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 La MedTech Leaders Podcast. Today our guest is Dr. Enrique Saldivar. Hey, Enrique, it's great to have you here in the show today. How are you doing?

Enrique Saldivar: 0:31

Hey , thank you very much for having me here. It's a pleasure. I'm doing great. Thank you.

Julio Martinez: 0:36

Awesome. Enrique. Well, listeners, Dr. Sal Diva's career in medical devices has focused on the transformation of cutting edge technology and development into meaningful medical solutions. His multidisciplinary background, combined with a deep sense of social responsibility, provides him with a unique perspective to provide solutions to unmet medical needs in underserved communities. Throughout his career, he has been appointed faculty at the Scripp Research Institute, LA Jolla Bio Engineering Institute, the West Wireless Health Institute, and Case Western Reserve University. Dr . VARs interest are focused on the use of technology to improve the quality of life globally, and to ameliorate the accessibility to first class medical attention in underprivileged communities. Dr. So Diva received his medical training in Universidad la , received his MD from Univers at Autonom Mexico, unam , his masters in biomedical engineering from Univers Atton Metropolitan, and he's PhD in bioengineering from the University of California San Diego. So, Enrique, thank you so much for accepting my invitation, is really an honor, a privilege to have you here on the show. We finally got to meet, I mean, it took us a while , huh ? <laugh> . Yeah. <laugh> ,

Enrique Saldivar: 2:00

Some technical challenges , uh, here. Jan , thank you. Thank you very much. I cannot not tell you enough. There are no words to thank you for having me here, and of course, to your audience to , uh, listen to our conversation. Thank you.

Julio Martinez: 2:16

Fantastic. Fantastic, Ricky . Uh , it's really a pleasure. You're welcome. All right , so let's get started here. Let's talk about your journey to Latin America. What's your personal story? What's your professional story? What's your link with Latin America?

Enrique Saldivar: 2:31

Okay. Well, first, the link is very deep. I'm Mexican. So I was born in Mexico. I live in Mexico. I did my medical training and my beginning of engineering training. Um , one of the things from the personal perspective, when I studied , I don't want to age myself, so I will not tell you when it happened, but , uh, biomedical engineering or bioengineering were not so well established fields. They were in the making for that matter. Bioengineering started in 1960, is when it , it started as a discipline. So when I started the university, I needed to make a decision on what to study. So it was a tough decision. I didn't want to study theoretical physics. That was one of my passions. So I decided to go to something more engaged with the wellbeing of human beings, and the natural choice was to study bioengineering, biomedical engineers. I make a distinction between bioengineering and biomedical engineering. But anyways, when I started , I went and saw , studied what universities had to offer in biomedical engineering, and I realized that they were lacking the basic medical education. So it basically, it was electrical engineering in these guise , so with a couple of courses in an anatomy, but it was electrical engineering. So after a lot of soul searching and , uh, very difficult , uh, set of decisions, I studied medicine first. So the joke that I make all the time, I studied medicine to become a better engineer, and I studied engineering to become a better scientist. So anyway, when I did my internship in medical school, I realized how unfair medical treatment or how in equal the medical treatment is for the poor. I did my internship in San Luis Potosi . They serve a lot of the rural, poor rural population in Mexico. And when I did my internship, I realized how bad the poor habit in all Latin America. Later on, I paid attention to what happened in Mexico City, and then talking with my friends. And so I, I realized is a very unfair situation. So again, I had the bias. I tried to see things all the time. I studied , uh, medicine with a engineering mind, and I studied engineering with a physician mind. So when I was studying medicine, I paid attention all the time to medical technology. And then I realized a couple of , uh, difficult things that underserved communities or , uh, emerging economies have that is, for instance, we have in the hospital that is a third level , uh, hospital. They realize that a lot of the medical equipment was not used. And I ask them, why is it not used ? Oh, because the technicians come from Germany, so we need to have a grant from the government to, you know, serve the equipment. And then I ask them , well, why did we buy it? And the answer was, I didn't buy it. <laugh>. So , so I realized , uh, very early in my career, I think this is a very convoluted way to say the common aspects, not only in Latin America, that in all underserved communities, there's a quote I'm going to add here from Anish Chopra, who was the first CEO of the White House under , uh, president Obama. I was presenting him. I was , uh, introducing one of our projects a few years ago, and I talk about, basically I talked about the situation, and that project was geared towards Latin America. And I said, because of the, you know, inequality of care and the poor societies and everything. And he told me, stop here. How he told me time , you know, you're talking as if we didn't have poor communities or underserved communities in the States. And after that conversation, I just widened my scope. I started originally talking about the rural areas in Mexico. Later on, I moved to Latin America. Later on I included Africa. And now every time that I talk, I include underserved communities, period. I think the commonalities of the underserved communities are way bigger than one would like to acknowledge . So I don't know if that answer, I don't know if I went through the tangent here. And so I, I hope I answered your question.

Julio Martinez: 7:36

No, that's fine. It's a great answer. Very personal, by the way. And it tells a lot about the realities of underserved communities, including Latin America. That's the right terminology. Right. So Enrique, what major epidemiological, political, social , or economic trends do you see in Latin America that are relevant to our discussion about medical technologies in the region?

Enrique Saldivar: 8:02

One can , uh, answer that question in many, many, many different ways. I mean, it's like a porcupine. It has, it pokes you no matter where you touch it or what angle you need to approach it. Okay, I am going to start with something that I hope answers the questions. In terms of epidemiological problems, there are a couple of issues. And by the way, later on, anybody wants to contact me, I have the information for anybody. Okay, we talked about the commonalities of rural environments or underserved communities. Okay? Now what happens, those aspects I think is fair to say that they are common throughout the entire universe that we see. But Latin America, there are a lot of resources in our countries. Then what happens is that industrialized societies or developed economies tend to go and create business in those countries, right? So it's a fair exchange, or not all the time is a fair, but it's an exchange between the raw goods and extraction techniques and industrialized products. Then what happens in our societies is that people tend to go to the cities . That is where the jobs are, where industrial jobs are. For instance, in Mexico, we have one of the major Volkswagen assembly plants in the world. So with the Mcla Dora industry and all the things , so we tend to manufacture for others because of course the raw goods are produced in those countries, labor is cheaper and many, many things. Then what happens is that suddenly you have a country that hasn't developed completely or haven't completely solved their basic nutrition and infectious diseases, problems or needs. They haven't solved that. And then they start having what I call the McDonaldization of the diet, right? So you have people, McDonald's makes an appearances, you have Big Macs, and then you have people who are heavy smokers who having completely solved their infections, diseases problems, and are start having heart attacks, diabetes and other things. I mean, same things happened in the States with the Native Americans. By the way, they are subject to, you know , a triple prong here. So that's what we call the double burden of disease. So that means the society hasn't completely solved the underdeveloped or underserved communities problems, and they start buying the developed communities problems, you know , cancers, diabetes, and , and other things . So that's actually one of the things that the way the economists are going and the way the globalization is going, we are just making that problem worse. So we are just increasing the double burden of disease. If anybody listens to this, I encourage you to pay attention or to do some research and see what happens in India, for instance, what happens in China and what happens in all Latin America, what happens in Brazil and is going to start happening more and more in Africa. As we industrialize those places, then it is kind of okay, we are starving adolescents before finishing childhood. And it's a very unfair situation because other countries like the US here in the US or Japan or Europe, they had years of childhood pre-adolescence, adolescence, adulthood and stuff. So they had the time to develop with these technologies. For instance, I don't know if you know, this is an interesting fact, but the telegraph in the US was developed at the same time as the railroad was developed. So other countries didn't have that vision, that level of organization, because the companies were pushing their products. So the telegraph arrived when it arrived , period. Right? So the framework in these countries is completely different than what happens in Latin America or underserved communities. That's actually my point. In Latin America, we did not go in many aspects through adolescence stage , and they want you now to be the man of the house, <laugh> , without being prepared, right? That actually sometimes it helps. For instance, Belize has one of the best electronic health records in the planet.

Julio Martinez: 13:18

Wow.

Enrique Saldivar: 13:19

Because they don't have legacy software.

Julio Martinez: 13:23

Yes. They jump from the donkey to the space shuttle <laugh>,

Enrique Saldivar: 13:28

Right? That has some problems, right? But also has some benefits. You don't need to maintain , uh, certain things. For instance, we are suffering here in the us we are suffering part of that. Kabul lately became a new needed commodity in software because the Social Security Administration, a lot of their computers work in Kabul .

Julio Martinez: 13:57

It's an old legacy programming language. Yeah.

Enrique Saldivar: 14:01

Nobody programs in Kabul anymore. And exactly. So now, please, I encourage any of your listeners, I encourage you guys to see this. COBOL became , uh, actually had a jump also, R the programming language had a jump. R was because of COVID-19 . So we have certain we are dealing with too many moving legacy pieces in the us . But anyway, that's the flip side of what we were talking about. So anyway,

Julio Martinez: 14:33

So you're touching some very good points, Enrique, but , uh, moving along here, let's talk about your opinion about Latin America as a place to, of course, before I jump into the question, what you're basically saying is that people are getting sicker in Latin America, right? <laugh> ,

Enrique Saldivar: 14:51

They have different causes for getting sick. We around the globe, were getting sicker, right? But they have different causes of disease . Yes .

Julio Martinez: 15:02

Yeah, yeah. And also we have the aging of the population. That's another element here of the Latin American population. Alright , so going back to my question is what do you think about Latin America? About a place to commercialize medical innovative medical technologies or to conduct clinical research? And , um, if you could also talk about your experience in the region that will complement the answer.

Enrique Saldivar: 15:29

I think it's the best place on the planet to do medical, to work on medical development and innovation. I think it is the best place.

Julio Martinez: 15:40

Why is that ?

Enrique Saldivar: 15:41

First, because the economies are very strong. Regardless. If we want to see that in a different way, the production of products is going to still be very, very, very solid for many years to come. In Latin America, the population is growing. They are early adopters of technology. That's another , uh, thing. And one of the, for political reasons, they are very eager and political reasons. I'm talking about their , their politicians are very eager to adopt the new technologies being in the modern times, so to speak, right? So that actually creates an excellent opportunity. Now, one of the things that I'm going to encourage your listeners , uh, to do is to create more than an instant gratification opportunity to create a long-term relationship, a sustainable relationship with Latin America. It's better for you as an entrepreneur, and it's better for the entire ecosystem in the states and in Latin America. So in other words, I think a lot of people have failed in Latin America because they try to bring the new technology that was developed here in the States and works very well in the states and has reagents and many <laugh> . Uh , it has , uh, many , uh, components that are created here in the States as a way of keeping the business going, create, you know, an ongoing relationship. But I think easy to see that as soon as that equipment becomes legacy, then the whole thing crumbles because then it becomes unsustainable. Here in the States, you can buy parts for your legacy products fairly fast, but there you can't. So the whole thing collapses. So I encourage everybody to create, to design technology for Latin America first. If that technology works and has a place in Latin America, it will most definitely have a place in the US and Europe. Our group had done that. There was an example sense for baby was the example that I had, the , the , the privilege to , uh, co-design and direct , uh, when I was at the West Wireless Health Institute, and it was created precisely with that philosophy. We created something that was deployed, used in Mexico, and it was later on adapted, fairly easy to be used in the States because in the States and Europe, by the way, it was deployed in the Netherlands, and it was very well accepted there, you know, so if you want to make something universal, you expand. If you take Latin American , please , uh, I'm , I'm going to use this term very limited. If you use , uh, Latin America as your play , uh, ground or your sandbox, you can then suddenly the applications or the applicability are universal. You can then very easily move and expand around the world. And the reason why I say the , you know, sandbox or playground that is , I said, okay, let's use that in a very limited way. I encourage everybody not to make the mistake that others have. That is try to skip the FDA process and then go to Latin America instead because it's cheaper, it's faster. And you know, they cannot even spell FDA <laugh> there , you know, they're trying to get around the FDA . When clients come to me and tell me they want to do that, I tell them, change product. So if your product cannot be approved by the FDA , then change product <laugh> . In other words, we shouldn't be talking about this. You know, I think you should have, everything that you do needs to be bullet proof . You should design for Latin America with the standards of the us . Then your product will never have the infrastructure limitations. You are going to apply your technology universally and nobody would come back to you either legally, morally, ethically, however you are going to be doing good thing and is just a slight change in your mindset what is going to be. It is not more technology. It's a very straightforward path. So,

Julio Martinez: 21:00

Wow, that's a nice answer. Very, very interesting approach. I've never really thought about it for that perspective. So let's get into more practical things, Enrique. In what specific countries in Latin America have you had experience? Of course, Mexico. Is there any other country where you've done something?

Enrique Saldivar: 21:19

Not directly. You know, I mean we have done a number of market studies in Peru and Brazil, Argentina and Chile. But directly, I want to be very, very clear here. In my experience, there was kind of a , a desk experience, you know, yes , phone calls, teleconferencing, talking with the researchers and so on. But , uh, the only time that my group has deployed from end-to-end solution had been in Mexico and in the States, other countries. For instance, Peru, there was a project, okay, I must misquote that. I think it was called Amman . That was a project that we have help with and we were working on the Ministry of Health View, helping the Ministry of Health in these places and how to deploy or how to explore what were their needs so they could deploy medical technology. So, but what we discovered there when we performed those studies was, except for a couple of issues, the commonalities of the problems in these countries are exceptional. This basically you can consider, or at least that's my own personal opinion, you can consider that everything that starts in Mexico to the south is one big country with some specific regional changes , but basically it's one country. But to give you an example of this , an exception, we realized when we were studying this that Chile presented a very unique , uh, we found that by serendipity provided a really weird, unique opportunity, great opportunity for them because the coverage of the cell towers is amazing. Chile has 97% of territorial coverage because it's a very narrow long country. Then you need to have, I don't remember how many were there, you know, like , uh, two or three lines running parallel rather than what happened here in the States. If you want to give coverage to the Mohamed Desert <laugh> . But those are few of the exceptions, I want to say. We find a couple of interesting exceptions and opportunities in general, the commonalities, surplus, everything.

Julio Martinez: 24:01

Okay, interesting. Have you ever had experience in Mexico with Karis and the regulatory approval process? Uh , can you talk about that?

Enrique Saldivar: 24:11

Yeah, absolutely. Again, the only products that I directly deploy was sense for babies , right? And I'm working on another one right now, but anyway, that's still yet <laugh> to come, right? Is a cardiology technology. But, you know, we realized by the way, the , the comment that I made , uh, about the FDA uh , process was probably the best way to go, is that we realized that covid pre precisely had they, if you present the FDA approval to them, they used that or they used to, you know, when we did that , they took the approval of the FDA as a predecessor for the process. So the process was a lot easier with covid pre ones that they saw that we had the FDA approved . So that my experience there, it was, I'm going to say marginal for us, but our instinct when we generated the whole thing first to be FDA approval proved to be right. And it makes perfect sense, right? When you have, for instance, an FDA approval is going to make your life easier, not more difficult if you get , uh, c mark or go wherever, right? I mean, it definitely will not make your life more difficult.

Julio Martinez: 25:43

Yeah. Yeah. Most countries in Latin America consider or um , FDA approvals as from the physician perspective, from marketing perspective is the standard, the gold standard of approvals in the world. And there are five reference countries, Canada, the us , Europe, Japan, and Australia. In the case of Columbia , for example , uh, AIMA , if you want to get a product approved, you have to have one of these approvals for one of these five reference countries or you home country approval. That's the only avenue outside of these five countries that you have to get a product approved. But what happens is that, let's say your home country is Nigeria, right? <laugh> , no physician in Colombia will accept a product for Nigeria.

Enrique Saldivar: 26:29

I'm going to extend on that comment that , that you are making. Yes. Let's say that you are medical product designer and then you want to get your product, you know, deploy in Nigeria, fine. You are going to find exactly the same obstacle that you were mentioning. If I go first to Nigeria, get everything I , you know, and it doesn't matter. I might be from Colorado, right? I get <laugh> , my , my approval in , in Nigeria. Then I try to send it, sell it in Colombia . That is another country that I might deploy it and I might face either a real or perceived obstacle. There it is better to center everything. Again, I insist in what I tell my clients, get FDA approval. I tell them, get the mindset needs to have an FDA approval, even if the clinical trials are going to be set in Mexico as what we did. Okay? But the IRBs came from the states, so nobody can tell me that we did it because we wanted to get around any process. No, no, no, no , no . We presented to the hospitals, the IRBs approval translated and everything from the states, then the entire dosier that we had here. And of course, you know, in few days they approve it because they saw the entire process, the comments that they were the same one that they have , how we answer and they approve everything. But anyway, that's repeating myself,

Julio Martinez: 28:12

<laugh> . No, no, but it is emphasizing your point. That's very valid. Alright , so moving along here, Enrique, what about clinical research? You just mentioned something about a trial. I mean , uh, what's been the extent of your experience during research in Mexico or elsewhere in Latin America?

Enrique Saldivar: 28:30

Well, just the clinical trials that we have done that I personally have been involved from the medical device perspective was precisely on the efficiency of the devices. And we basically run a couple of some hospitals. It was , uh, we did that in Mexico, we started in Tabasco and later on we moved to Chiapas. At that moment , uh, you know, is when I step out of the institute, I did, the first inhuman test was done by myself in Tabasco. I was the first one to put sense for Ravi on a human in Mexico. It was done for the clinical trial. And I have to say that the only problem that we saw there is that you face kind of the opposite problem. People are too eager. They believe everything that you have. 'cause you come from the states, you have this new technology, and then people are eager to try it. It's a great thing, but I can see how easily that can be abused by somebody and yeah , right? So if they are willing to trust you, you come here, you come recommend it from the director or the administrator of health or so you , you have this cool device, they want to use it, right? So that's another responsibility that you need to take, right? And so you need to harness that. But from their point of view, I have to say that, or what I experienced is that people were, if you wish , were eager to use the new technology. Remember, these devices were designed to work in the rural environment. And one of the things that we did was, for instance, we put in sense four babies , uh, cardio topography . It detects high risk pregnancies is a test that is done routinely in the third trimester of pregnancy. Every woman, it should be carried . That's the device that we , we created. It was invented in the 1950s, and we just made a digital version of that. We decided to put a microphone , uh, so the mom could hear the baby's heartbeat. So it was some done , you know, a win by myself actually. I , I told the in general, let's be , if it's as easy , let's keep the heartbeat there. And turns out that that was the main driver for people to use the device. When the nurse, when the proto came to their house, they were very happy because they could hear the baby's heartbeat. So it was great experience, but again, it gave me humbling , uh, feeling that, oh gee, okay, the power of the forces, so to speak, that I was dealing with, I realized I were way beyond what I originally envisioned, right? I thought that I'm going to be just a normal thing. No, no, no. So your responsibility as a developer actually needs to be taken into consideration because by the same token, you are going to impact , uh, in a more dramatic way , uh, many people's lives.

Julio Martinez: 32:13

Yes, Enrique, you're bringing up another good point. And , uh, it is also been my experience. Uh , I've been doing clinical research in Latin America for about 10 years now, and I see physicians getting really, really motivated with these newer technologies that we bring to the country because we bring science fiction, like medical technologies that they've never seen and they never imagined that somebody was already developing in the us . When we approach them with a protocol, with a sample of the device, they get really, really motivated and excited. And, and also it's a boost to their careers , uh, with their peers in the academic community. They feel more important, more accomplished, and they have the opportunity to write papers to author the , uh, journal or whatever paper, a publication that gets , um, published after the , uh, study. So it's, it's a great opportunity for investigators in Latin America to participate in clinical research.

Enrique Saldivar: 33:13

Also, there's a lot of potential partners that developers can have in the academic community. For instance, Harvard Medical School and Johns Hopkins are very involved in underdeveloped communities or the healthcare of underdeveloped communities. We actually found out it was a great surprise, and I didn't think about it when we deployed Sense four baby years after that. I might have been misquoting that, but a group in Harvard, in the Harvard Medical School use Sense four Baby and tested their acceptance in Uganda. And you know, when I read that paper, that was years after, you know, I just completely closed that door here , put away . When I read that paper, I thought, you know, that's a learned lesson that I'm sharing at this moment with you. If we had at that moment, everybody has limited resources. So it doesn't matter if you are the richest man on the planet, you have limited resources. If you go with schools with a great prestige that are eager to help you with this and are interested, genuinely interested in deploying or testing your technology, why not do an early partnership and then expand your horizons? Your technology is going to be better accepted the more people that promote and you're going to save . And by the way, I know that we haven't gone to the next question, but one of the things that I am going to encourage everybody to remember is that we do this to save lives. One baby that you save is pays for the entire project. So that's the way it should be done. You know, the products should be done to save people, and you need only one, one person whose lives was safe justifies everything. So do that for that person. <laugh>.

Julio Martinez: 35:44

Yes, well said. Enrique <laugh> . I like it. Yeah, well said <laugh>. Well, Enrique, we're close to the end of the show. Um, last question about practical matters. I mean, what's your opinion about corruption in Latin America? Bribery? I usually hear , uh, horror stories about it, or people have this sense that there's , uh, so much corruption that is so difficult to do business in Latin America. What's your take on that?

Enrique Saldivar: 36:10

Corruption is everywhere. That's my first concept here. Second countries are doing something. For instance, Mexico is now fighting corruption and it's making a dent against corruption. I personally , of course I'm Mexican, so I would encourage people to study in Mexico, but Mexico is really truly doing. Argentina too is doing , they are doing great , uh, job in , in controlling corruption. Second thing, what we have always done all the time , uh, when we go to a new country to do anything in Africa whenever you want, is we get a partnership with a local trusted person that can tell you what is appropriate there and what is not. So that actually can help you a lot to navigate the waters. And unlike what your grandmother told you all the time you feed , you don't trust them. You know, <laugh> , walk away, <laugh>

Julio Martinez: 37:18

Don't do business. Yeah. Yeah. Actually, the US Commerce Department advises us companies to really, really do , uh, very , uh, comprehensive due diligence on every business partner that you're gonna engage with in Latin America. And that applies a lot to distributors when you're trying to commercialize your products and all that.

Enrique Saldivar: 37:40

Usually an advisor that was recommended to you on a personal basis, you know, the classmate and, you know, broader , those guys help you a lot to navigate the waters .

Julio Martinez: 37:52

Yeah, that's , yeah . Agree, agree. All right , Enrique , we're very close to the end of the show. And one last question. What would you say to the CEO of , um, medical device company in the US or Europe that is looking at Latin America to do clinical research or to sell their technologies? What are your words of wisdom as a final last , uh, comment , uh, in the show?

Enrique Saldivar: 38:16

Well, I'm going to assume that their product is, they are thinking about it and is not developed. I'm going to imagine that

Julio Martinez: 38:24

<laugh>, I really meant products that are already developed in Europe or in the us Yeah, or hold on. If they're not developed, they are thinking about doing research somewhere else outside of the us for example.

Enrique Saldivar: 38:38

W well, you know, if you have a prototype, not necessarily a product, go there, talk with the people, see what they need. I personally start all my developments seeing what is the primary need in the country more than what I see very often as a mistake. Very often you see a solution seeking for a problem. I <laugh> I actually find first the problem and I find the solution . In other words, study your country and ask yourself, is this really going to help people there in wherever you are going to in Colombia , in Brazil? Or am I doing this just to expand my business? Why am I doing this? If the answer is yes, this honestly is going to say babies in Nigeria, you have my whole support and blessing <laugh> , you know , if not, I would recommend you to think twice what you are doing. That's

Julio Martinez: 39:40

Good answer. Great answer. All right . Excellent. Ricky, it is been delightful to have you here on the show, and thank you so much for being our guest , uh, today. I'm sure listeners got a lot , uh, out of your wealth of knowledge about product development and , uh, how can people find you? What's your email, what's your LinkedIn profile?

Enrique Saldivar: 40:01

The easiest way to find me is I have a website, enrique saldivar.com Also, you know, if I, I'm going to make a little bit of advertisement here, you know, is Cardio six , that's my current company, cardio six.com . You can find me there. So,

Julio Martinez: 40:17

Okay. And you do consulting , uh, for companies that are looking to develop product new products. Okay.

Enrique Saldivar: 40:23

That's one of the things that I do to bootstrap my projects. Yes, <laugh>.

Julio Martinez: 40:28

Excellent. Excellent. All right , Enrique, thank you,

Enrique Saldivar: 40:30

Julio. Thank you very much for the invitation and just to thank you for the time. Bye

Julio Martinez: 40:35

Bye. Take care.