’s 3000, like really loud, obnoxious people on one of them that are really making a lot of noise. And that’s what we need. We don’t need to be polite anymore. We need to be aggressive and charismatic and a bit obnoxious for these diseases.

Richard Miles (22:26):

I like how you put that and, as a comment, as an aside, I spent a good portion of my career overseas. And one thing that non-Americans are amazed by is the level for nonprofit activity that we have in the United States, directed towards all sorts of things, but in particular medicine or health, and the vibrancy of that sector really is something almost distinctly American. They obviously exist in other countries, but not nearly at the level and scope of what you see all over the place in small towns, big towns, and so on.

Dr. Michael Okun (22:53):

It’s a very special thing. And you’re absolutely right. I’ve done outreach to other countries. And I, I won’t say which country I was in, we actually brought some devices in and probably could have been arrested for doing that. And we were helping the doctors with some devices and some implants. And we were out seeing people all over, who just needed help. And it struck me in that experience, and I’ve seen it in other countries as well, that we helped a woman, and then they invited us to dinner, and we realized that, Oh my God, this woman that we helped is the mother of somebody huge in the country that has these huge business interests all over the country. And we said, why don’t you give a whole bunch of money to Parkinson’s disease? And they said, “give money to Parkinson disease? We don’t give money. This is an American thing.” You know, too, we’re having this discussion. “You all give away your money. We don’t do that. We don’t do charity.” And I thought, wow, it is really something special. And, and then I think they felt a little bit embarrassed. And then they said, well, we do give charity. But the charity we give is we support our sports teams. And so we explained to them, well, that’s not exactly charity. And so I do think that it is a uniquely American thing. It’s one of the things that differentiates us, makes us stronger and gives us the potential to mobilize and galvanize against diseases and other issues that face society.

Richard Miles (24:12):

And it’s also a perfect way to mediate between the individual who alone can’t do much, and the government, which often has a lot of resources, but is not terribly efficient in how it distributes them, so it creates this whole layer between small groups and very large governments. Dr. Okun, one final question or a couple of questions actually. At the Cade Museum, we like to not just tell a story of inventions, but the inventors, and not just the story of technology, but the researchers behind the technology. So tell us a little bit about pre-professional Michael Okun: what were you like as a kid? Did you know, early on you wanted to be a doctor or a researcher? What were some of your early influences?

Dr. Michael Okun (24:48):

Yeah, so I had it pretty good as a kid. I grew up with a good house. I had two parents. My father was a dentist, my mother was teacher. And so I kind of got left brain, right brain. They had very different ways of looking at the world. I was always memorizing things like the backs of baseball cards, statistics, things like that. And my life I’ve always had a joy. I’ve always been a person that’s had pure joy to be part of things. And so for me, a lot of my joy was in reading history and humanities and things like that. And so I saw myself more as a teacher and a teacher of history and even going into medicine for me, I saw myself as a black bag family practice doc. But what happened to me was life as a journey. And it’s like a lot of Chinese philosophers say, Lu Zhen is a famous Chinese philosopher who talks about roads, and there are no roads, and when there are no roads, a road is formed because people walk on that road. And so you walk your journey and you take your opportunities. And sometimes you don’t know exactly what you’re interested in or not interested in. And so even when I ended up saying, I want to go to medical school now and try to help people in underserved communities, I couldn’t tell you the difference between a neurologist and neurosurgeon you know, at that point in my life, and you just keep walking the road, and it turns out I’ve always been fascinated by people with tremors and movements and saying why. And I said, I would never do research. I’m a teacher. I would never do research. And then I realized that the government will give you a whole bunch of money to study things that you’re super passionate about that can help people. And so I was super passionate about figuring out where in the brain ticks came from. And so I’ve spent 20 years working on that problem, and we’ve developed devices, systems and things to try to address that problem, same with Parkinson and tremors and certain movements and funny walks. And so I’ve always been fascinated by that. I think the secret is, you find your passion, you spend as many minutes as you can doing your passion. And if you can get somebody to actually pay you to do it, then that’s the bonus, but the bonus doesn’t always happen. And I think in my life, all of those things have aligned and I have great joy every day that I come to work ,every day that we go to the operating room, Kelly and I, I have great joy. We’re always thinking, we’re always innovating. And we consider our labs a continuous beta test. We’re always writing papers. We’re always thinking about stuff. Now, one thing we’re not for people that are listening to this podcast, we’re not like business entrepreneurs. So we patented a whole bunch of different things: how you do a cap on this, how you do reporting on that, how a device would do this, how one side might turn this side on. And, we get involved with all of these things–vaccines–but our job is we just keep innovating, and then we hand that over to someone else and innovations square and let other people run with it, because our passion and our impact is trying to help as many people as we can. And so there are various different aspects to the creativity process, to the invention and the innovation process. And we have kind of a human laboratory, you know, in the operating room and in the clinics and in seeing people and they tell us what the problems are and we try to innovate for them. And the next steps happen as we try to create that, we try to write it down. Remember I like to write poetry and other things. We try to write it down and tell people what we did, and then the next steps will happen. So there is this beautiful process of innovation that happens, and there are a lot of people that quietly do that in the background like Kelly Foote and groups here that are just quietly doing their jobs, writing down what they’re doing, and then letting other people take it to the next level and commercialize these things and make sure that they get out there to help people. And there’s a great quote, I think it was Jonas Salk who they said, are you going to patent polio vaccine? And he said, well, that would be like patenting the sun. And so we’re all into patents and innovations and everything. But at the end of the day, we have a certain amount of minutes on the planet, and if we can come up with innovations that are going to help and impact people’s lives, I think that’s what most of the people, at least on the medical disease side of innovation, are interested in. And so you asked me what my message would be for kids or young people would just be follow your road, spend as many minutes doing the passion that you can, impact as many lives as you can. Don’t worry about the money. Don’t worry about that. Just worry about how much joy you have in your heart. That’s all you need to do.

Richard Miles (29:14):

That’s a great answer. And whether intentionally or not, you summarized also a good chunk of the origin story of the Cade Museum and Dr. Robert Cade, who invented as you know, Gatorade, because he didn’t have any idea how to take that product to market. He liked to write poetry. He had just a real joy in life for helping others and to his final day, he and his co-inventors, the number one thing they were proudest about, about Gatorade, was the fact that it became the cheapest and most widely available treatment for infant diarrhea in the third world. Wasn’t intended to do that, but that’s what they are really the proudest to have, not that it became a culture or a sports icon. And so it’s nice to hear you say that, but just in different words.

Dr. Michael Okun (29:50):

I think it’s a great story, and one I hope kids are listening to, but so many people will give you advice about your career and everything, and I think they make it more complicated than it needs to be.

Richard Miles (30:01):

You precluded my last question, was what would your career advice be? And you just gave it to me anyway, but it’s great advice and really appreciate having you on the show. You’re doing tremendous work, keep doing it. It’s inspiration on all sorts of different levels and wish you the best of luck.

Dr. Michael Okun (30:13):

It’s my pleasure, and we love the Cade Museum. We talked about being involved in non-for-profits, my wife and I are involved in, and we think it’s just a great thing for not only this community, but for the world. So thanks for all you do.

Outro (30:25):

Thank you. Radio Cade is produced by the Cade museum for creativity and invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie, Tom coordinates, inventor interviews, podcasts are recorded at Heartwood, soundstage and edited and mixed by Bob McPeak. The radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

TRANSCRIPT:

Intro (00:01):

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida, the museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

Richard Miles (00:38):

I’m going to call HR if you work for any size company, that sentence has the appeal of I’m going to tell your mom, but it turns out HR has a fun, sexy side. I’m your host, Richard Miles and today we will be talking about how much fun it is with Jeff Lyons, founder of a company called MindSolve and currently the Senior Vice President of Global Professional Services at Sum Total, welcome to the show, Jeff.

Jeff Lyons (01:00):

Thanks, Richard. Excited to be here.

Richard Miles (01:02):

So Jeff, when I look up fun and sexy in the dictionary, there’s a picture of you, right?

Jeff Lyons (01:05):

Definitely. And HR as well.

Richard Miles (01:08):

I also forgot to mention actually the pinnacle of your professional career has been serving as a board member on the Cade Museum, right? It’s pretty much downhill from here.

Jeff Lyons (01:16):

Yes, thank you.

Richard Miles (01:17):

And normally we’re talking about topics that are unfamiliar to a lot of people, advanced medical technologies, engineering marvels, that sort of stuff. Today, we’ll be talking about something that actually most people understand pretty well, performance evaluations, training skills management, but let’s talk about first of all, how those things in an organization can be a problem or at least what was the problem you saw in organizational process and what was the solution that you came up with?

Jeff Lyons (01:43):

So the first thing I should say is that the core technology that MindSolve took to market was not something that I came up with or, or that the folks at MindSolve really came up with. It was the brainchild of a guy named Harold Fethy who ran the HR function at a pharmaceutical research firm in Palo Alto. And so what was interesting was the problem, there was a unique, because he’s trying to do performance assessment with a company full of PhDs that are going to argue with any kind of measurement model or metric or calculation you can put in front of them.

Richard Miles (02:12):

What year are we talking about Jeff roughly?

Jeff Lyons (02:14):

This was 95, 96. Um, so sort of just prior to the founding of MindSolve, and so it was an idea that Harold had, and then we help develop the technology and then licensed to take that to market.

Richard Miles (02:25):

So what is the problem in principle that you were trying to solve?

Jeff Lyons (02:29):

So the main problem is how do we evaluate employee performance in a way that’s relevant and in a way that has a lot of quality in the data where you can make solid decisions on it, but in a way that’s also easy. Performance appraisal, as you said, everybody’s familiar with it, universally, everybody hates it. It doesn’t matter what you do. You’re never the popular guy walking into the building when it’s performance, appraisal time. But I think we actually did come up with a way to make it pretty sexy and pretty easy and at Aliza because they had a very high bar for data quality and for a robust measurement metric behind everything that was challenging to do in a way that was fun and easy. And Harold had an idea of doing a visual ranking. And I hope talking with my hands on the podcast that comes through, you could describe this to our listeners, but a way of doing just a very simple drag and drop stack ranking on a screen and took Aliza from a process that had very high data quality and was well-respected, but was miserable and onerous and people would do over the weekend with a case of beer and complain about it to something that people were finishing very quickly on time. Not only felt good about the validity, but it was easy to do, and that helped also make it well received. And so that translated very well to a broader audience, that wasn’t a company full of PhDs. And that’s what helped grow the company.

Richard Miles (03:45):

Instead of a long series of questions, for instance, like, is this employee good at X, Y, and Z, it would be more of a graphical interface or?

Jeff Lyons (03:53):

Exactly. So what else it was coming from was an idea called paired comparison, which has a lot of data validity. And you build up a data model by comparing A to B and then B to C and then C to A, and kind of making these one by one paired comparisons. And so the psychometrics behind that are great, but people are pretty skeptical and it’s a hugely painful exercise. Normal performance appraisal looks at every employee one at a time. And you just do like a one to five ranking on a bunch of questions and people try to make it better by asking more questions. And there’s a lot of counterintuitive stuff. You get better data up until about eight or nine factors or questions after that, your data quality drops way, way off. The more questions you ask because people get tired of it and they just start Christmas treeing. So this was a way, instead of doing each employee one at a time, we would take your whole team, put them on screen and say, let’s talk about communication skill, put your best communicator at the top, worst communicater at the bottom, kind of rank people in there. And then we’ll look at decision making and self management. And we ended up with about five criteria for most employees. And I think we added two or three extra for managers. So it was very simple, very fast, but we did a lot of work to look at the data quality and we ended up with very, very good decision quality coming out of the exercise.

Richard Miles (05:05):

That’s fascinating. I wish they had had that when I was in the federal government, which is probably the worst possible example for performance evaluations. But I remember in the army, they had a problem with the officer evaluations and that there were really only two types of officer evaluations. One, your the next Dwight D. Eisenhower and you should be promoted immediately. And the other one is you’re basically a trader to your country and you should be taken out shot. There’s nothing in between. And then the way the army saw that problem is it sounds like something similar. What they started doing is they started putting, I think they called it a diamond and it was after you’d gone through all this verbiage of how wonderful this person was. You were forced to say, well, this person is among the top 5% of officers I’ve ever commanded and so on. And the second and third tier, but then they would add a reality check and that you could then check what your average was. So you kind of knew that this raider was full of it because he gave everybody top diamond or whatever. It’s something like that. Is this something similar in principle to where you’re sort of forcing an accountability so that you can’t just go on and on about somebody’s qualities without comparing them to something? That that kind of it in principle?

Jeff Lyons (06:10):

You’ve hit on a lot of really, really dense stuff. There’s a lot of psychometrics wrapped up in what you just said. So the first is, yeah, if you evaluate people on a 10 point scale, you might have one person who rates his employees, all eights, nines, and tens, and then you have another person, especially in a room full of PhDs. Who’s just much more critical. Nobody’s perfect. And he rates all his employees five, six, seven, right? So the best guys getting a seven versus the best guy getting a nine. And when you want to make a decision across a broad organization, that’s not really fair. So the first thing that we did was we had to normalize that data. So, you essentially come up with a percentile. So what’s my number one compared to your number one. And we were doing multi-raider assessments. So it wasn’t just a manager evaluation.There were peer evaluations, direct reports would evaluate managers. And so you ended up with a lot of different perspectives about a single person’s performance and backing up for a second. When we took the data, we worked with a couple of really great people on the data model. And one of them, they had the advantage of being in Palo Alto is one of Harold’s close friends is a guy named Brad Ephron who was head of Stanford statistics department at the time, and a MacArthur fellow studying small datasets statistics, which is exactly what we had, right? So we’ve got not classic statistics, but five or six or seven ratings about an individual from a lot of different people. So he worked with us to say first normalize the data average that, and what we found was the absolute rating matters, right? A 3 out of 10 is not as good as a 9 out of 10, but the relative does as well. And what, having multiple people on screen at the same time does use your thinking, not just about what is decision making, but you’re thinking, how does Richard make decisions? And I can benchmark that against how does Jeff make decisions? And it helps me as a evaluator ground, something in reality and make better decisions. And there’s also an element of fairness to it. And then you mentioned kind of this idea that we would call like a forced distribution. Like if everybody fits into a bell curve, you can’t have all tens, you can’t have all ones. Where we ended up after lots of trial and error and back and forth and working with people is that it would be invalid to look at a large group of folks and not make decisions about who you’re starting five are, and who’s going to be cut from the team, right? You’ve got to be able to make those hard decisions in any organization. And it’s difficult because people say, well, we only hire A’s, everybody’s an A, but then you can’t get anything done if you’re not able to make those decisions, but we would not force a ranking. You could tie people, you didn’t necessarily have to fit percentages into those sections of the diamond, but you also couldn’t be flat. And what we would do is provide reports back to show where there wasn’t good differentiation in the ratings and go ask the question and you will get situations where we put our starting five all with this manager. So they’re all going to get high ratings or vice versa, but it was pretty rare. And you could look at the data and at least ask the question of, are we making a good, valid decision?

Richard Miles (08:57):

So you started out trying to solve the problem, or at least make more efficient performance evaluations, but then the company MindSolve that you originally founded, started doing other things, right? Like skills training and other types of management process. Can you describe, or the evolution from going to the performance evaluations to the other function.

Jeff Lyons (09:14):

Yeah, absolutely. What got us into more things was that we licensed that technology back from the company we built it for and started selling it to other companies. And what happens, I think this is true of almost any startup situation is if you go in and you help someone solve problems, they turn out to have a lot of problems and are struggled to solve them. And so they end up giving you more work. So if you look in HR, there’s a bunch of different functions. There’s performance, appraisal, there’s compensation, succession planning, learning, and development. And so you do good work here and they say, well, now we want to push that data into our comp process. For example, we use Excel spreadsheets, it’s miserable. We need to automate it. Can you help us automate that and just tie it right in that was the first sort of adjacent space we went into and then kind of worked our way around the wheel of HR. As customers started asking us to do more stuff. So we really grew in a direction dictated by our customers or requested by our customers.

Richard Miles (10:07):

Is there an optimal size of company that’s sort of like your ideal client for whom this is the most useful? Is it relatively small companies that for them you’re taking a huge burden in terms of HR off of their shoulders, or is this ideal for our company of say a thousand employees or more?

Jeff Lyons (10:24):

I think there’s a better ROI larger. And we used to talk about, if you’ve got 10 employees, you can kind of sit around a table and do this.

Richard Miles (10:31):

And rank them one through 10.

Jeff Lyons (10:32):

Yeah, it’s pretty straight forward, and everybody knows everybody. And the value of automation is greater when there, the data gets so big, you just can’t manage it. Compensation is a great example. People would send Excel spreadsheets out to every manager in the company, pull those back together, copy paste. It was a huge just labor problem. If you only have a few dozen employees, anything about maybe a hundred and fewer, is pretty easy to do, above that it gets very difficult.

Richard Miles (10:58):

And so some guy or gal spend their entire day just trying to figure out what everyone should get paid.

Jeff Lyons (11:02):

Yes. Every case that they’re tested around for everybody versus real time, everybody’s kind of in the same data.

Richard Miles (11:10):

Now, you have had as an entrepreneur being in that field, sort of one of those experiences that is both, I guess, a Mark of success, but also a challenge. And that is a company that you helped found, MindSolve became acquired by another company or sold. And then you became an employee for that company. So you’re making the transition from being the top guy to being a guy who probably has to fix a lot more your own coffee and that sort of stuff, right? So tell us, what’s that like mentally or professionally, how do you make that transition from being the person who started something to being the person who is at work.

Jeff Lyons (11:41):

I feel like I should lay down on a couch for this part of this session, that you’re, there’s a lot of scar tissue, your brain,

Richard Miles (11:47):

I just started my clock. I am billing you for this job.

Jeff Lyons (11:51):

Well, first I’ll correct. You going a bigger organization was nice because then you actually had people who would help with administrative stuff. At a small startup we were making our own coffee, we would draw straws on who got to clean the bathroom. You know, the biggest thing though, was the change in the level of control that you have. That was hard. But I think as we got closer to our acquisition, I was really becoming aware of our limitations, which is a really polished way of saying I had no clue what I was doing. And so we had kind of maxed out what we could do with the organization. We needed more funding. We had bootstrapped the organization, meaning just grown out of revenue. We weren’t burning through a ton of VC money, but we also a couple of guys straight out of college who had no idea about enterprise software. And so we really didn’t know how to sell well. And we had kind of maxed out the organic growth model. So I was actually very excited about talking to people who I thought knew how to run an air quotes, real company. There were definitely a lot of frustrations. Things move so much slower. I was not very politically astute at MindSolve our, our decision making model was yell at each other until somebody gave up and that did not serve me well as part of a bigger organization. And then I came to find out that,

Richard Miles (12:58):

So you’re really a consultant is what you’re telling me. You just tell other people to yell at you. And it sounds like a title of a great book or, you know, yell until you win right?

Jeff Lyons (13:06):

It’s probably a best seller, but it’s not a very good model. I’ve gotten definitely better models since then. But no, I think we definitely learned a lot post acquisition about the corporate world, how to sell to that world. Surprisingly, there were a lot of things we lucked into doing better at MindSolve. Then we’re done at the big publicly traded company that we went into. And we found that after a few years, that company was acquired by a private equity firm who was extremely focused on operational efficiency. And we looked at massive changes to how we approached management. So that was a big learning curve.

Richard Miles (13:39):

One thing that a lot of people talk about is AI, artificial intelligence and it’s going to take everyone’s job, right? Is this a sector loosely described as you, you weren’t consultants, but basically you are helping businesses do their business better, and by making the HR process across the board more efficient, is this something that you could write into a code, right? Where basically you’ve now got an automated way to swart and judge employees and give them training and so on. So is this in any way going to be, or is it already being affected by AI?

Jeff Lyons (14:10):

It is, at some total and it’s Skillsoft we have AI built into our code now and I think it’s an amazing tool. I think it can help you, but I don’t see it really replacing management judgment strategy, things like that. A good example is we use AI to look at, what do I know about you? What do I know about folks who are similar? And we can recommend, for example, developmental training, that’s better for you than if you just did a random search and found 200 courses on management communication. We’ll find the one that’s most relevant to you, almost like an Amazon matching, but there’s limits to that. As you know, you go into Amazon and you’ve bought a bathtub. Amazon thinks you want to buy five more bathtubs in the next week. It makes no sense, right? So there are those kinds limitations.

Richard Miles (14:52):

I stop at three bathtubs. I never buy that forth bathtub.So we’re not at a point where you ask Alexa what the weather is and she says, Jeff you’re fired, right? We’re not there yet right?

Jeff Lyons (15:02):

I don’t think so. And I think there’s cultural hurdles to that as well. People want a human safety net on that stuff. I think the technology can get you closer to a small set of decisions with good data to help you make a decision. But I think unless it’s just sort of a repeatable cookie cutter, kind of a problem, I don’t see AI solving a what’s best for the company.

Richard Miles (15:23):

And it seems to be the consensus on AI is that it will take away some jobs, but it really just helps people do their existing job better because it cuts out some of that mundane data gathering, I guess, or sorting. Right?

Jeff Lyons (15:34):

You know, I think people never ask the question of what new jobs is AI going to create. Right. And people think, Oh, well it’s just coding AI. It’s not that at all. What we saw with our technology is HR is spending 90% of their time on tactical logistical, moving data around not really adding value stuff. And when we can automate that, it frees up their time to do interesting things right? Drive the strategy of the business, which then creates more work and more growth and all of that. We never really downsized HR because we automated part of what they did. We freed up their time to add more value, to do more things.

Richard Miles (16:06):

So Jeff, now we sort of shift to the best part of the show and the one most likely to get subpoenaed in a few years. And that is what were you like as a kid, where you smart, curious, are you just someone whose parents drop them off at the mall as fast as they could, you know? And your a Jacksonville boy as well, so tell us a little bit about growing up in Jacksonville. What were you like? What did you do? That sort of thing?

Jeff Lyons (16:25):

I was a nerd that kind of sums up most of it.

Richard Miles (16:28):

It’s amazing how many Radio Cade guests describe themselves as nerds, it’s gotta be over 90%. So we’re doing something wrong here. I don’t know.

Jeff Lyons (16:33):

You’re definitely hiring to a profile. Look that just cuts out about 20 minutes of description right? Um, I was not at all athletic, I was super uncoordinated. I liked to do a lot of different creative stuff, all the normal nerd things in terms of reading and movies and watching Star Trek and I never really got big into the Star Trek versus Star Wars debate. I was more of, we can like everybody,

Richard Miles (16:58):

We can all get along here, we can.

Jeff Lyons (17:00):

Yeah, exactly, always did well in school to spite myself. I never applied myself at all until I got to college.

Richard Miles (17:07):

So you’re a little bit younger than I am. What was the cutting edge technology when you were say in ninth grade, what was the thing that everyone was talking about? Can you remember, or that you just had to have.

Jeff Lyons (17:17):

This is horrible. What we used to do was go to the Radio Shack in the mall and they would have their Tandy computer sitting out there and you could walk up and immediately just interrupt it and write little basic programs to scroll words at random, across the screen and do stupid stuff like that.

Richard Miles (17:30):

So Radio Shack, Tandy computers, maybe you are as old as I am. You just look, younger.

Jeff Lyons (17:36):

Keyboard built right into the monitor. You know, that kind of thing. I mean, that was just when Atari was coming out and Kaliko Vision and, and television and all that stuff. So that was kind of the hot stuff we wanted with just the home video games. We would spend all our time at the mall, arcade,

Richard Miles (17:52):

Re-programming. Okay. Was there a certain point in your childhood or later in high school where the idea of going into business of some sort of, kind of entrepreneur appealed to you? Or did you think about it? Did you have your own business? Did you know lawn business or whatever in high school, or did that come later?

Jeff Lyons (18:07):

I always worked. I was cutting yards when I was young. I worked through high school at a shoe store. That’s a nice embarrassing podcast we can save for later time. But I was never, I need to go start a business or dream of being an entrepreneur. It was more, I needed money.

Richard Miles (18:22):

So it’s a fine motivator. It works for a lot of people.

Jeff Lyons (18:27):

It went from, you know, wanting to be able to play video games at the mall to wanting to buy beer. There are always staples of life that I needed. No, it was more about that. And I think that’s one thing that served me well, it’s always had a decent work ethic. I was never afraid of working late.

Richard Miles (18:41):

Now you come from a family of engineers. Correct? Your father is a civil engineer. Right? And you have a couple of siblings that are engineers?

Jeff Lyons (18:47):

I have an older brother who yeah designs subdivisions.

Richard Miles (18:51):

Alright. But your degree was in, what? Was it software engineering?

Jeff Lyons (18:55):

No, my degree was in mechanical engineering. So back to your question of wanting to start a business, now, I thought I’d go into engineering and I used that approximately zero days after graduation.

Richard Miles (19:07):

So you graduate your mechanical engineering degree and what did you do?

Jeff Lyons (19:09):

Well, I was working part time for some folks in Gainesville doing software development. That’s what got me into software and then when,

Richard Miles (19:15):

Again, what year are we talking about here?

Jeff Lyons (19:17):

I started working with them in 90 and I graduated in 94.

Richard Miles (19:22):

So software was still kind of in its infancy in terms of,

Jeff Lyons (19:25):

Very much so.Yeah. I mean, we were writing really rudimentary code, but also doing really neat stuff. We doing three dimensional models and walkthroughs of, of hotel ballrooms, really, really neat stuff. And when I graduated, we had been developing some software that we decided to take to market. So that was kind of the first startup pre MindSolve, which was a big failure, but fun. And so I had this offer to come be employee number two, working out of a defunct dentist office in Gainesville. And my other offer was a company that was in the fortune one at the time. And so, uh, those were the two ends of the bell curve. And I said, well, I’ll go give this a shot. And if it doesn’t work out after a year, I can go back to being an engineer. And I did that these little one year, i’ll just give it one more year for quite a while and that led to today, basically. Yeah, so that was the last time I got a job was straight out of college.

Richard Miles (20:17):

Okay. Well, I hope you’ve worked on your resume recently.

Jeff Lyons (20:21):

Yeah. There was not a lot of planning involved or this was not a, this is what I want to do with my life. There was a lot of being open to stuff and working really hard and people going, Hey, come solve this problem for me.

Richard Miles (20:31):

Well, so that’s kind of a nice segue into my next question is asking you your words of wisdom and maybe you don’t have any words of wisdom, Jeff, I don’t know, but most people do or they make it up on the spot, but let’s say you magically encounter that the 22 year old version of Jeff Lyons, probably in the arcade at the video games, what would you say? What would you tell him aside from always wipe off the fingerprints, what would you say to that person?

Jeff Lyons (20:53):

You know, it’s really funny, I’m really of two minds of it because I think I’ve had a really fun life. I think it’s been really rewarding and I’ve liked the journey, but there’s a big part of me saying, don’t do what I did. I mean, we made like every mistake you can make. I was very lucky to have great mentors and advisors early on, right? Even though one of my co-founders, Dan and I were sort of straight out of college. Our third co-founder was a guy who had been an entrepreneur for a long time, was able to give us great advice was a very calming influence on, on a couple idiots, straight out of school. So I did have that, but I still think, just get more advice of people who had done it. There was no real startup community. And in Gainesville, um, as you said, software and the technology,

Richard Miles (21:32):

There wasn’t a startup community until like 2006 or 2007? You waited a long while.

Jeff Lyons (21:35):

This was before the.com boom. I mean, there was no model. And so we were just kinda making it up as we went along and our story is great and it sounds fun and everything until you realize that we had a competitor of similar size that we had better technology, but they knew how to sell things and were connected and invested. Right? And that company later sold to SAP for $4 billion. So I probably would have preferred to run that company. Um, all things being equal so,

Richard Miles (22:05):

Well then you wouldn’t be in a booth with me, it’d be on your private jet somewhere. So lets just be honest here right.

Jeff Lyons (22:10):

So we probably tried to do things too much on a shoe string. I think being well-funded especially now is even more important. So that’s a pretty easy lesson to share is don’t be afraid to give up a little bit of control to people. You’d benefit from them having a little bit of control and who can bring a lot of funding and not suffocate the business.

Richard Miles (22:28):

Well, it’s interesting because you hear a lot from other people saying, give up control, any control at your peril and don’t take any money because they’ll take over and so on. But it’s interesting counterpoint that that may limit a lot of what you can actually do. You don’t have the resources.

Jeff Lyons (22:43):

Yeah. Very much. And I’ve seen the downside of that as well. The other thing I’d say is more on a personal level versus a professional for me coming out of engineering school and just being a very technical oriented type of a person we joked around before about kind of the communication style and the debate style that decisions got made. But in reality, it took me about 10 years to realize that other people have feelings and that most people don’t enjoy vigorous debate as much as I do. And that I think held me back from being an effective leader for a long time. So to somebody who can recognize that handicap in themselves, paying more attention to the people side versus the technical side will serve you very well.

Richard Miles (23:25):

Well, Jeff, my invoice for counseling is already hit probably about a thousand dollars here. So I’m going to have to wrap this up, but Jeff Lyons author of the soon to be written book yell until you get what you want. Jeff, thanks very much for coming on to Radio Cade, wish you all the best in your professional career. And I look forward to having you back on the show.

Jeff Lyons (23:43):

Richard, it was a lot of fun. Thank you.

Richard Miles (23:45):

I’m Richard Miles.

Outro (23:46):

Radio Cade would like to thank the following people for their help and support Liz Gist of the Cade Museum for coordinating and vendor interviews. Bob McPeak of Heartwood Soundstage in downtown Gainesville, Florida for recording, editing and production of the podcasts and music theme. Tracy Collins for the composition and performance of the Radio Cade theme song featuring violinist, Jacob Lawson and special thanks to the Cade Museum for Creativity and Invention located in Gainesville, Florida.

Intro (00:01): 

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them. We’ll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace. 

Richard Miles (00:39): 

The sound of music, not just a movie about seeing Austrians, but also a fertile field of research, specifically the effect of playing music on processing sound, learning, and brain development. I’m your host Richard Miles. Today my guest is Nina Kraus, a professor of communication, sciences, neurobiology, and physiology at Northwestern University in Chicago. Welcome to Radio Cade, Nina. 

Nina Kraus (01:02): 

I’m so glad to be here. 

Richard Miles (01:03): 

So Nina, you’re one of those difficult guests that you have done so much, and we could talk a lot, but then this would not be a 30 minute podcast, it would be like a 30 hour podcast, but I have heard you speak before, and I know you were actually quite good about summarizing your research so I know you’re up to the challenge, but I’d like to start out by focusing on one particular area of your work. You’ve done a lot in sound processing and how the brain processes sound, but why don’t we start with some basic definitions for our listeners. So from a scientific perspective or researchers perspective, what is the relationship or the difference, I guess, between music, noise, and language. What’s the relationship between those three things? 

Nina Kraus (01:41): 

What a great starting question. So sound is the common denominator for all the things that you mentioned and sound is a very under-recognized force in our society. It is very, very powerful, and yet we don’t pay very much attention to it because it’s invisible, first of all, like a lot of powerful forces like gravity. So you don’t think about it. And we live in a very visually biased world. And even scientifically there was a National Institute for Vision 13 years before there was one for hearing. And that was the National Institute for Deafness and Communication. We share that with smell and taste, but all of the things that you mentioned, language, and, music, and noise, these are all sounds. And I’m a biologist and I am interested in sound and the brain. And so really the overall umbrella over everything that we study is sound and brain. How do we make sense of sound? How is sound processed in the brain and how does our experience with sound shape how we perceive the world? 

Richard Miles (02:52): 

I saw on one of your papers, you have a specific way or methodology that you can actually look at brain as it is interpreting sound, right? 

Nina Kraus (03:01): 

Yeah. Let me tell you a little bit about that. Initially, as a biologist, I came into science studying single neurons, actually, single neurons with scalp electrodes and animal models and one of my first experiments was to play sound to an animal while I was recording the brain’s response, the one cell’s response, to that sound. This was a rabbit, a bunny rabbit, and we taught the rabbit that the sound had a meaning that every time the sound happened, he’d get some food. So the same sound, same neuron, but the neurons response to that sound changed. And so we could see firsthand learning, the biology of learning, and that’s something that I’m deeply interested in. My lab, which we call Brain Volts has been looking at how our experience with sound shapes our nervous system, but I was coming from the specificity of recording from individual cells. And so these are signals. These are tangible signals that you can really define, and that felt good. And so the question was, well, how can we get a way of measuring sound processing in the brain in humans when we can’t go sticking needles into individual cells? You know, there are many ways of recording the brain’s response to sound with scalp electrodes. And of course, as I’m talking to you, now, the nerves in your brain that respond to sound are producing electricity. And so with the scalp electrodes, we can pick up that electricity and that’s been done for a long, long time, but most of the measures that we can obtain from the scalp are rather blunt with respect to what I’m interested in, which is the different ingredients of sound. So sound consists, again let me make a visual object comparison. So with vision, everybody knows that a given object has a shape, a size, a color, a texture, that’s all very obvious, but people don’t realize, first of all, that there is sound and secondly, that sound also consists of ingredients like pitch, how high or low a tambour, a violin and a tuba sound different when they’re playing the same note, that’s tambour. The harmonics that differentiate one speech sound from another. There’s phase that tells us where objects are in space, based on the time of arrival of the sound to your two ears. And there’s a huge timing. So the auditory system is our fastest sense, even though light is faster than sound processing sound happens on the order of microseconds because there’s so much timing information in sound. That’s how sound works, it’s fleeting. And so, what I was interested, what I am interested in is how do we figure out how the brain makes sense of these different ingredients? And we figured out a way of doing this because most of the methods that were available to us in the past, you could just see is the response large, is the response fast to sound, but I want to know how does your brain respond specifically to pitch and timing and tambour and phase all these different ingredients. And so one of the metaphors that I like to use is a mixing board. So if you think about the faders on a mixing board and you think of all the different ingredients and sound, when they are transduced into the signals of the brain, which is electricity, it doesn’t work like a volume knob. People, even musicians, are not good at processing all the sounds like a volume knob. They have specific strengths and weaknesses like the faders on a mixing board and I wanted a biological approach that would be able to look at that, would be very, very precise, and not only be able to tell us well, what is the effect of playing a musical instrument for many years? What is the effect of speaking another language, but not only looking at these group differences, but what about individuals? I mean, my auditory brain is different from your auditory brain, we’re all individuals. And so would it be possible to actually have a physiologic response that reflected these ingredients, A-of-all, and B-of-all would not only reflect what happens with experience in groups of people, but even on an individual basis. And we have really figured this out. So this is a response called the ‘frequency following response’ the FFR, which we have adapted to our use and we are able to use very complex, sounds like speech and music and analyze the responses in a way to see how an individual processes these different ingredients. And we’ve spent a lot of time on the methodology. So we have two tutorials on the frequency following response, which really speaks about these responses in a lot of detail. We have a number of patents on what we’ve discovered in terms of how to measure these responses. So this is really something that has kept us busy. So on the one hand, it was really a quest to search for a biological approach, which I’m really happy with now. And then it is a matter of applying that biological approach. Partly it was synergistic because we wanted to see, well, is this approach actually yielding the kind of information we want through research. And so we’ve done a lot of research and now we can really have confidence that a person’s response to sound really does reflect how their brain processes the different ingredients, how it might’ve been affected by the songs we sing, the languages we speak, and even your brain health, because making sense of sound is one of the hardest jobs that we ask our brains to do. So you can imagine that if you get hit in the head, it will disrupt this very, very fine microsecond level processing, which is one of the areas that we’re interested in looking at is, is what happens with head injury, especially with concussion, sports induced concussion. And so again, we can do that as well. 

Richard Miles (08:56): 

So on your website, I think you have this great graphical representation of the frequency following response, right? Where you will play a snippet of almost anything, but let’s say a piece of music and in the brain of the person listening to it, you have almost a mirror image right, of that same frequency. And you can see differences in the ability of the person to process what they’re hearing. And so you found, and again, I may have this wrong, you found that musicians had several advantages in the way that you will play for them something say Beethoven’s Fifth Symphony and a musician will hear it differently than when you say musician, it’s someone who actually plays an instrument, right? Not just a music appreciator, or someone who plays an instrument. Those people process the sound differently than those people who are not trained in playing music. Is that correct? 

Nina Kraus (09:55): 

That’s exactly right. Because what is so beautiful about this biological approach is that the response we get from the brain, the electricity actually physically resembles the sound that was used to evoke it. This hardly ever happens in biological systems. I mean, usually you’re looking at something very abstract, like lipid levels, cholesterol levels, to give you some index of cardiovascular health. Then, to actually be able to say, Oh, well, people process sounds in a way that we can actually see with a certain transparency. So the transparency is, as you said, is such that we play a sound wave and you can see the sound wave and you can then deliver that sound, wave to a person and pick up the electricity that the sound wave generates. And then, you know, we’re all familiar with taking a sound wave and feeding it through a microphone, and then you can play it through a speaker. And then the same way, you can take an electrical response that you have recorded from the brain, it’s just an electrical response, and you can deliver that to a speaker and play it so we can both see and hear a person’s response to sound. And yes, in fact, we can see the people who regularly play an instrument, so I’m not talking about professional musicians. I’m just talking about people who regularly play a musical instrument, you know, as little as half an hour, twice a week on a regular basis. And one of the things that we’ve been able to find is that there really is a neural signature for the musician. So remember I said, that sound consisted of these ingredients like pitch and timing and tambour. And what we see as the musician strength is a strengthening of the harmonics in sound and of various timing ingredients. And it turns out that both the harmonics and the timing are not only important in music, but they also overlap with what you need for language. So you can imagine how if you are doing an activity that is strengthening your brain’s response to the harmonics, which not only are important for playing a musical instrument, the harmonics are what distinguish B’s and P’s, and D’s, and G’s from each other. So these are the same signals. They’re the same ingredients. They’re these beautiful signals outside the head and inside the head that we can see, how does experience shape how we perceive the world. So the musician signature really has a strengthening of harmonics and timing, which it turns out transfers to language abilities and language abilities, including things like reading and being able to hear speech in a noisy place like a classroom, being able to figure out what’s going on in a complex soundscape. So these are advantages that seem to come along with the brains increased stability, strengthened ability to process these particular ingredients of harmonics and timing and what we call FM sweeps, which are basically the simplest FM suites. It’s a change of frequency over time. It’s like a cat call, right? It’s a sweep up and down. And it turns out that speech sounds have very, very, very fast FM sweeps that distinguishes one consonant from another, that happened in a very, very short period of time. And so the brain’s ability to process these FM sweeps is something that we see as a strength in musicians, and is very much an important ingredient in language. 

Richard Miles (13:32): 

I find all of this fascinating Nina. I remember the one example that you gave you tested musician’s ability to, as you said, pick out a particular sound in a crowded room, and you compare that to non-musicians and that the musicians had this definitive ability to recognize a sound pattern and all that. And then of course, different types of syllables or consonant, they also had that ability. The only time I can ever do this, I’m not a musician is if we’re at a party, I can hear Phoebe’s voice in a crowded room, and then she said, well, yes, that’s because research has found that men interpret women’s voices like music. So finally, I have a researcher. You tell me, is that true or not? 

Nina Kraus (14:08): 

Well, I would say that you have had a lot of experience with Phoebe’s voice and so you’re sonic brain is tuned to that voice. And we say this, when, you know, you pick up the phone, your son calls you and you say, “Oh, it’s so good to hear the sound of your voice”, the years of the sound to meaning, sound to emotion connections that you’ve made with that voice even before you hear the particular words, you have this very strong connection to what you’ve learned. And so I think that’s why you can hear Phoebe so well. 

Richard Miles (14:41): 

Let’s talk some more about work that you have done, very interesting work, with something called The Harmony Project in Los Angeles. This is something, I think in 2014 was the research, and essentially you worked with an organization in Los Angeles, it was giving music lessons, I think mostly stringed instruments, right? They’re giving them lessons for a substantial amount of time and then you started tracking them doing assessments to see if there were other advantages, right, that translated not just the ability to play a given instrument, but also the ability to do other cognitive skills. Tell us a little bit more about that. 

Nina Kraus (15:14): 

So, we’re really fortunate as scientists, and also if you read about Brain Volts and what we care about in our lab. We really are interested in sound in the world and we’re less interested in creating an experiment in the lab where people come in and they are given a certain amount of training with sound. We’re really interested in what is the impact of playing a musical instrument in actual music programs that live in the world? Also, one of the questions that one often asks is, well, is it that the brains strengthened response in musicians is just something they were born with so that if you have a strength in a certain domain, you might be encouraged to pursue that activity. A way of, of trying to understand what the effect of experiences is to do a so-called longitudinal study. Let me tell you the long in longitudinal is no joke, because that means tracking the same individuals year after year after year. So, we had the opportunity to do this in Los Angeles in the gang reduction zones of LA. And also we had a companion project at the same time in the Chicago Public Schools, where we basically had the same experimental design, which consisted of you take two groups of people and you match them at the beginning of training, or before training has started, and you match them on age and sex and reading scores and IQ and everything that you can think of, and then one group gets music and another group gets something else and you track them over time. So you track them year after year. And we were able to do this in LA with elementary school kids, second, third, and fourth graders. So we did this over three years and then the project in Chicago was adolescents also in low income areas. We’ve tracked the adolescents from freshman year until they graduated as seniors. And what was important is that the individuals in the different groups were in the same classroom, same teachers, same socioeconomic areas. And we could see, well, what happens if one group gets music and another group gets something else? So what we were able to find was, first of all, we were very interested in, well, we already knew from cross sectional studies across the, about this musician signature that I told you about that musicians had strengthened responses to FM sweeps, to harmonics, to timing in speech. The musicians had these stronger responses, but we wanted to know, well, is this something that develops over time? And in both studies after a year of regular music making in LA, these were after-school programs five times a week. If you also include Saturday and in the Chicago public schools, it was actually within the school day so that they had an hour every day of music, just like you had an hour of English and Math and History. We’d measure sound processing in the brain using our biological approach at the beginning of the year. And then at again at the end of the year, and after a year in both studies, we found no change in the brain’s response to sound. And that’s what the data showed but we kept going. And so in both of the studies, what we found was that it takes a while to change the brain. And that’s a good thing. If your brain was changing in a fundamental way, every second, you’d be really confused, but you speak a certain language that has certain sound ingredients after a while. And it’s really after years of speaking of particular language, your brain automatically changes and changes in a way fundamental or your default experience of the world. I mean, even if you’re asleep and I’m measuring your brain’s response to sound, you will have this heightened response to certain sound ingredients, because it has just become a fundamental way of how you perceive the world. But this takes, while it really did take two years to see these changes. And at the same time, of course, we were interested well, are these kids doing better in school in various ways, in terms of literacy, for example, and being able to hear speech and noise. And in fact, again, we were able to, to track the changes in the brain with these gains in literacy, and in being able to hear, for example, speech in noise, 

Richard Miles (19:52): 

So Nina, it’s fairly common observation that the younger you are the easier it seems to do things like learn languages, foreign language, play instruments, and so on. Is there anything in your research or other people’s research that indicates are there definitive windows of neuroplasticity past which it’s not really worth it or the returns are so diminishing that every 10 hours of effort you put into it is really not going to get you much. Do you find that there’s a cutoff? Does it happen in elementary school or middle school? Or can you go on up through your twenties and still reasonably hope to take up an instrument or learn a foreign language and accomplish a very high degree of proficiency with it. 

Nina Kraus (20:28): 

Great question, the answer is no, there is no limit. Certainly the way that a young brain learns is different from an older brain, but we continue to learn until the day we die. And in fact, there’ve been very beautiful experiments in auditory learning in animal models where you can very easily and in a very precise way, regulate an animal’s experience at different ages and see how their brain responds to learning an auditory task. And there have been experiments showing that certainly animals will learn differently when they’re younger and when they’re older, but they will continue to learn until the end of their lives. And this is born out in human studies as well, specifically with music. So in our own experience, in the harmony project, the kids were elementary school kids, in high school, the kids just began their music instruction as freshmen. So what was kind of a tragedy for these kids? The fact that they really had had no music instruction of any kind before they were freshmen in high school, turned out to be from a scientific standpoint, very important, because we could see that certainly the kids who began their music training as adolescents had the same kinds of brain changes that we saw in the younger kids. Moreover, the number of labs have looked at learning in older people. And even if you’ve never played a musical instrument, your brain can change and you can continue to learn music, to learn new languages. And we have this very, very dynamic system, and I think we should embrace the differences in the way we learn at different ages, because as we’re older, we bring wisdom with us and we bring an understanding of what we’re doing that is very different from the way a child might approach learning, for example, a musical instrument. But the fact is that the benefits of playing a musical instrument, which are profound, really in terms of memory and attention and emotion, sociability, these are gifts from music that you want to experience throughout your life. 

Richard Miles (22:41): 

If we could just stay on that just a little bit more Nina, one of the fascinating things I saw in one of your papers was the connection of musical ability or music training to reading, and that you expected to find obviously, a connection to speaking, cause that’s sort of an auditory sound function, right? But reading, and I didn’t realize the extent to which a solid understanding of how a word sounds, how are phoning sounds is essential to reading a written word. So comment on that, but there’s a second part of my question. Let me put it in right now, what are the other cognitive things that you have found that improve? I mean, is there a link with math, for instance, do you increase math abilities among musicians? Are there any other cognitive things that appear to be improved or beneficial as a result of music training? 

Nina Kraus (23:24): 

So your first question is what does sound have to do with reading? And we learned to speak first and what we need to do when we read is we have to associate the sound of the letters with a symbol on the page. And so, we’ve known from decades of research that kids who have difficulty processing sounds have difficulty reading. So there is a very, very strong connection there. Also there’s a part of speech. When you think of music, you know that there’s rhythm in music, right? Rhythm is a part of music, but you don’t necessarily think about rhythm as being a part of speech. But it is. I mean, think of the difference between the word rebel and rebel. It’s the same word, but I have a different rhythm. And even though the rhythm isn’t as regular, we have tremendous rhythmic ability in speaking. So every Martin Luther King day, my husband and I listened to the, I have a dream speech and listening to Dr. King speak, it has this wonderful rhythm and cadence to it. And if I was saying those same words to you, you’d be looking at your watch, you’d be, when is this going to be over? But so much of the communication is rhythmic. If you want to have fun, do some YouTube searches for rhythm and music. And you’ll find there’s a guy who plays drums along with while people are speaking, it really pulls out what is not so inherently obvious. But after awhile you realize, Oh, this is really rhythmic. So this is another thing that gets strengthened. If you make music, you really make abilities get better. And the reason that we know that this is tied to reading is that again, for decades now, people have demonstrated that kids who have difficulty reading have difficulty with rhythm. Rhythm is one part of what gets strengthened with music. And I would say that it’s the rhythm, and it is the tuning, if you will, of important sound ingredients that together help achieve the gains, which is now the second part of your question, which is why do we care? And well we care because we want to know what to pay attention to. And in order to learn, we have to be able to pay attention to sounds. So, for example, my husband’s a real musician. And one day I was trying to learn a dire straits lead on the guitar and he came by and he said, Nina, if you just listen, you would realize that Mark Knopfler is not using his pick on the string each time. He’s not going to Dee Dee Dee Dee. The reason that he’s playing those notes so fast is because he’s actually pulling off the string with the fingers of his left hand, it’s called a pull off. And it has a very special sound to it, that I was deaf to. But now I know what that sounds like. And so when I hear it again, I have learned what to pay attention to. And it’s kind of automatic like, Oh yeah, I know what this is. And so there are so many associations with sound and our ability to pay attention and to then be able to pay attention to other sounds in the world that might be important, like a teacher’s voice or Phoebe’s voice across the room. So that’s one thing. The other is auditory working memory, in order for you to make sense of what I’m saying right now, you need to remember what I just said. So a typical auditory working memory test language is I’ll give you a list of words and then ask you to repeat back only the words that were names of cars that started with M. And so you think, okay, so what did she say? Which ones are cars, which ones start with M. And this is your auditory working memory that is kind of helping you make sense of what you hear constantly. So it’s very, very important. So on the test like this people who are musicians, someone who regularly plays a musical instrument, by the way, singing counts, then across the lifespan, people who are musicians have stronger auditory working memory skills and stronger attention skills, and any teacher will tell you. And one of the reasons this was interesting to me is that teachers will tell me all the time that the kids who play music are the ones who do better in school. 

Richard Miles (27:33): 

Nina, you alluded to this earlier, you talked about Brain Volts, which is essentially, you’re looking at ways to take this research that you’re doing or the findings, and basically help others in other fields. And if I understand it correctly, you can use this in addition to research, but also as a diagnostic tool, right? If you find somebody and it appears to be their audio processing capabilities off, that may be an indicator of something else, such as a concussion or maybe dementia or something like that. I’m not entirely sure about that. So I’m waiting for you to correct me, but is that what it is? And then how’s it gone in terms of setting up something to try to commercialize the technology. And this is something we talk on this podcast, a lot, a lot of people like you, researchers have something that they know has a value outside of the research arena, and they want to take that technology to market. And it’s very difficult. So it’s kind of hit or miss. And we know for the genesis of this particular podcast, the museum project was Gatorade, a research project with great success, but isn’t a tiny minority of what happens to typical research. So first of all, correct me, or affirm me that I have that description of your business model, correct. And then how’s it going in terms of going to market? 

Nina Kraus (28:43): 

So I think the two areas that we have been focusing on, one is language and literacy. And yes, the idea is to use this biomarker, if you will, as a way to provide additional information about a kid who might be having difficulty in school or is having various problems with language and learning. And the question is, is this coming from the fact that his brain is not processing sounds in a typical way? And to be able to at any age, just deliver sounds and just use some scalp electrodes to get this piece of information is very valuable. And people talk about diagnosis. I wouldn’t say that this would be the only thing that you would look at. Any clinician wants to have an armamentarium of clinical results. You go to your physician and he’s looking at all of your various test results, and hopefully he can put together this constellation of findings and be well-informed. Well, I think at being well-informed, if you have a kid with a learning problem, when a language delay, if it was my kid, I would want to know, is there a bottleneck? Is there a problem here with sound processing? I would also want to know is my kid at risk? So I can envision this as now they have newborn hearing screenings where every child gets a hearing test to make sure that they can actually detect the sounds. I could envision the kind of technology that we’ve developed as being something that would be side by side with that. And you would also be able to see is my child at risk for struggling to learn language or struggling to learn, to read way before he actually begins to struggle in school. Wouldn’t it be great to just know that this is a child who is at risk. And so there are various things that can be done, especially if you are aware of a potential problem early on 

Richard Miles (30:39): 

Nina, just to clarify, going back to your analogy of the sound volume knob versus the mixing board the tests are doing now, essentially just measuring the sound knob, right? Can they hear or not? And your test would give the ability to say, well specifically, are there things going on at the auditory processing level that bear watching or concern? Is that? 

Nina Kraus (30:58): 

Yeah, I mean the typical hearing test now is really, can you hear, there’s a range of pitches that language consists of, and can you hear very, very quiet sounds and your ears ability to hear what I am measuring more is the brain’s ability to understand what you hear. And so the sounds that we deliver, aren’t very quiet, they’re conversational level. So we already know that they can hear their ears are working fine. They’ve passed the hearing test from an ear perspective, but we want to know now, if I’m speaking conversationally, I know that you can hear me, does your brain process these different ingredients properly or not? And what are the strengths and what are the bottlenecks? And we know that there are certain signatures, and this is again, one of the things that we have patents on is that we know that there is a certain signature that’s associated with a language delay and literacy problems. And so you would want to look for that particular signature in a child that you were wondering about in terms of their current or their future language potential. 

Richard Miles (32:02): 

Could you use it to detect mild concussions? For instance, if there is neurological damage and traditional tests, weren’t willing indicating one way or another, is this another tool that you could use to figure out something is wrong here? 

Nina Kraus (32:14): 

Absolutely. Because most concussions, unless you have a cerebral bleed, you’re not going to see them on imaging. You need a very sensitive measure and sound processing. The brain does provide that. It’s also noninvasive. It takes 15 minutes to obtain and we have found again and again, we have papers and patents that describe that we’ve established this effect in youngsters who are elementary and high school aged kids. And right now we have a big study looking at division one athletes or northwestern athletes and NIH study, it’s a five year project. That was won on the strength of the original work that we did describing what is now a different neural signature. It doesn’t look anything like the language signature. There are other ingredients that are especially sensitive to head injury. And we can see this right now. I know that the whole issue of diagnosing concussion is a tricky one. And again, historically, people have been looking at vision. They’ve been looking at balance, but looking at hearing is fairly new. And one of the things that we have done in a couple of our studies is we followed our North Side Football League. These are our kids, and we gave them the vision test, the balance tests and the hearing tests. And you could see that they each tell us different things. So they’re not redundant. So you know how wonderful my vision is for a clinician, a trainer, a coach, position, to be able to look at balance, look at vision, look at hearing, and to have this biological marker that would inform the diagnosis of the injury and also inform return to play, because we know that concussions often occur in the same person shortly after they’ve had a concussion. And so, it might be that with the current measures that we have available, it looks as though the athlete is ready to return to play. But maybe if you had a more sensitive measure and objective measure, because again, the athletes are very motivated to do whatever they can to get back on the field. But if you have an objective measure that doesn’t require any kind of an overt response, wouldn’t it be great to know? Let’s just wait another week. His brain isn’t quite ready, just to wait a week or two. I mean, we see that the changes in the brain change very rapidly, usually as individuals, athletes, recover from their concussions. 

Richard Miles (34:44): 

Nina, I know you have a lab there where you can assess people with that method. Is this something that could be done with a medical device? It could be done in a doctor’s office or even in a trainer’s room? 

Nina Kraus (34:54): 

That’s what we do. When we went out to LA, we did this testing in instrument closets, and wherever we could find a spot, it’s very portable right now. It’s the size of a laptop. 

Richard Miles (35:04): 

Nina, this has been fascinating. And like I said, this could be episode one of a thirty podcast series on just sounds. I could listen to this all day and I’ll go meta for just one second here. We’re actually doing this in the medium of podcasting, right, that has made a huge resurgence as people like to listen now. And I don’t know what that says about humans or our society in general, but it is a throwback to the days of the thirties and forties, right? When people consumed a lot of their entertainment from radio shows. Right? And what I like about it forced a little bit of your imagination, and play, because it’s not laid out for you visually, you’re listening to somebody sound or a sound clip of a particular event. And anyway, I thought I’d throw that in there. We’re talking about sound on a medium that is only sound. 

Nina Kraus (35:44): 

I love that. I love that. And actually I have to say for myself, I do a lot of my reading, listening to audio books. I think we all spend probably too much time looking at screens. And it’s just wonderful to kind of give your eyes a rest and listen. Of course I love radio and podcasts and I consume books that way. Sound is awesome. 

Richard Miles (36:05): 

Nina, thank you very much today for being on Radio Cade, hope to have you back maybe with an update on Brain Volts or your new research. Thank you very much for joining us today. 

Nina Kraus (36:13): 

Thank you for having me take care of Richard. Bye. 

Outro (36:18): 

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews, podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeek. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson. 

TRANSCRIPT:

Intro (00:01):

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida, the museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

James Di Virgilio (00:38):

Today, we are joined by Scott Melker. He is a leading voice in cryptocurrency. He’s a trader he’s an advisor. He formerly was a DJ and at times like these discussing cryptocurrency is more than just whether or not Bitcoin is an investment. It’s actually an indictment on where we are as a society, monetarily, fiscally. What does all of this mean? Scott, welcome to the program. It’s great to have you.

Scott Melker (01:04):

Thank you so much for having me. I’m truly honored.

James Di Virgilio (01:06):

Now, Scott, I know your background really for the first 15, 20 years of your career was as a DJ. In fact, you gained a significant amount of fame doing that. Then at some point in time, you got into dealing with the cryptos. Tell us about that transition and how that happened.

Scott Melker (01:20):

As you said, it was about two decades of DJ and music with a million other projects. On the side, I was always superficially interested in trading and investing. My parents gave me a pretty good base and understanding of money and finances and how to save. But as a trader, I was pretty much an amateur and actually pretty terrible at it, especially riding through the recession of 2008 and all of those things. But as I began to feel like I was aging out of music, I’m in my forties. Now I was deejaying to kids that were twenty, just became very awkward. I started to look for other things, but at the time when, if you were trading anything, crypto became just absolutely huge. You couldn’t stop hearing about it. It was at the end of 2016, beginning of 2017 and so I put a little money into it. I started trading it and just by virtue of being in the right place at the right time, it quickly became something that could sustain and become a career. So I sort of fell into it to some degree. And then interestingly, at the same time, my daughter who’s now five was born and alongside, already feeling like I was too old for a music production and deejaying having her really took me off the road and put me back in front of my screens to trading. So she was born and I had to go to South by Southwest to play a concert literally the next day and going away and having that feeling. I knew that that was just not going to be my future path. And so I decided to pack it in and focus on trading crypto.

James Di Virgilio (02:39):

Now learning is a large part of this podcast. We’ve had chances to talk to so many different innovators, entrepreneurs, creativity, leaders, you jumped into a field that was entirely different from what you did, how difficult was it to learn the concepts behind how to trade, how to trade correctly, how not to lose your money, how to invest. And then how did you learn? What was your primary tool for learning?

Scott Melker (03:02):

Like I said, I’ve had a level of base knowledge. I at least understood the basics of technical analysis and charts and had a bit of an understanding of chart patterns and things like that. And I think I also had a generally good understanding of how to balance a portfolio, not trade with all your money and basically just be responsible as a whole. But to some degree it was a trial by fire. Like I think it was for anyone else. Trading crypto is very different than trading stocks or any other assets. It is primarily technical being that almost everyone is using charts as opposed to fundamentals. There’s no PNL or quarterly earnings report for Bitcoin. There’s no CEO to call and see what your expectations are for the next year. So you’re really trading based on charts, which is effectively just trying to guess, where are the big players in the market are likely to inflict the most pain on retail traders, where they’re likely to sell and where they’re likely to buy and try to be on their team. So that’s something you can do by gaging sentiment and looking at a chart. But as I said, it was somewhat of a trial by fire. Luckily I found a friend who became a mentor who is an exceptional trader for over 20 years. His name’s Christopher Inks of Texas West Capitol and to some degree I forced myself under his wing. And when 2017, I really learned even more by multiples of what I knew before. And at that time, I really think I honed it in and became a pretty exceptional trader.

James Di Virgilio (04:22):

So as a voice for crypto, as someone who’s living this and breathing this every day, we’re going through a financial crisis right now, due to coronavirus. There’s a lot of thought that something like Bitcoin or maybe another coin, but cryptos in general could serve as the antithesis of what we see with central banks around the world here in the US we’re printing trillions of dollars to bail out the country. And obviously the idea for something like Bitcoin is if you can have a stable currency that maintains its value, you’re not going to have a Fiat currency, right. A currency that can be manipulated by a government that can be inflated. That can be cheapened. Do you see that as a narrative for Bitcoin in the long run? Or is that an idea that was nice and novel, but not reality?

Scott Melker (05:06):

Uh, honestly, it’s a bit of both. So I think that the notion that people would rush to Bitcoin when they’re losing their money in a risk off environment is somewhat absurd. Never in history have people when they’re losing their money in the market, run into something that’s perceived as riskier, they run to cash, right? And so at presence, even though a dollar is inflationary, it’s behaving somewhat deflationary in that the entire world is trying to rush into dollars. So I don’t know if you’ve seen lately, but for example, recently against the Australian dollar, the dollar rose 20% in value in a matter of hours. So right now people want dollars. And so I don’t think that notion is correct at the moment, but when you look at Bitcoin as a whole, it’s not a hedge against your portfolio dropping what it is a hedge against is that inflationary environment of Fiat because Bitcoin itself is deflationary. So I think there’s a differentiation between what the given price of Bitcoin is at any moment and what its actual true value is to look at a society like Venezuela country, like Venezuela, where they have hyperinflation a suitcase of money. It doesn’t even buy you a loaf of bread. There are people who, regardless of what the price is on Coinbase or an American crypto exchange, are there are people who are surviving strictly because they’re mining or trading or transacting in Bitcoin. So it has real life use cases in a lot of countries and a lot of the situations around the world, but that’s just never been seen on a macro level. So I don’t believe it’s a store of value like gold or something like that. I’ve never really subscribed to the digital gold or store value narrative. But I do think that in certain environments, when it really goes somewhat madmax on the planet, unfortunately, which could be a future that we’re somewhat headed towards. I think that it has tremendous value. So I believe that everyone should have at least minimal exposure to Bitcoin, just in case of the worst case scenario. Not because they believe that next week it’ll necessarily be priced higher or lower.

James Di Virgilio (06:59):

Well, the Venezuela example is interesting because as you mentioned, if we live in a Keynesian and if you’re not an economist, John Maynard Keynes, a leading economist in the 1920s and thirties, you could say is largely responsible for how most of the world manages debt and fiscal responsibility, monetary policy. Nowadays, you can certainly make, as you mentioned, this longterm argument that Bitcoin, if you lose your currency, right, runaway inflation becomes something you may go to because now you and I need to exchange goods and services in Venezuela. The last thing we want to do is do that in the Venezuelan currency, because that is wildly losing value every single day. So we choose to use something like Bitcoin, obviously gold function this way, really, for most of human history, the idea is Bitcoin of course could function that way. I think you’re articulating very nice that it’s nowhere near that yet. And the reason for that, it’s very simple to be a usable, consistent currency. It needs to be stable. And that’s why the U S dollar, despite I think a lot of real fundamental issues that we could bring up and spend an hour talking about today is still that safe haven is right now. As far as history goes, that’s your most proven safe asset.

Scott Melker (08:01):

The only true safe haven in my eyes. But I do think that we’re going to see that change likely very soon not to be alarmist, but the fact that the value of the dollar is rising so fast is not actually a particularly good thing. But like you said that’s a conversation for another day.

James Di Virgilio (08:16):

Right? And that is certainly an interesting one. I mean, like we said, fundamentally where we are as a world and what we’re doing with monetary policy matters a lot. In fact, that’s something I talk about in my profession. Maybe more frequently than anything is to learn about monetary policy study. What’s good or bad. That’s going to change the world significantly. And that could certainly in the future be an opportunity for something like Bitcoin. Now I think a big hurdle for most people on Bitcoin is understanding why it’s possibly even theoretically, a stable currency. Let’s assume the best case scenario in this becomes stable. What is a Bitcoin? How do we get a Bitcoin? It’s easy to understand gold it’s in the ground. I mine it, people think it’s valuable. Explain to us how Bitcoin has any value or how it’s stable or what it really is. Cause I know that loses most people right here in this part of the conversation.

Scott Melker (09:02):

Well, it’s certainly not stable and I don’t necessarily believe that it will be. And actually as a trader, the volatility is what draws so many people to trading Bitcoin and their interest in it. But a Bitcoin it’s a protocol it’s math. And the computer has to effectively at the most basic level, computers around the world are competing to solve a complicated math problem. And when they solve it, that creates Bitcoin. It’s a ledger that keeps these transactions on the blockchain. And once an individual block is locked, it’s effectively unhackable. And so the idea is that you’re not on a centralized server somewhere. You know, it’s decentralized, it’s spread all over the planet and the miners are creating Bitcoin. And like I said, you have these unhackable blockchain decentralized it’s trustless. You don’t have to trust a government or a central party. And that’s really the appeal to a lot of people because you want to use PayPal or your bank or whoever it is. There’s a third party involved in you transacting with someone else. And this eliminates that third party in a manner where you’re at much less risk. But that said as an average person to understand that, you have to understand that you are now your own bank, nobody is going to bail you out. If you get hacked or if you get your Bitcoins stolen, you’re not insured. So for the average person, I think it’s actually terrifying. Most of them don’t even understand that. I think they just buy it on an exchange and they leave it there. When you buy Bitcoin on an exchange and you leave it there, it’s not really yours. There’s a saying in crypto, uh, not your Bitcoin If you don’t have the private T’s basically. So unless you put it on your own hardware wallet or move it somewhere offline, I mean, there’s a conversation that could go for hours. And, and it’s funny because I actually was recently the victim of a pretty major hack attempt by some famous hackers in Europe. They swapped my SIM card. They attacked my exchange accounts, but because I have my proper security in place, I didn’t actually lose any money. They made my life really miserable for a couple of weeks. But stories like that are going to drive your average retail person away from Bitcoin. And let’s be honest, in 2017, when everyone was interested in Bitcoin, they were not interested in it because it was a hedge against inflation or because it could protect them from their government. They were buying it because someone told them that they make a ton of money selling it later. That’s not a use case. That’s just FOMO, fear of missing out. So at the end of the day, you can’t explain all of that to a five-year-old effectively. And I think that’s been one of the greatest impediments to Bitcoin because people just don’t want to learn and they don’t want to deal with that. They don’t want to go buy a private hardware wallet and understand their seed phrases and private T’s, and that they got to put one on a safe and one of the safe deposit box. It’s really crazy. I mean, you really are your own bank.

James Di Virgilio (11:32):

Yeah. And everything you just said there, I think is exactly the reason why Bitcoin is nowhere near a currency adoption, despite in a theoretical world, how nice it does sound on a macro level. Look at what it can do. Look at the hedge against currencies. Those are all nice thoughts. But the function as that kind of store of value, one of the things is it really needs to be simple and easy to understand. You mentioned something that obviously a significant hurdle for Bitcoin, and this is this idea of safety, your digital wallet being safe every single day. We know of people getting robbed or mugged or their money being stolen, their dollars being stolen. Right? But it’s rather unlikely that someone’s going to get into your bank account and pull your money out without stealing your credit card or something of that nature. But even when that happens, Scott, the banks will usually cover you, right? But if somebody comes and takes my digital wallet, what happens?

Scott Melker (12:21):

If they’re not taking your digital wallet, per se, what they’re basically doing is they transfer your Bitcoin through many ways of hacking, but they’re sending their Bitcoin from your wallet into theirs and becomes untraceable. They spread it around and it’s gone and there’s no way to go get it back. So yes, you’re at tremendous risk, but there’s a flip side to that, which is that if you’re carrying cash, say you’re leading an African country right now, or you’re a refugee, or you’re running away from this virus and you get to the border, we’ve all heard the stories you want to come into the country, give us everything you’ve got. Your cash, your gold, your everything. So physical goods are still far easier to steal and in an environment like that, going back to it, yes, we’re not talking about going into your bank and stealing your money.

Scott Melker (13:02):

But if you’re really in a desperate situation and you have physical goods, those are more likely to be taken from you. If you have your seed phrases in your head, you don’t even need to have a physical hardware wallet, all that is the place to store your private keys. Well, your Bitcoin goes with you wherever you go, and nobody can steal it from you in that regard. So as a hedge against bad actors, as a hedge against dishonest government or the hedge against all of these bad things that could be coming for us in the future, and I’m not trying to be alarmist, I don’t think we’re going on mad max or anything, but it happens in other places in the world and Bitcoin or some digital currency can save your life. In that scenario, you will be able to trim back when you cross that border.

James Di Virgilio (13:40):

And this is not historically unprecedented. If you think back on the history of gold and monetary value in general, that same problem that you just illustrated was the original problem that led to winding up with a dollar in your pocket, right? That was the issue. Hey, I’m carrying all of this value from the goods that I have just transacted with. And now I’m at risk of being robbed or mugged, or my train is going to get stolen. And so how do we find a way to deposit money now in the city I’m in. Travel to the next one with effectively, nothing but still have access to that money. And that was a very, a nice example. I think of something that does become appealing in a frontier situation. If you will, now let’s focus back in on trading it. You mentioned it’s very speculative in a lot of ways and an overly simplified version trading Bitcoin, it sort of feels like tulip mania and that it’s largely people driven. That’s kind of what you’re talking about. When you’re looking at sentiment and charts, no one has any idea what Bitcoin is worth, right? And you couldn’t tell me what it’s worth, but it’s fundamentally worth what you’re looking at is what people think that it’s worth. Talk a little bit about the human behavior impact on cryptos.

Scott Melker (14:41):

So it’s my opinion and on chain metrics, somewhat support this, but everybody has their own opinion. I believe if you look at the way that Bitcoin transacts, the it moves between exchanges and the ways that it trades is that it’s still a highly manipulated asset. And by the way, I believe everything is a highly manipulated asset. So that’s not necessarily a point against, but it’s a highly manipulated asset. That’s traded by a few huge players. That’s in our industry. We like to call whales and effectively in markets in general, they just players like compound operator or whatever you want to call them. Their general goal is to inflict as much pain on retail as possible. They want to take advantage of where your stop loss might be or where you might be interested in buying and selling. And they want to just basically abuse you. And that’s the way that markets work. And so it’s a very frictionless environment with Bitcoin trading. One person with a whole lot of Bitcoin can move the books, 30, 40, 50% in a matter of hours, but that offers a tremendous amount of opportunity. If you’re a trader and you can get on the right side of those moves, which is basically what I mentioned earlier, that you think about it. Everybody I think is somewhat, at least superficially aware of what happened to Bitcoin two weeks ago. And it dropped 50% in one day. But if you look at the on chain metrics, 70% of all Bitcoin basically has not moved in ages, right? It’s the people who mine it, the original holders, whatever they’re holding onto it for dear life, it’s going nowhere. So when you look at the way that Bitcoin moved around and also there’s a huge percentage that’s been lost, and obviously there’s a finite amount of Bitcoin that’s going to ever be mined. So you’re really talking about 20, 25% of the Bitcoin that exists in the world is what’s being traded and moved around and affecting the price of the market. So it’s very strange in that regard, but if you look at what was happening, it’s basically a few people likely got together and decided, Hey, we’re just going to dump all this Bitcoin on the market, on the exchanges. And we’re going to absolutely destroy the price. Why would they do that? There’s a million reasons to speculate. Maybe they had a margin call because the market was crashing and they had to sell Bitcoin for a margin call. Maybe they’ve mined so much Bitcoin since 2009 or 2010, that they have so much supply to dump on the market. That for them, it doesn’t matter if they sell it at 20,000 or 2000, it’s just profit. They did it for a dollar who cares if they sell it for 2000 or 10,000, maybe they want to move into cash. It doesn’t really matter the reason. We just know that it’s a few people who are doing it, but when you look at the price of Bitcoin, as we speak in the mid six thousands, it dropped basically from 8,000 to 3,600, that’s a humongous move, but it’s already back to 6,600. And from 3,600, it bounced to almost 6,000 in a matter of 12 hours. So as a trader theres far more money to be made by longing catching the bottom, buying somewhere between 3,640-4500 and just selling it 12 hours later at 6,000 than there even was in being short or selling during that entire move down.

James Di Virgilio (17:34):

So right. I mean, absolutely. Is there any element of catching a falling knife there? Did you just time that based upon, Hey, I caught the falling knife correctly, it didn’t cut me. Or is there a level of predictability, like you said, you’re telling story of really low volume, significant price trades that you feel like, Hey, there is a floor here, right? Basically cryptocurrencies, aren’t going to zero. Bitcoin’s not going to zero.

Scott Melker (17:58):

Right. It’s not, but there’s a leverage exchange. That’s the biggest in the world that almost took Bitcoin to zero during that move because of an inefficient exchange. So Bitcoin on that exchange could have touched zero that day. If it had not turned the exchange off, which is somewhat astounding and shows you how much the market is affected by traders and those being high leverage traders, which is effectively worse odds than throwing craps in Vegas, at least you get free drinks there. I think there’s always an element of touching a falling knife. I generally, as a trader and this becomes a technical thing, but I look for when a level that seems key is recaptured as support, as opposed to just trying to catch it on the way down. But I’ll tell you, I got very lucky on that move. I had orders at 4,000 that had been sitting there for I mean months and it happened in the middle of the night. I woke up, I looked at my phone, the price of Bitcoin was $5,800. And I had bought it at $4,000, three hours before, while I was sleeping. I sold it immediately for an almost 50% profit.

James Di Virgilio (18:54):

Yeah. Those are the moments as a trader, right? That keep you coming back now, how do we apply this? What’s your advice for the average family out there? They’re investing in their 401k. They’ve got some real estate they’re doing the very normal things. How do they employ or should they employ Bitcoin or a crypto in their portfolio?

Scott Melker (19:12):

I’m certainly not a financial advisor. I guess I should put that disclaimer out there. As I mentioned before, I believe that everybody should have at least minimal exposure to it. 1%, 2%, for me, I’m comfortable more 5% to 10%, but how do you do that? I think that the best way, like any market might invest in your 401k is to start small and dollar cost average until you have a full position. I mean, it’s such a volatile asset that one week you can be buying it at $8,000 in the next week at $3000 and then a week later at $14,000. So trying to catch a price that you’re comfortable with for most people, if they’re not traders is an extremely uncomfortable thing. So set up an automatic buy and buy $500 worth of Bitcoin every Monday until you’ve bought the $10,000 allotment that you have for yourself or do it once a month or whatever that is. I think that’s safer for more mentally stable people than traders, the safer and smarter way probably to acquire a position.

James Di Virgilio (20:06):

So Bitcoin is a tremendously creative and innovative idea. If this podcast could interview the founder of Bitcoin, of course, no one really knows exactly who this person is. Right. We would certainly do it because of creativity. I often find that fields overlap in life, whether you’re an artist or a musician or a trader, you can find commonalities. What commonalities have you found between your life as a musician and your life as a crypto guru?

Scott Melker (20:31):

The obvious ones, which is that I’ve forged the path where I never had to have a boss, which is always very important to me. It’s funny you guys had my dad on the show recently, definitely got the best of what the Melker had to offer in that case. You know, my parents and I was very fortunate. They sent me to an Ivy League University. They were able to leave me without student debt. And then one day I called them and said, I’m going to be a DJ. When I graduated with my Ivy League degree, I could have gone at that time. It was very easy to get investment banking job and go to the wall street route, like all of my friends, but I was just never the kind of person. I don’t know if it’s an acceptance of authority or that I’m a bit of an ADHD case and I’m scattered. And I don’t fit into those environments, but I was always someone who was trying to forge my own path. So I’d say the most common theme obviously is that I make my own schedule. I work when I want to work and I worked as hard as I want to work, which usually is very hard, honestly, when you’re doing it yourself. So that’s one I can tell you on a creative level, it’s very funny. I produced music for forever and using all of these different DWS, you have all your workstations, Ableton, Logic, Pro Tools. To me, it almost feels the same to sit in front of a naked chart and draw the patterns and lines. Even the shortcuts that you use on the keyboard are very familiar. So to me it’s actually very interesting, I almost feel like I’m making music when I’m drawing and identifying levels on a chart. And that’s something that other musicians have actually mentioned to me as well. So there is some creativity and kind of a big game, but I would say that those are the biggest similarities. Really. I think that transition was more of retaining the same sort of lifestyle of being a self starter and not having to really answer to someone

James Di Virgilio (22:05):

Let’s go to that moment where you told your parents that you were going to be a DJ after graduating from an Ivy League school. What was that moment like for them and for you? Were they supportive? Were they frustrated? Tell me about that.

Scott Melker (22:18):

My parents have never been, even for one second of my life, anything other than supportive, it’s more nuanced than that. So first I want to see a music business while also deejaying. So I got a job in New York with a music agent moved to New York. And the first day that I showed up for my job, he told me that he had given the job to his nephew instead. So it was a somewhat forced exit from the music business very early in that regard, but deejaying and making music was always at the core of what I wanted to do. My parents were extremely supportive. I think they always believed that I would find success one way or another. And I didn’t always, I mean, I’ve failed more than I exceeded to some degree. JingingThat’s definitely stumbled forward through certain portions of my life. And I have needed help. There was a time when I was an Ivy League graduate five years out of college and I was deejaying once or twice a week in New York at night for some somewhat of a pittance. And I was delivering packages during the day while all my friends were on wall street. It definitely, wasn’t always easy, but my parents never batted an eye for a second. I have an older brother who’s a very successful physician. So I think that I can’t speak to their mentality about it, but I guess it’s good that they had one who was on the right path out of the way all right for their creative lunatics son kind of came through. But yeah, I’ve never had a conversation with my parents that I felt was uncomfortable about my future, because I always knew that they would talk it through with me, provide good advice and then get behind me.

James Di Virgilio (23:37):

So they gave you a lot of independence and what that independence, you find yourself in New York, you’re deejaying a couple of gigs. You’re delivering packages. What was your mindset at that time? And how’d you get through it? How’d you stick with following your passion, pursuing the path you were on?

Scott Melker (23:53):

It was hard. I was broke and there wasn’t really that much hope, I guess. I mean, I always had hope, but there was no really a major light at the end of the tunnel. At that point, musically, I was playing local bars and clubs every once in a while. I get a big club gig, but you’re talking about sustaining yourself without health insurance. You know, you have to pay for your own health insurance or without any guarantee that that gig will be there next week. So great. You made $500 tonight, but maybe next Friday the club’s going to close or nobody’s going to show up and you’re not going to have a job the next week. So it was always a constant grind and hustle for the next gig or the next thing. And then eventually like an actor or any musician, you kind of catch your break for me, it was in 2006, a friend called me in and said, listen, they’re auditioning DJs for this big tour in Japan, they audition 50 DJs. I got the job for an artist named Toshi Kubota, who is effectively, you know, they call them the Michael Jackson in Japan. It was his 20th anniversary tour. I had no idea what a big deal it was. I was just trying to get a job. I happened to bond with the drummer who was doing the auditions and we kind of jammed out. And so I spent the next two months rehearsing. And then five months after that, traveling in Japan, playing stadiums in 30,000 to 50,000 person shows as the DJ and opening act and percussionist in a 14 person band for this huge Japanese artists that not only offered some financial help because I got paid well for it. But it also gave me a lot of confidence in the platform to jump from there and do other things.

James Di Virgilio (25:18):

So you mentioned that you’ve failed quite a bit, right? Like anyone who’s done anything successfully, especially somebody who’s blazed a trail on their own. How did you keep learning from the failure without letting it beat you down to the point where you would just quit?

Scott Melker (25:32):

I dunno. I think it becomes routine to some degree, not to say that you become negative about it, but hope for the best, but prepare for the worst. I started a print publication in Philadelphia after I moved back from New York to Philadelphia, where I went to school and it launched and it was really like great success, well received. And two months later, 9/11 happened and all the businesses that were my advertisers started to go out of business. And so that was interesting experience and kind of lighten it probably to a lot. What’s going to happen to people now, but I think I’ve always had a positive support system for better or for worse. I would say that I knew that if something really went bad, I would have a soft landing. I never feared being homeless. I could have always gone back to my parents. I never did, but I guess mentally, you know that. And so I’m very fortunate to have a good support system in that regard as well, but I really never cared so much when I failed. I always just looked on the bright side and enjoyed what I was doing. I absolutely absolutely loved music from the earliest age. I started playing piano at five. I was a singer and saxophone player and everything. So it was just, music was always what I wanted to do. So at any point, regardless of what my financial situation was or how much I was working, I was just really excited be making music and to be a part of that scene, my passion for what I was actually doing, carried me through largely the rough times.

James Di Virgilio (26:50):

And this is interesting because given your background as a musician, what would you say to people that are inspiring to follow their passion, but maybe there’s no money in it or there’s inability to make a career out of it at the moment, do you have a view on the balance between continuing to drive for your passion, but also maybe providing for yourself and your future and your family. It’s a delicate dance to make. What’s your counsel on that? Having done that successfully kind of in several arenas.

Scott Melker (27:16):

I think it’s largely dependent on the individual, their financial situation, where they are in their life. And again, like how much of, I guess a support system they have. I think that at a certain age, you probably have to give up and become realistic. If you have a family, if you have kids, but if you’re a single person in this world with a true passion, I think that you should give it everything you possibly have until you can’t anymore. I know that if I had quit in 2005, I would have never known what was coming for me. But I really think that I would have a lot of regret not try my best and most passions that people have are things that they could probably do part time to some degree, go to your job and then come home and sacrifice your sleep and sleep four hours a night and make music and get it out there. I mean, it’s never been a time in history where it’s been easier with social media and all of these platforms, the SoundCloud and Spotify to get your work out there. When I was making music, I was one of those guys, on Canal St in New York City with CDs trying to get stores to sell my CDs and handing them out to strangers and stuff. So it is much easier now I think, I mean, you have to cut through the noise, but if you’re truly talented and you truly believe and you work hard enough, listen, the important thing to understand is you can be passionate about something, but if you’re bad at it, it’s not going to happen. I hate to say that, but if you have a discernible talent and you try your hardest, I do believe that the career that you dreamed of probably won’t happen. But I do think that you can probably make a living pursuing your passion.

James Di Virgilio (28:40):

Yeah. I think that’s really good advice. You balanced a lot of things there. One is balancing responsibility. Where are you in life? Who are you responsible for, is what you’re doing, going to cause others to have to pick up the slack for you towards significantly alters their life. And then secondarily, if you are actually really good at something and you continue to do it, if you live in a society that’s free and able to invest in that sort of talent, I totally agree with you. It could be longer than you wanted it to be, but at some point in time, if you are good, if you are skilled, you will find a way to be able to craft something out of that. Now, who knows how much you’ll get out of that. But that’s a good feedback mechanism. And often failure, Scott is obviously feedback. It tells us whether or not we should continue or whether we should keep going as a trader. You know, the failure is really a part of every single day, practically in your life. Uh, because traders traders are seeking to make very small wins, right? 52%, 53%, 54% of your trades are wins. You’re a hero. You’re a legend. So failure is something you learned to live with. I think it’s very helpful. I read on your Twitter about how you said really emotionally. You’re not that involved in what happens if you lose a lot, you can take it. You have a high pain tolerance, and it makes sense, given what you’ve just said in your life, there’s a lot of dots connecting there to the foundational floor. You’ve built what you view as success, which you view as failure. And one thing I’m not hearing a lot in your story is a prideful angle. I’m hearing a lot of humility with, Hey, I’m going after what I like and what I enjoy. And if I fail, it doesn’t mean I, myself am a failure as a person. It’s a chance for me to respond to what I’m learning.

Scott Melker (30:06):

I’ve never heard it put that way, but I do think humility was another thing that was deeply ingrained from my parents. I just feel like unless you become the biggest artist in the world or the biggest, this and that, where your ego is being fed 24/7. And I think that most people probably maintain that humility because especially as an artist, you know, that it can all be taken away from you in a second. I mean, how many, one hit wonders are there who bought their Ferrari and then returned it for half or had it repoed six months later? It’s just the reality of being a creative is that it’s not the 1950s. You don’t have a job your entire life. You don’t have a pension. Eventually you probably are not going to be at the top of your game and it’s somewhat a cycle. So I think that you just have to accept that whether you want to skin it as failure or whether it’s just the downturn or whether it’s that slow, steep descent from popularity into oblivion, that it’s coming for. Almost all of us who are not, like I said, just add a job and working for a boss who is able that boring and, and you know that you’ll have your job. So I don’t see how you can really be too prideful. You know, I’m proud of the things I’ve accomplished, but I also recognize that it was not all my doing. I had a lot of support and that it was very hard along the way.

James Di Virgilio (31:13):

Scott, it’s been excellent talking with you today. Kind of getting your background, hearing your stories, talking about cryptocurrency, music, trading. So many things you can follow Scott and find a lot of his insights on his Twitter feed the Wolf of all streets. Very interesting stuff there. He is Scott Melker. Scott, thank you for joining us today.

Scott Melker (31:31):

Well, thank you so much. It was really my pleasure.

James Di Virgilio (31:33):

And for Radio Cade, I’m James Di Virgilio

Outro (31:37):

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade, a podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them. We’ll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace,

Richard Miles: 0:40

The weather: everyone talks about it, but so the old joke goes, no one does anything about it. However, using advanced algorithms and machine learning, we can make faster and better predictions about the weather that can help a wide range of industries. Welcome to Radio Cade . I’m your host, Richard Miles. Today I’m very pleased to welcome Dr. Leela Watson, a former NASA meteorologist, and the co-founder and CEO of InitWeather. Welcome to Radio Cade, Leela.

Dr. Leela Watson: 1:05

Thank you. Thanks for having me.

Richard Miles: 1:06

So Leela, I’m guessing that as a meteorologist, you have probably heard lots of jokes about the weather. Are there any good ones out there, because it’s not exactly comedy gold, right?

Dr. Leela Watson: 1:15

No, it’s definitely not. I mean, I’ve heard them all, so I’m waiting for that really great one. That real zinger, that–

Richard Miles: 1:20

That actually makes you laugh, right? Yeah. There are a lot of lame weather jokes, but none that I’ve heard that are really good. So that’s a tragedy for your profession, but anyway, why don’t we start out by explaining for the listener exactly what it is that InitWeather does. And as I understand it, you crunch a lot of existing data to come up with faster and more reliable forecast. Something that is very particularly useful for things like the agricultural industry. And of course, utility companies, as we saw in Texas a few weeks ago, actually. So, how does it weather differ from other weather forecasts?

Dr. Leela Watson: 1:51

So, at a really basic level, what we do is we use machine learning to create better weather forecasts. So, the way that we’re different is that weather forecasts are generally made from computer weather models that are out there and forecasters take that information and make their weather forecast . So what we do in our product takes that weather data that’s available. We run it through our machine learning algorithm, and then we do create better weather forecasts than what are currently out there now.

Richard Miles: 2:20

But you’re taking obviously, from more than one data set, when you see a weather forecast on the TV or in the newspaper, are they all drawing from the same pool of data or do they all have different data sources that go into that forecast?

Dr. Leela Watson: 2:31

So when you watch a TV program, say you’re watching the evening news and they’re showing you graphics of the weather that’s coming through the front, that’s coming down, or precipitation that’s going to impact that area. Those are graphics that are produced from a weather model. So, a weather model at the most basic level is really just a series of equations that govern the atmosphere and create forecasts of temperature, precipitation, and all sorts of other variables. So, those forecasters on TV and the government, anywhere, are taking those weather models and then creating their own forecast, refining them a little bit and specifying for their particular area of interest. So, that’s one source of data for weather forecasts, and of course you have observational data. So what’s happening. now? You have weather stations that can give you your precipitation amounts, so your temperature, humidity, and all that. So, it’s kind of a combination. Forecasters look at tons and tons of data to make their forecasts . So not everybody uses the same thing, but generally there’s a certain set of weather models that everyone’s looking at. And of course, using your observations for your own local area to help make your forecast

Richard Miles: 3:38

So InitWeather then, just so I understand, it’s not a person like you or somebody on your staff that’s sort of sorting through this like a news station might; you’ve got a software program, I’d take it right? That sucks in all this data. Is it faster guesses about what the weather’s going to be like, or do they turn out to be more reliable or is it both?

Dr. Leela Watson: 3:56

Most specifically, it’s more reliable forecasts because we do rely on other data that’s out there. So, whenever that data becomes available, then we take it and run it through our algorithm . So, sometimes in some cases, yes, we can be a little faster than what’s out there, but really what we’re shooting for is more reliable, so that various industries, people who work in those industries, can then use our forecasts more reliably than what’s already out there and available. Of course, everybody wants a better forecast. So, that’s what we’re trying to give them.

Richard Miles: 4:24

So, Leela, if you could give me an idea of what’s sort of the degree of precision that say a farmer or a large agricultural company needs in order to count as a better forecast for them? Let’s say next week, a normal weather forecast say, well, we think we’re going to have between three to five inches of rain in your area. If you say, okay, it’s only going to be two to four. Is that valuable information to that farmer, that agricultural business? What degree of precision are we talking about?

Dr. Leela Watson: 4:47

That’s absolutely valuable. And for the general public, a three-day to five-day forecast that you get from the local weather from the national weather service is good enough, but for a lot of industries, they need to have more specific forecasts , especially tailored for their areas. For example, in agriculture, temperature’s actually obviously a huge, huge issue, especially frost or freezing temperatures, or if there’s excess of heat. So for example, if we talk about when are we going to reach freezing? So say that we have a forecast that says, oh, it’s going to be about 30 to 32 degrees on this particular night. Well, that’s a big deal. If somebody is trying to protect their crops from being damaged by freezing temperatures, if they’re off, if it turns out to be 35, well, then they’ve gone through all these procedures to protect their crops and then they didn’t really need to do that. They could have saved that time and money doing something else. On the other hand, if the forecast is saying, oh, it’s going to be about 35 degrees, and then all of a sudden it hits 30, well, that’s a big problem too. They have to take these preventative measures to protect their crops. So, having something very accurate is very important for them.

Richard Miles: 5:58

I see. So if you can even buy them a few hours, for instance, if you know it’s going to hit freezing at exactly 2:30 AM, as opposed to 4 or 12 or wetter, then that could make the difference between getting out that equipment, say to save a citrus crop or something like that and not. Is that more or less accurate?

Dr. Leela Watson: 6:11

Absolutely. It’s not only how low the temperature will go, but like you mentioned, what’s the timing, especially with precipitation, also. We can do pretty good with precipitation forecast, but usually we’re off with timing or maybe location, and that stuff is very important to the farmers that are relying on precipitation for their crops and definitely in other industries as well.

Richard Miles: 6:33

So give us an idea of the other industries. I mean, I mentioned that the utility industry, the whole experience in Texas, where they had to sub freezing weathers for a long time, they didn’t really know, is that a one-off thing or is that a common problem for utility companies as they try to forecast demand and so on? Would something InitWeather give them as much of an advantage as say a farmer?

Dr. Leela Watson: 6:52

Absolutely. Yeah . Weather impacts almost every industry in some way or another. Of course, we hear a lot about severe weather and that has very detrimental effects on many industries. And then there’s of course, just the mundane weather. When are we going to reach freezing like I mentioned, or is it going to be very, very hot or lots of rain, but we work in many different industries, and one area that we also work in is aerospace. So, they’re not really concerned with temperatures at the surface; their big problem is upper-level winds. So, for them having accurate upper level winds forecast is very important, and it doesn’t even have to be a large wind event to make an issue for them. So, it’s just blowing slightly harder at the upper levels, well, that has an impact on their rocket. So, that could change their trajectory, it could blow the rocket, it could topple over. So there’s many, many different areas that, industries that the weather will impact.

Richard Miles: 7:46

That’s fascinating, because that’s obviously a case in which being a little bit off can cost you a hundred million dollars or a lot of money if you lose a rocket or something like that. Is it correct? Are you partnering now with a company to get into the unmanned aerial vehicle space to collect very, very high altitude weather? Is that correct?

Dr. Leela Watson: 8:03

That is actually a project we’re working on right now. So, we would love to be able to have better upper level observations, especially wind observations for the aerospace industry. And actually, it can be useful to other industries as well. Right now we rely on weather balloons. That technology is almost over a hundred years old and it does its job and it works okay, but we’re thinking let’s look to the future. How are we going to improve that some more? So the project we’re working on is to take a UAV and use it like a weather balloon and send it up vertically, collect weather observations, and bring it down and be able to do that multiple times in the leadup to a launch, so they can get that information and use that for their rocket trajectories and forecasting for launch.

Richard Miles: 8:47

So very much like a custom design solution. This would be for a particular client who wants a very particular, say, launch window or period of time that you would put up that UAV. This wouldn’t be an ongoing service, because I imagine that’d be pretty expensive.

Dr. Leela Watson: 8:58

Yes, it would be pretty expensive. Um, but so it would be designed for launches, and launches, they’re doing many, many more of them now, and there’s more launch sites that are opening up worldwide. So, there is a market for that. It’s still in its infancy, this project, but we’re hoping that it takes off soon.

Richard Miles: 9:16

Tell us a little bit, Leela, about the origin stories of InitWeather. For some young companies or inventors, it’s the classic Eureka moment: all of a sudden you have this blinding insight. Was it like that for you and your co-founders? Did it just dawn on you: hey, we’ve got something that we can package into a model that is very useful? Or did you just sort of iterate or stumble your way towards that model?

Dr. Leela Watson: 9:36

I would say it was years in the making for me. My job before I started this company was working for NASA’s applied meteorology unit. So, we had a contract and I worked on that contract and we worked with NASA and supported their space program. And, I was the resident weather modeler, so I ran weather models and I came up with solutions specific to Kennedy Space Center and Cape Canaveral Air Force Station. And of course, everybody wants a better model, better output, but there’s only so much you can do with what you have. Now, what’s out there is , is pretty amazing, but it comes to a point where it’s very hard to keep improving that model. So, a series of events happened , um , and I started this company, and the idea was: let’s come up with a different way to improve the models instead of the same old way of throwing more computing resources at it, which equals more money for very little improvement. Let’s come up with a new way to create a better forecast. And of course, artificial intelligence machine learning is not new, and it had been being used in other industries and even within weather, but I hadn’t seen it implemented in the weather industry, maybe in little pockets, but that was my push to develop this and to create that better weather model.

Richard Miles: 10:48

And Leela, remind me what year was that? That was 2016. Is that right?

Dr. Leela Watson: 10:51

Correct.

Richard Miles: 10:52

Yeah. And how has it been since then? This is a fairly common path, or it’s not an unusual path that a university researcher or somebody sort of in advanced research working in the private sector will say: Hey, I’ve got a new idea. They form a company and they take their technology invention to market. How has it been for InitWeather? How many employees do you have right now? And what has that journey been like so far?

Dr. Leela Watson: 11:10

So we’re still very small. We’re only three of us, and it’s been a very slow process, I would say, because I think at the end of the day, it’s great to say: Oh yes, we’re going to use machine learning, create a better weather forecast, but there are so many different ways that you can use machine learning to create these better forecasts. I always call it the original, big data problem. There’s so much data, and so it takes some time to gather that data, run it through the algorithm, decide what’s the best way to proceed, what the best data is. So, it has kind of been a learning process along the way as well. When I started this, it was: Oh , let’s just do this. And then when you dive into it, you realize why not so many people have been using machine learning within weather, because it is such a big problem. And just sorting through all the different ways that it can be done is a challenge, but we’ve gotten really great results. So, now we are in the process of selling product to a lot more customers, and we’re starting to grow now.

Richard Miles: 12:06

That’s great news. I know you’ve done well in competition, including the Cade Prize competition, when you entered there and you were a finalist. I imagine it’s a different world, right? This is what always fascinates me, is that a lot of these pitch competitions or so on, you rarely encounter a bad idea. I mean, all the ideas are pretty good and you , you see them and you, you hear about them and go: well that, yes, it’s plausible, it’s useful. But then, getting from that stage where people will say, yep , good idea to , okay, who exactly is going to buy it or pay for this great idea, how do you do it in such a way that it’s sustainable and not just a one-off thing?, And that is particularly for people from a research background, sometimes can be frustrating I imagine.

Dr. Leela Watson: 12:44

Absolutely. It can definitely be frustrating. And then within weather , we have to compete with free data, free weather, national weather service. They have issued their forecasts all the time and that’s free. You can just go to their website and look at it. But you know, private weather industry really focuses on specific industries and specific problems, and so that’s kind of what we’re going after. We want to help the industries and our customers that the national weather service forecast is not going to help them. You know, they need more specific information, and they need more consistently better information. So, I think that’s really important too . You know, there’s a lot of times that weather models or forecasters really hit one event really well. They nailed it, but we want to be able to do that all the time. And so that’s our goal with our machine learning product is be better and be consistent.

Richard Miles: 13:30

Right, it’s a reliability factor. I think you’re probably onto something, concentrating on the agricultural field. I interviewed last year, the national director of the 4H Foundation, and she pointed out to me that farmers in particular have always been actually early adopters of technology, because they have to be. When you present them with something that actually saves them money right away, they’ll try it out, and they don’t need a whole lot of convincing. And then if it doesn’t work, well, then they stop. But if you can show them that it’s going to increase the yield or protect crops in your case, then they’re willing to give it a try. And a lot of the innovation that is actually later made it to the broader market starts in the agriculture market because of farmers trying to solve problems or agricultural companies trying to solve problems.

Dr. Leela Watson: 14:09

Yeah, absolutely. Our first customers, the first people that came up to us were all within the agriculture industry. And that wasn’t actually even our focus at first, you know, we were kind of looking more towards commodities, which is agriculture to that in aerospace. And then we just had farms, farmers, anybody in the agriculture industry come up to us and say, well , this is really great. We could definitely use this. And that’s kind of how we got into that industry. So, they’ve been great. They’ve been willing to try our product and use it and it’s worked for them. So, we’re happy about that.

Richard Miles: 14:41

I don’t know how much you work with commodities traders or if you’re pitching this product to them. But this idea of being able to seize on a market opportunity, even a few hours before somebody else, it hadn’t dawned on me that wow, that of course would be a valuable service that you could provide. If you were able to provide that again, that reliable data, you can only be really wrong once, right. People will quit using it .

Dr. Leela Watson: 15:01

Absolutely. They do, they need that information and they need it quickly. And we’re definitely aware that we need to be correct. We’re not on a local news. We can’t be wrong and still keep our job if we don’t perform and produce something really great, they can just say: Hey, we’re done and move on.

Richard Miles: 15:15

I was going to say probably the second, most proper type of weather joke is complaining about the weather man , right, who got it completely wrong? I think you’re part of a trend that’s obviously been underway for a while of being able to take large data, big data and crunch it and use it, really add value to a certain segment of the market. Obviously, probably not the retail market for quite a while . I’ve mentioned this before my daughter works in the insurance industry and the car insurance industry, and she was telling me that there’s one company that basically just has a huge data set on every single car produced, every single feature down to the nth degree, so that a car insurance company knows exactly how safe or unsafe that car is particularly now with semi-autonomous vehicles. And those companies that aggregate that data and sell it to the car insurance companies do pretty well, because that’s extremely valuable set of information that a handful of customers out there are willing to pay a lot of money for.

Dr. Leela Watson: 16:05

Yeah, absolutely. I’ve noticed that there are many different industries that need that weather data and they don’t know how to get it, process it, and use it for their industry. So that’s definitely a big thing for weather companies too, is being able to get all that data, put it together in a way that is useful to them, presenting it in an easy to use way as well.

Richard Miles: 16:25

So Leela, you mentioned you’re still very small ,about four people. How do you spend most of your day now? I don’t imagine it’s in sort of the research and , or is it? Or are you on the phone talking to clients or potential customers, or where do you put your energies at this point?

Dr. Leela Watson: 16:39

A little bit of both. So I have a really great business partner, Jordanna, and she takes on a lot of the business side of things and allows me to keep my hands in the research part. So, I do a lot of coding still, and I really love that. I mean, that’s my bread and butter type thing. Of course, I am on the business side of things as well, but the idea was born out of my experience using weather models. So, we found that it was important for me to keep my hands in that side of things. I spend a lot of my day doing that. And then of cours,e we’re a new company or new-ish company, I should say, we’re small. So, we all have to do our part and do all the other administrative and business things that occur, so.

Richard Miles: 17:15

So, I have to wonder with my limited experience of starting institutions, just the Cade Museum, we had a staff of four forever. And then all of a sudden we went to a staff of 30 almost overnight. And you always worry about what if we fail, but you never really think, well, what if we succeed? Then all of a sudden your life gets a lot busier and actually more complicated. So managing success is often part of the managing decline. So just a word of caution. So Leela, you were born and raised in Massachusetts, like a lot of people from the Northeast, you ended up in Florida. You picked up a bachelor’s degree at the University of Miami and then a Master’s and PhD at Florida State University. And you said your first real interest in the weather was after experiencing or surviving a hurricane in Miami, I’m not sure which. Tell us what was that like and how did that steer you into meteorology?

Dr. Leela Watson: 17:56

It was actually just a small, small, I put in quotes, hurricane that actually had a big impact out of Miami, as far as flooding. I wasn’t very worried about it, and then I found that I was trying to get home–I was working actually–and the storm was coming up from the South, and I had to drive South back down to Miami. I was working in Fort Lauderdale and had to drive back down South. And so, when I left Fort Lauderdale things weren’t too bad, but by the time I got down to Miami, it was a different story, and my road was flooded and I had to find a different way of getting home. And it actually just left a big impact on me because for a small, again quote small storm, it had a big impact. So that really fascinated me. I’d always been fascinated by weather, but that was kind of the nail in the coffin that made me realize: Hey, I think this is what I want to do and study this. And so, that’s how I got into meteorology and decided to go to grad school and get my degree there.

Richard Miles: 18:48

So you’d already graduated with your undergraduate degree and you were working after that, and that’s when you figured out, okay, this is pretty interesting.

Dr. Leela Watson: 18:53

Yeah. So my undergraduate degree was environmental science. And so, I decided to move on to meteorology. I was still interested in environmental science, but meteorology just really fascinated me. So I moved onto that.

Richard Miles: 19:07

So inventors often marched to the beat of a different drummer, and we’ve talked a lot of inventors and entrepreneurs on this show and , and often they have very interesting paths. What were you like as a kid? Were you a good student? What were your interests? Do you remember when you were small, let’s say in grade school first or second grade, do you remember what you wanted to be when you grew up?

Dr. Leela Watson: 19:24

I was definitely an introvert, and I was a good student. Weirdly enough, when I was young, I wanted to be a stockbroker. I don’t know why.

Richard Miles: 19:39

Oh wow! That’s a very unusual first grade dream.

Dr. Leela Watson: 19:39

I know, very weird, but as I grew up and grew older, I realized science was what I was really interested in. And so it was just a no-brainer for me to go down that path. I never thought I would do anything else. And as I got older, I knew again, I was going to go to grad school. When, I didn’t know, if I was going to take some time off and then go. But my path was actually pretty clear. And then the whole entrepreneurship thinking about business, it kind of had always been there. My father was a doctor, he had his own practice, and he always talked about business and how he wanted to be in business. So, that kind of got ingrained in me, and I started thinking about it early. I didn’t know if I would actually ever start my own business, but that seed was planted early. And then of course, just working and having so many ideas of how we could do things better from the science side, from the business side, from the marketing side, it became clear. Alright, this is my time. I need to do something about it and start my own business.

Richard Miles: 20:31

So these things or these inclinations often run in families. You mentioned your dad was a doctor. Anyone else in your family, extended family, that is in the general field of numbers, number crunching? I think it’s really interesting you wanted to be a stockbroker. Ultimately, right, that’s processing big data every day for a lot of money or maybe a lot of money. Anyone else? Do you have siblings that do something similar, or?

Dr. Leela Watson: 20:50

My brother is an engineer. My other brother is in computers. My sister was a stay at home mom, but she’s in the political arena now. So not quite the same path as me. I think it is interesting. The fact that I did want to be a stockbroker and then ended up meteorologist I guess my path is always to try to predict the future. That was the path I was on for my job. So,

Richard Miles: 21:11

And certainly in both fields, stock picking and picking the weather, people know when you’re wrong, right?

Dr. Leela Watson: 21:16

Yes, absolutely.

Richard Miles: 21:17

There’s no hiding from your prediction, like oh I didn’t mean that.

Dr. Leela Watson: 21:20

Yeah. At least I don’t have to worry about other people’s money. It’s just the weather. Is it going to rain on their head or not.

Richard Miles: 21:24

Exactly. Exactly. You’re at the stage in your career now where you’ve had some early success and you’re probably asked to speak maybe to groups or people ask you for advice. What do you tell them? Are there any things that you know now that you should know known , say when you were a college freshmen or recent college graduate that you’ve learned either at NASA or in starting up InitWeather that you would impart to say a younger version of you,

Dr. Leela Watson: 21:46

As far as choosing meteorology, I would definitely say, be ready for math and physics. Because when I got into meteorology, you see on the weather channel the graphics and talking about the weather, but then when you get into school, you realize the fundamentals behind the meteorology are all math and physics. And I’ve heard that a lot with students that came in to the meteorology program, they didn’t realize that was what it was. So you have to love science. You have to love math in order to succeed. Um, as far as starting my own business, what advice would I impart? Just be ready to work. It’s a lot of work you’re going to work all the time. I work pretty much every day of the week, but on the flip side, it’s something you love. It’s something that gives you happiness. I wake up and I’m happy to start work, which doesn’t always happen for everybody. So be ready to put your head down and grind and the rewards will come.

Richard Miles: 22:38

So one thing I find fascinating is someone who goes from working for fairly large organization. So you’ve worked at NASA, a subcontractor, right? For NASA. So you worked for one of the largest organizations out there and you go to a four person business compare and contrast. What is that like? In terms of just the whole psychology of on one hand was my case. I worked for the Federal Government for a long time, you show up at work and you’re at a large office building with hundreds of thousands of people. You never have to worry. Who’s going to pay the light bill. You never have to worry about that sort of stuff. And then you go to this existence where you worry about that all the time. So was it a psychological hurdle? Was it exciting? Was it terrifying? All of the above?

Dr. Leela Watson: 23:15

All of the above. Definitely. So working for a larger organization, your voice is not heard as much when you have a conference, there’s 30 people in the room talking and you can put your ideas out there, but there’s a whole lot of other people and ideas floating around. So sometimes you’d feel like you’re not heard. So going to a small group. It’s nice because everybody’s heard everybody’s ideas are taken into consideration as far as paying the electric bill and , and keeping me awake at night. Yes, I’ve definitely gone through that. I definitely wake up sometimes and think we need to do X, Y, and Z. It has to be done right now. And it is somewhat terrifying, but it’s very rewarding at the same time. And I like being small right now. I don’t think if we grew overnight, like you mentioned earlier, it’s a different set of problems. So it’s nice that we’re a small group. Now I can handle that now and hopefully we’ll grow and I’ll be able to transition into that managing a larger group as well. But I like it, how it is now,

Richard Miles: 24:10

I think you put your finger on something you said earlier, and this is my own experience as well, going from the federal government to starting a little nonprofit . And when you’re working for larger organization, often you’re working on very big, exciting, important things, but you’re not exactly sure what your contribution was sometimes where you’re one of a cast of dozens or hundreds or thousands, but in your own little micro company or nonprofit by golly, you know, exactly at the end of the day, what you did get done or didn’t get done. And what your role in that success or failure was, there’s never any doubt about the importance of your role, whereas you do have sometimes at , and in much larger corporations, you think, well, I did a good job. It doesn’t matter. So what I tell people sometimes particularly if you were relatively young in your twenties and so on, consider working for a small corporation, small company, or a startup, because a lot of people that age want responsibility. And then unfortunately the large organization, you may not get that in your career until you’re considerably older before you get real managerial responsibility or decision-making authority. So it sounds like you’re happy with that trade off as well that you get to look back on your day and know precisely where the Leela Watson played a role and what it meant.

Dr. Leela Watson: 25:15

Yeah, absolutely. Every day is different. And I love that. And every problem and challenge is different. And I love that. And I absolutely agree with somebody who wants to come into a smaller organization. Yes, you’re taking a risk because who knows what the future of that organization is, but you will absolutely be given responsibility when we hire anybody. We want them to take the reins . We want them to think outside the box and come up with new ideas and go off on their own and be innovative. And we hope that’s what they’ll do, because quite honestly, we don’t have time to micromanage everybody. So that’s what we’re looking for. And so if that’s what interests you in a small organization is absolutely a great place to be.

Richard Miles: 25:54

So Leela, great advice. Thank you for being on Radio Cade and at a minimum, we now have at least one more person we can blame if the weather doesn’t turn out right now. We can be more precise about our blame. Like, Hey, it didn’t freeze exactly 2:30. Like they said it was going too.

Dr. Leela Watson: 26:07

Yeah, we’ll take it. We’re used to it.

Richard Miles: 26:10

Best of luck InitWeather you all have gotten a strong start and you look like you’re headed to a big things. And so I hope we can have you back at some point after your IPO, right. And you’re cashing out your millions of dollars. Anyway. Thank you very much for joining us on Radio Cade.

Dr. Leela Watson: 26:25

Thank you, thanks for having me .

Outro: 26:28

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews. Podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to radio K to podcast from the Cade museum for creativity and invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

Richard Miles: 0:40

3D nasal swab, a phrase that doesn’t roll off the tongue quickly and not the name of an indie band, but it has helped tremendously in COVID testing since the beginning of the pandemic. Welcome to Radio Cade. I’m your host Richard Miles. And today I’m pleased to welcome Dr. Summer Decker , Vice Chair for Research and Director, the 3D clinical applications at the University of South Florida’s Morsani College of Medicine. Welcome to Radio Cade, Dr. Decker .

Dr. Summer Decker: 1:05

Thank you so much for having me I’m looking forward to this.

Richard Miles: 1:07

Well , the first thing I got to ask is what’s up with Tampa. You guys are hitting it out of the park. Down there you’re one yourself, and now you have world-class research institutions. There’s something in the water. What is it about.

Dr. Summer Decker: 1:18

Beautiful Tampa Bay, we attract some top sports talent as you will have seen in the last few months here with our Lightening and the Buccaneers and even our soccer team and our baseball team. And , uh , yeah, it’s been an exciting year for us here in Tampa, especially during COVID when things have been so tough, we all needed a little bit of cheer. So I think it’s the Tampa Bay water.

Richard Miles: 1:38

I’ve got to say since we’ve started the Cade Museum project right away, USF University of South Florida came to our attention as just being this very innovative forward thinking research university that kind of started with humble origins, but man, you guys are doing pretty amazing things now.

Dr. Summer Decker: 1:52

Well, I appreciate that. I was lucky enough actually, to do my doctorate here. And one of the things they really do train us on here at the medical school is to think differently about solutions to problems that maybe have been occurring for some time. And so I like to say we’re young and scrappy because we realized we’re up and coming university or up and coming medical school. And so we have that liberty of not having to been, Oh, this is the way we’ve always done it. That we can actually look at things differently and use technology in different ways. And so that’s really what we train. And even as a student here as , okay, you have the way it’s always been done, but how would you do it differently? And it lends that intellectual freedom if you will. So that’s actually what attracted me here to come to USF. I had heard that too, and I’m proud to been able to stay here and hopefully train the next generation of physicians to think the same way.

Richard Miles: 2:41

You’re doing great things. One of the first people we reached out to when we started the Cade Museum, the Cade Prize was the Paul Sandberg.

Dr. Summer Decker: 2:48

Oh yeah, Dr. Sandberg.

Richard Miles: 2:49

Yeah. The Florida Inventors Hall of Fame and their attitude was like, sure, we’ll help you. And they didn’t know us from Adam. So we were pretty impressed with that. Obviously it shows at the USF, the whole philosophy there. So Dr. Decker a year ago, I would have had to explain what exactly a nasal swab is and why they’re important. And now I’d say probably just about everyone has had at least one COVID test and we all know what they do, but I do have to admit that I had never heard of a 3D nasal swab until I heard of the one that you all developed. So let’s start by you walking me through why a 3D nasal swab became necessary, how they differ from a conventional swab and how do you make them exactly?

Dr. Summer Decker: 3:27

A lot of great questions and I’ll try to keep my answers brief as possible. I think this interview is time so perfectly because this really did start out about a year ago, March 17th was the day we invented the 3D printed nasal swab. And the reason we focused on that is that when the rest of the country was trying to get tested, we were trying to figure out how many people in the us do actually have COVID. The first thing we started noticing was their PPE shortages. There were shortages and supplies and testing kits. And so part of that shortage was a supply chain disruption that was occurring with the nasal swab. That is part of the COVID testing kit. And this is actually one here I have on video. It’s a plastic device that has a little bit of a fuzzy tip on it. The problem, the reason there was a supply chain disruption is that these are actually manufactured in Italy. And as we’ll recall , back for a year ago, Italy had shut down completely. And so we really didn’t have no ability to get extra supplies. The backup site was in China and so China was shut down as well. So this actually presents a situation that we had never been in before. Okay. Now, where do you get your supplies? And so here at USF, I was actually in surgery about to hand off a 3D print . And my team does the 3D printing here at Tampa General and University of South Florida Radiology. And so we are handing in case off in surgery to this trauma patient and the surgeon , when I got a message that we were short nasal supplies. So the nasal swabs , and it started sticking in my head thinking all of the other PPE, those are things that I know other groups can do that nasal swab was of interest to me because there was going to be a lot of diagnostic value to that. That was going to obviously be what tells us if you have COVID or not. So that was going to have to come out of a medical school, a medical center, a hospital. And how do you make up for that supply chain? And I run a 3D lab. So we went back immediately started seeing, could we replicate that using a 3D printer?

Richard Miles: 5:21

Yeah , I’m going to reveal my ignorance here, but I thought that nasal swab was really just like a really big Q-tip. So I think it’s probably more complicated than that in order for it to work for COVID because obviously you can’t just use anything.

Dr. Summer Decker: 5:33

No so that’s what made it tricky with COVID was that the traditional Q-tip that you’re talking about, even the things that you’ve seen, maybe if you’ve had strep throat or something with the cotton and the wood actually interferes and the test and the PCR test, you’ve probably all heard about the PCR test that’s out there. So we have to use a specific type of swab that doesn’t interfere in that test and cause a complication. And so the current standard of care swab was a plastic kind of a nylon version with this fuzzy blocked tip on the end to be able to capture a sample. So we really got one of the last samples that they had at the hospital, and we started looking at it and we said, could we actually replicate that using a 3D printer? And it was myself, our technical director, Dr. Jonathan Ford, one of our radiologists, Dr. Todd Hazelton , who specializes in the pulmonary airway . So the lungs and the airways and all of us started looking at it and saying, I think we have some ideas. We ran literally down the hall to our colleagues in infectious disease and told them we have an idea. We’re going to try to 3D print you nasal swabs. And we’ve come up with a bunch of designs working with our colleagues here, and some colleagues on main campus. We just put out a call saying, does anyone have any design ideas? And so we were able to narrow it down to three different ones and the infectious disease team brave to the end. They actually tested them on themselves first. What was most comfortable? We wanted to make sure that we could get enough sample for the test, but also make sure it was patient comfortable and patients safe. And so this is actually what we were able to come up with here. I have a printed version of it. And so there’s some ridges on the edge that way we could actually make sure we had enough surface area to capture the sample and also a softer tip on the end so that you don’t damage any of the tissues. I know a lot of people were concerned about why was it a nasal pharyngeal swab because that region and your face is quite far back, you hear them call brain ticklers and all kinds of different things. But that is actually where the first place that COVID really set in. So it was one of the earliest spots that you can detect COVID. And so that was why it was very, very important to work with infectious disease, neurology, and radiology together to come up with the best safest tool, to be able to capture a sample on March 20th, we went to a bench lab testing. She means we went and tested it in the lab. We were able to have viral samples and our neurology team here worked night and day to be able to test it, make sure that it was able to detect a virus, make sure also that it held a virus. We knew it was going to be some time between people’s tests and when it could be actually ran and all of those things that passed by that Monday, we went to clinical trial.

Richard Miles: 8:07

Wow . So just to refresh for listeners in case anyone has a bad memory of the last year, March 11th, which is exactly a year ago, we’re recording this on March 11th, 2021. And so March 11 , 2020, I think that was the day when everything shut down the major sports leagues, churches, businesses, restaurants. And so you’re talking really a little over a week after that, where basically you were ready to go with something that you could submit to FDA for approval. Is that about right?

Dr. Summer Decker: 8:34

That is right. And the reason we knew we could use this material was in our clinical practice here at the hospital. We make anatomical models. We make surgical cutting guides to really help surgeons plan their cases. They’re really tricky cases. We really do get like the most complex cases that the hospital gets. And so we have materials that have already been cleared by the FDA. We have computers that are FDA cleared for us to be able to do that work in our normal day job, we have printers that are actually medical grade printers that we knew were FDA cleared to be able to do that. And then we had the surgical grade material that had already been cleared. So while standing in surgery, I started thinking, Oh, we can actually kind of jump to the end point if it works, because we’ve already been cleared all these different steps. And so that’s why it was very important to me to use the printer that we used, the materials that we used and also the medical team, because the first things the FDA said was that because it’s a crisis situation has to come from a medical center or licensed device medical manufacturers. And so not just anyone could go out and print, like you’d be at a printer at home. These were going to be diagnostic tools. Meaning they’re going to be used to tell you if you have COVID . So there was a high stakes situation. And so I got so many really sweet emails and stuff from around the world of elementary schools wanting to help print and the local aquariums wanting to help, but it really had to be a medical team doing it for it to be able to be used as a test. And this is what this hospital here, we printed for this hospital for Tampa General Hospital here, Moffitt Cancer Center, the VA hospitals here locally in Tampa Bay. And the reason we were able to do that is because we tested it here. We went through a very large clinical trial. That was a multi-site national clinical trial. And we went and lightspeed to be able to confirm it. We worked directly with Northwell Hhealth, our colleagues up in New York, they were in the middle of the peak of them up there and they had no test kits. So they were wonderful to work with as well as Thomas Jefferson University Medical Center. So all of us working together and that’s, what’s so exciting about this. All of these teams working together as fast as we could just to be able to bring this quickly to the medical teams in their hands. And one of our emergency room physicians has told me we are fighting a war and you gave us the bullets. And basically we were able to tell them if a patient was safe, we were able to keep them safe and keep our hospitals functioning by giving them test kits .

Richard Miles: 10:56

Right. That’s an important point you made just as a side note about FDA approval and most people aren’t familiar with, [inaudible] getting approval for new invention and why should they be? It’s a very short chain process, but I think the term of art is predicate technology, right? Where if you’re coming up with a new device of any sort, if all the components or some of the components of that device have already been approved by the FDA, it’s a much less onerous process because really you’re just taking pre-approved materials. You’re putting them together in a new way. And in theory, the FDA should just go. Yep. Yep, yep. You’re good to go. And it sounds like that’s what happened in this case.

Dr. Summer Decker: 11:30

So the FDA, we worked with them every single week and not to get too technical. It’s a class one exempt medical device. So they recognize it’s a medical device, but it’s not one that they regulated. So what you just said is exactly what was important. Is it been done on materials that are cleared by us? Is it been done on printers, cleared by us and has it been thoroughly vetted? And that’s why it was really important for us to do a full trial. There were so many people when the news broke that we were doing this, I woke up one night to 4,000 emails from around the world and people wanting their hands on it. And we had to make sure that no matter what pressures that were external, and we knew that people like in New York City had no test kits. We were lucky not to be in that position here at Tampa and just yet, but we were all very stressed about making sure we did our due diligence to make this the best clinical trial follow all of the standards that we knew in our normal practice when it’s not in a crisis situation. So we all felt the pressure to get it done quickly, but we also knew we had to do what we normally would do.

Richard Miles: 12:33

If you wake up and theres 4,000 emails waiting for you either you’ve done something great or you’re in really big trouble, right. Whether you’ve won the Nobel Prize or something bad has happened. So Dr. Decker, there was one point you made that I want to come back to. And that’s about, even though the process was relatively simple in terms of assembly, you still have to be able to have a medical grade printer and the supporting materials. Is that something now that is more or less standard at most hospitals or is that really mostly research hospitals are going to have that kind of equipment standing by?

Dr. Summer Decker: 13:03

Well , what a great question. So there are well over a hundred 3D printing teams like ours here, and most of the major hospitals that you’ll see out there and I’m lucky to work with all of them. We actually have a little network and within our radiology society, we have a group of us so that we can all communicate about different cases, that we’re seeing new technology, new materials, we have great relationships with industry so that we can see what’s coming out. I really actually have a voice in what comes out. The 3D printers that we use are often the same printers that aeronautics and the film industry, the automotive industry uses, but with different end points and purposes. And so some of the printers that we use have specific medical grade materials, because we’re all trying to get to as close as we can to human tissues. And so that’s why we have really special needs and special interest . And so you’re seeing more and more of these hospitals and teams like ours coming on board because we’re able to help with, as I mentioned, these really complex cases. I mean, if you knew your surgeon was about to walk in, but he or she’s practiced on this 3D heart on the print and can tell you exactly what devices he’s going to use, what size devices, all of that stuff in advance, or able to actually really reduce medical error and medical risk . I can tell you one of our cases with some cranio facial work that we do in our trauma teams here, we’ve been able to take surgeries that are normally 11 hour surgeries and get them down to three hours because we’re handing them a print. That is the exact, what they need to go in there. So not only does that reduce the operating time of that room and the surgeons being there, but for the patient, the patient risk of being under anesthesia, that long the risk of infection and let’s face it, we are all fighting the American medical system in costs. And so cost is something that you want to be able to do as well. So we’re able to reduce the time the cost and the risk of error by using 3D prints of patient’s specific anatomy and being able to create solutions specific to a patient. So cutting guides and things like that. It’s a really nice technology to have in a hospital. And it’s important for it to be in the hospital so that we can move very quickly. I never know who’s coming through the door behind me and what cases about to happen. So.

Richard Miles: 15:12

So you have an entire lab and staff that sits around and wonders what you can do to help people with 3D printers, which for a lot of people, that’s your dream job description. So what else do you have in the pipeline? What are you working on now at your lab or that you know of that’s being worked on that could be a breakthrough procedure process say next few years.

Dr. Summer Decker: 15:31

So things that we’re working on eminently , we worked directly, as I mentioned with industry to come up with better biomimetic or mimicking tissues. So we are working every single day, including just even today on creating tissue and a printer that feels like that heart, that feels like a face. And we work with a craniofacial facial team here and they can actually cut on the 3D prints and operate. And we work with the children’s hospital here in Tampa and their team over there. And we collaborate with them on that. So getting our clinicians really accurate feeling materials, and I think the end point goal eventually of all 3D printing and this kind of comes with more bio-engineering is being able to print directly into the body, whether we’re being able to use human STEM cells, to be able to do things like that, or be able to use materials that are safe to be embedded into the body. So thinking of my patient with a shattered face, instead of us being able to have to reconstruct all of that manually, we can actually print something in there. And our team holds a number of patents in this area. So that is our goal is to really get it to where we can print and embed into the body and make internal casts. If we break something, we can fix it internally and have that print grow with you, things like that.

Richard Miles: 16:45

So what you’re telling me is that within the next 10 years, we’re all gonna look like movie stars. Is that the message?

Dr. Summer Decker: 16:49

Can’t you tell?

Richard Miles: 16:51

I love it. This is great. So 3D technology or 3D printing, I should say in general, has been portrayed by some as this kind of miracle technology. And essentially you can eventually manufacture anything anywhere all the time. And I suspect the reality is a bit more complicated, is that even feasible? And what are the practical or the physical constraints that limit 3D printing.

Dr. Summer Decker: 17:14

We know that we’ve even had 3D printers sent to space so they can use them. And so I can tell you that we’ve worked with teams with the military, that they are on nuclear submarines. So you imagine that we have teams that are underwater somewhere and something breaks on the submarine and they can actually print from the 3D printers. That’s there a file can be sent from back wherever the team is and sent out to that location. So 3D printing is getting more affordable, smaller, there are printers for that, but there’s a big difference. There’s a big jump from the hobbyist type printers. And I hear this all the time, Oh, my kid has one of those are like a toy and that’s fun. And I’m excited to see children get involved in that. Cause that’s where it starts. These printers that we’re playing with are not the same kind of printers. They’re very complex machines. They’re very finicky human type machines. So I think that being able to do this in the future, everyone has them. I think that that is feasible, but it will be a matter of materials and really knowing what works for the solution that you’re trying to be. So you see right now, 3D printed houses happening, but these of course take up a lot of space. So I could see we’ve got 3D printers that are used for eating so you can actually print food and designs. So I think that really what’s exciting to me as I hear new solutions, new applications, all the time, things I would never have thought of. And so that’s what I really love hearing from younger students and kids, because they are thinking things so far ahead of us hearing the innovation come out of that age group. I can’t even imagine what the technology will look like. It’s a miracle now of what we’re being able to do. I really I’ve seen it myself. I’ve seen patients survive things that they had 0% chance of survival. And that’s what makes me happy when I leave work for the day, but to see what’s coming next, I’m excited about that. And I hope that I get to be part of it in some way.

Richard Miles: 19:03

So one of the things we like to do on the show is we realize inventors are actually real people. And I’d like to hear a little bit about your background. I know you were raised in Florida up in Jacksonville, right? So tell us what you were like as a kid. Were you a good student? Were you a wild child? What was the deal up in Jacksonville?

Dr. Summer Decker: 19:19

Well, I’m sure that my school up there would probably say what they thought about it, but I was actually a very quiet student, very much a reader. I loved science a lot. One of my favorite stories is that my fifth grade teacher actually had us write out what we thought we would end up doing in our lives. And I remember some of my friends saying, I want to be a football player. I want to be a ballerina or something like that. And years later they actually gave me the letter. I wrote myself and it actually said, I loved computers. I loved computer programming and I loved anatomy. And so, yeah , and also I liked forensics at that age. I loved mysteries. I read mystery books, lots of Nancy Drew. And so here’s the little kid, you know, single digits. Are she writing out that somehow I wanted to be able to use computers, anatomy to solve mysteries. And my training is actually in forensics beyond that. So when I look at it now, I think I must have had some early idea that this could come at some point. But when I went to college, my field really didn’t even exist. So I have been back to my high school and to my elementary school and they kind of laugh that I was the quiet, very reserved kid. And so it baffles them, seeing me talking on stages, talking in interviews because I was very quiet, but I love what I do so much that I want to share it. And so, yeah, I was the kid apparently who knew what I was going to end up doing.

Richard Miles: 20:40

That’s pretty amazing. Most kids do not. They think they do, and then they get it wrong. It’s interesting. You did go into forensic anthropology and also Spanish. Right. But then you eventually made your way into medical imaging, radiology, 3D printing. Tell us a little bit about that path. Was it an early class that you took as a freshman that kind of awoken those desires to go into the medical field? Or what was that like?

Dr. Summer Decker: 21:00

So the area that I went into anthropology is called physical anthropology. And what I really loved about it was basically it was osteology or the study of bones. And so we are able as trained forensic anthropologists and physical anthropologists, physical anthropology covers things from fossils fossil record to ancient historical remains. And I specialized in forensics because I wanted to be able to answer forensic questions, more modern crime type questions. And in the course of that, I actually started working with the medical examiner in Las Vegas because I went to University of Nevada, Las Vegas, and working with them. I started becoming an autopsy technician. And so I assisted there and I talked to the pathologist there and I said, I love this. This is what I want to do. And they’re the ones who encouraged me to go to a medical school. They said, we really would love to see you at a medical school. And the other thing they also did was they told me that in the future, they really could see that autopsies would be done using imaging. And they showed me the news story of a group in Switzerland that was doing virtual autopsies or imaging guided autopsies. So they started making me run all the x-rays. So I started reading x-rays and learning that. And so once I graduated with my master’s in anthropology, I ended up coming to a medical school where they actually had a 3D team. And while I really loved the clinical medicine, I really did love the research side of it too. And I didn’t want to have to choose. And so I’m really excited to be a clinical PhD. And that means that I have our clinical practice and I do what we do with our cases, but I also get to do a lot of research. And so my area of specialty is actually forensic radiology. And I actually worked very closely with the Swiss team that they mentioned to me as a baby student. And so I go over and teach with them and train other pathologists and radiologists how to get in this field. And it’s such an exciting area to be able to combine medical imaging and pathology and 3D and be able to solve crimes and solve who people are. And so we actually have funding right now with the National Institute of Justice here at USF, to be able to help identify people using lumbar scans is so you imagine lots of patients have lower back issues. So you’re seeing just as much as teeth are seeing lumbar scans. And so we’re now able to use those scans to identify people.

Richard Miles: 23:15

You’re the sort of person, the TV show is structured their entire show around you’re the character, right? Dr. Decker say, get Dr. here stat, you pal around with this cast of MCIs, I imagine.

Dr. Summer Decker: 23:26

Erotically . I was there when CSI was developed .

Richard Miles: 23:29

Really. Wow .

Dr. Summer Decker: 23:30

I actually remember the day they came and talked to us about it and Las Vegas that there was this TV show. We actually laughed that nobody would ever watch it. We said, well, we are a bunch of science dorks who cares about us.

Richard Miles: 23:40

Yeah. Wow. Yeah.

Dr. Summer Decker: 23:41

And so some of my cases that I worked on there in Las Vegas appeared CSI. So for awhile , that’s how people knew me. But as much as I love the forensics, being able to help a patient walk out of that hospital, it really does make it worthwhile for me. So I love being able to do both.

Richard Miles: 23:57

So this whole career Dr. Decker is really just a way to get to Hollywood, right? You can just,

Dr. Summer Decker: 24:02

As I sit here in a room that I’m normally in the dark, but you know what I actually do tell the students is the software that we use, the tools that we use are the ones Hollywood uses. Um , one of my people worked with me, went off to work for Pixar. And so a lot of it is the same thing. So we actually do go to Pixar movies and see like, Oh, we’ll be able to use that. And so there’s actually in the history of Pixar, a radiologist was actually involved in that because it’s all image analysis. So when I was in college, I had the opportunity to National Geographic Show. And I remember thinking that was the pinnacle of my career because I really loved documentary film growing up. And now I use the same tools that they use for that to be able to answer medical problems. And so I tell my students here at the medical school, I play video games for a living. It just happened to be medical ones.

Richard Miles: 24:47

One pointless anecdote about National Geographic, one of our daughters intern there for awhile . And she said that they had two popular topics that just always sold way better than other ones. One was anything about big cats and anything about Alaska. They didn’t issue an Alaskan big cats. And it just like broke all records.

Dr. Summer Decker: 25:03

Ours was on mummies , but again, using medical imaging to work with the dead and being able to answer questions, using the tools that we have for our clinical patients, then looking at the ancient remains or even historical remains. It’s what we should be able to do to progress the field and understand how things have worked even in mummies .

Richard Miles: 25:21

So one final question, one of the corollaries of being successful as you have been certainly in the last year, but really your whole career is that people start asking you for advice. So tell us what sort of questions do you get say from your younger researchers or students and what kind of advice do you give?

Dr. Summer Decker: 25:36

Well, thank you for saying I’m successful. I’m one of those people that constantly doubts. And I think that’s why I keep pushing and pushing. And that’s actually probably what I tell my students when I came through school and you kind of touched on this, my field didn’t exist yet. And so I had people think I was crazy. Why do you like computers? Why do you like all of these things? And I don’t know why, but I just really loved that. And so when I tell students, you don’t know, you’re so young, you don’t know yet what is going to even be possible. So don’t get discouraged because I was told by so many people you’re not good enough and that you’re not smart enough for that mathematics or whatever. It came a little bit harder to me. I had to work hard for it. And so if it is something that you’re passionate about that you love, don’t give up on it because you never know how you might be able to help a pandemic because you had that vision, that idea, we know that our swabs over 70 million people have had them and 50 something countries. And if I had listened to the people who told me that I can never do this, this is crazy. That’s not really a field then that wouldn’t have happened. And what I tell people is honestly, stick with your passions just because it doesn’t exist now does not mean it won’t. And maybe you’re the one that’s actually makes that field. And so when I see people around me that are like-minded, it’s like finding your high, if your bees. And so being able to be around friends and colleagues that thought the same thing. Now , we were all kind of crazy. Well, now we weren’t so crazy anymore. And so that’s what I tell students. When you walk into medical school, a lot of times people think, Oh , I’ll never do that reading again. Or I’ll never do that video game again, or I’m supposed to be serious. Now don’t give up on those things. If you’re passionate about it, because you never know how that’s going to come back and help other people. So that’s what I tell people.

Richard Miles: 27:22

Well, great advice. And certainly you’ve done the state of Florida proud Jacksonville girl, ending up as a medical researcher in Tampa. So certainly have represented the state well, but we wish you the best of luck. Thank you very much for the work that you’ve done and helping us get out of this pandemic as hopefully we soon will be and look forward to new and exciting things coming out of your lab.

Dr. Summer Decker: 27:41

And I appreciate that. Thank you. And I’ll tell the team that too. I’m just one of many thousands. I know, but.

Richard Miles: 27:47

Somebody’s got to take the credit, right? I wish it was them. Dr. Becker. Thank you very much for being on Radio Cade. Thank you so much.

Outro: 27:56

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak . The Radio Cade theme song was produced and performed by Tracy columns and features violinist Jacob Lawson.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade and podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

Richard Miles : 0:39

Making virus testing easy, or at least easier will enable companies and organizations to reopen faster. As we enter the beginning of the post Corona era. Welcome to Radio Cade. I’m your host, Richard Miles. And today I’m pleased to welcome Dr. Timothy Garrett an Associate Professor and the Chief of Experimental Pathology at the University of Florida, as well as the founder of three companies, including Juno Metabolomics where he remains the Chief Scientific Officer. And he’s also a friend. So welcome to Radio Cade Tim .

Dr. Timothy Garrett: 1:06

I’m glad to be here. Thanks.

Richard Miles : 1:07

So Tim, I usually save the toughest question for last, but I’m going to cut straight to the chase. How does a guy who did his undergrad, the University of Georgia and up at the University of Florida? Cause I thought we had rules preventing that from happening.

Dr. Timothy Garrett: 1:18

There are a lot of social roles involved in that. But the short answer is that at the University of Georgia, I got introduced to a technique that allowed me the new area of study. And when I came to Florida and one of the top people in my field was here. And so I decided once I got in and this was a great place to go and we liked the warm weather and living in Florida, was attracted to that. So somehow they let a Georgia bulldog and to the University of Florida. And now I guess you can call me a true bull gator because I am a bulldog and a gator.

Richard Miles : 1:46

Well, I hope I haven’t blown your secret and they rescind your tenure or something. Anyway, we’ll talk a little bit about your background later, but let’s start out by talking about what it is that you have actually developed and why we invited you on the show. And so you’re an analytical chemist and you basically specialize in finding stuff and by stuff, I mean small molecules and where they come from. And if I understand correctly, you have developed a test that can detect multiple viruses, including variants from a single sample and better yet. This can be done in a portable lab for remote testing. So has obvious implications for the era that we’re in right now, which is sort of coming out of the coronavirus . But first of all, did I get that completely wrong? Cause you know, I got my degrees in international relations, which should scare you. So tell us what this test does, how it works and why it matters.

Dr. Timothy Garrett: 2:30

You got it almost a hundred percent correct. So good job. It’s a test that basically allows you to look at saliva, right? Isolate out instead of small molecules, isolate out proteins that are specific to individual viruses and that includes individual variants as well. And then allow you to measure those individual proteins in a portal style format. So basically in general, it’s a fairly simple process. We isolate the proteins and then we measure those proteins using mass spectrometry. And the cool part about the reason mass spec is important for this is it’s the, of the masses. Meaning that how much the proteins way allows us to really distinguish which protein it is and which virus it comes from. And that includes SARS coronavirus and the original one, as well as SARS cov two. And in Florida, we care about mosquito borne illnesses like Dengue and Zika and other ones. And it allows us also to see those unique patterns that allows us to really differentiate, which is which, and so the really cool part is that from that simple saliva sample, we’ll be able to diagnose what virus the person is infected with. And that would then allow us to really start treatment very much quicker rather than waiting for PCR, which would really only capture one specific virus at a time rather than what we could do is really just search the library and find out what’s there.

Richard Miles : 3:38

So if I get this correct, Tim is the standard of care. Now that in order to really identify whether someone’s got virus A or B or C or D do they have to have blood drawn and then that blood goes off to a lab and then that you get a result back a couple of days later, is that the current state of affairs or is a real breakthrough here, this one, the saliva test part of it rather than the blood. And is there a speed element involved ?

Dr. Timothy Garrett: 4:00

So you can test primarily as nasal swabs or saliva. Most of it was done with nasal swabs until we started thinking about saliva better. One of the key parts with current diagnostics is the use of PCR, polymerase chain reaction methods that are designed to target one specific part of a virus to amplify that signal, to really give you a really strong response. That means that you’re limited to whichever piece of the DNA or RNA that you start with to amplify, which is very specific. And so you need multiple tests for that. The real aspect of this is basically being able to look at patterns. So using pattern recognition approaches to save this as one virus versus another. And that really equates to speed. So you can take 30 minutes to prepare the sample and be able to measure all the viruses versus what you might have to do in a normal clinical lab, which is conducted 30 to 40 to an hour long run to identify a single type of virus.

Richard Miles : 4:50

If we compare this to say like a lot of people have done already, like the saliva based coronavirus tests, but in that example, right, if I think I’ve got coronavirus, I ordered a test , they analyze it. If I had another virus, would that test pick it up or not?

Dr. Timothy Garrett: 5:04

No, it would . It would not. So if you, instead of having coronavirus had the Zika or Dengue Fever, it would not capture that. And those have similar symptoms in some ways, headache and runny noses and those kinds of similar clinical symptoms, but you wouldn’t know.

Richard Miles : 5:19

So with your process, somebody could walk into the doctor’s say I feel lousy. I don’t know what I have. They take a saliva sample and then you could potentially look at a whole bunch of different potential virus.

Dr. Timothy Garrett: 5:27

That’s correct. Yeah. And we’ve started small on purpose to build libraries in a small way, but then it would expand exponentially really. And the cool part about it is it because it’s a library of information it’s easily transmitted to individuals who have access to measuring in this way, which is part of the reason why it makes it very portable because it’s really just querying a new database of information. And that database then provides the diagnostics.

Richard Miles : 5:50

So it’s really in that back analysis, the saliva, right ? Cause this is an Elizabeth Holmes type thing, right. Where you’re just taking one drop or something and saying, Oh, there are 87 different things wrong with you right?

Dr. Timothy Garrett: 6:01

Definitely not that, glad that you brought that up. That’s one of the biggest concerns with developing a test is following that route. But we look at small steps to make sure it works, with just one virus at a time. Right. And then once you do that, then you say, okay, now we can keep building upon that. And eventually, yeah, you could do hundreds maybe, but that would be way down the road. This sort of translates what we do for bacteriology right now in the clinical world for bacterial identification, we use similar approaches to measure patterns, to help us understand which bacteria you might have an infection. And so that’s running a sample and searching against the database to say, yes, we think you have this infection versus this one.

Richard Miles : 6:35

Excuse me, for asking basic questions. But is there any difference from a practical standpoint or an analytical standpoint when you’re working with saliva versus blood? I mean, imagine working with slides a lot easier, right? Probably the way you handle it and care for it and store it is I’m guessing magnitudes easier than handling blood. But in terms of the information that you get from saliva, are you just as good or is it one notch down from what you could get from blood available?

Dr. Timothy Garrett: 6:59

Saliva is just as good. And I had the same feeling you had initially when we started working with saliva, that it should be easier. But in fact, it’s 10 times harder.

Richard Miles : 7:06

Really ok, shows you what I know.

Dr. Timothy Garrett: 7:09

I didn’t either as an analytical chemist, it’s sort of a fairly new medium for me, blood we know a lot about, and we have a lot of processes in place to deal with how to process it and how to get rid of different components. Saliva has higher variability from individual to individual, meaning that how much water you drink might affect the concentration of saliva. It has so many enzymes that are designed to break down food that those enzymes can get in the way of measuring other species that , that aren’t enzymes like viruses that are present. And it still has the same infectious capability as blood does. And so if you get contact with saliva with viruses , so could have possibility of getting an infection. So from a perspective of trying to measure species that are in really, really low concentrations, the amount of other stuff present, causes a problem, Oh, and the other thing in our saliva, we have bacteria, right? The normal bacteria that live in a part of our gums in our mouth that are part of a healthy, as well as unhealthy mouth that are also confounding some of these issues. So you have sort of like a weird experiment that happens in our mouth every day when we eat.

Richard Miles : 8:08

But from a patient perspective, it’s much easier obviously, right? Because nobody’s faints from giving a vial of saliva where a lot of people are still nervous and myself included about getting their blood drawn. They really don’t like it. So at least from the patient, it’s probably better.

Dr. Timothy Garrett: 8:21

That’s a hundred percent true and it is easier to collect, right? Cause someone could collect a sample and drop it off rather than having to have a blood draw a thousand times much easier for individuals. And you can even send them a kit.

Richard Miles : 8:31

They sent it to you in the mail and then they just walk you through it online. Exactly what to do. There’s obviously been a lot of attention the last year on fighting the coronavirus and almost exactly a year later, even as we’re doing this interview about roughly 20% of the population, a little bit less has received at least one shot. And it’s amazing. That is, I think some people have missed the breakthrough or maybe don’t fully understand in the underlying technology of messenger RNA as a process to make the vaccine and what that could mean in treating other diseases. I know that’s not exactly your field, but is that as big a deal as I’ve read or is that just hype?

Dr. Timothy Garrett: 9:07

It is a big deal. Not only because of the speed at which it was developed, but the technology that’s in there and it opens up the idea of changing how we do vaccines in the future, right? So normally we have a live virus, right? That’s how you get the flu. The live virus has given you give a little bit of it that tells your body to react to the flu. And then when you get a real stimulus of the flu, you’re immune to that, that’s has some issues, right? In terms of growing it in terms of giving it to individuals, this one tricks your body in the same way to have an immune response, but uses messenger RNA as that trick. Right? And so now you can think about developing a flu virus. That’s not a live attenuated flu virus that could be used to in the same manner and then follow the same procedures and also potentially being a lot broader spectrum coverage then we get with the current life virus where we have to guess, which is going to be the biggest outbreak this year. So to me, as a scientist, looking at it, people worry about the speed of development. They have to sort of understand that all of that speed, we still went through all of the same clinical trials. It just went a lot faster because we had the money upfront to get people in the trials and do this trial as much faster than it would normally take. But the science behind it to me is exciting. And the next four to five years and how this is used is going to be another phase of neurology.

Richard Miles : 10:16

Right. And if I understand it basically with the messenger RNA, you can basically trick or command your body, whatever verb you want to use into producing almost any protein that you want it to produce to fight off or handle a lot of different types of pathologies or diseases. And that is what has got researchers super excited. Yeah .

Dr. Timothy Garrett: 10:32

Yeah. Some of the concerns was keeping it stable, right. And that’s the only real concern right now is making sure that it doesn’t fall apart or degrade, which is why you have to keep it that cold temperatures, but we’re going to solve that and Johnson and Johnson’s one came out and that somewhat solves that issue without worrying about cold storage. But yeah, and it’s tricking your body using a way to really hone in on a specific response is really intriguing. How we then grow from here is something, I think the scientific community is really gonna learn a lot from in this phase, but also in controlling other viruses.

Richard Miles : 11:02

Yeah. As bad as this year has been for coronavirus . And certainly other people that have died has been a tragedy. Ironically, historians may look back on 2020, 2021 as making this huge breakthrough in treating, not just coronavirus, but other types of diseases and viruses that even five years ago or 10 years ago, if we’d been talking about trying to develop a vaccine inside of basically a year, less than a year or 10 months, that just would have been on the level almost of scifi .

Dr. Timothy Garrett: 11:26

Exactly. And then also scaling it up and then manufacturing, not just developing but manufacturing yet at a high enough level to get people, even if we’re at 20%. Now we really only started vaccinating people in late December, January, right?

Richard Miles : 11:38

The first few weeks is pretty chaotic if not incompetent. And so really a ton of the vaccination have taken place and probably the last four weeks or four to five weeks.

Dr. Timothy Garrett: 11:46

Exactly. And you’ve mentioned something about the scientific part of it to me as a scientist, when the world sort of stuff went on different lockdowns, depending on what state you were in, the scientific community , started digging through the science really fast. We had some more time on our hands because we couldn’t sit in our labs and do experiments. So we started looking back at old papers that maybe we had to study before. And so what we saw then after that two month hiatus was after that you saw an explosion of scientific discovery, which to me was really fascinating to see. And if you look at the bio archives where people publish early work, you can sort of see how many COVID related publications came out from people who aren’t even studying viruses in the past that sort of got interested in thinking about a problem in a new way. So the scientific discovery, I think from this is one of the very interesting things to see, and then what comes all through this and what generation of scientists tackle this in a different way .

Richard Miles : 12:34

That’s a great point. So let’s move from science to the world of business, like a fair number of researchers you’ve taken several of your technologies or research that you’ve done informed several companies and every story is different. So let’s hear yours, what, or who gave you the idea of commercializing some of the technologies and how are these companies doing?

Dr. Timothy Garrett: 12:54

Commercializing really comes from me within and from other people that I’ve learned from the idea of taking something that you develop as a scientist and then write a paper on, but then also deciding how can we help communities with this? How can we design something that not only has good scientific background, but also can be implemented somewhere that helps us grow it as a community. Part of that, of course, the Cade. Robert Cade was a key part to see a scientist who’s working at the University of Florida, right? Developing a product that then becomes something that people really use and need in many different ways, whether there’s a , for normal healthcare , but also just for sports management. So seeing another scientist go that route is a way that I’ve really enjoyed trying to solve the right problems in a way that balances being an academic, but also trying to be an entrepreneur. And so with this new company that we’re in is only a couple of years old. It’s still growing as a company with not just the virus. In fact, we didn’t start it as a virus based company. It started as an analytical testing company for metabolomic measurements and performance, right? Measuring performance enhancement and understanding that how we can improve individual’s recovery and those kinds of components that go into management of athletes. And then when we couldn’t do that research for a little while, we moved on to thinking in new ways and how we could use the knowledge of the company to help and the virus space. And my background is a scientist.

Richard Miles : 14:08

So Tim, sometimes as you well know, the world of basic research and academia is quite different than the world of startups and entrepreneurs and venture capital firms and so on. How did you negotiate that transition? And what do you notice in terms of those two different universes?

Dr. Timothy Garrett: 14:23

So speed is one of the first things academic research is fairly slow and partly because you have to find funding right through different areas. And so you ended up having a much slower pace. And when you switched to a corporate or company based work, do you have to be much faster in terms of implementing something and coming up with a solution faster and you can’t necessarily do that without compromising sort of the science behind it. So part of it is making sure you have the right funding in place fast enough to hire the right people, to help those right problems, putting my academic hat on. It’s harder to make that fast paced translation for me. And so relying on others that we have in the company to help move that at the right pace is really what I’ve found to be the most beneficial part. Because training me is sort of like training a dog, a new trick, right? It takes a lot longer to train something new. You don’t end up keeping your old tricks. So really finding new people is one of the key benefits to me.

Richard Miles : 15:13

The Cade Prize competition, we talk to a lot of folks who have done exactly what you’re doing in terms of moving their technologies to market. And several them have commented that the first shock was mostly in academia. And I know I’m generalizing here, but particularly in research, you work on research for a long time. You make a breakthrough, you publish it. You might go to a couple of conferences and talk about research and people applaud and go great job. And then you’re off to the next research, right? You’re sort of done, you’ve published your paper. And they’re shock was when they take this to market and investors go, yeah, that’s a great idea, but who’s going to buy it. Who’s going to pay for it. How fast can you produce it? So they all acknowledged the idea is great and that’s not really the benchmark anymore. Good idea versus bad idea. It’s good idea that can also be manufactured and sold. And that was a cold bath for some of these researchers. Who’ve never had to deal with that before.

Dr. Timothy Garrett: 15:59

Yeah. And you’re sort of right. We do the research. We eventually published a paper on it and we talk about it. And then we think about the next research project. Can we sort of encapsulate that this is a publication from the work and go read it and we might often stop there versus yeah. The industry part is, okay, now this is a cool idea, but is there a market for it, right? Or is there protection for it, right. Maybe that maybe you don’t have protection. And we run in this space in biomarker discovery all the time. You find a new biomarker, they’re very difficult to protect. And so when you think about a company, you can still use a biomarker, but you might use it to develop the technology to measure that biomarker. And that would be then how you might translate a cut to make a company successful, putting that mindset on. It’s like, okay, this result has a high percentage of being successful in terms of diagnostic of patients. So how can we then translate that to making a product that works and that makes money and that also provides value to the community. Right? And so one of the hardest parts for me is really that part of taking that research idea and really thinking about what it would look like in the marketplace and not all of them will work that way. And you have to sort of bounce those ideas off of colleagues or friends or people that you think about to say, is there really, truly a market for this? And then find investors that might be interested in sort of helping you translate that to something that they might envision as a different route to it. So I like the publication part, but I also really like trying to see if it really will make a dent. And to me, healthcare is a big part. So healthcare.

Richard Miles : 17:17

That’s what a lot of people say is it gratifying as a recognition is from colleagues in the academic world. It’s knowing that the technology, the research is actually helping people. And the only way that really happens is getting it to market right where it can help a bunch of people. And that’s really provides a lot of satisfaction,

Dr. Timothy Garrett: 17:33

Right? And often our studies are on cells or on other kinds of systems and not on say human samples. And so really you have to see how it works testing in humans to understand really, will it have any impact in the same way that it has in normal laboratory setting .

Richard Miles : 17:46

So Tim, at the beginning of the show, we talked about you did your undergraduate University of Georgia, but you actually spent your childhood in the Midwest and your dad also was a chemistry professor or a researcher and a lead scientist at Owen Corning’s fiberglass. But when you entered college, you told me you wanted to be an English major, but then chemistry found you. So first of all, what happened? And secondly, was there any evidence when you were a kid running around with four siblings, right. That you would be a top scientific researcher, did that just sort of come out of the blue?

Dr. Timothy Garrett: 18:15

If you ask my siblings, there’s no evidence whatsoever.

Richard Miles : 18:18

They’re still looking for it. Right.

Dr. Timothy Garrett: 18:20

They’re looking for it. Yes. And I’m the youngest of four. I’m a twin though. So I’m the youngest by three minutes. And so as a kid, I struggled in the beginning with math. I didn’t do great about in middle school. I didn’t really come into understanding what I was really good at it until college. So I sort of was just a normal high school kid, did the normal stuff and I have good grades here and there. I did like science and I knew stuff for my dad. I got to visit his company and see sort of stuff he did, but I didn’t really quite understand it. And so you’re right. That chemistry really did find me. And the only reason is because I had to take chemistry because at Georgia, I was in college of liberal arts and sciences. And so I have to have a scientific program. So I was like, Nope, chemistry. I’ll take that. I can ask my dad any questions if I don’t understand them. And then I took it and I really enjoyed it. I didn’t think I would enjoy it. So then I had to take another general chemistry. So I took that and then I still was an English major or thinking about being English, which doesn’t make any sense to me nowadays. But then it made a lot of sense, but I do like reading and I do like writing, but it really wasn’t until I took organic chemistry. And a lot of people will tell you that organic chemistry is sort of cutoff points for both people, whether you like it or not. And so I took organic chemistry and I loved it. I could visualize the molecules in my head. I could really make connections that I didn’t think I could ever see before. And so it really was connecting what was on paper, putting that three-dimensional figure in your head of a molecule coming together or the shape of a symbol , like cyclohexane ring, whatever. And that part was so fascinating to me that you could then see what it looks like, but then also make reactions happen. Right. And then make products from that. And then the last part was doing research in college. Right. And then figuring out like it take one a, the size of a needle, a sample type, measuring what’s in that. And you can measure what was in that. If you just look at your pencil for a second, that’s smaller than that we can measure. Right. And that’s the , wow. You can really measure that amount of material and come up with an answer was pretty fascinating.

Richard Miles : 20:08

I’m guessing that your dad was quite pleased, right? His , his kid goes off to college to be an English major and comes back as a chemistry researcher. Right. He must have been quite happy about that.

Dr. Timothy Garrett: 20:17

He was happy, but he kept pushing me into polymer chemistry because that’s what he did. And so he wanted me to go that route cause he didn’t really quite understand what I could do with analytical chemistry right away. But definitely he was encouraging a hundred percent of the way. And I learned a lot about how to do science or how to think about science from him and got to sort of bounce ideas off of him because he could understand what I was trying to go through in grad school and trying to understand different parts of it. He could really help me think through scientific discovery and because of his background, even though it wasn’t the same field, he still sort of had that training and knowledge to help a lot on the way.

Richard Miles : 20:48

Right. Well, it’s funny you had the opposite experience that I did. I was actually fairly good at math in high school. And then I got to college. I took my first advanced calculus class and just completely wiped me out. And I said to hell with that, I’m doing international relations. So, but , um, but my daughter became a math major. So it skipped a generation. So maybe your kids will be English majors Tim, theres still hope.

Dr. Timothy Garrett: 21:07

There’s hope that they could be there. That’s that would be awesome. Yes. I totally support them whatever they like to do.

Richard Miles : 21:12

So Tim, you also told me earlier that research is hard and that experiments don’t always work out. And one fascinating thing is you said, what you have found at least is at rest is really important. So can you expand a little bit about that? Because I get lots of rest. But I’m not working on any pathbreaking technology. So I feel like I’m doing something wrong. So what is your secret?

Dr. Timothy Garrett: 21:31

Well, we sometimes get stuck thinking the same way all the time. I’m thinking about the problem , the same way all the time, because we either have our mindset that this is the way I’ve done it in the past. And it always works this way. And I continue to do that and we reach a part in research when you don’t know what the next experiment is, or you don’t know what the result means. If you keep trying to plug away and trying to just run experiment after experiment, you’re not going to necessarily come up with the answer. Right. But I look at it as is, you have to forget about it . And the reason you have to kind of forget about it is if you read a science fiction novel, or if you read something unrelated to your field, that you might get this ding that comes off that says, wow, that’s cool. And think about it in a different perspective. It’s like, well, I’ve been thinking about it this way for the last six months. What if I just do this? And you might just get a clear mind and my wife is an artist, right? And so part of that comes from seeing an artist think and seeing how an artist takes a lot of time and energy to go through many things in their head draws, sketches, and then trying to really balance between science and art to me has been part of that rest. Right? So turning off my scientific mind and just thinking non scientifically for awhile helps me think about new ways. And that then might be the next experiment that you designed, that you could then write it out on a napkin because then all of a sudden you think this would be a cool experiment to do, and I need to do it. And then you still have the knowledge to know how to do the experiment, but you’re just started from a different perspective.

Richard Miles : 22:47

I understand that rest of you is a relative term. You have a young kids at home and a creative, energetic wife who I feel your pain. She’s usually volunteering you to do things to him that maybe you don’t want to do, but you’ve got to do them anyway. But it’s interesting what you say because a lot of brain researchers have said that there’s creative sparks come in fact, when we do relax our brains , so to speak and we take our hyper-focus off of our, our subject area and we stand back a little bit. And then like you said, as an artist maybe stands back from their painting, they’re able to see something there that they didn’t see before. So you’re definitely onto something.

Dr. Timothy Garrett: 23:18

Yeah. I’m and to me it’s been the most beneficial parts are just taking a walk right outside and just looking at nature and not really contemplating anything, except it’s talking with a friend or just looking at the birds or here in Florida, looking at the alligators and then you see something or it reminds calm enough to see through the problem. And I think that calming part is really what we sort of miss. Sometimes this high stress high speed environment, you have to have a calming force to really put pieces together. And I deal with data sets that have thousands to hundreds of thousands of features, right. Or signals. And we have to try and make sense of those and that you can’t physically do that without having a relaxed kind of approach to it.

Richard Miles : 23:57

Very well said, Tim, and really have enjoyed having you on the show, wish you the best of luck with your research and also your companies. And look forward to having you back for an update.

Dr. Timothy Garrett: 24:06

Thank you very much for being a part of this. This is a great thing, and I’m glad that we could spend the time together talking.

Richard Miles : 24:11

Great. Thanks Tim.

Outro: 24:13

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. Richard Miles is the podcast host and Ellie Thom coordinates inventor interviews, podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak . The Radio Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

Dr. Peter Khoury, is the President and CEO of Ology Bioservices Inc.  He is an expert on vaccines and biologics and during his 30-year career, he has worked for the Bill & Melinda Gates Foundation, Merck, and Baxter International. Dr. Khoury has involved in international forums on vaccines, pandemic planning, and biodefense preparation, including working with the Olympic Committee.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade and podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida, the museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

James Di Virgilio: 0:39

Welcome to Radio Cade . I’m your host, James Di Virgilio. And today we are bringing you a special episode. It is part two of the, everything you need to know about vaccinations and COVID-19, it’s been almost a year since I last spoke with Dr. Peter Khoury, you can catch that episode anywhere you listen to this podcast. Dr. Peter Khoury is the president and CEO of Ology, Bioservices, he’s an expert on vaccines and biologics. And during his 30 year career, he’s worked for the Bill and Melinda Gates foundation, Merck and Baxter International. Dr. Khoury has been involved in international forums on vaccines, pandemic planning, biodefense prep, including working with the Olympic Committee. Dr. Khoury, welcome back to the show.

Dr. Peter Khoury: 1:20

Thank you, James. And it’s unfortunate. We can’t do it in person. Certainly. I’m sure you, myself and others are so used to doing teleconferences and Zoom calls. So we’ll see how this goes. And hopefully you can hear me well.

James Di Virgilio: 1:35

Yes, we can. We’ll make this work last time. In our first episode, of course we were together. We were in a large room sitting far apart, but it is always great to have, of course, the person you’re talking with in front of you, like all of the listeners know and understand as well. So since the last time we spoke, a lot of things have changed, but really a lot of things that you had talked about on the first episode have essentially come to pass. You mentioned there’d be a potential small wave of infections followed later on by a much larger wave of illness that certainly happened. And then we got into the discussion, which is really going to be the crux of our discussion today of essentially game theory and viruses, which again, viruses are smart. They react, they change, they have different strands. I think a lot of the public across the world has learned about these things. And how do you deal with them? How do you stay one step ahead. So let’s open up now with that in the background and ask you sort of this big question, looking back now, what happened that maybe you didn’t foresee the first time we spoke?

Dr. Peter Khoury: 2:29

There’s a couple of things and they, I guess aren’t really biology related, but they really did make an impression on me and were something I did not foresee. The first really was the amount of compassion and caring that people show when they’re in uncertain circumstances. It did once again, show me that compassion is an inherent trait and caring helps ease the burden. A pandemic can cause think about the long hours and risks that healthcare workers put themselves in, especially at the beginning of COVID-19. And there was so much unknown in so many people being infected and to be an emergency room nurse or physician at that time, and having to put in those long hours and put yourself at risk and your family at risk and not really sure if one mask or two mask or a shield or what exactly was going to really protect you, but they came in for work day after day, policemen, firemen, emergency workers, all of them. It’s amazing for them to really take care of those who had severe cases of COVID-19. So I think that’s the first thing that I didn’t really foresee that there would be that kind of positive response. And so many people that really took up caring for others. The other thing that I didn’t foresee was the ability of people who may otherwise be intelligent to actively ignore the science and the data. And instead believe what I thought were ridiculous, conspiracy theories and false information generated by self-proclaimed experts whose credentials are measured by the number of people who follow them on social media. So I was surprised by that, that otherwise people that I thought were pretty intelligent would trust that for their information instead of the experts in the field. Actually, there is another thing, a third thing that I didn’t really foresee a year ago, and that’s really how different people’s tolerance for being inconvenienced and then their mental calculation of the risk and reward removing something that is inconvenient. So simply stated their reasoning for justifying doing something that increases their risk . I happen to live out towards one of the most populated Springs in the area. And it was amazing during the weekends of this past summer, the hundreds, if not thousands of people that would go to these Springs and no mask, no nothing, whole family. And they would put themselves at risk. And it’s hard for me because I wouldn’t do that to actually see that. And now here we have, I think at least two States, Texas, and Mississippi that are basically taking down everything, no mask, full restaurants, everything back to normal, and I’m afraid. We’re just going to see another huge wave from this. So people need to understand, yes, you’re going to be in convenience for awhile , but that’s the only way to stop spreading a virus like this. Or of course, get everyone vaccinated and protected at least to a number where you get protection of the movement of the virus amongst a population.

James Di Virgilio: 6:05

Yeah you mentioned an interesting narrative there with listening to experts and in my own field of investing, I like to tell people all the time, if you ask me questions about investing, I can speak as an expert in the past. This is why this strategy worked here are the data sizes and samples. Here’s the research done here. So we know it’s worked in the past. Here’s, what’s likely to work in the future, but if someone asked me six months from now, what exactly is going to happen in this market or this investment? The only right answer is, I don’t know, and neither does anyone else. And there seems to be some confusion between experts that know how to speak on things that have occurred, that they’ve witnessed and people making prognostications, using whatever kind of modeling, either simple, or as you mentioned, an opinion that comes from your mind and gets put onto social media, prognostications are difficult, but the hard data, the data we’ve observed, the data we know to be true of course tells a different story. And that I think is what you’re looking for. Obviously in a free society for people to begin to clean to what is the truth are things that we’ve observed before. So let’s set the stage for vaccinations. In general, last time you had mentioned, there’s essentially five main ways that you can create a vaccine to overly simplify and with Corona virus with COVID, we have essentially not used all five of them. If you could kind of walk through the landscape right now for the vaccines, we have the ones that may be worked on, and then we’re going to walk through them because I know that’s a huge question area for most people. Should I get an mRNA vaccine? Should I wait? What’s the difference? Is it risky? So if you could set that landscape again, what these vaccines are, and then we’ll dive into each one and give everyone out there a good chance to grasp what the differences are.

Dr. Peter Khoury: 7:41

Sure. And I have to admit, I didn’t listen before this, to what I had said a year ago, but there are tried and true methods for making a vaccine, whether it’s a live attenuated vaccine, where they take either a virus or bacteria and they make it. So you have, what’s called a subclinical infection where you don’t really get sick from it, but your body responds as if you did. So you produce antibodies and an immune response to this modified bacteria or virus that’s been attenuated, or sometimes you just kill it and put it in hall in the person. An example is at the early days of vaccines, the very first one was a smallpox vaccine made with Cowpox. And they realize that milkmaids were not getting serious cases of smallpox it’s because they were infected with cowpox, which was a milder version. And that’s sort of like an attenuation in a sense. And so then they were able to take that and literally just bake it or whatever you want to do to kill the bacteria and use that. Then as a virus itself, you can also put it in a mixer and slice it up and you have a bunch of small pieces of a virus or a bacteria. And I say a mixer. It’s nothing like that, but you get the idea of slicing it up and in your body sees that as foreign. And it can develop an immune response to that. But the vaccines that are now on the market actually use newer technology, which really is ingenious. And unfortunately people fear mRNA’s or DNA and they think, Oh, this is genetic engineering. And they’re putting something into me and it’s integrating into my chromosomes. And I don’t know, the government can track me because of that. And it’s nothing like that. Really. If you look at it in the science behind cell biology is just amazing what each of your cells can actually do. And it’s really using that mechanism as a small factory in itself. So I think most people realize there’s a third vaccine that was just approved by the FDA, by a company. You know, them as Johnson and Johnson, they have a subsidiary called the Anson, which is out of the Netherlands, their vaccine portion of the company. And so this new vaccine just came on the market. It’s given us a single dose and the other two, which had been around now for a few months, the Pfizer in Moderna vaccines, those are really two dose vaccines. And so the Pfizer Moderna vaccine utilizes this manufacturing platform that you mentioned, which is mRNA or messenger RNA. What they do is they have this piece of genetic material that in a sense codes, it’s the recipe, for what’s called the spike protein or part of the spike protein, which is part of the Corona virus. And they encapsulate it in like this fatty particle. So it’s called a VLP. And so inside this, let’s say glob of fat, little glob of fat is this little piece of genetic code. Well you’re cells need energy. And so when they see that they use that for energy, this gets injected in your arm and your cells in your arm , see that those fatty particles and they start sort of sucking them in for energy use. And as they suck them in. And the middle is this little piece of genetic material, which is the messenger RNA once inside the cell . Well , your body has all the mechanisms to take that recipe, which is in a sense listed on this piece of messenger RNA and start producing the protein it’s encoded in it, which is that spike protein. So that spike protein is then released from yourselves and other cells. See, it may say, Hmm , that’s not part of our body that’s foreign to us. And so it generates immune response by your other cells, by your immune cells. In those remember seeing that particle after it eats it up or whatever. So it sees this spike, protein decides it’s foreign to your body. The immune cell then ingests that, but it remembers seeing it. So if you’re ever infected with a virus, your body immediately elicits an immune response. You don’t even know you were infected because antibodies instantly take up the Corona virus that you’ve been infected with. And that’s how you’re protected by that type of vaccine. Johnson and Johnson vaccine actually uses a different type of technology. They use what’s called a viral vector in what that is. It’s a virus, the one they use is called adenovirus, 26. It’s basically a virus that’s similar to what the common cold viruses is. They genetically engineer that. So it can infect cells, but it won’t replicate inside the cells. So it can’t spread throughout your body and give you any kind of infection or whatever, but it does have inside of it , the genetic instructions like that recipe again, to make that spike protein that is used to elicit an immune response. So instead of being carried in these little fat or lipid balls, the genetic instructions are injected by that weakened virus into the arm cells. And then they make that particle, which is the spike protein of the Corona virus. And that again is identified by your other cells as being foreign in your body. And it elicits the immune response. So that’s sort of the mechanisms for the three different viruses. Again, hearing that people consider that genetic engineering, you know , I just want to set the record straight. There is no modification of your genetics or of the virus genetics. So what is happening is, as I said, it’s truly amazing. If you think about that, the cells in your body, which have all the machinery to make any kind of protein, it has the recipe for that’s what’s included on your chromosomes are all these recipes for proteins that make your eyes a certain color and your hair, a certain color, et cetera, all it’s doing is simply introducing a new recipe, which either is delivered by a harmless virus that won’t replicate or that’s provided in like this little energy bar, these little lipid fat balls, and that recipe delivered uses the cell machinery to make the part of the spike protein that causes the immune response. Sorry, that’s a long-winded answer, James.

James Di Virgilio: 14:41

No, it’s a good start. So mRNA founded in 1990 or so essentially by a Hungarian scientist, she had this novel idea and then all the way up until COVID-19 was never used or approved. Should there be concern that it now for the first time is being used in a vaccination that is going to be used worldwide. If it’s never been used in the real world before.

Dr. Peter Khoury: 15:04

Now, it really should not be in the reason as is it does not modify your genetics at all. It literally is just, as I said, use the mechanism of your cell to produce a protein. I’m trying to think if there’s any other comparable in either veterinary medicine and nothing’s coming right to mind. But as I said, it’s not genetic engineering by any means. It’s literally putting a small piece of messenger RNA, which is normally in your body. So your chromosomes, which are DNA are transcribed into messenger RNA, which is read to make the proteins, this just skips the DNA part and goes right to the messenger RNA.

James Di Virgilio: 15:47

So we don’t have to worry as the public, as far as we can tell scientifically that this is going to turn into something that’s going to alter body chemistry cause sickness down the road have any longterm effects. As far as anyone can tell. There’s nothing about these MRNs current vaccines that we should be afraid of.

Dr. Peter Khoury: 16:03

Right. And it’s new technology. You really can’t tell the future. All indications are that it’s very safe in very efficacious. The amount of clinical studies that go behind products like this before they’re released is truly tremendous. I think that there would have been clear indications as they were either studying this technology early on or as it gets further on and goes through the phase one phase two and finally phase three clinical studies that there would have been warning signs that there were problems, but certainly none have arisen yet with this technology. And if you think about it, theoretically, there really is very little, if anything that could rise from having this done, but you never know until time’s passed.

James Di Virgilio: 16:55

Right? The famous French economist in the 1840s, Frederick [inaudible] would talk a lot about unintended consequences of whatever you put in place in society. There are always unintended consequences that you cannot foresee, but scientifically it is good to note like you’re mentioning as far as anyone can tell scientifically this is not injecting a large risk into your own body. It is not altering genetic code, as you mentioned. Um , and that that’s , that’s something to hang on. So now let’s talk about something more nuanced. So we have two mRNA vaccinations that are available. Obviously big advantages are it’s much faster to bring them to market logistically before we get into the other ones. Are there any hurdles with an mRNA vaccination logistically with regards to freezing or refrigeration or transport that maybe would give a more traditional vaccination at advantage and delivery and rollout ?

Dr. Peter Khoury: 17:41

Yeah, actually there is. I know with the mRNA vaccines, as far as the fats surrounding it, the VLP structured itself needs to be kept at low temperatures. So would that Moderna and Pfizer vaccines, the storage in shipping was between minus 80 centigrade minus 60 centigrade. So that’s minus 112 degrees Fahrenheit to minus one 76 Fahrenheit. So that caused a lot of trouble at first for States or for injections sites and clinics because they didn’t have those special freezers. We have them because of the work we do here, but they’re just not readily available. People don’t keep these in physician offices , et cetera. But what they did do is immediately started looking at temperature changes and how long the vaccine in a sense could survive at regular refrigeration temperature or in a freezer, regular freezer. So the FDA did ease up on those requirements, but even now that vaccine still only can be held in a refrigerator for five days and then must be used within six hours of being thawed and diluted. So there is a small window, and it’s because of those VLP that ball of fatty acid , that carries, that, that makes it. So you have to have careful handling per both the Johnson and Johnson vaccine, which uses the adenovirus actually can be kept at refrigerator temperatures for up to three months. So it’s far easier to store and ship because of that. Another difference between these one, as I mentioned is a one dose vaccine and that’s the Johnson and Johnson vaccine in the Pfizer and Moderna, the vaccines are both given as a two dose series. Obviously giving one dose is much easier since there’s no follow-up visits, which involves making sure the person in the vaccine are there at the right time for dose number two. So coordinating all of that goes away, where if you do have to come back for a second dose with the Pfizer/Moderna vaccine, you obviously have to coordinate it. So the person and the doses they’re at the appropriate time to administer at , but there are clinical studies were done a little differently. So when you look at the efficacy of Pfizer and Moderna, those vaccines had a rate of effectiveness during the clinical trials of 94 to 95%. So that means that they vaccinated people and they looked for antibodies production. In those people. It makes sense . Every hundred people that we vaccinated basically 95% over, I think it was four weeks had developed immunity by , in contrast with the Johnson and Johnson or the Yansen vaccine, they said it was 85% effective against severe disease and a 100% effective at preventing death. So during their clinical trials, not one person who got the vaccine. And I think there were 44,000 died from COVID-19. And I think 100% didn’t even go to a hospital. There were some people that did have severe disease about 15%, and there were people that had what they call moderate to severe illness. So that would be in a sense they were home, not feeling well, et cetera. So it’s hard to compare apples to oranges. In this case, since one was a two dose vaccine looking purely at efficacy and production of antibodies in the other was a one dose looking at severity of illness. So getting either vaccine is a great thing to do. If you get the one dose vaccine, you don’t have to go back for a second dose, but there is some chance that if you’re exposed to COVID, you may get a mild illness from COVID. And in fact, there’s a lower chance of only 15% that you could have a severe illness from that. We don’t know if you’ll die from it, but for the 44,000 people they had in their clinical studies, I think it was 44,000. None of them died from illness. So I think those really are the main differences. There’s a little difference as far as how quickly you’re protected that Johnson and Johnson vaccine works about two weeks after people get vaccinated with Madonna and Pfizer people don’t get full protection until about two weeks after the second dose. And the second dose is usually three to four weeks after the first dose. So from the very first dose, you’re talking five to six weeks after the first dose and you’re fully protected.

James Di Virgilio: 22:53

Let’s bring this down to the granular level now and get to a decision point. So let’s assume, and I’m going to throw a fourth one in here with Novavax, which may or may not come through, but it’s another different type vaccine just to give us the thought experiment of being, let’s say late August, you haven’t had a vaccination yet. And you have this choice in front of you. You essentially have the mRNA, which you’ve mentioned is Moderna and Pfizer. You have Johnson and Johnson, and then you have Novavax, which is going to be one of the most traditional and time-tested vaccinations. If it makes it again, we’re speculating here, just to give an idea of what this may look like, and you have a choice. Does it matter Dr. Khoury, which one you choose? Is it simply saying, you know, it doesn’t really matter. Take either one of these for convenience or one you can follow through on, or is there a more educated decision that needs to be made if you’re facing a choice between these let’s call them three different vaccine deployments,

Dr. Peter Khoury: 23:44

Right? Of course, a choice like that is personal on whether people want it to be vaccinated or not. I would say that the first hurdle is get vaccinated. There is no doubt that vaccination protects you when it comes to the choice. And there are so many people in videos, out of people, literally on their death bed, dying of COVID by themselves, in a hospital saying, I wish I had not gone to that party. I wish I had done this or that. You may think you’re otherwise healthy, but you’re playing Russian roulette with something that impacts people in very different ways. Even though they think that I’ve never been sick in my life, this couldn’t impact me. You would be surprised at the number of younger people and other people that get this disease and either suffer long-term consequences from that, or truly die within a few weeks of contracting the virus. The question is if you had the choice of vaccines, which one based on the technology used would be better. I always tell everyone if it’s been reviewed by the FDA in the United States or the other one is the Korean FDA. Korea has an incredibly competent FDA based really off the US FDA and both are very, very good at looking at the risk and rewards of every vaccine, European union, also very particular and conscientious about looking at the impact of vaccines. So I would say that if it’s been approved by the FDA in the United States, it’s a safe and effective product . So if Novavax does get approval, I would not hold back at all on getting that vaccine versus either Moderna Pfizer or the J&J products. All of them are winners. If you get at , if you’re needle shy, obviously you may want the one dose versus the two dose. So there may be some advantages mentally for you there. If you want to make sure the odds of being protected the best look at efficacy after two doses, it’s much higher than it would be after one dose. But again, all of them are safe, effective vaccines, and the technology makes very little difference in this case.

James Di Virgilio: 26:12

So the take home there is assuming that they all have FDA approval and you have that choice. The reality is you don’t need to spend a ton of time researching which one to get, because the odds are, all of them, of course are going to work for you. And there’s just different sort of personal mechanisms. Like you mentioned one dose or two things like that. But right now there’s not a significant difference that should have you necessarily favoring one over the other. If you’re looking to get a vaccine.

Dr. Peter Khoury: 26:37

Right. Just based on the last sentence you mentioned, I’m not sure what the composition is of the vaccine that may come out later on this year, but I know the Moderna, the Pfizer, the J&J vaccines do not have adjutants in them. So in they’re not produced like an egg. So if you have an allergy to eggs or egg protein, it’s no issue with these vaccines. If you have been issue , there’s what are called adjuvants, they help boost the immune system with certain vaccines. None of these have this. So they’re pretty pure vaccines. Some of the older technology you’ve had to use either a chicken, eggs, or hens eggs to produce the product. I think the one you had mentioned is a Viro cell product . So it is not produced in, in hens eggs, but some of that older technology does use adjutants and other things, which is that chemical treatment. So some people have had reactions to that in the past.

James Di Virgilio: 27:39

To look for individual things that maybe you yourself have an allergy to, or , or some reaction to, but all in all, if it gets FDA approval at this stage, it’s gone through the rigors. And if you want to get a vaccination again, no need to sparse out exactly which one to get. The differences are not going to be, as you mentioned significant, despite the fact that they are in fact different delivery mechanisms. Now let’s talk about different variants. This has obviously gotten a lot of news play here. When we first talked, we talked about how stable COVID-19 was. Uh , we also talked about, of course, the fact that virus has changed and that we could expect COVID-19 to change. We just didn’t know how yet, given what you’ve seen with the variants . And we know we’ve seen numbers, Johnson and Johnson is almost 70% effective against variants. Each one of these is a different number. What is this variant landscape look like to you? And I know you don’t see the future, but as of right now, if I get a vaccine tomorrow, do I have decent protection against the variants we’re aware of right now?

Dr. Peter Khoury: 28:32

Yeah . It’s important that people get vaccinated as quickly as possible because the quicker we can shut down the circulation of this, the chances of it mutating in doing what I had talked about is drifting and shifting gets eliminated. So through replication, that genetics change is virus adapt to their surroundings, just like humans do. If you look back at Neanderthals and us you realize that certain people are born with traits that allow them to survive better. In certain circumstances, that’s true with virus and bacteria. It just happens thousands and thousands of times faster than we replicate. So literally in 24 hours, virus have gone through 10,000 fold replications where humans takes nine months to birth out a baby. And it literally happens so fast that these genetic changes in that adaptation to your surrounding can happen very quickly. And as long as those changes have little impact on the spike protein, that’s a protein has been utilized by all manufacturers that I can think of as the target for the immune response, then really vaccinating now should protect you against most of the variants. The variants, it wouldn’t protect against would be ones that have totally shifted away from that current spike protein configuration. So if there’s a little drifting away that protection will go down a little bit. Some people won’t be protected as well, but if there’s a major shift, it doesn’t provide any protection. Now you don’t know if that’s going to happen. I talked to other people that are experts in the field, and some believe what’ll happen is this’ll become like the yearly flu vaccine that will be able to see the shifting happening in other parts of the world. And people will just change the messenger RNA or whatever it is that’s coding for the latest variant that’s circulating around the world. And then a few years later, if it changes again, you need to get another dose of vaccine against that. I’m hoping we don’t have to do that. I’m hoping that we’re able to shut this down as quickly as possible and make it just a one-time pandemic event and basically eliminate it from the world soon.

James Di Virgilio: 31:03

And that’s a great point. And that’s something again, that wisdom would say, no one knows the answer to that question, but certainly we hope that COVID is not here to stay like influenza or influenza has some mutation strains that become very famous, like the Hong Kong flu in the sixties, for example, right. That’s influenza just a different strand. It’s still here today. Obviously it’s just not that significant bumps. So that’s a , we’re all hoping for, as you mentioned, and of course, like you said, one of the best ways to make sure that happens is if everyone does get vaccinated faster than you’re going to give this virus less of a chance to make these game theory changes, to look at what humans are doing and respond and say, okay, well, I’ll do this to try to keep myself alive. Essentially you’re reducing its options. And if you’re doing this options further enough, it may just totally be gone. Of course, that is over simplification . So here’s a question for you. What happened to the flu in this flu season? The CDC records indicate that the flu is essentially non-existent despite about a million tests. You’ve had very few positive results at all. Hospital admissions are down to levels, never seen before. What does influenza and COVID have to do with each other? What does this mean for the future? Any thoughts on that?

Dr. Peter Khoury: 32:10

What we may be seeing is just impacted by the distance. People keep from each other and making sure they’re washing their hands, wearing masks, all of that impact flu also the transmission of flu. So I think flu is still here. There are cases, but people have become very conscientious about spreading viral diseases during this time. I think once the unmasking happens and people are back to what we consider a normal life, I think you’ll see dlu come back to the levels that it was before.

James Di Virgilio: 32:50

Yeah. It’s an interesting thing to follow, obviously, because one of the major fears was, you know, what if you had COVID and influenza stacked on top of each other, and we don’t know yet how much these things co-mingle. Do you get one and not the other, can you get both in States like Florida, which had been largely open, you still have extremely low or non-existent really statistically influenza cases. There’s just a lot that we will unpack obviously in the future. All right . Let’s ask you this big question before we talk about what you were working on to close up today’s episode. So let’s put you in hindsight mode a year ago. If you knowing what you know now had the power to implement one change to impact the outcome of what we’ve gone through in the past year or so, what would that change have been?

Dr. Peter Khoury: 33:30

Hmm , I think if truly there was a chance of getting all governments in the world together. I mean, that would potentially never happen. But I think in hindsight, if they were able to take a year and take a look at where we are now and the impact that it’s had on people’s lives. So the morbidity, the mortality, the impact on economics, all of that. And you could take all the decision-makers to this time and look back. I think all of them would agree that if we literally shut the world down for a week, made everyone stay home, put in very, very serious measures, whether it was a week or even two weeks that we could have stopped this right at the beginning, it literally wouldn’t have been able to become what it did. And if you look back at countries going to use Korea as an example where they did exactly that, or China or India, here’s a country with over a billion people and boy did an impact the number of cases they had much less than we have, but it’s an inconvenience obviously to do it. And if we had done something like that worldwide for a week or two, of course, people would have been inconvenience without knowing in the future of the impact or what that could prevent from happening. So looking back and having that hindsight now it’s nothing I could have done alone or whatever, but that would have been my advice to get as many people to stay home and watch Netflix or whatever you want to do for two weeks. Just get ready, implemented day that it starts in the day and the day it ends and enforce it .

James Di Virgilio: 35:10

Yeah. It’s so interesting that the topic for a whole different podcast, like you mentioned, the hindsight hindsight analysis is always undefeated because you have information you don’t have. And as you mentioned, the question then becomes, how many days is it? How long is it? What if it doesn’t work the way we think it works? So then what happens is there’s a lot of decision points, but that’s why it’s a hindsight question is knowing what we now know that it did spread, it was highly contagious. It was going to go all over the world. Of course, as with any virus, if you can isolate you reduce the spread, right? It’s like playing tag as a kid. If you’re too fast and they can’t touch you and tag you, then you’re not going to be it. And so , uh , that’s an oversimplification, but that’s a good point about potentially the future. What do you do the next time this happens and what happens if it does fade away and its own. Okay. Will you said we lost 14 days, 14 days, certainly a lot better than a year. So lots of interesting thoughts there, let’s bring this right back down to what you and your company are working on. Tell us a little bit about an update. Last time we spoke, you are working on something COVID related. Tell us what’s going on with that.

Dr. Peter Khoury: 36:07

Yeah, so we work with the US government on a couple projects, specifically with the department of defense to help protect military personnel and war fighters. And so we manufacture a vaccine for COVID-19 and we manufacture what are called monoclonal antibodies, which are also utilized to protect and treat, actually treat COVID infections. Both of these are in clinical studies. Currently we are expanding here in the Gainesville area. We’re in Alachua, we’re doubling our capacity . So the construction is underway for this. And I think it’s a great opportunity for this region because of University of Florida, some of the great research that goes on at that university in gene therapy and cell therapy, and in vaccines, it makes a lot of sense for us to make an investment, expand our workforce. So we’ve almost doubled our workforce. Since I last spoke to you, we’re over 300 employees during 2021, we expect to expand by over a hundred more employees. So there’s a lot happening here. All of that, very cutting edge science and all use to provide protection against infectious diseases.

James Di Virgilio: 37:34

And let me bridge a gap here, because this could be maybe the best way to end this podcast. You obviously are an established expert in this field. You’re an expert on viruses on vaccinations, on deliveries. You’ve done it for your whole career. If you saw something that you thought was risky or reckless or not good for society or the population I’m imagining you would be standing on the rooftop, shouting this out, don’t take this vaccination, don’t do this. This is not safe. That would be correct.

Dr. Peter Khoury: 38:01

It’s funny, James, because those that know me well, including our employees here, know that I speak the truth, I have great courage of conviction about what I say. My father was a United Methodist minister. My mom was a nurse that took care of some of the riskiest patients and both were just devoted people to what they did. And I think one of the most important things for any human being is their own dignity and not being able to stand up for what you think is right. And when you see something that, especially if you’re a professional and you know, information, not raising your hand saying that there’s an issue in something’s wrong is not good at all. So it’s not part of my being to ever cover anything up or whatever. And that’s a philosophy actually of our business here. I attend every one of our new employee orientations. And I tell them that everyone has the right to stop the process. If you see something being wrong done, or you’ve done something wrong immediately, we will stop. We’ll look at it, figure a fix and find a way of putting a parameter around it. So it never happens again. That’s all I care about. No one’s getting fired. You’re not going to be yelled at. We’re going to find a way. So it doesn’t happen again and fix what happened. That’s all there is to it.

James Di Virgilio: 39:27

Yeah. That’s such a great commitment. And I think that perhaps is something that’s really gotten lost during this pandemic, is that not everyone is on two sides of offense fighting with each other and not every expert one way or the other is out there just trying to run a political agenda. It’s safe to say that many people are doing exactly what you said. Hey, if I think this science looks good or this looks good, I’m going to say this is safe. And if it’s not, I would say the opposite. And perhaps that bridge, as we mentioned, is something to move forward as a free society in the future. We’re looking for truth via evidence and data. And recognizing, as you mentioned, there’s a lot of people with that, very commitment. You’re simply trying to follow the evidence and say, Hey, look, I think this is what’s best for you and your family. You’re my neighbor. I love you. I care for you. And this is why I’m saying that. So a wonderful stuff as always, thank you for being with us. He is Dr. Peter Khoury, the president and CEO of Ology, Bioservices. You can find them on the web with a quick Google search. And of course, as we mentioned before, your illustrious bio, an expert on vaccines and biologics, and certainly one of our favorite guests here on the Radio Cade podcast. Thank you for spending a considerable amount of time with us today, Dr. Khoury.

Dr. Peter Khoury: 40:29

Always my pleasure, James, thank you.

James Di Virgilio: 40:31

And for Radio Cade I’m James Di Virgilio.

Outro: 40:35

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville FL. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heardwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists , Jacob Lawson.

TRANSCRIPT:

Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

James Di Virgilio: 0:39

Welcome to another edition of Radio Cade . I’m your host, James Di Virgilio. And today we’re going to talk about detecting Corona virus . All of us are familiar with the variety of tests that are being done right now, but none of them are able to detect very important things like viral load, which makes them less accurate than we’d like to see. My guest today is Dr. Vanaja Ragavan. She is the founder, president and CEO of Aviana Molecular technologies, and she’s working on something that could be very impactful for the world’s fight against coronavirus . Dr. Ragavan welcome to the show.

Vanaja Ragavan: 1:13

Thank you, James.

James Di Virgilio: 1:14

Now tell us what it is you’re working on and how it’s going to help us in the fight against curving Corona virus .

Vanaja Ragavan: 1:20

Thank you so much for having us on. We are developing a chip based diagnostic system to be able to detect Corona virus so we can detect a lot of different biomarkers and viruses and bacteria. However, at this point, we’ve pivoted to be able to use our technology to detect COVID-19. And the nature of our technology is based on a radio frequency chip, and it works like a radar system, really in a small little space. One of the advantages of our system is it’s called a mass detector it detects the amount of mass that’s sitting on top of the chip. And because of that, we have the unique ability to be able to actually distinguish the presence of the whole virus or would be called the infectious virus in a clinical sample. So most of the other diagnostic tests detect either the internal makeup of the virus called the RNA, the genetic makeup of the virus, or it detects one of the many proteins that are found in the virus. Most of them actually detect a protein that’s found inside the virus called a nuclear capsid protein. And we know a couple of tests that look at the spike protein as a detection, but those are small proteins compared to the whole virus. And although they can be good surrogates, they don’t give you a direct analysis of the infectious nature of the virus in a particular person or in a group of people or in a population. So we can do that. We can do that at an individual level and because our system is based on cellular communication, it’s in our DNA, so to speak. To be part of the cellular communication internet, we can actually add further data on tracing and population-based studies. So we’re hoping that this technology can help us at this time in detecting the whole virus, the infectious virus, and give us some idea of the viral load. And we’re working towards all that data.

James Di Virgilio: 3:14

Now, what is the advantage of having a more accurate coronavirus tests right now? It seems like a lot of people would think, well, look, I go get tested . I’m positive or I’m negative. What’s the advantage of your solution?

Vanaja Ragavan: 3:26

Well, let’s take an example. For instance, if one of our technicians actually developed coronavirus COVID 19 , and we wanted to know when she can come back to work, the current tests tell us whether this virus is present or a part of the virus is present, but it doesn’t tell us is she going to be able to transmit this virus? Because we don’t know the actual viral count that she possesses. So if we can detect that, we can have a much more accurate picture of when she has the virus and when she’s free of the virus. So that’s the position that we can bring to the marketplace. There are studies that have shown, for instance, at the RNA can hang around for several days, two weeks after the infection is no longer present, and those are correlated with actual culture of the virus, but that takes several days. And so if you rely purely on the RNA test , sometimes it can take a while to clear the body to clear it, but we can have a much more precise tool that tells us whether the person still has an infection or free of an infection. The other thing is that it’s been shown that this virus can live in the presence of the vaccine. It just doesn’t cause a severe disease. So shedding of the virus in somebody who has been vaccinated is still an open question and we believe we can add some real value in that particular circumstance too .

James Di Virgilio: 4:45

So now if you imagine you mentioned an employer, but perhaps a sports team, which has gotten a lot of press in the past year, they have 20 athletes on the team and they’re testing. And right now, if you test positive, you might be out for 14 days or they’ll test you every three days. Uh, but like you mentioned, you could keep showing positive test results and potentially not really have a viral load at all, or the opposite is also true. So in your solution, you would get a much more accurate result where you could then confidently send the employee or the athlete back into action, knowing this person is fine because of the heightened accuracy right?

Vanaja Ragavan: 5:17

Exactly. And we’re sort of focusing a lot on openings , um , colleges and doing the studies on students because they know if somebody’s positive, they quarantine for 14 days. And that’s pretty awful for a student on a campus to stay within their rooms for 14 days. So we can give a much precise estimate of when that person is no longer infectious or doesn’t need to be quarantined. So we can add some precision to this very qualitative world. And that’s kind of what we’re hoping to do.

James Di Virgilio: 5:46

Yeah. And that would obviously be welcome, I think for everyone and anyone who’s had to quarantine, as you mentioned, that kind of isolating experience, is this something that we can use now? Can I go use your test, your solution right now?

Vanaja Ragavan: 5:59

No, we’re not quite ready yet. We’re collecting all the data for the FTS approvals . So we’re working with some pretty important consultants and so on. So when we get the data together, we’ll be happy to let you know James and the Cade Museum. And we’ll be happy to let you know when we launch.

James Di Virgilio: 6:16

Do you have any loose timeframe. I know you can’t know for sure, obviously, but do you have any ideas like this year, next year, longer?

Vanaja Ragavan: 6:23

Well, we’re hoping to do it by the end of this quarter or the beginning of next quarter. We’ve solved a lot of the problems with the technology had, we’ve had some difficult situations. For instance, I need to measure the virus viral load, and it’s been really hard for us to get the inactive virus. Most of the methods used for inactivating the virus that we’ve tested, we’ve tested about six or seven of them seems to destroy the ability of the virus to bind to our system. It destroys the spike protein, which is kind of what we’re binding to our system. So it’s been a really difficult task to try and find this nag , the virus mostly because the whole aspect of the scientific basis of this virus is still in its early stages. And so we’re trying to work around that system with our consultants.

James Di Virgilio: 7:09

And at this point, given the science, you’ve done the research you’ve done. It sounds like you feel pretty confident that this solution, not only will it be released rather soon, but that you’ve gotten over the hurdle of proving the concept, right? It sounds like you feel like the concepts proven this is doing what you think is going to do. Now you’re at the one yard line about to kind of finish the task. Is that about an accurate summation of where you are ?

Vanaja Ragavan: 7:29

Yes, I think so. We’ve done a lot of studies on clinical samples and we’ve shown we can detect the virus. We’re going to dig into it further and do some more science on it because I think we want to be a very scientifically based company. And we’re working with some of our investigators to determine the correlation between our tests and actual viral culture in the lab. And so we’re going to be continuing to do some of that work for both publication and for the scientific community and the medical community. But our basic test shows that we are detecting the virus. And the way we know that is because our system, the one we’re using is based on an acoustic wave, detects a mass about the size of the virus. And we have not been able to detect the protein we’re detecting the virus. So we’re pretty shored and similar systems have been used to detect viruses successfully. And that’s in the public literature too.

James Di Virgilio: 8:22

And it’s your knowledge at this point in time, right? You would be the only, let’s say it’s a quarter now or two quarters from now in 2021, you would be the only solution out there that would be doing what you’re doing.

Vanaja Ragavan: 8:33

We believe so, James, you know, it’s really hard to know exactly who’s working on what, but we believe we are. Yes.

James Di Virgilio: 8:39

That’s exciting stuff. Now let’s take ourselves into the future. And imagine now that this is actually available and I’m able to use it, what does it look like? Am I going to my local doctor? Am I going to like a pharmacy nearby? Am I using it myself? How is this going to work in the real world once it’s launched?

Vanaja Ragavan: 8:53

Well , as I mentioned earlier, the first aspect of it will be in a laboratory, but while most of the other studies take many hours to a day to get the results back, once we get the sample into the laboratory, we can determine it within 15, 20 minutes and the results can be sent back electronically to your physician or your carrier. What we’ll do initially is how the nasal swab that’s done sent to a laboratory that can do the testing and send the results back to the provider or the patient. But eventually what we want to do is to do the clinical studies and the technical studies that are needed to become what’s called a clear waiver. And that allows us to take our system to the point of care. And so the test can be done and the patient notified within 15, 20 minutes. So that’s our ultimate aim though. That’ll be our second step in the process because according to the FDA, we need to do some more studies to show that the technology can be worked at a point of care. So we have to do some added studies and we’ll be doing that as soon as we launched the laboratory system, consultants have told us that it’s better to do it in a two-step process, even with the FDA. So the FDA gets familiar with our technology, and then we do the clear waiver studies afterwards. So they recommended a two-step process.

James Di Virgilio: 10:11

Okay. So right now it’s July, we’re imagining, and I go into my doctor’s office and this is just like a normal test. They’d give me and say, we’re going to run some tests. We’ll send it to the lab. We’ll give you your results. But in the next step, really the one I’m sure you’re most excited about is going to be the one where I go in my doctor or my physician’s assistant, or perhaps down the road, even someone else that has maybe no medical training, if we’re getting weighed on the road is able to immediately give me the test and then tell me my results before I even leave. Right. 10 or 15 minutes later.

Vanaja Ragavan: 10:39

That’s our aim. Yes.

James Di Virgilio: 10:41

Okay. So now that we have the idea, which obviously is very exciting, that’s something that I think we can all imagine would really help with getting a more accurate way to deal with Corona virus. But let’s dig a little bit into how you got here, the origin story. So you went to Harvard, you went to NYU, you’re a physician. How did you wind up spending five or six years or even 10 years? I think in your case researching this idea, how did that transition go from practicing physician to entrepreneur innovator, and then someone who’s on this path?

Vanaja Ragavan: 11:09

It’s an interesting life journey. So after I finished medical school and residency and fellowship and all that stuff, I actually ended up working at the food and drug administration. As a medical officer its completely serendipitous. I went to DC, I needed a job and I found one at the FDA and then ended up just loving the work that I did. I have a lot of respect for the FDA. I think they are a highly scientific organization that provide probably some of the best reviews in the world on drugs and devices and attracted they’re so well respected that many countries around the world base their entire approval process on the FDA. So it was really thrilling to be there, to be able to help large groups of people rather than an individual patient. And from there, I went on to work at a global pharmaceutical companies. I worked in three large ones. I worked at Wyatt, which is now part of Pfizer at the ventures , which is part of Sanofi-Aventis and Novartis, where I led the therapeutic areas globally. And then eventually I ended up going to a startup in Philadelphia and then I became, what’s called an angel investor. So I joined a group in New York called Golden Seeds. And I started a company before, which had exited. And so I was able to take some of that money and put it into angel investment. When I joined a group called Golden Seeds and our mission was to invest in women owned and women run companies. And I became part of their life science due diligence teams. And as part of that, I came across this technology. It was presented by one of the women that came to present to us. And I thought that the technology was really interesting. So I founded a company around it, very unusual technology didn’t really know much about it when I started at, of course, since then, I figured out that it isn’t in fact unusual it’s based on radio frequency chips, as I mentioned. So we tried for a few years in Philadelphia to make this technology work, but eventually found that the most advanced smart device technology was actually in Orlando. It had been developed at the University of Central Florida for NASA. And t hey put in about 10 years of work into it to develop what’s called a passive wireless system to go on the space shuttle. What we did is we licensed it from UCF and then we then further advanced it into a sensor for human diagnostics and animal diagnostics, and also other areas like r esearch b ased diagnostics. And so we’ve been working on that for about four or five years and through the work of some of our brilliant scientists, we were able to solve a lot of problems. As you know, w e’re based on r adio f requency chips, which are found in cellular communication. And they’re used as acoustic filters in those systems. Y ou probably got about 20 of them in your cell phone, but we had to adapt it to biological use. That’s not easy because as you know, electronics and liquids, don’t like each other very much, but we figured out how to adapt the system successfully. And we had done exploratory work on diseases like Lyme disease and Influenza. And then when Coronavirus hit, we thought we were an ideal system to detect the virus because we had already had some experience with Influenza. And so we decided to pivot to COVID. And so w e’ve been working on this since about October a nd now h ave shown a proof of concept that it works. And now we’re doing our studies to go to the FDA with our first product.

James Di Virgilio: 14:32

And so you’re pivoting. It’s not really a pivot in your case, actually, when you’re just deciding, Hey, our technology can also work for detecting Corona virus, perhaps walk us through at a very high level, what that looks like, how do you get a sample of the virus? How do you test something like that? Like what does that actually look like in the lab? Most of us hear these of this companies testing this , or they’re working on this vaccine, but take us behind the curtain here backstage to what it was like to have to try to apply your technology to the coronavirus .

Vanaja Ragavan: 15:01

So we had to focus on getting the right reagents . We found out that one of the critical aspects of our system is that we need to add a binding agent to a chip basically. And it’s a very tiny little chip. Actually, the volumes needed are in the microliters. So we had to find the reagents that would work. We found out from our previous experience that this system works very well. When the affinity agents like an antibody has a very high affinity for its biomarker . In this case, it would be the SARS cov two virus. So we had to find the antibody. We had to figure out how to put it on the chip. So it bound what’s called covalently, which means that it’s a tight binding. And then we had to test it with the virus itself in order to determine the output. Now, our output is it’s really interesting. It’s an electronic readout because it’s an electronic readout. And because the affinity reaction is so rapid, our system reacts within seconds really to the binding of this antibody with its virus. And so we had to adapt our software in order to determine the best method to detect this particular reaction, the antibody and the virus. So, you know , we took a little bit of time doing that. We also had to prove that we could detect it many times. And so now we’ve collected clinical sample data. I would say with about, I don’t know , a hundred samples to show that we can determine. And then we had to tweak our software to be able to do the optimal determination. And so now what we have to do is we have to actually do the samples needed for the FDA approval. And that’s kind of what we’re launching on. So the way the system works is that you would take a sample in this case, it could be a swab of the nasal pharynx. I don’t know if your listeners have had a COVID tests , but there’s usually a very long stick with a swab at the end and they try to get it from the back of the throat. So we would take that in because it’s a dry swab, we need to put a liquid into our system . So we put that into a buffer of some kind. Then a small sample of the buffer is removed and added to our chip. And then we have a reader that actually reads what’s going on electronically. And so we will add a graphical user interface that gives instructions on what the user has to do to determine whether the virus is present or not. And in addition to that, what we’re trying to do in our first instance is to look at what we call a viral load. I mean, does the patient have a high, low, or medium viral load or no virus at all? So we’re trying to make those determinations at the same time. So really once a sample is put on the system, the whole system can do the detection in about 5 to 10 minutes, and then the readout will be provided on the reader on a screen. And then the data is provided to the provider or to the patient.

James Di Virgilio: 17:59

And you just described the process really well. Right? What was it like when you first had that moment that, Oh, this is working like we’ve made this happen? Like this is actually doing what we want it to do. What was that like for you and your team?

Vanaja Ragavan: 18:11

I think it was really thrilling. So we have a contract with the Air Force to develop this for the Air Force. And so we had to provide the Air Force with an early milestone where we repeated the sample several times. And when we put that report together, it was approved by the Air Force. That was a really big thrill for us. We were able to do repeated studies and send it to them. So it was an external validation that our system is working. And so we fulfilled our first milestone for the Air Force. And we also told the Air Force, we would ruggedized the system. That means that we take the reader and if we drop it from different levels and so on, it still survives. And we’ve just finished that. And so we’ve shown that the system is pretty rugged because if you’ve got a warfighter carrying something like this to the field, it needs to be rugged. And so now we’re doing our final studies to demonstrate how well it works against the standard laboratory tests . So it was a lot of work. We have a great team really, that is sort of half electronics, half biology. And I think it’s really interesting to combine these two totally very in fields into one system because we can take advantage of both fields of use the electronics part of it gives us incredible ability to do data analysis, data, distribution, artificial intelligence, and the biology aspect of it allows us to go into lots of different areas that probably could not have been done without a portable system like this. For instance, traumatic brain injury. Somebody has a problem in the field. We can take this and make the diagnosis at the time of the injury or other infections. And so we see a lot of potential for this technology because of the nice marriage of electronics and biology.

James Di Virgilio: 19:55

Yeah, its not a one-stop shop like we’re spending all of our time today talking about coronavirus, because that is obviously the topic of the day. But as you mentioned, this is going to have wide ranging effects. If it is in fact able to do what you want it to do, especially down the road. If you dream up a world where I could take my cell phone as a layman and potentially use a technology like this to detect things that would affect me and my family down the road, but let’s take this in a different direction for a second. So obviously your company has tremendous human capital. You have all sorts of smart people doing all sorts of collaborative things to come together, to create synergy, to craft what you’ve crafted. It’s one of the neatest things about a free idea marketplace, a place where we can come together and share expertise. On the other side of things, you have to have physical capital, you have to have money and resources. How were you able to maintain funding as you’re spending all this time researching and gathering ideas and testing ideas to get yourself to the point to you’re at now.

Vanaja Ragavan: 20:48

So we’ve done primarily private investors, mostly small investors. A lot of physicians have funded our company, which is good because they see value in it. And then most recently we received a large contract from the Air Force to do this work. So we’re still looking for funding. Money is always in need. And so we keep looking for further funding, but that’s kind of how we’ve been funded really at this point.

James Di Virgilio: 21:11

And if we imagine a rollout here, logistically, if you’re able to begin rolling things out, quarter one, quarter two, quarter three of 2021, whenever that is, what kind of distribution scale are we talking about? We’ll just a couple of hospitals or doctors have this. Are you going to be able to send this all over the place? I mean, how many units essentially are we thinking of being able to put out into the world?

Vanaja Ragavan: 21:29

Actually, the interesting part of it is the manufacturing, because these chips are made in the billions every year, literally about 2, 3 billion a year. We have a built-in system for expansion, which is really good. And the electronics, as you know, is something that can be done pretty much anywhere in the world. We happen to focus in on Germany because we found that a lot of our base technology is well-established there. So our fabrication system is in dressed in, and they’ll be doing all of our worldwide fabrication. They will probably use facilities elsewhere too , but they’ll coordinate that. And our electronics is also made in Germany, in Munich. That is the heart of the electronics, but the other electronic components will be designed and put together in the US so because both the chip is commonly available on the electronics is commonly available. That is not a rate limiting factor for us on the biology side. On the cartridge side, we’ve had to build some cartridges that work with the system because the system is sensitive to external pressures. That’s why it was developed for NASA to be able to detect external strain and stress on the spaceship and temperature. So we have to account for that with our cartridge and with our software. And so we are working with some pretty high level companies in the US to solve those problems. And I think at that point, then we’ll have to coordinate and put the entire manufacturing process together. So w e’re working on that now, and we’ll have a final solution by the time we launch. I think the system can be taken anywhere, maybe not in the first instance, but in the second instance, when we do a point of care, we’re hoping we can take advantage of the s cale-up available for the electronics industry and the biological industry to be able to provide what’s needed.

James Di Virgilio: 23:14

And you can imagine an incredible application for so much of the world, especially if you’re like me. And you’d like to travel around the world in places where the nearest hospital is not close to you at all right. And you’re traveling or you’re somewhere, or you’re in a third world country that just doesn’t have access to high level medical care, but they may have a cell phone. And again, this is in the future, but to have an ability to detect some of these things would certainly be a game changer. So let’s take us down to the end here and close the curtain on this with this question, why do this, why launch a company? Why leave a day-to-day practice with the FDA? Why take all this risk, spend all this time? What motivated you to do this?

Vanaja Ragavan: 23:52

I don’t know if I have a real answer except that I wanted to use my knowledge of business and medicine to create something that could help people. And I didn’t quite understand that technology when I started. So maybe it was a little [inaudible] when I started, but I think I’ve learned a lot and it’s just allowed me to get into an area that I would never even have an emission doing. Otherwise, the people I’ve met, the knowledge I’ve gained and the collaborations that I’ve been able to pull together has been a real thrill and the persistence to try and find the smartest technology, the best available, and the people that make it happen. It really is what keeps me motivated. And the ability to help people. We can truly help people with this. I think so.

James Di Virgilio: 24:36

And I think thats what’s interesting is we live in an ever fractured world at times, with how they feel about free market versus essentially planned market versus a bunch of other economic topics that interest me a lot in my daily life. But what you said is what I come across the most frequently and discussing things like these as entrepreneurs. And it’s almost always, I wanted to use my skillset , my knowledge, my expertise, to help others, to help my community, to help the world around me. And that’s often the origin of the idea, which is, I think so rewarding. So immensely deep, it’s connecting you to your fellow people and allowing you to obviously change the world for the better, which I think is one of the great things about what the Cade celebrates here. What I celebrate, what you’re celebrating in your daily life, not only as a founder of your company, but also as you mentioned, an angel investor funding, other ideas. So I wanted to thank you for coming on the show today. Obviously we’re very excited for what you’re doing and how you’re trying to help the world around us. Once again, our guest today was Dr. Vanaja Ragavan the founder, president and CEO of Avianna Molecular Technologies. You can find her on the web. You can find her on LinkedIn. Just thank you so much for being with us today. We really enjoyed having you.

Vanaja Ragavan: 25:40

Thank you, James. We’ve enjoyed learning more about the Cade Museum, and I think we were one of its awardees this year.

James Di Virgilio: 25:46

Indeed, you were. And congratulations on your success for that. For Radio Cade , I’m James Di Virgilio.

Outro: 25:53

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates inventor interviews , podcasts are recorded at Heartwood Soundstage and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinists, Jacob Lawson.

TRANSCRIPT:

Speaker 1: 0:01

Inventors and their inventions. Welcome to radio Cade and podcast from the cave museum for creativity and invention in Gainesville, Florida, the museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them, we’ll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace,

Speaker 2: 0:38

Shoulders, hips, and knees. Maybe you saying that as a kid and maybe you’re getting ready to replace them all. Welcome to radio Cade. I’m your host Richard Miles. And today I’m pleased to welcome Dr. Bill petty, the former CEO and chairman of Zack tech, a company that makes orthopedic implants. Welcome to radio Cade bill. Thank you . So bill, usually I save the personal questions for last, but I have to ask and only cause you look in great shape. Have you had any joints replaced yet? Are you still all original bill petty?

Speaker 3: 1:04

I am all original, but Betty Petty, my wife has had two exact technium plant , so we do have it in .

Speaker 2: 1:11

Okay, good. So you’re living the brand, you’re using your own product. So that’s good. What I want to do. I think most of our listeners are probably fairly familiar with orthopedic implants and what they do. But I do know that probably some particularly on the younger side are not exactly sure what that even means. It occurred to me that they’re probably not tracking this technology. Like guys say who were in their late fifties, purely hypothetical example. So why don’t we start by you explaining what an orthopedic implant actually is and what it does.

Speaker 3: 1:37

There are many different kinds of orthopedic implants. Perhaps the ones people are most familiar with are the ones that are used for fixing fractures or torn ligaments in actuates , but that’s not our business. Our business is orthopedic implants for treating arthritis and basically arthritis is a disease, hugely degenerative or osteoarthritis that the joint gets damaged. The cartilage is damaged, that comes painful, limitation of motion, those sorts of things. So what our orthopedic implants do, what the surgeons do with them rather is we go in and shave off a part of the bone and replace that part of the bone with on one side , usually a metal, a very high tech metal, such as cobalt, Chrome, or titanium. And the other side with ultra high molecular weight polyethylene makes a very low friction artificial joint , not quite as low friction is our normal cartilage that God gave us, but still very good. Now the implants or the ExacTech currently makes include total hip replacement, total knee replacement, total shoulder replacement and total ankle replacement. So basically that’s what they are. Uh , results are excellent. I would say in general, 95% are better. Good results. That’s not to say there aren’t potential complications as there can be with any surgery, but overall the results are very good. And in fact, it’s been stated rather kind of people have studied this sort of thing is total joint replacement or total joint. Arthroplasty is one of the best medical procedures developed over the last 50 years. So

Speaker 2: 3:14

That helps a lot, I think, to understand what these things do. You mentioned that primarily these are implants related to things like arthritis. So I’m guessing here that a typical patient for an orthopedic implant probably tends to be on the older side, but are there any other demographic characteristics of people who need or get orthopedic implants, background, occupation, that sort of thing, or is it sort of all over the map eventually? Do we all need orthopedic implants or does it tend to group itself? Demographically?

Speaker 3: 3:41

Let me first just answer the question back page, probably two thirds of patients you have, or TPD implants at this time are in the Medicare age or 65 are older, but that means one third are younger than that. So the most common as I’ve already mentioned is osteoarthritis or degenerative arthritis. And frankly, other than post-trauma or some deformity, we don’t really know why some people get that kind of arthritis. And don’t now rheumatoid arthritis, which is a less common cause of meeting on arthroplasty or replacement of a joint. We have learned a lot about, about the immune part of it, but even that, that we now have better medications for it. We still don’t know all the causes of this kind of our sprites.

Speaker 2: 4:28

So that’s really interesting. Cause I remember growing up that one of the causes of arthritis and I didn’t know if this was true to Smith was overused, right? So runners are skiers. I remember distinctly being told as a little kid, not to crack my knuckles because that would cause arthritis. Is that a myth or is there something to that that’s overused or extensive use or particularly joint is going to cause arthritis and some people under that age of say 65,

Speaker 3: 4:50

It’s mostly a myth. Actually one of my colleagues at the university of Florida was Rick Panish. He was rheumatologist . He was an avid runner as was, I still run some. He actually did a study and did an age matched and otherwise matched controls of different age groups, comparing runners to non-runners and he found no difference in the incidents of arthritis. One could even argue maybe not running, but at least aggressive walking. Our normal cartilage gets each nutrition by the fluids being pumped in and out or the cartilage as we use our joints. So it’s probably worse to not use the joint than to use it. Now, overused now become operative. People run a hundred miles and whatever I don’t know about that, I’ve never done that. I’ve run a few marathons, but that’s it for me and my joints are all still really good. So I think that’s mostly myth. On the other hand, let’s take a football player who plays for many, many years and may have some cartridge chairs and some ligament tears and those sorts of things that then sets up the joint to be not normal like it should be. And because of that, they may be more likely to get arthritis at a younger age.

Speaker 2: 6:03

That’s a huge relief because I’m a runner. And a couple of years ago, I actually started developing osteoarthritis and I thought, well, that’s it. I can’t run anymore and should have quit running a long time ago. And I was relieved to find the physical therapist said, no, some stretching and so on. You can get through this. And so now I’m back running again, not quite as much as I used to, but I’m glad that submit that makes me feel a lot better. And I can at least another 10 years for, I have to worry about this. So bill you , this technology of orthopedic implants has been around for a while and we’re going to hear more about how you started the company in just a minute, but first let’s peek into the future. What in your field, in the field of orthopedic implants, orthopedic surgery, what is the cutting edge or now under development? What will the next generation for instance, be able to expect or is likely to see coming out of the field

Speaker 3: 6:47

First to talk about joint replacement. There’s not already mentioned results over many, many years are better than 95% are in many series better than 98%. So when we talk about an improvement where you have to be very careful that an improvement is really an improvement or not just to change. And in fact that exact check , one of our mottoes was evolution, not revolution because sometimes it’s revolution, you may get some unintended consequences for total joint replacement. Actually there’ve been some conferences established by the NIH and the American Academy of orthopedic surgeons. And they actually came to the conclusion that improvement in surgical technique is one of the best ways. And there was a famous surgeon who said for a total joint replacement the best time to do it right as the first time. So there are some technological developments , particularly related to using digital means of being more accurate in the placement of the joint , exact tech . It’s worked on a , what we call a GPS system, which is a digitally control instrumentation system just to help the surgeons be more accurate. So I think that’s the area for total joint replacement. Now we can get into that , say more future risks. Are there some genetic things we can do to begin to curtail the incidence of arthritis? Are there some, let’s say biologic materials. If we had an artificial cartilage , wouldn’t that be wonderful if you were your joint out and you’d get the osteoarthritis. If we had a way to go in and replace the actual cartilage, that would be fantastic because then the body renews, it just like it does under the normal circumstances, there are some treatments like that, but currently they’re for small defection the cartilage . So let’s say you have a defect in your car. What’s the size of a dime or a size of a quarter. There are some biologic treatments that work for that , but not complete joint as we did with joint replacement . So those are just some of my thoughts about where we may be going in the both with joint replacement and with other more bottom line ,

Speaker 2: 8:59

That’s really exciting. And again, probably should emphasize for the younger listeners who would think like I’m not going to have a joint replaced for a long, long time. This is really can be life-changing for someone who has lost mobility, right? Who can no longer walk or lift or something to be able to get another 10, 20 years or more of a full use of their limb or their body. That’s a big deal, isn’t it

Speaker 3: 9:18

Sure is. And in fact, one of the things we’ve always said it exact tact . In fact, it’s part of our purpose. And I think inspirational to our employees that really our purpose as a company, to help people regain and then retain or maintain their activity and independence. And whether that activity named dependence means working so they can earn a living or maybe they’re retired and they just want to go out and do something with their grandchildren and kick the ball around. So it makes a huge difference. And I think also keeping people are off of crutches, out of wheelchairs, out of nursing home so they can have a more productive, active life .

Speaker 2: 9:56

So now we get to the part of the show. I always enjoy on radio Cade . We’d like to hear about origin stories and you’ve got a great one. You were trained as an orthopedic surgeon and you decided to form this company way back in 1985, along with your wife, Betty and Dr. Gary Miller, a biomedical engineer, and also has been on the show was a guest of radio K last may. And I have a little bit of experience with that on a much smaller level with the kid museum, working with my wife to found that. And so my obvious question is like, what on earth were you thinking and why? So take us back to 1985, you’re a surgeon. What made you decide you wanted to start a company? And what were your expectations? 36 years ago?

Speaker 3: 10:33

You may have gotten some addition , Gary, I don’t know what you talked to Gary about, but Gary is very integral in this as has been Betty and of course, many, many others. So Gary and I were both on the faculty in the medical school at university of Florida. I was just searching . There is an engineer, as you pointed out. And we did a fair amount of research related to joint replacement because they weren’t as good as they are today. They certainly were not perfect. It’s still not perfect . So we were doing research and one of the companies happened to be Johnson and Johnson ask us to do some work with them and develop an instrument system for a total knee system. They had developed basically Gary and I were having a conversation one day and he said, you know, if I were doing this kind of development, I would approach it differently. And I said, what do you mean? He says, it seems that that what we’re doing is we’re trying to touch up with your competitors. I said , makes good business sense. Of course, what would you do? And he said, you know, we have our own knowledge. We talked to surgeons, we go to conferences, we read the literature, we understand what some of the complications, some of the problems are. If I were leading this kind of development, I would look at those problems and say, let’s focus on one or two or three or whatever. Let’s try to find a solution or a partial short sheet that really a bell with me. And I started thinking about it because I was taking care of patients into your every day and began to study the industry. I studied entrepreneurship , uh, all those kinds of things and dairy was in my office. One day we were talking about some research and I said, do you remember that conversation with , he said, Oh sure. I actually don’t think he did. I think it was just said in passing by him . I said, I’ve really been thinking about it. And I think we should start a company and try to do what she, she just, and he looked at me and said, we’re going to compete with Stryker and Zimmer. And I said, sure. And he said, you’re crazy. So that kind of ended that conversation . So I went home and convinced Betty that this was a good idea. And we’d been talking about it for months. And actually our vacation time, I would sit on the beach and read these books and try to understand if this is early a feasible thing to do. So Betty , I actually went to Tallahassee, got the company incorporated, all that we had Gary over for lunch on a Saturday, showed him the corporate papers. And he said, Oh, you’re serious. And I said , yeah, I said , are you going to join us? And reluctantly he joined. So that was how it got started. I know this is often about invention. We didn’t have a product, we hadn’t invented anything. We just had a lot of knowledge and research related to orthopedic implants. So once we did this, we said, okay, how are we going to get a problem ? And we met some wonderful people up in the Northeast who are supportive of our idea and that’s how we got started.

Speaker 2: 13:23

Well, as I’m sure you’ve known bill , a lot of people are , you know , ideas , truly original, right? I , and ideas , really a formulation of other ideas that have pre-existed it all the way back to the Bible, there nothing new under the sun, but it’s fascinating how people do get these insights. And I want to go back just one minute to that insight or the comment that Gary May or may not have made about why just form a company to chase competitors. Because I think that was probably key right? To your longterm success is that from the very beginning, you weren’t just a, me too type of company making another type of widget. You were doing something at least different than the competitors. So you establish , I imagine a niche from the very beginning.

Speaker 3: 14:00

Just let me make one other comment about that in our work that we have really an engineer’s daring , an awful lot of others in the company. Now it’s absolutely essential that we work with surgeons because they’re the ones in ELR, they’re the ones samey issues in the, or they’re maybe the ones seeing an issue with the patient postoperatively may not be quite as good as either the patient or the surgeon wanted them to be. So we do that now. That’s not to say other companies don’t do that, but we have had surgeons that if we’ve put on what we call a surgeon design team , and they’ve said, you really want our input. You really showed it. You need it to get products better for our patients . And I think that’s a subtle nuance, but I think it’s been important to the surgeons we’ve worked with and also important to our success.

Speaker 2: 14:45

When you started this, you know, you had a good idea, you got Gary on board, but what were your actual expectations in 1985, fast forward 36 years. So on exact tech has over 900 employees in seven countries, annual sales of plus or minus $350 million . Did you imagine your company would do so well back then? Or were you just initial goal was like, you know, let’s just sell a few implants and see how we do, and maybe we can hire somebody. Well , what was your vision back then?

Speaker 3: 15:12

Before I answer that size question, our vision was to do just what Derek originally recommended, make a difference. You make a contribution, reduce complications and hopefully help surgeons get better results. Of course, if we don’t get on the market with it, it doesn’t do any good, no matter how smart we are, how great our products are, any of those things. But that was key to us from the standpoint of growth. Sure. We wanted to grow. I just gave the reason we can do the best. We can have the best for the surgeons, the best for the patients. But if nobody uses our product, we’ve not really done it. So did I expect exact tech to be East coast ? Largest city is now the answer’s yes. Maybe even larger. I don’t consider it where we are in any way, a lack of success, but sure. And I think if you’re going to be an entree for newer , if you don’t have that approach, you’re probably wasting your time. Now I’m more a developer and an operator, and that’s why we’ve stayed with exact tech because we know a little about serial entrepreneurs and how they do one thing and sell it in five years and go do it again. That’s great. And I’m all for that. It’s just not what we set up .

Speaker 2: 16:20

So you really anticipated my next question and that is you’re trained as a surgeon and you did that successfully for a while , but then you started a company and obviously this sort of your to-do list every day , when you wake up and running a company is different than a to-do list of a surgeon who goes in and does surgery. So did you like that aspect of running and growing a company, the hiring people that doing the market research or did a part of you want to stay in surgery?

Speaker 3: 16:44

Correct . The answer is yes. And in fact, for many years I did stay in surgery. People often ask me the difference of the personal gratification and my kind of surgery, total joint replacement. I’ve already talked about the positive results and what it does for people. People do everything from come in and hug your neck to bring your stone crab claws because they’re fishermen over on the West coast of Florida to show that appreciation. So that’s a very direct one-on-one appreciation. However, being involved in the company and all of that involves if we can have our products used around the world and they benefit from those products to surge in juice , that’s also very gratifying. It’s not the personal, one-on-one that being a surgeon is , but still very gratifying in a more indirect way.

Speaker 2: 17:35

Yeah, that’s a great answer. And I think again, the limited experience I’ve had with starting organization, one big difference that I think people who don’t have the experiences to realize how many different things you have to worry about. Because I imagine the surgeon, obviously you’re working with a team in the, or, but yet you don’t have to sit there and worry how the hospital’s going to pay the light bill or who’s cleaning up at night or locking up the hospital at night. But when you start your organization, you do worry about those things you have to, and you have to use a much bigger part of your brain to solve a long and never ending list of issues. One thing that I’d like to ask specifically, bill, and again, only cause I’ve done a little bit of as well. I have to ask, what was it like working with your wife, especially starting your own company. Now you can take the fifth amendment on this if you’d like, but I want to see what I did wrong. So what was that like?

Speaker 3: 18:19

Yeah. We’re often asked that and sometimes we’re asked that in the way that, how do you spend all day with your husband at work and then go home and not Betty’s answer usually? Well, it works . I don’t sit on his lap. I’m doing what I do. And he doesn’t like he does . And of course is a company got bigger. We got more separated geographically within the facility. And there were plenty of days that I didn’t see value at all at work. We may see each other for 30 minutes or an hour and a meeting and then go about what we do. I think more deeply though, we were both very passionate about what we were doing and we want her to be successful. We want her to be helpful to surgeons and patients. So I think I can admit more driven than Betty is, but still we were both driven by this passion to be successful and to use our individual talents and competencies, as you well know, everybody’s different and everybody has a different talent and everybody has a different ability ready. For many, many years, I was in charge of our human resources department and was very passionate about hiring the people that would fit the values of exact tech . Later. She became more involved in facilities administration and was passionate about that because our facilities important to our employees, for sure, we have a lot of surgeons to visit from all around the country and all over the world. They want to see what we do and how we do it. For some people think of manufacturing machine it’s kind of dirty and all, all over the floor . We’ve often said you could eat off the floor. They check, check. It’s not quite like an LR , but we’ve tried to make it a little bit like that. So we’ve used our different talents to try to help the company succeed.

Speaker 2: 20:01

Phoebe and I have talked to other sort of husband, wife, teams, particularly ones who’ve run their own organizations. And there are definitely pros and cons, right? I mean the pro is, as you said, you both share the same emotional investment and passion in making this thing work. You don’t have to worry about separating those two parts of your life. But on the other hand, we found with the kid museum at a certain point, you have to draw a line in the day and go like, okay, we’re watching a movie or we’re going out to eat and we’re not talking about this project anymore. Cause otherwise you can go to midnight discussing various things for various aspects or organization. And there’s no end point, which doesn’t really happen. If your spouse has nothing to do with your work .

Speaker 3: 20:37

That’s a super important point. And we worked very hard to maintain a good family life. When our kids were still with us, coach basketball at the boys club, Betty was supportive of Judy’s ballet. In fact, she said she put in a lot of miles between the boys club in the ballet and we’d go to theater and after dinner and she’d say, and try to have a normal life and marriage. I won’t say that we’re never came up, but we certainly had a life beyond work .

Speaker 2: 21:03

So bill, I always ask each guest a little bit about their CRE professional selves. So take us back to a young bill petty. I know you were born and raised in little rock and your mom was a homemaker. Your dad was a salesman. What were you like as a kid? Were you a good student? Did you play sports? Did teachers love you? Or were you always in the principal’s office? Like I was, I know there’s a lot to unpack. So take your time.

Speaker 3: 21:24

I was a good student. I was never in the principal’s office except to get awards. My parents were very supportive, but also let me be somewhat independent. Obviously I was a normal kid. My sport was track . Maybe that’s where I’m still a runner. I was pretty good at it. Pretty good at it. They want to try to recruit me to the football team , but I didn’t want to get knocked around like that. So I feel about experience was when I was in the air force. We did flag football because there must be . And I was pretty good at that as well, but I didn’t get knocked around because it was flag football. I’ll tell you a very quick, interesting story. I don’t have a high school diploma. You’ve already noted that I’m from little rock Arkansas and you may or may not remember or have learned that little rock was one of the first school systems in the South to be integrated. And I went to little rock central high school, great school by the way still is. But that’s where her father was first close to schools and subsequently president Eisenhower since a hundred first hour born. And it was very interesting. So in the 10th grade I went to school with just soldiers. Everything was fine. This was a school of 2000 students. There were seven black kids that came obviously all good students. I mean, they’re going to pick them very carefully. Then it was the following year. The governor fathers closed the high schools in little rock that was bad for some, but kids do different things. They went to other cities. There was relatives, there were some private schools that were already there and open. I took correspondence courses from the university of Arkansas during the 11th grade. If the end of that, nobody knew what was going to happen. So the colleges in Arkansas said, if you have a certain number of credits and can make a certain grade on the sat or act or whatever, you can come on to college, even though you have not graduated from high school. I did that. I actually went to little rock university. That was an easy discovering and I’m still a pretty young kid. It’s now part of the university of Arkansas system, but that’s where I went. And two or three weeks after I was there, they opened this high schools and middle rock . So I had a decision to make, I should, I’m already here. I think I can do this till I stayed in college. So I have a bachelor’s degree, a master’s degree and a medical degree. I do not have a high school diploma still. Don’t early in my life. I would get all these advertisements, finish your high school, get your over to fall in love with . And that went on for years and years and years. The other wonderful thing about that is they’ll allow you to be a 12th grader in college. Betty’s family had moved back to lower rock from another city in Arkansas because they knew they were doing that. She finished high school in a regular way . She did extra, got all the credits and graduate . So Betty and I met when we were 16 students at little rock university and you know, the rest of the story,

Speaker 2: 24:08

That’s a great story bill. And I imagine it gives you a , probably a fair amount of empathy for the students last year in high school who basically couldn’t finish or had to finish online or whatnot. And it makes me wonder all of a sudden, I wonder if they’re gonna be some future bill Petty’s out of that cohort because they had to do something similar. He sort of patched together the last year, their school, and maybe they started your early in college and so on. But that’s a great story. And I got to ask, is that like a trivia question at an exact tech dinner? Which one of our C-suite executives doesn’t have a high school degree ?

Speaker 3: 24:38

Yeah. When I was chairman of orthopedics at the university, they would make light of that in one time. One of the guys gave me a certificate to make up for not having a high school diploma back to your point. Yes. There probably are people that what’s happened over the last year. It worked out better. As we also know, there are a lot of people don’t have that kind of support. And so I’m sure they’ve been hurt by it. So we’ll have to see how we work through all of that

Speaker 2: 25:04

One particular moment in your early schooling where you thought that maybe one that you’d become a surgeon and two, that you would run your own company, you remembered liking the idea of that or thinking about it or did that come much?

Speaker 3: 25:16

Well, Betty always laughs . When people used to ask me in my youth, what I wanted to be, I said a charter boat captain. I still love voting . But in answer to your question, I started in college and business administration. So I had an interest in business. However, I also had a real interest in science and I was just talking before class one time with a girl who said a friend, but his girlfriend, actually, this girl is the one who had kind of introduced to me also, but she said, well, why don’t you try more science and think about medical school. That was really the first time I’ve thought about it. So that was kind of toward the end of my freshman year in college. So I kind of went that way. And then other than that early business experience, no, I had no plan. Once I got into medicine and eventually orthopedics to go into business that really came more from the work that Gary and I were doing and the conversations we had. And that’s when I more studied business. Now I will say one other thing about that. When I first moved to Gainesville, I got to read orthopedics all the time, you know, and that’s what I do. That’s who I am. I want to read something else. So I started taking a couple of business magazines, really just more as a diversion to read something outside of medicine and orthopedics. So over probably gosh, 15 or 20 years probably got a pretty good business education from reading those magazines, even though I don’t have any formal business degree or anything of that time . So, you know, you’re somewhat

Speaker 2: 26:44

Of an unusual combination because we talked to a lot of inventors, entrepreneurs, founders, and generally speaking, it’s rare that you have somebody say the inventor themselves, the researcher, the physician also start and run a successful company and a to start companies, but they quickly step aside because that’s not really their deal. So to have someone who is both trained as a surgeon, worked as a surgeon and then develop and run a company it’s not unheard of, but it’s fairly unusual. Yeah .

Speaker 3: 27:10

There are a few who have been very successful. I know one ophthalmologist was very successful and then much later, so this company out Johnson and Johnson, so there are some, I think for me it was, you cannot combine the, to make the kind of contribution for the treatment of arthritis that I would like to make way back in medical school. I became interested in arthritis and said in my career, I’m on developed a cure for arthritis. Well, I learned a lot along the way. There are a lot of different kinds of arthritis. I haven’t done that, but I would say that kind of where I’ve got to was a combination of orthopedic surgery and business has helped a lot of people with arthritis. So from that stoma, I did have that little thing in my brain very early in my medical career, even before I graduated from medical school, physicians are pretty smart people. First of all, just to get into medical school was extremely difficult. And then you work really hard. So it’s a matter of , do you have the desire and then are willing to apply yourself in another way? I think most of those shoes start companies that maybe eventually become very successful, but step aside, fairly early and remain on it as consultants, whatever, I think that’s what they want to do. And I totally respect that. I wanted to go a different route and be more involved in the whole situation. So I think that’s how we got where we got with exactly.

Speaker 2: 28:34

So bill final question, people in your position who’ve done really well, very successful, often get asked for advice. So I’d be really interested. What are the most common questions you get from people seeking advice and what are your answers?

Speaker 3: 28:47

It’s a straightforward question. How do you do what she did? I know a very, very successful surgeon in Arkansas, by the way, who sediment. I want to be bill petty. When I grow up, I mean, he’s a very successful renowned surgeon . He says that . So how do you do it? Study what you’re interested in it . Some people say, I want to make money. We’ve done okay financially. But that was never our goal. Our goal was to make a contribution, do something that we were passionate about. Perseverance don’t give up. I think it was Winston Churchill there . I’m sure many people have said never get up. It was back in world war two that Winston Churchill said we will never give up. So don’t give up because there are going to be obstacles things you’re going to run into, associate yourself with competent, passionate people of integrity who are positive and also want to make a contribution golden rule or platinum rule treat others as you would like to be treated. It’s actually Stephen Covey who developed the platinum rule, treat others as they would like to be treated. First of all, you have to figure out what that is and then you can treat them that way. And I’ll get you in a little bit , bit to exact text values and my own personal values. You have to build trust and exact X values are integrity. Number one, compassionate, teamwork, excellence and innovation. So work with the people and live there because there’s, I don’t see you doing that. They’re not going to do that communication skills, especially for me, I’m a very shot or there’s nothing. I hate more than a cocktail party because I don’t feel comfortable with that though. My wife now says, Betty says, you’re really very good at it . It doesn’t mean I like it. And then finally recognize your customers may know more than you do a whole lot of things. So be a great listener and in pay attention to them and work with them. So that’s kind of been my, our company’s philosophy. And I think that to what success we’ve had,

Speaker 2: 30:49

It’s all great advice, bill. I got a comment on the cocktail party. I don’t like cocktail parties. It didn’t come naturally to me for a while . And then finally I realized the secret to cocktail parties is you find the one person who looks like they’re having a worse time than you are. You go up and just say, how you doing? And they’re so happy to be saved. I actually was originally an introvert and then I joined the foreign service and I finally decided, you know, if the U S governments pay me to diplomat, I’d better get good at this. I got to talk to people,

Speaker 3: 31:15

Enjoy the same for me. I talked about listing, unless you can communicate with people, you’re not going to be a good listener . Right?

Speaker 2: 31:22

Well , thank you very much for being on radio Cade . It’s been a great conversation, strongly encouraged listeners to also listen to our interview with Gary Miller ILS co-founder of exact tag . That was from May, 2020, I think may of last year. Listen to those together, I think would be a great combination, but wish you all the best. Thank you for everything you’ve done. Particularly for people who now can probably walk or do things they couldn’t do before and look forward to having you back at some point.

Speaker 3: 31:44

Thanks a bunch. We have huge respect for the K kids can learn what they can do and they can be , I think it’s fantastic. Thank you. Thanks. A bunch.

Speaker 1: 31:55

Radio Cade is produced by the Kadan museum for creativity and invention located in Gainesville for Richard Miles is the podcast host and Ellie , Tom coordinates, inventor interviews, podcasts are recorded and Parkwood , soundstage, and edited and mixed by Bob McPeak radio. Cade theme song was produced and performed by Tracy Collins and features violinist Jacob Lawson.

TRANSCRIPT:

Intro: 0:01Inventors and their inventions. Welcome to Radio Cade, the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We’ll introduce you to inventors and the things that motivate them. We’ll learn about their personal stories, how their inventions work, and how their ideas get from the laboratory to the marketplace. Video motion analysis of disabilities or anyone in motion. That’s what we’re going to talk about this morning on Radio Cade. I have with me Cara Negri, who is involved in a company that is taking this to market or is already in the market. So welcome Cara.

Cara Negri: 0:52Thank you.

Richard Miles: 0:52So before we begin talking about you and about the company, why don’t you tell me exactly what the underlying technology is and what it does. We’ll come back and talk later about the applications and so on.

Cara Negri: 1:06Sure. Basically video is becoming the ultimate medium for us to communicate with people. It tells a story much broader than a image or a paragraph. And so with 2D motion analysis or video analysis, we can take our smartphone and take a video of someone moving and then we can actually measure some of the progress that a person is making. So let’s say you hurt your shoulder and you’re not able to lift it 100 percent up, we can take a video of you now doing the best that you can and we can measure that angle and then we can go through some rehab, maybe provide some intervention with a brace, and afterwards we can measure that intervention in the same way that we did by measuring that angle again and measure how well you’re doing. And that also gives you the person that is going through this process, the feedback to see how you’re doing in your progress of rehabilitation versus me just shouting feedback to you or you’re not doing good enough or that you need to lift higher. When you can actually see it, it actually connects to your brain a lot faster and you can actually improve your function through that bio feedback. Little to no response by me, I don’t have to intervene as much

Richard Miles: 2:20I see. And so Cara, just so I understand, is the technology here, do you use, for instance multiple cameras or is it a software solution which you’re taking video in theory from anywhere, like a smartphone and you’d simply analyzing it with that software?

Cara Negri: 2:34Yes. So you can take video in any way you want. So if you want to use a really high fancy camera, high definition camera, then you can or you can use your smartphone because smartphone cameras are actually pretty good these days. So it’s about the practicality of it.

Richard Miles: 2:51I see.

Cara Negri: 2:52Um, we all may have seen how Avatar is made with lots of pinpoints on the person and we’re tracking their motion and we can do lots of animation with it. And that is the 3D motion analysis that some people may have seen. And that’s great for research and for higher capture of what we need to find out about a person. But for the practical uses of physical therapy or prosthetics and orthotics, we don’t need that much information. We need one dimensional or two dimensional information for us to observe, so the reason that video is that ultimate solution is because our eyes are not very reliable. We make mistakes, we see things that aren’t really there. So using video to even just play something back and see that event again, as you see that we do with the World Cup going on, other sports, video playback is becoming a part of even professional athletics. So if we can just record a video and use that for playback, that’s the first step to seeing things that you may have missed in the real life event.

Richard Miles: 3:59So the name of the company is PnO? Correct. And that stands for

Cara Negri: 4:03Prosthetics and Orthotics.

Richard Miles: 4:05It’s associated or owned by a New Zealand firm, is that correct?

Cara Negri: 4:09The New Zealand firm is called the Tarn group and they create software solutions for a lot of motion analysis as well as learning management systems. So we all started as a group providing software solutions for athletic coaches. So thinking of golf or bike fittings, tennis, professional swimming, rugby, different athletic associations were using the software to provide feedback to their athletes. So that they could perform better.

Richard Miles: 4:40I see.

Cara Negri: 4:40So when I started using their products, I saw the opportunity for me to use it as an educational solution as well. So when I was trying to teach other practitioners what I was seeing in a video why I was making a clinical decision. I started to use video as that medium so I could slow things down and say that right there. That’s that moment of why I’m making this clinical decision here. And so I was using mostly their bike fitting software to do so. And it’s actually very similar bike fitting, if you think about it, the biomechanics, if you have a pedal that’s not correctly placed than it, it’s going to affect the performance. So if we can do the same for healthcare, we look at how something might be affecting someone’s performance and we can make adjustments biomechanically with interventions or therapy.