EPISODE 89: JOSH COHN, CHIEF COMMERCIAL OFFICER AT ENDOSOUND

Episode's transcript

Julio Martínez-Clark: (00:00)
Welcome to the Latam MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Today our guest is Josh Cohn, he is the Chief Commercial Officer at Endo Sound, a company dedicated to expanding access to endoscopic ultrasound technology worldwide. So Josh, it's great to have you here today. Welcome to the show.

Josh Cohn: (00:53)
Thank you for having me. Glad to be here.

Julio Martínez-Clark: (00:55)
Awesome, Josh. So let's get started with your journey to the region, to Latin America. Josh, how is it that you got involved?

Josh Cohn: (01:02)
Well, I mean, my journey to Latin America started at birth, so I'm proud to be a descendant of a Venezuelan. My mother migrated to the United States in college, and she's been here ever since. So my affinity to Latin America started at birth and I've had the opportunity to be immersed into that culture from a very early age. Um, had the opportunity to visit Venezuela a dozen or more times over the years. And my love for Venezuela and Latin America kind of started there. From a business perspective, my journey started a little bit later, of course, I had the opportunity to meet a number of KOLs and physicians who visited the states for conventions. I was the resident Spanish-speaking person in the booth when my Latin-American colleagues were at other meetings or hadn't arrived to the booth quite early enough. So that helped me forge a relationship with those folks in the sense that I could help communicate with their customers when they weren't there and that helped me forge a relationship with them that really was ongoing for a number of years. So we kept in touch. We talked about strategy, etc. And then, when I started at EndoSound, my friends there really encouraged me to, and the organization, to look at Latin America as an opportunity to do a lot of our early work and reach out to some KOLs down there and we took their advice and it's been fantastic.

Julio Martínez-Clark: (02:32)
Excellent. I'm so glad to hear that. Josh, so let's talk about trends in Latin America. What do you see happening in the region that is relevant to the discussion about clinical research or commercialization of medical technologies in Latin America?

Josh Cohn: (02:46)
Yeah, I mean, historically med device would go to Europe. That was the kinda feeding ground for early device work, first-in-man work, and you know, it was always a struggle to see all those devices being developed and sold in Europe first, and then it would come to the United States. And now, with what is perceived to be a much more difficult and arduous process with the MDR, medical device companies are looking for other areas to do some early stage work, and I'm seeing a lot of companies like EndoSound look to Latin America where there's lots of opportunity to work and learn. And the ground in Latin America is fertile with wonderful physicians, KOLs that are very well respected here in the United States and around the world, and our experience down there has been second to none. So I see a lot of companies starting to do what they did in Europe years ago, now going to Latin America and doing a lot of that early stage work.

Julio Martínez-Clark: (03:49)
Excellent. Yes, I see that too. That's certainly a trend that is been happening for probably five years now, where in essence I see Latin America getting more mature and companies are looking more seriously at the region as a work class region for many activities including clinical research and also commercialization.

Josh Cohn: (04:18)
It's great for patient care, right? especially in Latin America as well, right? The patients there are getting access to technologies that they may not have received previously, but quite frankly, it's really expediting these technologies to become available to people around the world, right? Just in the same manner as it was done in Europe. Now it's done in Latin America, you know, I think if companies take advantage of the opportunity down there they'll see some enormous benefits from a time to market perspective to building better products, being to market sooner, but also with a better product that enhances patient care.

Julio Martínez-Clark: (04:53)
Yeah. So now that we are talking of trends, what I have your take on what's happening in Europe for the audience to understand what is it that we're talking about here? What do you think is happening in Europe? What is it that is so difficult to commercialize or to do research in that region?

Josh Cohn: (05:10)
You know, I'm no expert right, in regards to the regulatory environment in Europe, however, some of the clinical requirements that are required as part of the MDR has really made it more difficult to go to Europe. It's a much longer process. There are a lot more requirements that are required. Then there's the the process of, oh, I can't think of it now, my apologies. But there's, there's a number of policies that are in place that are making it a little bit more difficult to go there.

Julio Martínez-Clark: (05:42)
Yeah. The number of notified bodies got produced dramatically. So there's a backlog.

Josh Cohn: (05:48)
That's correct. Yeah. That's another issue as well, getting in with the notified bodies and now that they've reduced them is also a challenge.

Julio Martínez-Clark: (05:56)
Okay. So hopefully that means more business and newer technologies in Latin America.

Josh Cohn: (06:03)
I think so. I really do. I've been, you know, working for a startup now, really in a consulting and full-time capacity for over three years now. I've had the opportunity to meet and talk to other leaders of startups and this idea of going to Latin America is very intriguing and there are so many advantages to going down there. I think we're gonna continue to see the trend of folks going to Latin America and getting some work done.

Julio Martínez-Clark: (06:27)
Beautiful. Alright, so let's talk about what you're doing in Latin America today.

Josh Cohn: (06:33)
Yeah. So, you know, we started in Ecuador. We've done all of our first-in-man or all of our clinical work in Ecuador, and we've done a little over a dozen casesmand it's been incredibly beneficial from not just a commercial perspective, but an engineering perspective and an r and d perspective. We went to Ecuador under strict clinical readiness reviews to be sure that the product was ethical and safe for patients. Our physician partner received our protocol, looked at our protocol, accepted our protocol. After a number of changes and we were able to get a bunch of feedback, we've actually been able to iterate or quickly whereas if we would've not gone to Latin America prior to commercialization, we might not have as good a product to market. So we've been able to, our engineering team has been able to take feedback from some of those early cases. We've actually iterated, we've changed the product to do a little bit different things and we thought it could do and it's been incredibly helpful. The gentleman that we're partnering with is Dr. Carlos Robles. He is a thought leader, not just in Latin America, but in the United States. He's on the circuit here in the US, he visits here quite frequently, and many of the things that he has learned down there has informed our R&D group and we believe that when we go to market in the next six months, we're gonna have a better product, which is gonna give better patient care.

Julio Martínez-Clark: (08:05)
Very good. Wow. And how is it that you found Dr. Robles in Ecuador?

Josh Cohn: (08:10)
Yeah, so, having been at Pentax for 14 yearsand having developed relationships with the Latin American team, the US side used Carlos as well as a speaker, as someone who we could get early feedback on devices that Pentax may have gone to Latin America with first. So I had the opportunity to first meet him there, and then one of my latinamerican mentors, Peter Mandiola, who has run the Latin American market for a number of different companies, really encouraged us to reach out to Carlos early on, and we did that and Carlos actually did a lot of our early animal work as well.

Julio Martínez-Clark: (08:49)
Nice. Okay.

Josh Cohn: (08:50)
So, he came over here and helped us with that. So it's been an awesome partnership and I believe he's going to be starting a study here in the next couple months in regards to our technology and how it compares to those that are already existing.

Julio Martínez-Clark: (09:06)
Very Good, very good. The study in the United States led by Dr. Carlos.

Josh Cohn: (09:11)
He's gonna do the study in Ecuador and he'll lead the study.

Julio Martínez-Clark: (09:16)
Ok. So, Josh, any comments about the hospital infrastructure in Ecuador, about the skills of the investigators or the team, the research team and all that?

Josh Cohn: (09:29)
Yeah, great question. The facility that we've done our device work at is really second to none. The folks are always surprised when we take 'em down there with us, we take our folks down, look at it, and, you know, they have the latest and greatest equipment on the market, really is a benefit to an early stage company because that's what we're comparing ourselves to, right? When we come to the United States, they don't want you to compare yourself to an older technology that might not be on market. So in our case, we actually compare ourselves to equipment that is the latest and greatest being sold across around the world. So from an equipment perspective, from a facility perspective, second to none. And then from a clinical expertise perspective, second to none. So, the center that we use is a training center, is endorsed by the world endoscopy organization and a number of other societies. They train a number of advanced fellows every year. I had the opportunity to meet a number of those fellows that have now gone back to Mexico, for example, in one that's gone back to Romania. And the benefit to them is that they're getting their hands on the latest and greatest of technologies, and they've had the opportunity to see and use EndoSound as well, which is been a great benefit. They're highly motivated to continue to work with EndoSound cause technology can bring benefits to their markets as well. So, the clinical team there, the research team, again, second to none, we have no reservations in regards to doing our clinical research there and doing our early stage work there.

Julio Martínez-Clark: (11:16)
Wow. I'm so happy to hear that. and Ecuador, it's not a country that I usually hear companies do research on. so, usually you hear Colombia, Paraguay, other countries, Mexico, but it's the first time I hear Ecuador. So that's why I'm so curious about your experience.

Josh Cohn: (11:38)
Yeah, you know, the staff is amazing, maybe it's endoscopy, maybe it's different specialties have their different areas in Latin America or whatnot, maybe it's a new and up and come in and Carlos certainly is one of those folks that is highly respected and he did a lot of his training in Europe as well. I think builds some credibility for him. There's a number of companies in the end actually and centers Ecuador. Um, so if we find Ecuador to be, again, just a wonderful place to work from a culture perspective and ease to work there, and in regards to this particular, it's five minutes from the airport to work every day. So it's convenient. The food's not bad. Uh, we like to. have fun seafood, right? . Yeah.

Julio Martínez-Clark: (12:40)
Excellent. Thank, glad, thank, glad. And, uh, do you have to go through at this committee review or Ministry of Health reviewwhat was experience in that area?

Josh Cohn: (12:49)
So the account handles it all right. So we provide them with a protocol, we provide them with our clinical readiness reviews, show that we've done certain tests to make sure it's safe and applicable. Um, and then they handle that through their IRB process. So they kinda handle all of the ins and outs of what's required, um, for us to come there and do early stage work.

Julio Martínez-Clark: (13:10)
Nice. Very good. So you do have to use the services of a consultant, regulatory consultant or third party agency, uh, CRO or anything like that?

Josh Cohn: (13:19)
Correct. It's turnkey, uh, which they make it very easy right. To work with. Um, now we do consult and we have consulted with our regulatory consultant to make sure that the things that we're doing down there, um, you know, are, are able to be done, et cetera. You know, one of the things that we also were allowed to do, uh, and this is just based on the fact that Carlos is a rockstar, um, he's, he's been invited, uh, to be on global, um, endoscopy courses, live endoscopy courses. So back in, um, I guess it was earlier part of this year, um, there's a program called Endoscopy on Air. And, um, Carlos and EndoSound were asked to participate. So we were ableto do some cases with Carlos in preparation for that. And then we went live, so we had a live case done on, on a patient in Ecuador where thousands position we're able to see the technology, and again, because the facility is second to none, you know, uh, they're able to pipe in, you know, the recorders and video everything and streamed perfectly. And, uh, the responses that we received worldwide were almost too many that we could handle. Small team, absolutely small team. Um, but that was another huge advantage of going down there. We could have never done that in the United States, but cause Carlos was asked to participate, he thought highly enough of our technology to use it. And, um, it was just an awesome opportunity that we took advantage of.

Julio Martínez-Clark: (14:54)
Beautiful. I'm so happy to hear that. And do you mind naming the city in Ecuador?

Josh Cohn: (14:59)
Yeah, Guayaquil, sorry.

Julio Martínez-Clark: (15:01)
Beautiful city, right by the water.

Josh Cohn: (15:03)
Yes. i hadn't have the chance to go to the Galapagos, but that's it's on my bucket. That's when I go down there again soon.

Julio Martínez-Clark: (15:11)
Have you gone to Quito?

Josh Cohn: (15:14)
You know, we have not been to Quito yet.

Julio Martínez-Clark: (15:17)
Okay. Quito is a nice city. Very historical. So you fly directly from the US to Guayaquil.

Josh Cohn: (15:22)
Miami, Guayaqil, four hours, five minutes to the hotel, Hotel bar, and then we left.

Julio Martínez-Clark: (15:33)
Great. Set up. Love it. I love it. Alright. So Josh, let's talk about your future plans in Latin America. What is it that you wanna continue doing in Latin America? Or you wanna do differently in Latin America?

Josh Cohn: (15:47)
Yeah, I think our experience down there has been so good, um, that we plan to continue down there. There are certain markets that are a little bit easier to navigate in regards to the regulatory environment, and we plan to take advantage of those opportunities. We are in discussions with markets such as Venezuelan, Costa Rica, Brazil, Chile and we intend on going down there very soon after our submission to the FDA. So, once we have all of our vnv work done, everything where we feel like, um, we're ready to pass the test here in the u in the US with our submission, we plan to be aggressive in Latin America. So we'll be attending a number of those countries. Certainly Columbia is also another country that we're interested in going down and working in because it'll be an opportunity to get a lot of more work done. So our goal is to, to get, you know, a hundred, 200 cases done down in Latin America prior to full commercialization in the United States. And as you can imagine, it gives us enormous advantages to our strategy to commercialize successfully. Um, and then once we get done with those, those cases in Latin America, we'll be a much more informed organization in regards to what this technology can do on a larger scale. Um, and then we plan to work on distributorships down in Latin America, because Latin America, um, for our technology in particular, um, could be really a game changer. Um, unfortunately the technology that we're looking to not necessarily replace, but to be a compliment to is very expensive. And unfortunately, uh, many countries have very little access to this technology. Uh, patients have to drive hundreds of miles to get to the main center. Um, and even then, it may be a long wait, um, to get in and we're able to provide the same technology at 10, 15% of the cost of traditional systems. So, um, you can imagine what kind of access that will provide to folks in Latin America. So we're really excited about the opportunity down there. Uh, we're exploring distributorships down there that make the most sense for us. Uh, and when the time comes to fully launch in Latin America, hopefully we'll be prepared to take care of patients down there as well.

Julio Martínez-Clark: (18:17)
Beautiful, beautiful. Have you had prior experience with regulatory approvals for commercial devices in Latin America, your prior company?

Josh Cohn: (18:26)
So I do not, I do not have any of that experience, but again, one of my mentors in Latin America, um, has been, uh, very helpful and insightful in regards to kinda the regulatory environment. And he doesn't claim to be an expert either, but certainly having run Latin America for a couple decades now, he has folks that he relies on from a regulatory perspective that has given us a little bit of feedback here and there. And when I think when we're ready to, to launch down there and go through the process of each country's ministry of help, I think we'll be looking for experts like you, right? Could help us navigate those waters.

Julio Martínez-Clark: (19:04)
Absolutely. Absolutely. Yeah. Latin America, it's certainly a challenging and potentially lucrative region challenging because it's, you know, you have 33 countries, every country with a different regulatory body, regulatory approval process and all that. But 33 countries, most companies only focus on about five to seven countries. You know, the usual suspects, Brazil, Mexico, Colombia, Argentina, Chile, Peru, maybe Panama, Costa Rica, Ecuador and the rest of the countries are very small.

Josh Cohn: (19:43)
Now, what's been your experience with the regulatory environment once you have FDA clearance?

Julio Martínez-Clark: (19:49)
Very good, very good. I mean, I will say that FDA or CE mark approval is kind of the seal of acceptance, of key opinion leader acceptance. For example, I'm gonna give you the case of Chile. Chile is a country doesn't have a regulatory approval process by law, is wide open. You can import devices tomorrow in Chile without a regulatory, uh, certificate. However, if you come to Chile with a product that is not FDA approved or CE Mark approved, no key opinion leader in a reparable hospital will buy the product or will use the product on patients. So it's kinda a market driven regulatory process. That's how it works. So also in Colombia, I mean, you, you get, especially with, with lower risk technologies, you get all these Chinese Indian companies trying to sell products in Latin America. However, I see the value of American products being on the, on the higher risk spectrum, on the, on the more sophisticated on on innovation, that's where American products really have a fit in the market or a market fit, I'm sorry. And, um, and key opinion leaders will accept any FDA approved product. I mean, day. In the case of the regulatory approval process, every country in Latin America has a different set of reference countries. Uh, for example, uh, Mexico uses FDA as a reference country, Canada, I mean the US FDA, Canada, and, uh, Japan. Mexico doesn't accept CE Mark and that's odd. That's really odd. Mexico doesn't accept CE Mark as a reference country or Europe as a reference country. However, Colombia accepts Europe as a reference country. So if you have FDA approval, uh, Canadian approval, uh, European approval, CE Mark, uh, Japanese, Australian approval, then it is very straightforward to register a product in Colombia. Or you also need home country approval. Let's say you are a company from Korea, right? It's not a reference country, but you have the approval of your national regulatory agency to sell the product in Korea. So you have home approval. So that will help you get access to the marketing Colombia. However, a key opinion leader, as I said, will not look at the product favorably because it doesn't have FDA or CE market approval. Right? So,

Josh Cohn: (22:38)
Makes all the sense in the world. Makes all the sense.

Julio Martínez-Clark: (22:41)
So anyway, Josh, before we end the interview here, uh, any final words of wisdom, any final thoughts that you wanna share with the audience? I mean, if you have the CEO of a newer medical device company looking to do another feasibility trial or to sell innovation in Latin America, what would you say to him or her?

Josh Cohn: (23:03)
Yeah, I would say find a key opinion leader in Latin America that is respected. Um, it also, I will say this, it also depends on that particular device company's exit strategy, right? Um, you know, I, I would argue that if their exit, I would argue that regardless of their exit strategy, that Latin America is a good place to go. Um, but if their exit strategy is not acquisition and it's a brick and mortar long term, then I would absolutely go down to Latin America. And choosing the right KOL might not be as important. Um, if acquisition's not a target, for example, we may choose a KOL based on one of our potential acquirers, right? Someone that know that they use, someone that they respect, etc. If your acquisition isn't your exit strategy, then that might not inform who you work with, right? You might go down there and work with who makes the most sense for your company, right? Regardless, you know, choosing the right KOL is important.

Julio Martínez-Clark: (24:07)
That's a great point. I never heard of it.

Josh Cohn: (24:10)
Yeah. So, I would encourage them to, to go and find KOLs in, in the country that they find, um, easiest to work and, and, and to do work in. And then, develop those protocols alongside that physician. I would, uh, I would encourage them to use their counterparts if it's a US company to validate some of the things that you're doing back and forth. I will say this, one of the huge advantages of working in Carlos's lab, for example, are he receives physicians from the United States all the time. Huge names down work with him. So we've had the opportunity, for example, Dr. Sandy Patel outta Texas, um, a very, uh, respected name actually did a case with, with Endosound in Ecuador on another live course that was being streamed globally. So there was huge advantages there in the sense that an American doctor was now able to use our technology as well. But I would, I would strategically, I tell them to, you know, choose the right KOL and do as much work down there as possible to inform the R&D team. Do it as early as possible, right? Um, you know, doing it after your manufacturing process is validated and you have a go-to-market product isn't advantageous to anyone, right? Because they're not able to inform anything. So as early as they can get to Latin America with a KOL safely, I would go down there and learn, and I'd have your R&D turnt team learn, you know, the pros and cons of your device. I would iterate quickly and then I would get down there for additional clinical work as soon as you have your next device, um, or prototype. And then from a commercial, from a commercial perspective, again, I would highly encourage, um, those companies to go down and do as much work as possible once they've submitted to the FDA. I've been a part of two very large organizations and, um, you know, some of the clinical work that was being done in the United States were oftentimes the first time, uh, representatives like myself that were there, saw the equipment use. And I believe that was opportunity lost, right? If we train our people on the products that we're selling at an earlier stage that really benefits everyone. So we intend to go down there with our market development team to Latin America. We plan to train them down there so that when they're in the US they're not watching their first Endosound case that they've ever seen, right? They know the benefits of our product, right? Not every product is perfect. Um, actually there is no perfect product. So be able to understand the advantages and the disadvantages of the product so that we can set expectations with our customers here in the United States is gonna be priceless.

Julio Martínez-Clark: (26:54)
Beautiful. Thank you so much, Josh, for your insights and words of wisdom. So thank you for being the show today. I really appreciate your time and you sharing your knowledge with your audience, and I look forward to being in touch. Yeah, thank you.