Episode’s transcript

Julio Martinez: 0:04

Welcome to the loud time MedTech leaders podcast. This is a weekly conversation with med tech leaders who have succeeded in Latin America. Today our guest is dr Leishman at Gluck. Looked her act rock is a Harvard train heart surgeon and entrepreneur. He is the chairman and CEO of[inaudible], a multi-product medical device company which he co founded in 2014 basically when our portfolio or five of his own inventions, he previously co founded pavilion holdings group, a holding company that created for medical device companies including venture backed vortex medical which developed and commercialized. He's lifesaving in Beijing AngioVac which was sold in 2012 to angio dynamics. Well, the Shannon, very mindful of your time. Uh, first of all I like to say that I'm very honored to be on the phone with you and the reason I reached out to you initially was about my topic on the E U M D R and I know[inaudible] is involved in commercialization of medical technologies and then wanting to explore or how involved you are in Europe, how the E U MBR. There's going to come into effect in 2020, it's going to affect your business and how you see Latin America market to commercialize medical technologies in general.

Dr. Lishan Aklog: 1:34

Yeah, the landscape is clearly changing. Uh, prior to 10 years ago when myself and my partner Brian DeGuzman and my vice chairman, Mike Glennon, formed our current enterprise of doctor to Guzman. I haven't been very involved with a medical device companies both large and small and, and helping bring products to market and the second technology and so forth. Right. And because I've been at this for a long time and, uh, the landscape is clearly changing. I think historically, uh, given the differences between the regulatory hurdles, uh, for, uh, medical devices in Europe versus the United States and the market sizes of those being heavily dominated the world market being heavily dominated by those two entities. The standard practice was to, in many situations, I wouldn't say all, but in many circumstances, especially for products that required PMAs and required clinical trials, of course, to go to Europe first, very much embedded in sort of the standard script of medical device, uh, commercialization. Um, let's continue. Mark, let's go to Europe. It may be a little bit challenging after you've got regulations to get commercialization as it's country by country, but at least you get a foothold and to launch and either generate revenue to support the company, other endeavors in the U S or she had to generate patients, generate a clinical evidence for use in us regulatory. I think the things that have been that have led to the evolution and the towards the current landscape, which is much more broader and its view of the entire world as a market, um, is that one is that the market opportunity has clearly expanded beyond just the U S and Europe and the growth of the economies. And therefore the growth of the development of economies around the world has led to that being a significant portion of the market opportunity in Asia, Latin America and you know, and hopefully increasingly African and middle East as well. So that's, I think one factor that's just macro economic factor, that there's a reason to be involved in Latin America and Asia, which is bad. Those will ultimately be important markets. And I worked for companies, been involved in an advisory capacity for companies that have had significant, a reasonable portion of their business in Latin America. And so I went to Argentina at one point. I was really for a training course in the symposium on behalf of a, an orthopedic company that, that had some cardio thoracic, um, products. So one is the market opportunity, but now as you sort of enter that as to the regulatory hurdles in Europe appear to be increasing and perhaps increasing quite significantly, that further expands the opportunity for, you know, countries in Latin America and elsewhere to be more directly involved in the, um, not just the early innovations and through testing for first the human, but even you even further beyond. So I think that's clearly the direction things are heading. You know, we of course prior to now, you know there were companies, but I think the most typical example that I'm aware of, it may not be limited to this Paraguay where companies will go to Paraguay to do a few cases to say, okay, we got a few cases on dried dog, but it was really just limited to that. Right? It wasn't

Speaker 3: 4:53

dr[inaudible] we know him.

Dr. Lishan Aklog: 4:56

It wasn't really going beyond that. But I think now the opportunity for the experiences, clinical experiences to go much farther than that and to really go much, much further than just a couple of personal human cases. I think it's quite there. I mean the MDR, we have a diagnostic device that we're looking at both MDM beyond the IVR activities in Europe are both a bit daunting for companies, especially small companies like ours who would, who have incorporated a Europe strategy within our broader laboratory and commercial strategy. And also as we discovered, we've been quite active since are the founding and the Adam ed organization here in the U S and instead have been keeping tabs on where on where things are headed. And you know, one of the challenges is a lot of the uncertainty as to why things are going. So you kind of plan the strategy. Okay we'll go off the Medford, see Mark on this particular date and we have three products that have projected T Mark's admission for this year. But you know, there's a lot of uncertainty as to the rules and regulations that we're aware of with MDR are going to truly be helping folks complete turnout and also whether they can even be executed in their current form. Just on the practical logistical point of view. So all of those are definitely significant challenges for a company of our size and looking to commercialize multiple products. And so the emergence of a country like Colombia and others in this space is really of great interest to us.

Julio Martinez: 6:26

Fantastic lesion.

Dr. Lishan Aklog: 6:27

And I'm not just trying to feed you what you want to hear. I mean all of that is real. I got, you know, we, we are, you know, the reason why our conversations with your group have been really interesting is because, you know, I think the fact of the matter is human beings are human beings. Yes. You have, you know, there are some, let me just say some of the things that we have to work through and are going to be relevant and um, and into yeah. For this expansion that you're working on to really be consummated are of course when it comes to regulatory data, they, you know, companies in the U S that are looking to get regulatory data outside of the U S are dependent on obviously dependent on them, cognizant of the fact that FDA will demand that any data that you present, you know, that they're open to look continue F O U S data that'd be comparable, you know, so that both in terms of the quality of the health care that's being provided as well as the patient population. So to the extent to which again, as countries develop their economies, everybody, you know, sort of comes through similar disease processes kicking in. Right. So, so that'd be developed. They get, you know, eat less from diets and they never become sort of a standard of homogenizing

Julio Martinez: 7:49

one of westernized. Yeah. More Americanized.

Dr. Lishan Aklog: 7:53

But that's going to be critical, right. For that data to be useful. We just went through this, uh, with'em a N O U S study I think you might be aware of with one of our other products that we're going to be launching a study in the upcoming week in New Zealand and we have to go through the format. We have to go through the formal steps of, of explaining to the FDA and providing data to the FDA that, that the patient population and the health care, um, uh, politically mechanisms that we would be tapping into are analogous, similar enough to be racking up the data that we generate is the data that we generate is generalizable to the us population. That's never gonna go away. You're gonna have to work, always going to have to prove that if it's going to be beyond just a couple of person human cases from the company knows that technology basically the one that's going to be important. I'm sure you know that. I'm not telling you you don't know, but that's obviously a critical part of the fantastic,

Julio Martinez: 8:47

excellent.[inaudible]. Um, I, I can't thank you enough. I mean it's been a great um, call I think. Uh, we got to know each other. We have some people in common, we talked about Latin America as a potential person, human this nation, Columbia as one of the top places for that.

Dr. Lishan Aklog: 9:08

Let me ask you something beyond that, I don't know if you've talked to Sean about this, but do you directly participate in or do you have partners that you work with on the commercial side? So that just seems like if you're going to do clinical cases, any particular country and go through the regulatory hurdles of, you know, the important licenses and all that, even as the market opportunity is not massive, it's still worth taking the next step and getting local clearance and being able to commercialize them. So have you talked to Sean about identifying potential distributing distribution partners and so forth and is that something that you,

Julio Martinez: 9:40

we haven't but the dust actually something that we do, that's one of our services. We have a market access services. Yeah. Market[inaudible] to find the distributors putting together a market actors expand that has, you know, man, uh, has the Mandarin aeration on top of, I mean distribution on the Peters.

Dr. Lishan Aklog: 10:00

Given that, do you, do you do with that, do you do sort of some market because obviously the decision about how hard to push on that is going to be a function of, we get called a lot from distributors all over the place. All over the world. Right. I'm sure I am Brazil and wants to to Carfax. I've got a guy that only wants this stuff. I in Japan once it's all this, you know, and we're a small company so we have a limited bandwidth in terms of being able to target individual country markets one at a time. So obviously an important element of that would be some type of initial analysis that says, look, if you were to bring product X into our, into, into Columbia, then it would be, you know, there would be a, you know, this is what the commercial regulatory hurdles would be. This is what the, you know, these are the lead institutions that you might be working with the distributor that works at B and really end here at the bottom line, short term market opportunity because that's what it would have to be because we would be generating resources and you know, it'd be nice to get it, we'll be using your resources and it would be nice to know sort of very early on in that process. So then what are the prospects for some, you know, for some meaningful commercial, um, opportunity in the short term.

Julio Martinez: 11:09

Sure. That's exactly what we'd definitely,

Dr. Lishan Aklog: 11:13

perfect. Okay. Then we should do that. So yeah, just tell Charlotte I told you to have the mic.

Julio Martinez: 11:19

Absolutely. I'll send him a text about that then that will get the computation we started in that, in that the average. Okay. All right. Good talking to you. I look forward to meeting in person. Thank you. Likewise. Bye. Bye.