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Dr. Brian Kinney - The Journey from Brainstorm to Market.

Join Dr. Brian Kinney, a well respected serial innovator, surgeon, and entrepreneur as he shares wisdom gleaned through the process of launching new products and devices, from breast implants to radio frequency devices.

Dr. Kinney: Motiva is another thing. I've done the original science work with electron microscopy, animal studies, tissue things for the Motiva breast implants which have just started their FDA trial in the last couple of months.

Tamarin: We were speaking about that just a moment ago. Would you go a little further with the Motiva implants and discuss the differentiation— why they may be an improvement upon today's implants?

Dr. Kinney: Sure. We have some data to say why they really should be, and then other things that we'll discover as we go along. The patents on the existing surfaced implants, the textured ones, and the smooth ones date from the late ‘80s to the early ‘90s. They've been around 25 years. That means they're tried and true, but it also means that we may be due for a wave of innovation. The patents for the Motiva implants are in the late 2000s, so they are less than 10 years old. What's interesting about implants and texture is that we have gone the last 25 years from smooth is better, texture is better. Smooth is better, texture is better, back and forth.

Dr. Kinney: Without going into all the science of that, Motiva came along and said, “I wonder if we can make a different surface?” They call it nanotech. Technically, it's about 13 microns so it's not really nanotech. If it was .99microns, that would be in the nanotech scale. These little bumps and the way they're manufactured seemed to affect fibroblasts and macrophages differently. In clinical reports, it was put into ASJ, the official ASAPS journal. They showed capsular contracture rates within three years of less than 1%, actually even less than .5%.

Dr. Kinney: If you look at the FDA data for the trials of existing implants, those capsular contracture rates are in the order of 7, 9, 10%. The capsular contracture rates seem to be lower on data outside the US. The FDA trial started just a few months ago in the spring of 2018, and we have about 525 patients slated to be in the trial, and you can find us on if you look for more information. About 25 people around the country are centers, and I'm one of them, but in addition to that, I've been involved with animal, and basic science studies with them for many years, long before there was even a prospect of bringing the FDA trial here.

Dr. Kinney: One is the Nanotechnology Institute at theUniversity of Manchester was etching different patterns on the surface of silicon, and then taking cell cultures and putting them on there, and watching what fibroblast did for big bumps, little bumps, variable bumps, steady bumps, dips, hills and valleys with bumps on them, all kinds of stuff. We found a number of things, and that is that this area around 10, 12, 13 microns produced relatively less activation of macrophages to convert into fibroblast and cause connected tissue.

Dr. Kinney: Now, are they getting too deep in all the rest of the science? What is practically shown is fewer capsular contracture in clinical studies outside the US. We'll find this out in the next few years in the US to see if US surgeons experience the same thing. Secondly, we take in what I call the crock pot. It's a CDC bioreactor. You put the various implants in there, and then put in your various bacteria and see what grows.

Dr. Kinney: What we've found is not only is this surface not growing a lot of fibroblast and stuff, it's not growing a lot of bacteria. We think that might just be surface area related, and may not be particularly magic in the geometry. We don't know, but it's really exciting because we were through a long, long period talking about texture, and smooth, and capsular contracture, and we had various clinics that had said this is better. No, this is better. We all know that as surgeons, when you start to do one thing and you get good at it, your results with that will be better.

Dr. Kinney: When you have one clinic and one part of the country that says we're better with this and the other clinics say, “No, no. We're better with this,” it may not be the device, it may be the surgeon's skill. We now think that at least on our basic lab studies that there's a difference in how much bacteria grow, and how many inflammatory proteins and cytokines are secreted, and so we’re trying to go back to some more hard science on this. That may or may not impact all this stuff with ALC, or we don't know.

Tamarin: How much of the outcome, do you think is based on the device versus the technique?

Dr. Kinney: It's a very good question. I actually think, and I say this when I lecture, and I say this when I talk to my colleagues, I say, “You know what, I think the devices are better than we are.”

Tamarin: It's more consistent.

Dr. Kinney: It's not what us, surgeons want to hear, but I get pretty consistent, and when you look at complications, rupture and these kinds of things, a lot of things that cause complications are probably surgeons. To tell you the truth, I don't know how much of it is implant related versus device related, but if you look at the FDA data for existing implants approved here, a lot of those things, size changes, hematoma, inframammary fold, dropout, symmastia.

Dr. Kinney: Most of those things are surgery related problems which are higher than rupture, and even maybe higher than capsular contracture. Now, capsular contracture could be surgeon related or implant-related, so we have a lot to figure out. We could get better as surgeons but the implants can make us better surgeons.

Tamarin: I'm really curious about when you think about the best use of these implants. They have two different populations they would serve. One would be the breast aug population, and the other would be breast reconstruction. How would you feel they would differ or would they in terms of providing optimal benefit?

Dr. Kinney: We don't have a large scale study on capsular contracture rates for example with cancer patients, and the Motiva implants. We have none in the US because we just started our clinical trial. If overall in the aesthetic market, capsular contracture rates are lower, we have every logical reason to assume in a long-term trial with the constructive cancer patients. They'd be lower as well

Tamarin: Not just cancer patients even but the prophylactic patients, those that have elected.

Dr. Kinney: Right. They're of course a little bit more like a-

Tamarin: Breast aug?

Dr. Kinney:… cosmetic patient, right?

Tamarin: Mm-hmm (affirmative).

Dr. Kinney: When you have very thin layers of tissue left or none because you're doing subcutaneous mastectomies, then the implant really does need to perform well, because it's a lot higher incidence of capsular contracture.

Tamarin: What about the rippling that often occurs in breast reconstruction patients or the upper pole defect based upon the size or height of the implant, the projection aspects? How are some of those different or similar with Motiva?

Dr. Kinney: Well, it's interesting. One of the ways that implant companies have tried to do with rippling is by making firm implants, so make Jell-O, and companies that have softer implants, when you touch it, it feels better, but when it's too soft, it ripples. Of course, that's a problem with saline. We started working on this concept of ergonomic gel. If a woman moves, how does her breast move? Okay. Instead of making something firm like Jell-O, why don't we make something that moves like abreast?

Dr. Kinney: You actually do … My background is master's and bachelor's in engineering, mechanical, electrical engineering, so I'm very into the design part, the research part of this. You monitor the impedance, the resistance to motion, and the jiggling if you want to call it that. There's a number of things. You look at elasticity, and you look at compressibility, the G prime modulus, and you look at the delta which is the sheer force, and then you say, “Can we model that?” It's really not easy to do, but it looks like some of the newer generation implants are doing better at that.

Tamarin: That's really interesting. The upper pole defect that's common in the older traditional implants when you have a reconstruction patient, will Motiva be shaped in a similar manner to accommodate?

Dr. Kinney: One of the current ways to try to solve that uses a stiff implant so that the gel holds in the upper pole, and it works. If you take a picture then that implant looks pretty good but if you take a movie, then you don't see it moving like a breast. The newer gel that I'm referring to and the name they use is ergonomics. If you’re laying flat, it looks a little bit like a round implant. We know that even regular gels if you tilt top, it tends to not hold this much at the top, but the ergonomics gel tends to have a little bit more natural shape.

Dr. Kinney: You engineer the viscosity and the elasticity of the gel to look a little more like an implant. Now, this is not data that's easy to prove numerically, it's subjective. There's been a trend by companies that manufacture the stiffer implants like a gummy bear or Jell-O towards softer again because looking good on a picture is not the same as what a woman feels. When a woman wants to look like when she puts on her bathing suit, so it's a challenge. We're pretty good at what we do, but there are enormous numbers of ways we could get better.

Tamarin: One of the things I'm curious about is if the gel has a tendency to follow the line of the natural breast which means it would tend to, I guess be weighted towards the bottom obviously. Then that upper pole would you accommodate for any deficit with fat grafting?

Dr. Kinney: Well, the combination of fat grafting and implants is clearly a really evolving and hot area. Some people just say, “We do fat,” other people say, “No, we do implants.”Everybody realizes you put an implant in. It could be a teardrop shape or it could be a round shape. The problem with a teardrop shape is it's only one particular teardrop shape, and any woman's breast that's alive and moves don't have one shape. Lie down, it falls to the side, lean forward, it has a different shape, back and forth. The soft-soft gels can follow the breast, but then they won't hold the upper portion.

Dr. Kinney: You put a round object into a breast, and you get around augmentation of a non-round piece of anatomy. This is where fat can help because fat doesn't have to be put into a perfect semi-sphere, a hemisphere. What happens is when you put fat in, you can individually tailor shapes. A natural breast has a tail of Spence that goes off towards the axilla. If you wanted to, you could recreate that, and you know that large, sharp curve in the upper pole where there's not much breast tissue, and you wear a push-up bra, and it looks advertisement, “I've got implants.”

Dr. Kinney: If you can get 10, 15, 20 millimeters of fat up there, you can blend it in a gentle slope from near the clavicle, all the way down. That will fall the same way because fat is not put in as a big ball or a big bag, it's put in as microdroplets. A little bit like when you spray insulation foam, it clings everywhere. Like snowflakes clinging to a tree.

Tamarin: That's very interesting, and another thing that we're watching is fascinating over the last few years, I mean, we've had a great up-spike in gluteal augmentation, body implants, but then also an opening market for body implants in general, calf implants and such like that. As you go down the road of Motiva is there a place for other body implants in its design?

Dr. Kinney: I think that's a very clever idea and it's something that a lot of us have thought about clinically, and approach a bunch of companies about. I was asked to be involved in a case as an expert where one doctor had done some implants, pec implants at that time. Pardon me, gluteal implants, and then another doctor had seen this patient as a second consulting opinion. An attorney came to me and said, “Can you be the expert?” This was about 2000, and I said, “I'm not really an expert. I've done about 15.”

Dr. Kinney: They said, “Well, you're an expert.” I said, “What do you mean?” He says, “I've called about 40 doctors to see if I could get some opinion, and the original treating doctor had done about 40 or 50. The second opinion doctor has done about 80 but could not serve as a source for me, and you're the third most.” Now, that was a long time ago, and now the number would be hundreds and hundreds, but we were in an era where implants weren't working well, and they were stiff like almost a sports mouth guard or like an impact pad that a football player would put in their thighs or somewhere, or catcher's chest protectors.

Dr. Kinney: Those are really undesirable implants. We've clearly evolved to better softer, custom implants that follow the shape of various pecs or various gluts, but we have a long way to go to get better. There's one camp of the implants which is clearly rising into the multiple tens of thousands nationwide. I mean, there was a time when two or 3,000 were done per year in the late ‘90s and early 2000s, and now it's in the multiple tens of thousands.

Dr. Kinney: Fat grafting on the hand has exploded. It's in the hundreds of thousands. The problem though, we think conceptually. If I wanted to bioengineer a buttock, it would have fat, it would have muscle, it would have connected tissue, and so when we just put in fat, we're asking fat to serve the purpose of multiple tissues which it can't. I believe in five years, when we look backward in 2018 or 2015, we're gonna say, “That's a good idea, but that's not the complete solution.”

Dr. Kinney: While we're making 500 and 1,000 CC augmented buttocks, we're gonna get better. We must get better because of the problems with complications. , and Alfredo Hoyos, and some others published in the White Journal PRS in 2016, a case of 57 deaths between Mexico, and Central America, and South America. That is a true emergency. In Florida, there have been a number of deaths. Now, responsible doctors do a good job, but even in good hands, there's potential for problems because of the fat embolism. You've apparently talked to other people in your research. You know about this.

Tamarin: Correct. In one of the questions that came up for me just through what I know of those in the field as well as those that I've interviewed is that the knowledge was based, fat grafting, large volume of fat grafting knowledge was based on actually very poignantly trying to inject into the muscle because of the opportunity for the fat to survive. Only to come forward a few years later because the volume went up, the volume of patients, the volume of opportunities to study the reaction of the body to fat injected into the muscle.

Tamarin: That went up, then we saw a higher percentage of deaths for an unexpected reason, the fat embolism. In 2018, the recommendations were made to steer away from that particular technique, but you still have those early innovators and pioneers who were utilizing that technique believing that it was exactly what they should be doing to generate optimal outcomes.

Dr. Kinney: The gluteal veins have a plexus, and we all know that the back of the nose's area that's highly sensitive to bleeding, and if you haven't [inaudible] you can get a lot of blood back there. The gluteal veins deep in the muscle and under the muscle are a big plexus and some of those are pretty big veins. Not as big as your little finger, but big. When you are injecting deep into the muscle, you're pumping into those veins, and some anatomy studies were done, and then some autopsies were done. ASAPS, ASPS, and ISAPS all got together and issued a joint statement with this task force.

Dr. Kinney: You just have to be very careful. The consensus among the experts was it's not safe enough for hundreds or thousands of surgeons to be injecting into the muscle. It doesn't mean that some experts can't do a good job, it means that the official recommendation is only to inject subcutaneously superficial to the muscle. That will change the way we do things. Now, what is a desirable buttock? If you pinch on a butt, and you pinch an inch, we don't wanna pinch a rock.

Dr. Kinney: Do we wanna pinch four inches or six inches? I still think conceptually in five, six, seven years we're gonna look back and say, “Maybe our butt shouldn't be so fat? Why do we do that though? Because we don't know how to make our muscle bigger other than we say go to the gym, and even that, that doesn't work much.

Tamarin: That's really interesting because I'm fascinated by the cultural shift, and so there have been some really interesting bodies of work that are around the desirable female form based upon countries, and they change dramatically. The cultural norms defined by geography are really, really interesting. In the United States, we were always top oriented. Primary surgeries were generally breast augs, and so I was interviewing a surgeon a couple of months ago, and we were talking about the fact, he does a tremendous amount of butt implants, and so he was saying that generally, a woman had breast aug as a primary, and then she had gluteal as a secondary. For the first time, he was starting to see gluteal implants as a primary. That has been just an interesting market demand where there's been a totally different focus.

Dr. Kinney: I'll tell you something else that's interesting is if you look at that approach at implants, implants are hard and when you sit on it, it's sort of messy. It doesn't feel so good. It, on the other hand, they will give you instant volume and the chances of bleeding fat embolism … You can't say zero but far less than fat injection. We don't have a lot of data in combination. Put a hard implant underneath, and put some fat on top. Layering? Who knows? There's still an enormous future for innovation in the area of the buttock.

Tamarin: It's interesting. You have done fat grafting, correct?

Dr. Kinney: Yeah.

Tamarin: Because you mentioned you had a patient that I think it was 500 CC on each side.

Dr. Kinney: Yeah.

Tamarin: What technique did you use at the time?

Dr. Kinney: This patient is an interesting story. Young girl, 23, already pretty curvaceous, and she wanted a bigger buttock, so we did about 500, and you saw it, and it was really darn good. After two or three months, she was kinda happy, but not really excited, and then I lost her. Two-and-a-half years later, she comes back to me with three different surgeons, and four operations later, several months on antibiotics, and abscess. She has a divot about the size about of a baseball in her right buttock, and she needs to be reconstructed now.

Dr. Kinney: I said to her, “I'm gonna call in my friends.” I called up my friend, Tino Mendieta, and said, “Tino, give me an opinion. I have an idea.” His opinion was very close to what I wanted to do which is I said, “We have a reconstructive procedure here.” I took care of a girl years ago that was swimming and a motorboat run over her buttock and ripped right through her. I had another guy who was on a motorcycle, and a truck hit, and dragged him, and ripped open his buttock.

Dr. Kinney: I've seen some horrendous reconstructions that are your real true roots as a plastic surgeon reconstructing. You can take some of those principles and apply them here, but this is something that shouldn't happen to have a divot the size of a baseball in your buttock from too much injection.

Tamarin: You're saying, your primary injection was the 500 CC.

Dr. Kinney: And it wasn't enough for her. She went to get a thousand more on each side.

Tamarin: Explain-more was added?

Dr. Kinney: When you do these large, large volumes and you don't use a microdroplet technique, and the blood doesn't nourish the grafts, then it forms a big hardball, and then the fat dies, and then you get a liquid pile of old fat, and then you get infection in that. It gets called as a bacteria, and then you develop an abscess. We all know that microdroplets are right. It sounds very simple. Just do small droplets. What that means is you do again, and again, pass again, pass again, pass again over, and over, and over, and over again.

Tamarin: In one surgical procedure?

Dr. Kinney: In one surgical procedure. If you took all of your fertilizer, and dump it in a big pile in the middle of the field, it's not gonna work. You have to sprinkle that stuff, or your seeds all the way down the field down every single row back and forth.

Tamarin: It would create time in the OR. It creates a longer surgery, higher cost …?

Dr. Kinney: More demanding technique. You have to fuss and get it just right. It's pretty easy. I would do what I call a“push the plunger.” That's not hard.

Tamarin: The microdroplets are a technique relative to the volume in any one spot at any one time all during the same surgical procedure?

Dr. Kinney: Right.

Tamarin: Then a secondary or a separate topic would be whether it's injected superficially or into the muscle?

Dr. Kinney: Right. Now the current recommendations, the current wisdom is superficial, don't go in the muscle, too risky.

Tamarin: I guess to go to a lot of the heart of the matter on pioneers and early adopters, you have that first advent of both surgeons and patients who were desiring of a higher volume that was really fitting into the patient's idea of her ideal body type. At that time, you're using high volume, fat grafting and purposely injecting into the muscle because that's what the literature supported at the time?

Dr. Kinney: Right. We just didn't have enough data, didn't have enough experience.

Tamarin: To go down that train of thought, as a pioneer yourself, as someone who has lead the way on so many innovations, how do you cope with or successfully navigate those early stages where you're applying the very best of what you know at the time only to find out with a little bit more case study that you really need to alter the technique dramatically or that there have been serious adverse events as the result?

Dr. Kinney: I look at the difference between a trade and a true profession or a calling. If you learn a trade, you learn techniques and just apply them, and just do your thing. There are surgeons who will go through a career, and after five or 10 years, have a skill set that seems to serve them pretty well, and then they choose not to innovate enough. I would tell you that half of my practice changes every three to four years, and if you're not paying attention, and not going to conferences, and not learning, and not challenging every one of your assumptions, then you're gonna stagnate but your also not gonna help your patients, and you're also, besides falling down all the time, you're gonna find out as you do more and more, you have more risk.

Dr. Kinney: I'll give you an example. Along with my colleague, Leonard Miller in Boston, I was the first … The two of us did it together. First two people to do Thermi. We had that device two years before there was a company, and we were playing with it. Here's how it went. I'm very lucky in my practice. I have a hundred patients that I've done seven or eight FDA clinical trials, and a lot of them have been out. They say, “Anytime you have some new idea, call me.” I say to the staff, “I got an idea. Let's start calling the usual suspects. I'm like Humphrey Bogart in Casablanca. They round up the usual suspects.

Dr. Kinney: We have this idea, the NeuroTherm device could be put into the spine and could be heated to knock the nerve out and get them off narcotics. Leonard Miller said to me one day, “Brian, that's safe in the spine. We must be able to stick that thing in the neck.” I said, “Okay. Let's stick it in the neck.” We called up a bunch of patients. I did about 20 patients for free. We'd heat it and instead of going to 85 degrees, we went to 60, 55. Every time I think of something new, I ask myself what is the intellectual backbone of this, and how can I test it?

Dr. Kinney: Thermi was temperature control, tissue selectivity, continuous infrared monitoring. People had used the fluorescent camera in the lab, but nobody said, “I'm gonna take a continual movie infrared of my procedure as I'm going....I'm gonna use that to guide therapy.” You see pictures all the time of infrared... Now, everybody uses the machine infrared for everything.

Tamarin: Just to clarify, the original use of the machine was to go into the spine, to deaden the nerve.

Dr. Kinney: Yes, that's right.

Tamarin: It's a method for controlling pain, but you're use of putting it in the neck was not to put it into the spine, it was to tighten...

Dr. Kinney: The submental turkey neck, platysma, SMAS, to tighten … That's a good point.

Tamarin: So skin tightening?

Dr. Kinney: Yeah, skin tightening. Then we realized, of course, we can do it in the nerves and the face because if it works in the spine, we can certainly knock out the nerves. We weren't looking for sensory nerves which they were looking for in the spine, for pain control. We started knocking out the motor nerves so you could have a long-term toxin effect, and it works. That device, the company was founded in 2012 and I was there on the day of the founding, or the founding meeting. Actually, a couple of business guys started before.

Dr. Kinney: That grew in 2012 to now where they have 2,000 machines. They've done 100,000 procedures. We now do vaginal rejuvenation, vaginal tightening, other things, and we do nerves, and we do necks, and we do tummies, and mommy makeovers, and other stuff. It was really a lot of fun to be involved in that. I have been involved in what I call “coffee table to clearance” four times. You're sitting around chatting, you have an idea, you say, “Hey, I wonder if that'll work.” Four, five years later, it's approved. Now, I've also been involved in “coffee table to failure” about, seven or eight, or nine times, and that's just the way this entrepreneurial…

Tamarin: The nature of innovation. To go back just for a second on ThermiTight because I had the wonderful privilege of being in one of your training sessions, and it was on the neck. One of the things that I remember was how much you stressed staying away from the jugular. It seems like there was a very, very high focus on technique, making sure that physicians were properly trained, and the right attention to detail was offered. Were there any concerns or things to overcome when Thermi was released to the market in terms of…

Dr. Kinney: Yes. Theoretically, on day one I thought, “Oh my god. If we hit the carotid artery, the jugular vein or the parotid gland, we'll get blood flow, we'll have a big problem.” Fortunately, I can tell you now six years later, we've never had a parotid gland, or a carotid, or had a jugular injury. However, what we do know is that about half a percent to three-quarters of a percent of our patients, maybe 1%, we don't really have a good data, will have a marginal … May develop a nerve injury which means their mouth drops.

Dr. Kinney: I've had seven of them. I've done at least 800 cases, so it's a little less than 1%, but I've had them, and what we find out is that all of mine have come back in six weeks or less. They get a partial nerve injury. I use to tell people, “When we knock out the nerve, we find the nerve, we map it. We put the probe exactly on it. We hold it there at 85 degrees for five minutes and sometimes we don't completely knock the nerve out. Therefore, if we're doing a neck at 60 and we're moving around, it shouldn't happen.” I said that.

Dr. Kinney: My first patient was a year-and-a-half in and had a single problem, and it was the doctor's wife. Then about nine months later, in June of 2014, the next patient was a doctor. Then about eight or none months later, my third patient who had a nerve injury was a lawyer. I'm not kidding. Now, fortunately, all three of them were wonderful patients. Everything was fine. They all got better, but if somebody comes in to be beautiful, and their mouth is opened like this for six weeks, they're not gonna be happy.

Tamarin: It also takes away the ability to have privacy because this is one of the themes that was … I guess, interesting to the market about the minimally or non-invasive techniques or devices was that it would allow a patient to do things subtlety. If you have an injury, suddenly, you're explaining something or you're just put in a very difficult position in a public forum.

Dr. Kinney: Right.

Tamarin: I have a different question. ThermiTight, as it relates to arms and legs, have you used for circumferential tightening of the extremities?

Dr. Kinney: Yeah. We used it circumferentially in the arms. You can do the biceps and the triceps, and go around. It seems to work better on the triceps than on the biceps. The biceps skin is attached a little bit more tightly attached. With the legs, the thighs, it works. I've got some really nice pictures but it takes a long time. It could be a three-hour-plus procedure.

Tamarin: What's the risk of nerve damage to the extremities?

Dr. Kinney: In the thigh, it's minimal. It's not zero. I've had a few patients that say, “Afterwards, it's a little numb and tingling.” No one…

Tamarin: Sensory numbness, but not impeding one's function?

Dr. Kinney: No motor, we have never seen it. We've actually never seen one in the arm, never seen one in the thigh. To just jump back for a minute on the neck, satisfaction rates are probably 90% … Some people will say, “Well, it didn't really work so well.” We know that you're heating and contracting tissues but then your body needs to generate collagen response, and some people don't, so I'd say, on the low end, 83, 84, 85% on the high end, 94, 95%for satisfaction.

Dr. Kinney: The cool part as you were talking about privacy, you have swelling for a couple of days, and if you did it on Thursday or Friday, you can work on a Monday. You might be a little swollen. You'd say, “I had some dental work, it didn't work much.” You can drive in, and you can drive home yourself. You don't have to be sedated for Thermi on the neck or on the legs. If you do it on the legs, you could go to work the next day. As long as you don't work as a lifeguard.

Tamarin: Right. That's really interesting. As you talk about the technique, it’s clear you made adjustments for things that came back from the field.

Dr. Kinney: Absolutely, necessary. Innovation. The business people in the company used to … When I gave these seminars, and they would attend and watch, they would say, “Oh my god. You told them you didn't know.” I would say to them, “To the extent that I'm honest, this technique will evolve. To the extent that I get stuck on something and try to put up a good face, and pretend like I know everything, we will stagnate.”

Tamarin: That is such a profound statement because we enter this with ideas from the best of minds, and the best science, and the best desire to solve a problem one way or the other, but if you aren't open to the nature of the learning, you can’t evolve. You have to take in new information, you adjust, you apply it, or you end up stagnating instead of reaching an optimal outcome. A lot of the question, I have around pioneers and early adapters is what happens to those surgeons that are courageous, those that are the brave ones at the forefront of technology that are stepping out there to raise the bar, what happens when adverse events occur.

Dr. Kinney: A couple things, I'll use the Thermi example before we go on to others. Our initial emphasis was the neck even though it was approved for nerves, and it worked well in the neck, and we did arms, and then we did use it for other things, and it worked really well, but then we thought, “Oh, we can do the vagina.” I started working with a number of obstetrician and gynecologist, and ThermiVa grew in about a two-year period from year one-and-a-half of Thermi to about year three plus. All of a sudden, ThermiVa was becoming dominant.

Dr. Kinney: There's an example that started we thinking we're gonna use that on the neck. The original purpose was on the nerves, and probably now, I don't know this, 15, or 20, or 30 doctors in the US or in the world consistently doing nerves, I probably do more than anybody else in the world. It still works well. Most doctors say, “I don't want to do that. It's too technical. It's too precise. It's too demanding, and it's really hard to find those nerves.” Our device which was a nerve device that we were using on necks and cheeks, which is still done, the dominant thing it's used for now is vaginal. There's an example of something that morphed into something else.

Tamarin: Interesting. That it started with one focus and because it had a secondary benefit that translated into its primary use…

Dr. Kinney: Patients and doctors ended up defining the greatest importance of it.

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