Nov. 10, 2022

James Reinstein, President & Chief Executive Officer at Conformal Medical

Show Notes
Transcript

James has more than 25 years of medical device experience and is currently the CEO of Conformal Medical. Prior to joining Conformal, he led Saranas and private companies such as Drawbridge Health, and Aptus Endosystems as their President, CEO, and member of the board of directors. He held a similar role at the publicly traded medical laser company, Cutera from 2017 to 2019. He was part of the management team that led the turn-around at Cyberonics where he was the EVP & Chief Commercial Officer. James spent 17 years at Boston Scientific in various roles and functions including business development, marketing, and general management. Most of his career at Boston Scientific was spent working and living in Europe, Asia, and Latin America. Additionally, Mr. Reinstein has served as a board director for several medical companies, including publicly traded Mainstay Medical in Dublin, Ireland, Pixium-Vision based in Paris, France, and Monteris Medical a privately held company located in Minnesota. James began his professional career with Proctor & Gamble after earning his Bachelor of Arts in Marketing (BA) degree from the Terry College of Business at the University of Georgia in Athens. He also completed graduate studies at INSEAD in Fontainebleau, France.

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Welcome to the Latin MedTech Leaders podcast, a conversation with me, Tech leaders who have succeeded or plan to succeed in Latin America.

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Welcome to the Latin Metech Leaders podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America.

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Today our guest is James Weinstein, CEO Crans.

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Hey, James, great to have you here today in the show.

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Thank you for

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Joining us.

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Hey, thanks, William.

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Great to be with you.

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Awesome, James.

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So tell us about you a little bit, James.

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Uh, so long time, uh, med tech, uh, med device person.

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I, uh, spent a number of years, almost 20 years at Boston Scientific, working, living in, uh, multiple countries, multiple regions throughout the world.

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Uh, started in a sales position with a division called Meditech.

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We didn't even know Boston Scientific was the name of the parent, but, uh, so basically Meditech was their Peripheralvascular division, So balloons.

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Um, then I moved into a BD role and actually got the company, the corporation involved in interventional oncology, uh, started that, that, uh, division basically within Boston Scientific.

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They eventually sold it.

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Um, but I was, uh, um, then tapped.

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We emerged with Sied Life Systems and Sied had a very significant, uh, portion of their revenue and, and business were done in, in international markets.

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And Boston Scientific Legacy, Boston didn't really have anything going on.

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So Jim Corbit was leading, uh, international at the time, and, and he started tapping into the divisions and saying, Okay, who is willing and able to take on an expat assignment?

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Um, I had always had an interest and, and raised my hand.

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Um, my interest stems from my father-in-law who ran, uh, uh, Kodak, South America, lived in sa Paul and Brazil for, for 10 years.

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And, uh, so did a lot of visiting there.

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And, uh, and I thought, Wow, this, this expat, uh, role could be pretty interesting.

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But, but more importantly, I thought, if I'm ever gonna lead a global med device company, you, you gotta have that on the ground experience.

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Uh, so had to convince my wife to move to Paris, which is where the European headquarters was, um, and was there for five years.

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And during those five years, we acquired about 15 companies.

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Oh my God.

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I mean, amazing.

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And, uh, I integrated about half of them into the various divisions of Boston Scientific, at least the European organizations, um, which was a great learning experience, uh, very interesting.

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And, and the whole concept of integrating the last company that I was involved in was target therapeutics and neurovascular companies.

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So did that integration was very successful, at least from Europe.

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And Europe was about 70% of the revenue of target therapeutics.

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So it was, it was a critical, uh, integration for, for the corporation that had just spent a billion dollars on them.

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Um, and so that's what, um, uh, started this whole travel through the expat, uh, life.

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And, uh, then I, I did return to Boston.

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I was in a meeting and I was, I was in a, a role where you, um, uh, we were sort of regional support for marketing, so we were called the Intercontinental, some people call it emerging markets.

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And I ran the marketing for the two divisions, Peripheralvascular, and I was in a quarterly business review with Juan Zeke, who is the VP of, of Latin America for Boston Scientific.

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And he was lamenting the woes of the situation he had in Mexico.

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And, um, I was saying, Well, have you thought about this?

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Or did you think about this?

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And at a certain point, he just kinda get fed up with the, the, you know, the kid in the corner kept asking these questions and he goes, Well, well, why don't you do it?

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And I looked over at Jeff Goodman and Dan Moore, who are the heading international or intercontinental emerging markets at the, and I kind of shrug my shoulders,.

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I'm like, Wow, I guess I could.

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And, uh, two weeks later my wife and I were house hunting in Mexico City,, and uh, she was seven months pregnant with our second child,, and we were there before she had the, we, we had our second child in, in Mexico City.

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Oh, nice.

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.

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We have a, uh, I dunno if this is, is probably a terrible thing to say, but we have a chia me do.

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.

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I love it.

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Yeah.

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Yeah.

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So, uh, um, we actually loved it so much.

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We, we had a second child in Mexico City, so I have Dolans

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Oh my God.

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So they have dual citizenship now.

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Yeah, yeah.

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We've kept up their passports.

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They're now, I mean, they're now, uh, 20 and 18, but, uh, yeah, beautiful.

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Good for them.

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Yeah,

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Yeah, yeah.

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Yeah.

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And that was, I mean, that was, uh, just one heck of an experience.

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Uh, it was my first sort of general management experience.

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So the way we ran countries back then would be, um, you know, all functions were autonomous in, in the country.

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We had a regulatory, we had a finance department, and once a quarter my boss would come to town with his team, and it was kinda like a board meeting.

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Uh, so it was, uh, it was, it was very interesting.

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And, um, a lot of, you know, dynamic, uh, business opportunities there.

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I just, just had a blast.

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Five years.

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We, we spent, um, and, uh, you know, we had had just a great time and, and, um, that allowed, or that that success led to an offer for me to go run, um, a region in Asia.

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So I basically, instead of running a country, I ran sort of the area, um, of, uh, Hong Kong, Taiwan, and Korea.

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And because Korea was the largest and most dysfunctional of, of this, of these countries, um, it was, uh, that's where I lived.

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We lived in Seoul, Korea for, for three years.

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Um, and I was on my way to come back and report to Jim Tobin, the CEO of Boston Scientific at the time.

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Um, but in the interim, I had a call from a guy, uh, Dan Moore, who I'd worked for on and off over the years at Boston.

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He had just, just become the CEO of Cyberonics, so a neurostim company based in Houston.

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And, um, that was, uh, you know, it was, it was one where I actually called Tobin and I said, Look, I'm not gonna come, I'm not coming, but I'm gonna go down to to Houston.

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Boston Scientific owned 20% of the, of the equity.

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I was a publicly traded company.

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And, uh, Jim said, Well, you realize that's not a turnaround.

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I know you're a turnaround guy, but you know, that's a reclamation.

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And I said, Yeah, I know I got a pretty good, uh, you know, Dan being the honest guy that he is, I said, I got a pretty good idea what we're facing.

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And it was, it was an interesting, I mean, they, they had about a hundred million in revenue with a good margin, you know, probably solid 70% gross margin, but, uh, had lost 60,000,002 years in a row.

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So they were good at, um, so we came in and basically, you know, we had to, they had, they had a significant number of people on the team, and we, yeah, I was Chief Commercial Officer.

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I think I had an organization of about 300 people.

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Um, I took it down to 80 and grew revenue, 18%.

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Sure.

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Yeah.

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Streamlined the operation.

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Well, I mean, you had five different customer facing groups.

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None of them, not a single one of them was in charge or responsible for bringing revenue.

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And it was, you know, so when, I mean, so whenever, you know, something went wrong, it was like, Oh, you know, it's this.

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Yeah, exactly.

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Everybody blamed each other.

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Yeah, yeah.

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So it was like, okay, well this is, um, you know, we weren't splitting Adams.

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I mean, it didn't have to be that smart, but it was just really good business acumen and putting in place the right people, getting the right people on the bus, maybe getting rid of a couple buses,.

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But, uh, yeah.

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So, uh, I was there for, um, almost five years.

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Took the market cap up from about, it was about 400 million when I got there, and over 2 billion when I left.

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Oh my God, James, that's was a great run.

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It was a great run.

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And, uh, the, Dan had signed a four year agreement, and he was, um, he was up coming up on that.

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And the, so the board did a process and they said, Yeah, Rheinstein, you're gonna replace him, but we're gonna try to keep him, and they succeeded.

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So, and I'm like, Well, you guys think I'm ready to, one of these things.

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I wanna run one, It's not gonna happen at this company.

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And at the time I'm in Houston, I said, Well, it's not gonna happen in Houston cuz there isn't a company.

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Uh, so that's when I, I left, went out to the area and ran, uh, APPO Systems, did that for, for three years until Medtronic bought it.

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Um, and then, uh, have kind of been on the CEO run ever since.

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And, and, but what I, what Aptus was, was a, um, adjunctive, um, it was sort of the, the helical screw, uh, the, the endo anchor they called it, um, that was adjunctive to stent grafts for aaa.

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And when I looked at Crans, the company I'm running now, which is here in Houston, um, they finally, and I'm, I'm here operating into this incubator where you've got close to a hundred companies that are incubating in the, uh, they call the Texas Medical Center, the tmc.

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Oh,

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Yes.

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Yeah.

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I've about

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It just a really great, uh, um, you know, environment and, uh, a very positive, uh, place to work.

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Um, and so, but when I looked at Crans, I thought, Wow, okay, adjunctive technology, but it's not as expensive as the app's product was.

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It can be a join to multiple procedures, not just triple A, but, you know, the mechanical circuit sports tavr.

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And when we get our next generation product, then we're talking about peripheral vascular, neurovascular, all kinds of these vascular disease we're, we're bleeding complications do occur.

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Um, and, and what we've discovered or proven, uh, in a clinical study do a larger one is, is, is that if the care team either para procedurally or post procedurally is aware that there's a bleed beginning right now, they, they basically feel for it or look for the hematoma, and it's almost too late.

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You're heading into complication land by then.

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Um, our device lets, you know, when you've got about 50 cc of blood that's, um, you know, extra arterial in the tissue, uh, and then all the way up to 200, you're still less than half a half a unit of blood.

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So it's, it's phenomenal.

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Technology works extremely well, a hundred percent sensitivity and a very high specificity.

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So it's, um, really, really good technology.

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And we're just now funded and hiring the team, the sales team, we're gonna do a larger clinical study, uh, and it's, um, yeah, really excited about it.

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We, we just got funded, BA Venture partners led the round.

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Uh, so they, they've been, they'll be a great partner for us going forward.

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Excellent.

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James, I mean, quite a right, quite a journey.

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And you've had, uh, and it's the Latin American piece of it.

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Uh, so let's talk about Latin America in a little more details.

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Uh, James, um, what trends do you see happening in the world or in Latin America, political, economical, social, that are kinda beneficial to our discussion today or for the business of, uh, doing trials or selling devices in the region?

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Yeah, so I mean, there's, there's, I I would say definitely opportunities for, for the commercial.

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You know, there's commercial opportunities and finding the right partners.

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Um, you know, most companies like Crans would not be trying to outfit direct teams.

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So it's trying to find third party partners.

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Um, and that's, that's pretty much the norm.

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In the past, I've done some hybrid versions of that, uh, such as Cyberonics, where we had a, we had a small kind of tiger team on the ground that managed the distribution network.

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And I always thought that that was critically important because you need to have, uh, someone on your team that speaks the language, speaks the culture, and is, you know, um, you know, supporting the, the third parties or, or maybe a, you know, a boot in the tail of the third parties, which sometimes is necessary, but, you know, that's, uh, but it's really about training, support and, and getting, uh, getting, providing that to them in, in the best way possible.

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And you really need somebody on the ground to do that.

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I, I believe,

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Yeah, I agree with you.

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And I've seen that trend or, or that, um, structure happening, um, in the region a lot.

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And I, and I think that's, that's the ideal way to enter a new, a new market, Asia, Latin America, because, uh, the shooters come and go, but, uh, your people are advancing your agenda.

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They are helping you generate demand and supporting the work of the shooter, doing co-marketing activities, training the shooter and the new shooters, because they don't always stay with you for for as long as you want.

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So you always have to be looking for new shooters, new ways to, to expand the coverage in the country.

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So, for example, in Columbia, Mexico, such large countries, Brazil, you need a few distributors, I mean, more than one certainly to cover the whole country.

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So,

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Yeah, I mean, even in Mexico, when, when I went there with Boston, San Diego, we were predominantly direct, but we still had to distributor because the process to get into military hospitals or did the es, the Es really, really needed a third party to, to do that.

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Um, in, in most instances, most cases.

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So, um, but, uh, you know, smaller companies like I'm in now or even, you know, Cyberonics, we, we did that sort of hub and spoke, uh, approach.

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Uh, we had, we had a group in, in Sao Paulo, and then he had one or two of his, uh, marketing support people, uh, in, you know, I think one in Mexico, you know, the larger countries, uh, Brazil for sure.

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He was in, he was in Sao Paulo.

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So, yeah, so I see that, um, you know, the other area, and this is what we did when I was at Cyberonics, Mel Nova is, um, initiated manufacturing, uh, in, in Costa Rica.

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Um, you know, there's a, there's a whole, you know, center, Uh, you've got almost every large company there.

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Um, but you know, the one thing I did while I was at Boston Scientific, we had about five of these Maia dos, uh, you know, on the frontier in the, on the border border towns.

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Um, and, uh, I was the in-country representative.

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I really didn't have much to do with it and, uh, other than, you know, quarterly board meetings and, but I never had to physically go, which was interesting.

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But, uh, you know, that was, that was a great, uh, you know, opportunity for companies, uh, you know, obviously NAFTA driven at the time, but, um, uh, but, but, you know, putting the, we were deciding between Costa Rica and Ireland, uh, to put manufacturing and, and it really wasn't even close.

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I mean, I had worked very closely with Boston Scientifics Irish manufacturing in Galway, then we even opened up another one in Cork.

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But, um, it really was, it just made so much more sense, uh, for, for Costa Rica to be the, the destination for that manufacturing plant.

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Hmm.

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You know, Costa Rica is coming up a lot in colo because Columbia is now targeting near assuring, Right.

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You know, that term now where countries are, where the relationship between the United States and China, you know, has some tension.

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So, uh, companies are looking to nearshore their operations, and Columbia is going after that market.

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And, uh, recently the government just announced an initiative to bring pharmaceutical and medical device near assuring to Columbia.

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And they're looking at Costa Rica as one of the examples of a successful policy, state policy to attract near assuring.

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I mean, such a small country, All you hear is the jungle and, and the, the kids from high school going on vacations to Costa Rica.

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You never imagine that such a small country has such a strong manufacturing, medical device manufacturing industry.

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I'm very sophisticated, by the way, so

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Oh yeah, no, it's, uh, I mean, concerted effort on their part to develop it, I dunno when it was decades ago, maybe.

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But, uh, you know, you go to that region and you've got every, you know, Boston striker, every, every company, seemingly Abbot has a huge facility there.

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Um, and they have the infrastructure to support

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It.

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Exactly, exactly.

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So, uh, they're doing something right.

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And, and Columbia should get inspiration from, from there.

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That's certainly something that I, that I see happening in the near future.

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Uh, um, in terms of Columbia or other countries in Latin America.

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I, I think countries in Latin America, James, are maturing.

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They're realizing that exporting coffee and avocados, and in the case of Columbia cocaine and bad news, for Netflix, it's not gonna cut it.

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They need to diversify and get more, uh, complex in, in what they export, Right.

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Knowledge, Yes.

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What we need to export in the country.

00:17:24.130 --> 00:17:28.920
So, you know, Columbia keeps coming up for me as well for, um, doing clinical trials.

00:17:30.118 --> 00:17:30.608
Yeah.

00:17:31.089 --> 00:17:33.730
Uh, as, I guess a couple key centers there.

00:17:34.368 --> 00:17:42.490
Um, you know, we, we are gonna do a post market study, but, you know, just in, just in US centers, uh, for, for Crans.

00:17:42.490 --> 00:17:50.559
But I know that, uh, there's actually a company here called Presi, I believe they're doing, um, they did their initial first in man in

00:17:50.799 --> 00:17:50.799
Columbia.

00:17:51.279 --> 00:17:51.559
Excellent.

00:17:52.200 --> 00:17:53.680
I'm, I'm happy to to hear that.

00:17:53.681 --> 00:17:54.319
Very good.

00:17:54.320 --> 00:17:54.799
Very good.

00:17:55.309 --> 00:17:57.960
Yeah, James, uh, you're bringing up a good point.

00:17:58.190 --> 00:18:01.910
I, I think, um, I mean, this is what I do.

00:18:01.911 --> 00:18:09.390
I do clinical trials, early visibility, clinical trials, and we also help companies sell medical devices in Latin America.

00:18:09.890 --> 00:18:22.029
And I've seen the regulatory framework of pretty much all countries in Latin America, because a lot of my clients, uh, first come to me thinking about Brazil, or thinking about Argentina or thinking about Mexico.

00:18:22.720 --> 00:18:29.549
So I have to study the regulatory framework and their environment for clinical research, specifically early stage.

00:18:29.970 --> 00:18:33.549
And it's not that friendly, um, as compared to Columbia.

00:18:34.289 --> 00:18:36.630
And Columbia has some, some good advantages.

00:18:37.309 --> 00:18:46.069
Uh, and, and one of the, the advantages is the, not only Columbia lot, Latin America, um, but is the ease of patient recruitment.

00:18:46.070 --> 00:18:52.630
It's a lot easier to recruit patients because they have, they don't have as many options as patients have in the United States, Right?

00:18:52.630 --> 00:19:05.349
You have 20 other FDA approved options that may delay, or you can do pain management or something that can delay, uh, some, some more drastic intervention.

00:19:06.549 --> 00:19:16.430
Um, uh, you're not gonna subject in the United States yourself to a, an investigative, uh, device that has not been tested in humans.

00:19:17.269 --> 00:19:21.430
They just tested a device in a couple picks, and you wanna be the first one, right?

00:19:22.309 --> 00:19:23.190
At least out in the United States.

00:19:23.191 --> 00:19:27.990
Whereas in Latin America, unfortunately, patients have delayed access to medical innovations.

00:19:28.240 --> 00:19:40.029
So if you come with a, with a device, it can treat your chronic disease in 15, 20, 30 minutes, they will send out for it, I mean, immediately.

00:19:40.329 --> 00:19:41.950
And then you also trust the doctor.

00:19:41.951 --> 00:19:46.150
So if the doctor suggests that you get the trial, they will take the advice of the doctor.

00:19:46.240 --> 00:19:47.069
So that's one thing.

00:19:47.390 --> 00:19:50.920
And another thing is the, um, it's cost savings.

00:19:51.210 --> 00:20:01.259
In the case of colo, the Colombian peso James has become the third one of the, the top three most devalued currencies in the world.

00:20:02.700 --> 00:20:09.019
And, and so it's really a bargain to buy services from hospital in Colombia now, because is so cheap.

00:20:09.500 --> 00:20:09.500
.

00:20:10.430 --> 00:20:11.380
So, so yeah.

00:20:11.779 --> 00:20:14.339
So those are kind of the advantages of doing trials.

00:20:14.819 --> 00:20:16.099
Are they gonna move to Bitcoin?

00:20:16.101 --> 00:20:16.700
Like, uh,

00:20:19.089 --> 00:20:19.819
I don't think so.

00:20:21.339 --> 00:20:21.819
That's kinda a joke.

00:20:22.420 --> 00:20:22.420
,

00:20:24.089 --> 00:20:25.140
I dunno why they're doing that.

00:20:25.368 --> 00:20:30.259
I think they're seeking publicity or something, but, uh, but is interesting not trying something new.

00:20:30.260 --> 00:20:32.299
At least credit credit.

00:20:34.210 --> 00:20:42.890
Anyway, so, So James, um, what do you think about the e MDR about that trend happening in Europe and the relationship with Latin America?

00:20:42.891 --> 00:20:44.890
Do you think that will benefit the region, somehow

00:20:46.299 --> 00:20:48.599
Benefit, uh, Latin America or

00:20:49.079 --> 00:20:49.079
Eu?

00:20:49.089 --> 00:20:51.160
No, the, uh, Latin America, Yeah.

00:20:51.161 --> 00:20:55.319
More trials, more companies looking at Latin America to start their sales airports.

00:20:56.470 --> 00:21:04.160
Yeah, I mean, you could already see this trend between us, the fda, and notified bodies in Europe.

00:21:05.240 --> 00:21:09.599
Um, even leading up to, to mdr.

00:21:09.630 --> 00:21:14.279
I mean, it was the notified bodies, you know, I call them, they're like the airlines.

00:21:14.280 --> 00:21:16.920
They really don't care about you as a customer.

00:21:17.680 --> 00:21:20.118
Um, and they forget that that's actually the relationship.

00:21:21.160 --> 00:21:32.000
Um, you know, they just, and I've multiple companies that I was helping, uh, back when I was consulting, were just lamenting, oh, this, this notified body that notified body, and it's just amazing.

00:21:32.480 --> 00:21:33.839
And, you know, these are the smaller companies.

00:21:33.840 --> 00:21:36.200
They're not gonna get the Boston Scientific attention.

00:21:37.559 --> 00:21:50.960
Um, so it's, it's, uh, making what was already, uh, what I would consider a dubious opportunity to make money, um, commercially in Europe, uh, that much more difficult.

00:21:52.210 --> 00:22:09.170
Um, now the other side of the coin is, as a small company like Crans, you, we really need to have CE mark, um, if, if nothing else, not so much for the commercial benefit, but to be able to say to a potential acquire, you know, where you already have market access.

00:22:09.970 --> 00:22:23.890
Um, and, but, you know, having FDA is irrelevant to, to mdr, uh, fortunately or unfortunately, uh, but in some Latin American countries that it's the benefit that's kind of all you need.

00:22:24.450 --> 00:22:33.690
Um, but, uh, you know, it's, it's, it's no, you know, kind of layout in, in, as you know, in some countries it's, it's, it's great.

00:22:33.691 --> 00:22:39.049
I mean, it's easy access like Chile, but, uh, you know, Brazil was probably the other extreme.

00:22:39.050 --> 00:22:41.569
Maybe even Argentina now I think has gotten more difficult.

00:22:42.170 --> 00:22:45.970
Um, Mexico is making some effort there, from what I understand, and

00:22:46.170 --> 00:22:48.410
Still is a little convoluted.

00:22:48.839 --> 00:22:49.329
Yeah.

00:22:49.330 --> 00:22:49.769
Yeah.

00:22:49.880 --> 00:22:59.930
I mean, it's, it's, it's too bad that, you know, with FDA approval, which isn't, you know, as is isn't that easy, but actually compared to mdr, it is,

00:23:01.049 --> 00:23:01.650
It's the park

00:23:02.130 --> 00:23:02.130
.

00:23:02.970 --> 00:23:02.970
Yeah.

00:23:03.410 --> 00:23:03.410
Yeah.

00:23:03.411 --> 00:23:06.730
I mean, we were surrounds, our product was a de novo five, 10 K.

00:23:07.769 --> 00:23:10.809
Uh, we did a clinical study already for 60 patients.

00:23:11.599 --> 00:23:15.289
I guess it was post-market, um, but it wasn't required for, for approval.

00:23:16.549 --> 00:23:25.819
So, um, but you know, this is, this is a pretty arduous, uh, requirements, You know, the tech file is not necessarily the same tech file you're gonna give to the fda.

00:23:26.660 --> 00:23:40.059
Um, so, uh, I think it, it could create opportunity for, for Latin America, but, you know, here's the door, the door is open, are, are the government's gonna react and say, Okay, let's figure out a way, you know, least burdensome path, uh, approach.

00:23:41.009 --> 00:23:43.750
And if they do, then, then certainly opportunities will exist.

00:23:44.140 --> 00:23:44.630
Yeah.

00:23:45.250 --> 00:23:45.250
Yeah.

00:23:46.079 --> 00:23:52.049
I think, uh, going back to Columbia, Columbia is poised to benefit from it somehow.

00:23:52.890 --> 00:23:59.608
Um, cuz by the way, it has the fastest regulatory approval time for a clinical, uh, uh, trial.

00:24:00.769 --> 00:24:17.450
Uh, and also for a commercial device, if you already have the approval of a reference country, reference country being Canada, the United States, uh, Europe, Japan, and Australia, uh, getting envi a approval in Columbia is pretty straightforward by law.

00:24:17.990 --> 00:24:21.049
The agency has to reply in 90 days, and they do.

00:24:21.339 --> 00:24:28.170
So it is considered one of the, the concept with faster, with the fastest access to mm-hmm.

00:24:28.250 --> 00:24:28.690
to,

00:24:28.900 --> 00:24:33.250
So one of the questions we were talking earlier about, uh, distributors come and go, right?

00:24:34.099 --> 00:24:48.089
So in some countries the license is held by the third party, and some countries you can actually as a company, hold it yourself or appoint it to somebody who isn't the distributor that you need to, to change out.

00:24:48.090 --> 00:24:48.410
Yeah.

00:24:48.890 --> 00:24:55.690
Where, you know, for me, the ideal is company can hold it, but, uh, sometimes that's, most cases not the case.

00:24:56.170 --> 00:24:59.368
Where is it an opportunity to have it in a third party?

00:24:59.369 --> 00:25:03.569
So if you do change out, a distributor is not another period of time that you're out of the market.

00:25:04.079 --> 00:25:06.809
That's, that's a interesting comment that you're making here.

00:25:06.910 --> 00:25:19.529
And, and going back to Columbia, because is the only country in Latin America, James, by the way, that allows foreign entities to be the title holder of their registration.

00:25:19.670 --> 00:25:31.930
You don't have to rely on a local distributor or in a third party registration holder that is also a local company and pay like$300 every month or something like that for that privilege.

00:25:32.460 --> 00:25:39.849
So yeah, that's one of the benefits of Columbia without mentioning the, the fact that healthcare is a constitutional right.

00:25:39.851 --> 00:25:47.608
So you get reimbursement pretty much guarantee in the system, which is European style, kind of a universal coverage.

00:25:47.759 --> 00:25:55.380
Everything is covered kind of easy access to the system, uh, from the patient standpoint.

00:25:55.839 --> 00:26:04.700
And, and, uh, if they don't get you the device or the diapers that you need or the medicine that you need, you can go all the way up to Supreme Court and get you Right.

00:26:05.940 --> 00:26:07.940
Respected and, and, and, and they get, you.

00:26:08.259 --> 00:26:08.259
Are

00:26:08.380 --> 00:26:11.019
There a lot of, are there a lot of diaper cases heading to the Supreme Court?

00:26:11.339 --> 00:26:11.339
,

00:26:13.500 --> 00:26:17.259
There's a gay of a lady that, this is Al case, I'm not joking.

00:26:17.260 --> 00:26:24.299
There's a lady who went through a procedure, James and, uh, is a famous case in Columbia that ex exemplifies my, my point.

00:26:24.799 --> 00:26:34.618
And, uh, she couldn't go up to the second story in her house, so she needed an elevator, and she went all the way up to the Supreme Court to that elevator Wow.

00:26:35.019 --> 00:26:35.420
In her house.

00:26:36.059 --> 00:26:37.180
So, yeah, that's the way it's,

00:26:38.900 --> 00:26:39.500
Okay, interesting.

00:26:39.900 --> 00:26:39.900
Yeah.

00:26:40.259 --> 00:26:57.358
So anyway, but going back your point, it, it, that little things like that, like you as a foreign entity, being able to have total control over your registration is, is, is really, uh, an advantage that makes Columbia a very business friendly country.

00:26:57.858 --> 00:27:06.509
And, and, and, and colo with Mexico, with Chile and, and Costa Rica now are O E C D countries.

00:27:06.750 --> 00:27:10.470
So they're adopting work class policies to attract business.

00:27:11.039 --> 00:27:16.230
So Columbia is, is leading this in, in, in, uh, in the regulatory framework.

00:27:17.000 --> 00:27:19.630
So, so yeah, that, that helps a lot.

00:27:21.069 --> 00:27:25.430
So, so what are your plans with Sato, uh, James?

00:27:25.618 --> 00:27:29.670
I mean, how do you see Latin America playing a role in your company, your future?

00:27:32.089 --> 00:27:34.118
Do you have any markets in in mind?

00:27:34.140 --> 00:27:36.160
Any next steps in Latin American mind?

00:27:36.829 --> 00:27:54.160
Yeah, I mean, our initial focus certainly is, is getting us traction, uh, getting some, uh, getting this enrollment into our clinical trial, which will be a 260 patient, um, trial to demonstrate a reduction in, in bleed complications when our product is used versus not.

00:27:54.579 --> 00:27:58.160
And we'll compare that to, uh, existing published data that's out there.

00:27:58.799 --> 00:28:09.480
Um, with regards to, you know, commercialization would be, uh, you know, we're, we're hiring the team up here for, for us, but, but we'll also start looking to external markets.

00:28:09.900 --> 00:28:39.400
The company never did anything outside of us, don't we, You know, we're gonna start from ground zero with the CE mark, um, so we've got to go after, but, but what I am looking at is what can we do in, you know, countries like Latin America, even countries, you know, regions like Middle East, um, or countries in Latin America and Middle East, that, that have sort of the criteria that I want, um, which is, you know, what's the status of, of the license holder, call it that.

00:28:39.960 --> 00:28:43.319
Um, what's the, what's the, you know, size of market?

00:28:43.320 --> 00:28:55.960
There's, there's obviously the, the, you know, ability to sell into that market, public, private, uh, you know, what was the process, not just, not just for approval, but, but what's the, uh, financial side of the reimbursement,

00:28:56.640 --> 00:28:57.480
Uh, status and

00:28:57.599 --> 00:28:57.759
All that?

00:28:58.009 --> 00:29:01.920
So there's, there's kind of a extensive checklist that, that I operate off of.

00:29:01.930 --> 00:29:10.759
So, you know, but we probably won't start looking to, uh, Latin America until next year and more likely second half.

00:29:11.920 --> 00:29:19.599
Um, but, but at that time will be because ideally what I want is somebody dedicated inside Crans to manage that.

00:29:20.200 --> 00:29:23.000
Um, right now I'm the only, right now I'm the only one.

00:29:24.039 --> 00:29:28.599
And, uh, I'm, I'm not prioritizing, uh, you know, Latin America.

00:29:28.601 --> 00:29:35.400
However, um, you know, I, I do think the countries that you just listed earlier, you know, Mexico, Columbia,

00:29:35.759 --> 00:29:36.319
Chile,

00:29:37.079 --> 00:29:39.240
Chile, certainly mm-hmm.

00:29:39.319 --> 00:29:45.559
, and then if, if, uh, you know, Brazil's obviously a great and large market, great country.

00:29:46.319 --> 00:29:50.680
Uh, it's just a, it's a regulatory, uh, um, behemoth.

00:29:50.681 --> 00:29:54.200
So it's, it's, uh, pretty, pretty much a barrier.

00:29:55.000 --> 00:29:55.000
Yeah.

00:29:57.240 --> 00:29:57.680
Excellent, James.

00:29:58.289 --> 00:30:08.920
So it looks like that, like the America innovator, that's what I wanted to hear, and that's what I wanted listeners to, to, to hear directly from you that, uh, you certainly,

00:30:09.200 --> 00:30:32.400
And I definitely have a lot of, uh, a lot of friends, obviously, particularly in Mexico, but, uh, you know, having, uh, worked in, in the entire region and, uh, you know, reported to Argentina while I was in, uh, certainly have a lot of friends and, uh, and old colleagues that, that are, uh, in fact, I think a good, good friend, uh, Carlos Flores is in, uh, is in Columbia, or he, I mean, hes Columbia, I think he's got a business going in Columbia.

00:30:33.079 --> 00:30:36.730
So yeah, he reached out to me recently, so

00:30:37.569 --> 00:30:38.170
Excellent, excellent.

00:30:39.049 --> 00:30:43.170
And, and Juan, good friend too, too in Columbia.

00:30:43.299 --> 00:30:44.329
Oh yes, of course.

00:30:44.730 --> 00:30:44.769
.

00:30:47.410 --> 00:30:52.609
All right, James, it's being a, the delightful conversation and, uh, we're close to the end of the show.

00:30:53.809 --> 00:30:55.329
Uh, any final words of wisdom?

00:30:55.930 --> 00:31:06.049
Uh, what would you say to the CEO of, uh, newer medical device company that is just starting to look at Latin America as a place to do business trials or commercialization?

00:31:06.050 --> 00:31:08.930
What would be your, your final words to

00:31:08.930 --> 00:31:09.130
Him?

00:31:09.849 --> 00:31:13.089
Um, yeah, I mean, I, I, I think that there's, there's plenty of opportunity.

00:31:13.090 --> 00:31:28.089
There's, there's plenty of reason, uh, to want to, to have activities in Latin America, be it clinical study, uh, certainly the first in man opportunity is, is presented itself as, as, as being real.

00:31:29.170 --> 00:31:34.890
Uh, the commercial opportunities are certainly there, and then one that we're gonna pursue, uh, for sure.

00:31:34.891 --> 00:31:46.210
But then, you know, finally is, is as you get larger and in wanting to do this offshore, near shore, as you said, um, manufacturing, uh, it's, there's, there's an industry there, and it's not even burgeoning.

00:31:46.490 --> 00:31:46.970
It's, it's there.

00:31:47.039 --> 00:31:48.089
I mean, it exists.

00:31:48.490 --> 00:31:54.970
Uh, so it would be one for all those, um, opportunities exist for, for certainly medical device companies.

00:31:56.089 --> 00:32:00.009
Um, you know, and then, you know, something I've always looked at.

00:32:00.170 --> 00:32:06.369
So people said, Oh, you, you've did multiple expat assignments, you are pretty successful at each of them, which led to the next one and the next one.

00:32:07.450 --> 00:32:10.410
Um, and, you know, somebody asked me, how, how did you approach it?

00:32:10.411 --> 00:32:22.019
I said, Well, look, I believe that, um, you know, everyone in the world is pretty much the same, maybe 80%, and I don't even, I'll just make up a number, say 80% the same.

00:32:22.660 --> 00:32:26.539
It's that other 20% that is really different.

00:32:27.359 --> 00:32:33.420
And that's what is the shiny toy that if everyone focuses on, And that's what you absolutely need to ignore.

00:32:33.910 --> 00:32:34.700
It doesn't matter.

00:32:34.769 --> 00:32:36.980
Stay where the commonality exists.

00:32:36.980 --> 00:32:38.900
You know, you want to do well in your job.

00:32:38.901 --> 00:32:46.049
You wanna be recognized for that success you wanna provide for your families, You know, all those intangibles that don't separate us.

00:32:46.390 --> 00:32:48.089
You need to focus on ignore

00:32:50.410 --> 00:32:50.410
Words.

00:32:50.930 --> 00:33:00.250
good is being, again, a, a fascinating conversation.

00:33:00.440 --> 00:33:06.329
I, I learn so much every time I speak with somebody of your caliber, with somebody of your experience.

00:33:06.829 --> 00:33:10.170

James Reinstein, President & Chief Executive Officer at Conformal Medical

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