Feb. 23, 2023
Etienne Nichols, Medical Device Guru
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has manufacturing and product development experience, even aiding in developing combination drug-delivery devices, from startups to Fortune 500 companies, and holds a Project Management Professional (PMP) certification. Etienne has managed cross-functional teams for updating legacy products as well as developing new medical devices. His expansive knowledge, experience, and passion for medical devices are evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market.
WEBVTT
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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.
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Please subscribe on your favorite podcasting platform.
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Apple Podcast, Spotify, Google Podcast.
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Amazon Music is teacher tuning.
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I heard radio, Pandora, or these are
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Welcome to the Latin Metech Leaders podcast, a conversation with leaders who have succeeded or planned to succeed in Latin America.
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Today our guest is et Nichols.
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Yeah.
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I hope I'm pronouncing your name correctly.
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.
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Nailed it.
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Yep.
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, excellent.
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A medical device girl and mechanical engineer who loves learning and teaching how systems work together.
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So et thank you for being in the show today.
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It's a pleasure to have you here.
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Yeah, great to be with you, Julio.
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Thanks for, thanks for having me on the show.
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Awesome.
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Let's get started.
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So, et tell us about your experience or your journey to Latin America.
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How is it that you got involved with the regional and personal professional level?
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Yeah, so on a personal note, it, you know, when I was in college, I had a, a really good friend of mine whose name was Juan.
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He was, uh, from Columbia.
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And, uh, I just remember he and I worked, you know, when you're in engineering school, you work long hours and then you get up early to go to work, you just, it's just around the clock.
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And we would be at his house constantly and his dad, who couldn't speak English to me, but he would always make the best milk and, and rice, I don't know what it was, but I said, someday I'm gonna go to Columbia and I'm gonna eat this in the country.
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Uh, so that's my personal, kind of like, where I was like, oh, Columbia, I wanna go there someday.
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Um, uh, professional, we have a few customers that I have personally worked with in, uh, um, in different places in Latin America.
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Um, one in Columbia, one in, uh, I believe in Brazil.
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But, uh, just a f just a few customers that I've interacted with in Latin America as
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Well.
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Excellent.
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Very good.
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So, um, at the end, let's talk about trends that you see happening in the industry that are relevant to the business of doing studies in, in, or commercializing innovation in Latin America.
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Please.
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Yeah, so the thing that, the thing that I go to when I think about, I mean, you almost have to look at it globally.
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It's not just, you know, you can focus on one country over another and Latin America, certainly, obviously it's the, there's the focus today, but if you look at it globally, what's happening, U M D R has always been, uh, or, or the, the European market has always been, you know, go there first because, uh, it's a little bit easier to get to market.
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And then eventually you, you bleed over into North America and, and, uh, and the rest of the world.
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Uh, the, that's changing with E U M D R.
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Um, especially with deadlines.
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A lot of the industry has been expecting, uh, another shift or another, uh, delay to those requirements.
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And I don't think that's really a safe way to go.
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And so it's looking like now, uh, this pendulum has shifted.
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So now where people may have been trying to be, you know, first in human in overseas, now it's looking, looking like, you know, America is one, one, you know, north America.
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Sure.
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But, uh, Latin America is even, is even more, um, appealing because of the, the increased timelines as far as first in human, some of these clinical trials.
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Um, and then also some of the, uh, uh, the trends that you see as far as, um, uh, the cost.
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So both timeline and costs are, are hugely appealing when you look at Latin America compared to some of the other regions in the world.
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Totally.
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Yes.
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What countries, um, did you hear, or do you usually hear your clients talk about when they were thinking about early feasibility or first human trials?
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Yeah, that's a good question.
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Um, I don't have a specific country, um, you know, that comes to mind as far as that goes.
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Um, it, lately I've just been hearing about the shift, uh, shift more away from the European market.
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That's true, that's true.
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Um, and, and, and also I would say that, uh, I just met with, uh, sponsor the ceo, e o for medical device company, uh, is a company, uh, out of, um, Seattle, Washington.
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And, uh, it's just shocking how, um, unsatisfied he is with the FDA ID approval process for a, an early feasibility study.
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And then the word he used was uncertainty.
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Uncertainty is the enemy of a startup.
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You cannot have uncertainty.
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You, you can have risk of course, but not uncertainty.
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And there's so much uncertainty in Europe, of course, as you correctly said.
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And there's so much uncertainty in the US as well.
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So that's probably the reasons, the main reason why companies are looking at other places like Columbia, et cetera, to do early visibility
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Work.
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Yeah.
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And, and I know, I mean, I see you, Julio is kind of the expert as far as Latin America as a whole.
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There's certain things that I, I know about the different regions of different things, but, um, I'd love to hear, I, I don't wanna flip this around necessarily, but I'd love to hear some of the things like you as specifically say, Hey, this region, you know, maybe Columbia, but just because, you know, that has part of my heart there, um, you know, some of the, the things as far as the uncertainty, cuz because I latched onto that word, uncertainty.
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Why would, uh, you know, what are, what are your thoughts as far as, uh, you know, the flip side, um, in Latin America?
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Yes.
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Yeah.
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The, the way it works, the approval process, uh, the way it works in a country like Columbia, for example, and I'm Colombian as well, so I'm, I'm biased, uh, and we do most of our work in Colombia.
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But I've, I've analyzed pretty much the whole region, pretty much the whole region.
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I just finished an article about, uh, comparing the regulatory, regulatory approval process in Columbia, Mexico, and Brazil.
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And, uh, it, it is, I mean, if you put the three countries together, the timelines, the process, I mean the steps, the review cycles and all that, I mean, it's just obvious that Columbia is perhaps the most appealing country and the country that offers the most certainty to these companies.
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And that's what they're looking for, uh, without mentioning cost savings and, and, uh, patient recruitment potential because of the size of the, uh, of the country, the population.
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So I, I will say that, uh, Latin America is getting more and more mature, uh, countries like Columbia, like Chile are really, really making efforts to, to become, uh, knowledge economies versus, uh, commodity exporting or agriculture exporting countries.
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And, and knowledge economies means that you have to, to, to somehow connect, uh, your industries to the world, especially the service industry, uh, in, in, in the clinical research is a great, it's just a fantastic way of, of connecting a country to the world to high level of, of, of, uh, knowledge about innovation and all that.
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So, so yeah, I will say that, uh, Columbia is offering a lot more certainty, way more certainty than Europe or the United States right now.
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Yeah, absolutely.
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Yeah, it's a good summary.
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All right.
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So let's, uh, continue.
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Um, I heard that, uh, you guys did a great survey about the state of the industry.
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I'm just so thrilled to, to to, to have you here and to, uh, speak about it.
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I mean, can you elaborate on that, where you guys, uh, what you guys, uh, concluded after reading all those surveys?
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answers?
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Yeah.
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Yeah.
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And, and so yeah, we did do a survey.
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We called it the, uh, quality management and product development surgery survey, um, uh, the 2022 State of MedTech.
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And, uh, you, there were, there were several, several things that came out of it.
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I guess I should start by saying, we interviewed 519 quality professionals.
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Um, and so when I say 519, um, about 60% of those were quality and regulatory clinical.
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Um, about 26% of those were product development or engineering.
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And then we had a, a small sliver of manufacturing, and then, uh, about 11% worth corporate or executives.
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So the majority were quality and regulatory.
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Um, that survey, uh, it, it covered a broad range of topics and you asked about conclusions, so we'll talk about in just a minute.
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Um, but I also wanna say, we actually just, I think we just closed, uh, our most recent survey as well.
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So we, we have about 600 this time, uh, quality professionals that we have interviewed.
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So we're getting ready for, for next year.
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So that'll be coming up.
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Um, we'll definitely let your audience know when that's out.
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As far as the, uh, the conclusions, there were some interesting findings.
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And before I get to conclusions, one of the things that really stood out was that timing really matters.
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And, uh, um, to your point with Columbia, um, that's, that's the thing that I noticed when I talked to, when I looked at the, the timelines between Brazil, Mexico, and, and Columbia.
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Just the, uh, the speed at which you could expect to get through with Columbia was, was pretty mind boggling compared to some of the others.
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Um, I mean, it's almost an order of magnitude, isn't it?
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You know, the difference, um, so when we looked at the different classes, so, so class one, class two, class three for class three device, um, on average, well, I don't know if it's really fair to take an average, but let, let's use percentages.
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The bulk, 47% of, uh, uh, class three devices, um, for the FDA took three to five years to get to market.
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So that's actually probably a little bit, I mean, that actually might even be a little fast compared to what I was expecting.
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Um, about 23% of those expected, you know, they, they were around two to three years, um, but the majority are expecting to, to take longer than five years.
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So if you can shave a fi a year off of that, totally.
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Yeah.
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Yeah.
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I mean, you sha you, you now have 20% faster to market.
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20% is huge.
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So, um, just timing, timing matters, you know, and, and we heard that from several, uh, several different tiers, um, MedTech professionals as far as, you know, the different things that we, we heard.
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We, um, another thing that we looked at was whether or not, uh, these medical professionals were using what kind of tools they were using, whether they're using purpose-built solutions or, um, you know, uh, just general purpose tools.
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It was about half and half.
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And when we looked at that, the ones who were not using, uh, purpose-built solutions, you know, something that was specifically built for their industry, um, timing, uh, timing was affected as well.
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So that was interesting.
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Um, let me, I'll kind of skip to the end as far as some, the, the top four things that we saw happening.
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So as far as, um, uh, the things that we saw was a disconnect between management and quality, the actual quality, uh, department.
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So there's a disconnect as far as whether or not, um, they were actually on target or excelling in quality.
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So management typically said, no, we're not doing well with quality.
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It was kind of like a, um, uh, the, the majority of them, whereas a lot of quality management said, we're doing pretty good.
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So there was a little bit of a disconnect there.
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So that was interesting.
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You know, something that to think about, um, when we kind of, when we kind of did a few interviews with some different people as to why might that be the case, uh, one of the thoughts was, well, management is thinking about two different things.
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You know, the quality may be thinking how many CAPAs are open, how many CAPAs have been closed, uh, whereas quality in the, the, the upper executives might be thinking more along the lines of something like, um, you know, how fast are we getting to market?
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Have we produced more revenue?
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And, and, you know, what's the outlook look like?
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So that was one of the things that we noticed.
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Uh, supplier management was another one.
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And, um, and I don't know, I, I, again, I, I love hearing from you Toolio, you know, I know you were all on our podcast.
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And so when I think supplier management, uh, that's one of the things that I love to, to hear about as far as, you know, the, the Latin America and how you've seen some of those supplier, um, you know, just cuz MedTech companies are gonna call it a supplier, whoever they are.
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But that partnership, um, across those country lines, what have you seen as far as that management?
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Well, um,
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Is that something I'm, I'm allowed to ask
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?
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No, no.
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Uh oh, it's a good question.
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I don't know the answer to be honest with you.
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I, I, yeah, I don't, I don't get involved.
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We don't get involved in, in, in quality issues with our clients.
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They just ask us for SOPs, and that's it.
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I mean, we're a US company, so we are not really, so, no, I don't, I don't have an answer for that, to be honest with you.
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I'm
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Sorry,.
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Well, so No, no, that's okay.
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And that's okay.
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I just like to ask the question.
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I don't mean to put anyone on the spot.
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I'm supposed to be the one on the spot here,.
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So,
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Uh, one of
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Anyway.
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Well, you know, when, when I think supplier management, you know, we're going to a remote world, you know, and, and that's inevitable.
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But when you talk about certain aspects of your suppliers, there are certain things that you need to be doing in person.
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And I'm, yeah, this is me a little bit selfishly as a, as a, as a, you know, a world traveler, traveler, not necessarily by choice.
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My wife has turned me into one.
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She, she takes me different places.
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And, and that's wonderful.
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I'm very thankful for that.
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Um, when you choose your suppliers, you know, one of the things you need to think about is how close are they?
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How can I, can I get to them?
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Um, you know, can I have a relationship with them?
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And, uh, so you don't necessarily think of a country, you know, at least I don't necessarily think, is this country a place I wanna go to for that supplier?
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But that actually plays into it, um, your relationship with those things.
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So that might be another thing to think about when you're thinking about your, your long term
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Suppliers.
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Yeah, that, that's a great point.
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That's a great point.
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And, and, and of course, uh, we operating in Latin America, and one of the things from the get-go, we started the company, we set it up as a US corporation.
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We are a Florida based company.
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And that's also to, to give our clients that level of trust that you're, they're dealing with a local supplier, they're dealing with a US company.
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We're a real people in the us.
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We're not some remote company in Columbia with a bank account with a Swift number that takes whole page,,
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Right?
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I mean, a whole page of wiring instructions.
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You don't know if you're gonna get your money, these people.
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So, so, yeah.
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So, so, so, no, it's a great point.
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And the word that buffer between our clients and our research centers, uh, not our research center.
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I mean, the hospitals that we deal with are in our network of, uh, research centers, um, so they don't have to deal with foreign suppliers.
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So we make it easier for our clients in, in that way.
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Yeah,
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Yeah.
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Yeah.
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So that's one of the things that, uh, you know, so supplier management just in general was one of the things that, um, we saw quite a few people really felt like was below average.
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So actually 75%, 75% felt like their supplier quality management program was below average, or average or below average.
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So that was something to think about.
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Um, and, um, yeah, it's just one of the things that you need to think about.
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Um, another thing to think about.
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So one of the other issues with our, you know, when, with that we found in this survey was one of the, uh, um, one of the things that people experience is if you experience a warning letter, it may take three years to reach resolution for that.
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Now, I'm, I come from the quality regulatory side, so I, I think a lot about the quality.
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Um, uh, so that's, that's one of the things that, um, again, uh, that uncertainty and start tying, tying it back to that word that you said, you know, certainty that what you have as a quality product, what you have is something that you, uh, you know, what is going to meet your expectations, um, that's important in the quality world.
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Um, because if you, if you don't cut corners, if things don't work out the way you expect them to and so forth, um, yeah, those, those warning letters can take a long time to resolve.
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Yeah,
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Yeah.
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I'm sure.
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All right.
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So, so basically, um, the issue of time is probably the, the, the issue that we can all help in Latin America, uh, or the issue with Latin America can, can, can play a, a predominant, uh, role for the MedTech industry, uh, as you correctly found.
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And that's, that's also my, it's been my experience.
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That's usually what I hear.
00:16:36.330 --> 00:16:37.980
I mean, time, time, time.
00:16:38.360 --> 00:16:43.580
How can we start this trial faster anywhere in Latin America?
00:16:43.779 --> 00:16:57.899
Sometimes I have conversation where I have to give them the whole, my potential client, the whole framework around the different countries so that they can understand where to go and where they can get their study approved faster.
00:16:58.549 --> 00:16:59.340
So, so, yeah.
00:16:59.539 --> 00:16:59.539
Yeah.
00:16:59.980 --> 00:17:08.960
Um, the other thing that I, that I, I'm very thrilled about is your acquisition of, um, smart trials.
00:17:09.480 --> 00:17:09.680
Smart trials.
00:17:09.799 --> 00:17:09.799
Yes.
00:17:09.960 --> 00:17:19.480
That will also save time and, and, and effort in managing these smaller medical device early disability studies, which are different from pharma studies.
00:17:19.490 --> 00:17:33.579
So, uh, I think, uh, the partnership that we have and, and what we're putting together here is gonna benefit the whole industry, uh, because we're gonna, uh, uh, solve one of their pain points.
00:17:33.858 --> 00:17:38.339
One of the problem is, which is the time to take that takes a device to get to market.
00:17:39.210 --> 00:17:39.700
Yeah.
00:17:40.299 --> 00:17:42.740
Uh, not just the time too, but like you said, the certainty.
00:17:43.019 --> 00:17:43.259
Um, the
00:17:43.259 --> 00:17:43.660
Certainty.
00:17:43.661 --> 00:17:44.019
Exactly.
00:17:44.130 --> 00:17:44.940
Yeah, exactly.
00:17:44.970 --> 00:18:02.069
When you have, uh, clinical trials spread over multiple locations, and, uh, you're trying to capture all that data, whether it's on paper or through, you know, just however that's being captured, um, really a solution like smart trial is, is really the way to go as far as that electronic data capture.
00:18:02.099 --> 00:18:10.710
I mean, it's just, it will increase your, your certainty and your ability to, um, just have a lot of more confidence in, in what you're actually performing.
00:18:10.711 --> 00:18:11.029
So,
00:18:11.170 --> 00:18:11.589
Yes.
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Yes.
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