Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Be Resilient as a Startup Medtech CEO: Interview with Aqua Medical CEO Lloyd Mencinger

Episode Date: April 12, 2023

In this episode of Medsider Radio, we sat down with Lloyd Mencinger, CEO of Aqua Medical, developers of a platform technology for vapor-based endoscopic ablation designed to treat type 2 diab...etes with a 30-minute outpatient procedure.  Lloyd is a high-energy CEO with decades of international experience in medical device sales, marketing, and business development. He has a strong track record of delivering results in both blue-chip and early-stage companies, including Boston Scientific, Edwards Lifesciences, and Baxter Healthcare. In this interview, Lloyd highlights the critical role of capital efficiency and rapid iteration in the early-stage development of medtech startups. He also discusses the importance of driving value for the company versus solely focusing on an acquisition. 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.Lastly, here's a link to the full interview with Lloyd if you'd rather read the summary instead.

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Starting point is 00:00:04 Disappointments and mistakes are requirements. The only thing that will propel you to success for the next days, you have to make mistakes, you have to learn from them. It's the only way it's going to keep you going up into the right. 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.
Starting point is 00:00:32 In this episode of MedSider, I sat down with Lloyd. Fincing are a high-energy CEO with decades of international experience in medical device sales, marketing, and business development. He has a strong track record of delivering results in both Blue Chip and early-stage companies, including Boston Scientific, Edwards Life Sciences, and Baxter Healthcare. Currently, Lloyd is the CEO of Aqua Medical, a company on the verge of developing groundbreaking technology for type 2 diabetes and other GI conditions. Here, for the key things that we discussed in this conversation.
Starting point is 00:01:01 First, embrace capital efficiency and rapid iteration in your startup, Keep your organization lean and focus on quickly cycling through prototypes. This will help you reach proof of concept faster considering your resources are extremely limited in those early days. Number two, focus on driving value in your company rather than solely aiming for an acquisition. Or towards achieving milestones that increase the company's worth and provide a sustainable path forward. Third, persevere through the fundraising process. If you encounter low success rates for pitches, don't get discouraged right away, but keep reaching out to potential investors. investors. Remember that journey can be lonely, so lean on your support network, faith, or other
Starting point is 00:01:37 sources of encouragement to help you navigate the challenges of raising capital. 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 Medsider interviews over the last six months or so. Look, it's tough to listen or read every single Medsider 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 the 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
Starting point is 00:02:11 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 AliveCorp, 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 medsiderradi.com forward slash mentors.
Starting point is 00:02:52 All right, Lloyd, welcome to Medsider Radio. Thanks a lot, Scott. I appreciate it. Yeah, definitely looking forward to this conversation. It should be a fun one, especially considering all of your startup experience. With that said, Lord, I kind of touched on your bio at the outset of this interview. But let's start there. Give us a sense for your kind of professional background, you know, without getting too far into the weeds leading up to your current role as CEO of Aqua. Sure, sure.
Starting point is 00:03:20 And I mean, for me, it's really been kind of this winding road. I kind of started with the big blue chip med device company. So Baxter, Edward's Life Sciences, Boston Scientific, then went to the provider side tenant health care. And then really since then, it's been, you know, four early stage startup companies. And a big part, I would say a big chunk of that was international as an expat for 12 years. So much of that was a lot with Boston Scientific. So we lived in London, in Paris, in Moshek, Netherlands. And then, of course, we moved around a lot back to the U.S.
Starting point is 00:03:55 and in terms of jobs, I ran, let's say Bustas Scientific, I ran a third of the company across Europe for, you know, eight years. And that was really the end of surgery group. So probably, yeah, third of Bust Scientific. And then, you know, a number of staff roles. Back in the U.S., I went into strategy and business development, which was really the M&A side. So basically, basically, aligned running businesses and then to the M&A side. And that's where I really got interested in the startups. I said, look, it would be nice to be on that side versus this side. You get no bonuses for doing a deal in Boston Scientific, right? So the good side would be on the M&A side. So I'd say that the tenant health care experience, the provider side, was fascinating
Starting point is 00:04:41 because now I got to see. I was in the top 20, 40,000 people at 10, $10 billion, you know, 50 hospital system. It was very interesting to see because we were always pushing products to that side. from the med device side and to see what their reaction is. It's funny because in the hospital system, they think, oh, yeah, you guys, you just pay off the doctors. That's why they buy your expensive stuff. So that was kind of their attitude.
Starting point is 00:05:08 But really, I learned that they want, like, good pricing and a basic device. Whereas, let's say, with Boston, we're pushing all the bells and whistles, the most expensive device. And they're saying, look, if it's, if it's, okay and it works in people, then that's the one we want. So it was kind of a lesson on the side of the development side of, you know, for the med device piece. Yeah. So that's kind of a, that's really my background. Yeah, no, that's helpful. It's interesting that you bring that up because, and I, and I've shared this, I think, in a maybe a couple interviews ago that I, that I did for,
Starting point is 00:05:45 for MedSider. But a conversation I had with, with Nick Anderson, who kind of specializes in in healthcare economics. He made a really good point that still sticks with me today. He said, you know, I have all the startups that I consult for, it's so rare that I actually see someone on the payer or provider side, actually on the board. And he goes, it's such a huge gap because to your point, like, it's so easy to, you know, be knee-deep in developing the next greatest, you know, device or system and to lose complete sight of like the economic side, right?
Starting point is 00:06:18 And how are you actually going to convince, you know, not only the, the, the provider, the clinical provider, but the actual, the payer as well, the hospital system or the insurance payer to actually cover, cover and, and pay for your, your device. So it's a really, really interesting point. But just to circle back around your career. So you're, what was your first startup then, kind of coming out of, out of the land of the strategics? Oh, yeah, it was uptake medical. It was uptake. Yeah, endosem, defined. Was the spine. Come, we sold that for $100 million. And then now I'm doing Aqua. Okay. Okay. Got it. Got it. Okay. That's super helpful and I remember worked with a couple,
Starting point is 00:06:54 a couple friends at Define back in the back in the day. So, okay, so let's kind of transition to Aqua, like current state, right? And then we'll kind of rewind the clock and go back in time a bit. But again, kind of without providing too much detail, give us a sense for kind of what you're developing at Aqua. And really maybe frame that up around how the idea even came to be. Sure, sure. Well, this is the most exciting thing I've ever been.
Starting point is 00:07:22 involved in, we have a 30-minute outpatient procedure to treat type 2 diabetes. And it's a, it's, it's pretty simple. It's a catheter goes through an endoscope, goes through the mouth, 30-minute, you know, potocidation, patient can go home or back to work the same day. And it's hot water vapor ablation into the actually through the, through the esophis, the stomach into the duodenum, ablating the duodenum can actually pre-type 2 diabetes. That's kind of the very interesting finding. And the origin story is funny because one of my, the chief medical officer in 2008 thought he actually was a GI doc doing procedures every day, a key opinion leader in his own right. But he ran a sort of an ASC with 10 doctors and 60 employees. So he's every day kind of a practitioner as well as a KOL.
Starting point is 00:08:15 And he was looking at different ablation, you know, methodologies, radio frequency, etc. and kind of came upon this vapor ablation as a great approach. So developed it over the years filed IP, which was very important, kind of like in 2008. And as, you know, kind of developed the early technology. And it was going after Barrett's esophagus, which is a common, it's treated by ablation, and we had sort of better, faster, easier. And the interesting sort of the pivot story here is we were going after Barrett's, And we talked to investors, we talk to doctors, we talk to folks, and they'd say, well, that's interesting.
Starting point is 00:08:53 And then docs would come to us and say, by the way, you know, this is, while blating the esophagus, the duodenum is underneath the stomach. It's also a tube. The GI tract's just a long tube of different diameters through the body. They said, if you, there's a technology they're proving that if you ablate the duodenum, you can actually treat type two diabetes. And their device is extremely to cumbersome, you have a device that's ideal for this, better, faster, easier. Switch from Barrett's to diabetes. The market's, you know, probably 100,000-fold bigger opportunity. So it was kind of that we weren't smarter.
Starting point is 00:09:32 We were just going by basically folks told us, go ahead and make this pivot because you have the perfect product for this. Yeah. So interesting, letting your classic case of like letting your, your, your, your, your, your, your customers, like drive the direction for the product and the company. But just a couple of quick quality questions. So if I understand this right, and I don't expect you to like make bold claims about your product or your system currently. But in a future state, right, this, this, you know, the, the system, you have the claims that you need. It's in, you're in market. As a patient, I just,
Starting point is 00:10:05 I would go to like an outpatient GI ASC and, you know, go in, get this procedure done in 30 minutes. It's like a tube, you know, it's a, it's a, it's a, it's a, you know, kind of, sort of down my, you know, through my mouth, down my esophagus. Right. Duadum's ablated and then I'm out. It's that easy, huh? It would be that easy. It is that easy.
Starting point is 00:10:25 Yeah. Okay. Got it. Got it. And then kind of circling back around to like the concept of ablating the duodenum, I mean, is the mechanism of action understood? And like, how long, how long would it, does it last? I mean, if I, if I were to be treated, and again, I'm not expecting you to get yourself
Starting point is 00:10:43 in trouble from a reg standpoint, but if I'm in a future stage, but if I'm in a future state if I'm treated with the aqua, the aquascope. I, uh, you know, how long with this, how long would the, the efficacy sort of last? Or what is there kind of an ideal, ideal target before I'd have to maybe, you know, get in another intervention? No, this, you're asking, you're asking actually the two central questions that are the key to the entire, the entire approach. And, and, uh, it's, it is, it is fascinating. First, we are not in humans yet. So we've got all this animal, body of animal study. we are on the cusp of getting into first and human for diabetes.
Starting point is 00:11:18 We've actually done first in human in the esophagus. But the real answer to mechanism of action is people don't know. That's number one. If you have the honest answer, however, you know after bypass and ruin why, all those procedures for obesity. So those procedures, they actually bypass the duodenum. That's what happens. So it's in various, you know, billy, pancreatic diversion,
Starting point is 00:11:44 these other obesity procedures, obesity is resolved over weeks and months in those patients, type two diabetes goes away within a couple of days. It's resolved. Wow. And so people are like, what the heck is, and it's not food related. It's really because they found that the duodenum is really this epicenter. And there are all kinds of thesis for, you know, vagal efferine pathways and all kinds of metabolic, you know, feces. And you go to these DDW conferences. There's hours and hours of discussion on mechanism of action. But then another company came out with a sleeve, basically a tube covering the duoden, the food passes it. Same result. Over weeks and months, obesity resolved, diabetes away, almost immediate. However, a company failed because they couldn't keep it in place.
Starting point is 00:12:31 So the company ahead of us has demonstrated in randomized control trial, and they're seeing durability. I thought it would be six months. They're seeing durability up to two years for a three-minute of the glation procedure. So that's why, I mean, this is really exciting. That company has raised $322 million. Their market, their post-money value was $870 million. Wow. So we've only spent $15 million so far.
Starting point is 00:12:58 Okay. And we have, we have 3, 5, 10Ks, by the way. Now, we don't have an indication of diabetes. We have indication of baris esophagus, but we are able to ablate throughout the entire GI track. That's where we have clearance. so we can back into, you know, expand indications. Okay, okay, great.
Starting point is 00:13:17 Yeah, that's super helpful because that was going to be my next question is kind of where, where's the company at? So you've got three 510Ks in hand, and it sounds like you're preparing for inhuman work specific to type 2 diabetes treatment, right? Yes, exactly. Okay, got it. Got it. And what, you know, out of curiosity, what is that to get those sort of claims around,
Starting point is 00:13:37 around, you know, for type 2 diabetes? Is it a 5K pathway then? or is it a PMA or what does that look like? Okay. Well, that also is a very good question. One of the companies is pursuing PMA, and it may be a PMA, maybe a 510K de novo. Got it. It depends. Yeah.
Starting point is 00:13:55 Okay. Okay. Got it. That's super helpful. And again, for those listening that don't, if you don't get a chance to get to the interview summary for this particular discussion with Lloyd, and you're interested in the technology, go to aqua endoscopy.com. That's AQUA endoscopy.com, aqua endoscopy.com.
Starting point is 00:14:13 You can learn a little bit more about the company, the tech. You can see Lloyd in his background as well as his team's background, etc. So let's kind of use this as a bit of a transition to kind of go back in time, step inside the old Medsiter time machine. And I'd like to, and this maybe this first question I guess I have for you is not necessarily specific to Aqua, but feel free to kind of frame it up based on your experiences at Aqua, but I'm really kind of more interested in, you know, your other, you know, you've got to thinking about your other early, you know, experience with early stage startups as well. But the earliest kind of
Starting point is 00:14:43 prototypes, right? You know, you're in your alpha and beta, you know, kind of builds. When you think about that point in the, in the life cycle of a, of a company or in a startup, where do you think most, you know, med tech, health tech and entrepreneurs, what do you think they go wrong, you know, at that, at that point in time? Yeah, that's always. You know, actually, I was actually thinking about that. And I think that mistakes are kind of part of the process. I mean, there's almost no, I mean, it's really how fast can you cycle the iterations? Because it will not be right quickly.
Starting point is 00:15:22 How fast can you cycle it and how capital efficient you can be? You know, it's funny when we started, and I've been very lucky to have a great board. I'd, you know, sort of Pete Nicholas, who passed, he was the founder of Boston Scientific, and I have a lot of these experienced board guys. They've done, you know, many more exits than I have. And we sat around and said, you know, together we've made every possible mistake you can make in a medical ice company. We said, okay, so what would we do differently this time? And a couple of things came up.
Starting point is 00:15:53 One was capital efficiency. Do not build out a big organization. Do not, you know, kind of scale up and think you need. need all these things. I mean, keep it super, super lean because runway oxygen is your life, you know. And so rapid prototypes, to your point, try to do as many prototypes, try to do it as cheaply as you can to get to proof of concept. And we do a lot of things before, I mean, animal studies even now are very expensive, right? I mean, you know, so try to do bench top, any, if it's possible lean beef, different types of, you know, and just try to do the iterations as quick.
Starting point is 00:16:33 and as inexpensively as you can. And I guess, yeah, capital efficiency is one. And the other was, I don't know if this is related necessarily to the prototypes, but to not build only to be acquired, right? To try just to drive value in the company, take enough, our thesis to sort of take enough money to get to the milestone that would drive the value up in your company. And that also helps your early investors, right?
Starting point is 00:17:05 Because they want to see a lift in their ownership before they get the cram down effect from some other VC coming in next. So that's one of the big. And we talk about that. We have our models, we say it's like driving from Los Angeles to New York. Let's say New York is an IPO or you're building out the company. Los Angeles where we're starting from, you know, the idea is build clinical value. You might get acquired in Arizona.
Starting point is 00:17:36 You might get acquired in Dallas, but just take enough and build enough value at each point. But don't count on it. If you're building for acquisition, you may miss the window. Yeah, that's a great picture, right? That story of kind of your cross-country trip, right? And the next sort of stop, right, you need to be at another milestone, right? A value inflection milestone for the company. It's a great kind of picture.
Starting point is 00:17:59 And I, and you know, in kind of the, the, the conversation, kind of the pre-interview conversation we had, you know, we talked a lot about sort of the similarities in terms of structure between Aqua and Fastwave, right, which is where I'm, you know, I spend most of my time. And it's super interesting that it's like so many, to your point, so many startups, they get focused on building out like a complex org structure and don't think about they're burn, right? And they're maybe cognizant of it, but they're not practically doing the right thing. is to keep that burn as low as possible, yet still, to your point, rapidly iterating, right, in order to get to that next stop on the journey, right, on that cross-country trip. So, yeah, totally right there with you. And I mean, I fundamentally think that, and I'm not sure if you'd agree with this, but if you're doing a startup, you need to be cognizant of who are the national acquires here, right? Who would pick up this technology?
Starting point is 00:18:52 But I remember, I remember a discussion I had, it's probably been a couple years ago, with Robert Klein, Bob Klein, who's done a number. of startups. So both are surgical most recently. And he mentioned something similar to you. Like you can't solely rely on that, right? You've got to be building to get to the next, you know, the next major value in a flexion point. But there needs to be sort of a sustainable path here, you know, in the event that you're not, you're not acquired, right? And, you know, that can't be a singular focus, which I think is a good point. Right. You know, if I could mention something I think helpful to people listening to that would be, I was doing the job of business
Starting point is 00:19:28 development of Boston Scientific. And I had a company lined up. It was actually my chairman's company, Barks, and we wanted, I said, okay, this is ready to put, we put the whole dossier together. And when you're in a company like that, Boston or Metronic or, you know, Jane, it's like one business should be after another, an executive committee, in the next level. And okay, we got approval. We got the green light. Okay, it looks like it's good. Everything's right. And you have to redo it, you know, 40 times, you know, and what are your assumptions and low case and high case? And then we said, okay, ready to go. And then my boss comes in and he said, ready to pull the trigger and says, you know, sorry, Lloyd,
Starting point is 00:20:04 cardiology just did a billion dollar deal. You don't have any money until next year. So that can happen, right? I mean, like you said, it's not until the wires in the bank, you do not have it. So everything made sense. That company was probably counting on us, you know, acquiring them and it didn't have. So that can happen. Yeah.
Starting point is 00:20:23 So that's a really, that's a really important story, right? It's like all the dots, you know, could align, right? But then you have some sort of adjacent event that happens that's completely outside of your control and unforeseen. And it kills a deal, right? It kills a deal. It prevents a deal from going down. Yeah.
Starting point is 00:20:38 So, yeah, super valid point. And I think just kind of hearing you describe, you know, some of those, some of those experiences in the stories just reminds me of like, you know, always, you know, in the world of startups, right, you kind of always need to be pushing forward with multiple plans, right? You know, if you're stuck on plan A and not thinking about a potential plan B or plan C, that's kind of a dangerous, dangerous position to be in, you know. And so, yeah, yeah. You know, this another, I mean, another sort of corollary in that is sort of a picture inside some of the going, you know,
Starting point is 00:21:10 sometimes I start wondering, what the heck's going on with the strategic? I mean, everything's here. They're asking me again, all of a sudden you get a question from this, like, where did this come from? You know, and so some of those meetings I would have, I would be the BD guy in the company. trying to get a deal done. So all the people around the table, the legal, the IP folks, the marking, whatever, I mean, everyone has their own agenda. And nobody gets a bonus on this, right? Nobody gets a bonus on having this deal happen, you know? In fact, some people, they see their job as to be, look smart and say, oh, did you think of this? And this could be a problem.
Starting point is 00:21:46 Or the IP, maybe it's, IP is never black and white, right? I mean, it's sort of there's gray zones. And so you have someone say, oh, no, this is going to be a risk. We can't do it. And so a lot of times in acquisition, you'd fall apart. I had one also fell apart because of an IP thing. I thought it was non-issue. Somehow they convinced the executive VP, executive committee that this was an issue and it didn't happen. So, you know, growth opportunity lost for the company, but it's kind of hidden.
Starting point is 00:22:14 So that happens. So it's just that from a startup side, you don't see any of this, right? And so, but that could be happening behind the scenes. So I guess the thing is, discouragement will find you. Like they say, you're not afraid until fear finds you. So that happens. That's a great way to put it. I haven't heard that describe like that, but that's perfect.
Starting point is 00:22:37 I mean, discouragement will find you in a startup, right? I mean, always being aware that you're pushing a boulder uphill, right? There's always friction along the way. And if you're expecting some sort of smooth ride, you need to kind of open up, open up the eyes a little bit because that's not, that's not going to be the case. But you know what's interesting about that story? And I, and I think the fact that you've got such a broad base of experience, right? Commercial, BD, running startups, spending a bunch of time on the kind of the provider
Starting point is 00:23:09 payer side, right, at tenant. That, I think, I think sort of obviously that that's helped you, right, in your scenario now being able to kind of see who's sitting on the other side of the table, right? But if you're, you know, if you're listening to this, conversation, you know, whether you're reading a startup or whether you're running a startup or inside a large organization, I think just at that point, right, of being able to understand there's multiple stakeholders in the room. Some of, most of them maybe not, are likely not going to be incentivized to do your deal, right? So you need to be thinking about the impact of that. You know what I mean? And it reminds me of a conversation I had with, with Bruce Shuck,
Starting point is 00:23:46 who sold, sold VESPR medical most recently to Phillips. And I think. intact prior to that, if my memory serves me, were correct. But he mentioned, he mentioned that. He was like, you know, in one of these recent deals, it was super important for us to get really, really strong commercial buy-in, right? Because the commercial leaders were actually, and I'm paraphrasing here. I can't remember if he said this specifically, but sort of painting for this picture that it was the commercial leaders that really kind of pushed the deal over the, you know, over the, over the fence because they understood by having this product in their bag, it was going to, I mean, it was going to be pretty, pretty impactful, right?
Starting point is 00:24:22 And they, you know, that commercial buy-in, you know, is maybe much more understood, right, than someone's sitting in IP or someone sitting in, you know, regulatory or whatever, you know. So that's very, that is a really strong point, very powerful. Yeah, those guys could sway it in one direction because those other people sit, you know, and just talk to each other, legal and IP and those internal. And everything is negative for them. Right. compliance. They have their own little circle, you know, circle of life that, you know, keeps going because
Starting point is 00:24:55 everything that's wrong, you know, and has to be fixed. Yeah, yeah. But you bring up such a good point, though, just understanding like those nuances that someone in IP, there may be incentivized by raising a lot of attention to a certain risk, not necessarily, you know, talked about how great the opportunity could be. I mean, they want to raise, you know, awareness for, you know, certain risks that they see. And those kind of folks typically are a little bit more conservative than. others. So I get your point about just understanding who you're dealing with, you know. We used to call IP and compliance to sales prevention department. That's right. It's been acquisition prevention department. I mean, really, because they're like the cops,
Starting point is 00:25:35 you know, kind of inside. So. Oh, yeah. Yeah. Yeah, totally. Yeah, totally. But yeah, I mean, it's such a, it's such a, a good point that, you know, can't be underappreciated. It's just understanding those stakeholders, right? You know, you could, you could be, getting such good vibes, right, from your BD contact, right? But, you know, four or five people around him or her are like all saying, no, no, no, I see this problem, I see that problem, et cetera. So yeah, really, really good stuff. But your point of going around them to the commercial is very powerful because those guys have sway. They say, look, this is a winner in the marketplace. They can kind of bypass and go above. Yeah, which is really what you want inside
Starting point is 00:26:13 strategic. Yeah, yeah, no doubt, no doubt. Let's circle back around to kind of, your regulatory approach at Aqua. You mentioned that you've got three different clearances now, and you're in the process of, you know, of trying to expand upon those claims, right, for diabetes purposes. But what, like, when you think about regulatory in general and how to, you know,
Starting point is 00:26:39 sort of setting the roadmap and using that as a, as sort of a growth driver for a startup, rather than just a hindrance or a roadblock, like, do you have any, any pieces of advice that you can offer up to other Medcheck entrepreneurs or founders that are in kind of the same boat? Right. Well, actually, mistakes that, I mean, I have made enough mistakes.
Starting point is 00:27:00 So that's where it comes from. But we have found, well, maybe it was some serendipity, but some of the large, the big consulting firms, they can, not all, but they can't err on the side of conservatism and safety. So they'll say, we went to one. They said, well, you're going to need, before you can even think about this, a 30 patient, not bench top, not lean beef, not animal, but a 30 patient clinical study to be able to even think about this, you know. Then we went to another regulatory firm through connections, very smart people, very practical, small boutique shop, had relationships in the FDA and really kind of knew the space.
Starting point is 00:27:48 And we did it without even animal. We got the 510K basically just a little bit of animal work, but mostly bench top and lean beef. So I would say find people that really can, I mean, it's worth looking diligently trying to find connections to a good regulatory firm. Because that would have been, I mean, the company wouldn't exist if we have to go the way that this large regulatory company kind of guided us. So I think that's one thing. really and really pressure test because yeah they they really explored you know how we can pull this package together and obviously spending enough time on the package and and the dossier to to write it in a way and someone that has relationships in the FDA knows the domain is very very important
Starting point is 00:28:37 yeah so yeah that's probably the biggest takeaway i had from the regulatory no no doubt it kind of I mean it sort of reminds me of just you know the the topic we just discussed right which if you're talking to a large regulatory, you know, RAQA organization, there's a high, probably high likelihood that they're kind of, they're kind of biased towards being pretty conservative, right? And trying to take the safe,
Starting point is 00:28:59 the safe path, you know, not going to be overly creative or aggressive with the approach. And I like that word you used to describe kind of being able to pressure test different opinions, right? And I think that's a really not being afraid to kind of push, push the limits, you know? And at the end of the day, you may get, you know, nine out of ten regular stories folks that all kind of say,
Starting point is 00:29:21 nah, it's not, you can't do it that way. But you may force them to kind of rethink kind of what, how they normally would approach something. You know what I mean? So just being able to kind of, you know, push a little bit hard and, you know, strive towards maybe more, a little bit more of a creative approach. There's no harm in that, you know, typically, right? You know, and if you have to back into, you know, a safe zone or a comfortable approach, that's fine.
Starting point is 00:29:44 But, you know, why not? I'm kind of with the opinion that why not, why not start out a little bit more aggressive and think about it a little bit more creatively, you know, and then, yeah, yeah, so. Exactly, yeah. 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.
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