Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Listen to What the Market is Saying: Interview with CurvaFix CEO Steve Dimmer

Episode Date: April 18, 2023

In this episode of Medsider Radio, we sat down with Steve Dimmer, CEO of CurvaFix, a medical device company focused on developing innovative solutions for orthopedic procedures. Steve holds a Bachelor of Science in Electrical Engineering from San Diego State University and a Master’s in Business Administration from the University of Washington. He has over 30 years of experience building medtech companies, including multiple start-ups and stints at several large multinationals.In this interview, Steve highlights the importance of mitigating risk and pitching to investors early in the development process. He also provides valuable advice on designing clinical trials that meet specific goals based on his own experiences at CurvaFix. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.

I would say without a doubt is, you know, making change in health care is really difficult. There's so much inertia in the system. So don't expect it to happen without years of focused effort and many obstacles across the way. And, you know, if you're an adventure like I am and, you know, you start a journey not knowing where you'll end up and you're okay with that, go ahead and do it. I mean, it can be so rewarding. I mean, as a health tech entrepreneur, you have a chance to influence countless lives. I'm not through you have any other way. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought

leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of MedSider, I sat down with Steve Demer, CEO of Curvix. Steve holds a Bachelor of Science and Electrical Engineering from San Diego State University and an MBA from the University of Washington. He has over 30 years of experience building med tech companies, including a handful of full of startups and stents at several large multinationals.

Currently, Steve is leading Curifix, a medical device company focused on developing innovative solutions for orthopedic procedures. Here for you the key things that we discussed in this conversation. First, stay focused on your mission, but don't put on blinders. Be open to exploring new opportunities and pivoting when necessary in your startup journey. Second, don't be afraid to ask questions and listen to feedback from potential investors. Use this feedback to improve your pitch and strengthen your narrative. Third, develop a tailored regulatory strategy for your specific therapeutic area

and assemble a team of domain experts to help you successfully navigate the often complex regulatory landscape. Before we jump into this episode, I wanted to let you know that we recently released the second volume of Medsider mentors, which summarizes the key learnings from the most popular Medsiter interviews over the last six months or so. Look, it's tough to listen or read every single Medsiter interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create MedSider Mentors. It's the easiest way for you

to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of AliveCore, and so many others. In addition, as a premium member, you'll get to join live interviews with these incredible

med tech and health tech entrepreneurs. Learn more by visiting medsiderradio.com forward slash mentors. Again, that's medsiderradio.com foreign slash mentors. All right, Steve, welcome to Medsider Radio. Appreciate you coming on. Thank you, Scott. Appreciate the invitation to share our story and anything I can do to help educate your audience on what it is to be a medical device entrepreneur. Yeah, definitely looking forward to learning a little bit more about kind of what you're

building at Curvex as well as just your journey, right, over the past, you know, a couple of decades building other medical device companies. So with that said, Steve, I recorded kind of a brief bio at the outside of this of this interview, but we'd love to kind of hear from the horse's mouth, you know, so to speak. I would love for you to kind of touch on, at least at a high level, kind of your broad experience leading up to your role as CEO of Curvex. Sure, sure. So I have a technical background originally.

So I'm a recovering engineer, basically. You know, 30 plus years in medical devices. And doing my first startup actually over three decades ago. So it's not a couple decades, it's a few decades of experience. And, you know, I've done some things that I think have kind of made a difference in my career. I joined a startup back in 2000, moved me up from Southern California to Seattle, joined as founding vice president of Calypso Medical, so it was a radiation targeting system for radiation oncology. At that time, you know, it's great, helped build the business.

A few years into it, I thought, you know, I'd like my own shot at starting and running a startup. So I did that. I partnered with a clinician out of Washington University in St. Louis, and we started NUvara. I left my job. I started raising money in January of 2009. So, you know, despite the financial crisis we had, 18 months later, I had a term sheet from a top tier venture capitalists, and we got Newvera off the ground, which was great. Ran that for about 18 months afterwards. about five years into it for me. And then I left, I did an entrepreneur in residence for a division of Johnson and Johnson. So I've also been inside the world's largest medical device company as an advisor.

And for them, help them look at some new technology, help them understand a white space. For me, it really helped me understand how they think about startups. And along the way, I got as a favor to a local venture capitalist. I went up to visit with a surgeon up in Vancouver, Canada, who had an idea. He was kind of a frustrated surgeon who had been struggling with a particular problem his whole career, Dr. Robert Meek, kind of an inspiring guy. He kind of founded and built the orthopedic trauma department at Vancouver General. And he said there's got to be a better way to fix fractures of the pelvis.

And, you know, I'm sure we're going to talk about the journey, but that was kind of the beginning a Curbifix. I started out doing some consulting for the VC and then, you know, several years later decided I was going to take it on as a project and focus on it full time. So that's my background. So five different startups, all in different areas of medicine, a few of them pretty much from scratch. Got it, got it. And when you went to have that first conversation and started digging a little bit deeper on Curbifix, was that while you were in EIR at J&J then? It was, yeah. So the EIR for me, the way I set it up was, I'm not moving to New Jersey.

And, you know, I'll say based in Seattle, and it was pretty much a half-time gig. So I was the person who could give them kind of an outside perspective inside of the company. And they had an area of medicine they wanted to learn about. And, you know, they don't really do things from scratch. So they wanted me to kind of help them think about it. And where it ended up, I ended up kind of educating them on a space and told them to take a look at a company. and they ended up buying the company. So it was kind of fun.

I did it for about 18 months. Got it, got it, cool. Cool. And then so we're recording this in early, 2003. When you started, you know, taking a harder look at Curve Fix, this was kind of 2016, 2017 timeframe, so about six years-ish ago or so. Yeah, yeah. 2017, I decided, you know, if we were going to make a go with this, it needed focus.

That's when I jumped in. Okay, cool. Awesome. Sounds good. I just kind of wanted to set the stage for, you know, in terms of the timeline. So without getting too far into the weeds, Steve, give us a sense for, for Curve Fix, right? Like what are you, what are you building, you know, what is it, what is it solve for? And really maybe tell us a little bit.

You touched on kind of the origin story, but we'd love to maybe, you know, go a little bit deeper, deeper on that. Sure, sure. So I'll step back a bit. So, so your pelvis is a complicated, you know, a set of bones that are curved and it's got to support most of the human body weight. you've probably heard of hip fractures. So, you know, but the hip is actually the top of your femur. It's one of your long bones. And, you know, hip fractures are commonly fixed.

There's been a lot of innovation over those for about 30 years, and they've gotten really good at fixing them. The pelvis, there really hasn't been much innovation over the last period of time, the 30 years where they're innovating in hip, they haven't done it in pelvis. Basically, what surgeons have are straight screws that really have dramatic limitations in a complex curb bone. that has to support most of human body. And bone plates, which require expensive,

lengthy surgery with all its drawbacks. So if I break my pelvis today, I'm in one of two types of patients. The first are high-impact trauma patients. You or I take our motorcycle and wreck it. We'll go to a level one trauma center. They'll put us back together. If we're lucky, they'll use straight screws.

They'll use a lot of them. and then tell us, you need to stay off your feet for six weeks while this heals, and then you can start walking again. The second cohort of patients, which is growing at 9%, and that is actually the biggest problem today, and probably the thing that got me most excited about curfix, our patients who have something called fragility fracture of the pelvis. What that means is they're old, right?

Their bones are weak. 80% of these patients are women, and I'll give you an example. A woman who's 60 years old, when she turns 80 years old, she have a nine times greater chance of breaking her pelvis. And when she turns 90 years old, that's 27 times greater. So there's 150,000 of these patients every year who break their pelvis. And what really struck me as dramatic is that same woman, and these are ground level falls.

You know, this elderly woman, she slips and falls in a shower, or she just falls from her ground level at home, And if she breaks her hip, which we've all heard about, those have been common, 95% chance they'll receive fixation, which means they'll put a device inside of the bone. It'll hold the bones together with minimal motion, and it's really the bone motion that causes pain, and when you have pain, you stop moving. That's been pretty well solved with hip fractures. With pelvis, on the other hand, those technologies I talked about, those 30 years old technologies,

which are really pretty straightforward and simple. Don't solve the problem. Only 10% of those patients today receive surgery. Got it. So there's 90% of those patients, probably 135,000 patients in the U.S. today, who, you know, you take a 70- and 80-year-old woman, you put her on bed rest or you put her in a bed and you say,

please don't move. Here's some pain meds. This will heal. For six weeks or longer, many of those patients don't recover. They have multiple bad things that happen to them. Got it. Got it.

So the vision here is to put something in the bone that's minimally invasive that holds the bone together with minimal emotion. And I can go in the details. But when that happens, pain is mitigated. Patients get up and move. And that's what we're about at Caroreffects. Restoring mobility for those elderly patients, we think we can 80 plus percent of those will benefit from it. So it's almost a billion dollar market just of itself. And for high

impact trauma, we can solve problems and get patients up moving like no other technology can. But so that's, that's kind of our market. Got it. I know you touched on kind of that that second cohort that you mentioned, right? That's much larger appears to be growing pretty pretty, you know, the prevalence seems to be pretty high. It reminds me of one of my business partners, Brady Hatcher, who runs switchback medical as part of our accelerator at Big Sky. He had a snowmobile accident this past, this past winter and fractured. I'm pretty sure he fractured his pelvis. And it's like,

I mean, and he's pretty, pretty, mid 40s, you know, pretty fit guy. And it's just like it's, I mean,

it's no mobile. I mean, it's just, it's just all, all his weight sits on that. So it's just, it really prevents a lot of, a lot of issues.

It makes me wonder if he's, if he's checked into curve effects. You always, you always have weight on your pelvis. Yeah. You're standing you do, that's obvious. If you're sitting you do,

it's on your isrial tuberosity. And even if you're like, lying down you do. So these patients are never comfortable. And your friend may have, if he's lucky, he went to a place that does straight screws. There's a few specialty places that do a reasonable job. But he may have been told, and standard care for him would have been six weeks of immobility afterwards.

Yeah. With curve fix, the strong fixation, patients can get up and move very quickly after surgery. And these include fragility fracture patients who basically the next day get up and walk. where, you know, they may have gone six weeks. They may have gone two years in the system being put around from provider to provider. They get curfix. We really do help them. So it's really an inspiring contribution to medicine, humanity we're doing.

And it's very fun to watch it come together. Oh, I bet. So just one follow-up question before we kind of like rewind the clock here and learn a little a little bit more about your professional journey as well as just, you know, what you've experienced kind of building up curfix. From a patient's perspective, do I mean, do I get this done in an outpatient sort of center? Is the surgery pretty, you know, relatively minimally invasive? Like, can you touch on that?

Well, yeah, it depends. So if you're a high impact patient, right, you've been in a major car accident, your friend with a snowmobile, motorcycle, you know, fall from height, you're very likely going to go to a level one trauma center. You're probably going to have other issues in addition to your pelvis, right? So that's more complicated. If you're a woman who's slipped and fall at home, a fragility fracture patient, that's a minimally invasive. You probably don't have any other issues. Single small and save them in 15, 20 minutes per implant.

A lot of these patients need two. Okay. And you'll probably stay over the hospital one night or so. We've had a couple of been outpatient procedures. I think longer term, it could go there, but they're probably going to watch and make sure you've done a good recovery, you know, one or two nights and then send you home. It won't be, you know. Some week-long process or something like that, yeah. Well, or months, right?

So we've had patients who have not been able to walk for, you know, extended periods of time. Six weeks, we've had some that have won that, recent one, our last press release was two years, the broke her pelvis that didn't heal. And you got treated by Dr. Brett Chris, the University of Missouri, right, good middle of the country. Doc, really great academic. and that patient got up and walked the next day for the first time to pass physical therapy the next day. Her pain scores went from a nine, which is really high, to about a three. Wow.

So 12 hours from surgery. So that's a really cool thing about bone fixation. If it's done well, it really does alleviate pain. And the implant shares a load with the bone so these patients can get up and move while it's healing. Got it. Got it. That's cool. And then give us a sense before we step inside the old Medsiter time machine here, give us a sense for kind of where you're at. Sounds like you're actively commercializing then the device. Yeah, we just recently got our second FDA clearance. Our first one was in 2019. Okay. And we did a small clinical study before we commercialized. We want to make sure we're ready. We really have done about a year in the commercialization. We just crossed our first million in sales.

And I will say for anybody who's going to start a medical device company or med tech company, that first million is the hardest. So we crossed that chasm, you know, a couple hundred patients that we treated, you know, 270-some implants. So the technology is quite robust. And the company's ready to go from our pilot launch, which we did last year. We always do these things in phases to expanding it. Okay, cool.

Kind of countrywide. So to your friend on the snowmobile, there's a good chance. He may not have had access to Curva Fix. You know, some small number of years from now, that won't be the case. That's their next stage. Cool. Cool. That's certain, that helps a lot.

And if you're listening to this interview and don't get a chance to read the, you know, the summary of this conversation on MedSider, the website's CurvaFix. So C-U-R-V-A-Fix.com. C-U-R-V-A-F-I-X.com. Really cool website. Some really nice visuals. as well as videos that kind of explain the technology and the procedure as well. So curfix.com is the website.

So with that said, Steve, let's go back and learn a little bit more about your experience, right? You've built several startups, spent some time as an EIR and now leading, you know, Curvex, which is well on its way to kind of making a dent in the orthopedic space. So when you think, first question I've got is really with respect to, companies in the earliest stages, right? So we're pre, we're pre, you know, we're pre, maybe preclearance, definitely pre, preclinical. When you think about that, that stage of an early, you know, that sort of that life cycle stage of a med tech company, where do you see most, you know, founders and or CEOs make the, make the biggest, biggest mistakes?

That's a good question. So is it pre-series A? Yeah, yeah, yeah, kind of seed, Seed, maybe, yeah, maybe, maybe, you know, pre-series A, kind of that, that phase. Yeah. So I would probably turn the clock back even from there. So I would say, first of all, is make sure you're solving a big problem that whoever your customer is understands is a problem before you go ahead and even get to that stage. Because these startups are not easy. They require kind of focus, dedication and struggles and learning and conquests.

And you know, you've got to be a bit of an adventure at heart to want to lead one of these companies, especially early stage because it can take dramatic changes in different directions. So number one is make sure that's the case. Go out and validate with whomever your customer is early. Ask them a lot of questions. Make sure you're on track. And then the other thing I would say is once you're there, look for opportunities. So there comes a time when you're trying to solve a problem, trying to develop a technology to, oh, we have it. technology, we think it'll solve the first problem, then ask yourself, is that really the problem

you should be solving or do you have a bigger opportunity that you didn't know about because you weren't deep into this? So I'll say with curve effects, that is fragility fractures of the pelvis, right? I started this as kind of a consulting gig and a favor for a local VC, and I didn't really get excited about it because high impact trauma is great, but it's for pelvis, but it's not a huge market, right? And it's got other solutions, and many cases work okay. fragility fractures, we're an enabling technology, right? And it's a bigger market. It's growing, and it's very easy to explain with that analogy with hip fractures.

So it kind of gave us what we need to kind of bring it up to the next level. So there's a lot of noise out there, and there's more and more noise every day with med tech and devices. Make sure you're going to stand out in a way where you're solving a problem that can't be solved other ways. the market's more than big enough to justify an investment. And with all that's the case, you can pull them the right investors and the right team and make it happen. If you don't have those fundamentals, and I can go to keep it makes sense, it's going to be a struggle.

And you may find out a few years later, gosh, you know, we knew that a few years ago. And maybe I should have been working on something else. You don't want to do that, right? There's an opportunity cost of these. So I like to go for the Achilles heel early. I like to challenge the thing that's most likely to make a lot. it fail. And if it survives all those challenges, you should do it. Yeah, great. That's, yeah, such a great point, especially around, I mean, it sounds relatively straightforward, but to

your point, you need to be solving like not only a fundamental problem, right, but a problem that serves a large market, right? Because all of these, whether you're in pure play medical device or maybe, you know, more health technology, regardless, it's almost always going to require a lot of capital, right? You're going to have to have, you're going to, I mean, unless you're just, you know, sort of filthy rich or want to take the risk yourself, you're going to need investment partners. And it's going to be extremely difficult to get buy-in from those partners. If you're not solving a real need with a very large, addressable market, because at the end of the day, you've got to make it, it's got to make sense to them, right? From an investment standpoint, right?

They've got, they've got LPs that they need to, that they need to kind of, you know, provide a return for. And if you're not, if you're not, if the math doesn't work, right, it's going to be extremely hard to get them on board. The answer is no and you won't get the money. It's pretty simple. It's pretty simple. Yeah, no doubt. Yeah, it's pretty, yeah, yeah, very, very simple. But oftentimes, you know, ignored, right?

I mean, you like, I, you know, chat with a fair, as I imagine you do too, if, you know, chat and discuss this with a fair amount of early stage, you know, Mentech entrepreneurs. And they're oftentimes so sold on, on the problem they're trying to solve for. and this idea or this technology that they maybe have prototypes for. And they just, it's hard for them to overcome the fact that it's just, it's, it's, it's, relatively small market, you know, and it may be, it may solve a real need, but if it's just a really, really small market, you know, it's just going to be a really, really challenging, you know, path forward, you know, if you can even, you know, even if there is a, is a, is a path forward to begin with. So, yeah, such a, such a good point. And your other, your other comment around,

sort of listening and being far enough in the weeds, right, and listening to feedback to understand, oh, there's this other kind of market here, right? I was like, originally maybe this thing sound like it was positioned for, you know, very acute trauma, right? But there was this other, you know, sort of much broader, bigger, massive market opportunity, you know, with a very real problem to solve for, and just, you know, by listening to feedback, you're able to kind of be flexible and kind of pivot towards that, other more, you know, compelling. compelling opportunity. Well, it's, it's, we were staging it, right?

So we started this as a helping the VC out and then doing a little exploratory work. And, you know, we didn't buy in. I didn't buy in until, until kind of, I knew we had something else. So some of that just comes with experience. And I think the best entrepreneurs are really kind of kind of self-critical and, you know, critical of what they're doing. I think you need to be to be good at it. If you're drinking your own Kool-Aid, you may be up for, you know,

you know, finding out later that, that you weren't right. Yep. Early on, it's best to bring in critics, ask them to be critical, you know, in nice ways, and learn because in those learnings there may be other opportunities, or you may decide, hey, this isn't really kind of what I thought it was. The sooner you understand it, the sooner you can decide what to do. So, yeah. Be as proactive as possible.

Yeah, healthy, it's a healthy balance between, you know, being optimistic, but also kind of being your biggest critic, too, right? right? Totally. Careful balance. But, you know, one of the other things that you mentioned, Steve, too, is this, this idea that you've got to be solving a real pain point, right? That's something that's obvious that when you're talking with an end user, right, it sort

of, it resonates, you know? And I bring that up because if you find your, you know, if you're listening to this and you find yourself having these conversations and you're really struggling to sort of connect the dots for the end user and trying to get them over the, to really just even understand the problem, I think you probably. probably need to maybe take a step back and understand, you know, are you, what, like, what are you trying to build? What are you trying to solve for, right? Not that it can't be, not whatever you're working on can't be done per se, but if you're having a really difficult time

convincing someone that a problem exists, ooh, that's a, that's a, you know, that's a tough I totally agree. And then you convince them that you have a solution to a problem they didn't think they had. Yeah. It's very difficult. So it's much better to, maybe find a different problem. You should act with up if that's what you could be thinking about. Right, right. Yeah, that's a really good point. Let's talk a little bit. You mentioned the the second 510K clearance that you guys received, I think in late, late last year, late 2022. This topic of regulatory, right? Sometimes it can be, it can seem pretty daunting, right, depending on the therapeutic arena you're working on. But it's, you know, the waters can be kind of choppy

sometimes. And it's, you know, fairly, fairly subjective, right, depending on who you talk to. So when you think about navigating those waters, and again, maybe frame this up around, you know, seed series A kind of land. You're kind of just beginning to figure this, your approach out. Do you have a couple pieces of advice for other entrepreneurs or, you know, METTEC start or CEOs that are in that same boat? Yeah. So I think it's really smart to look at comparative companies.

And if there aren't comparative companies, you may have some serious challenges in your hand. So I'll give you a couple of examples. So, so NUVERA, we knew it was a PMA. We knew it was a long practical. we knew is a long contract regulatory, right? So that that one is probably more straightforward. It's a huge, huge market, but huge obstacles regulatory wise to get there, but you knew and you understood them. Curve fix, on the other hand, you know, for us, there's a significant question there, and it was

one of the early risks, again, I said to be critical about. So could we get 510K clearance without doing a clinical study? That was the question. Could we get it based on standards testing versus kind of comparative devices. Spray screws or rods that are using the long bones, right? Those are kind of the two comparative devices. So we are very similar, but we're different in one key way, right? We're flexible when we go in and we're locked in a curve shape. That's the only way we're different.

So we went out and, you know, interviewed some regulatory experts who understood this stuff and didn't have a background orthopedics at the time, but we got enough confidence that That makes sense. So we made it a priority for us to get regulatory clearance before we did anything else. We built kind of the minimum viable devices that we could do the testing to make sure we pass the standards with the comparative devices. We got good data. We wrote up our 510K and we submitted it.

Got it. There's a longer story I could keep going on this because what happened next is important. Yeah, no, no, I'd love to go there, right? Because, I mean, this is a common challenge, right, with any device company where you're similar, but you're just different enough, right? And so you've got to make this argument oftentimes through a 510K, you know, submission to FDA. And, you know, you could have as many presubs as you want leading up to that. But ultimately, you're not really going to get definitive guidance until you actually just submit, right? Yeah, yeah, yeah, yeah.

So that is a strategy question. We decided no presubs. No precepts, okay. No presubs because the standards of the standards, we knew what the comparable, were we knew what we needed for an indication for use, that was all clear. Got it, got it. Our differences were just those small number of things,

and we needed to prove they didn't cause any new questions of safety or efficacy, which we thought was doable. So we put together our submission, we did it. Okay, you may ask, did we have done some pre-subs? Well, you can look at it both ways. I'm not sure. On this one, that's what we thought was the right case. With Nouvera, tons of pre-subs, right?

different. And we got back some questions, and Nicolet was very favorable. And that, wow, this is great. We're going to get it. Then there was a period of time, then we got another round of questions in from the chief medical officer. And they were good, reasonable questions. But they were a little bit outside of what he really should have been asking regulatory-wise. So there was a public patient that was brought up and that the lead author on that was actually on her third intervisor board. So he's using a public patient kind of to get us to do some other things that we didn't think were appropriate. And we had that the person wrote the paper. So he said, all right, you know, we got in a good, solid regulatory attorney. We figured out that, you know, we had, we're in the right. We decided, okay, let's do a meeting at FDA. We'll bring this doctor and we'll run through this with them and educate them. So wrote up this very nice response. You know, all these things. It wasn't unreasonable what they're asking. It's just, you know, here are the regulations. And, And here's what we're trying to do and all those types of things we had to sort through. And in the end, they read it.

They said, no, you're good to go. So we got it. But we got exactly what we asked for with no changes. So we were in the right. But, you know, it took a lot to understand, are we in the right? What is the law? What's appropriate here? What do we do?

And that took nine months, right? So nine months. And it was a very painful nine months because you don't know that you're going to get it. And then we got it. We got everything. So that allowed us to help get what we needed that and a couple patients and we had enough to raise series B. The second round was really straightforward.

It's been solid clinical. We haven't had any issues out in the field and we got it in 70 days. Yeah, that's great. And I want to be mindful of time and not get too stuck on regulatory, but this is such an interesting topic. And your feedback is, I think, is extremely valuable because for a couple of main reasons. One is that, you know, you made the point earlier about you went, you went straight to submission versus doing presubs. And so many people almost think it's almost like a mandate or it's a must that you do pre subs.

And it's like, they can be valuable. But you strategically said, no, I think we're actually going to go, I think we're going to go straight to submission. And I think that's really, really helpful for other people that are listening to this is like you don't always have to do presubs. I mean, it's not, it's not always black and white. And it may make sense not to. Every other company we have, but this one we decided, no. this is straightforward. Other companies that are, you know, not the same as us,

but we're also different from standards in different ways. Got it. So on this one, let's not create more work for us. Let's not get other, you know, things from FDA and or have an, unquestionable questions FDA ask us on the spot. We let's just do what we think is right and we got it. But my advice for anybody doing a novel technology, it's going to take longer than you think.

Get, get a bunch of experts. And, you know, if you're not in time, really comfortable get another expert too because it's it's really important that you get it. Yeah. The other, you know, as you were kind of describing that scenario, right, which played out it sounds like over the, almost a year, like nine, nine months. Yeah. I think that that's also just, just to help, you know, folks understand your approach was, was a bit different, right? I mean, it was strategic, but it was a bit different than, you know, having one to two presubs in advance of submission, et cetera. But I think it's helpful, you know, if you're going into that and

you're going to try to make an argument for, you know, in this instance, a non-clinical 510K, you need to understand that you're going to have to make, this is going to be an argument, right? You're going to have to convince others. And it's not just going to be, you know, what you say. You're going to need to bring a team around you, right? And you mentioned you had a sounds like a pretty impressive, you know, sort of roster of folks around you, including those on your medical advisory board. That's probably about, yeah, that helps substantiate and justify, you know, the argument, which I think is crucial, you know, it sounds like that ultimately, like really, really helped, you know, kind of win the day, ultimately is, is that fact.

exactly what we asked for. And for the right reasons. We weren't, you know, data facts, logic, and reason prevailed. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miarid, CEO of CVRX. and so many others. As a premium member, you'll get to join live interviews with these incredible medical

device and health technology entrepreneurs. In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium. Again, that's Medsiderradio.com forward slash premium.