Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Move Forward After a Thumbs Down from FDA: Interview with Kevin Sidow, Former CEO and President of Moximed

Episode Date: February 8, 2020

In late 2016, I was able to sit down with Kevin Sidow. At the time he was President & Chief Executive Officer for Moximed and had been since 2008.Prior to his time at Moximed, Kevin was President & CEO for St. Francis Medical Technologies, a privately held, venture-funded company focused on developing innovative treatments for patients suffering from degenerative spinal disorders. In January 2007, St. Francis Medical Technologies was sold for $725 million to Kyphon, which was acquired by Medtronic later that same year.Previously, Kevin was the Worldwide President of DePuy, where he supervised the global orthopedic, spine, trauma, and sports medicine businesses, with annual revenue responsibility of over $3 billion dollars. Kevin holds a B.S. in Accounting from West Virginia University.Here are a few of the things we learned from Kevin:- How Kevin felt when Moximed’s first patient was treated with the Atlas System after 8+ years of research and development.- What makes the Atlas System different than other orthopedic knee implants?- How medtech professionals looking to take the next step in their career can utilize Kevin’s advice and learn from his meteoric rise to Worldwide President of DePuy.See more...

But I also think there are lessons that you learn as an entrepreneur that you can't learn anywhere else. And part of that is a really hard lesson about your capability. I know it sounds funny, but you find that you can really do a lot more than you think you can do. You can work harder than you supposed that you could. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut interviews. Now, here's your host, Scott Nelson. On today's program, we have Kevin Seidow, who in February 2008 began his role as president and chief executive officer for MoxieMed. Prior to his current role, he was president and CEO for St. Francis Medical Technologies,

a privately held venture-funded company focused on developing innovative treatments for patients suffering from degenerative spinal disorders. In January 2007, St. Francis Medical Technologies was sold for $725 million. to Kaifan, which was later acquired by Medtronic. Previously, Kevin was the worldwide president of DePue, where he oversaw the global orthopedic, spine, trauma, and sports, medicine businesses with annual revenue responsibility of over $3 billion. Kevin holds a BS in accounting from West Virginia University. Here are a few of the things we're going to learn in this interview with Kevin,

how he felt when Moximate's first patient was treated with the Atlas system after eight years of research and development. What makes the Atlas system different than other orthopedic knee implants? Kevin's meteoric rise to worldwide president of DePue, and his advice to other medical device professionals looking to take the next step in their career. How Kevin and his team responded when the device received an unfavorable response by an FDA panel. Kevin's approach to financing a med tech startup after raising nearly $100 million to fund MoxieMed and Kevin's favorite business book, the CEO he most admires and advice he'd give to his 25-year-old self.

So without further ado, let's get to the conversation with Kevin. All right, Kevin, welcome to the program. Appreciate you coming on Midsider Radio. Yeah, great. Thanks for having me, Scott. Appreciate it. All right. Well, let's start with MoxieMed. You founded it back in February of 2008, or at least started there back in February of 2008. And we're now recording this conversation, you know,

almost nine years later towards the end of 2016. And that's a long time, I think, from anyone's perspective, especially in sort of the startup med tech ecosystem. So tell us how you felt when that first patient was treated with the Atlas system for your IDE that was announced earlier this month. Yeah, no, it felt great. I mean, you're right. Scott, it really is a long time. But we feel we've always felt that the size of the opportunity will make it work the weight. So when the first Atlas went in in Boston recently, it's really the culmination of eight years

of clinical history with the predecessor device, which first went in June of 2008 in Australia. And all of the studies between the Atlas and that first implantation of the Kinnispring device, is what we call it, really show consistent success across a patient that we feel has been underserved by current surgical therapy. So, yeah, we're absolutely tremendously excited about prospects and happy to see the first case take place in the U.S. I bet. It's probably almost hard to describe that type of feeling like looking back over the past, you know, eight plus years or so in all the efforts that went into, you know, the product, you know, the regulatory approval process, clinical trials, et cetera.

So obviously I wish you congratulations for sure. And so let's go ahead and level set things for the audience. Can you go ahead and provide a high level overview of Moxumet and the Atlas system? And then I think in the past, in doing some research for our conversation here, you called it a shock absorber for the knee. And so just curious to get your take on how it differs from other knee plants that are on the market today. Yeah, and that's a great question. So I guess I'll back up a little bit and just say that a Moxymet came out of the incubator,

ExplorerMed, that also spawned a Clarenth and Neatrack, which are both companies that built great success in treating patients and filling an unmet need. And ExploreMed and Moximed were originally and continued to be funded by NEA. So we've been very, very fortunate in that they share our vision that this is the area of unmet need is one, that's well worth investing into. So what makes it different is, I think it's, first of all, it's a procedure that if for some reason it doesn't work for a particular patient, you haven't compromised any downstream therapeutic options.

So what we're offering really is this proposition for patients. You can maintain your own natural anatomy, in other words, we're not cutting out any bone or soft tissue. you can maintain an extremely high activity level without compromise. And as I said, you can also maintain those downstream therapeutic options such as unic compartmental knee arthroplasty and total knee arthroplasty. So what's different about it versus those things are knee replacement surgery works great. And, you know, my background was I worked for Johnson Johnson's Orthopedic Unit

and a lot of the time is spent on the hip and knee division. It's a great therapy, total knees, but it's really targeted and most successful for those patients who have moderate activity levels or low activity levels. What we've targeted with the Atlas device are those patients who are high activity levels, who either because of their job or because of their hobbies,

you know, require or desire high activity levels. And we think in 2016, that's a fair proposition to allow patients to maintain and not compromise their quality of life. Sure. That makes a – thanks for that overview, by the way. That makes a lot of sense, and I couldn't agree with you more in regards to your comment about in our current era, patients are becoming that much more proactive about their health. And I got to think that that sort of bodes well for Moxumet into the future when it comes to

that type of patient population and aging and needing maybe something. like the Atlas system. So before we kind of go back in time and learn a little bit more about your career in MedTech, help us understand your current commercialization efforts. So you've got a, you started your IDE trial, as I mentioned before here in the U.S. Are you currently commercializing in Europe right now?

No, we really, we do have some, we have a few cases being done and being paid for in Europe because it is CE mark. But our primary focus of the company is really addressing the U.S. market availability through the regulatory processes. And the activity in Europe really is to do either registry or single patient or, excuse me, single center studies, you know, support the clinical portfolio that we will submit to FDA for approval. Okay. Very good. And on that note, is there a date in mind that you sort of anticipate FDA clinical?

or is it too early to tell? Yeah, well, it's not too early. What I would say is that we expect that, first of all, all the patients have been enrolled in the primary endpoint will be hit early in 2017. So beyond that, I probably can't say too much. Sure. Okay. Very good.

Well, yeah, we're going to circle back around to Moxamede here later in the conversation. But let's use this time as a transition to go to rewind. the clock, as I mentioned before. You know, you started out at DePue in the orthopedic division as the VP of Sales for the Midwest. So what were you doing before then? Because I'm curious sort of like your entrance into the medical device arena. Well, so I started out with How Medica, actually, as a sales representative. And at How Medica, I was promoted up to the level of a director of sales position within Halmedica. I always had this entrepreneurial instinct and interest.

So at a certain point, I went to work for a small spine distributor, which was selling at that time Medtronic products. I wanted to learn about the spine business because my main involvement had been hips and knees. But I also, we were considering a financial partner and I were considering buying a small independent hippony manufacturer. That did not come together, but in the meantime, I got to know the spine business very well,

which certainly later, because one of the worldwide businesses reporting into me at Depew was the spine business, so I had a sort of baseline understanding of the surgeries, the needs, the patients, et cetera. Got it, makes sense. And so you ended up not buying that manufacturer, but instead ended up kind of landing at DePue, is that correct?

Yeah, so it just came up. A friend of mine had recently started with DePue, and you said, look, we have a need for a, I think originally they were proposing VP of sales, but I didn't want to move. So I became sort of the VP of sales for the central part of the country. I didn't want to move to Indiana at that point.

So that's where it started with DePue. Okay, and it seems like, you know, I guess before we get into kind of, you know, you're what seems like a meteoric rise within, within DePue. It's pretty clear just in our early conversation here that you did in fact have that sort of entrepreneurial bias or bent early on if you were considering a, you know, purchasing a, uh, an actual, you know, device manufacturer. Have you always had that instinct or was there, um, you know, was it, was it your career sort of post undergrad that really, uh, kind of fostered that type of,

uh, behavior? Yeah, that's a great question. I think, I think I always felt like I wanted to, to be able to build something fairly directly. And, you know, I think you cannot substitute for the things you learn by working for a big company in terms of process and in terms of, you know, even strategy and needs. But I also think there are lessons that you learn as an entrepreneur that you can't learn anywhere else. And part of that is a really hard lesson about your capability.

I know it sounds funny, but you find that you can really really. do a lot more than you think you can do. You can work harder than you supposed that you could. So those sort of lessons I learned fairly early on in just sort of regular jobs, and I always wanted to put those lessons to work sort of for myself, or at least as a small company that I could play a heavy part in building. Yeah, yeah, no, I can completely appreciate that. Appreciate that. And your statement about the lessons learned at a big company. I mean, I've certainly experienced that in my career.

And, yeah, you just don't fully grasp the nuances at a large device company, unless you've done that, you know, and had that sort of experience. So cool. It sounds like you've similar thoughts anyway. So let's talk a little bit more about your time at DePue because, you know, like I mentioned, the VP of Sales in the Midwest. But then within two and a half years, you were president of orthopedics. And I think less than a year later, if my timeline is right here,

you were the worldwide president of DePue. So can you talk to us or help us understand what led to those rapid promotions during your time there? Yeah, so it was interesting because, you know, shortly after I joined, and really I think it was a matter of a couple of months, Depew was acquired by Johnson and Johnson. So I think that accelerated my ability to be offered promotions because, you know, the work was intense in integrating the companies. I think people had greater visibility to, you know, we're spending a lot of time together, and I think people had greater visibility to who works, how, and produces what results maybe a little more quickly than they would otherwise.

So for me, it really was a unique situation in that at that time, there was no worldwide president of DePue, or excuse me, of the combined company. There was an international president and a U.S. president of the hip-and-kneed division now. This is what I'm talking about, the hip and knee division only. So what happened was, I actually was offered the international president position on the hip and knee division was in the process of taking that position because I thought it was the right time for my family and it would have been a great opportunity, English-speaking company because DePue's international headquarters are in England, which makes it a little bit easier for the kids.

And in the middle of that, actually, when we were just about to move, the U.S. president resigned and moved out of the company. So it left us with a dilemma. But in the meantime, and what that dilemma was resolved by then asking if I would take the U.S. president's job, which I did. But in the meantime, I learned quite a bit about the international business. So a year later, when they look to flatten the organization a little bit and combine some things on the hip-and-e business,

I became the worldwide president of the hip and knee business, and at that time, the worldwide trauma business started reporting into me as well. It wasn't until maybe another year. So I think it was probably a year or two maybe that the worldwide sports medicine business, MyTech, and the spine business started reporting into me as well. So that's how I meant. Okay. So it sounds like definitely some moving parts along the way.

that sort of opened up a path for you for sure. On that note, though, so I mean, I know I think for most listening, as they're hearing you describe that, looking back, it sounds like it's, oh, okay, that makes sense. At the time, I mean, those were rapid advancement, especially at a time when, you know, J&J was acquiring DePue. There's big business involved. So I guess I'd like to ask the question, you know, for those listening in the audience that are at a, you know, at a similar point in their career, whether it's at, you know,

a midcap or a large strategic, you really want to go to a startup, but they sort of like, they want to continue to advance their own career where they're at. Do you have any tips or tricks or advice that you can offer up? Yeah, I think it's just the stuff that you hear constantly, Scott, and that is, you know, you have to go where the work is, you have to go where the challenge is, and you have to be willing to step outside of your comfort zone, or you're never going to grow.

That's one thing I did. I put myself in a position where it would be slightly or more than, or significantly uncomfortable, because I knew that's the way to accelerate your learning, and to become a better, ultimately, general manager. So I did do that. But fundamentally, you also have to believe and trust in the people you work with

and either engender that trust or develop that trust, depending on which side of the equation you're on, and also with the company and the products you're working with. Johnson & Johnson's a tremendous company. They really are, and there are a lot of really good people there. So that made it easy for me, you know, every step of the way. But that's the advice I would offer, including when you look at those opportunities,

you really do have to be flexible in terms of, you know, role, location, and everything that goes along with those things. Thanks for those nodes. I mean, they sound relatively straightforward, but, you know, maybe easier to speak to, less harder to actually, you know, put into action. But, you know, your last point about being flexible, you know, I remember a point in my career where, you know, I had a similar conversation with a regional sales manager. And he made the same exact point that, you know, throughout his personal career, he's always

been flexible and been willing to make the necessary moves from a geographical standpoint. And if you don't have that flexibility, you're kind of making it hard on yourself. So that makes a ton of sense that you sort of reiterated those same thoughts. So let's kind of move on from your time at DePue. I think you spent about three years as worldwide president of DePue and then made the move to St. Frickle Technologies. And to be honest, I had never heard of St. Francis medical technologies before you agreed to do this interview.

So I had to do my own research. But, you know, can you tell us a little bit more about what drew you from DePue to St. Francis and then where the company was at at the time you joined? So it's an interesting question and it caused me to think back because it was a question I was asked about a lot when I made the move. People thought this really looks like a bad career move, you moving from large responsibility to this startup that, as you say, not that many people knew about at the time. But what attracted me was, as I mentioned earlier, I always had a very strong interest in doing entrepreneurial work.

I loved the space. I love the fact that there was a large, unmet need. And in this case, it was that the need was just pure numbers. There were a lot of people with spinal stenosis, which is what the company, St. Francis' product, addressed. So I really was attracted to that. And it was a less invasive device that was reversible. So again, for some reason, if the product didn't work, you could take it out and you haven't compromised any other therapy that the patient could go to.

So those are the things that attracted me to it. And, you know, quite frankly, it was also based in San Francisco in the Bay Area. So that was also a positive. But the main thing was it was a big space and it was, you know, it was the startup that had many of the elements that I had always had on my list of interest. And that particular device, that become the X-Stop at Kaifan? That's exactly right. Okay, got it. That's exactly right.

All right. And then when you joined St. France, was there a product in commercialization, or was it still a pretty early stage? So it was early stage, but it was in commercialization. So it's an interesting tale, really, because the company was doing a little bit of business in Europe with the device. They had completed enrollment and had some minutes. for FDA approval and the panel meeting was scheduled for U.S. approval. So they were doing, you know, in Europe, I don't know, maybe a million or two at that time. So what happened was shortly after I joined within two months, certainly, we went to the panel meeting and the

company had picked their clinical endpoint, but the panel did not approve the device. So they turned down the device and sort of sent us back to the drawing board. Now, this, This is really where I learned a tremendous amount about the regulatory process. So what happened was we started to have conversations with the next level at FDA. At that time it was Donna B. Tillman and she was great to work with because while there wasn't much interaction, she really had sort of a more of a big picture perspective. And so ultimately we were granted a meeting with Dr. Tillman and her team and the other numbers of the reviewers of the X-Stop and sort of took them through where we were, the fact

that we had had a number of these implanted with no safety issues in Europe and FDA ultimately granted approval to the device. I would say maybe a year, 15 months after we were initially turned down. In the meantime, I also learned a lot about cash burn, you know, because when you're dealing with a multi-billion-dollar company, you don't get a... concerned about this. But what we did, unfortunately, we had to terminate, you know, between, I think it was 35, 40% of the people. It was a small group, so it was only, you know, maybe 9, 10, 11 people, something like that. I don't remember the numbers now. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only

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