Functional Electrical Stimulation for Paralysis

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. Richard Miles: 0:39 Helping people with paralysis. That's the subject of today's Radio Cade and with me, I have Alan Hamlet who is with a company Myolyn. Welcome, Alan. Alan Hamlet: 0:47 Thanks for having me, Richard. Richard Miles: 0:48 So Alan, let's start out by explaining the core technology, what Myolyn has done, how it works, and who it's supposed to help. Try to use no jargon. Make it as simple as possible, mainly for me, but also for our listeners. And then at the end we'll sort of get into the direction the company's going. Alan Hamlet: 1:05 Okay, I'll do it again. So Myolyn's mission is to improve health and human performance by empowering people to move. And our first product Myocycle is essentially a stationary exercise bike designed for people who have paralysis. So a lot of people don't realize, but if someone has paralysis, you do something like a spinal cord injury or any damage to the central nervous system due to multiple sclerosis or traumatic brain injury, oftentimes the muscles and the nerves and the lower body itself are perfectly fine. They just can't hear what the brain is saying. So what Myolyn does with the Myocycle is we bypass the damage to the spinal cord and apply electrical stimulation using electrode pads that we place on the skin. The sticky adhesive backed electrode pads over target muscle groups, and we can apply a small amount of electrical current to stimulate those target muscles and get those muscles to contract. And by timing and coordinating the stimulation applied to those different muscle groups in a coordinated way, we can allow someone who is completely paralyzed form a functional motion. So the Myocycle allows someone who's completely paralyzed to actively participate in therapeutic cycling exercise using electrical stimulation, which we call FES, Functional Electrical Stimulation. Richard Miles: 2:22 Okay. Functional electronic or electric? Alan Hamlet: 2:24 Electrical. Richard Miles: 2:24 Electrical. Okay. Alright. So now we know what it is and you're the principal inventor of this technology Alan Hamlet: 2:30 The inventor was actually my co founder. We were actually both getting our PhDs in robotics at the University of Florida and the technology was really the topic of his PhD dissertation, so controlling the human body using electrical stimulation. So while we were still in grad school about five years ago, now, we started the company to take this technology to market and help people who are living with paralysis. Richard Miles: 2:52 So Alan, let me ask you a bit about your background. How did you come to this stage, getting involved in the project and maybe tell us a little about growing up. What were your interests as a kid? What was your, either inspiration or role models or curiosity that sort of led you to what you're doing now? Alan Hamlet: 3:05 Sure. There's a lot that I could use to answer that question, but I started out throughout my entire life just really interested in science and technology and math. I always knew I'd be an engineer, basically. I was just always the kid who was taken apart my toys and trying to put them back together and half the time I couldn't do it, but I just wanted to know how everything works. Richard Miles: 3:21 That's a recurring theme on this show. Most guys who have taken apart their toys and don't know how to put them together. So... Alan Hamlet: 3:26 Yeah, I had this curiosity of just how stuff works. Right. So went to school for engineering, kind of fell in love with robotics and always looked up to the big innovators that are making a big difference in the world like the Google cofounders and Elon Musk and Albert Einstein and Nikola Tesla and people who have created these once deemed crazy ideas that are now social norms and making a big difference in the world. So both my cofounder Matt and I had people in our lives who've been affected by mobility, had health issues. For me, it was my uncle at a very young age. He fell off a ladder, hit his head, suffered a traumatic brain injury that left him paralyzed. And throughout my years as a high schooler, I witnessed firsthand how immobility really affects your health and quality of life. His health just steadily deteriorating due largely due to his lack of mobility. And so this idea of empowering people to move really... Richard Miles: 4:18 You saw it up close. Alan Hamlet: 4:20 Right, you know, we know firsthand the terrible side effects of not being able to move. Everyone needs exercise and if you just can't use the largest muscle groups in your body, you just... Richard Miles: 4:29 Atrophy Alan Hamlet: 4:29 Yeah, you'll atrophy, you'll deteriorate. You won't be able to have those cardiovascular benefits. Richard Miles: 4:34 And did Matt have a similar experience or circumstance? Alan Hamlet: 4:38 Yeah. Well his mother has had all sorts of health issues, different types of cancer. Man just has been impacted. And I know that he likes to relay a story where when he started going to engineering school, he's actually was into prosthetics and she's like, I wish you could make me a new body. And so... Richard Miles: 4:53 Interesting. Alan Hamlet: 4:53 We're not making people new bodies, but we're helping them utilize the bodies to the best of their abilities. Richard Miles: 4:57 So when you both entered engineering school, did you already have in the back of your head sort of the problem or the set of problems you wanted to solve, or was it only after studying a little bit of engineering that you realized that you could actually do something about these things that you've been thinking about? Alan Hamlet: 5:11 Yeah, I would say absolutely not. We didn't know. I mean we really just knew we had a passion for technology. We had a passion for solving problems and this happened to be a problem that we weren't actively trying to solve at the time. But we really saw the opportunity, right? We, we knew that robotics specifically, which is what we're very, very interested in, kind of led us here when our PhD program was in robotics, but started seeing how the analogs between the human body and robotic systems and how the technology that we were working on can be used to solve this problem that we recognize and have firsthand experience with. And so we saw this opportunity to really make a difference and we seized it and went for it and started the company and are bringing this technology to market. Richard Miles: 5:57 Was there a particular point in your engineering training, either for you or for Matt, in which it boiled down to a particular class or a teacher or even a certain lesson in which all of a sudden dawned on you like, "Wow, this is not just theoretical stuff I'm learning in a book that I need to pass for a test to get a degree. This is actually something that functionally I can figure out something really useful to do this." Or was it just sort of a dawning realization? Alan Hamlet: 6:20 Well, I would say it was more gradual over time. And especially during graduate school, you start doing things that are still very theoretical, but you can see directly the implications of some of those theories that you're learning about. But again, my cofounder, Matt and I are very entrepreneurial and very wanting to solve problems in the real world. So we actually took a class called Engineering Entrepreneurship. And that's actually where... Richard Miles: 6:44 At University of Florida? Alan Hamlet: 6:45 At the University of Florida. Yeah. And Erik Sander was actually the teacher of class. Richard Miles: 6:49 Oh yeah, Erik's great. Alan Hamlet: 6:49 Yeah, he is great. He is great. And we've wrote Myolyn's first business plan. That's when the light went off in my head that wow, this needs to be a product. Like there's a huge, huge problem. We have this technology to help solve this problem and writing the business plan and looking at the market, you know, I realized how big that market was and looking at the competitive landscape, there's nobody solving this problem. And so I realized that somebody needed to do it and no one else was going to do it. So we had to do it. Richard Miles: 7:16 So it sounds like you and Matt were somewhat unusual, and again I'm trafficking in stereotypes here, but often the knock on engineers is that they don't maybe look at the wider business applications or they're focused on the numbers and the actual calculations. And then the knock on the business students is that they've got all these great ways to go to market, but their ideas are lousy. And I know some universities, I can't remember if University of Florida does this, did you have a class in which you were thrown together with business students who were in the same orbit and you're trying to solve on a wheel or a hypothetical problem coming at it from the engineering angle on one side and kind of the business entrepreneurial angle on the other side. Alan Hamlet: 7:53 I never really had an experience like that before with the engineering entrepreneurship class and we had to form a virtual company with what it was all engineering... Richard Miles: 8:02 So it was all engineering students. Alan Hamlet: 8:03 Yeah, so neither me or my co founder had any business background, but then we Richard Miles: 8:08 Found that you had an knack for it or... Alan Hamlet: 8:10 Well we learned it, you know we learned it. And one of the ways we did that is we audited the business colleges business plan lab and they have a business plan competition around that class. So we audited the class and competed in the competition and actually got second place. I won $10,000, which helped us hire employees and get started. Richard Miles: 8:30 Let's talk about where you are now in terms of your company. Let's start out by saying it sounds like you've got a great core idea. Have you been surprised, I guess of either A: how easy it's been to convince others that it was a great idea or B: how hard it's been to convince others or to bring them along to the concept. Alan Hamlet: 8:48 I think a lot of people immediately see the need for the technology, but kind of to your point earlier that they don't necessarily see the business model around it. Right? Especially when we're talking about paralysis, everyone's like, oh, that's a niche market, right? That's a, that's a niche market. Oh, that market that can't afford this product. You're not gonna make any money. Right. Richard Miles: 9:06 So their argument is that the number of people affected is too small for it to really be viable. Okay. Alan Hamlet: 9:11 You know, which is kind of a sad answer. That doesn't mean that it's not a huge problem and it's not something that rides tremendous value to people who have paralysis, but a lot of people don't realize how many people are actually affected by paralysis. You know, the Christopher and Dana Reeve Foundation estimates that over 5 million people have some type of paralysis and that's just in the United States. It depends on who I'm talking to, right. If I'm talking to investors, sometimes it's hard to convince them of the value proposition, but if I'm talking to patients or clinicians or physicians, they see the need and they see. They recognize that this is a great product but not necessarily the business proposition. Right. And that's something that we had to develop over time. Right. From as being an engineer without a business background. Richard Miles: 9:50 Tell me a bit about the cost because from what I saw on your website, and hopefully we'll be able to put this up on our website. It doesn't look like that expensive, a core proposition. I mean you have essentially it looks like kind of a modified exercise bicycle almost, but obviously you've got the electrical stimulation component. Are these expensive to manufacturer to the standards that you're doing or what's the general cost point, I guess? Alan Hamlet: 10:12 Well, our goal is to really bring this technology to all the people that can benefit from it, so we're trying to get as high volumes as possible. Right. We're shooting for thousands of systems per year and at that level we can bring the cost down significantly. Right now we're not at those volumes, so the cost is relatively high for us and it's also regulated by the FDA, right? It's a class two medical device prescription only. So there is that kind of aspect to having to build it to FDA quality standards. But again, it being a medical device, we help file insurance reimbursement. So oftentimes our customers get it at no cost to them. We have financing options, right? We work with a third party financier. A lot of states actually have programs to help get assistive technology that this qualifies for, so a lot of times the patients don't actually have to pay anything out of pocket. But to kind of give you an idea, the next closest thing to what our product is is about $17,000. And I could say that our product is significantly less than that. Richard Miles: 11:11 Okay. And do you have FDA approval for this? Alan Hamlet: 11:13 We do. Richard Miles: 11:13 You do? Okay. I've heard horror stories about getting FDA approval. How did yours go? Alan Hamlet: 11:20 Took us a long time to get all the documentation and get our ducks in a row, finalize the product. We wanted to make sure we built what we wanted to build, which took a long time, but once we submitted, we did a great job and got cleared in record time. It took about 97 days from submission to clearance. Richard Miles: 11:34 Wow. Sounds amazing. Alan Hamlet: 11:35 Yeah. Everyone said it was gonna take six months and we're like, Nah, I don't know. I think we can do it sooner than that. Richard Miles: 11:40 Did you hire a specialist or an expert at FDA approval process? Alan Hamlet: 11:44 Yeah, we hired a consultant, local consultant here in Gainesville, and he was instrumental in helping us put our application together and my cofounder, Matt Delman, the chief officer, did a phenomenal job at really analyzing all the standards and what needed to be submitted. All the documentation we needed to put together Richard Miles: 12:00 And does Matt have a patent on this or does the company have a patent on this technology? Alan Hamlet: 12:03 Well, the university is patenting it. Richard Miles: 12:04 Got it. Alan Hamlet: 12:05 The technology was developed during his research here at the University of Florida and so we have an exclusive license. Richard Miles: 12:10 All right, so going forward then, assuming you're successful and you've established yourself, are there other applications beyond the paralysis market, so to speak? Is it something that older people who are no longer getting much exercise, who are maybe partially mobile, would that be a benefit to them or are there other markets out there that if you could manufacturer to a competitive cost point that you're thinking about? Alan Hamlet: 12:34 Yeah, so Myolyn's mission again is to improve health and human performance by empowering people to move. Mobility is a huge issue, especially with the aging population, right? The baby boomers getting older. I think the population of 60 plus is starting to surpass the population of 60 minus right now, so it's a huge issue, mobility, and mobility has a direct correlation to quality of life and lifespan and so Myolyn is not just one product, right? We're, we're developing a lot of other things around robotic mobility, right? From both rehabilitation and functional mobility. So there's definitely a huge market potential for a company that is helping to build products, incorporating some of this state of the art robotic technology that is coming out. Algorithms are getting much better. My background is AI and machine learning. Electronics are getting cheaper and just the understanding of control systems are getting better and understanding of human physiology is getting better and I think now is kind of really a turning point. I don't know if how familiar you are with robotic exoskeletons, but there's several companies that are doing that now, but they've all missed the mark I think, and so there's a couple different products that we're working on that utilize the core concept of using robotics to improve health and human mobility by empowering people to move. Richard Miles: 13:56 The conventional wisdom for startups, particularly those originally at a University of technology is that, you know, it's really hard to make that transition for the academic into the entrepreneur slash business world. Some people manage to do it, but eventually, you know, the conventional wisdom is that you got to sort of choose, right? Either you stay in academia or even a business, but you can't do both. Where do you see yourself say in five or ten years, you and Matt, do you want to stay kind of in that world of research and keep cranking out great ideas and handing them over to business people who will take it to market or do you want to do both or... Alan Hamlet: 14:27 I want to be involved in bringing products to market. R and D is extremely fun and as an engineer that's kind of what I like to do, but I always, you know, even getting my PhD, I never saw myself as being an academia. I want it to be out building things that are having an impact in the real world. Five, ten years from now I see myself with Myolyn pioneering new products that are solving bigger and more and more problems. Richard Miles: 14:55 Virtually every entrepreneur I've talked to has a great disaster story in which, you know, they made a key assumption that was wrong or an investor pulled out. Now you had a great FDA process. So I know it's not your FDA approval. Did you have anything, you know, in the past couple years or at all that you and Matt encountered that you just said, "Wow, this sucks, we're done." Or has it been fairly smooth sailing? Alan Hamlet: 15:16 Definitely has not been smooth sailing. I wouldn't say that, but I think one thing that has been the bane of my existence as CEO of Myolyn has just been fundraising, right? So just begging investors for money and trying to get the capital required to achieve our vision. You have something you always need to be trying to do and it's not fun. I don't enjoy doing it right. I'd rather be at least business planning or developing product or something. So there's been times where funds got low, things got very difficult and really hard decisions had to be made and that's just something that you just have to deal with as an entrepreneur. Richard Miles: 15:52 When you talk to investors, are you surprised by any of their assumptions or questions about either the technology or the business model? Alan Hamlet: 16:02 I would say the most enlightening thing that I've learned throughout the last five, six years or so is how complicated the healthcare system is. There's just so many different parties involved, different stakeholders involved with making decisions and getting patients the care they need, right?. So this is something, our product, the Myocycle, is something that we believe every person with paralysis needs in their home to maintain their health and wellbeing. This is something they need, but in order to really get it to them, we need to convince the patient, we need to convince the physician we need to convince the health insurance company and then all the suppliers in between, right? As a manufacturer, we sell direct, but we also sell through suppliers and there's a lot of moving parts, right? And the difficulties of working with different insurance companies of which there are a plethora and they all have different procedures and processes for submitting insurance claims and you might have to be a licensed DME supplier and in certain states and you have to be a contracted provider for them to even look at your insurance claim. It just makes the whole process very cumbersome. Everyone should be aligned and improving care and quality of life and reducing costs for the patient. That should be the... Richard Miles: 17:09 Right, right. Alan Hamlet: 17:09 And oftentimes it is, but it's just. It's very difficult to do with the processes that we have in place here. Richard Miles: 17:14 I think what comes as a surprise to a lot of people who are building businesses or building institutions is the extent to which you have to essentially be a storyteller, right? You have to communicate ideas to various audiences and then it dawns on you that they actually each need a different story. The message is going to be different depending on if you're talking to a regulator or an investor or the general public for that matter. Alan Hamlet: 17:35 That is absolutely true, yeah. Richard Miles: 17:37 Alan, the name of your company is Myolyn spelled M Y O L Y N what is your website? If people want more information. Alan Hamlet: 17:43 It's simply Myolyn.com. M Y O L Y N .com. Richard Miles: 17:47 Okay. Well we wish you all the best. Thanks very much for coming on Radio Cade, and once you've hit the big time and you're a billionaire in Silicon Valley we'll have you back on the show and you'll have a huge following by then... Alan Hamlet: 17:57 I'm looking forward to it. Richard Miles: 17:58 I'm sure you are. Thanks Alan. Alan Hamlet: 18:00 Appreciate it. Outro: 18:03 Radio Cade would like to thank the following people for their help and support. Liz Gist of the Cade Museum for coordinating and inventor 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