Episode’s transcript

Julio Martinez: 0:00

Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher Tune in iHeart Radio, Pandora or deser . Welcome back to the Lifetime MedTech Leaders podcast. Today our guest is Gerardo Noriega. Hey Gerardo, it's great to have you here in the show. How are you doing today?

Gerardo Noriega: 0:28

Thank you, Julio. Thank you for the invitation. I'm really excited to be part of your podcast. Thank you so much for the kind invitation.

Julio Martinez: 0:36

Sure, my pleasure. Alright , listeners, Gerardo is a C-level executive, zero entrepreneur, inventor and scholar in the medical device industry. He founded five medical device companies and he's a consultant to over 50 medical device companies in the Silicon Valley area. He's an advisory board member of the Santa Clara University, SCU BioE , the University of California, San Francisco UCSF Catalyst Program, the UCSF Surgical Consortium, and the Simon Fraser University Bioengineering Innovation Boulevard. I hope I said all these right. <laugh> . He's also an adjunct professor at the SCU Graduate School of Bioengineering. Herardo has a BS in Industrial and Systems Engineering from the San Jose State University. So Herardo, I'm really pleased to have you here in the show. I really look forward to our conversation today. I'm quite impressed with your experience doing clinical research with innovative medical devices in Latin America. So let's get started. So first, could you please tell , uh, listeners about your journey to Latin America? How is it that you got involved , uh, in the region?

Gerardo Noriega: 1:51

Well, who , I've been in the industry for over 30 years. Uh , all in medical devices like most of the engineers that graduated from the Silicon Valley area. Uh , we typically end up in high tech . In my case, I started in , um, telecommunications, fiber optics technology very early on in my career. But very soon the company decided to stop the work with fiber optics and we were the only company in the Silicon Valley at the time. I just simply couldn't believe it that they were doing such a thing. And they asked me to move to LA and I said, no, I'm not. So I decided to join a medical company and since then I haven't started, but I always, in my heart, I knew there was a huge , uh, benefit for most of early stage companies to do studies in Latin America all along. 'cause I knew the , the quality of the physicians, the need for the Society of New therapies and how well received would be someone , uh, bilingual that understood the society and the, the details that , um, are useful for clinical studies. And sure enough, I executed my plan accordingly.

Julio Martinez: 3:14

All right . But you are from Peru, right?

Gerardo Noriega: 3:17

Yeah, I came to the US to the San Francisco area in 1977 , uh, from Lima. And I studied engineering , uh, San Francisco State University.

Julio Martinez: 3:28

Fantastic. So you have a personal link to Latin America, which is even better for what you were doing with clinical research because you are able to understand the local culture and the language of course, and it makes things a lot easier.

Gerardo Noriega: 3:43

Yeah, a lot. Definitely Julio. Definitely.

Julio Martinez: 3:46

Yeah. So let's talk about the trends that you see happening in Latin America. Herardo, what the pdmi logical economic or social political trends you see happening in Latin America that are relevant uh , to our discussion uh , today?

Gerardo Noriega: 4:02

Well, it's quite evident that , um, Latin America needs simpler, more effective type of therapies. Also more affordable is needless to say , uh, the high-end , uh, like heart transplants and those type of things probably are a little bit on the heart to reach for most of the Latin American society. But there are new therapies that are more affordable for people that , um, need more expensive type of therapies such as robotic surgery and so on and so forth. So the need is huge to improve the medical care at affordable prices. So that's something always in my mind when I try to assess whether we should go to Latin America or somewhere else for the initial , uh, validation of our , uh, technologies.

Julio Martinez: 5:01

Yeah, makes sense. Absolutely. Alright , so let's talk about what's your overall perception of the region as a place to conduct clinical research or to commercialize medical technologies?

Gerardo Noriega: 5:13

What I found through my travels in , in different countries in South America, that the physicians are very, very receptive and always very inquisitive. And to find someone that is bilingual in which they can express but are to trying to accomplish or the needs is huge. Like when I was in Brazil, I was in the, OR I was able to communicate in Portuguese with the nurses, the physicians, the assistant, even with the patients sometimes. So that was huge 'cause I could say, how are you feeling? What do you think of the therapy? You know, right after and with the physicians, they didn't have to translate. So I became part of the team. So I suggest for companies that are , um, trying to do studies to bring someone that , um, is bilingual, but also knowledgeable on the clinical aspects, because you don't need a translator. You need someone that is able and is skilled to talk to the physicians and the team, then what happens? You get firsthand information from them. There is no translation, nothing, just this is it. And, and that's the best way to see how well your technology is performing in general, all the physicians that I found in every country that I have been to , um, they have been very receptive to new therapies.

Julio Martinez: 6:42

Okay. Very good. Alright , so let's get a little bit more into the practical experience now that you mentioned countries. What specific countries you've been involved in trials in, in , in Latin America?

Gerardo Noriega: 6:54

Well , I used to do a lot of studies in Venezuela when the situation was, it wasn't as bad. You know, this , I'm talking about the year 2000, almost 20 years ago for about I would say five to six years. I did a lot of studies there and I found that the physicians in Venezuela were really engaged and they very knowledgeable on the latest therapies. In fact , uh, the most of the cardiovascular meetings that I used to attend, the largest groups worldwide were physicians from Venezuela. The US obviously were the majority, but the second Venezuela and then Asian countries after that, even more than Brazil. So most of the physicians really were up to par with the latest technology and they knew what I was talking about. So that was very helpful when I went there. And they were very, very receptive. Also, the fact that , um, I've done studies in Brazil at Dante , which is , uh, the number one center in Sao Pao for Brazil, other Einstein. So again, the fact that I was able to communicate with the staff and I became part of the group. So I didn't need anybody to tell me and get lost in the translation. And I was able to communicate carefully with , uh, my engineering staff . 'cause I was the only one that was bilingual. So I've done a lot of work in Argentina, the center of , uh, Olo Cardiovascular Institute also. And that was an incredible experience there too. Um, also in Colombia , uh, with you, Julio , um, I , I've been exposed to and I really want to go to Columbia . And first of all, the proximity's incredible for us. It's very practical, but also the fact that the physicians that I've spoken to, I've been very receptive to new technology, new therapies, and almost inquisitive as to why, you know, where I bring fits in their society needs. So other countries I spoke with , uh, some physicians in Chile, Chile and Peru, Ecuador, oh , also Mexico, definitely. I did a lot of work in Mexico as well, Mexico City. I talked to many physicians there with the advisory board , uh, the clinics and so on and so forth. So pretty well versed what's, you know, what the needs are. But in general, commonly all the physicians were really skilled and very perceptive, willing to adopt new therapies.

Julio Martinez: 9:41

Okay. Can we talk about , uh, Paraguay ? Why is Parkay a place where a lot of companies in the Silicon Valley area go to their early feasibility trials ?

Gerardo Noriega: 9:51

Well, first of all , um, Dr. Ebner have done an incredible great job promoting, and he's very skilled surgeon. So many of the cardiovascular , um, companies know him. So he personally , uh, oversees the study . So it's not like he's just a connector. He actually gets involved. So companies feel very comfortable that he's able to, you know, to perform the surgeries or the procedures , um, himself. So you get firsthand feedback. So that's one reason, although logistically that was the biggest complaint. It was kind of far to go to per where you had to go to Brazil first and then take another plane or that was an issue. But , uh, in general, most companies were very satisfied with the clinical outcome. Also, the fact that , um, the requirements to get into the country were very accessible to companies. So that's one of the hurdles that I found. And the bigger stopper, I would say the level of bureaucracy that you have to endure to get to your study. And sometimes company get antsy and say, forget it, we'll go somewhere else. And if that hurdle could be overcome, I think it could, because other countries have done it in the Eastern blocks, now they're going to Slovenia. I mean, no one in the past used to go to Slovenia or Georgia, even , um, you know , Prague. These are new countries that companies are going to. Uh , the reason is because , uh, the , the hurdles to overcome from the administrative point of view are nominal to none. I heard for instance, Malaysia, if you wanna go to Malaysia, all you need is ethics committee approval.

Julio Martinez: 11:47

Yeah. And that's the same way in New Zealand, right?

Gerardo Noriega: 11:51

In New Zealand is some of it. But still you need to have , um, you know , the ethics committee approve your protocol, and then the country authorities giving the clinical feedback from the committee, they approve it, which makes sense in most countries. Actually the opposite, the administrators. And you cannot move unless the clinical is afterwards. And it doesn't really make sense because really this is a clinical concept. So if you can have the feedback from the clinicians first, then the administrators can ask the right questions to the companies. Okay.

Julio Martinez: 12:27

Okay. So a follow up question to what you're referring to Herardo, is what country or countries in Latin America are the forefront of being receptive to facilitating medical device companies from the US or Europe doing trials in their territories?

Gerardo Noriega: 12:46

Well, Brazil used to be the one, but um , the amount of , uh, administrative , uh, due diligence that you have to go to is basically have turned off just about every company that I spoken with. So nobody goes to Brazil anymore for commercialization, obviously. Yes, because once you get FDA approval, they adopt that and they allow you to. But by then, you know, you have other markets competing for your products, especially , uh, you know, in Europe that basically they have more money to pay for your products. So salespeople, they tend to focus that. And we become secondary. We, meaning Latin America becomes a secondary or complimentary market . So you focus European markets, Asian markets, and then Latin America, there's no need to do that. I mean , quite frankly, 'cause the need is huge. If we can overcome the administrative hurdles, like in Mexico, it's just right across for us, it's one hour flight, I mean, to Mexico City. But it takes six to eight months to get response Doesn't work. No , you cannot wait because we don't have revenues. All we have is expenses. So we need feedback that adds , um, you know, makes our investors more , uh, at ease with the level of risk that they have taken. Okay . Investing in a company. Okay . That is new. Okay .

Julio Martinez: 14:11

So Brazil used to be a great place. Not anymore. Mexico, not anymore either. While countries are the forefront, Columbia , Columbia

Gerardo Noriega: 14:20

Definitely is in the forefront of everybody. From the people that I've spoken with. It is, although I must say Julio, the administrative hurdles is still I think a big , um, stopper I would say for , um, getting there. But , um, from the technical point of view, I hear that , um, and I , I can verify this for my own , um, company, the data profile of the patients is better than anywhere else I've seen. So in Colombia , you can identify very quickly where you want to do your clinical studies because you know, the data on the potential patients exists and you have access to that, unlike other countries in Latin America that they have some information, but not to the level that Columbia does .

Julio Martinez: 15:14

Yeah. This may sound like a commercial because I'm Colombian , I focus my efforts in Colombia . But uh , um, objectively speaking, Colombia to my understanding is the best country in Latin America in gathering data from the healthcare system. Uh , in other words, the Ministry of Health does the best job in Latin America, capturing every patient encounter, every patient treatment that is happening in the system. And it's a large country of 50 million people. And the database called syspro is the most complete database in the whole region of Latin America. And that helps companies identify patient cohorts or subsets that they need. And in terms of the quality of the data, that's another great point, Gerardo. There's something in Columbia that I don't know if happens in other countries. I've never heard about something similar before. But um, in 2008, the Ministry of Health in Colombia , probably because of the pressure from big pharma that was doing trials in Columbia a lot wanted to increase the level of sophistication and the level of ity on gathering the data, the clinical data that they needed. So they implemented a certification process following I-C-H-G-C-P guidelines where you don't have to be not only certified at the personal level as an investigator and also as a part of the staff that is participating in the trial, but also at the institutional level. You have to be certified. And it's a very long and rigorous certification process that takes about a year and is expensive. So only fairly decent and sophisticated healthcare institutions can have these certifications. So that ensures that you have quality data. So, yeah. Alright , so moving along here, what about choosing investigators in Latin America? What would be the process that a company will have to go through to find an investigator in Columbia or any other country where they want to do their trials? What's been your experience?

Gerardo Noriega: 17:17

When I go to the cardiology meetings or neurology meetings or any kind of medical meeting that I'm interested, I typically like to see what is the profile of the attendees. And then I see which countries from Latin America , uh, attending. And then when I hear somebody speaking, you know, the language, I approach 'em and I ask them where are they from? And you know, what is their background? And I can read in the batch they're , you know, salespeople or , uh, physicians. So I approach them and I start to learn, you know, what is, why are they there? Typically the ones that attend the meetings are the , the most well known physicians in Latin America. Uh , so I know that I'm talking to the people that are really interested in new technologies. So that's my first step. More of a personal one-to-one connection. And that's a method that I've used for years, but perhaps not the most effective because only the locals know , uh, which centers are more prominent than others. Now they're better than others . But the ones that the physicians that are more interested in new approaches, they can identify that for me. So in the past it was more of one-to-one and personal connections or referrals. Uh , the doctors in Venezuela that I used to work with, they refer me to the ones in Columbia . So I make that connection and I talk to them, but they don't know the hurdles, the administrative hurdles that I have to go through. So there's a gap there. And now , um, because of , um, company Julio, that gap had been minimized or reduced to , to the level that , um, companies such as mine , uh, will find very, very beneficial. So that is really a huge, huge hurdle that we have to overcome every time we go to a new country. Even though I speak the language, even though I know the local, but the physicians do not know the administrative heralds , they refer , oh , call and visa , oh , call, you know , Amma , I call coffee priest or call them, give me a , I'll never, first of all, who am I gonna call?

Julio Martinez: 19:38

<laugh> ? Exactly. <laugh>. Alright , so you're bringing up a good point. Will you use as contract research organization in Latin America for a clinical trial as your o Yeah,

Gerardo Noriega: 19:48

Yeah. Initially in the past I used to bring my own team, but then the team have to find somebody local to interface. So that worked because I speak the language and because I was able to connect directly with the administrators. But that's not really the case in every single company. In fact, most of them probably are not. So you need someone that knows the local , um, procedures, the local connections and how to walk through. So going forward, because there were not companies such as yours operating in the past, if there were, there were very few or very small or not sophisticated enough. So more of an administrator handler. And what we need is some , uh, real organization with clinical structure that says , don't worry about, we'll do the follow up . We know the culture, we know how to work with the physician , we guard your data, we will guard it like you would , uh, in the other countries. And that's huge for a company because really the data is all we have. So we need , um, someone that , um, is , recognizes the importance of gathering the follow up data. How do you find the people? Because that's a hurdle. I mean, even here, you know, when you tell the patient come back, you have to call them and it's kind of a stay on top of it.

Julio Martinez: 21:22

Yeah, you're bringing up a good point . Very good point. Uh , in the past , um, what I've seen and , and what I still see even in Colombia and other countries is individuals. I mean, you may have a consultant here and there in Peru, in Colombia and Chile that kind of help you navigate the waters of the administrative hurdles as you've mentioned. But it's just one person is a solo show without any structure, without any formal organizational , um, entity , and it doesn't generate much trust. Versus having a company that has a long history of helping medical device companies do trials in Latin America. I , I think , uh, that model is kind of , um, unique in Latin America, having a a third party be the facilitator of the whole process for a US company or European company to enter this market , uh, for clinical research. The other question that I had , Gerardo, is about your plans. You mentioned that you are engaged in a company right now, you are the CEO that wasn't in your bio, but could you please explain to listeners what you're doing now, what your plans are in terms of clinical research in Latin America?

Gerardo Noriega: 22:40

Sure. In 1999 , uh, I joined forces with a very well known entrepreneur, physician, Dr . Al Chin . And we are both a part of the UCSF catalyst program where we assess and novel technologies in different fields. So we got to know each other and we, we like our style of , um, running the business. He's a physician, which is of tremendous value for , uh, early on startup . So we decide to join forces. And in January this year, actually in December, 2019, we were able to receive our first , um, funding from investors. And in January 1st we opened our facility and here we are six months later and we have , um, animal data showing our technique for congestive heart failure, supporting the left ventricle to provide , um, um, and improve hemodynamic flow into the human anatomy works. I mean, in six months I was able to build an incredible team of people, software, hardware , um, catheter based type of engineers. And we are here, we are, we're ready to do more studies. So hopefully this time next year we'll be looking into our first in inhuman . I would say October, no , probably October timeframe next year, October , November timeframe, next year God willing will be , um, doing our first studies in humans. But , um, you know , I've done this enough times to know the path and not to take , uh, shortcuts. We need to make sure that we have safety first and efficacy next. So always looking after the safety aspect of your technology. Because efficacy, we don't know. I mean, it's an unknown. This is new, but safety we can prevent when the physician opens the device, it better work. That's the bottom line. So once you have that , um, you need a good center and be very careful and very selective the type of patients that you'll be treating. So that's what I meant by the data provided by Columbia authorities, ministry of Health and so on and so forth is crucial because you can identify your first patient, which is extremely, extremely important. Uh , when you bring a new therapy, regardless what it is, where is dentistry, oral x , urology and ecology, cardio, neural whatever, robotics or non robotics is very important, that data. So once you identify the , the pool of patients , then you need to find a , the right operator to that is willing to also communicate with the physician from the us . So language barrier, not necessarily because , um, medicine uses typically the same terms, kind of Latin-based names. So everybody knows and they get it because you look at the fluoro and they know exactly what you're looking for. So, but the language helps definitely if the doctor is bilingual, doesn't have to be totally fluent, but he has to be able to communicate with the US physicians. That is of tremendous value too . So I believe , um, from the doctors that I met in the past , um, Columbia has a very good, you know, pool of physicians that are bilingual and willing to work with us. Also working with you clearly. I mean that , what am I looking for? What is my technology all about? So you can identify because you know the local physicians better than I do. I have some friends that , but the friend can refer me to a friend. And then it's kind of like the broken phone. You start with a friend at the end, it's totally distorted, you know exactly who are you dealing with. So , um, and that's of huge, huge value. When I went to Brazil form more of a personal connection, the CRO was introduced by the physician to us. So I did not have a connection with the CRO , which is not your case because in this case you are the CRO and you handle the administrative stuff for the company. And so in my case, I was a bit disconnected, my status in Brazil because I didn't not know anybody in the CRO . So I had to do some homework there.

Julio Martinez: 27:25

Okay. Have you found that , uh, a lot of these individuals, consultants that you find these countries and also local CROs are not really Americanized? In other words, they may not speak the language well enough or they may not really understand the way to do business in the us And my experience that has happened , uh, to me, you may find a consultant in Columbia for example, or in Peru, in Chile, but uh , his or her English is broken. And when you are about to sign a contract, they don't understand the contract, they don't understand the legal terminology, they don't understand the , the American way of doing business. And that's sometimes a , there's a disconnect there.

Gerardo Noriega: 28:11

Yeah, they're more like an expediter. The expediter, you give the documents and they know where to take it for a stamp and that their job is done and then they give you the paper with the stamp right from the Minister of Health. No need to ask either because that's, you will turn, you will say, no way , all I wanna see the paper, can I move forward with this paper? Yeah , you , you can take it to the ethics committee and they , that's it. And then you go to the ethics committee with the papers . Okay, great, now let's talk. And then what, who is gonna do your, oh, I have a friend or the nurse is part-time, do the follow up ? Or do you need to ring your own? You bring your own and he's not bilingual. How is this person going to communicate? So it's better to use an organization that is professional and also knows the American way of doing business, which is not really the American way, it's the proper way to conduct a clinical study. But you know, we kind of created this format that many countries follow. Don't take me wrong, if you go to China, it's probably the same. You know, it's not easy to go and conduct a size in China and they have more than 1 billion people. I mean, you'll find the right population for your medical technology .

Julio Martinez: 29:32

And you know what I um, I think that uh , um, and this sounds, it may sound like a commercial, but I , I think it's very relevant to discuss here. We are a US based entity and uh, I've been living in the US for over 25 years. And that in itself generates so much trust because when I get on a call with an American company, with the CEO of a medical device company, for example, Francisco for example, I mean I can speak fairly decent in American English, I can use the same words that he uses. I write the same type of emails that he writes. I am a US based entity. If there is , God forbid any problem or something, he can take me to court in the US so he feels comfortable doing business with the US entity, with the same contract, with the same language, with the same terms. So with the Florida law, in my case, or Nevada law was a company from Nevada. So it makes things a lot easier versus sending or wiring money to Columbia , Peru, or Chile to somebody who you don't really know what they're gonna do <laugh> , if they're gonna follow through with the promise that we're gonna do. I mean, so yeah, with the payment. Exactly ,

Gerardo Noriega: 30:40

You're right. So there was an issue when they did size in Brazil. Where do we wire the money in Venezuela too ? How do we know you're gonna get paid ? Does it go to the personal account or the physician or how do we pay? And then the physician have to pay the , the group. And that was always a challenge. Um, and I'm telling you, Brazil, it was kind of the top place to do a study , but the hurdles have become worse and worse every year. They tried to revamp it that I don't know why there are so many layers the same as in Peru to Argentina. You would think, you know, oh wow . A lot of people go there, but the same, the hurdles will overcome are astronomical. And that turns you off right there in para Hawaii is that's why people go there because the hurdles are nominal to none .

Julio Martinez: 31:36

Okay. Okay. And , uh, let's talk a little bit about Paraguay because it , it is really a , a country that is kind of intriguing to me and the work of Dr. Ebner is phenomenal. I mean, he's being able to draw attention to such a small country with the quality of his work. And also he's a US trained physician. He trained at the University of Miami, if I understand correctly. But , uh, there's also some limitations. I mean, the population of the country is small, he's just a cardiovascular surgeon or interventional cardiologist, I'm not so sure. But he focuses in cardiology. So if you are a medical device company in another therapeutic area, Paraguay may not be the right place. Am I correct or, or

Gerardo Noriega: 32:18

Not? That is correct.

Julio Martinez: 32:20

Okay.

Gerardo Noriega: 32:21

But the level of skill or the physician might not suit your needs , you just don't know . But , uh, Ebner is known for the cardio peripheral vasculature and so on and so forth. But if you go to neuro, he may recommend a friend that I never heard of , um, company outside of that space, although I approach him once in a urology company. But , um, he was not like totally into it 'cause it's not his field. So, and I went, I did studies in Venezuela when I could go there and it was great. I mean we did very well. We treated seven patients on that trip and it was very successful.

Julio Martinez: 33:10

Yeah, what I've seen Herardo is that some companies go to Paraguay, they do 3, 4, 5 patients just proof of concept real quickly without many administrative huddles. Sometimes even bring the devices in their personal luggage, in their computer bag <laugh> . And they show that the device actually works in humans, at least on five patients. And then they move into a larger country on a more structured, more organized trial like Columbia or Chile or, or Mexico. I mean, have you seen that as well?

Gerardo Noriega: 33:43

Well , but even those studies are conducted , uh, with proper protocols , uh, every company, because it's costly. You wanna capture the data the best way you can, even though the support might not be in the local entities, companies want to have this information properly recorded for , uh, quality issues, also for ethical reasons. In addition , uh, if the FDA inquires, where did you do your studies? Not that they have any, you know, oversight what's going on in , in Paraguay , but they do have oversight of our companies in the us So you better have your document and your , uh, validation , uh, documentation in place because you could be questioned.

Julio Martinez: 34:33

Yeah, yeah. That's from the, from the ethical standpoint, right?

Gerardo Noriega: 34:37

And also from the legal, because from the US point of view, you are a US company exporting a , a product outside of the US that is not approved in the US You have to be , uh, extremely careful. And also it's good business practice to have your documentation properly kept because we are in the business of documentation too.

Julio Martinez: 35:02

<laugh> agree. I agree. Good point. Alright , so we're approaching the end of the show , uh, Gerardo, a couple more questions. One is about Latin Americas people, its culture, the way to do business in Latin America. Is it a fun place to you? I mean, do you enjoy doing business in Latin America and dealing with , uh, Colombians, Peruvians, Chileans, <laugh> ? What do you think about that?

Gerardo Noriega: 35:29

I do, I do. One thing that I noticed that is I kind of have to learn the terms. Like , uh, you know, I'm working on congestive heart failure and that is insufficiency, cardiac . So if you try to translate it, it doesn't make any sense. So I need to know the medical terms used locally because each country might call it, most of them probably medical terms are the same, but the translation might be different. So that's one thing that I notice I need to brush up a little bit, but I'm very, very in tune . It doesn't take me too long to figure it out. What is the right terminology? So , um, I found that , uh, an interesting aspect of doing the study. But , uh, other than that, I love the way the physicians, they're so receptive to , uh, new approaches and willing to, you know, to try something new for the benefit of the patient. And also making sure that they're very , uh, also very passionate about their patients because they're a lot closer and they have more time to talk to the patient. Unlike the us which the doctor is , they talk to you for 15 minutes, what's going on? Okay, this is what's going on. So, and there , um, the physicians, they , how is your husband doing? It's a little bit of a warmup session before they talk. So tell me what , how can I help you? So this is the warmup section, which is about five to 10 minutes personal interacting. And they say , oh, doctor, you know, every time I walk, I get up, my back hurts. Oh, let me take a look. Let me check your heart. So the doctor could spend , you know, 30 to 45 minutes with you before, you know, he issues a statement, what's next here in 15, 20 minutes? Sit here , go on , do your blood test , I'll call you when the results Latin America a lot or knows the patient a lot more, a lot closer. Does that help with recruitment? That help with the recruitment? Because you know the history of these , which are the best patient for your therapy. So when I went to do the studies on the prostate in Venezuela , um, in a week we were able to recruit seven patients that they were able to meet our inclusion exclusion criteria. Now, the question was, and this is a challenge, the follow up , how do you bring them back to see how are they doing? And the first week probably is okay, but after a month the situation gets a lot harder. And I I 90 days, you know, if they, if they come back and see the physician, maybe you're able to grab a little bit of a , you know, the follow up information. So A CRO will facilitate such a

Julio Martinez: 38:37

Exactly. Good point. Very good point. Absolutely. Absolutely. Yeah. Sometimes you have to bring them from another town close to the hospital, half an hour or an hour away. So you have to go an Uber or a taxi cab to do whatever it takes to bring the patient back. Sometimes they cannot even come back to the hospital because they don't have money for the bus or for lunch, or they need somebody who can come with them and they don't have that person, that company. That's

Gerardo Noriega: 39:03

Another thing. Typically they like to come with somebody else even when you go to the market, right?

Julio Martinez: 39:09

Yeah . Yes. <laugh>

Gerardo Noriega: 39:11

They like to do in pairs for whatever. And you know, it's funny because it , it happens to me when I go to the , even here, I , it's kinda lonely to go shopping by myself , <laugh>, and now with the Covid, they don't like to , to bring two people up , you know, to the market. So

Julio Martinez: 39:27

Yeah. Anyway. Alright , so before we close the show here , uh, Gerardo, what are your final words of wisdom to the, what would you say, in other words, to the CEO of a medical device company who is just starting to explore destinations for clinical research? What would you tell him or her about Latin America?

Gerardo Noriega: 39:48

Number one, I obviously identify the type of patients that you're looking for, chronic or acute. Uh , and then second, which centers are probably the bigger cities might be best because they might have the supplies that you need, you know, for your therapy. Otherwise you have to bring all the supplies. So it's better to be in larger cities or in smaller cities, but kind of at the top of the supply chain for support of, you know, supplies, eh , they call it sutures or call it catheters or call it wires. You have all , every single size available because that'll be impossible. And you can bring some of it with your kit to make sure that you don't, you know, you're not searching for these materials you're looking for. So make sure that you have all the supplies in place. I mean, make sure meaning triple, quadruple check . And so that's where your CRO is so crucial when you get there. You just want to execute. You don't wanna be searching for all Bogota , uh, for certain size of that you might not even have, and then all your crew have to wait until you get that material from Miami and so on and so forth. And it had happened to me, so I , I'm telling you so, but obviously in every study I learned , so I got better at it, better and better every time. So it's crucial to have a great , um, organization supporting you locally. 'cause we don't know the market local , we don't know the, these are idiosyncrasies that are needed to execute a spotless, well run clinical study, which is the value of a startup . That's what we, you know, are geared for not only to create technology, is to show that our technology safe and effective. That's our job. And with that you have to have proper documentation. Otherwise, whatever you do has no value. And I've done this enough times.

Julio Martinez: 42:00

Well said. Yeah, yeah. Well said. Excellent. Alright, Gerardo, how can , uh, listeners get in contact with you,

Gerardo Noriega: 42:09

Julio, if anybody wants to reach out to me, I consult for many companies, over 50 companies in different fields. And , um, you can reach out to Julio and they , he can put you in touch with me many which way, if it's appropriate for the business, technical, clinical and so and so forth, or regulatory for the matters.

Julio Martinez: 42:30

Okay. Very good. Gerardo, thank you so much. Thank you for our friendship. I <laugh> have enjoyed , uh, meeting you for, or knowing you for years already. And I also thank you for accepting my invitation to be on this podcast. I think , uh, you are quite a , um, fascinating individual from the personal and professional experience that you have doing business in Latin America, specifically with clinical research and the development of medical technologies. So I'm sure listeners are getting a lot of value from, from this conversation. So thanks and thank

Gerardo Noriega: 43:05

You, Julio . Thank you so much for the great service that you provide to all of us.

Julio Martinez: 43:09

Awesome. Awesome. I'm glad that you think so. Uh , so, and , and thank you <laugh> coming from you. That means a lot to me. <laugh>. All the best, Julio. Ciao. Thank you.