Early Feasibility Studies in Latin America

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices. 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Julio Martinez-Clark, CEO and co-founder of Bioaccess, about early feasibility studies in Latin America.

Since 2010, Julio has supported more than 100 Medtech opportunities to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America.

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Some highlights of this episode include:

• Julio is a big believer in the potential for medical device companies in Latin America. He explains how U.S. Medtech companies can succeed in Latin America with early feasibility clinical trials and market access entry initiatives.

• Latin America is a good location to conduct easy feasibility clinical trials because U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.

• More companies are coming to Columbia because it is difficult, expensive, and time consuming to recruit patients in the United States and achieve regulatory approval at the FDA.

• Although the FDA implemented its Early Feasibility Studies (EFS) Program several years ago, it does not work well. Trials are still expensive, and it’s still difficult to recruit patients in the United States.

• Patients and physicians in the United States and those in Latin America tend to share a similar culture when it comes to their health and lifestyle.

• However, there are challenges for companies in Columbia, such as language barriers. Documents for regulatory approval need to be translated into Spanish.

• Columbia’s reputation has evolved into a knowledgeable country for companies to visit, feel safe/comfortable, and find patients to conduct trials for quality data.

Links:

Bioaccess

Julio Martinez-Clark on LinkedIn

OECD

Pacific Alliance

FDA - Early Feasibility Studies (EFS) Program

ISO 13485

True Quality 2022

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru

Global Medical Device Podcast Email

Memorable quotes from Julio Martinez-Clark:

“U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.”

“The struggle that these companies go through is immense. They find it very difficult, very expensive, and time consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA.”

“The Early Feasibility Studies Program that they implemented about seven, 10 years ago, it hasn’t really worked because of the dynamics of the U.S. system. Trials are still expensive and it’s still difficult to recruit patients in the United States.”

“It’s really a bargain to buy services from a hospital in a country like Columbia.”

“These companies are, in essence, looking for fast regulatory approval, ease of patient recruitment, and cost savings.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne: Greenlight Guru is committed to improving the quality of life. Now, we're ready to improve the quality of education and training in the medical device industry. Greenlight Guru Academy is a comprehensive training resource for anyone looking to learn industry best practices with actionable training from industry experts. You'll get on demand courses that allow you to move at your own pace on topics related to quality and regulatory, product development, design controls, risk management, DOT control. Honestly, it's too many to fit into a short ad. So if you're ready to level up your medical device education, visit greenlight. guru/ academy today. Hey, everyone. Today we're going to be talking with Julio Martinez- Clark, he is the CEO and co- Founder of bioaccess. In this conversation, we talked a little bit about Columbia and how it represents an untapped destination for early feasibility, first- in- human clinical research and for companies to first enter the Latin American market and sell their innovations. Since 2010, Julio has supported over 100 MedTech to design an operational successful clinical trials, regulatory market access strategies in Columbia, as well as other countries in Latin America. Julio writes a column at Med Device Online, and he's a clinical leader where his articles have been featured editorials on several occasion. Julio is the host of the LATAM Medtech Leaders podcast, a weekly conversation with MedTech leaders who have succeeded in Latin America. He has been interviewed on Columbian TV by Hernán Orjuela, Columbia's most popular TV presenter about his work, helping American MedTech succeed in Columbia. If you've seen Encanto, you know more about Columbia than maybe you did before. He is a big believer and you'll see, during this episode, just how much of a believer he is in the potential for medical device companies to succeed in Latin America. So I hope you enjoy this episode. Let us know what you think by emailing us at podcast @ greenlight. guru. Thanks. Hey, everyone. Welcome back. Excited to be with Julio Martinez- Clark. My name's Etienne, the host of today's Global Medical Device Podcast. Today's topic, we're going to be talking a little bit about how can US MedTech companies succeed in Latin America with their early feasibility clinical trials and their market access entry initiative. So we're going to be talking a little bit about that. Julio's an expert in this field. He's written articles, done many interviews on this topic. So do you want to say a little bit about yourself real quickly, Julio?

Julio Martinez-Clark: Absolutely. Thank you for having me here. Yes, I started working with medical device companies, doing business in Latin America for about 12 years. Really was my brother, Pedro, who is a physician who trained at Harvard, at the Beth Israel Medical Center as an interventional cardiologist and then became a professor at the University of Miami. They started working for a lot of medical device companies, trying to do early feasibility clinical trials in Latin America, and also to sell the products in the region. That's how I got involved in this world. My past life was in another industry. I came from telecom and networking. I worked for Lucent, I worked for Nortel. I had regional roles. I travel over Latin America, and I am very much in love with what I do, helping companies succeed in the region.

Etienne: Awesome. So what area do you live in now currently, if you don't mind me asking?

Julio Martinez-Clark: Orlando, Florida, but from Columbia.

Etienne: Yeah. Okay, excellent. So some of the things that I'm curious about when I think about this is why Latin America? What makes it a good spot to conduct early feasibility trials?

Julio Martinez-Clark: Well, Etienne, you know that US companies struggle to find cost effective ethical and quality sites overseas. They usually go to far places like Eastern Europe, especially now it's really difficult to go to Eastern Europe for obvious reasons, but they usually go to Poland, Czech Republic, Ukraine, by the way, and Georgia and places around that part of the world. They also go to New Zealand, Australia, and a little bit of Paraguay, surprisingly enough. I started working with companies who were going to Paraguay and they quickly realized that they needed to have a larger set of patients. So after doing three, five patients in Paraguay, they expand to other places around the world. Modesty aside, thanks to our work promoting Columbia as a top destination for early feasibility clinical research in Latin America, these companies are now coming to Columbia. The struggle that these companies go through is immense. I mean, they find it very difficult, very expensive and time- consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA, the early feasibility study program that they implemented about seven, 10 years ago, it hasn't really worked because of the dynamics of the US system. So trials are still expensive and is still difficult to recruit patients in the United States. So these companies have to find a place outside of the United States, where they can find, as I said, this ethical quality and cost efficient overseas clinical research sites. Latin America is closer, specifically Columbia is closer to the United States, same time zone, same culture in many ways. A lot of US trained physicians have come back to Columbia or to countries in Latin America. Also, on top of that is the cost savings. The currency of these countries, specifically Columbia have been devalued so much, that is really a bargain to buy services from a hospital in a country like Columbia. So for many reasons, I think Latin America, specifically Columbia is a better place than many of the traditional destinations that these companies usually go to.

Etienne: Interesting. So when we talk about the economic advantages are obvious, it seems, when we talk about these different things, especially the devalued currency and so forth. I love that there's technological similarities possible, I suppose equivalents, and that's very encouraging to hear. Wherever I hear that in the world, that's awesome. But the other thing I would think, so you mentioned the similarity in the culture, and I don't want to push back too hard, but how does that translate when you're doing a clinical trial in the actual people in the clinical trial, do they truly reflect similar disposition as far as their approach to health, their lifestyle and so forth?

Julio Martinez-Clark: Yes. That's really what I said. That's really what I mean exactly. The word culture encompasses many things. To be more specific, the way we practice medicine in Columbia is very similar than in the United States. The clinical guides are copy and paste from the United States. As I said, many Latin American Columbian physicians train in the United States and they come back to Columbia. So it is not surprising to find US board- certified, fully bilingual doctors at a regular hospital in Columbia. That helps a lot with the communication and make things easier with the trial and collaborating with the US sponsors.

Etienne: That makes sense.

Julio Martinez-Clark: You also mentioned something very interesting. I'm sorry to interrupt, which is the lifestyle of the population in Latin America, the growing middle class population make it very similar to United States. So people are eating McDonald's or barbecue, fast food. Every day there's-

Etienne: You know what I was talking about.

Julio Martinez-Clark: Exactly. Yes.

Etienne: Okay. I've not ever been, this is slightly complete... Well, it's completely off- topic. Columbia is one of my bucket list destinations. So one of these days I plan to be there. So that's really cool.

Julio Martinez-Clark: Welcome here.

Etienne: Well, that's really awesome. So we're talking about Columbia. We started to talk about Latin America. What sets Columbia apart? Or is there something special about Columbia as opposed to other Latin American countries?

Julio Martinez-Clark: Great question. Etienne, I've been involved in this world of medical technologies, medical devices, MeTech for about 12 years and a lot of my clients come to me and ask me exactly that same question. Even some of them already have a physician identify in Argentina or in Brazil or in Mexico, or other countries in Latin America. I do my research. I call the physician, I call the ethics committee, I call regulatory experts in every country, I do my research online. Regardless of what research I do, in what country I do, everything leads me back to Columbia. Columbia is probably the most... This is friendly country in Latin America right now. It is considered the closest US ally in the region. Has a free trade agreement with the United States. The size of the US Embassy in Colombia is larger than any federal building in any major city in the United States. So is a close ally. I mean, just last week the Columbian president was with Joe Biden, visiting the White House. Colombia was designated as a NATO ally, not officially, but it's a nonofficial NATO ally of the United States. It's the only country in Latin America that has this designation. So it says a lot about how the United States are open to do business with each other. They have a 200 year relationship of business and trade, et cetera. So with all this said, the regulatory framework of the Columbia regulatory agency, the healthcare system in Columbia, which by the way, is a top performing healthcare system in Latin America, Columbia has about 50% of the top hospitals in Latin America in annual ranking that reparable magazine does. So many things lead to Columbia for early feasibility clinical research. I think just to conclude my point here, these companies are in essence looking for fast regulatory approval, ease of patient recruitment and cost savings. Those are the three aspects that these companies are looking for when choosing of this nation, without mentioning geographical proximity. I mean, instead of going to Poland, six hours away, jet lag, time difference, et cetera, or New Zealand or Australia, you are two and a half hours from Miami to... So many things really check the boxes for Columbia.

Etienne: That makes a lot of sense. So when you talk about fast regulatory approval, what does that look like versus other places?

Julio Martinez-Clark: First of all, it's predictable. In other countries like Brazil, Mexico, is very predictable. We're probably talking in Columbia about 90 days tops, from the time you submit to a hospital at this committee or IRB to the time you get approval at the national regulatory agency to get import permit for your investigation device. So that's really competitive.

Etienne: Absolutely. So I was reading somewhere, I believe it might have been one of your articles about Brazil possibly being upwards of 300 days or something like that versus Columbia, the quick response. But that's very interesting. So we talked about some of the pros and some of the positives. Are there any challenges? Just full disclosure. So anyone maybe coming out of US, coming to Latin America. What kind of challenges could a company expect to see?

Julio Martinez-Clark: Well, I would say language barriers are the first challenge that I usually see. The regulatory agency in Columbia wants everything in Spanish. So we have to translate 1, 000 documents in Spanish. That's something that I don't like, but that's the way it is. Also, communicating with the staff at hospitals is a challenge, because even Columbia is a country open for business, it's part of the world economy. It's actually an OECD country, by the way. Only three countries in Latin America are part of the OECD, the Organization for Economic Co-operation and Development: Mexico, Chile, Columbia, and now Costa Rica just became a member. So that says a lot about how open Columbia is for business. But regardless of all this, people in Colombia do not speak English unfortunately. So only physicians who have been trained in the United States or receive very good education, either in Colombia or other countries in Latin America or Europe, they are more fluent in English. So that's always a challenge.

Etienne: That makes sense. Okay. So if I was a company working on my feasibility study and I want to come to Latin America, there's a few different things that I'd be working on. Obviously, maybe a company like yours would do the translation maybe.

Julio Martinez-Clark: Yes.

Etienne: I mean, correct me, but what would I do? What things would I be pursuing at that phase of development?

Julio Martinez-Clark: The first phase is to start identifying potential investigators. That's something that we easily do with the study protocol or the summary of the protocol. And then we look at the inclusion criteria. We looked at the type of physicians that needed to be involved, the investigator or the sub- investigator that need to be involved in the trial, et cetera. We look at the type of imaging equipment that is needed for the study, et cetera. And then we start scouting the country for potential investigators. Columbia's a large country, by the way, just to put things in perspective. It's the third largest economy and it's the third largest country in Latin America. So it has, as I said, a large pool of hospitals to choose from. This is an interesting fact, is probably the country in Latin America that has the most number of metropolitan areas.

Etienne: Really?

Julio Martinez-Clark: Most of the population of 50 million people live in metropolitan areas. So if you go to other countries in Latin America, for example, you go to Argentina, you go to Buenos Aires and that's it. Outside of Buenos Aires, you find very small cities. It's the same as in many other countries. So Columbia is not like that. I don't know why, but that give us a lot of options. So Bogotá is a huge metropolitan area of over 10 million people, then Medellín about five, six million people, then Cali about four, then Barranquilla and the Caribbean Coast about 10 million people that covers the whole Caribbean Coast. So there's a lot to choose from.

Etienne: No, that's great to hear. I was also reading some about the good clinical practice. I don't know if you could speak a little bit more to that.

Julio Martinez-Clark: Good catch. Yes. That's something that nobody really talks about, Etienne, but that Columbia is the only country in Latin America that has a GCP certification process or auditing process at the institutional level, not at the individual level. Everybody knows that every healthcare professional involving clinical research needs to have an ICH GCP certificate training. They go through an online course, three, four hours online, and you get your certificate. But no, in Columbia, the Ministry of Health needs to make sure that you as a hospital you know how to conduct research. So you have to go through a rigorous process. You have to hire an external consultant to do all the quality checks in your institution, to make sure you submit an application to the Ministry of Health for them to come and visit and audit your facility, and to give you the seal of approval that you are indeed qualified to conduct clinical research. This is something that US pharmaceuticals pushed in Columbia around 2008. That's when the law was issued. Since 2008, Columbia has had these certification process, and is the only country in Latin America that has it. That's to ensure quality of the data that comes out of the country.

Etienne: I don't know if this is something you could speak to or not, but with that certification process, and then you also mentioned the faster IRB approval, maybe 90 days being on the top- end. Are those related or is that something you could speak to? Any thoughts?

Julio Martinez-Clark: Well, not really related, but... Well, you're picking up a good point. Both the IRB at the hospital needs to be certified by the Ministry of Health. I see age GCP certification that you mentioned, and also the institution. So both parties, both bodies have to be certified, which ensures quality of the work that they do.

Etienne: Right. So if we zoom out and look at it more globally, what is the comparison like, not just in Latin America, maybe Columbia to Argentina and so forth? Are you able to comment more on the comparison with the Columbia and those certifications with New Zealand, or as you mentioned, Paraguay or even Ukraine and so forth?

Julio Martinez-Clark: Well, I don't know of any country that has this type of certification to honest with you. This is something unique of Columbia. I don't know why it was implemented in the country, probably because of the... I mean, this is in speculation on my end, that probably was the US pharmaceutical companies doing research in Columbia at that time that pushed the Columbian government to ensure the quality of the data. Really the background of all this, Etienne, is that Columbia is a country that has decided to diversify its export base. Traditionally, Columbia has been seen as a country that export coffee and minerals and commodities, and some other things that we don't want to talk about unfortunately. Because of the push of the OECD, for example, the country has decided that it needs to diversify its economy. It has to become a knowledge economy. So for that to happen, they need to bring US companies, European companies, working innovative medical technologies, they have to incentivize the life science industry in the country, and other industries as well, biotech. In general, they're doing the same thing with the creative industries, like movies, et cetera, BPOs, call centers, things of that nature. So it is part of that push to diversify the national economy. By the way, the Ministry of Health of Columbia was just created last year. So that says a lot about the country's intention to become a knowledge economy and to export knowledge.

Etienne: That's great. Well, I hope that progresses the way it's intended to progress and improves the quality of life for those in not just Columbia, but maybe broader Latin America as well.

Julio Martinez-Clark: Yes. Absolutely.

Etienne: That's excellent to hear. So if we go back to the early feasibility, those first- in- human studies, are there any differences then in how you would set up your study. Maybe the short answer is no, but where you do it anywhere else. I'm just trying to think as a company, what do I really need to know in order to go to maybe these places versus that place? Any additional thoughts?

Julio Martinez-Clark: Well, what we usually do is we bring sponsors to Columbia before they make a decision. So we invite them to come and to tour the country, to visit at least three, five facilities and shake the hands of the potential investigators, look at these staff, get to have dinner with them, tour the facility in general, tour the city, look at the hotels and everything. From the moment they arrive at the airport, they have to feel safe and certain that this is a place they want to come back to. Because if you decide to do your trial in Columbia, you're going to be coming here at least 20 times, I'm not kidding, during the course of the study. So I don't know if that answers your question or not, but I will say that that's something that they have to keep in mind, that they have to feel comfortable with the country. Because Columbia has had a bad reputation in the past as you and I know, and Netflix is not helping.

Etienne: No. Well, how often has Netflix helped us?

Julio Martinez-Clark: Anyway, but the country is different. Now, it's very different. We work with the sponsors every single day. We bring sponsors to Columbia every single day. Today I'm in Columbia because I just tour the country three times with three different groups of sponsors, and I'm waiting for two more sponsors coming in the next month. So we tour the country, we go to site in Bogotá, we go to site in Medellín, in Barranquilla, without even signing a contract. We just want them to come and feel comfortable and make the right decision.

Etienne: Yeah, that makes sense. So when I think about where I would want to conduct my study, so my instinct... Well, there's two things that go on. Number one, if I'm working with consultants, I'm probably going to do whatever they suggest that I do. It comes down to what are you aware of. Awareness, I suppose. So this knowledge sharing is very important. The second thing I think about is, okay, if I want to do a study, I typically want that population of people that I'm going to be marketing to at some point, So that's a truly accurate study. You already handled that a little bit with the cultural similarities and so forth. But I guess what I'm curious about is, what about if I were to sell in... If I'm going to do a study in Columbia, there's a good chance, well, maybe I want to pursue that regulatory pathway as well, are there any difficulties in there? Maybe that's a little bit outside the topic of this conversation. That's fair if you...

Julio Martinez-Clark: Well, what happens, Etienne, is that none of these companies are interested in selling devices at this point, nowhere else in the world. I mean, it's not particularly Latin America or Columbia. It's just that at this early stage where all they're looking at is to sell the company to unstrategic, to an exit. So they're looking at gathering ethical quality, cost efficient clinical data so that they can present the data to investors, the FDA, so that they can start their pivotal trial in the United States. That's really where the population comes in, where you're going to sell, because the FDA will demand that you do the pivotal in the United States. I recently heard that for the first time in history the FDA accepted 50% of the clinical data on a pivotal trial coming from Mexico, which is great for Latin America. It says a lot about how Latin America is becoming more serious. It's being seen as a place of quality clinical data. So these companies are probably five, seven years away from selling the product or thinking about selling the product in a country like Columbia or Paraguay or Chile, because they need to do first their trial in the United States, the pivotal, and then they negotiate their acquisition or they sell the company with unstrategic, Boston Scientific, Medtronic, Abbott, J& J. And then they include the product in their portfolio, and then they decide if they want to sell it in Latin America or not, if that's something that they want to do eventually.

Etienne: Yeah. Business development.

Julio Martinez-Clark: Yeah, exactly. That's business development, that's commercial strategies. That's probably 10 years away from the day that they start doing the trial in Columbia.

Etienne: So you work with a lot of different companies doing these different things from start to acquisition maybe. Maybe you could talk a little bit more about what bioaccess does, just so people can be aware of just the options that are out there.

Julio Martinez-Clark: Yes. We are a contract research organization based in Orlando, Florida. We are probably the only CRO in the United States that specifically focuses on early feasibility, medical device, clinical trials, and medical technologies in general. We get involved with stem cells. We get involved with gene therapy, and of course medical devices, but advanced technologies in general, that's really our specialty, our niche. So any company in the United States or Western Europe that needs to do an early feasibility trial in Latin America, they will probably look online and we'll find us. We also have evolved, a lot of our clients look for market access services from bioaccess. So we have a portfolio of services where we help companies succeed in their sales initiatives in Latin America. We help with the market clearance in the different regulatory agencies in all the countries in Latin America. Because even though Latin America is a huge market, over 600 million people, I mean, double the size of the United States is very fragmented, over 30 something countries. So you need regulatory market clearance in every single country. So if we're talking about the five main countries, Mexico, Brazil, Columbia, Peru, Chile, et cetera, then you have to go one by one. There's no recognition. So we can help with the regulatory approval process in every single country, we can help to find distributors. We can help engaging key opinion leaders. We can also help doing market research. If companies need to understand the size of the market, the players, pricing, reimbursement, all that, we can also help.

Etienne: Okay. That makes sense. It was good to know what the options are and how you can help. So you mentioned, you'd say three companies you're going to be taking around maybe today or this week.

Julio Martinez-Clark: In the next month or so.

Etienne: Yeah. Okay. So the reason I asked that is... So you talked to a lot of these companies, I guess you see them interact with a lot of different hospitals, facilities and so forth. What are some good questions, or I'm sure every now and then you get somebody like, " Man, that was a good question," or" that's good information that they're digging in." What do you see? Do you see anything like that?

Julio Martinez-Clark: Patient recruitment is always a challenge. How are you going to recruit patients for me? That's really what I'm here for. That's what the sponsor usually says, I'm here for patients. I don't care about the size of the facility. I don't care about anything else. All I care is about patients and quality data. That's what it is. So the investigator is interrogated. So how many patients do you think you have in your consult right now? How many patients do you see every month? How many patients do you have in your database? How many patients you can recruit in my trial and how much time? I mean, can you recruit something in three months? So that's usually the best question you can ask.

Etienne: Okay. No, that's good to know.

Julio Martinez-Clark: By the way, we support the work of the hospitals at the end, by implementing social media marketing campaigns. We're probably the only company that does that, that I know of. I don't know why-

Etienne: That makes a lot of sense though.

Julio Martinez-Clark: It may makes sense. We place ads on Facebook, on Instagram, we do a landing page. We have a questionnaire with Typeform where there's a logic map embedded in the questionnaire. So it adapts to the questions and the answers and everything. So we are very successful in recruiting patients online to support the work of the investigator.

Etienne: That makes a lot of sense. So really there's more than just finding a clinic, finding these different things, assisting in the patient recruitment. Any other pieces of advice you can give to somebody who's, maybe they're ready to start their feasibility, first- in- human, et cetera. Any piece of advice you can give a company like that?

Julio Martinez-Clark: Learn a little bit of Spanish because that will help you a lot with your investigators, and they stop. Learn a little bit of Spanish, read about Columbia, because the culture here is very social and they will invite you to have dinner with them at a restaurant or at their houses. We've had cases where they take us to their houses, we drink scotch and they introduce their family to us. We sit in the living room, in the dining room. And so speaking Spanish is helpful always in these social interactions, because that creates a good brand. I mean, think about this, you are a startup company from Silicon Valley, from San Francisco, from Boston, from Minneapolis, and you raise$ 10 million or whatever amount of capital for your device. And then you are looking for a site where you're going to do your early feasibility trial. And then you find this hospital in Bogotá, Columbia, for example. You find Dr. Gomez. And then Dr. Gomez now has become probably the most important person in your company because the future of your company is in his hands. You're going to train Dr. Gomez. You're going to teach him how to implant your device. You're going to bring all your team to Columbia to be in the ward with Dr. Gomez and he better performs. He better be motivated and enthusiastic about your technology, right?

Etienne: Yeah, absolutely.

Julio Martinez-Clark: So you want Dr. Gomez to be your friend.

Etienne: That makes a lot of sense. When you put it like that, they are a key player in the future of your company.

Julio Martinez-Clark: Key player.

Etienne: Yeah.

Julio Martinez-Clark: Totally. Yes.

Etienne: Okay. No, that makes sense. That's good advice, and learning Spanish in today's age in America, I don't know why we haven't all been required yet, but that's a different subject, I suppose.

Julio Martinez-Clark: Yeah. It's a different subject. Now, it's so easy with Duolingo. In the plane, two and a half hours from Miami, I started practicing with Duolingo.

Etienne: Well, now I have no excuse. Well, next time we talk, maybe it could be in Spanish. We'll see.

Julio Martinez-Clark: Well, that's a stretch.

Etienne: Okay. Well, no, this is good information. Where can people go to find out more about you? Do you have any maybe some different thoughts that you want to share with the audience before we shut it down?

Julio Martinez-Clark: Well, I would say that Latin America is a region that has matured a lot and there is a lot of lack of information. There's really no quality information online about the opportunity that Latin America represents both for clinical research and also for commercialization of medical technologies, especially now that Europe is going through a transition phase, first, with the UMDR and second with the war and without mentioning COVID. But I think Latin America is having a more protagonistic role in the world economy for many reasons and including the reasons I just described. So countries like Columbia are really, really making an effort to bring business, to bring investment and to bring science technology and innovation to the country so that the country can become diversified economy and export knowledge. So with that said, again, my name is Julio Martinez- Clark. Our company is bioaccess. We are easily found online, bioaccessla, Latin America. com.

Etienne: We'll put the link in the show notes as well.

Julio Martinez-Clark: Yes. Excellent. Also, I'm very active on LinkedIn.

Etienne: Okay. Awesome. Well this is great information. For anybody who's starting the early feasibility studies, think about them as an option. Yeah, I appreciate it.

Julio Martinez-Clark: Also for commercialization, I mean, countries like Chile, for example, you don't need regulatory approval in Chile. In Columbia, you can get regulatory approval for a medical device, commercial device in 90 days, as soon as you have FDA or CE mark approval. So sales in these countries are pretty easy to do if you want to put the effort.

Etienne: That's something we didn't really talk about much. Do you want to talk some about commercialization? I know with MDSAP you have Brazil. I'm a little on the fringe of my knowledge here, but you want to speak a little bit about some of those other countries or whatever.

Julio Martinez-Clark: Yeah, sure. Yes, absolutely. I mean, Latin America beyond the clinical trial opportunity also represents a region that is hungry for innovative technologies. I wouldn't say the lower end of the spectrum, like catheters and the commodities in the medical device world, that market is full of Chinese and Turkish and Indian, Pakistanian products. The opportunity really lies on innovative technologies. Something that can save money to hospitals, and because healthcare in Latin America, I'm sure the audience is not really familiar with this, but healthcare in Latin America is a constitutional right. So every citizen in every country, not every country, but most of the countries in Latin America have the right to receive medical care regardless of the cost. So cost containment is a big issue. So whatever you can bring to save money to the healthcare system is welcome. So that's usually something innovative. Countries like Columbia, as I said, Chile, have a very straightforward regulatory approval process, Panama as well. I usually suggest my clients when they are new to Latin America to start in Columbia. I even wrote an article where I state this position, because if you start in Mexico or in Brazil, it will cost you$ 20,000, $30,000 and it will take you a year or so, or more sometimes. In Mexico right now, COFEPRIS, for a class three device, year and a half. In Columbia, 90 days.

Etienne: Yeah. And so what are the requirements for Columbia? You said if your FDA approved, easy for Columbia, are they sort of relying and leaning on that FDA approval?

Julio Martinez-Clark: Yes. Columbia has what is called... Most countries in Latin America, not only Colombia, they have what is called a reference country approval. So they rely on a reference country approval, of course. I mean, reference country is Canada, the United States, Europe, Japan, Australia. That's for Columbia. For Mexico is a little different. For example, Mexico doesn't recognize the European community as a reference country, oddly enough. But they recognize Japan and Canada, and the United States. So every country has a different reference country list. For example, Chile doesn't really have a reference country. Chile doesn't have a regulatory body. It does, but they don't impose or they don't mandate regulatory market clearances for mid- risk and high- risk devices, only five different type of low- risk devices.

Etienne: Okay. Interesting.

Julio Martinez-Clark: So Chile is an open country for business.

Etienne: Yeah.

Julio Martinez-Clark: Yeah. I'm sorry to interrupt, but it's an important point just quickly here. The thing in Chile, I think is that no reparable physician will, even though there's no mandatory requirement to reassure your device, no reparable key opinion leader will use a device that doesn't have FDA or CE mark approval, because that's the goal standard of approvals.

Etienne: Yeah. So that makes sense. FDA or CE.

Julio Martinez-Clark: Yeah. It is a market driven approval.

Etienne: Right. So in a sense, it has a built- in reference country, so to speak, I suppose.

Julio Martinez-Clark: Yes, exactly. But you're free to import the device. You don't have to go through any red tape or anything to import the device in Chile.

Etienne: It brings up an interesting point that we talk about on this podcast occasionally, and that is compliance versus quality. You hope that every company that's developing medical devices is pursuing quality. I mean, you have to be compliant. Maybe you find a place that doesn't have anybody that is governing those things. Maybe, okay, well, you're compliant automatically, but you hope that those companies are instilling that quality requirement on them. So following those standards, whether it's ISO 1345 and so forth, the requirements there. That's interesting. But certainly, like you said, there's an opportunity for marketing in the Latin America then.

Julio Martinez-Clark: Absolutely, yes. Very few companies have seen it, but because of what's happening in Europe with the UMDR, they're now looking at newer markets, where can we go and sell in Latin America, Brazil, Mexico, Columbia are in the top of their list.

Etienne: Yeah. It almost goes into a different conversation, but the ability to work anywhere with remote work, there's sort of a reshuffle going on and I almost wonder how that's going to affect this in the future. If it's an opinion, you're free to comment, but...

Julio Martinez-Clark: Not really.

Etienne: No, you're a smart man, wise man. A lot of respect there. Well, any other thoughts about whether early feasibility trials or commercialization, any other thoughts just kind of advice you want to give to the listeners?

Julio Martinez-Clark: Well, I would say that pay attention to the Pacific Alliance, pay attention to the OECD. The OECD, for listeners, and I'm repeating, is the Organization of Economic Corporation and Development, is a club of wealthy countries around the world. Is a club of countries that have the most advanced economies in the world. Recently, in the past, probably seven years, 10 years, they started an initiative to bring Latin America to the club. The first country was Chile. Chile is considered a very forward looking country in Latin America. Then the second one was Mexico. The third world was Columbia. And then Costa Rica just a few months ago. So only four countries in Latin America, out of 30 something countries. So imagine that. It says a lot about how these four countries are really, really trying to diversify their economies and they are looking to implement best practices, social, economic, policies. So we're going to be... We're all citizens.

Etienne: Yeah. I'll put the link in the show notes as well for the OECD to understand that a little bit better.

Julio Martinez-Clark: Yes. Also, the Pacific Alliance. The Pacific Alliance is the only trade bloc in Latin America that is promising to make Latin America become similar to Europe. Is the trade bloc of Mexico, Columbia, Chile, and Peru. These are three OECD countries, and Peru is in the ascension path to become a member. Peru just started recently. Even with the new government, Peru is seriously slowly in the path to become an OECD member. So these four countries are going to... They created 10 years ago, the Pacific Alliance, which is an integration of their economies. It started in the Indian region, which is something unique in the history of Latin America, the Indian countries, Colombia, Peru, Bolivia, Venezuela before, now is no longer part of the trade bloc, but is called the Indian Pact. These countries, Ecuador as well, there's free movement of people, there's recognition of medical degrees and any type of degrees. If you want to live in Ecuador, all you have to do is just go to a government office and say, " I want to become a resident from today." It's as simple as that. They started regulatory recognition of cosmetics and low- risk devices. The same thing is going to happen in the Pacific Alliance, which is the broader alliance of Mexico, Columbia, Peru and Chile. So eventually because one of the issues in Latin America, I think is that it's a fragmented region or economy. You have to get regulatory approval in every single market. With the Pacific Alliance, they're looking to have a homogeneous market where everybody recognizes the approval of any of the member countries.

Etienne: That makes sense. I'll include that as well. So the Pacific Alliance, the OECD.

Julio Martinez-Clark: Yes.

Etienne: Very cool.

Julio Martinez-Clark: Very important developments in the history of Latin America right now.

Etienne: Yeah. Okay. Well, I think that's a great place to stop unless you have any additional bombs you want to drop. I thought that was really good.

Julio Martinez-Clark: No, I'm good. I think I'm done.

Etienne: Okay. Well, thank you.

Julio Martinez-Clark: It's enough.

Etienne: And I hope in the next month that the introductions go well in your companies and I'm excited to see the new technologies that reach the market in the future. So this is good.

Julio Martinez-Clark: Thank you, Etienne. I appreciate you having me here.

Etienne: Absolutely. Thank you for those of you who are listening. Thank you. You've been listening to the Global Medical Device Podcast. Stay tuned, read the show notes. We'll have a few links for you to check out. As Julio said, some of the history and some of the different alliances and things that you can learn more about early feasibility studies in Latin America, if that is something that would be beneficial to your company. Thank you. And we will see you all next time.

Julio Martinez-Clark: All right. Bye- bye, Etienne.

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