Show Notes
When Carolyn Yarina, today’s guest, walked into her university’s Center for Entrepreneurship one day as an undergraduate, she was convinced that she would never become an entrepreneur herself. “I remember tapping my foot, being impatient,” she recalls, laughing, “I couldn’t wait to get out of there, thinking that entrepreneurship wasn’t for me.” Fast forward to a few years later, and she is now the co-founder and CEO of Sisu Global, a company that is committed to providing medical technology which enables healthcare for each person in their own community.
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.
