EPISODE 38: OSCAR SEGURADO, CHIEF MEDICAL OFFICER AT ASC THERAPEUTICS

EPISODE 27: JOSÉ E. CABRERA, INDEPENDENT CONSULTANT AND FORMER VP OF RA/QA

Jose E. Cabrera is a 20 year veteran of the medical device industry. His focus has been in Regulatory Affairs, Clinical Affairs, and Quality Assurance. During his career, he has successfully created regulatory strategies for start-ups to find the quickest path to commercialization and reimbursement. From De Novo Petitions and Q-Subs with face to face meetings with the FDA to 510(k) clearances and routine change management and regulatory reporting. Jose has also lead teams in Latin American with regulatory, quality, and clinical compliance for Bausch and Lomb, and Zimmer Biomet Globally. He has an undergraduate in cellular biology and was a double-major in philosophy. He is currently acting as a VP of RA/QA and Clinical Affairs for a subsidiary of a $20 billion multi-national company headquartered in Germany, overseeing eight (8) global manufacturing sites for cardiovascular and neuromodulation devices. He also leads the company’s efforts to conduct due diligence activity for potential merger/acquisitions. He also served as an Army medic and trained West Point cadets while he was enlisted with the 101st Airborne Division, in Ft. Campbell KY. Jose currently resides in St. Paul Minnesota but he calls South Florida his home, having grown up in Miami and born in Havana Cuba.

Episode’s transcript

Julio Martinez: 0:04

Welcome to the LA MedTech Leaders Podcast. This is a conversation with MedTech leaders who have succeeded in Latin America today. Our guest is Jose Cabra . Hey, Jose, it is great to have you in the podcast today. How are you doing today?

José E. Cabrera: 0:21

Hey Julio. Thank you very much for having me. All is well, thank you.

Julio Martinez: 0:25

Fantastic. Jose, welcome to the show. So listeners, Jose is a 20 year veteran of the medical device industry. His focus has been in regulatory affairs, clinical affairs, and quality assurance. During his career, he has successfully created regulatory strategies for startups to find the quickest path to commercialization and reimbursement from the novel petitions and Q subs with face-to-face meetings with the FDA to five 10 K clearances and routine change management and regulatory reporting. Jose has also led teams in Latin America with regulatory quality and clinical compliance for Bausch La Zimmer biomed globally. He has an undergraduate in cellular biology and was a double major in philosophy. He's currently acting as vice president of regulatory affairs and quality affairs and clinical affairs for a subside area of a 20 billion multinational company acquirer in Germany. And he oversees eight global manufacturing sites for cardiovascular and motivation devices. <laugh> . He has also led the company's efforts conducting due diligence activity for potential merger and acquisitions. He has served as an army medic and trained West Point coed while he was enlisted with the hundred and first Airborne Division in Fort Campbell, Kentucky. Jose currently resides in St . Paul, Minnesota. He calls South Florida his home, having grown up in Miami and born in Havana, Cuba. So Jose, I think you're a superstar and I am really privileged to have you on the podcast today. So let's get started.

José E. Cabrera: 2:14

Thanks, Julio. That was a great intro . Thank you.

Julio Martinez: 2:17

Awesome. So could you please tell listeners, Jose, about your journey to Latin America? How do you make it to the region?

José E. Cabrera: 2:24

So otherwise, being born in Havana and I'm immigrated to Miami, I've lived in Miami all my life, and Spanish being my first language and always being , uh, spoken in the home. You know, I was always interested in doing something in the medical sciences. I went into biology and , uh, after doing some teaching, I found myself , uh, doing medical device work with a , uh, small startup company in Boca Raton, Florida, way back in 2000. Um, but immediately upon taking on those types of jobs because of my language skills in Spanish and my connections to family and friends all over Latin America, which I had , uh, made and had throughout growing up in Miami, I immediately gravitated towards helping organizations create that connection of commercialization in Latin America. And because I was able to connect quickly with some of the key players and key companies that are participating in the Latin American market, I was able to immediately provide good service to them on the regulatory and then eventually on the quality side.

Julio Martinez: 3:40

Okay, very good, Jose. So could you please tell us , um, about any major trends that you see happening in Latin America that are relevant to our discussion today?

José E. Cabrera: 3:53

Well, in general, from my perspective of regulatory and quality , in the 20 years that I've been able to see the market and the industry evolve, you know, one big example is , uh, the Brazilian market participating in the , um, uh, medical device , uh, standard audit program that is, that notified bodies, you know, for medical device companies offer as an option to qualify and certify your quality system. So Brazil opted into coming into that standard audit practice, which gives not just Brazilian companies that are participating in , uh, global markets, sort of a leg up in providing evidence that your quality system is up to standards. That is a trend that I've seen on the quality side. On the regulatory side, I continue to see Latin American regulatory agencies, ministries of health, become more sophisticated in understanding the management and the regulation of medical devices , the sophistication of the medical device itself, the technology and them having to continually understand and be plugged into these rapidly changing technologies that exist in medical device. But I will always see the Latin American market as a lagging market for the large medical device companies, typically when they launch a product, their first markets that they're interested in are those. That getting through FDA approvals is usually the harder path historically besides getting approval in Europe. But now, you know , I could talk a little bit about the European changes, which are very broad and very drastic now. It's pushing a lot of companies to initially market their products in the us uh , because of the difficulty , it is how difficult it is now to get CE marking. So with that FDA approval, immediately you can gain access and if you're in a US company, you can gain access to the Latin American market. Because typically what I've seen, there's some exceptions, maybe Brazil would be one , uh, where most of the ministries of health in Latin America will leverage a country of origin approval for a US company of FDA , whether you have a clearance with a five 10 K or a PMA device, I think that that's probably not gonna change. I think once you are able to get your FDA approval, you can get into the Latin American market. But if you're a Latin American company that's trying to gain FDA access or the US market access , uh, that's a little bit of a different hurdle. And you know, at that point you have to have enough people in your company to understand how to prepare applications for the FDA if you're starting to launch. And the trend that I'm seeing as well is mid Latin American being a stronger location for manufacturing. I think we're seeing a lot of this effect of the global pandemic now. You know, I've seen even Japan paying Japanese companies to get out of China. Uh, the company that I work for currently and others I've seen as well are focusing their efforts in central America for manufacturing. Costa Rica right now is becoming of large ecosystem for medical device manufacturing. We see Edwards Life sciences, you know, Invisalign, the company that's making the , uh, braces, those are all Boston Scientific has locations there , Medtronic as well. They're all focusing efforts in manufacturing in Latin America, in Costa Rica specifically. And Puerto Rico is also coming back a little bit with the medical device side. We know the history that they had with , uh, pharmaceutical manufacturing. So in general, those are the things that I'm seeing in Latin America. I mean, it's kind of an exciting time, especially now if we see all this manufacturing move back from China that we've seen in the last 10 years. I think a lot of this manufacturing could be easily done in Costa Rica and the universities and the educational systems in Latin America. And specifically, I'll continue talking about Costa Rica because that's my experience currently. Those college and universities are producing excellent engineers that are teaching quality concepts to these engineers almost right out of the door of school, being well prepared to come in as a , uh, entry level engineer in some of these medical device manufacturing locations. That's something that is really surprising and really exciting.

Julio Martinez: 8:47

Hmm , fantastic. Jose . That's quite a good answer <laugh> , by the way. And , uh, you know, it is the first time in this podcast that I touch, or that I guess touches on the topic of manufacturing medical devices in Latin America. It's a sector of the industry that nobody, I mean, people do not really talk about that much. And I'm very glad, very glad to hear that Costa Rica has become a , a hub of medical device manufacturing. I also heard something about Mexico , uh, the the northern part of Mexico. Do you know anything about that?

José E. Cabrera: 9:22

Yeah, that's been going on for probably the last, I would say, 10 years. You know, while there was an effort to transfer a lot of the manufacturing, the orthopedic companies were the leaders in going to China because it's fairly straightforward manufacturing. But for example, Cortis Technologies , Corti that was owned by Johnson Johnson that was headquartered in Miami , uh, and started as a Miami company, believe it or not, had moved their manufacturing to Juarez and the northern parts of Mexico where it's easy to get to the border and have, you know, NAFTA obviously drove a lot of this, these initiatives at the time when NAFTA was written. And it provided this ease of manufacturing. And there was, you know, it was close to the border because you wanted people, you needed talent to be able to run those manufacturing sites. cortis , which did , uh, stent technology, cardiac stents, and drug eluting stents. That's, you know, 25 years ago it was a very difficult many manufacturing process. But after a while, these products became more commodities. So as a commodity starts to evolve from a novel product, you eventually wanna bring down manufacturing costs. And you do that by going to places like Mexico. And if you nail down your quality system and your manufacturing processes and you have those well under control, it's possible to, to be able to go to , uh, countries in Latin America to get that manufacturing. I mean, I think, I think this is a trend that we should be seeing. If not, we should drive it ourselves. Because in order to serve the US market, bringing product from China is a long way, right? That's the slow boat to China as they call it. But if you have your manufacturing sites here in the Western hemisphere, you could easily serve the, the major markets, US , Canada , uh, easily sent to Europe as well. But I think that there's companies, there's medical device companies that are earnestly looking at Latin America as the next growth in manufacturing opportunities. And for those people that are involved in medical devices in Latin America, I know most of them, the distributor networks that, you know, work across all the types, all therapies. They could look at the portfolio, see what their products are that are selling at , uh, high cost , and maybe consider finding investment in Latin America to be able to build those products in Latin America, bring those costs down, serve those markets even better, and perhaps even serve the US market as well. But you know, you have to be very specific in the choices of the types of devices that you're making because the more complex designs of manufacturing obviously would cost more. Uh, we're talking about products that were novel at some point and that are eventually becoming commoditized, and we could look across all the entire medical device industry and find probably 20 or 30 devices that fit that criteria.

Julio Martinez: 12:26

Interesting point. Jose, have you heard about any other country in Latin America that is starting to have a medical device manufacturing facilities?

José E. Cabrera: 12:34

Well, I mean, Brazil has had a history of medical device manufacturing. Bausch and lom , as a matter of fact, has a large manufacturing facility in RE that does all their contact lens solutions that they still own Biomet, the orthopedic companies as well , uh, started setting up companies. But the Brazilian political landscape, you know, the fact that you cannot predict the ebbs and flows of politics, which then eventually affects business always with the fear of nationalization in very socialist minded countries. That's what American companies or global companies look at and, and, and eventually are reluctant to invest in those environments. I think Columbia being, you know, probably the closest US ally and the most stable of governments in Latin America would be an excellent location. You know, and being able to have a port where you could export easily and not have to, you know, bring it out of the center of the country or Brazil, how far, you know, that's, you might as well be bringing it from China if you're bringing it to the US market from Brazil, because that's a long, long ride as well. So all these ideas of logistics and efficient manufacturing, some very smart people could sit down and figure out and solve some problems that the US supply of even PPEs, we're seeing it now during the Corona pandemic. We're seeing the need for these types of simple devices that were commoditized long ago being manufactured in China. I would love to see a trend come back here to the Western hemisphere and have manufacturing facilities providing those types of devices because those, at the end of the day are medical devices, believe it or not, coming back here and supplying the US market without disruption or without fear of supply.

Julio Martinez: 14:30

Okay. Going back to the case of Brazil, because that's an interesting case. Brazil is famous for being a very protective country. They incentivize companies to set up their own facilities, manufacturing facilities so that they can create jobs and everything locally and companies get , uh, tax incentives and things of that nature. And so the, the manufacturing facilities in Brazil is my understanding, please correct me if I'm wrong, is to satisfy the local market because these companies wanna save money, wanna, wanna comply with local requirements, otherwise they won't be able to do business in Brazil. Um, but the other manufacturing that we were speaking about initially, Northern Mexico, Costa Rica, is to satisfy the US market, <laugh> and probably European market . So <laugh> kind of a different setup , but , uh,

José E. Cabrera: 15:18

You're exactly right. Brazil has been a little bit protectionist. China did the same model, right? In order for you to get an approval in China, it would be easier if you had a manufacturing facility in China. So Brazil took on sort of the same model as well. You know, whether that hurts them or benefits them, I, I can't really say, but it does create the opportunity for the type of business that maybe US companies don't really want to be involved with from a compliance or legal standpoint because you get into , uh, sticky situations where you're taking advantage of this incentive, but then your hands are tied , uh, to some degree because I think with those agreements, you have to supply the Brazilian market with a certain percentage of your production or certain prices. You know, obviously we know that there's price control in Brazil and uh , other parts of , uh, Latin America as well. So I'm not sure if it's very attractive for US companies, but maybe a Mexican company, maybe a , a company that's participating in the Merko Sur , you know, treaty triangle , uh, treaty with that creates ease of trade with other countries in Latin America. I think the products that are manufactured in Brazil have perhaps a good reputation in Latin America, but I would still see a US doctor preferring a US or European made medical device over a product made in Brazil. You know, and we do see when we see the label made in Mexico for a a , a stent that's gonna save someone's life. But Boston Scientific has its logo on it, or Medtronic or Abbot Vascular has their logos on it. You know, that the quality system that governs that manufacturing facility is at the US standard. So there's not much fear from that regard. And also, I think going back to the Costa Rica example, I think that those companies as well, when you, when it says made in Costa Rica and coming into the United States to the US market, I think that that is better received than something that says made in China. And I don't mean to, you know, to come down on the Chinese situation, but right now I have personal experience with some Chinese companies that were trying to get their COVID-19 testing , um, kits approved under the emergency. You know, the FDA created a regulatory framework for you to be, be able to get an approval under certain emergency situations. And in this case, this pandemic has created that situation, but it's also created, you know, dozens and dozens of medical device companies coming outta China trying to sell their useless non-working non-validated. This is not my opinion, this has been substantiated. Yeah, Abbott was the first company to get the , uh, COVID-19 quick test approved by the FDA and they on taking it on themselves, they purchased , uh, and this is an article as well that's been published. They purchased a series of the COVID-19 instant tests or rapid tests, and they tested it themselves and 75% of them came back with false positives or incorrect results. So, you know, this is World War iii , not with guns and tanks, this is with economic , uh, fraud and, and strategies to bring down , uh, the US economy in such to , to its sneeze . I'm not gonna get into where Covid came from, but that's a different podcast or topic <laugh> . Uh , but you know, there is the trend here and there's gonna be a lot of backlash in my opinion, especially when Japan comes out, like I said earlier, and says, we will pay you millions of dollars, you know, talking to their Japanese companies to pull manufacturing out of China. So we're gonna see an interesting trend here. Hopefully I'm still around and alive to experience it because I'd love to see manufacturing come back to the United States, come back to the Western hemisphere at least, and reclaim what is ours.

Julio Martinez: 19:29

Yeah, that's a very good point. Very good point. Yeah. Hopefully Latin America will benefit from that because , uh, it's vastly needed, especially now with so much economic uncertainty going on in these countries because of the covid.

José E. Cabrera: 19:42

Yeah, if you see what happened to Costa Rica, if you visited Bens and , uh, Cartago in 10 or 12 or 13 years ago, it was still a third world country town. But if you go today, you know, Hyatt has set up every American company, Denny's of Starbucks, you could walk down the streets of Cartago and you think you're in little in Miami actually, because it's become so modern and has benefited the local economy, it has benefited the local people. It has given 'em the opportunity to take high level skills like engineering , um, and apply those and create a little ecosystem of a medical device, free trade zones where medical device companies are setting up. And that's the incentive that the Costa Rican government allows them to set up in these free trade zones so that they could produce product and sell product without any tax .

Julio Martinez: 20:41

Interesting. Awesome. Alright , so let's move forward here. So Jose , I know that your time is limited, but , um, the next question that I usually ask my guests in this introductory section of the episode is about your overall perception of Latin America as a place to either conduct , uh, clinical research , uh, or to commercialize medical technologies. What are your thoughts on that? Mm-Hmm,

José E. Cabrera: 21:04

<affirmative> . So, okay. So on the clinical side , um, I think that Latin America and certain countries in Latin America have created or gained a good reputation of being able to conduct clinical studies according to GCP standards that are recognized by Europe and by the us . I don't have to remind your audience that if you are conducting clinical studies in Latin America and you intend to use that clinical data to support a US FDA pre-market application, the reviewers at the FDA are gonna look at your clinical data and they don't really care where it came from. They're gonna measure the requirements, they're gonna measure it against the requirements of the code of federal regulations. The, the parts that apply to clinical studies, trying to remember the part number now and a , uh, part 50 and part 56 a part A 20 is the , uh, medical device manufacturing. But part 50 and part 56 are the ones, and for IDs as well, those are the regulations that you have to meet. So if you're able to conduct a clinical study, find reputable part partners and contract research organizations in Latin America, which have been evolving, and I've seen that as a trend as well for the last 15 years, there's more sophistication in these organizations in Latin America to understand how to conduct clinical studies. What are the requirements? What are the elements of a informed consent form of a case report form? What are the things that you need to design and build for a clinical study to have weight and , uh, and leverage when you're going for an FDA application? So that's something that, you know, can be verified with the experience of the partners that you, that you find. It's very rare. Do I see large companies like Medtronic or Boston Scientific or Abbot Vascular to pick on them, as I always do, to set up, you know, clinical affairs or medical affairs offices in Latin America, what they'll do is they'll typically just partner , uh, and smaller companies will do this as well, to save money from the cost of conducting an IDE study in , in the United States, because you have to pay those clinical sites and you have to pay those clinical doctors US value versus , uh, being able to, you know, save some money and go to Latin America. But again, it's very important that you do your research, you do your due diligence and make sure that the people that you are choosing to run your clinical study in Latin America are very familiar with what your strategy is, where they understand where your application is gonna go, where your data's gonna be used, if you're doing marketing studies or if you're doing approval studies, or if you're doing follow-up studies, maybe to even support Europe, because now the European market is very difficult to get in, and the type of clinical data that you need to get into Europe is gonna be almost at the same level that the FDA requires, if not even more so. European companies might see an opportunity to go to Latin America to do these types of clinical studies that they would normally not had to do for class two products in Europe. Now they, because of the new regulations in Europe, they have to go find this clinical data somewhere. And you think it's expensive running a clinical study in the US try looking at running a clinical study in Europe Now under the new regulations. I mean, it's a complete pendulum swing. And this is gonna benefit the US because we're gonna see more clinical studies in the us uh, perhaps to support , uh, European companies. We're gonna see u US companies focusing first on the US on the US market, rather than getting a , a quick and easy CE mark for a class two device. So that it's interesting to be alive at in these times the regulatory landscape is reshaping how businesses are spending their money, what markets they're choosing to go to first, what the reimbursement strategies are as well, how , how do they formulate those from the very beginning. So that's on the clinical side. And then on the commercialization side, you know, I think that model has been in place and that one's pretty stable. I've seen, you know, the typical business model , uh, for distribution of US products is that if the company is large enough to have an office in Mexico , um, like Biomet does, or Baal LOM has an office in Brazil, they'll serve as their in-country representation to sell their products, right? But if you're a, a smaller company or a mid-size company that have not built , built the inf the sales infrastructure yet to be able to reach those markets, then you have to work through the distributor networks. And the choosing of the distributor is the most important decision that you're gonna make when you go to that market, when you go to that country, because that relationship , uh, aside from these distributors being around, you know, these organizations have been around 20, 30, 40, 50 years in some cases. Um, these are tried and true companies that have a family history owned by generations of families , uh, in some ca not in all cases, but in some cases I've seen, seen that they've seen it all. They've seen CEOs come and go, they've seen salespeople come and go and they stay true to their portfolio selling the products that make them money. So if you're able to approach these companies that have been around for a long time and plan to be around for a long time, these are your best bets for your distributors. Look at the portfolios that they have, see what other products that they're selling, are they aligned with your type of product? Are they gonna have to make an effort separately to sell your product, or are they gonna be able to walk into their normal , uh, hospitals and doctors' offices already with the products that they've been selling and just supplement their portfolio with the product that is along the same lines and being able to sell to the same people. You're not gonna sell dental products to an orthopedic distributor, they're not gonna take you, right? Because they don't have , uh, even though it might be implants and titanium and the same types of technology , uh, I'm not gonna , we're not gonna see orthopedic companies sell dental devices. So you have to be very strategic , uh, in, in finding your distributor. Uh, if you find that relationship, it's gonna be for a long time plan to be with them for a very long time because to get out of those relationships , uh, it could cost you more than , uh, just to get in. So , um, and, and, and not that, not that they're gonna hold your product for ransom. The thing is that you would have to perhaps re-register the product , uh, with a , with the other distributor, because the distributor in many cases in Latin America, acts as the marketing authorization holder. So they have your approval , uh, as a US company. Um, so you just can't walk away. You have to sit down at the table and have a , a , you know, a conversation about, you know, why you have to break up, you know, it's like a bad divorce sometimes, but hopefully it doesn't have to be like a bad divorce. You could make it , uh, so that everybody benefits , um, because I'm sure they're doing it as a result of being acquired by another company or some other force that, you know, because nobody wants to make these changes. Everybody wants a continuous supply of the product, continuous un uninterrupted commercialization of your product. Nobody wants to break up, right? But occasionally you're forced to because of circumstances that are not under your control. A

Julio Martinez: 29:06

Common mistake that companies , um, make sometimes even consciously, they know they're making the mistake <laugh> , and they do it anyway , uh, to save money is to let the distributor control own and pay for the registration certificate. So you cannot really predict the future . I mean, at the beginning, the relationship is very rosy. Everybody's happy, you have great, great goals, great expectations, but um , uh, after a year or so, you realize that the shooter didn't really meet their goals. It wasn't what you expected. So then that conversation that you're talking about will have to take place. I mean, how can we transfer the registration to a competing distributor? So then the distributor can name pretty much any price that he wants. So that's not a good position to be in. So companies have to be a little smarter , uh, on that. Actually, the US commercial service on its website has a very clear message, at least for Columbia , uh, where I have a special focus. Um, if you go to the , uh, section where they talk about the Columbia medical device market, they give some recommendations and the first recommendation is do not let distributor hold the registrar certificate under its name. Because the validity of the certificate in Columbia is 10 years. So you are actually, you're implicitly giving the distributor a 10 year exclusivity <laugh> for the sales of your product in Columbia . That's not a good thing. <laugh>.

José E. Cabrera: 30:39

Yeah. And you know, at the very center of that relationship is a, an agreement, right? It's a supply agreement, but there's also a quality agreement and the regulatory agreement you have to incorporate all three elements into your negotiation with these , uh, distributors. And , uh, you know, it's very, everybody's very business focused , right? Let's set the quotas. How much are you gonna sell? What's your commercialization strategy? Do you need marketing materials? Do you need me to translate them? All that stuff could be negotiated, but you should have very clear language in distribution contracts that have clear quality requirements, because now that's being sort of emphasized by US companies and certainly by European companies. If they're using a distributor in Latin America for their European product, they're gonna have to have a very strong quality and regulatory agreement in place. You know, I've negotiated hundreds of those and it's very difficult sometimes to be able to negotiate the fact that I will keep my registration if we're, if this relationship is dissolved. But still, even with that type of language in the contract, depending on which country you're in, it's not possible to just transfer the registration. You have to reapply and right there you could open up a six month to a year gap in being able to sell your product. So the negotiation away from the old distributor should be something to the effect of, help us continue selling this product. You know, we will negotiate a new rate, negotiate a new margin , um, but do not, you know, let us interrupt the supply of this product coming to the market. And you know, and again, leave amicably with the relationship. Do not make enemies <laugh> in , you know, in that market because the distributor that you break his heart, he knows who the distributor that you're gonna go work for or work with. And, you know, they could share information very easily because at the end of the day, they're competing, but they're also in the same market that both require that market to stay alive and viable for them to operate and survive. Yeah,

Julio Martinez: 32:53

Yeah. Well said. Well , um, yeah, you touch on very good points . One is there's also the figure of the registration holder in many of these countries in Latin America, it's a third party that can hold the registration under the local entity's name. Uh, or in the case of Columbia , there may be another country in Latin America also, but in the case of Columbia , as a foreign manufacturer, also allowed to, to have the registration under your foreign entity's name, which is a really, really good advantage. Um, the other thing that I like, I really like what you said about every distributor agreement, and it's the first person that I hear saying this so clearly is really three agreements in one. It's a commercial agreement. It's a regulatory agreement, is a quality agreement as well. That's well said. Uh, Jose. Yeah, yeah,

José E. Cabrera: 33:43

That's right. The quality agreement is gonna dictate how are you storing their products? What warehouse are you at? Are you using first in , first out first ? Do you have procedures for recalls and for collecting , uh, complaints from your Colombian doctors or wherever country you're in, you have to feed that information back to the quality system of the larger company that you're selling products for. It is a requirement for them. It , they have to have that, they have to bring that to the table, to the distributor in those agreements. If they're not doing that, they , I they need more

Julio Martinez: 34:16

Help <laugh>. Absolutely. Just say that . Absolutely . Yes. Yes . Thank you for the commercial <laugh>. I like that. I like that . Alright. Uh , Jose, I know we only have about , uh, one minute left. So before we sign up for today, what would you say to the CEO of a medical device company that is just starting to look at Latin America as a place to, to do research or to sell its products? What, if you had him in front of you, what would you say to him?

José E. Cabrera: 34:44

First of all, find someone who in their team that has experience with Latin America, don't go in completely blind. You know, make sure that you, you surround yourself with people that have , have done business in Latin America. That's for one. Once you do that, then find the right partner. And you could find partners in Latin America that could serve the entire region. So for example, you could find a company in Columbia that could help you organize, strategize every single thing that you need to do business in Latin America, from conducting clinical studies to the regulatory approvals, to setting up procedures for many quality systems that you might need. Um, but please, I would encourage every CEO that's listening to this podcast that is considering Latin America to please go and investigate it because there are opportunities there, there are underserved therapies there, there are products that , uh, that are not getting to the Latin American market that need to get to the Latin American market. And if you can come with the right price, you'll be extremely successful. I've seen it over and over again. Um, and if you're on the manufacturing side, even more so, I think there's even more opportunities there for very simple devices. Uh , class one , class two devices that are normally manufactured elsewhere in the world. I think Latin America is another great opportunity for that. So I'll leave you with that.

Julio Martinez: 36:06

Fantastic. Jose, how can people contact you?

José E. Cabrera: 36:09

LinkedIn please. Jose E. Cabrera, JOSE , middle initial e, last name Cabrera Cabrera , C-A-B-R-E-R-A. Please reach through there. Um, I have , uh, over 2000 followers and , uh, you can see my profile and , uh, and easily communicate through there.

Julio Martinez: 36:28

Fantastic, Jose, we're gonna include a link to your LinkedIn profile in the page of the , uh, podcast episode. So thank you so much, Jose. You are a wealth of knowledge. I mean, I really enjoy our conversation today and I , uh, and I'm sure listeners got a lot , uh, out of this as well. So thank you again. Have a great day. Be safe and we'll talk soon.

José E. Cabrera: 36:51

Thank you. You too. And thank you to all, all your listeners. Alright . Take care and uh , be safe and healthy. Okay, Bye-Bye bye-Bye .