The End of One Road and the Beginning of Another | LSI USA '24

This panel talks about the strategic planning and key imperatives needed to go from pre-FDA clearance or approval to commercialization.
Tonya Dowd
Tonya Dowd
, PRIA Healthcare
Dr. Luc Marengere
Dr. Luc Marengere
, TVM Capital Life
Cody Simmons
Cody Simmons
, DermaSensor
Pierre Lemire
Pierre Lemire
, Kent Imaging
Scott Janssen
Scott Janssen
, LS Associates

Tonya Dowd  0:04  
Thanks, everyone for being here this afternoon. And we are the only thing standing between you between happy hour. So you know, so we, you know, we I did ask Henry to bring in a bar but he hasn't he hasn't brought it back yet. Hopefully he'll Hilah he'll he'll be able to. So again, thanks for attending. This is a very exciting panel. My name is Tanya Dowd. I'm Executive Vice President of reimbursement, value generation and market access with PRIA Healthcare. And I have a very esteemed panel here today to talk about the strategic planning and the key imperatives that are needed really to go from pre FDA clearance or approval to commercialization. So with that, I'll have the panelists introduce themselves, and we'll get right into it. So,

Luc Marengere  0:50  
thanks. Thank you, Tanya. And thank you to LSI for for this opportunity. So Dr. Luc Marengere, our Managing Partner with TVM Capital, and where we invest is early commercialization. Thank you.

Cody Simmons  1:05  
Hi, my name is Cody    Simmons. I'm the co founder and CEO of Derma. Sensor. We just received FDA clearance two months ago for an automated skin cancer detection device up Ron pocket, labeled specifically for non dermatologist physicians.

Pierre Lemire  1:22  
Hi, everyone. I'm Pierre    Lemire. I'm the CEO of cancer imaging. We're one of the TVM portfolio companies, we manufacture a medical device that uses near infrared light to measure oxygenation in tissue. It's nice to be here. Hi, everyone. My

Speaker 1  1:37  
name is Scott    Janssen. I'm the co founder and managing director of Ellis associates, we provide augmented C level talent to companies pre and post FDA approval.

Tonya Dowd  1:49  
Great. So besides funding, which is imperative, and and very, very important, what are the what are the three key strategic imperatives pre and post? FDA, from each of your perspectives? From a planning standpoint?

Speaker 1  2:08  
Yeah, give it a start. So for us, it's it's for any company, it's laying out that roadmap right and going for success and, but also as a, as a CPA and a CFO, we want to make sure we're using our capital wet wisely, right. So there's certainly we got to capital intensive companies, and to get the approval is capital intensive. So what we provide is and we encourage people is to, to bring in some augmented talent to play and practice and prepare for your commercialization stage. Right? You're, if you don't know exactly, when you're gonna get approval, it's kind of hard to get the right headcount in place. But you know, use augmented consulting talent to make sure that that roadmap looks good, and that you have every chance of success to move forward, bringing in people who've been there done that before.

Pierre Lemire  2:57  
Tiny I can't, we've had a lot of lessons learned and, and prior to Kent, I was with another medical device company. So we're working with the FDA for over 20 years. I think the first thing that I've learned is the FDA, even though you don't want to treat them as your friend, you need to treat them as your friend and as a consultant as much as possible. Because if you don't either pay upfront, or you pay later. And it's better to pay up front, I've learned that lesson. I think, in terms of looking at the commercialization journey, and understanding where you're going to be at the end, which is getting a paying customer. There's a lot of things in between that path and you think, Okay, I'm gonna go get FDA and 510 K clearance, or if you have to create your own indications, you know, going down the de novo path is like, Okay, that's it, once I get that, then I'm off, I'm going to be commercial, that's just the start. And in fact, it's fine. If that's where you're at, you missed the boat already, you need to be thinking about what is going to be my reimbursement path, or my clinical claims that I'm going to make when I'm trying to sell the product, and ensure that when you're submitting your FDA, that those claims are clear. So if you have an advanced product, but do you think you're gonna get to market quicker because you're 510 K against let's say, a bandage or as a simpler product? You're not gonna get the reimbursement that you want when you go commercial?

Tonya Dowd  4:25  
Yeah, that's a really good point.

Cody Simmons  4:28  
I think for us, we took a certainly considering Kirkland of what does the customer want. And also reimbursement but I think for us invested a significant amount upfront when I joined seven and a half years ago, to see basically, reimbursement landscape assessment. And could there be a study that makes FDA and payers happy? And basically, the answer was no, because we couldn't get real world utility evidence with a device that can't be used real world data. And so, you know, for us, I think that pretty much simplified things for me in the company because it's okay, just focus on FTA with a product that we know, customers will want. And I think for us, not every, certainly many companies don't have this luxury, but by miniaturizing, a, you know, $50,000.30 pounds system into a one pound device, that's low cost, and so quick and easy to use. Were like, I don't know, if we necessarily need traditional cat three cat one route, and so far that that's looking to work is working out quite well. Obviously value based. That doesn't matter in the first place. But I think for us, we kind of have the luxury of okay, if the product is so quick and easy to use and low costs for the customer. Do you necessarily need to go that route? I think at some point, we'll want to go on that that few year process or death march, pick your pick your term, but yeah, getting that clarity up front, I can imagine juggling the rounds of preset feedback with FDA, and input from investors and others, and trying to figure out what payers want with limited resources. So it's nice kind of having that up from clarity, that it's probably not going to be doable on a way to just focus on FTA. And having a quick, easy to use effective product that customers are gonna like and figure out embarrassment later. Great point.

Luc Marengere  6:22  
So maybe let me offer you the the investors perspective. Okay. So when we when we look at a company that is early in its commercialization path, so you got the FDA tick box, you have a little bit of clinical validation. And and now you're facing the commercial, the commercial scale up, right? And the first few steps are critical, in fact, right. So the way we plot it out is that we take a look at the company and we say, Okay, what is what is the journey for us the journey is to a strategic m&a. That's the journey that can take three years, four years, five years, but then we work backwards after that, right. So today, you're here a little bit like when walking in a mall, right? You're here and you want to get there? Where do you need to go to actually get to your destination? Right? It's absolutely crucial. And we will, we will work with companies. In fact, we've worked with a lot of companies prior to getting their FDA approval, right? Where we've impacted their their path to approval, their path to clinical validation, right. And then, basically, we're creating our own farm at that point in time. It's absolutely important that when you do graduate with your FDA approval, that you have a strategy for additional clinical validation, right? It sometimes you'll get away with with investigator initiated research, right? You don't I do realize that this meeting has a few big CROs as sponsors. So you don't always need a prospective double blind, CRO driven study. Sometimes you do. But we work with companies to understand the path to more clinical validation that will drive adoption. If you drive adoption, and you do clinical validation, you also need to work on the reimbursement side, right? There light bulb moments, right. So you get FDA approval. Great. What's next? You got a cat three? Fantastic, how the hell are you going to get that reimbursed? Right. So that clinical validation, I cannot emphasize that enough. So when we put together a syndicate of 20,000,025 30 million, we we Vin, the cost of working with a Priya working with with these types of groups to drive adoption, drive reimbursement, successful reimbursement. And if you do this, let me throw another thing in there, right. If you do get reimbursement where you're supposed to get it, it means that you will be able to sell your product without eroding your ASP, right? And when you're going to talk to your your strategic buyers at the end of that three, four year journey. And they're going to take a look at that. And they're going to say okay, your ASP is at that level, which drives your gross margins, but it also drives them from a creative perspective, right? You're going to be a winner. If you if you don't think about that ahead of time, and you start having to do bulk deals, where your ASP erodes by 30 by 50 by 60%. To drive revenues and because you're a little desperate to get revenues and show investors you are selling this right. That's going to come back and bite you. You know where? Okay,

Tonya Dowd  9:45  
excellent, excellent. Amen. I will say I completely agree with you. Evidence and evidence generation strategy that's end to end is critical. FDA wants to know is the device safe and Effective, the payers and the health care provider community facilities want to know, how does the device impact clinical outcomes?

Luc Marengere  10:08  
So so the adopters want to want to have that answer. The reimbursement the third party payers convinced me of the economic value proposition.

Tonya Dowd  10:20  
So how do you how do you balance? And by the way, it's been stated several times that reimbursement is the new regulatory. How do you interpret that statement? And Cody's maybe not matter not agreeing with that statement? i It wasn't it didn't come from me, by the way, but but I like it.

Cody Simmons  10:40  
I certainly hope not.

Tonya Dowd  10:42  
But I will say that it is a balance because you want to get a quicker path to market, you want to do a 510 K Street 510 K with a predicate. But then you've got to still develop that evidence to really appease the other stakeholders. How do you how do you? How do you interpret that statement? And do you agree and how do you balance?

Pierre Lemire  11:01  
Well, they're definitely two different things, even though they're they're interrelated. Because you can't really move on to those clinical studies without having the FDA, you might get dispensation in some cases. But in most cases, the FDA wants you clinicians, you want you to get the FDA so that safety there is taken care of, and the liabilities are taken care of, then you can move on to those clinical studies that are critical for all the things that Luke just mentioned. So they're not the new FDA. They're in addition to the FDA. Yeah.

Cody Simmons  11:40  
I was just reflecting on you know, we've conducted 13 clinical studies, we submitted 620 5 million r&d budget over seven years. So I'm like, Man, I hope, I hope, I hope it's not harder for but, ya know, it's we have a couple of real world evidence studies planned and oh, yeah, the other piece I thought of was just likelihood of success with achieving the FDA. As many of you know, de novo is and we didn't even know where to note we submitted a de novo. And they're like, Okay, accept it for substantive review. By the way, you might be a PMA, we'll let you know, in a couple of months, when we give you a deficiency letter, which our Lord never seen in the decade she's been doing this. And And anyway, for de novo generally, there's about a 50% clearance rate of those submissions accepted for substantive review our divisions 12%. And so when I was when you said that I'm like, thinking of the cost, the timeline and the likelihood of success. You know, I think we've gotten providers on what, you know, larger idea and providers on board already. So I hope that more traditional payers, at least some progressive ones can be pretty quick, too. But cracking the blues and CMS, I know can be can be tough.

Pierre Lemire  12:57  
Tell me a little bit more about the difference between the two. So obviously, everyone's really clear on the FDA and the submit for a 510 K or to novo, when it comes to reimbursement you first, if you have to get your own code, the first thing you deal with is the AMA. And it may has three meetings a year you have to attend, submit your application to them. And if you're lucky, you get accepted to one of our meetings. If you have enough support from from the different societies, then you'll get a category three code. And then Wow, you're really screaming. And then the next thing is to get payment on that category three code. And that's where that's the tough road. It's a journey. That's the journey. And that's where it's way different. The FDA path is easy compared to that. Because if CMS doesn't give you a guidance on payment for that code, what they'll say is, it's up to the max. Okay, so now you're you're battling with each Mac who has the authority to set their own policies on that code. And Noridian it's a no payment, no payment.

Cody Simmons  14:11  
And I'll just chime in that. And that's if your customers even know what a cat three code is. A lot of the primary care physicians were dealing with, like, what's a T code? What's a cat three code? What do you like, you know, they're not used to new novel procedures and devices like specialist star, right. So that's part of what kind of turned us off. You know, we could have got to get through code easily in recent years, but like, let's see how things go just billing under e&m Because that's what PCPs are used to right stethoscope so to scrubs, like they don't have their own distinct procedure code.

Pierre Lemire  14:47  
So we finished the journey, you need to get five key published papers that you then come to the committee again to get your category one. Oh, but you also need usage and so sidey support and society support and if you don't have a PIN code, that clinicians don't want to use it because it affects their cash flow. And I'll tell you all about that later. So it is a journey, way different than the FDA. No,

Tonya Dowd  15:16  
no, it is. And I think that's absolutely right. It's, it's, it's, it's the, the FDA approval or clearance is the start of the marathon, right? So you better have trained prior, so you're ready for and you have the stamina to go through the iterative process of establishing, I would say, commercialization and market adoption, it could mean that it's a new reimbursement pathway, but it might not, it might not be, but you still have to generate the evidence to show the clinical and economic value. So I completely agree, and it's it's very political, the AMA process is extremely political. And

Pierre Lemire  15:52  
there are a lot of healthcare great healthcare companies in the health care graveyard who didn't have the cash and investment support to get through that process. So they died on the vine, great products died on the vine.

Tonya Dowd  16:05  
Well, there are a lot of great products that have died on the vine, because they haven't thought about the reimbursement piece or the commercialization plan or the business plan. What is the business model? And how am I going to get paid and who is going to use it and who's, who's going to pay for it?

Speaker 1  16:18  
You can't start too early, right? I mean, this is if you're pre FDA, you got to get the right team in place. I mean, you guys articulate all these different work streams, I mean, the Gantt chart, I'm picturing the Gantt chart in my mind. And the players, and who's going to do it, who's going to review it, who's the accountability and who's been through it before. So UK got a plan, practice early. And if you're going to run that marathon, you can't just strap on a pair of shoes, your converse, you got to have trainers and nutrition and you got to run eight miles and 10 miles and you got to have some training partners all the other things. I

Cody Simmons  16:51  
will just jump in I'd say more an Iron Man than a I'm thinking they're metaphors for like the swim is product development. The run is a is the kind of cleaner I get into the FCA. And then And then oh, now you have a marathon to run. That's the reimbursement. Yeah. So if you just keep

Pierre Lemire  17:12  
moving, keep moving the end. Oh,

Cody Simmons  17:13  
yeah, by the way, it was a half Ironman, nevermind. Mid mid race? Yeah. Still not enough. I think that's a anyway. Yeah. Good metaphor. I tried to build on it a bit.

Tonya Dowd  17:23  
No, no, that's, that's great. We're, I know, we've touched on reimbursement a lot. But what are some other other items that are that are really imperative to plan for that commercialization? QMs, systems? Staff, you know, fractional management teams, when do you move from a kind of an r&d phase in a team to a real commercial commercial? Team? Yeah.

Speaker 1  17:47  
That went up real quick. So yeah, I mean, that's, that's our main offering is companies that key inflection points, right? Because you have absolutely, you're shifting from an r&d focus to commercialization focus. I've done a whole bunch of IPOs, the same deal. It's like private to public company, completely different culture, there's a whole bunch of different processes, but it's kind of the same team, right? Ish, right? So we want to make sure that, again, you're, as you lay off this iron man that you said, okay, yeah, I'm gonna start to do all this, and I gotta get on a bike. And I haven't, I'm good at swimming, but I'm not going to bike riding. So let's bring in somebody who's an expert at the bike riding. And let's make sure that you're you're planning to run this thing successfully, because you definitely don't want to run the race or do all this unprepared. Right? So again, we just dropping people been there done that help you guys out, kind of back off, and then see how it how it moves along.

Luc Marengere  18:41  
And maybe I can add to that. So So again, when we when we think of these companies, and we do we do go forensic. I think that'd be the right expression. We go forensic on the due diligence on anything that is manufacturing, right? Pre COVID. No one really thought of really double checking supply chains, that that has now taught us that you better be on the supply chain thing, right? A general comment is that when you when you do transition, from swimming, to running, and so on, there's also a culture change that needs to happen in that company. It's not just Yes, we're approved. Yes, we're trying to sell but as soon as you start to manufacture, right, that means you need now to have a quality mindset, right? You need to have a quality engineer you have you have to have the quality guy report to the CEO and not report to the guy who runs the r&d. So that quality shift is very, very important as well. And this is where a lot of companies break their necks. This is when we're a number of companies that trip and fall off the vine or die on the vine right and they commit the the cardinal sin, right? There are two cardinal sins that that we've we've seen, right? They, they, they get approved, and they go commercial too quickly. And then they seed the market that they seek to deserve right to serve. And then they have to pull the product back. Because there's a deficiency, right? That's a great way to kill your company, right. And then the other great way to kill the company is you are ramping up on your manufacturing, unique to think about automation. By the way, thinking about automation is a two year process. One year you hire the consultants and you think about what you need for automation, you set up a plan to effectuate the automation, year two is implementation. Right? So for most manufacturing lines, when you're thinking about automation, it's a two year process, right? So where I've seen companies get into trouble is they signed contracts, and they can't supply. Right? And when you let people down, right, then they go to the competitors. And let me add a tidbit of even more poisonous information. The ultimate ultimate cardinal sin is that they sign a contract with a, say a premier, for example, okay, one of these very, very large groups. And they don't really pay attention to the fact that the bat contract will read that if you don't, if you falter on your supply, that group can now go and buy from the competitor. And if the competitor is more expensive than you, you're on the hook for the Delta. That's a phenomenal way to kill your company. That is the Krakatoa of cardinal sins. Okay. And we've we've we've seen this. So obviously, obviously, when we invest in companies, we make sure that they're not going to go and do these kinds of things, but not to be under under thought, all of these all of these points. Is that very common. Thank God, it's not it's not that that last bit is not. But but having companies go and rush to the market and have to pull the product back. That is unfortunately a little too common. Right? A little too common for sure.

Cody Simmons  22:25  
I'll say, and we had real board debate about this. It's probably one of the only few things in the last several years that we did have kind of pretty significant disagreement on was whether to do anything commercially internationally. Because we're we knew we'd be a de novo PMA here, but abroad or class one under MDD in Europe, and also Australia. And but a couple of board members felt strongly you under resource, it was an early product with our you know, small batch manufacturer like stuff could go wrong, and it shoot you in the foot for raising money and for you No. And but me and another our largest investor felt really strongly that we're gonna get a lot of learnings about the product. And I'll say I didn't think through so much. What you just touched on is that also you get a lot of learnings just logistically and operationally, of being able to provide product supplier that works. And, you know, fulfillment and just kind of getting payment. A lot of those ironed out and I think yeah, we I mean, first of all product may not have been cleared because of the different products if we didn't do that. And second of all, yeah, we learned a lot from our Australian efforts, which did have a lot of the challenges and setback mainly due to manufacturing supply. So we fix it, we spent $100,000. Switching into manufacture we fix that we change the product. So in retrospect, definitely glad we kind of did the dry run, the Australia team calls themselves the company's guinea pigs. Yeah, if we don't, if we did not do that a we would perhaps not be cleared. Even if we weren't cleared to be a product that I know customers wouldn't like as much and potentially run into many of those serious operational issues. I mean, we may still have some but there would certainly be more relatively than whatever we will experience in coming months.

Pierre Lemire  24:18  
Maybe Twitch a little bit when I think about our FDA experiences, but there's a few things that I have the right to comment on. One is definitely invest in a QMS we we started with a paper QMS because who wants to pay the fees for a system when you only have a few dollars to spend, but we get killed in the audits. Those audits come way too fast. And they affect your business when you're not ready for them. And so to have a QMS where all your training records are clearly shown or you can show those to auditor that that's invaluable. invaluable. The FDA has a new program to get your Your products approved, where you can use a third party reviewer now instead of the FDA, and we've just went through it actually was pretty good. We couple of months to get them to review and very fast feedback. And now the FDA has 30 days to review. So it's kind of streamlining things taking little bit of pressure from the FDA. They take the more complicated cases now. And the the easy 510 K ones a third party reviewer can do, and it's streamlining things.

Tonya Dowd  25:27  
And that's a new program, right new program, what is it called?

Pierre Lemire  25:31  
As a third party reviewer? If you just Google FDA, third party reviewer, you'll see it costs a little bit more money, but it's a little bit faster. For what step Did you say for when you submit your 510? K? Yeah. And it's just for 510 cases or from to gay. For all products, you need to check on it first. But but it's it's expediting things. Speaking

Tonya Dowd  25:52  
of fast, fast, what do you what is your bidding? But what has been your experience with breakthrough designation? And I guess, as an investor loop, do you see that as a big benefit from companies you might invest in?

Luc Marengere  26:05  
I mean, it's it's certainly not a negative. But but it's not. It's not as though Oh, you've got breakthrough designation? Okay, let me reach for the checkbook. I mean, it is a positive, I would, I would say it is. But at the end of the day, it's it's the data that will really drive that to the adopters, right? So the Texan designation itself, is is attractive. But then, you know, in God, we trust and everybody else, please show data. Like I like that statement.

Tonya Dowd  26:42  
And it is, well go ahead here.

Pierre Lemire  26:43  
I'd like to say that I have experienced with IT program, but we that both of the I think the FDA has won but also there is a program similar to that with the A with CMS, and we haven't been able to break through to heart, the SPRINT program. But we still have to go through the regular process.

Tonya Dowd  27:04  
Yeah, it seems breakthrough. What is the just what everybody wants to do now? So

Cody Simmons  27:09  
I, we had five free subs. One of them was after breakthrough designation, and then it goes maybe a month faster. I think it helps a little bit. But yeah, definitely helped me raise last financing, which mainly from like family offices, and folks are like, you know, like, Okay, you're cleared abroad. You don't have your pivotal study data yet. But you have FDA breakthrough or sanctions. I think some of them didn't know exactly what that meant. But so I think just kind of help from an optics standpoint, perhaps not with really sophisticated med tech folks. But I think the commercial broad FDA, formal FDA breakthrough status, they'll probably get FDA clearance. You know, you're

Luc Marengere  27:51  
right, with a comment from an optics perspective, it does help it makes it it makes a positive point.

Cody Simmons  27:59  
Yeah, I would agree. And with the T SAP program, who knows if that's actually going to come through, but the SAP program, that's why so many people suddenly flooded into it. But but but that's not even that's not it's not a fact and B five devices, you're like, okay, yes,

Tonya Dowd  28:14  
yeah, that's, I think there's a lot of confusion in the industry about tea set the biz em set previously. Now, it's tea set, trends, trends, transitional coverage for emerging technologies. And the promise there is CMS would cover the technology that has breakthrough for a period of four to five years, and also establish coding and payment mechanisms. But it's really, if you're familiar with coverage with evidence development, it's pretty much the same thing. And they, like you said, they're only taking five applicant. I'm

Cody Simmons  28:44  
on the ABA mode, like Subcommittee on that and don't get too excited about with all the restrictions that we submitted written commentary, and I'm going to supposed to be mid last year than late last year than earlier this year. And then, you know, it's the government and it's, you know, a tough the last I heard, realistically, it wasn't might not be till the end of this year, I guess whatever the bill is that it's part of I don't know, this House Bill. Yeah, exactly. There's a lot of

Tonya Dowd  29:13  
uncertainty, but we do I hear a lot of better than nothing. I do hear from a lot of clients that that's their reimbursement strategy, which that's not a strategy. I think everybody would agree with that. Right? Hopes, not a strategy upside of strategy. Exactly. We are running out of time quickly, I'm going to ask each of you to just give us some advice. One thing that you've learned that's really maybe scarred you or is that a best practice that you could share with the audience? Yeah, I

Speaker 1  29:45  
think the you know, I've seen a client that commercialization and they went to go ship a product and it wasn't sitting in the inventory location that it was supposed to be at. So your revenue generating your shipping product and he didn't worry, darn product was. So that error started. Months and months and months ago, you just have to prepare, you have to get your people processes and systems in place to get ready for primetime and you can't start too early. And, you know, again, fractional is great. But whether it's full time or fractional, you can't start too early for this roadmap, because there's a lot of we talked about all the moving pieces. And that's a pretty cardinal sin, if you're about to ship revenue, deliver product, and you can't even find it.

Pierre Lemire  30:33  
My mind's racing, all the different things that we've gone through. But I think the probably the most important thing is to be as prepared as you can. And know that there are strategies. So you don't always have for every iteration of your product, you don't need to submit a 510 K, you can do an internal filing for small changes. And so knowing when you're going to do a bigger change that where you have to go through that process, and when you can do minor changes, so that you can still keep up with customer requests that are gonna keep your, your product moving, I think is important. And as an example, cybersecurity seems to be really high on the FTAs list right now. And man is it, it's deep, and it's it was deeper than I expected. And so we had to best in consultants to make sure we're clear on what the guidance actually meant. It's, it's drinking time. And so and on this topic. So I think that's the big thing is you just never know what's coming in the guidances do keep changing from the FDA. So you need someone who can stay on top of that, and look at how that's going to potentially affect your roadmap.

Cody Simmons  31:44  
I won't give advice on the commercial side, because we're just a few weeks in so don't are we Am I good? are we successful that I don't know yet. But I do know we're one of the 12% I got FDA cleared in kind of the first category. So my having just gone through that, too. Just very tactical pieces of advice. One is keep the same couple point people biostats CLIN rug on the submission basically from when you're writing this Yes, ours all the way through clearance just for that consistency and attention to detail and and the other one is be ready for at least maybe maybe it won't be as relevant for subsequent products. But as the first product in that category, there are major last minute changes, like literally in the last two or three hours to the labeling. And I really wish I'd had like a one hour call with some of our, you know, reimbursement, a couple of medical advisors to think through, okay, if the door opens to change x, what are a couple options? What do we prefer and why we choose I just had to make a decision in like 20 minutes, I call like five people to have them picked up on whether are labeled the primary care physicians or physicians who are not dermatologist. I ended up opting for the 1 million physician tam versa 300,000 Just but some terms like Well, wait, why is it not for us right time will tell if that was the right call? We could have had a lot of robust thinking and planning around that and a dozen other things. So that I was frustrated by didn't plan, it would have been very easy to think through some of those alternatives beforehand. And we never thought the door would open on something so big as that. But it did so. Right.

Luc Marengere  33:32  
I mean, advice wise. I think you just got some very good advice from the three co panelists here. Start your conversations early, with with investors, as well as service providers, ask investors who do they like to work with? Who do they bring to the table when they do due diligence? Very quickly. Our approach is we do due diligence, very systematic fashion. And the consultants that we bring on with whom we've worked for, in some cases, decades. Then they become the consultant that that helps the company on a going forward basis, whether it's on manufacturing or registration, regulatory, or reimbursement, right or clinical as well. So even though we're not invested in your company, there you know do come in and approach us approach approach other investors and say, look when you guys make an investment, who do you like to work with?

Tonya Dowd  34:34  
So the message is clear. Start the Iron Man early. Start training, start tread start training for the Iron Man early. Exactly. Thank you, everyone for sticking with us this afternoon. Please go enjoy. Thank you, panelists. Thank you

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