Medsider: Learn from Medtech and Healthtech Founders and CEOs - Why Early Revenue is the Most Credible Proof in Medtech: Interview with restor3d CEO Kurt Jacobus

Episode Date: May 12, 2026

In this episode of Medsider Radio, we sat down with Kurt Jacobus, co-founder and CEO of restor3d.restor3d provides patient-specific orthopedic implants using 3D printing and advanced software.Kurt has over two decades of experience in medtech entrepreneurship, including successful exits to Enovis and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey & Company. He holds a PhD in Mechanical Engineering and is an Adjunct Professor at Georgia Tech. In this interview, Kurt discusses how restor3d used the FDA's 520(b) pathway to generate revenue and regulatory proof simultaneously, why self-regulating beyond FDA requirements makes submissions a competitive barrier, and how to approach investor relationships and board construction with long-term thinking.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Kurt Jacobus.KEY MOMENTS FROM THE INTERVIEW(03:21) - How Kurt went from wanting to build race cars to 20 years of orthopedic entrepreneurship (06:03) - How restor3d’s patient-specific implants challenge the “8 sizes fit 8 billion people” model (15:36) - Why early-stage companies should “ring the cash register” as soon as possible (17:16) - How a 520(b) pathway helped restor3d generate revenue before full FDA clearance (31:48) - How restor3d treats every FDA submission like a PhD thesis and holds itself to standards beyond what regulators ask for (35:24) - What Kurt learned from restor3d’s limited market release (40:03) - How Kurt raised is last$100M+ round, and why fundraising is really a networking game (45:13) - What makes a great board, and how the wrong one can quietly derail a company

Revenue, early stage revenue, just matters more than anything, right? And otherwise you're selling, you know, a vision or some vapor or things of this nature. And, you know, there's the old adage, there's nothing in business that sales can't fix. It's generally true, I think. So what we endeavor to do in this business in prior businesses is really kind of ringing the cash register early. Because that shows that you can cross regulatory hurdles, cross-manufacture transfer hurdles, put stuff in the warehouse, construct a sales team, commits the market that what you have is differentiated seed trial and hopefully seed retention. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology.

Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, in this episode of MedSider, I sat down with Kurt Jacobus, co-founder and CEO of Restore 3D. Restore 3D provides patient-specific orthopedic implants using 3D printing and advanced software. Kurt brings two decades of med tech entrepreneurship, including multiple successful exits to Enovus and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey and Company.

He holds a Ph.D. in mechanical engineering and is an adjunct professor at Georgia Tech. Here are a few topics we explored in this conversation. First, how revenue changes not just company valuation but the type of capital available. Second, ways you can generate initial revenue before full regulatory clearance. Third, who actually makes the investment decision and how should that change your fundraising approach? And last, when is a no from an investor actually just a question of timing? Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter fundraising cohort.

This four-week live workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never-ending slog. Over the month, you'll walk away with an investor-ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content plan that keeps you on investors' radar, and a repeatable system for running your raise. You can join the waitlist at medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview.

All right, Kurt, welcome to Medsider Radio. Appreciate you coming on. Great to be here, Scott. Thank you for the opportunity. And thanks for putting the other great podcasts. I've enjoyed it when I've listened to it. Thank you very much. Try to do our best.

Sometimes they turn out really well. Sometimes they're okay, you know, but such is the case with these types of shows. But nonetheless, I'm pumped to talk about the company that you're running, your store 3D. But let's start there. I recorded a very abbreviated buyout out so that this interview, but I always like to hear it from the horse's mouth, so to speak,

right? Give us like a one to two minute kind of overview of your career before, you know, taking on the CEO role at Restore 3D. Of course. And it's very much initially a meandering career. So my career is marked by doing things that I discovered I didn't enjoy and then moving into orthopedic entrepreneurship, which I've enjoyed a lot. I've been doing that for the last 20 years. But long story short, when I left high school, I wanted to build race cars. I went to a degree in engineering. When it became clear to me, I was going to have to work for a truck and bus company in the middle of Indiana. I decided that the automotive industry wasn't for me, and race cars are too far afoot. And so I decided to go to grad school and spent time there

completing a PhD at the intersection of manufacturing material science, but I realized there that I didn't want to be an academic. And so then I decided to be a consultant. I joined McKinsey and Company for four years, did some cool stuff. Some chem farm of biotech. stuff, which is relevant to what I do now, but also some mining and airline work, retail banking, a variety of things. But I realized there I didn't want to write PowerPoint documents for a living, no offense to the very smart people at McKinsey, but not the right thing for me. And then after that, reconnect with one of my lab mates from PhD, and we've been doing entrepreneurship and startups and ortho for the last 20 years. I've been a CEO 20 years. And I've had a good

fortunate being involved with a bunch of companies that have improved a lot of lives and have done well for their shareholders as well. And that's what has me here today at Restore 3D. Yeah, awesome. You're being a humble. What a pretty impressive background. But the one question, right, that's bugging me is at your time at McKinsey, did you get a race, work on any race car projects? No, I did not. I got close. This is interesting at our, we had a foot and ankle business called MedShap. We got reached out to by the 401 team for Mercedes Amends. And they were having difficulty with head gaskets and ask us to do something with the unique material called polyether at the ketone, which is used a lot in spine, other places in ortho. And we did some work for them.

We never got spec onto the car, though, Scott. That was the, I ever got. Do you happen to know, I don't want to get too sidetracked here, but you happen to know, some Michael Hoy, am I pronouncing his last name? He's the, he's founded several Metsac companies, one of which is Francis, which I believe my understanding is sort of the concept came from like him experimenting on race cars. Do you know him at all? Have you crossed me? I do not. I may ask you for an intro that might be fun to chat with him about. Do not know him. Two race car enthusiasts turned MedTech entrepreneurs.

That's awesome. But let's touch on Restore 3D at a high level. And then we'll, of course, rewind a clock and go back in time and learn a little bit more about kind of the past, call it close to decade now, building the company. And then hopefully you can kind of weave in a lot of your other learnings across your pre-story career. But let's start with Restore 3D. I'm on the website right now, which is Restore without an E. So R-E-S-T-O-R-3D.com, or restore3D.com. We'll link to it in the full right up on MedSider.

But give us, like, the high-level overview of kind of what you're building and maybe frame it up as, you know, for those that have never heard of the company or don't know really what you're doing at all. Of course. So we are orthopedic device manufacturer, and what that means is we make implants and instruments to support procedures that happen in orthopedics. And we are the world's leading provider of customized orthopedic devices. And we do them literally head to toe from a cranium, tip of your big toe.

everything in between. And what makes this different than other manufacturers is that we will take your unique anatomy and make patient-specific implants and instruments to restore that anatomy. And we do a lot of the manufacturing with 3D printing, and that should give you a sense of how we came up with the name, Scott, Restore 3D. And so that's very different than traditional ortho, which is where, you know, I had occupied, you know, over half my 20 years in the industry in that traditional model, which is, you know, in very simple terms, kind of an eight sizes fit eight billion people at 80% patient satisfaction business, which has, you know, it's improved tens of millions of lives over the years. But we thought that we're going back even 15 years ago, that things could be

done better with emerging software technologies and 3D printing technologies and have built this business to demonstrate that and are well in our way to doing that. It's interesting. Literally just yesterday, at Alfred Griffith, who's the CEO of founder CEO of Lightforce, and they're doing 3D printed like braces, orthodontic braces, really, really cool company. I had never really even heard about it until I started doing some research before the interview.

But like two CEOs with vast 3D printing experience here back to back, this is pretty interesting. As of right now, current state, we're recording this in Q226. Are you focused on certain anatomical areas then at Restore? We do everything head to toe, but the, areas that are best developed now for us, our ankle and shoulder. Those are where our product portfolio is most complete. Hip is in very good condition, and our knee, while being a big part of our revenue,

is in a refresh cycle to drop in 2028. So, you know, while we will do cranial maximal facial work and hip knee and shoulder and ankle and everything in between, the bigger gross segments for us right now are extremities, which are a shoulder and ankle, and that's for the reason we got started in those earlier. When we started the business, we initially started in ankle, lower extremity, and that's why that part of the portfolio is best developed there, and then later in shoulder, which is almost fully developed as we sit here today. Got it.

As a cardiovascular of METEC, obviously less familiar with ortho, know enough to be dangerous. What, as a patient, like, why wouldn't I, like, why wouldn't I, like, opt for a 3D-printed, like, you know, implant that's built specifically for me. Like, is, am I missing something? I'll turn the question back to you. Why wouldn't you? And I completely agree. And we often get the question.

It's interesting, we got a big shoulder conference that starts tomorrow. And on that shoulder conference, you know, we get a lot of attention there because we tend to do very, very difficult cases, you know, and that's a point of entry for many of our surgeon relationships. And surgeons don't want to talk about on a podium in everyday case, a boring, you know, you have a run-of-the-mill shoulder. And they want to talk about very difficult cases, but the question or the concern that's sometimes thrown at us in those environments is,

yeah, but, you know, not everyone can afford the patient-specific stuff that Restore 3D is offering. Well, what they don't realize is that for the vast majority of our cases, we price at parity with off-the-shelf, shoulders, hips, knees, and ankles. Very divergent things, of course, we have a very high engineering burden. We will charge a premium, as the case may be. but there really is no good reason. And when you get out and talk to a lay person and Scott, you're not quite a lay person, but you're not an ortho expert.

And you say to them, wait, hold on, or when they realize, wait, there's eight sizes for eight billion people, but you can restore my anatomy that's something specific to me and I'm cost indifferent. They have the same question in their mind that you just posed to me is why wouldn't I do something personalized? Yeah, yeah, makes a ton of sense. And I would consider myself very much a layperson when it comes to ortho,

maybe a little bit more than the average draw on the street just because I've been in the MetTech space for gosh, close to 25 years now. But no time really spent in ortho. But it seems like kind of a no-brainer, you know, of why in fact my dad just had a meet implant. Gosh, it's been about nine months ago. It's like I should I should have known better, right? I should have, we should have had this this conversation a year ago. And I should have said, dad, you know, you should be checking out Restore 3D. So with that said, I mentioned this that we're recorded this in Q226. For someone that's listening to this, maybe three, six, six months down the road. What is a, like, company, like current, current focus over the next,

let's call it year. Like, kind of where are you guys, what's next kind of over the, over the, what's the biggest play over the next three months or 12 months here? So the most tactical play that we have before us is we have a FDA clearance in front of the regulator for shoulder that we expect to have drop here in Q2 that will give us the capacity to do the most difficult shoulders to everyday shoulders and everything in between, and will allow us to more vigorously promote our shoulder, which is a big part of our business and a very fast-growing part of our business,

but we'll finally actually be able to fully promote it into the market. And so that, along with ankle, which achieved kind of that status in 2025, mid-year 2025, those will be the biggest thrust most immediately commercially. But, you know, every day we're out, of course, advancing our hip business and knee business, the only difference, particularly in the need business, is that product line is in a refresh cycles, as I mentioned, and will drop in 2028. So that's what we're doing. But business is really

a play of execution now. So we own our own production assets. We go from powder to finished product, sterile product, inside the four walls, the two production facilities, one here in Durham, North Carolina, where I am today, and where we're headquartered and one in the Boston suburban, Wilmington, Massachusetts. And so, you know, those production assets have been operating for many years and are operating very well. But what we have to do is continue to convert new surgeon accounts, penetrate existing surgeon accounts with our existing product portfolio and the new shoulder that I mentioned. And then just continue to be in increasingly better delivers a product on time, on cost, and on quality. And that's really what's before us for the remainder this year.

and frankly for many years ahead of us. I often get the question, we raised some money last year and are contemplating a fundraising round in the first half of 2027. What are the use of proceeds? And my answer has been three things. Release new products,

release new products, and release new products. If you're listening carefully, those are the same three things, Scott. So that's really what matters in an orthoped device. Maybe that matters in your neck of the woods. But I think, you know, there's nothing that excites surgeons more than new products. Nothing excites the sales force that serves them more than new products.

And nothing that's more given to improve patient outcomes and new products. And that's what we're fully dedicated to. Yeah. Keep it simple for us, for us, for us non-Ortho folks, right? Like, what are you focused on? New products? New products and new products. You know, it's interesting.

I was listening to this podcast. I should spend probably a couple months ago. But it was actually in a different vertical. It was in the e-commerce world. But I always like to listen to these other, like, really smart people that are doing interesting things in other areas and try to swipe as much as I can, you know, pull it into what I'm doing. But he runs a, gosh, it's an e-com first business in the consumer space. And it's, gosh, they're probably doing six, 700 million a top line a year. Like, so it's a pretty impressive business with a relatively small team.

And he was like, whenever I default to like, whenever there's like multiple hard, what I think are hard decisions on the table, he's like, I always default to just launch new products. just launched new products and that I'll solve for that solve for a lot of my challenges. And so it's like, yeah, that's a, it sounds, sounds easy enough to say, much harder to execute, but, uh, but nonetheless, it makes, it makes a lot of sense. So, um, I think it's a really,

really helpful overview. And again, restore3D.com is the website. So restore R-E-S-T-O-R-3, 3, like the number three and the D restore3D.com. We'll link to it in the full write-up. We'll also link to Kurt's, uh, linkden profile. So you can check out his background a little bit more detail. With that said, let's, let's, let's, uh, rewind the clock. and spend maybe the next 20 or 30 minutes learning not just about kind of what you've gone through

building restore but also like your previous experience as well and I want to start with kind of early stage development and it looks like based on your LinkedIn profile Kurt, did you come into the restore 3 initially as an investor and then eventually kind of took on the chairman's CEO role or tell me a little bit about that I want to talk a little bit about kind of the early stage early stage development seven eight years ago yeah so a company was founded in 2017 I am a co-founder and immediately began sharing the board one of my co-founder's PhD students my co-founders on the faculty of Duke came on. It was initially the CEO and did a fine job.

He remains our COO here today. And he built the business for the first roughly four years, a little bit longer than that. And then I came over and joined as a CEO in 2021, had been the CEO since then, have chaired the board since its inception and continued to do so. And so co-founder, but was initially kind of a chairman only, but a young business requires some operating. the work. I want to do some very tactical things, which I think happens in a young company, but I've been doing, of course, a day to day since October 2021. Okay, got it. Take us back to, like, maybe those early years. Call it, if you want to maybe even go back to 2018, 19,

but really kind of since taking over the helm and maybe layer in some of your previous experience at other startups. But those are some of the hardest days when capital is hard to come by, right? But you're trying to make like these meaningful iterations on your development. like what are what are like a couple key things that you think maybe not first time CEOs or like younger CEOs that don't have the breadth of experience you do what do they really need to get right in those early early stages yeah I and I think you know this one as many of these things are they often seem very obvious but are sometimes difficult to pull off I think in most businesses and certainly ones in device and ortho device your revenue early stage revenue just matters more

than anything, right? And otherwise, you're selling, you know, a vision or some vapor or things of this nature. And, you know, there's the old adage, there's nothing in business that sales can't fix. It's generally true, I think. And so what we endeavor to do in this business and in prior businesses is really kind of ringing the cash register early because that shows that you can cross regulatory hurdles, cross-manufacture transfer hurdles, put stuff in a warehouse, construct a sales team, commits the market that what you have is differentiated seed trial and hopefully seed retention. Even small scales, revenue, early stage revenue matters. You know, the challenge that you face, though, once you start ringing the cash register,

is everyone wants you to ring it a little more frequently than you did before. And so, but that has made a big difference in the businesses we've built. And the faster you're able to grow at the earlier stage, the easier it is to recruit town and recruit capital. And I don't think that can be overstated. this business, we initially were serving the market through 520B custom device exemption pathway, which meant that we did not have to go through an entire PMA or 510K or 510K de novo pathway, which even if you're very good is going to take a year plus couple of

years, right? We started serving the market that way, which allowed us to learn many things about indications, particularly divergent anatomy and divergent pathology early while also ringing the cash register, right, which allowed us to kind of get some money in the door. So I would, the only one that's starting a business, the sooner you can get to revenue, the better. It just, I think that goes without saying, Scott. Yeah. And do you think, do you think that's definitely the case in ortho?

Do you think it differs based on the specialty, or generally, that's your advice to anyone regardless, is like try to, try to show some semblance of a product market fit and commercial traction that you can actually rig the cash register as you, as you, as you, as you, put it. Yeah, I think you have not worked, you know, meaningfully in the other spaces. So I'm sure there's some nuances I wouldn't understand. But I think to the extent you can, you know, demonstrate product market fit, right? And customer conversion and retention, that seems to answer most of the questions to come to professors. But also, I mean, that is the purpose of one's business, right? Like, you're going to endeavor our number one values improve human health. You're not going to do

that, you know, filling around with an FDA submission or working on manufacturing. transfer activities or developing vendors or even manufacturing products, right? You're going to have to be in an operating room and you're going to have to serve a surgeon that's serving a patient and that will do it. And so I think that there's that benefit as well. It gives a very clear mission to a business. And once you have customers, you know, in this case, surgeon's asking for product, that can be a very strong North Star as well, right?

And have you solve problems that you might not have solved otherwise if you're waiting to get to market. Yeah, yeah. You're right in that showing some semblance of commercial traction just solve so many questions, right, that whether it's coming, the questions are coming from investors or maybe other strategics that are looking at possibly acquiring the company. You know, it's no longer do you have to rely on, you know, a COGS model that's kind of like, you know, does this really work? No, it's actually working. Like, these are literally the, this is where we're building the product that's going into a patient. You know what I mean? So it just, you know, that's just one example of many, but so many things are solved by actually demonstrating some sort of commercial. And in the limit, right, if, I mean, the sales growth is strong enough, I mean, you know, one could be selling pretty uninteresting product and folks will, I believe, just based on the quality of the financials. And investors are, after all, financial actors, right? They're very, very interesting in the financial statements. And so I think that provides a wide berth, you know, sort of operating room, right, when

business is performing well, particularly from revenue point of view. You get the revenue right, then as we talked about it, you're going to have to get the revenue even right or later. You know, the treadmill never slows generally. But then people begin looking at cogs, of course, and OPEX leverage, right? And if you're fortunate, you'll get to those, you know, those problems to solve later, which are how do I make it more cost effectively and how do I deliver this to the market, sort of the market, with a reasonable amount of OPEX, that can really matter.

So I do think to the extent one can ring the cash register early, great. Very hard to do with a molecular therapeutic or a PMA. So that may not be meaningful there, but in the world of 510Ks and 520B is certainly worth doing. Yeah. And I think you touched on something that is part of the conversation of this balance of having to chase commercial revenue. And that is a legitimate concern. I think that a lot of CEOs have is like I don't want to get stuck in this cycle of having to just chase the next quarter of revenue, quarterly revenue target. But that said, if you are demonstrating commercial revenue, like it does open up the options to so many different, I guess,

for lack of a description, investors, right? Whether it's the public markets, whether it's, you know, a wide range of private investors, etc., yeah. In the limit, you know, successful enough doing that you don't need investors, which is very, you want to talk about it, you know, an extraordinary place to be, right?

Then you raise money when you need to, not because you have to. And that tends to change those conversations really dramatically. It changed the pricing of the instrument you bring on as well, right? And so I just think it, you know, that can't be overlooked.

And then I think in respect of it, like what I have seen in some young companies, are, you know, well, if we begin selling now, we'll be expected to sell more later, right? And the answer to yes, you're CEO of business. This is, you know, but the other part is, you know, and this one takes a while to develop is the capacity to manage investor expectations, just draw broadly expectations for the business, right? And I think the better folks that I've worked with, you know, within this business and other businesses, both as a, you know, a peer, a team member, or as, as, you know, board member are very, very good at managing expectation, right? And so the notion that you had a

really hot sales year, there may be real conditions why that won't be repeatable in the next year, right, or the next period in managing investor expectations is very, very, very, very, and team expectations, very, very important. And the ones that do it well do a very good job with doing that. Yeah, I can't remember where I saw this recently. I thought maybe it came from Darnas Shaw, but it could have been someone else, but he said one of the, his thesis was for the, for the, for the rationale of why the CEO role is the lolliest job in the world of startups, was that you're always playing this game of if the company's running hot, you want to temper the expectations and kind of like,

hey, look, there's a lot of challenges ahead, et cetera. You want to like keep, you know, tamper that to a certain extent. But if the company's not doing so hot, you've got to like lift the boat, you know, almost by yourself. And there's this, it's hard to go against the grain all the time. But that's like that. I was like that. Yeah, that's pretty accurate, pretty accurate description.

I think that's a very wise way of putting it. I've had folks also ask me, you know, what is the sweet spot where you feel like you can relax as a startup CEO? And I said, I don't know that I've necessarily found that. So maybe I'm not the right person to ask. But, you know, I mentioned earlier if you get to free cash flow positive, right, that is certainly a time that you might crack a, you know, non-alcoholic or alcoholic beer, depending on your point of view, right? That might be a good point. but I think the only time that, you know, I felt like I could relax outside of that even for a moment. You know, it's not in moments of terrifyingly hot growth, right?

That's all consuming, right? Like the, you have a situation where the sales is outstripping the infrastructure, production asset, quality system, inspection, vendor network, right? All that kind of stuff. That one's near impossible to blink on, right? because if you've done this long enough, you realize that conditions like that don't last forever and you better make the most of them. The other one that's probably slightly more terrifying is the sound of silence is deafening from the cash register, if you will. You're not hearing a lot of things over there and you're receiving many questions as to why you're not doing that. That one is also terrifying in a different way, right?

And that requires that middle, which is a good, steady growth, where you're delivering the same products and whatnot. But I think that's a myth in the sense that if you choose to take that moment off and just relax for a long period of time, you're going to realize that your product will decline in terms of competitive capabilities, right? New entrant will come out and release something new. And so I think that's a myth to get there. The middle one, what I tend to encourage folks to do if they get mad and feel like they're comfortable is make yourself discomforted, particularly with new product introductions talking about. that's the way to ensure that they're not periods of great discomfort later, particularly of the second variety of the three I mentioned, which is where is the growth gone variety?

I totally understand where you're coming from. It's like a little bit of a misnomer. Like if you ever find yourself kind of reaching that point of comfortability, it's probably probably need to look in the mirror, you know, and ask yourself what you maybe could be doing differently because that's very typical for the startup. I think there are a lot of comfortable jobs out there, right? I'm not here to place of value on that.

It does time to time, you know, long for a comfortable job like, you know, probably many do. But I think the challenge for, I think folks who are well-suited entrepreneurship is they have restless minds, right? And restless hands. And they want to continue to do things, right? And if you put me in a job that paid me extremely well and I had to do the same thing every day for a year, I don't think I would last the year, Scott, and that's part of it. And so I am probably more attuned to feeling comfort than I am to feeling stress. The comfort I find to be more stressful than the normal stress. Yeah.

Growing quickly or not growing as quickly as we'd like, right? That one feels to me very stressful because it means I feel like I'm not looking hard enough with the stuff I need to be working on. Yeah, 100%. I like the way you put it, restless mind, restless hands. But you're right there. Like startups, sometimes they're glorified for the wrong reasons, and they're not for everyone, right? I mean, like, it's like, and that's not a knock on someone that maybe doesn't want to do this, live, live this sort of life in the world of startups.

I mean, there's definitely a lot of upside and a lot of positives, but it's not, it isn't for everyone. And I think that's why I encourage a lot of other people that are like, want to take a swing, you know, into this, into this world. It's like, if you do and don't realize it's for you, that's totally fine. Like, it is, it's hard. It is, it is hard. And that's, that's fun. Yeah. I realize consulting wasn't for me. You know, gladly moved on to do something else. And I don't, you know, start time for everyone, but I think there's only a way one way to find out is actually to do that work. And people often ask me, what's the right time to get it into a startup? And it's a bit like the question being asked, when's the right time to have a kid, you know, that right now is probably the right answer or there is no good time to pay on how you answer it.

It just, it is that type of commitment. And it is in many respects like having a child or several children all at once. You know, there's not a great time for it. You just have to get into it and you have to decide if it's for you or not. You know, one nice thing about it in respect to having a kid is you have a kid, it's not that easy to walk away from. And start up, you can go and do something else if you want to. Yeah, very true.

Hey, everyone. Let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy or IVL systems to tackle complex calcific disease. Over the last few years, we've closed a series of oversubscribed funding rounds, bringing the total investment into FastWave to over $50 million. Corporate interest in the IVL space is growing to, the $900 million acquisition of Bolt Medical by Boston Scientific in 2025, and Johnson and Johnson's $13 billion acquisition of Shockwave Medical, signal a lot of attention on emerging IVL startups like FastWave. And we're making serious progress. In addition to recently receiving our ninth patent, we've successfully completed peripheral and coronary feasibility studies and are gearing up for pivotal trials. If you're interested in investing in the fast-growing IVL market, head over to fastwavemedical

dot com forward slash invest. Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. Let's jump to the topic of Ray Glenn. If this is, I mean, obviously you're in a lot of patients at this point in time, right? You're almost 10 years in the business. But, you know, pretty, still pretty novel concept, right, of 3D printing, you know, implants. Any unexpected things that surfaced, you know, bringing this to the market with FDA and, and maybe, you know, maybe layer in, you know, some of your clinical experiences in terms of like that, the interface of demonstrating enough clinical evidence for, you know, for various regulatory bodies as well. I would say this, you know, I think it's fashionable for folks in our line of work to, you know,

say, you know, behind closed doors, the FDA, very difficult to deal with, right? You know, the regulator side, but you know, fill in the regulator's name and sigh about it. The FDA has been very front-footed on personalization and in respect of our business and I think generally. And they have been open to the prospects, of course, of the period of this 520B custom device exemption pathway, which has been a good way of exploring that for divergent anatomy and divergent pathology. We tend to write 510Ks around most of our patient-specific stuff.

And that is a very different 510K than 6-6.5.5.5. of suture anchor, right? Like that is a much more suture anchor just to, you know, over, you know, burden the conversation here. You've got a guidance document there. It's pretty straightforward and follow a guidance document and check the boxes. Easy to find predicates. Easy to know the performance of predicates, you know, easy to get that done. The hard part with a patient specific 510K is the FDA has not seen many of them and they don't quite know how to react to them. And that's not a knock on FDA. Like I said, they've been very good. But it has meant long and difficult.

clearance timelines, and we just have had to plan for that. And so, and they have permitted us to use some of the data from HUD, HD, HD, and 520B pathways to file 510Ks, which has been quite powerful. And they seem to be more open to that. And so, but, you know, the hard part is that FDA has not come to understand this. It's not six sizes fits all, you know, eight sizes fits all. It's a bracketed range across a bunch of dimensions of the product. And FDA is not well suited to do that because they haven't done a lot of it, just like, you know, I'm not well suited to, you know, swing a cricket back. I have not played a rally cricket in my days. It's no different.

But they certainly are very open to it. And we've learned a lot along the way. The clearance we have on shoulder is basic clearance. And, you know, it's a challenge with clearance to get through. we have been very appreciative of what FDA has done. But we also recognize that in a real sense, there's a barrier to competitive entry in the sense that the regulatory hurdle is hard to get over, Scott. If you may get over it, it may provide advantaged position in the marketplace for a period

of time. Yeah, regulatory is the moat. When you think about your dialogue with FDA over those like lengthy 510 case, right, because of the personalization aspect, the fact that this is new to FDA, For another CEO that's maybe working on something that's similarly novel, you know, there isn't a lot of experience on the regulatory side. Like any words of wisdom to like how to how to best approach the agency, anything that stands out? You know, our approach has always been the following. We attend to think about ourselves as self-regulating, right?

And what I mean by that is, you know, we have internal standards that would exceed what the FDA might ask for this at every turn. And that's not always the case. or otherwise that every clearance that we submit, every submission we submit would lead readily to a clearance. FTA asks for things that sometimes we don't anticipate, and it's not always stuff that we would agree that would have to be answered, but we tend to just, instead of disagreeing with FDA, say, you know, we'll look into that.

And we tend to be very data-heavy, very test-heavy, very prototype-heavy, very submission-heavy, right? And think about each of them in a sense of a PhD thesis, in terms of quality of discovery. And that, I think, has made for very good reactions to submissions and very good path to clearances. And we have good offline relationships of the FDA for that reason because I think they look at us as a practitioner,

that manufacturer that actually sort of stretches the quality of what's put before the regulator. And that's what I encourage people to do. It's fashionable, you know, or might be simple to say, we'll submit the bare minimum and hope we skate by and we'll save money in time that way. That can work, right? And I've seen it work, right? You know, someone's going to win mega millions, Scott, this week, I think.

I don't know what the drawing is, but we're not in the business of buying lottery tickets, right? We're in the business of having date certain regulatory clearance that serves our patient's needs. And that, to me, means a full submission is a much better way to go. And that works very well for us. Yeah, I think there's this debate that I've had with a, others, right, of, of, I hate to all, you know, keep giving back to this word of balance, right? But, but trying to move quickly through submission, but also balance that against maybe future submissions and setting the wrong kind of, I guess, relationship baseline with, with

FDA for lack of had a description. And I think you hit the nail on the head, right? If you're, like, if you're submission heavy, and this is just maybe the first or second of several submissions that are only maybe going to get a little bit more interesting down, down the road, probably make sense to kind of not slow it down per se, but like, you know, be more methodical the way you described it. One thing I can share with you that we have done for time and time. So, you know, imagine a very broad-based submission. Regulator is unhappy with one-sixth of the submission, right? You know, we often find ways into those circumstances to push the five-sixth, the remaining part through to clearance and then come back with a, you know, a additional

510K clearance for the 1-6 that didn't clear or in some circumstances letter-to-file. I don't think we've done a letter-to-file here in this business, but that has proven to be a good strategy as well, right, which is you sort of get as much cleared as you can get cleared at that, you know, first kind of bite at things. Hopefully it'll be commercially relevant. Sometimes it isn't, right? Like that 1-6 may be vital to being able to sell the product. But that's worked well for us as well, just to kind of mark wins when you can in terms of clearance and then expand things along the way. Let's transition to commercialization. I want to touch on this briefly before we maybe get your take on, you know, scale fundraising and how to scale up a business at the stage. But

on the topic of commercialization and ringing the cash register, I love that. I'm going to steal that and use that a little bit more in these interviews. I'll make sure to try to credit you. But looking at your most recent launches, right, the ankle system, our notes show that, the LMR was, you know, mid, mid-2025, and then you, you know, your first clinical cases with the knee and the implant late 2025. When you think about kind of the market research, the build-up to each of those kind of those launches, anything unexpected, you know, or maybe interesting that you maybe wish it you'd built into that plan or maybe we're glad you did build into that plan because you saw it, you know, come to fruition in those, in those commercial releases.

The good news is with these, you know, it'll make for boring discussion here today, but no real surprises on ankle or knee. And part of it is we have a few things that benefit us on both those products. They're already in market, right? And so these were, in essence, kind of line extensions, but pretty significant ones. And so you know the procedure well, you know better alternatives well, right? You understand. And we do a lot of categorical work as one would in our line of work, so it's not to get surprised. And then we tend to do the limited market release, you know, for patient safety reasons, right,

for training reasons, you know, but also for reputational reasons, right? So new cases go poorly. They get talked about that's not favorable to the business. But there's a whole other backdrop to it as well, which is, you know, the production asset, because, you know, we're, you know, we're not like the big players in our space. I don't go to market with a bunch of large contract manufacturers. we do have some support there on instrumentation, a handful of components, but most of the stuff we produce in-house.

And what we don't want to do is excite the market about a new product and then be unable to serve it, right? And so making things the first time, second time, third time is hard. And so that's the main reasons we do it. On both the knee and on the ankle, we did have some learnings. The knee learnings were a little different, the ankle learnings. The knee learnings have been around scalable manufacturing with cementless knee, right? and we are 3D printing those knees here.

We three print cobalt chrome for the femoral side and titanium for the tibule side. And we're very good at doing both of those things. But every time you print a new geometry, you learn new things, just how it is. And so we've learned some things about scalability of that, which is important. Really nothing on instrumentation implant design there.

Those have been good. On the ankle, the implant side is good. This ankle is very complicated procedure from an implantation point of view, surgical procedure point of view. And so we learned, as we might have expected, that some of the instruments could use refinements, right? And that has been probably in all the product releases

that I've been involved in, I've probably been involved in nearly 50, not quite there, maybe 45 the last 20 years. The instrumentation always needs a tune-up, right? And you always said the situation where doctors A-B-B-N-C really loved that fill in the blank instrument and Dr. C through F think it stinks. And then you've got to, what are you going to do? You're going to make two instruments or are you going to not listen to A, B, and C,

or D, and F. You have those challenges that come up for time and then. We didn't have those in the ankle, but just overall refinement or procedure. Kind of going back to your facilities, you said that you're, you've got one, you're in your, your North Carolina facility. You've got one in Wilmington, Mass as well. That's right. Yeah. I didn't realize that the Boston area was such a hub for. for 3D printing. Like that's it. Is that correct?

Am I? It is. Yeah. So you've had many of the manufacturers that make machines, particularly polymeric, printers are up there. And we use some of their equipment up there. And there's been a lot of shakeout in that spot as well. It's got many companies, a few spacked, at least one spec, two spacked, I think.

And then there are some weird combinations that happened and didn't happen and then some lawsuits and whatnot. But I think ultimately as happens in it. in many spaces that are novel like that. There's been a shakeout. But we use two of the Boston-based manufacturers to make instruments. Mostly here, though, in Durham as a case-based. Not in the Boston facility.

And in the Boston facility, we use equipment from a European manufacturer and one based in, well, split between South Carolina and Colorado. Those are the level that we use. Yeah, very cool. Let's talk about fundraising because you've raised your fair share of capital over the years. We don't have a ton of time to go to this topic in great deal. detail, but so I'll maybe, you know, just ask you one question that's a little bit more philosophical in nature. But when you think about your experience raising, I think last year,

what was that, $104 million round last year, I believe? And it sounds like maybe you're, you're thinking about, you know, raising again, you know, next year. What are like one or like one or two things that you know, you know, 10 years ago when you were, you know, when you were fundraising back then? You know, I think that one I'd already spoken to, which is, you know, sales and sales growth can answer a lot of questions, right? And, you know, I think that alternative to that is if you're truly pre-revenue and you have a very interesting technology, I think that could be sold. But tepid sales growth and obviously contracting sales are near impossible to sell equity around, right? They are. It's a good sales growth. But the second one is, it took me a while to realize this.

And part of it is the approach that we took, a lot of the money we've raised is private direct financing. that kind of goes all the way back to our earliest days. In 2006, we raised our first round. That was the nature of the round we raised. And those folks, some of them were from McKinsey, those folks that private direct raise a bit different. You know, it's a bit of a hurting cats thing. But it's definitely a networking program. And, you know, I, you know, sort of came to realize that early on that if you offer an investor, good story to tell, or you offer them a good return, they'll tend to talk about you at dinners and, you know, at, you know, however they spend their time. And that tends to prove to be a very good approach on the private direct.

You know, it took me a little while to realize that the institutional investors are that way as well. It took me to want to figure that out. And they all talk to one another, right? And it's a smaller community than their private directs. And they also all talk to the investment bankers that are in around these deals, right? And so that one took me a little while to figure out. And, you know, it probably longer than it should. And so the thing that I would suggest that people do is, you know, meet with investors,

importantly when you're not raising money. And it's a fairly obvious statement. But tell them the story. Tell them you're going to need money in early 27, you know, or mid-27. And begin preparing them for the story of what you're going to raise, why are you going to raise it, and what the plan for this year will look like in next year, right? And that has proven to be incredibly helpful. And we also do that on the private directs as well.

That part of not going and meeting someone the first time when you're about to raise money, but having met them before has proven to be quite helpful. But interestingly, the group that we closed last year, we met only last year. So that's sort of a contrary to the statements I'm making, Scott. But ultimately, I think that part of is you can never spend enough time meeting investors, provided your business is not struggling operationally. You can never spend more than that. Yeah, two things that stuck out kind of hearing you,

hearing you a riff on that answer a little bit, was one, people are people, right? Whether it's people inside an institutional investment firm or private directs, right? Like, they'll talk, and they're relatively, you know, run in small circles. So, you know, good to keep in mind. And then, and then two, like this notion,

I run into a lot of maybe, I should say, first-time fundraisers that almost, They get disappointed if they pitched an investor once and they got a no or like they was like not very clear next steps. It's like this takes time. I mean, this is like, you know, if you're, if you're asking someone to write a pretty sizable check, they're not, they're not really going to get to an answer in a week, you know. I mean, this is, this is a long, a little, a longer game, you know, and so I think that's really just an important point to keep in mind. No, no, no question about that, right? And ultimately, you know, a business is not a static thing,

particularly a young company, it better look awfully different six months from now or a year from now than it did. Otherwise, you may not be having it on the right trajectory, right? And so the notion that someone told you to know two years ago, they're going to think very differently about you now. And I'll give you a great example. If you decide you're going to raise credit or debt, right, if two years ago you're a while they are unprofitable and this year you're profitable, a bank or private credit lender is going to think very differently about you than they did two years ago. And it's no different with equity, right? And to the point you made earlier, I think it's often the case that, you know, I'm thinking

in early days and I thought about institutional equity, these huge organizations filled with thousands of analysts and, you know, portfolio managers and the like. And how do you get to them? It's actually a very small group of people that make decisions in them, right? And so, you know, it's not these enormous behemists you have to get to. Now, many of them have many different funds of them, of course. But, you know, it's a handful of decision makers that make it and just have to get to them and tell a good story. Yeah.

And getting to them is like that's part of the job, right? I mean, it's going to sometimes in a lot of cases take a fair amount of work. But that's part of the role. We don't have enough time to get to all the rest of my questions. I wish we did. But I did want to get your take on board, on healthy board function, right? Because you've been around enough startups sitting on boards, running them as CEO. So this is like an issue that seemingly happens quite frequently, and I don't think maybe gets

enough attention, is like, how do you solve for like challenging board scenarios? How do you begin to build a good, you know, foster a good function at the board level? Because it's, I mean, it could, I don't want to say make or break a company, but it could cause a lot of unnecessary challenges for a startup that doesn't necessarily need them. Zero question about it, right? The board has to be an asset. The board is, I mean, it's so hard to build a business without a board at all, right? and the board has to be aiding you in that development.

And they have to bring knowledge, skills, relationships, sometimes encouragement and sometimes challenging, you know, challenges to the management team. And, you know, I've seen boards at their worst are, you have someone that lacks vision or lacks risk tolerance or wants to act like a manager when they're, in fact, a board member, or is overly negative or thinks it's their job to beat on managing, when misses are made. And of course, they have to hold management to account, but there are a variety of ways of doing that.

Those type of board members, I just tend to not want to bring into anything I'm involved with, and I don't think they're helpful. Now, the flip side of that is the person that's checked out, not engaging, doesn't have the relationships, doesn't have the skills or experience. And it's just a, you know, a suit on a hanger in there. Yes, you can have a board like that. But when you most need your board, you're going to be lacking there. And there's a pretty big universe of folks in between. that do it. In my experience, some of the better board members have been operators. But I say that as an operator. Scott's more than to be biased towards them, right? But there's some very good financial investors, right, who have seen great operators operate and can help bring that to the table as well. And so a board that's filled with positively minded people that share the vision that are prepared

to open their Rolodex or make phone calls or make other investors. introductions or customer introductions, spend time offline with the management team to make them better, to understand that what they're trying to do is hard and you're not going to achieve 100% of the stuff you step forth to do and be understanding when mistakes are made, those are, in my experience, great board members, right? And they're hard to come by. They are very, very hard to come by. You're going to get some by virtue of the investment that you knock down.

And the best answer there is to try to steer them in the door. direction of folks that are like that. And, you know, our investor-oriented board members or investor, I guess, originated board members or ones that have been in operators, will look and feel like operators, which has been quite helpful. And so long answer, a short question, not particularly helpful. You know it when you see it. Scott, that's the hard part and you're not going to know it until you spent some time with it. So it's not unlike any other job interview. Yeah. Yeah. Or building a building a team, right, and dealing with the personal dynamics. You're right. I'm biased too towards operators, well, largely because I'm an operator.

But I have to say, like, good, good investors that have a long track record have been around enough operators that they, they tend to have or bring some really good advice and counsel to the, to the table. So with that said, I know we'll be five, five minutes left. I want to be sensitive to your schedule, Kurt. But let's get to the rapid fire portion of interview. Before we get there, restore3.com at the website. Again, R-E-S-T-O-R-3D.com, restore3D.com. We'll link to it in the full write-up on Medsider as well as Kurt's LinkedIn profile as well. So first question, feel free to answer in rapid-fire fashion. If you want to expand a little bit, that's totally fine as well.

But next 12 months, you already kind of mentioned this. Next 12 months, what's like the most exciting thing that you're looking forward to at Restore? It would be the shoulder clearance. That's been two plus years in the making. You know, as I may have mentioned, it should happen here in the second quarter. And that will really allow us to unleash, you know, marketing efforts and full sales efforts in the shoulder. That'll be very important to it. It's a demonstration of what we've already done in ankle, right, more clearly in shoulder

and where we're heading a knee. And so that, without question, is what I'm most excited about. Let's take a hypothetical scenario where in maybe your neckler woods in North Carolina, small intimate group of med tech entrepreneurs, and you want to leave them with one thing after dinner, right, that they really need to like take home in order to see some semblance of success with their startup. But would that be? You know, I'll skip on that, you know, sell early, bring the cash register early, although I do feel like that's the most important one.

I think the thing that's vital is you've got to have a team you trust, right? And also a fairly obvious statement. But where I have been most concerned about the trajectory or something I've been involved with is when there's weakness in a key functional area, right? And the minute you know that, you're going to be better off making a change. then trying to rehabilitate someone that may be, you know, unable to be rehabilitated or, you know, just sort of looking past it and hoping for the best. And that part is very important, right, because, you know, I sit here, I want a vacation a couple weeks ago. And I was not worried about the business. And the reason I wasn't worried about the business, so great people in the

senior roles. And so that's hard to know also, right? It's kind of like the board member question, like, how do you know you have a great chief commercial officer if you've never seen one? Well, you're going to have to talk to your board members about that, right? I'll help you understand whether what you're getting there is very good as an example. Yeah, such a good point because it's easy to want to try to hang on as long as possible or to try to mold that weak spot into something you think it could be, but oftentimes you're right. It's like it's best just to make a decisive decision.

But going back to your vacation, it sounds like you're kind of comfortable on vacation, Kurt. I mean, is that, are you getting comfortable? Briefly, I did not check my email for two days, which was a, long time for me. Probably felt like a long time. Yeah, like ages. Yeah. But I could, you know, I suppose I could blame the internet was weak in spots. Yeah. I blame the internet. But, yeah. Maybe that's the strategy. Go to go to, go to spots where the Starlink is not, is not present, you know.

Yeah. Last question I got for you. Um, to either take us back maybe to your graduate days in Champaign, Urbana, or maybe your early career at McKinsey building, you know, really nice looking PowerPoint decks. Anything you whisper in the younger, in the ears of the younger version of yourself? Yeah, no question. I would. I think about the amount of time I spent worrying about things that didn't matter. Or, you know, there's a sort of corollary to that, which is, you know, wanting everything to happen faster than it can reasonably expect it to, and then just being concerned about overall trajectory and performance. And I think it takes a while to develop patience. It does, right?

And it would be interesting we pulled my team here. I don't think they describe me as impatient, but I don't know they describe me as patient either. Scott, it's a good place to be. But that part, I wish I'd known that earlier, that one can be patient. One can think about the timelines over which things can and should happen. Not everything has to be done, you know, excellently at half the time that others do it. And the things that aren't being done at that rate, you don't have to spend a huge many of your time worrying about them, right? We pick the right couple of things to worry about, put the right team around them, solve those issues, and then pick the next right couple of things to worry about.

Because a startup, you know, particularly in its early days, you have nothing. You've got nothing. Maybe it's a PowerPoint, you know, and a little else, and you have nothing to rely upon, and everything has to be built. And so, you know, the notion that everything would be perfect day one is just not the way it is. You're going to fix some things. Those are going to be better than other things you have to go fix then. your job is constantly fixing and improving what you've built from that PowerPoint deck. Even if it started off with a nice, very good PowerPoint deck, right, because of your experience

in McKenzie. But joking aside, this has been a lot of fun. I don't want to embarrass you, but like I can tell, like you're, you're like a great leader. You're like you're genuinely humble, but also confident at the same time. And it's like it's a really, it feels, I don't know, we're just meeting for the first time, but it feels like it feels like a really, really healthy blend that's probably built on a lot of experience, a lot of scars. Very kind of you to say. I think anyone that's done this type of work for a decade or like me, two decades, you go and it's going to require a lot of genuineness.

Even if I think you came into it as a poor leader, it's going to make you a better leader. And I really appreciate you saying that. I appreciate you having me on. It's been great. I've enjoyed your podcast. I mentioned. I wish you tons of continued success. And if you want to check back in a couple of years, it may have some cool stuff to share. I always like the round two for sure. But, Kurt, I can't thank you enough for coming out sometime. I know you've got a busy schedule. So I really appreciate you coming on the program.

Thank you, Scott. See you. Thanks, Kurt. Take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach even more ambitious doers who share our passion. So if you found value in this podcast, if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with Medsider, please take a moment to leave us a review. It's super easy. Just open your Apple podcast app or the

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