Nicholas Focil is the CEO at Fomat Medical Research, a network of research centers based in Oxnard, California. Nicholas graduated from California with a Biochemistry and MBA degree. During his undergrad days, he spent his extra time in a research lab working with a nominated noble laureate performing investigator-initiated studies, and publishing weekly articles for a spectrum of publications. Was then recruited by Medtronic MiniMed Diabetes division to do pre-pivotal trials. Thereafter, was recruited for the purpose of managing and expanding Diverse Research Solutions. He then spearheaded the spinoff and expansion of FOMAT Medical Research through both the U.S. and Latin America with current operations in the USA (California and Florida), Ecuador, Colombia, and Peru. With well over a decade of research experience, Nicholas, as the CEO of Fomat Medical Research and proud founding partner of hyper core International, continues to innovate and pioneer clinical research in both regions.

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Julio Martínez-Clark: (00:00)
Welcome to the LATAM Medtech Leaders podcast, a conversation with Medtech leaders who have succeeded or plan to succeed in Latin America. Today our guest is Nicholas Focil, CEO at Fomat Medical Research, a network of research centers based in Oxnard, California. Hey, Nicolas, thank you for joining us today. Welcome to the show.

Nicholas Focil: (00:43)
Thank you. Thank you for having me, Julio. Thank you for having me.

Julio Martínez-Clark: (00:46)
Awesome, Nicholas. I'm so pleased to be here today, uh, recording these podcast episodes. Uh, you and I have been friends for I don't know how many years, and, uh, we've been one way or another in contact, and, uh, I've been following your steps. You've been following mine. So I've, I've always wanted to, to have you on camera and, and, uh, and to record the, an interview about your, your experience about your plans and your journey to Latin America. So let's get started with your journey. I mean, how is it that you got to where you are today in Latin?

Nicholas Focil: (01:20)
Well, first off, thank you for having me, and, um, I've been, you know, I've cherished our relationship. Thank you for, for, for this and, and it's exciting, uh, to have a 30 minute break with you. Um, so the journey, the journey I was, I was born in California, raised in California for the most part, um, but to parents that are Hispanic. And, uh, so I've always known that, you know, some of my blood blow, you know, flows with, uh, Hispanic culture, if you will. And, um, as I graduated college, I did research, I did Pivotals, uh, I did bench research. I worked under a nominated no Laureate. I then worked at a bio, uh, medical device company, sorry, doing pivotal trials, uh, pre pivotal trials and, um, kind of working between the ClinOps department and research development department. So I had a lot of experience from kind of that angle And then I got recruited by site management organization called drs. And at the time, um, they were focused on California growth. DRS stood for diverse research solutions. It was more of a diversity in re in research. And, um, you know, my father, who was a clinician and researcher, he was part of the board. He was a board member at that company. And he, you know, told them about, about me. And they, they, you know, they recruited me. They brought me on board, and I was part of their, their team in ca in California. So, um, at the time we got recruited a company, a special company, and a very close friends with them to date. They, they saw something in us and they saw that they needed more, uh, either recruitment or diversity or, or in this case, it was had to do with the seasonality of diseases where, you know, in the United States or in seasons and Latin Americas are in seasons. So, um, they wanted it to, to, you know, put their position in their company in a place where they could, you know, recruit in both seasons, if you will. So they asked us and the company at the board level, half the board, or you know, percent of the board, if you will, was interested in, in expanding and taking set opportunity to open Latin America while the other was, you know, let's focus on California, let's, you know, let's be laser focused. So I saw this as an opportunity, and I kind of going back to my roots and saying, you know, what, wanted to explore what it would live like in Latin America. Um, I took, I jumped on the opportunity, so a, a spinoff, a sister spinoff company called Pharma Medical Research was built to open in Latin America. And so they, they were two separate companies, but they worked so closely together, um, almost inseparable. And, um, I sat on both of them, their both management teams, but I was a leadership over here. I was a ceo, kind of managing director, if you will, of format. So as, as I kind of expanded into South America and what an experience, what an amazing experience, I've, um, it was phenomenal. We outgrew drs uh, four or five years later format actually acquires drs. So, and today, you know, we, we sit in California, we actually have some growth in Miami at some point, but then we've, we've since just focused on California in, in Latin America, our US business now sits, as you know, of predominantly the largest part of our business. It's more than, you know, 90% of our business, I would say. But Latin America is still very much in our roots in everything we do. I mean, we obviously do research and everything in Latin America, but the expansion, the way it kind of flowed, um, it enabled us, the success in the US has enabled a success in Latin America, and the success in Latin America has enabled us, and the success in us is very synergistic in so many different ways. And, um, and yeah, so now, you know, fun, then went, acquired drs, and now it's all kind of one big, uh, fun company. Fun family. That's my story.

Julio Martínez-Clark: (05:35)
Yeah, it's about having fun, I mean, into to the world and, uh, making a little bit of money here and there. I mean, Mo is not really the r I mean, what you guys do, what we all do, I'm also involved in greater research is fascinating to see the, the outcomes that you reach with all these innovations patients, how you can change their lives. At least put medical devices, implantable devices are just fascinating. So anyway, I'm going off topic. The point is that, uh, I, I admire what you do. Uh, thank you for sharing your, your journey. It's a fascinating one. And, uh, I'm so glad that you got reconnected with your roots.

Nicholas Focil: (06:11)
Yeah, I did. I did. And, you know, throughout the process and learned a lot, learned, Oh my gosh, you learned so much from, from mistakes and, and you learned probably more from mistakes. So I've had a few of those, and yeah. So yeah, that was the, yeah. But luckily, you know, as long as you keep on pushing forward, it's always been very, very, a very fun ride.

Julio Martínez-Clark: (06:32)
Yeah. Yeah. All right. So Nicola, let's talk about, uh, trends in Latin America that are relevant to our discussion today. What do you see happening in the region, uh, that, uh, you see are win to make it more appealing for clinical research?

Nicholas Focil: (06:48)
Well, I think a big one, a big one that's happening right now that's very specific to the recent, you know, uh, to our recent history, uh, of a, of kind world current, current, uh, what's happening right now in the united, in the world is, uh, the, the, the wars Ukraine and Russia. So that hasn't, is having a direct impact on Latin America. And people's like, Wait, wait, what? And, uh, so when the us many of the pharmaceuticals, see, I mean, we can kind of go into details as to kind of how they strategize, but, um, usually that region of the world is in competition with Latin America. When you, when it's a, when it's a bidding process, and this sucks to say this because obviously you don't ever wanna, um, benefit off of something negative, if you will. But given that, that area of the world right now is, there's a kind of a question mark. You know, when does the war end, um, kind of what, what is, what does the aftermath look like? Um, you know, logistics, you know, bringing kits to taking out kits, uh, monitors, recruitment, uh, your, you know, your, your compliance, retention, etc. That, um, even, you know, from, we can go into further detail on, on kinda like all the implications of that. But so as a strategic perspective, Sorry.

Julio Martínez-Clark: (08:17)
No, I was gonna say the MDR too is affecting, uh, the environment in Europe. I mean, They're busy research centers. I mean, they can't keep up with all the research that they have to do now.

Nicholas Focil: (08:27)
That, that too, that too. But spec when it comes to specifically Latin America, the, in, in a competition, when you're like in the, the war room or strategy room, if you will, in Pfizer, and call it, you know, medtech, biotech, pharma, um, kind of, you know, your first tier, you got the, you got certain like Europe, the North America areas that kind of, uh, that sit as like maybe your first tier places you have to be at. But then your second locations and sometimes your third, there's, there's re they, they're broken down by regions, you know, and, and regions that we fight against are gonna be your Ukraine, your Russia, uh, those are very much where I would say 80, I don't know. I'm throwing this percent out, but more than 50% of studies that Latin America today loses is to that region.

Julio Martínez-Clark: (09:25)
Wow. Eastern Europe in general. Yeah.

Nicholas Focil: (09:28)
Yeah. Eastern Europe in general, Right. Eastern, I'm not speaking only Europe, Ukraine and Russia. I'm speaking Eastern Europe. Yeah. But, but there's, again, there's a huge question mark, you know, do these other countries get involved? Um, do you know how, what is the aftermath? What about flights? You know, what about electric? What about electricity? What about, you know, there's a lot of, because there, there's, there's a scare of of gas being, um, controlled by Russia. So, so there's just, all of these little uncertainties are now being, because clinical research is a very trust driven industry. So if you do a, if I do a job with you and you do a good job, I'm gonna come back to you. And if you do a good job, again, I'm gonna come back to you again. Why am I gonna take a risk on this person over here? I'm not really, I don't know who they are. If I've done this job and is doing a really good, I'm having a really good relationship. Uh, so we've seen that time and time again where, where Latin America comes a little short to Eastern Europe, just a little short, always, because they already have this track recruit of the history. But for the first time caused by, had to be a war, unfortunately. But you're seeing where there's like this uncertainty over there, and there's a lot of, the pipeline is becoming larger and larger for Latin America. So I, I do expect in the next 24, 36 months to see a, an increase, a large increase in Latin America, which is kind of be interesting. Cause at first is everybody's gonna be excited, but then as kind of time progresses, there's gonna be saturation of the market, there's gonna be, So, you know, I, I'm very interested to see, you know, where we are three years from today.

Julio Martínez-Clark: (11:05)
Very good. Interesting. All right. And, and I will also add that countries are becoming, uh, a lot more mature in Latin America. I mean, their middle classes growing. Their economies are stronger. They're joining the we c d and that's a big deal for Latin America. For the first time in history, we have all these countries, Brazil, Chile, Colombia, Costa Rica, Peru is in the Saint Path. Brazil is in the Saint path. So the we CD is really, really, uh, making an impact in Latin America by, by increasing the, uh, the, the, uh, standards, uh, that this country have to abide to, you know, best practices for social policies, economic policies, et cetera. Even clinical research policy. There's a document from the c d on how to do clinical research, how to regulate clinical Research.

Nicholas Focil: (11:59)
That's awesome. I'm sorry. There's a little bit of a connection issue on my end. Um, but, but you're absolutely right. You know, Latin America is, and it, it's kind of difficult. Many people like try to like sum all Latin America together. You know, there's, there's certain countries that maybe, and, you know, you have the, the right politics versus the left politics. There are some difference, but if you wanna talk it as a whole, you are seen, uh, a kind of an acceleration in these countries and standardization. Uh, and the beauty of it is, is because if you can see what works, right? If you're kind of like, from the outside forward, you can see like, what, what's working in these countries? And you can kind of implement them. So you're seeing like, you're, like, you like what you just mentioned, um, those things, like tangibly, objectively make your country better. So, right. So now you're, you can make that decision knowing, okay, there's a clear path. If I do this, then this happens. And you're, you're starting to see Latin America. It's hard to say all Latin America. Cause I don't think it's all, but, you know, a vast majority of Latin America taking, taking these kind of strides towards, towards improvement, towards standardization, towards equality yeah, I, I totally agree with you on that.

Julio Martínez-Clark: (13:27)
Yeah. Yeah. All right. So Nicholas, let's talk about, um, what you're doing today. I mean, uh, what's, how is your involvement in Latin America now? I understand you had, uh, a big involvement in Ecuador. You had some involvement in Colombia and other countries. Please, can you elaborate a little bit on that?

Nicholas Focil: (13:47)
Yeah, absolutely. So we are a, a local cro. So one thing that I, I, I think the main, um, success of any project really in Latin America is finding the right partner. And, um, you know, Julio, I think that you're, by the way, amazing, by the way. I, I've told a lot of people about you. And, and, and for those who are listening to this podcast, I would definitely recommend them, you know, it's about being able to communicate and there's a cultural aspect to that, right? There's a cultural nuance there that I think is super important because for a Latino, like myself, for example, um, when somebody says, Hey, I'll be there in 10 minutes, I'll see you in, You know, it's, that means like, Hey, I'm on my way. I'll be there in 30 minutes. Right? You have, you have time to get a call. You might still be at home taking a shower. You haven't even left. But, you know, for, for maybe, you know, the US that, you know, I'll see you in 10 minutes means 10. So having that person that has the clinical research expertise, but able to speak it in both cultural languages not even like English and Spanish, but cultural languages, it's so in, it's invaluable really, because they'll able to translate, no, he's not gonna be here in 10 minutes. The do sign a shower, and he'll be here in like 35. Let's go get a coffee. You know? And it gives you time. And not in, like, from a regulatory perspective, from a patient recruitment perspective, from a, you know, from your importation expectation expectations, it allows you to plan better. It allows you to do, uh, project. Yeah, project management is huge when it comes to like a global project. And I think that is one thing that these local niche, uh, CROs really have, have that your global CROs might lack. Uh, because the way that, that the system kind of works from a global perspective is you usually hire local, which is great, don't get me wrong. But then you don't have that, that's lived one foot in both countries. Yes. Right? Like, you're exactly like you're calling me right now for Miami. I think you're, I think you're in Miami, right?

Julio Martínez-Clark: (16:21)
Yes, I am.

Nicholas Focil: (16:23)
Yeah. So you're in Miami, so you, you kind of, you've lived this world and you live that. So that kind of, that dichotomy, or I don't know if that's the right probably word for this right now, but, uh, it, it's super important. And that's kind of where I think we excel because, uh, in large part, we have that kind of symbiotic relationship between Latin America and the United States. Many of our countries, many of our contracts, uh, will sign 'em, the US so they can sue us here if they need, if, you know, we do something wrong down there, they can sue us here. So I think that's, those little, those little details are important. Um, but yeah, I mean that's, we have presence in Latin America. We do, you know, phase pretty much all phases, phase one's a little bit less to be completely frank. Um, and in some countries we don't have presence, but we have local partners that we work with. And, um, and so that's a kind of a little bit of different model. Uh, it's the same concept though. Again, still having that relationship, still having that knowhow locally, but we don't have, it's not our boots on the ground. It's our partner's boots on the ground. And, um, but yeah, so that's kind of our, our footprint across. And, um, and yeah, I mean, from a local cro, so we do let regulatory IRB importation exploitation your monitoring services. But where we also kind of, where we started our company, and this is where our, we specialize, is our site management side things. So we actually do the recruitment. We actually do the, the visits in some of our countries. That's the one. We don't do it in all countries that we only do in the ones that we are physically in. But, um, and the other is more of a local cro. So if you need ask help in, you know, entering to Mexico if you need help, like that is where our local side enters local CRO side. Um, if you need more help recruiting, so with our doctors, with our coordinators, you know, that's more of an like an Ecuador thing, You know, you want a vaccine research. So that's kind of our, our, our model in Latin America. And we have people super valuable. I mean, people that are, you know, they like you, Julio, like honest truth. you can go into any boardroom and, and, and speak and speak your mind, speak the not with knowledge cetera. So people like you are super valuable across Latin America, right? So, uh, you need to be able to find yours is kind of the expertises from my understanding, you know, Colombia and medical devices and, and in that space, you know, maybe there's, you're second to probably nobody, right? You know, that world really well.

Julio Martínez-Clark: (19:04)
Yeah. There's really nobody doing this type of work, Right?

Nicholas Focil: (19:07)
So, but like that. So now you need to be able to find that person for Bolivia, for, you know, Argentina. So luckily I've been, you know, lucky, really, and very lucky that, uh, you know, the world and kind of has allowed me to meet people like you and, uh, and to collaborate with people like you.

Julio Martínez-Clark: (19:25)
Thank you. Yeah. Yeah. Likewise, something is an owner to, to, to be, uh, part of your network and, uh, be friends and, uh, to somehow work together, uh, when, uh, we have an opportunity. Right. So, uh, what challenges, Nicholas, have you faced in all these, uh, years in Latin America? Let's talk about that a little bit.

Nicholas Focil: (19:48)
Oh, challenges, um,

Julio Martínez-Clark: (19:50)
Too many to count

Nicholas Focil: (19:53)
That's, that's a difficult one too. Like, you know, I wanna need like a five hour podcast for that one

Julio Martínez-Clark: (19:58)
What would you say is the top three challenges in, in Latin America that a company will find

Nicholas Focil: (20:09)
Setting realistic expectations? I think that's by far my number one, it's being able to deliver, communicate realistic expectations across all, um, stakeholders and, and kind of, so I think that would be number one. That'd probably be the number one problem. You, you know, because everybody, you have the person that provides the service that wants more time, and you want the, and you have the person that, that's hiring the service that wants it in less time, Right? There's a conflict of interest. They speak different languages. Yeah. Uh, culturally speaking, accounting, I mean, they may speak English together, but culturally speaking, and then the aftermath of, of like the reconciliation, you, you'll always, the, the way Hispanics kind of deal with, with, um, and this is a, a people person management type of, this is probably my, my second conflict would be, uh, a people, a people problem, which is, um, managing emotions. So if, if I as a, with my friends from the us, you know, if I get mad at one of them, and when we reconcile, it's totally different in, in the business world, in the US than it is in Latin America. And, you know, so very different. So when you have these meetings that somebody will like, undoubtedly, you know, timeline isn't met, right? So some, so somebody will, you know, get mad or something. And over here it's, it's, it's a different way that it's perceived. So you have to, it's a little bit of a, like a, you're a firefighter slash babysitter, uh, where you're having to massage and kind of, Hey, this is what they really mean. Hey, this is what they really mean, and, you know, let's, let's continue to be successful in this project together. So I think that, because if you don't manage that correctly, then you, you've just now, you took some motivation away from one of the sides. So, and, and that in turn's kind of a spiral effect, because if they're not motivated, they're not gonna perform even better. So you wanna continue to motivate your team. Um, I mean, I think that's, it's, it's a difficult ask, but I think that's the number two problem. And, um, and the third, which is not the best thing, but it is the truth is the revolving, uh, socioeconomic p political landscape of Latin America. And again, I, one thing that one of the silver linings of this pandemic is that if you look at depression, if you look at, I'm totally going off a tangent here, but if you look at depression, if you look at depression in the United States versus depression, you know, pandemic induced, uh, depression of the United States versus pandemic induced depression in Latin America, you would be shocked that of the difference. The United States has a significantly higher percent, and you know, hundreds of reasons as to why. And I've heard 'em all, I've read 'em all. But one of the ones that, that i, I, I think I, I find to be true or at least holds a, a, a very large percent to, um, to why is Latin Americans, through and through are used to change, are constantly used to your dollar, changing your value of your dollar. Presidents, ministers, uh, inflation. You have inflation rates, right? Argentina, right now, it, like, I was there, uh, not long ago. So I remember going, What was it? Cause I remember this vividly. It was, I remember the, the story. I don't remember the year, but call it six years ago or something. Cause I remember this, this specific story. It was one, maybe it might have been further out, maybe it was eight. Uh, it was actually during Brazil's World Cup. So that's about eight years ago. So eight years ago, the, the, uh, the dollar was worth So it was worth 10 pesos today, as of right now, well, as a check as a, like a two months ago I checked, it was like at a hundred. Uh, so just eight years. Eight years, 10 times, like $1. Got you. 10 pistols. Today, $1 gets you a hundred pistols. Or like two years ago, I don't, or when I last check was, I'd love to check right now to see, But anyway, so eight, eight years, right. So you're, you become used to it. You become, yeah. You become immune to so much change that the pandemic that created, right. This pandemic has created inflation in the United States has created, Look at the, you know, Trump versus Biden and all of the political changes. You have all these riots and, uh, people are not used to like the great resignation. Uh, you have all of these change that's happened all like for centuries in Latin America, right? So you're born into that. And, and, um, so I think navigating that for the Hispanic person is super easy, is super easy to navigate changing a president's pandemic's, inflation, like we're used to it. Uh, but I, but I do think that for somebody that's used to like having a constant president for eight years, having your dollar valued at roughly the same for about eight years, you know, inflation of two to 3%, uh, it, it's a little bit like, Whoa, this, that's a lot of change, but, but not really, you know, change is constant. Change is the only constant in Latin America.

Julio Martínez-Clark: (26:39)
Yes. It's constant. The only constant is chanfe. All right. So, well, uh, Nicholas, we're close to the end of the show. And, um, usually the, the last, uh, question that I ask my guest is about, uh, mores of wisdom. What would be your final words of wisdom? How would you encapsulate your message to somebody who is just starting to look at Latin America as a place to do business? Um, for, I mean, in relation to clinical research in this case,

Nicholas Focil: (27:14)
I mean, I would say don't think about it. Do it. Uh, without a doubt. I, I think the most important thing is don't approach Latin America as if you would to approach, uh, the US and even within the us. Like, you don't usually approach one state the same as you do, approach another financially, you pay differently. Depends on different states. You pay them differently. Um, you know, the way you approach a university is different than you would approach, uh, a rural clinic. Yeah. You know, why would that hold any different in Latin America? So, you know, approach these differently and find a local expert. I, I definitely think you need to be, have somebody locally that can help you navigate. And that, I mean, it doesn't have to be you, it doesn't have to be me. It could be anybody. Yeah. Um,

Julio Martínez-Clark: (28:05)
Especially as you correctly said somebody who has Yeah. Especially somebody who has been in both worlds, who has feet, uh, his or her feet on both worlds. Yeah. Can speak both languages, culturally speaking.

Nicholas Focil: (28:27)
Right, Right. I think that would be my one recommendation, because quality, you have it patients, you definitely have it patient naive. You have, you have people that are eager to just continue to do more research. Um, cost is, you know, it's, it's a more affordable, um, you have very talented people. Actually, just the other day, the other day is like, I see the other day, it was yesterday, This is like eight, eight months ago. Um, I, I was going through an audit and, um, and I brought some of my team from, from South America to the audit in, in North America. And, um, they, the agency, when they left, they were, they complimented us on the, you know, the expertise of our South American team as well. And just, and just, it goes to show that there's so much talent at a elite, you know, level, um, all throughout Latin America. So, you know, I definitely, definitely the quality is not something I would be concerned about. Recruitment's not something I would be concerned about. Again, I, I think I've harped on it a lot this call, but I think communications where I think is the most, it, it is the most important piece.

Julio Martínez-Clark: (29:51)
And expectations, time, expectations. I mean, the meaning of my man is so different man in, in Latin America can mean in a week or in a month. I mean, it's later. It's not tomorrow, the day after today. No, it's in the future.

Nicholas Focil: (30:13)
Right. It's also like the tone and another thing is the, the holidays. That's another one.

Nicholas Focil: (30:23)
Holidays. Yeah.

Nicholas Focil: (30:26)
I just find that there's so much more holidays in Latin America than there are. Like,

Julio Martínez-Clark: (30:30)
I mean, and yeah, that's a religious issue. Something that we inherited from the Spanish culture. And, uh, every, every two or three weeks there is religious holiday.

Nicholas Focil: (30:42)
You have to embrace it. Do embrace it. Like learn, lean into it, realize that that is what, you're not gonna change this system. This system's not changing. So, so lean into it. Real is expectations, and I promise you it'll be successful. That's my takeaway I suppose.

Julio Martínez-Clark: (31:04)
Beautiful, Beautiful. Nicholaa, thank you so much for being the show. I really enjoy our conversation as always, and I look forward to, to being in Touch.

Nicholas Focil: (31:12)
Thank you for having, for having me.

Transcribed by Temi