Oct. 22, 2021

Michael Hill, Former Vice President, Science & Technology and Innovation at Medtronic

Show Notes
Transcript

Dr. Michael Hill is a global-minded senior executive with a history of success creating meaningful, patient-inspired, medical device technology innovations. He is a skilled entrepreneur demonstrating repeat innovation execution from idea/discovery to commercial scale. He was inducted in 2012 as an American Institute of Medical and Biological Engineering Fellow and awarded the Distinguished Engineering Alumni from Duke University in 2013. He possesses deep domain knowledge of science and technology and has more than 27 years of experience with research, product development, and clinical research/regulatory. He is adept in successfully leading large global organizations, as well as multiple programs and projects, to achieve target goals. He has a thorough understanding of the fundamentals related to global healthcare systems to deliver impactful transformative innovations. Dr. Hill received his BSE [Biomedical and Electrical Engineering] and BS [Mathematics] Degrees from Duke University, MS, and Ph.D. [Biomedical Engineering] Degrees from Case Western Reserve University, and MBA [Management] Degree from the University of St. Thomas.

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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 to the MedTech Leaders Podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America. Today our guest is Michael Hill, or I should say Dr. Michael Hill , right. , a former executive at Medtronic Sports over 7 27 years, a now a partner at Science Innovations, LLC, a medical consulting firm that partners with MedTech companies, big or small, to bring therapy and technology innovations to the market. So during Michael's 27 year career, has, he has consistently championed the Latin or Latin American opportunity in the innovation cycle from speaking at the National Hispanic Medical Association training of clinicians in Puerto Rico and Mexico, and novel medical device technologies supporting first in human clinical trials in Chile and Columbia , participating in country specific market access team discussions, meeting with local regulatory and reimbursement officials, and consistently supporting the local people and teams in in country. Dr. Hill or Michael Hill , uh, receive his bachelor's degree in biomedical and electrical engineering like me, , and another one in mathematics from Duke University. And he has a master's and a PhD degree in biomedical engineering from Case Western University and a and an MBA Master's of Business Administration from the University of St . Thomas, also like me. So Michael, it is really, really a pleasure to have you here in the show. I look forward to our conversation. How do you ,

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Well , thank you. Thank you. Good to be here.

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Awesome. So let's get started, Michael. Um, please tell listeners about your involvement with Latin America. How do you get involved with the region in a personal professional level?

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Yeah, I have been involved with Latin America throughout my whole career. So even as a scientist, when I started at Medtronic , um, I actually started working with several different research people , um, in , um, Latin America. And so we actually were, you know, I love to travel and so I, I enjoyed traveling quite a bit, and I spent some time over in Europe and our European groups were actually well connected with Latin America, as well as with Japan at the time. And so I actually started interacting quite a bit with some of the people who were doing atrial fibrillation research down in Latin America. And so even at that very early beginning, I started working with Latin America. Um, it continued with my clinical and regulatory experience. Um, so we actually, even up to the last three years that I was at Medtronic, I had the , um, whole global clinical organization report into me. And that included Latin America as a geography. Um , we have the largest at Medtronic, they have the largest , uh, CRO, if you will, for clinical research. Um, over 800 people worldwide for all the

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Operations . Nobody , nobody knows that .

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So we have a lot of people in Latin America, feet on the ground. Um, but you know, we can do , um, clinical trials. We had probably, you know, a hundred trials in Latin America at one point with over 500 to 800 , um, subjects. Um, so we spent quite some time and energy in Latin America, but country by country specific as we'll talk as we go through.

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Excellent, Michael. All right . So what major trends do you see happening in the region from the disease standpoint? Political, economic that are beneficial to our discussion or beneficial to newer medical device companies doing business , uh, doing trials or commercializing medical technologies?

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Yeah, you know, it just like much of the rest of the world, the populations aging. And so everywhere you have aging now , again, it's country specific and there's more aging in certain countries than in other countries. Um, but we are aging as an overall population. That's a good thing from a longevity standpoint, but it also means that we are starting to now move from communicable diseases to other things like the whole western, you know, cardiac disease, neurological disease, stroke, things like that. And so those are areas where more specific types of therapies are needed. We know a lot of what they are, but we need to have access. So that's one part. The other part is the economy. You know, people think, well, can I make money, if you will, in Latin America? And the answer is yes, you can. In fact, there's a lot of money in Latin America , um, to say it bluntly, and I think this is not just Latin America, it's the whole world. Politics plays the role in whether that economy is good or not. So stable politics means good economy, and you can look at different countries that have been stable, such as Chile and Chile. We actually have very good reimbursement for e even very high end products like pacemakers and defibrillators. And so stability matters when you think of politics, and that's why it's important to look at how those things change over time.

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Very good. Yes. Yes. Agree. All right , Michael, so what's your overall perception , uh, about Latin America as a place to do business, as a place to do human trials, as a place to commercialize medical technologies in general? What do you think? Are you positive? Are you upbeat about the region or what?

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Yeah, so, you know, it , it can be a very good place for clinical research. Um, you know, it's, I , I'm a people person, and so I think that Latin America operates as a people or, you know, as people, they like relationships. And I think that's a very important thing. The other interesting part is Spanish is the second most common language in the world. First is actually Chinese. So English is actually third . It's not the , it's not the first . So , you know , most people speak Spanish. And so from an overall, you know , interaction of people , um, you know , that's a great population that is probably untapped from an overall global standpoint. Now, I would say one thing, it's a great place to do clinical research, but do consider your exit strategy or sustainability. So what I mean by that is, is remember, if you're doing something like a five 10 K or what we would call that in the us , you know , those, you might say, you know, well , you do something and then you take it away. So it's a, it's a surgical dressing or a external diagnostic device. So you might only follow the patient for 24 hours or 30 days, but if it's something that's implantable such as a pacemaker or a stent, you might need to think ethically, what's the right thing to do? And you might be saying, okay, it's a clinical study of a year, but your sustainability and your responsibility is to be there for the life of the patient. And so that's just something to consider when you start to move into those areas to think, what do I mean by doing clinical research in Latin America? The need is there. Access is very well received. It's just making sure that there's the exit or the sustainability strategy.

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Well said. Yeah, Michael. Alright , so let's , uh, talk about your experience in individual countries. Um, let's talk about , uh, I understand you have great experience in Mexico, Colombia , uh, Chile, even Puerto Rico. So let's talk about that. Let's start with Mexico. So what you did in Mexico.

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Yeah , so, you know , um, I did, I have traveled, in fact, I think I was trying to put a list together. Some of the countries, so you know, Brazil, Chile, Columbia , Argentina, Panama, Mexico , um, and Puerto Rico, like I said, is the , is the brother, right? And Uruguay. And Uruguay and as well. So, you know, I've been to a lot of the Latin American countries and you know, Mexico is an interesting one. You know, there you actually have self pay for a lot of device work. So medical devices , a lot of self pay , especially high end , so a pacemaker people have to buy, right? And so , um, I actually spent quite a bit of time in Mexico training on a new type of defibrillator that had an added therapy for heart failure called , called cardiac resynchronization therapy, which I helped to bring forward as an innovation. And so I spent time going through, in fact , oftentimes at some of the regional , um, cardiac society meetings. I was the only English language , um, presentation. Um, but it , it was great because I got to print present to large groups, but then I also got to work side by side with clinicians in , in the lab. And that was great. Um, if I take another example , um, where heart failure , um, that was actually where we actually went to Columbia and the, the head of the Heart Failure Society of Latin America at the time was a female physician from Columbia. And so we met with her at the heart failure , uh, heart Failure Society meeting here in the us . Um , she was very interested in starting to do remote monitoring of patients to see if we could keep them outta the hospital or keep them from having an exacerbation of heart failure. Yeah. And so we did a study there in Columbia. I'm using remote monitoring to actually look at several patients and trying to keep them outta the hospital due to the heart failure problems. Okay. And then

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The last , do you know what hospital it was? Do you remember?

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Um, uh, I don't.

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Okay, that's fine. That's

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Fine. Yeah. I don't, I don't, I can find it out, but , uh, no , that's fine. Yeah ,

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It's , it's probably infantile in Bogota , something like that.

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Yeah. Well , I don't remember the physician's name. That's what I was trying to think of, but

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I can't remember . Yeah . But , but the hospital, Bogota has one of the top cardiovascular centers in Latin America, probably funda the infantile .

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Yeah. Yeah . And , and they're great to work with. I mean, this is an institution as well. They were actually excellent to work with . Yes.

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Yeah . Yeah.

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And then the last one was , um, Micra. So Micra is the world's smallest pacemaker. It's a transvenously implanted, it's actually goes through a femoral , um, insertion through a sheath, and it's implanted into the right ventricle. And it's a fully functional VVIR pacemaker for 10 years. And it's about the volume of one cc . Okay . So it's released with tines into the ventricular wall , it stays there. Um, but it's fully operational. And the very , we did a 760 patient global study , um, in order to get regulatory approval because this had never really been done as a pacemaker before. And so the first patients implanted were on the same day, and they were in Chile and in Austria. And so our very first implant in our clinical trial of 760 patients was in Chile. And so it was , it was really great to be able to work there and to get things done there too, and to , and the excitement of being the first and one of the Latin American countries. So that was actually really nice.

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Yeah. Yeah. So Michael , um, I understand you have experiencing heart disease, mental health, diabetes by looking at the, the notes that I have , uh, from our conversation , uh, before the show. So can you talk about that? I mean, these other areas, mental health, I mean, that's a fascinating topic nowadays , uh, with the pandemic, right?

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Yeah, well, you know, it is . And different countries have different needs. Um, you know, we, we actually formed a, a very interesting group for our Latin America and team. Um, so I will name a few names here. The people that I think are very important that are still X-Men or with Medtronic, but Hugo Foli , um, who actually is the director of clinical for latam . Um, Hugo Viega , who is the general manager and vice president for Latin American geography. And then Rafa COAs , who is Rafael COAs , who is the , um, vice president of Marketing access. And so they actually were very , um, collaborative if I, if I should say, and they were actually interested in getting a team together. And it consisted of marketing people , um, in Latin America. It consisted of the clinical research people. Um, we cl in the regulatory people, the reimbursement people and the government affairs people. And then we started targeting the different countries, and we looked at both their clinical need as well as what their business opportunities were, as well as the difficulties or burden or , or , you know , burdens we'd have to overcome in order to operate there . And so, for example, Brazil, which has a lot of difficulty in regulatory problems, but they have a huge experience in some of the neurological spaces. And so they actually started some of the very earliest , um, denervation and, and, and working in the neurons along the spine. Some of the surgeons in Brazil, they were doing some of this work 20 years ago. Very novel, innovative research work. So that's, you know, something going on there. Um, like I said, Columbia was great with the heart failure because of the physicians that we were working with there in the remote monitoring piece. Um, you know, it's, it's just different places worked very differently, but it was great to see how we could target certain places. You know, Mexico was great for our surgical group because we could actually expand and, you know, they, they do a lot of just normal surgery in , uh, in Mexico. And so having the equipment from our acquisition at that time of Covidian really expanded our access into Mexico. Um, and we were basically in every single hospital in Mexico. And so it was a great, great opportunity.

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Wasn't the St tent invented in Argentina?

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Yeah, . Exactly. Yeah , absolutely . Absolutely.

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Yeah. I mean, that's something that very few people know. I think , uh, out of all places. Argentina.

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Argentina, and so, you know, and also the atrial fibrillation work. So I actually worked with a physician from , um, he was in Alabama , um, at the University of Alabama. He moved up to Case Western before I moved there. Um, and he was working on atrial fibrillation, but in fact, there were several people from Argentina that actually were working a lot on atrial fibrillation as well, on atrial fibrillation ablation. And the whole area of how to do , uh, you know, how to treat patients with atrial fibrillation, which is probably the worst arrhythmia that , um, is in the cardiac space and leads to, as you age, to probably most of the strokes that occur in elderly patients. And so it's actually , uh, something that was done quite a bit in Argentina as well.

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Yeah. Excellent. Excellent. So Michael , um, an area of interest to me, and a lot of listeners is clinical researchers, specifically first in human . Let's talk about the, the, the reason why companies lead the United States or Europe. And, and , and we, we should probably talk also about the UMDR and the repercussions in Latin America. Is Latin America gonna benefit from what's happening now in Europe with the UMDR or not? Uh , like to get your thoughts on that too, but first, let's talk about the United States. I mean, why is it that companies are looking at places like Latin America or Eastern Europe to do early visibility clinical work?

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Yeah, you know, it , it's easy to say that it's cheaper, but that's, that's not the only reason, and that would be the wrong reason to do it only. Okay. And what I mean by that is, is it's important to have, if you're doing clinical research, clinical research is important to have quality and also to have people on the ground . And so , you know , we were lucky because we did have a small handful of clinical people that lived in country and worked and did our work for us. Now, we did work with some of the CROs. Um, sometimes it was easier, especially if we expanded in a country. We did a stent study , um, and we actually hired a CRO in Brazil because I mean , we were at probably, you know, 15 clinical sites, and we just had one person there in Brazil. So we , so it works out very well that way. But you know, you, you need to make sure that you have the , you know, capability to work there locally. But it , you know, it's, it's an important aspect to understand. One of the thing that I wanted to mention was about, you know, culturally Latin America is, as I mentioned before, very people oriented. Um, and the reason I mentioned that is because relationships are essential to be motivated and successful. And so to do that, you put your trust in these relationships, so you have to build these relationships. It sounds very soft, but I tell people actually, it's not soft skills at all. This is the hardest skills to have usually. So, you know, trust is put into relationships rather than contracts or transactional events, as in other parts of the world. So, you know, if you operate in Japan or if you operate in Germany , um, those tend to be a little bit more transactional, even in the us right? I mean, people in the US will do business with people that they don't like, even though they know they can make money. And maybe that's, maybe saying it , but, but it's just that, you know, it's important to build that trust because that trust is what hap helps the motivation and the success. And we have been very successful with quality in Latin America. So, you know, we did that when we expanded into Eastern Europe. And I can tell you when we, when we expanded into Poland and Hungary and into other parts of , um, in Slovakia and, and everyone, yeah, we, we had, we had the best quality of our clinical team. I mean, we almost had no errors, nothing. And the same in Latin America. I mean, the Chile group that we had there, again, just, you know, they had very few, few changes or, or errors that we found when they were monitored in the clinical trial. And so, you know, that was very nice to see, especially when, you know, unfortunately, there were other centers that you would think did very, you know, should be good centers we worked with before. So, you know, in here in Barcelona or in , uh, in , in New York. And quite frankly, you know, they may enroll several patients, but on the other hand, they also have lots of findings.

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Yes. Yeah, yeah. You know , um, I was just reading an article , uh, article AC actually was a research paper, an academic paper , uh, and that the argument of the , uh, paper Michael, was why is it that companies , uh, wanna go outside of the United States offshore clinic ? Uh , I mean, that , that's the term they use , offshoring of clinical trials. Why is it wanna go outside of the United States? And , um, the argument is most people think it is price, as you correctly say, most people think it's price, but it's really about patient recruitment and quality. Mm-Hmm. . Yeah . So it's a lot easier to recruit patients. And, and, and one of the reasons why it's a lot easier to recruit patients, and correct me if I , you , you have a different perspective, is that patients in Latin America and places in in Eastern Europe may have lesser options, right? So in the US you have 20 FD approved treatment options for any disease or any illness. So , uh, even if it delays the management of your pain for 20 more years, I mean, you don't wanna , uh, subject yourself to the invasive procedure or anything if you can avoid it, right?

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Yeah. I mean, you know, you do want to be very , um, objective when you do a clinical trial and, you know, you hope that the result is gonna be positive. And believe me, I've done studies, great studies where the result has been profound, you know, mortality benefit. We've also done studies, large studies where we've found absolutely zero change, right? And so those are disappointing, but they happen sometimes. And so, you know, you , you go into it with , with eyes wide open, but you're absolutely right. In many of the , um, underserved countries , um, patients are very willing to actually try for trying to do something. And that also, I think is part of the reason that ethically, it's important to have that sustainability, or at least that exit strategy that's there, because patients will be willing to do things and try things because there's hope and there's an opportunity. Um, many of the clinical trials, these things are offered at , um, free of charge, even diagnostics and stuff, which can be very beneficial. Um, but on the other hand, I think we do have a responsibility, a societal responsibility to think about it ethically and make sure that we're doing it for the right reasons. But you are right. You know, we did a study in Serbia , um, way back when, and it was the pacemaker study, simple pacemaker study. We enrolled 76 patients in Serbia in like two months,

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, right ? And ,

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And part of that is also economy, because, you know, Serbian government, their allocation, because they are a government paid , um, you know, insurance , um, they only allow for a certain amount of high-end device implants. Wow . Research is beyond that , right . And so it wasn't taking up their quota of implant devices. And some of the Latin American countries operate that way as well. Yeah. But it's different in different countries.

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Interesting. Yes. And , um, also the, the physician patient relationship is different in Latin America, would you say so? Mm-Hmm . I mean , uh, my , my brother's a yeah , yes. My brother's a doctor here in the United States. He's a cardiologist, interventional cardiologist, and he says, Julio, sometimes I get patients that come to my office with 200 pages of Google searches, , and they just wanna , uh, uh, have a discussion with me. They don't want me to tell them what to do.

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Yeah . Well , you know , it , it depends a little bit on the finances, right? So I'll go back to Mexico for an example, you know, in Mexico it is patient pay. And as you know, my whole experience has been in the high end kind of cardiovascular devices. And so when they , you know, I've helped several, you know, friends who are Mexican, think through the situation of how do we actually purchase the right pacemaker for granddad, right? And so, you know, the doctor says that they need this kind of pacemaker. And so, you know, they say, well, you know, it's like buying a car. You can get the, you know, the, the , the Maserati, you can get the Rolls Royce, you can get the BMW , you can get the Volkswagen, you can get the Hugo or whatever. Yeah . Or , or you can get the scooter, right? . And so it , it's, you know, because there's a lot of pacemakers, but what's the right thing for the patient? And, you know, oftentimes, you know, Latin America is probably a little bit more trusting in that area than, say, India, for example. I mean , in India, people don't trust the physician.

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Right . That's fascinating. That's a great insight . I didn't know that.

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Yeah, they, they, they, you know, if , if a physician tells 'em something, they go get a second opinion, right? Because they don't know if the physician is just trying, because again, it's a lot of self pay , right? Are they just trying to make money? Do I really need the echo? Do I really need this test ? Um, and so Mexico can be a little bit like that, but it's because it , you know, when's something serious like a pacemaker implant? You wanna make sure that it's the right thing for your grandfather. Yeah . And so having the right opinions and discussions are important.

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Yes. And the other issue why patients enroll quickly in clinical research , uh, Michael, I think is because of the care that a patient receives in a clinical study versus the care that he receives in the universal healthcare system of every country. Because as you and I know, pretty much all country in Latin America has , has a , a single payer system, a universal healthcare system that covers a big percentage of the population. Countries like Mexico have five different healthcare systems, one for the military, another one for the teachers, , et cetera. So , um, I, I think , uh, that's something that I've seen a lot specifically in Columbia , uh, because , uh, the system covers 95, 90 6% of the population is one of the top performing systems in Latin America, by the way. However, access to the system is sometimes difficult. You have to stay in line for since three in the morning to get an appointment to see a general or family doctor, and for him to refer you to the specialist. And then another , uh, three hour wait in line from three in the morning, you know? And then going to the drug store , you have to stay in line for a couple hours to get access to the drugs. So in a critical trial, you don't have any of this because they send an Uber driver to pick you up for the visits and everything.

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Yep . It facilitates the care. Absolutely. Exactly.

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Exactly. That's another reason why patients are encouraged to, to join clinical trials anyway, Michael, so let's , uh, talk about the UMDR . I'm very curious about what's happening in Europe and how Latin America could benefit from it. What , what are your thoughts on this?

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Well, you know, it's , uh, so I've spent a lot of my second half of my career in talking to , uh, regulatory bodies. In fact, I mean, I've spoken to the CFDA, to the PMDA, to the Health Canada to , um, you know, the group in , um, Australia , um, you know, the FDA as well as certain notified bodies in Europe. And I've even spoken three times, I think, to the European Parliament. Um, and most of that is not because I see regulators as the enemy. In fact, I see them as great partners in what we do. I mean, their mission is very similar to ours in promoting and protecting, you know, public health. Um , what I do ask for is better harmonization. Um, and the reason is because, you know, if we have to do five large trials in different geographies just to get local approval, that is five times the cost for us to bring something out that from a physiological standpoint, most of the time is almost very identical. Now , not always. So there are care practices differences. I don't, I agree with that, I understand that. But there are fundamental times when, you know, we have to carry out large studies and we've done that , um, in different geographies just to bring them to market. And that can be very expensive. So harmonization is one key that I really push for. Now, the EMDR , um, you know, it actually is , um, going to cost a lot of money , um, , um, basically to keep things on the market that are already there. And people are estimating, you know, it , it's a lot of money. I mean, in the multimillions, just keep products that are already there on the market. Now I'm an opportunistic person. Um , I'm always very optimistic and very, you know, but I am realistic. But one of the opportunities that also helps us do is look at our, our , um, supply of devices and things that are there, and what are the things that we should obsolete, right? So we, it's hard to take things off the market. And so, you know, we actually have gone through at least Medtronic when I was there. Um, in fact, part of the E-U-M-D-R , I sat on this , the council at Medtronic to help decide how we were gonna operate and what we're gonna do with it. And , um, we actually had had a great plan. We actually talked to all the business units, all the regions. And so we did look at how we could actually take certain products off the market and move into where we could streamline our manufacturing. Because a lot of that approval BA is based on manufacturing. And if you have special manufacturing lines, that makes it difficult, especially even trying to grandfather anything in. So a lot of money spent , um, still spending a lot of money , um, in trying to do that. And for Latin America, you know, from my standpoint, what that can benefit, there's , I guess there's two things. One, again, depending on how you count Puerto Rico, , you know , Puerto Rico is gonna be a very interesting opportunity here because Puerto Rico, of course, is a manufacturing powerhouse for the United States. And as it gets closer to statehood, and as people look more, as it as an opportunity to become more inclusive with the United States , um, the tax haven that it once was will go away. Um, and so much of that means a possibility of opportunity for Latin America. Um, we have moved into Mexico to do manufacturing. We have moved into other places to do manufacturing.

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Costa Rica, I imagine . Yep .

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So if there's place , you know, so that's actually an opportunity because of the problem. It was just like in Europe where Ireland , um, you know, once , same part of the eu, Ireland, now everybody does business in Ireland and manufacturing is done in Ireland, and we do too for most of Europe. So it, it became a very nice tax haven. Now that's starting to wane away. And so people are looking at where do we move to , um, you know, back way before my time it was, it was Belgium. So we moved from Belgium, we moved from Belgium to Ireland for a lot of our manufacturing, but that was almost before my time .

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Okay. fascinating how things change. So, alright, so that's manufacturing. Um, Latin America may benefit that . This is a interesting take. I've never heard that before and I think it's very valid and , uh, different. I , I , I , I didn't see that perspective, however, what about clinical research or commercialization of medical technologies?

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Yeah, well, you know , um, we will have to of course get, it depends on how the Latin American countries look at the E-U-M-D-R . Um, you know, some of the countries have their own approval process. Some actually have, you know, once you get , um, um, competent authority, I mean, once you get , um, CE mark , then you can actually bring it in and import it. So it depends on how they look at the new regulations and whether they accept them or not. Well , again, because I want harmonization, what I'm concerned about is if the Latin American countries start to change their regulations on top of , or at the , in the follow through from the E-U-M-D-R , it could make it even more difficult to actually do that. Um, because again, I want streamlining, I want people to agree that this is the, you know, the , the , the bar that we have to reach. And then once we reach that, we can import it into, you know, Brazil, we can import it into Paraguay, we can in , you know , Ecuador as well as, you know , um, uh, you know, Israel and where rails. So that , that's the problem. So the EMDR is causing a lot now, doesn't mean we can do a lot of clinical trials. We are, and Latin America can be part of that, at least from a Medtronic standpoint. They will be, because oftentimes when we do these studies, they are global. Um, but believe me, we are trying to minimize them. Um, and we are working very closely because those can be expensive when it's just to keep the products that are already

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On the market. On market. Yes . That's, that's what's behind my question, Michael, because , um, it may happen that there's an overflow of clinical research in Europe. I mean, how many sites are in Poland? Only a few. I mean, in Lithuania. So companies will start thinking about, that's , this is my, my take. Companies could start thinking about Latin America as a place to for the overflow. Okay. So we , we, we can only have three sites in Poland, only Lithuania, let's do two sites in Colombia , three in Chile, because , uh, these sites in Poland are so busy that .

00:30:23.674 --> 00:30:49.434
Yeah . Well , you know , I tell you, you know , but , but , but there is a little bit of a competition. So, you know, India and China and Latin America, I , I still see as opportunities, right? And so China is, I mean , China still is one of the fastest growing economies. It's just incredible. Um, you know, for Medtronic, we have grown from probably 10 years ago, we probably had 50 people there. We have over 5,000 employees, China,

00:30:49.434 --> 00:30:50.035
5,000.

00:30:50.734 --> 00:31:12.724
So I mean , and it's grown and it's, and the growth has just been incredible. Now, India, we've also grown, but India is a little bit more chaotic , um, a little bit more, it's just not as well integrated as well. But there's lots of opportunity. Latin America, I mean, those are countries, right? Yeah . Latin America is a bunch of countries. Yeah.

00:31:13.884 --> 00:31:14.805
33 or something. Yeah.

00:31:15.234 --> 00:31:23.605
Yeah. And so trying to say, you know, where you're going into Latin America, it means you're really opening up a can of worms because we're where in Latin America. Exactly.

00:31:23.634 --> 00:31:27.484
Yeah. You cannot think about Latin America as a one unified regions, right?

00:31:27.765 --> 00:31:39.404
Right . But there will be opportunities, like you mentioned, I mean, I think Chile, Costa Rica , um, Mexico, Columbia , um, those are places where certainly clinical studies can pretty well straightforward be done very, very easily.

00:31:40.464 --> 00:32:28.255
And I also think that that mentality that US startups had that they, they will say, you , EU first, that was their approach. We develop a product, a device, and then we seek C mark approval. First you EU first, and then we commercialize, we get acquired and we let the buyer, Medtronic bio scientific handle or deal with the FDA and invest the millions that are needed for the pivotal or the big trials in the United States. And, and , and I guess now the mentality will change, the paradigm will change. It's gonna be United States first probably because it's probably be as, as difficult to get approval in Europe as it is to get in the , in the United,

00:32:29.015 --> 00:33:46.125
Well , yeah , Germany , Germany, Germany over the last 20 years has done that. Right? So, you know, in the past, Germany usually was the very first place in Europe that we could do a clinical implant. Um , and then B Farm came along, and that happened probably about 15 years ago. And I would say now Germany is the last country that we can get started in a clinical study in Europe. Wow . And so their approval process has become so burdensome that it's just, it, I mean, literally Germany used to be the best place when I started, you know, 30 years ago. Wow . And it's just changed it literally. And so that caused a lot of change. Germany is the largest economy in Europe, and so there's a lot of physicians who want to do the research and want to do the implants. And you know, when you are doing a hundred patient study and they implant patient 99, then , you know , yeah . They finally got approval on the last day of the study, , and you know , and somebody in Poland has, you know, 25 implants and somebody in Italy has 25 implants. Um, it , it's tough. So, you know, it's, it's one of those things where it really does matter and people will make those decisions to go because speed is important. Um , speed is money and time, you know, you say money and time are the most important things. And I always say, well, time is the only thing that's important, . 'cause time is money.

00:33:46.515 --> 00:33:48.204
Time is money. Yes. Agree . Agree .

00:33:48.325 --> 00:34:12.244
And so you're really only talking about time. And if you could actually go to Latin American countries and do a , even an EU approval study , um, you know, to get your initial CE mark. Um, because again, we do global studies. Um, so it's not uncommon to have that happen anyway, where we would include, you know, a couple of centers in Latin America, a couple of centers in a European country, depending on what it is. Yes . Um , just to get the CE mark approval.

00:34:12.864 --> 00:34:47.045
Yes, exactly. Yeah. The, the other , um, thing that I'd like to get your thoughts on is would you think that companies will look at Latin America as a place to commercialize their innovations before the, the eu, I mean, American companies, if I were an American company and I see how difficult and expensive, and I see all these notified bodies that are, can , cannot keep up with the demand. Some of them are going out of business, they have to be re-certified and and the number have been reduced dramatically, right? Yeah . You

00:34:47.195 --> 00:35:33.284
Have to follow the money though, right? So what I mean by that is Brazil has lots of money, but it's hard to do business there in the healthcare space. Yeah. And so that's the difficulty. If there was a country, like in the old days, Germany, that had lots of money and they were easy to access, then I think it would flood in. But you know, you , you look at some of the countries and so, you know, Columbia may be a possibility. Costa Rica may be a possibility, you know, but then there's the economic problems of Argentina and, and Venezuela and you know, so, so it, it, you do have to look , um, because you need both that financial, you're gonna follow the money and you need the time . So Columbia could be Costa Rica, could be , um, Chile

00:35:33.445 --> 00:35:33.885
A little bit,

00:35:34.855 --> 00:35:44.204
Chile a little bit. Like I said , we get great reimbursement in, to be perfectly honest. Um, you know, they, they are a great country to do it. They're very stable economy, stable politics, and it works pretty well.

00:35:44.715 --> 00:36:12.804
Awesome. Well, Michael, well close to the end of the show. Uh , it is being a delightful conversation. So the last , uh, question that I have for you is a question I usually ask , uh, my guest is if you had the CEO of a medical or a newer medical device company in front of you, what would you say to him or she or to her? I'm sorry. Um, what would be your most more souls of wisdom about Latin America? Yeah,

00:36:12.804 --> 00:37:15.164
You know, definitely look at latam when you're ready to expand, you know , but do your homework. , right? Each country has specific marketing, regulatory reimbursement, clinical needs, right? So find the ones that match your sweet spot. So if you have a sweet spot, if you're a device, you know , five, 10 K, whatever it is , um, and then, you know, spend lots of time on building trust relationships locally. So, you know, to me, I can't under underscore that, you know, make sure that you look at the different countries, find out where your sweet spot is because maybe you have something that's, you know, like I said, lots of surgeries are going on in Mexico and they're really good at it, right? Um, if you wanna do brain stimulation, you know, there's only three countries that really do well with that. What about diabetes? Diabetes is rampant everywhere, but there's probably four countries in Latin America where diabetes is reimbursed and it's actually important and the government recognizes it, right ? And so, you know, target correctly and then try to build those trust relationships locally.

00:37:18.775 --> 00:37:28.005
Thank you so much, Michael. It is being a great , uh, conversation and I'm sure listeners get a lot out of it. Uh, how can listeners get in contact with you at your company?

00:37:28.804 --> 00:38:42.485
Yep , yep , yep . So, you know, best way is LinkedIn, so it's , uh, Michael RS Hill, so that's the, you know, LinkedIn like piece that you put in there or search on. So it's Michael RS Hill. That's the best way to do it. And you know, I just, I just wanted to mention one final thing before we go. Yes. And you know, that is, you know, as I mentioned about time, if you truly wanna speed up innovation and grow your business , um, you know , collaborate, seek diverse thoughts and share knowledge, you know , knowledge is power. Um , most businesses make mistakes or fail because of poor timing, of sharing critical information. And so what I find is , is that people withhold information and bad decisions are made and businesses fail. And so people need to collaborate more. And you think, well, you know, it's competitive. It's competitive, it's competition. And yeah, I get it. I mean, I worked at the largest medical device company in the world for, you know, almost 30 years. It's truly competitive, but you have to collaborate, you have to collaborate with regulators , with other companies, with people locally. There's a lot of collaboration. And that collaborative approach will go far. And also finding out different opinions. Um , if you think you're always right, you are not . So

00:38:43.635 --> 00:38:48.724
Well said , . Alright , Michael , thank you so much. Thank you .

00:38:49.605 --> 00:38:50.085
Appreciate , appreciate .

Michael Hill, Former Vice President, Science & Technology and Innovation at Medtronic

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