Objectively Measuring Motion - A New Frontier
Frank Fornari is the Founder and Chairman of BioMech, a leading company in motion analytics. In this episode Frank shares information on how our movement can indicate health, injury, decline, disease or neglect; why assessing motion can help to understand if we are getting better or worse over time, or after an intervention or surgery; the BioMech system; options for commercializing a platform technology; and the future of motion analytics.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! Imagine managing high blood pressure without a blood pressure cuff. How about fever without a thermometer, or your cholesterol level without a lipid panel. objective tests are the gold standard for diagnosing and managing disease because they provide clear data, data that can't be manipulated, misunderstood, minimized or exaggerated. One field that hasn't had adequate objective tools or technology is a study of motion. Our guest today is Frank Fornari, founder and chairman of Biomech, a leading company in motion analytics. Frank spent the first part of his career in biotechnology and co founded and was CEO of Dominion Diagnostics, one of the leading pharmaceutical monitoring laboratories, he has now shifted his focus to understanding how motion as an objective biomarker can be used to diagnose conditions and also to help patients optimize rehabilitation. In our conversation, Frank shares that how we move can indicate health, injury, decline, disease or neglect. Why assessing motion can help to understand if we're getting better or worse over time, or after an intervention or surgery, the biomech system options for commercializing a platform technology and the future of motion analytics. Here's our conversation. So Frank, the majority of our conversation today is going to be on motion analytics and how it may change different aspects of medicine. But before we do, I'd like to get understanding about how it all started. I believe that we're all developed based on our past. And we all have different things that occur as a result of us growing up. So can you take us back a little bit into your childhood, where you were born, what was going on, and how that impacted you in your career?
Frank Fornari 03:01
Sure, I landed in Cleveland, Ohio in 1958 in and I spent the majority of my young life growing up in western Pennsylvania, you know, my family, or were worked in the coal industry, they were coal miners. So I grew up in, in the Appalachian Mountains in the coal mines,
Patrick Kothe 03:21
that must have been a little bit a little bit challenging.
Frank Fornari 03:24
I tell people, I say like, they live with people that on the other side of the tracks, we lived on the tracks. So you know, it was it was certainly not easy. And you know, everybody worked really hard. And obviously, it wasn't a you know, we weren't very financially privileged, everybody just really worked like a ton just to make ends meet. And the nice thing about it is, you know, everybody was in the same boat and you learn how to work together, you know, the people people really help each other. When I grew up,
Patrick Kothe 03:59
did you come from a large family, small family,
Frank Fornari 04:02
I have one brother, but my mother had a brothers and sisters and you know, most of the people there, you know, had large families and, you know, everybody rolled up their sleeves and pitched in. And, you know, we all struggled I had a full time job when I was eight years old. So, you know, the times were very different than they are today. So, you know, we grew up you know, just making sure every day was was just like you get up you try to figure out where you're gonna get your resources, your money and how you're going to eat and how you going to get you know, stay safe and make it through the day and make it the week so we didn't have a whole lot of long range goals or, or, you know, people weren't really able to plan because life was pretty tough. So you just, you know, we live kind of day to day so that's what I was used to growing up but, you know, where I grew up was, you know, riddled with healthcare problems. So, as you would expect, you know, working living grew up the coalfields, you know, it was pretty, pretty bad most people had bad health habits they smoke, they drank, you know, alcohol was, you know, sort of a, you know, a depressant, it was an anxiolytic. But it's also a painkiller. So it was overly utilized. And smoking was really prevalent because it calms people down and, but between smoking and drinking and all the hydrocarbon emissions cancer was was just kind of rampant where I grew up. So most of my family died of cancer and in my brother had cancer at an early age. And so as a, as a small child, you know, that affected me, you know, I was just like, you know, what, you know, I'm gonna, if I were ever in a position to grow up and do something, I would go to school and see if I could, you know, make an impact on you know, really kick in cancer in the ass. So, I spent a lot of my early years working toward that. So I went to went to school, my schooling was aimed at that. So, you know, I went to college fairly early, you know, while I was still in high school, and then got a master's in neurophysiology and, and went and spent some time in medical school and, and I have the equivalent of two doctorates in biophysics in what we call molecular pharmacology or genetics, and IT training in an advanced organic chemistry. So the whole training was about identifying that particular disease process, finding targets during that process and developing treatments and or tests to fix that,
Patrick Kothe 06:26
frankly, advanced education that you had, were you the first one in your family to have such an advanced education.
Frank Fornari 06:32
Well, I was certainly the first one in my family to have this much education, I have more education than probably most people have. But, you know, my grandmother, who, who, you know, came over from Poland at age nine, and, you know, didn't get much of an education after that had nine kids. But it was a very smart, practical person, you know, sat me down when I was about four years old and said, you know, one of the only things you can not stop doing in life is thinking, you know, she goes, Listen, if you can get good at thinking and learn things, you'll find a really good place in this world, she she'll be able to survive and, and do well for yourself. So, you know, I think that was, yeah, from I mean, you know, these were, these were tough people who really had brutal lives, you know, that was not easy by any stretch of the imagination. But, you know, they were they were unselfish people who, you know, pushed you forward. So they came here to America, you know, so I would have a chance to do the things that they couldn't have so many incredibly grateful to, like both my grandparents, my, my grandfather, on my father's side, you know, I mean, he came over here at age nine, and worked in the coal mines. And I remember asking him one day, and like, you know, you're, you know, why did you come over here? You know, why didn't you stay in Italy, where, you know, it would have been better for you because, and he said, I came over here, so you could do what you're doing, which I always thought was just just, you know, wonderful. They don't they don't make people like this anymore. I wish we did. I wish, you know, kids today could experience some of that, or the world could, you know, experienced that kind of generational, you know, support. But, you know, we live in an age where everybody's III, me, me, me, and what can I get, and nobody cares who the tramp on. Where I grew up, everybody just passed the torch along, we all stood in each other's shoulders, you know, was a different time. And, you know, for me, it meant a lot to have that kind of support, you know, and it helped me persevere, even though it was not easier for me to get through school. So I had to work two, three jobs. And, you know, it's fortunate to get some scholarships, but it was still I had didn't have any financial resources to, to make it through all the schooling and it's expensive, you know, so it took me a lot of time where, you know, other people weren't paying their bills, I was working all night to make enough money to buy books and pay my tuition and, you know, trying to study when I could so, you know, it was, it was a lot of work, you know, it was a lot of work, but I wouldn't change anything, but I think, you know, gave me so much confidence and strength, and I think I can beat anybody, you know, let's just just because I, you know, can, you know, so, you know, that's kind of what drove me over the years. But you know, that it spurred me on to, to, you know, learn enough different aspects of science where my goal was always take something from like brain to biter, right? Most things happen in science just kind of sit on a coffee table, or in the Library of Congress, they never see the light of day, you know, for a million different reasons, you know, maybe they've just developed for an IPO or, or, you know, there's no practical utility for them. But I always wanted to, you know, make something that was clinically relevant, meaningful, you know, that was actionable for the patient could help the physician do their job and, you know, ultimately help the payer, you know, find a way to treat people better, more efficiently, more, more economically, medically. So, you know, our system arguably is, is kind of broken now. You know, we not enough people have health care, it's too expensive. serve, I've always just tried to maybe make my little part of it better. And, you know, hopefully everybody else would do the same thing.
Patrick Kothe 10:06
So you had a dream early on. And that dream was to help people to be involved in the medical space, and got educated with it, tell us about the early part of your career, tell us about your entry into the working world,
Frank Fornari 10:21
I was fortunate enough to to, you know, to really get a good education. And, you know, when it came time for me to move into the working world, you know, I was lucky enough to, you know, work with a group, you know, it was at the Medical College of Virginia in Richmond, and, and there was a group of folks who had been working on, you know, mathematical algorithms to design drugs on a computer screen using what we call first principles. So we mathematically modeled, you know, the bonding characteristics of molecules, and how they would move, you know, bond rotations, literally electrical chemical properties of these drugs. And if you, and that's really, you know, it what is now called AI, like, we just call it mathematical molecular modeling back in the day, but we have some really, really talented people that we work with it put these things together with us. And we were able to actually design compounds on a computer screen. So some of the first drugs that we worked on, my first company was involved in a pharmaceutical startup that did very work very well led to a successful IPO, that grew out of the university, we spent time using structural biology coupled with molecular modeling to fine tune the compounds. And then we did some work with those algorithms to help in part in some small way design, some of the drugs like in the HIV cocktail came out of that work. And, and so some of the math that's, that's buried inside the tools that we have at Biomek, you know, spawned from my first entree into science and medicine was back in the mid 80s. And I've always used mathematics, as the is the language for what I would do. So we became quite good at mathematically modeling things. And so I spent most of my career, you know, doing sort of what you would call mathematical biology. It was
Patrick Kothe 12:14
that what you were educated on? Or did you just use it, you know, find that that was a great tool and started learning about it,
Frank Fornari 12:21
you really have trouble if you just want to try to stay within one little silo of science, right? You know, you you really have to, if you combine all that, you know, right, and you look for answers using any tool in your any arrow in your quiver, you'll, you'll find an answer I think better. So I always tell people, you know, discoveries and accident to the train mind that that's really what it is like, if I look at a Petri dish in you look at the same one, I might see something and moves in there, or you might miss it, because you're you just weren't trained to think about it that way. So, you know, the more you can know about different aspects of, of physics, chemistry, biology, math, you know, all those kinds of things in there, you're stronger when you go to try to solve a problem, right? Because that's really what you want to do is use all the tools you can to solve a problem. Like as a scientist, your goal is to put yourself out of business, you want to find a disease, eradicated and move on to something else, you just want to stop doing that. But you know, a lot of people who only see the world through like one single plane, if you will, of a discipline may not get there, because they just don't know what they don't know. So they tend to not see it, or they won't have the ability to use those other tools to fix something that they're observing. So, you know, one of the biggest problems we have is exactly that, you know, if somebody doesn't know what they don't know, they tend to human nature, they tend to dis diminish, it is unimportant. So I didn't learn that into my education. So it can't be that important. Well, I took the opposite approach. I was like, You know what I'm going to go learn as much as I can, from all these different disciplines. So if I'm sitting in the middle, like, I'm sort of my job has always been more of an interpreter. So I'm happy sitting in a room with chemists, physicists, mathematicians, biologists geneticist, because I can speak their language, I may not be as good as all of them. But in total, you know, I can crystallize a lot of those ideas and sort of be the translator to get people to take ideas from their disciplines, and you know, distill a solution that may be the answer to the problem that we're all trying to solve.
Patrick Kothe 14:38
Well, I think I agree with you 100%. You need to go deep on your own domain expertise, but being a generalist is has really great benefits too, too, because you can't put some pieces together that other people may not be able to put together and you're also involving other people in the process too. By being a junk generalist, you can help to bridge the gap and a lot of those things as well. So as you're coming up, you are coming up on the scientific side, pretty much in the research development side, is that correct? Correct, yes. So as you started moving up, and within the organizations, were utilizing some of these generalists skills and developing some of these generalist skills at at that point, too.
Frank Fornari 15:20
Sure. And, you know, and, you know, because, because I've got degrees in most of these things, I can drill down into the details if I have to. So, you know, if I, if I need to get in the weeds with these guys, I can do that, which is, which is also, you know, gave me credibility, you know, to work within a group or assemble a group of experts. So, you know, if, if I, if I had to get down and get in the dirt with them, you know, science is incredibly hard. I mean, it's really, really difficult. And we only know like this much, you know, we we just know a tiny little bit, it's imperative that a lot of people who have ideas, they need to be validated. So somebody needs to be heard in sometimes, you know, they're saying something is really, really important, that would just get missed by the other people that are members of the group, because they don't know or understand what that person's point is, well, in reality, without that little piece, none of us can move forward. So it's always kind of been my job, like Tinker Toys, put the right pieces all together, and you know, and build the house out of that, no matter who made the, you know, the brick or the, you know, the wall or the window or the door, never everybody brings something to the dance, right. And we really all stand on each other's shoulders, no one person ever, you know, figure something out by themselves. One of the, the best things that humans do together and, and it bothers me, because we're losing some of this, humans are the best species on the planet for like, inter conductivity or interplay. So, when you get in your car, that car is the is the amalgamation of a million years of people inventing things, like someone had to invent the plastic, someone had to figure out how to smelt metal, or somebody that I actually had to isolate, it figured how to make steel, they had to figure how to make glass, you know, to make rubber to make, you know, a machine, the middle all the gears, so that car is is is been built by millions of people, you know, touching things and improving upon things. So, we do a really, really good job of working together, whether we want to or not, it's why we've advanced so fast. And if people would just embrace that, you know, and realize, if you've got a problem to solve, everybody working together, you can get a solution. So when When HIV hit, you know, they called a whole bunch of experts around the world. And I was fortunate to be a tiny, tiny part of that, in a matter of six months later, we had, you know, the HIV cocktail that stopped HIV, dead in its tracks. That is, that is like a small miracle. But it's also a testament to the ability of people to work together to solve a problem, that's is still pretty serious. So, you know, there isn't much that humans can't do. Because we understand, you know, all the building blocks to a pretty good level of what makes up the Earth and the universe and that kind of thing. I always tell people, you know, by definition, you know, that the answer to every question that there is, in our world is the answer is somewhere right in front of you. And, and most of us just can't see it, because the answer the question itself is defined by the building blocks that make up the environment we live in, that means the answers in there, you know, it's already it's part of that. So, you know, if you know more about the environment, and how it all works, solving problems is, is pretty easy. So, you know, we don't teach that a lot anymore in schools, which we, which we should, you know, we were kind of losing, you know, our way with that. So that's kind of disappointing to me. But we would certainly solve a lot more problems. If we would teach people you know how to do that.
Patrick Kothe 19:01
I've been thinking about that a lot to Frank, and one of the things that I believe is that the less humble we are, the less we're going to learn as well. So as as you kind of described that it's like, okay, I know, I know. So my ability to put things into my mind and, and learn more. And to solve that problem. You have less of a chance of that occurring, because you believe that, that you've got the answers. And if you are not able to say, hey, I don't know this, I can learn this. That isn't I believe that that's really an impediment to solving problems. It's definitely an impediment to learning. But I think it's an impediment to solving problems because that's kind of they they go hand in hand.
Frank Fornari 19:50
Well, arrogance is just a is just a way to cover up ignorance. Right? It really has no place in the world. It's it's Just a, you know, a waste of energy, it prevents so many good things from happening.
Patrick Kothe 20:05
And as you're describing that you had, you've got deep domain expertise and a number of different things, you study things, but you probably also didn't study finance or sales, or regulatory, some of those things are not exactly in your wheelhouse. And, and if you don't appreciate the people that are coming in there with their level of expertise, the ability to to build a company is also really limited as well, as you were growing up, what did you What did you learn about that aspect?
Frank Fornari 20:40
Well, you know, I learned the hard way. So I built two successful companies. And I had to learn all that, you know, the hard way, you know, I've made every mistake you could possibly make, but I only tried to make them once, you know. So I tell people, I've learned so much from my mistakes, I'm going to go make a few more today, you know, because really, that's really the basis of learning is learning what not to do, you know, and because it's just stays with you. So, you know, I took one business course, in college, somebody said, the only course you really need to take if you want to be successful business is accounting. So I took accounting, that really helped me, you know, it just made me think about, you know, every transaction or every event, you know, as a value assigned to it. And, and, you know, it's just same as science, you know, you you place value and in sort of a hierarchy on things, and you know, how to build a process from start to finish. And I think, had I gone the traditional business path, you know, I certainly probably would have found a way to do what I do now. But I certainly would be so far detached from the science. And to me, you know, I just enjoyed the science part of this and not to diminish the business piece. But I did start several companies and grew them into big company. So that, to me, is real business, taking something that doesn't exist, inventing it, and commercializing it, and turning into a successful Corporation. And I've been able to make payroll every Friday for the past 35 years. So you just kind of thrust baptism by fire, if you will, Patrick, you just get out there and realize you've got to take care of, you know, hundreds and hundreds of families who are all working to help you and you better get your your butt out of bed and get out there and try to find ways to make cash. But should I have gone to get an MBA? If I would have had the time? Yes, I think it would have really helped me, you know, I would have struggled less, with a lot of the principles that I had to learn from other people. And I've made a, you know, a lot of dumb mistakes that I probably wouldn't have made had I, you know, understood sound business practices, and that sort of thing, but compliance, you know, I'm good at because, you know, the science is full of it, and healthcare is full of it. And we actually helped develop a lot of the compliance standards that are in place today. So, you know, in medicine, you can't fudge anything, you know, what you do has to be precise, accurate, reproducible, it's got to be honest, you know, you cannot get away with things, if you try to, you will get caught. I mean, you have to do the right thing all the time, you know, because somebody's potentially, somebody's life is in your hands. So we take that very seriously.
Patrick Kothe 23:25
Thanks for that portion of the conversation, I think it's fascinating to hear how people grow things, how they, how they view things, and how they, how they grow from their own level of or their own areas of expertise, and developing other areas as well. We, we all you know, grow from one perspective, and then bring other things in, and we all in my estimation, we all fall fall down, and learning from learning those other things that that's where our real problems are, we're good at what we know, and we're not so good. And as we're learning we're making making mistakes. So I really appreciate your perspective there. So let's transition and kind of go from your farmer days to where you are right now. So let's talk about motion analytics. And what was the aha moment to move into that area?
Frank Fornari 24:21
In science, you know, there's, we have what are called sort of fundamental platforms that we all build everything else on. Right? So you take, for instance, like magnetic resonance imaging, which you know, is MRI is a wonderful technique to image things that you normally wouldn't see. So, it's like a fundamental platform to that you can build things on top of and there are certain phenomenon in in the world that that you know, need to be measured. So, Western medicine, primarily is is laboratory medicine or what we call objective medicine. You know, if if every clinician had a way to get a laboratory result or a battery of results that made sense that that objectively could help them, diagnose, monitor, and even even help people therapeutically. That would be the goal. So for instance, if if I was your oncologist, and you had leukemia, and I would ask you a Patrick, you know, how's your white cell count today? What do you think, good or bad? You know, you, you would laugh at me, like you're doing now, because that sounds pretty silly, doesn't it? But back in the day, before we were able to count blood cells, you know, that's the kind of questions and rhetoric that we had. So, you know, the laboratory industry went to work. And they do, quietly, do the bulk of the work in medicine, you know, these are dedicated people that are that sit behind machinery all day running tests, validating the results, getting it back out to the clinicians, who then use them to do all the things they need to do. My job has always been to find fundamental platforms, in science, but also develop the tests to test those treatments or those platforms. So when we develop drugs, we have developed tests for the drugs, right, so you could, you know, make sure the patient had the right drug, which was metabolized properly, you know, what genes was working on, you know, the cases it was we're looking for an endpoint to measure just like white cell counts an endpoint for chemotherapy for leukemia. One of the one of the last or final frontiers in medicine is to be able to measure, not just measure but actually make motion measurements, clinically, actionable, meaningful, easy to do therapeutic diagnostic, because motion is a fundamental, fundamental part of the universe. So everything in this universe has one thing in common and moves, right. And it either moves poorly, very well, and everything in between. So the way you move is a functional biomarker, if you will, for all sorts of pathological states. So if you have a bad knee, you start to limp. So you're moving wrong, you've got a limp. That's a term that describes a pathological motion pattern, right. So when you start to limb, your neuronal firing pattern, or your central neurons, that code for that motion, they readjust, and your new normal gait pattern is a limp. So if you come to me and I put a new knee in you, you're still going to limp because that's how you now walk normally, well, if you continue to do that, you're going to blow out your other knee or your hip or your spine, or something like that. So, you know, not only can motion be used to help reprogram that neuronal firing pattern to bring people back to where they were before the pathology after some of the wonderful treatments that we have like joint replacement or reconstruction, or injections or physical therapy or pharmacotherapy, or even cognitive therapy, whatever the therapy is, that helps you move, we needed a fundamental way to get clinicians and patients to, to appreciate that, to see it, to experience it, to measure it, right. We want to quantify that, instead of me going, Hey, Patrick, how's your knee today? You know, good. Yeah. So that's the same thing that a caveman could do with for you. So that is prehistoric in medicine, like we have, we have not advanced, it's like taking your temperature like this, as opposed to shooting it with a gun. So what we do at Biomek, we have developed over the past come to work in this for about 35 years, we have, we have taken a lot of the hardware, the components that that that we can use to build motion analytics sensors, to make capturing motion, you know, precise, accurate and more importantly, reproducible, so I can measure your progress over time, right, that's what I have to be able to do. And now, with the advent of these mobile devices, which are really like small supercomputers, you know, we can now grab data from you, from your motion, have these mobile devices process it, and within within milliseconds, you have the results available. So every single movement we make in our world is predicated on my homeostatic state or my pathological state, right? So if I've got a deltoid injury, I may not be able to do this, you know, extend my arm all the way up, I'm able to go halfway up. So that pattern of movement halfway up is is unique. It's a fingerprint. So by capturing that motion in all three planes, we can build systems using AI and machine learning, that can diagnose that injury for the physician rather than having them try to look at me, which you know, they can only see in two dimensions, they can see one point at a time, it puts a lot of pressure on them. Plus it takes too much time. You know, we live in a day and age where where, you know, the chasm between The clinical delivery system and the amount of people accessing health care gets bigger and bigger every day, we just don't have enough people to treat everybody and in technology is certainly maybe the best way to build a bridge across that chasm. So, you know, I can put a motion sensor on you that we build it biomech in 10 seconds, I can diagnose your injury, you know, without a clinician even being in around the room. So they could go on their porch and say, Oh, Patrick's got a Supraspinatus paralysis, you know, we need to get in here and take a look at his, you know, look at his shoulder and do that. So, you know, what we try to do is, is the same way where we developed a complete white blood cell counter complete blood count for leukemia, or anemia, or any of the things we use blood to use as a diagnosis, the sensors can do the same thing. So if you think about the most Alec system that we developed here, it's a fundamental imaging platform, we can see how you move. And more importantly, unlike a traditional laboratory test, it can be used as a real time diagnostic, because every motion is a pattern, I can also put it on a patient, they can stand in front of a TV screen and see how they're moving. When you set thresholds for them, they can actually move the system can tell them in real time, whether they're making the motion properly or not. So this becomes the basis of physical therapy. So, you know, I always tell people, no matter what your clinical discipline is, everybody's really a physical therapist, if whether you're an oncologist or a surgeon or a PT or neurologist, the goal is to get the patient to move better, because motion is what keeps us alive. When you stop moving, you start to die. And so, you know, if we can help you keep moving properly, you know, better, more often, you know, motion, that means something so at Biomet, we, we like to tell people, you know, what we do is create motion with meaning, we can extend your life if we all know this ends badly, you know, but you want to be as vital and healthy, right to the end. You know, you don't want to be limping along or, or hunched over if you don't have to be if we can keep you out there moving, we give you real goals to achieve. So you can actually see that the treatment you're getting are making a difference to your health and your motion status, you're more likely to adhere to that. So it patient care, no matter what the treatment is patient adherence is probably somewhere between 30 and 40%. You know, if I'm your oncologist, and you're a smoker, and I say, Patrick, you know, you gotta quit smoking, or else you're gonna get lung cancer and die, maybe you'll throw your cigarette out when I'm sitting there with you in the room. But as soon as you get in the parking lot, you're firing one up, you know, you get away from me, you tend to fall off the cliff. So, you know, we live in a day and age where where we have a million gyms, we've got remote health care monitoring, so devices like ours, can be used in the home. So people can be empowered to take care of themselves and get information back to their practitioner from wherever they are. And I always tell people this and this is something I you know, I really want to drive home. health happens everywhere, everywhere you our health happens not just in the hospital, or not just when you're with your physician, or not just when you're on WebMD it happens 24/7 throughout your entire life. So you know, this is where you live your bodies where you live, you know, just like you take care of your house, you need to take care of this. And being able to move certainly is one really great way to keep keep yourself healthy. Keep yourself from you know being obese, keep yourself from you know, getting things to cause by non motion like heart disease, high blood pressure, you know, stiffness, arthritis, all these kinds of things that happen when you stop moving. In this day and age, what we invaded. biomech is sort of the first step in changing the culture of our species to now they cannot realize, Hey, listen, instead of asking you, How does your knee fell, Patrick, I can go last week, you were 10% this week, you're 16% Good job. You know, whatever you're doing, you're moving the needle, because people need goals. You know, they just don't need me telling you, hey, I think you're doing great, Patrick, that's not enough. You know, it's like weight loss. You know, we have so much obesity in this country and people constantly struggle. It's a huge industry. So, you know, you can get on a weight loss program and maybe lose 25 pounds and, and you know, you're looking at your number on your scale. But really what moves the needle is is using a system like ours, we can not only tell you that you've lost 25 pounds, we can tell you how much functionality you've regained by doing that. What how much better is your quality of motion, you can put down steps you can play tennis, your balance is better, your gates better your symmetry is better. That's going to keep you from putting that weight back on. We know most people will Vail after a short period of time, but if you really show people this is the functional improvement you're getting, you know, you can measure it, make it meaningful, patients are likely to continue that trend. And we'll have a population that's healthier, right? It's, it's kind of putting the fun back in function. Not to sound corny, but really, that's really what tools like this do.
Patrick Kothe 35:24
I remember the first time I got a video camera, the first thing I did with it, is I had my wife, video me running, swinging a golf club, hitting a baseball, because I had never seen that before, right. And you always watch it on TV, and you see it. So that visual thing is, is is one piece is I wanted to see, but I've always been fascinated when you're watching somebody a baseball coach or a golf coach breaking down a swing, or breaking down the run or breaking it down. And they're and they're talking about it, I'm trying to understand how I'm doing it, and what they're teaching how they can see that because I can't see it. And in order for me to improve, I need to have feedback, I need to understand it, I need to have a lot of data about if when I do this repetition, I did it correctly. I did that repetition, I didn't do it correctly. So a system like this, where you're getting that feedback is really the only way that you can know if you're doing it correctly. Yeah, you're measuring, you know, the results. But the rehab or the training, it's so important that you get that immediate feedback, so that you can make the modifications and know why you made the modifications and know that you've now you've done it correctly. Now you can keep doing it. Because you know, we've all heard, practice doesn't make perfect, perfect practice makes perfect. And that's why, you know, that's that type of feedback is so important.
Frank Fornari 37:02
And we're the tools we have, you know, we're fortunate to be able to, to reach out to other scientific disciplines and add on to what we're doing at Biomek. So, learning, learning takes about six weeks, you know, it's called long term potentiation, it takes about six weeks for learning to become permanent. And the more feedback you have, for more senses, the faster that happens. So I'll give you a quick question to put you on the spot. What's the most important thing you can learn to do as a human?
Patrick Kothe 37:35
Learn how to learn, know, eat?
Frank Fornari 37:38
Because, because if you don't eat, you die. Okay, so eating touches all five senses, okay, so the more sensory input you get, the faster and more permanent that learning is. So it biomech you know, we're building systems in augmented reality and virtual space. So your comp your complaint about not being able to see yourself move, we've solved that problem. So the patient can actually watch themselves move, we have haptics, we have audio feedback, so we've got at least, you know, three of those systems. So, you know, one of these days, maybe we add smell and taste to it, you know, but but you get my point. So we were able to do these things now with the systems that we have. So people can see, hear and feel how they're moving. And I always tell people, you know, I went to Catholic school, and I only made one spelling error when I got hit in the back of the head, that that instant feedback. That's the last time I made a spelling error, right. So you know if we can do the same thing with patients moving because the quality of the data we capture, and the quality of the ability for a patient to rehabilitate is again predicated on that proper motion anatomically. So we can use things like, you know, visual feedback, auditory feedback, VR AR haptics to place the patient in a position or the subject in a position to make the motion properly. So instead of them focusing on the pain of rehabilitating, they focus on the performance of it, you know, so right now, without this feedback, all they feel is the pain and they typically will stop. So if you move them away from the pain and have a look at a TV screen where I say look, see this number right here, make this as big as you can in this number of here, make it as small as you can. That same patient who were a minute ago wouldn't move their arm is now moving it because it's a game for them. They they're focused on the performance and it that really moves the needle. That's that's gonna that's a game changer for for physical therapy for orthopedics for family practice for neurology podiatry for chiropractic medicine board, pick something because every one of those discs blends suffers from that same problem where, you know, the pain or the discomfort prevents the patient from from, you know, moving and relearning what they what it was like before they had the pathology. So it biomech we're trying to help them optimize their, their therapy. So the person's therapeutic adventure, you know, we'll end up with a successful outcome.
Patrick Kothe 40:21
Frank, can you describe the technology describe the product itself? What does it look like? How big is it? What is it doing?
Frank Fornari 40:28
sensor based system is based on made up of three particular components, we've got motion sensors in our motion sensors are not a low end, you know, very inexpensive accelerometer, like, it's in a lot of other products that I won't mention here. But, you know, you've seen them all around, we have about, you know, over 100 components on our sensors, we've configured them, you know, mathematically and physically in a way that we increase the signal to noise ratio, we've eliminated the problem of drift things that that other lower end products have. So if you don't have the data, again, be precise, accurate, reproducible, those are less laboratory grade data, you can't compare one day to the other, or one week to the other one month of the other, you can get the same result 10 times in a row. So you have to have that precision, in accuracy. So the it all starts with our sensors, we're capturing 48 vectors of data at, you know, an incredibly high sample rate between 100 and 1000 samples per second in all three dimensions. So we're sending that data stream to a mobile device. And, and these mobile devices are literally mini supercomputers. So we're able to process those data and send the result back with a 21 millisecond delay, back to the end user or the clinician, or even, you know, someone, I could be doing an evaluation right now in Naples, Florida, you could be watching it from from, you know, wherever you are in, you know, you could be in Cleveland, and you could see it in real time. You know, that's, that's the speed of what we do. And it taking advantage of the speed of the Internet. So home health, remote monitoring, all this is a reality now, you know, it's here. So,
Patrick Kothe 42:15
Frank, Frank, could you hold on a second, the sensors themselves? When you say sensors? Are we talking about, like electrodes? Or what are they what are they
Frank Fornari 42:23
it's a, it's a small device, about a little smaller than a domino, you know, weighs about a half an ounce, you know, that you don't even know you have it on. You know, it's, it's really just a, you know, a very lightweight, you know, very robust, you know, motion capture device. It's quite miraculous, it can do what it would it does. So,
Patrick Kothe 42:44
so, so in the example that you use earlier, and we're looking at our motion, so let's say somebody's rotator cuff, surgery, and we're doing that, and that that domino is placed on the hand, and or Where's where's it placed?
Frank Fornari 43:00
It depends on it depends on what the clinician, what part of the body the clinician is interested in measuring. So, you know, if it were a rotator cuff, we would place the sensor somewhere on the shoulder on the shoulder joint, depending on what we're looking for, you know, and then the sensor would, would, you know, using AI machine learning, we would, we would have a pattern in the background of that motion. And then the system would measure the quality of that motion, it will give you the range of motion gives you the angle it's moving in, it would tell you, you know, what pattern of pathology is indicative of that particular pattern of movement, you know, we'd all do it in real time. So the patient in practice should be watching that,
Patrick Kothe 43:42
in general, or using one sensor at a time or using multiple sensors we
Frank Fornari 43:46
use, we try to use one you know, is it we're pretty good at this, the sensors are, you know, the sensors in our math are pretty sophisticated. So, you know, we've gotten really, really good at at understanding how to how to, you know, use all 48 vectors of data in one sensor to capture a particular motion, that someone's desire. But if we need to do use more than one, the sensors can talk to each other. So you know, we can use more than one certainly, if we have to do that. So if we're looking at someone's spinal issue, we put one cervical thumb, lumbar and thoracic, we can look and see how they're talking to each other as someone in neutral spine, what their spinal twist looks like, you know, as they're doing a task, you know, all those kinds of things. So we can, there isn't anything that our system can't measure, anything that moves that we can measure, but it's all being driven by our AI engine called cortex. So, you know, it's, you know, we just were fortunate, we just won the 2022 Ai, breakthrough Award for Best Overall biometric solutions. So, you know, our AI engine can measure anything that moves, whether it's a financial transaction, going through a bank or a hospital or a store, to you walking down the street, it doesn't matter. Whatever moves we'll find a way to measure it and analyze it.
Patrick Kothe 45:03
So I interrupted you, we started talking about the sensors. And now we've got the the AI platform, as well. And then I'm assuming there's also a, you know, there's still there's what's underneath the hood. And then there's a UI that's available for sure. The clinician and patient cetera. Yep. So that that's, that's the total system.
Frank Fornari 45:25
Yeah. And on the back end, we have a pretty sophisticated database that lives up in the cloud. So you know, people can, you know, get their data and analyze your data. So if you're doing studies, you have access to it. And, you know, medicine is still very, very paper heavy, you know, the promise of electronic medical records and data sharing, really hasn't been realized physicians still spend an ordinate amount of time still dictating into a headset, and someone transcribing it, and having a piece of paper, send it a file somewhere, and, you know, it to me, all that is, is is just something that kind of takes away from their ability to see the patients and, and do what they were trained to do, you know, rather than me, clerical people, just to satisfy, you know, the the amount of compliance standards that keep being thrown at health care, I think, you know, the compliance industry really needs to come up with the technical solutions that don't burden our healthcare system, you know, the clinicians are tired out here, you know, it's stressful dealing with SICK AND DYING PEOPLE, you know, you don't want to sit up, you know, till 1030 At night signing forums and fighting with insurance companies to get payment, and these things still exist, you know, and I think, you know, we've got to do a much better job of that. And we've also got to do a much better job of keeping people healthier, you know, rather than, you know, what we have in the US, we have more of a sick care model, you know, nothing happens until you're sick, nobody gets paid until you're sick. You know, I'd like to see sort of devices like we're making and, you know, really happy to see a lot of the young people really pushing on exercising, eating right, and, and the explosion in healthy foods and exercise, because we really need, we really should be paying our healthcare system to keep us well, first, you know, rather than just waiting around for something to happen, and then we make money from trying to try to cure somebody. And by that time, usually, it's kind of too late, they've already done too much damage to themselves, we're never gonna get them back to where they need to be
Patrick Kothe 47:35
for a platform technology, like yours can be utilized in so many different ways. I mean, we just talked about, you know, surgeons, orthopedic surgery, cardiology, could do it rehab, identifying Alzheimer's patients, all kinds of clinical issues that can be solved. Let's talk about the business a second. And what your business model is, do you plan to be a motion analytics expert, do you plan to outsource or OEM this to other other groups or partner with other groups that are taking and looking at a particular aspect of how they can utilize the technology within their specialty, because sometimes it's not necessarily the company. But the specialty, so every orthopedic surgeon can utilize this for knees, everyone can do this for shoulders. But if you partner with one company, it becomes a little bit myopic, in where it ends up. So what's the business model look like? For you guys?
Frank Fornari 48:38
It all depends on on, you know, if you're going to if you're going to partner with a strategic or you're going to be acquired by a strategic partner, it all depends on on, you know, how diverse they are, you know, so there are strategic partners in the healthcare space, you know, large, large corporations that, that, you know, do all sorts of things in health care. So, you know, ideally, if, you know, we were to move this technology into their hands, I would be looking at it at a larger global healthcare system, or a partner like that, because they can scale this thing up overnight, you know, for for me to do it. You know, I'm the guy that comes comes up with, like, an answer, you know, and, and, you know, I built two companies, and, you know, it was a lot, a lot, a lot, a lot of work doing that. But for this one, because it's such as you say, it's such a fundamental platform that can be used across a ton of spaces. I think, you know, we built a really robust platform, it couldn't be better. Sure. Is it really good now? Yes, it's, it's really great. And we're starting to see some, some larger global players in this space, you know, approach us and say, you know, we're really looking for motion analytics. We're really looking for AI. We're really Looking for an AI solution that uses validated data, not just sort of garbage in garbage out looking for data that are, you know, big data should really be relabeled important data, you know, because you need to take in the proper data, to spit out an answer at the other end to, you know, to optimize the outcome. So, in my ideal world, you know, we're, we've, you know, we were doing really, really well until a little thing called COVID. Kind of just put the kibosh on everybody. So we couldn't get in to healthcare, it shut down. We couldn't get in industry, we really couldn't get in anywhere. So we just decided to really go fine tune our AI engines and our mass. So we were fortunate enough to stay alive during that time, in our kind of climbing out of it, and the world is reaching out looking for this solution. So we're selling it to, you know, orthopedic practices, PT practices, chiropractors, family practice people right now. But we're also aligned with companies that make medical devices where they need a quantitative assessment, to show the payer that their medical device is actually doing what it's doing, like spinal cord stimulators, joint replacement, spine spinal stimulators, like, you know, prosthetic devices. So instead of just somebody saying, Yeah, I put a new, new hip in Patrick, and he seemed better to me three smiley faces, you know, like, the claims adjuster really can't do much with that. But if they say, Patrick, your Patrick had a functional gait index of 10, we put a new hip at him, that was up to 85. Now, that means something right to them, and, and now they're able to do evidence based medicine, which we promised the payers years ago, we would do that, and we really haven't delivered that, you know, the way we should. So, in my ideal world, you know, right now, I think, you know, I, I've taken the ball down the field, you know, as far as I can take it, I would love to have, you know, a global health care group, you know, say, Listen, this is great stuff, and we really want to insert it in every aspect of of our business, to just acquire US and scale it up. And they can help set standard of care, best practice guidelines, you know, regulatory and compliance around that. So you don't have somebody tomorrow, who's got a really cheap, you know, motion thing that's going to try to get in and sell to a surgeon, where a patient is going to have a problem or suffer some problem, because the technology was just junk. And the clinician couldn't recognize that it was bad like that, they just been sold a bill of goods. So you know, as if you if you sit hurdles, you know, that's why these regulatory agencies like the FDA, and cap and CLIA exists. So we built our product to satisfy those regulatory agencies, I worked with him for 35 years. So you have to jump over the hurdle of, you know, precise, accurate, reproducible to play in that space, you just can't make some cheap, get a two cent accelerometer and dump it in a piece of plastic and try to sell it to, you know, Dr. So and So over here, you know,
Patrick Kothe 53:22
so what was your regulatory pathway? What, how did you take it through us?
Frank Fornari 53:27
Right now, nobody's regulating this technology is too new.
Patrick Kothe 53:31
Are you going for a 510? K? Are you going, you know, how are you approaching approaching regulatory,
Frank Fornari 53:36
it's waived right now. So you know, you know, the FDA is inundated with all sorts of things, but this technology is is just too new for them to, to look at. So right now, you know, because it's FCC and CE certified, you know, it doesn't cause cancer, the plastic safer skin contact is right now seen as a fancy ruler, if you will. But very soon, we'll be taking it out to get a class three certification, because with our AI engine and machine learning, we can use it to diagnose disease. So we'll be taking it out there and doing some clinical trials where it becomes a diagnostic. And that's where we can pull the FDA into that process. And I've worked with with him for years, and one of our partners, you know, used to be a section head there for years. So we've got a lot of experience with these with these type of regulatory agencies. So that would be our next step is kicking it up a notch so it can become a diagnostic tool.
Patrick Kothe 54:35
So right now you're you're a ruler, you don't have claims for it. But as you start to develop that data, and that data has got to be specific to a particular disease. So it could be that we're going after the cardio thoracic stuff and rehab there. Then we're gonna go after knees and we're gonna go after hips and we're gonna have to park it's as each one of those would be a separate data set a separate group of clinical trial or group, yes, clinical trials to be able to do that to, to have a claim or claims for what what exactly that does, whether it's a monitoring device or a diagnostic device, kind of all of those those issues. Yeah, got it,
Frank Fornari 55:14
I will not make anything that isn't clinically relevant are moves the needle for the patient. And more importantly, we will not make anything that doesn't satisfy the most stringent compliance standards of all the agencies that are out there. Unfortunately, I can't say that for a lot of the companies that are in this world today. But you know, at Biomek, we will, we will never do anything that compromises the patient, or any of the data, you know, regardless of whether somebody's tuned with our business, because you may be able to fool people for a short time, but they'll realize the stuff is not useful, and those people will fall by the wayside. So, you know, I build things to last. So they stay, they become the standard.
Patrick Kothe 55:58
Data always wins. Yes, knowledge,
Frank Fornari 56:01
knowledge always wins. You know, smart always wins.
Patrick Kothe 56:07
Well, this has been a really fascinating discussion. And I applaud you for taking this on. The ability to have objective data to base decisions on and to base rehab on and base diagnosis on is so important. And you're bringing that objectivity in, as opposed to just as you said, How's it feel? More more subjective type of type of type of information. So thank you so much. My last question really, is has to do with, you're at the beginning of motion analytics, looking down the road? What do you see the future being?
Frank Fornari 56:50
Well, I will tell you that that most people don't realize sensors are everywhere. So I would tell you, you wouldn't buy a car, if it didn't have the sensors in the sideview mirrors that lit up, right, you wouldn't buy it, we're at a point where sensors and the ability to capture massive amounts of data and analyze it quickly, which we can do today are way more efficient than than our brain doing this. So you're living in an age where, you know, evolution happens all the time. And right now you're looking at the evolution of man, and the ability to develop better ways to sense our environment that are much more robust, much faster. So you're looking at, at the next phase in human evolution. And what I mean by that is, give me a good example. So you know, when you get to be, you know, my age, like, I don't like to turn my neck and hurts, right. So if I get in my car, you know, and my sensor in my left mirror lights up, you know, I have trouble turning my head. But let's just say I get in my car, and I put a sensor back here. And when the light goes on, I turn my head, and it's linked to my car seat in my car seat terms. And now my visual field is improved by up to 60%. So that connecting the sensor to the man, you know, or to a human is the next phase for us, right. So all these things are going to have a dramatic impact on on how efficiently we move, how much easily we can accomplish tasks, how much safer, we can accomplish things. Because life is all about sensing right before we had eyes, you know, we reach through the muck and mire with our fingers. So we have more and more nerve endings of our fingertips because they can sense pressure, heat and cold. If I got close to a fire, I jump back, right. So you know, sensors are the equivalent of that. They're just another wonderful way to allow us to sense the world if we couple them with the proper Analytics, you know, which which we call AI, which takes what's in here, you know, AI is not magic computers don't think on their own. We programmed to think the way we think we just have the ability now to code those in grams into Logic, right? So if we're smart enough to code things, and allow sensors to capture and analyze a million times more data than I can in the same amount of time, then we're going to win, we're going to see things that we can't see now, we're going to understand things that we couldn't understand before. It's just going to help us learn better move better, see better understand better, you know, there's no limit to you know, answering some of the questions that we have to do now using like almost like an abacus if you will, right? It's the next phase in our ability to process information, faster, better. And one last thing I just want just wanted to thank all the people who biomech because these are people doing you know they're working 80 hours a day they do they do yeoman's work, we've got some of the smartest folks on the planet, who are you are building these things, doing the math, testing it every day finding ways to make patients better and healthier. And, you know, without them, you know, I wouldn't be able to be sitting here talking to you. So, you know, they, they can't be here with me today, but it's certainly they deserve, you know, most of the accolades.
Patrick Kothe 1:00:25
Developing a new field. And platform technology can be very exciting, yet also can be very overwhelming. clearly defining your pathway and how you're going to enter and expand a market is critical to your success. Frank is in the middle of all of that. But he has the benefit of having done it before. I really enjoyed hearing how he thinks about the problem, the technology, and the possibilities, a few of my takeaways, first, the importance of family and life experiences. When Frank discussed the history of his family with cancer and the coal industry, and then how he got motivated to do something about it was really spoke to me when he talked about his grandfather saying, I came over here so you could do what you're doing. And then he discussed that every one passed the torch along, and we all stood on each other's shoulders, really talks to me about the importance of giving and the importance of, of not thinking of yourself, but thinking thinking about others. The second was when he discussed discovery as an accident to the trained mind. And he really took that to heart to say that that is how you learn that is how you get these ideas as you're trained to do that. And we discuss attitude. And you know, if you don't know something, you tend to diminish it. And that can can be a real impediment to learning. But what Frank talked about was he earned degrees to help him to solve problems. But what he also found that it also helped him to manage teams. So he said, use all the tools you can to solve a problem. And those tools can be your degrees, your training, go as deep as you can with them, but also have a broader perspective, to be able to, to put these things together and to solve problems. The final thing is I'm just going to read you what he said, I will not make anything that isn't clinically relevant or moves the needle for the patient. Or more importantly, we will not make anything that doesn't satisfy the most stringent compliance standards of all the agencies. This is something that we as an industry should all believe, but not of not all of us always do. I just wanted to say that I that I appreciated when he said it. We sometimes we don't say this out loud. I appreciate it when he said it. And I hope that all of them share that said thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
