Adam Torres and Julio Martinez-Clark discuss bioaccess®.
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Show Notes:
What trends are shaping the Medtech industry today? In this episode, Adam Torres and Julio Martinez-Clark, CEO at bioaccess®, explore Julio’s journey and insights into the state of the Medtech industry.
About Julio Martinez-Clark
Julio is the co-founder and CEO of bioaccess®. Julio believes Latin America is an untapped destination for Medtech clinical research. Since 2010, Julio has supported +100 Medtech in operationalizing successful clinical trials in several countries in Latin America. Julio was the chairman of the board of the Association for the Advancement of Clinical Research in Colombia (AVANZAR). Julio writes a column at Med Device Online, where his articles have been “Featured Editorials” on several occasions. Julio hosts the LATAM Medtech Leaders podcast, interviewing Medtech leaders who have succeeded in Latin America.
About bioaccess®
bioaccess® is a top contract research organization (CRO) in Latin America, specializing in clinical research for the medical technology (Medtech) sector. Its focus is on accelerating the advancement of medical devices from first-in-human studies to commercialization. bioaccess® supports Medtech startups with cost-effective, high-quality research services. With over 15 years of experience, the team understands the industry and its regulatory requirements.
Full Unedited Transcript
Hey, I’d like to welcome you to another episode of Mission Matters. My name is Adam Torres, and if you’d like to apply to be a guest on the show, just head on over to mission matters.com and click on Be Our Guest to Apply. All right, so today’s guest is Julio Martinez Clark, and he is the founder and CEO over at Bio Access.
Julio, welcome to the show. Thank you, Adam. I’m glad to be here. Fantastic. So excited to get today’s topic. So we’re gonna talk about innovative clinical trials in Latin America and really med tech leadership in general. But just to get us kicked off how did you get started in this industry? Like, where’d that start for you?
Well, Adam, it’s been a long journey of about. 15 years I was in the telecom and networking industry. I worked for Lucent and Nortel. I did business in Latin America, Europe. And then my brother called Pedro called me one day and he said, Hey, Julio, i’m working in, he’s a physician. He’s a Harvard mm-hmm.
Trained interventional cardiologist, and he’s, he was advising US medical device startup that were developing advanced cardiovascular technologies. And I’ve always been a, business guy. I got my MBA in Boston, so I, led international teams for losing a Nortel, so it was kind of a, perfect fit for what Pedro wanted to do.
He realized that in his work helping us medical device startups. That were developing innovative devices. He saw that there was really nobody in the US helping these companies with their first human clinical trials overseas, more specifically in Latin America. So we joined forces and since 2010 I’ve been leading bio.
We’ve grown the company exponentially. And yeah, it’s been a fun journey. Wow, that What an amazing story. And maybe go further into bio access, like in your work. So you’ve been in business now for, what, 15 years? Or going on, you know, over tell us a little bit more about like the work you’re doing today.
Well, the struggle that us medical device companies face is really about time to market. Time to, to get a clinical trial started. Anywhere in the world in the US is becoming more difficult and expensive, et cetera. So there are. Forced to explore options overseas. So they usually go to Eastern Europe.
They go to Australia and Latin America. Mm-hmm. So we help these companies finding these sites or hospitals mm-hmm. That can test the safety and efficacy of their innovations. It is usually a, the first experience in live humans that these companies have. So they are very meticulous in the site surgeon selection because they’re putting all their eggs in one basket.
Yeah. They just need an investigator overseas who has the right patient population and can recruit them for the study and can benefit patients. And the, these studies are usually small, 5, 10, 20, up to 20 patients. And we help them finding those investigators in Latin America and other parts of the world as well.
But our focus has been historically in Latin America. We’re also expanding to Australia and Eastern Europe. But we help them with the site search and selection, the regulatory approval processes and the importation of the investigational devices, the management of the studies, the reporting of adverse events, et cetera, et cetera.
Everything in between that is needed to make these clinical trials a success. Hmm. Can you talk about any trends you see shaping the med tech industry today? Like what kind of trends are you following?
Yes, there are a couple trends that I’ve seen recently. The first trend is the growth of the medical device industry. Before about 15 years ago or so, devices were very patch. They weren’t really that smart, but with advanced manufacturing techniques with the onset of artificial intelligence.
And also the aging of the population devices are becoming smarter. They’re everywhere. There are. Outside of the, of a hospital setting, they’re in our hands, in our pockets, in our homes. Mm-hmm. So they’re all over us. And devices are now something that is trading the pharmaceutical industry in I mean in the outsourcing of the clinical research.
Efforts the, the outsourcing of clinical research started with the pharma industry about 20 years ago. That’s why you saw I-Q-V-I-A-P-P-D park. So the big contract research organizations mm-hmm. That many people know about. But in the past five years or so, there’s being an increasing trend to.
MedTech contract research organizations. In other words, these are newer companies that are being created just to cater to the needs of the MedTech industry as opposed to the pharma industry because pharma MedTech. They are different. I mean, they look similar, but they are different, so, mm-hmm. That’s the main, the main trend that I see smarter devices new organizations that are being created to cater to the needs of the device manufacturers.
And the other trend that is more recent has to be with political changes in the United States, which is the layoffs of the FDA, the delays in getting trials approved in the, in the us. The increasing expenses associated with healthcare procedures in the us. So this is forcing a lot of companies to go overseas, so that’s why.
Mm-hmm. We exist to help them find sites overseas. Hmm. Now I know that this can vary, so I wanna make sure that I, I asked the question correctly, but when you talk about conducting fast clinical trials like what, do you mean by that? Can you give any timeframes of maybe if, if somebody went maybe one route versus another working with your company?
Like, like just gimme a, and I know that can vary, but I wanna make sure I understand what fast clinical trials means. Like what, what some of the benefits are working with biox. Well in the us, getting a first in human trial approved can easily take a year. Mm-hmm. I mean, by the time you start. Exploring your options with the different hospital systems.
Having all these meetings with these large hospital institutions, trying to find a willing, able investigator who can lead you your trial. Then getting through the IRB approval process, getting through the FDA approval process, getting through the, the difficulties in recurring patients because these trials are very, very risky.
And it’s just difficult to, to get these trials approved in the United States. Mm-hmm. I mean, at least a year or more with the political changes that we’re seeing now mm-hmm. In the different government agencies, more specifically at the fda companies can go overseas and they can save. A significant amount of time.
I’m talking about activating a site or starting a trial in just 60 days. 90 days. Oh, wow. Wow. Which is record time as compared to the the other option. Yeah. So yes. And if you think about that, like that time that other, let’s say nine months or eight months, or even seven months, I mean that’s, you know, when you think about the burn rate of a company, right?
That’s valuable time where every day they’re burning cash to get this, you know, done. Yes. Right? Absolutely. Yes, yes. so that’s one piece of it. So obviously possibly the savings. Is the, is there a savings also in just overall cost for doing it a abroad, other than the burn rate and obviously it’s faster.
I’m just curious. Or if that’s kind of like neck to neck. Of course, yes, there are, there are two more advantages Adam. The first one is just time savings, which is mm-hmm. Money really being saved. Yeah. Significant chunks of money, as you correctly said. The other is the, how easy it is to recruit participants in these trials.
Patients are really, really in need of participating in these trials because of the way the healthcare systems work in these different hospitals, I’m sorry, countries in, in, in Latin America more specifically, they are public healthcare systems. So patients have to wait for months to, to just to see a primary care physician and to see a specialist will take thing, it take them even longer.
They have to wait in line from three in the morning until nine to get seen by somebody who can give them an appointment or give them a medication. So it’s just difficult for regular patient in a Latin American country where developing economy to to have access, quality access. To the healthcare system.
So a clinical trial is a fast track way for patients to have access to the system and to be treated with dignity. Mm-hmm. And post savings, of course. I mean, we all know that the cost of living in, in, in developing economies in Latin America is way lower than the United States. I mean, many of the medicine have going to Mexico on vacations or, have traveled around Latin America, and they know that everything is.
Just cheaper. I mean, the salaries are lower, the cost of bleeding is is lower. You have meals for cents in the dollar, so it’s just a different cost structure that you have in Latin America. So usually companies save about 50%, anywhere between 30 and 50% of what the same procedure would’ve cost in the United States.
Yeah. Well well, Julio, this has been great. First off, learning more about what you’re doing at Bio Access in your journey. I just have to ask what’s next? I mean, what’s next for you? What’s next for the company? Tell me about the plans moving forward. Yes, the company is expanding. Adam, as I alluded to earlier during the call we are expanding operations to Australia and to Eastern Europe, and also we’re expanding operations in, in, in the biopharma space.
In other words we see the need for these companies to have more options and by I. Other countries in our portfolio in our value proposition, we can give our clients options rather, I mean, beyond Latin America and also Biopharma, biopharma has the same struggle, the same needs that MedTech startups have in the us and they’re also looking to, to conduct fast clinical trials overseas.
Mm-hmm. So I think the next chapter for bios is to, get into. Two different areas. I mean, geographical expansion and also industry expansion. Mm. Fantastic. Hulu, if somebody’s listening to this or watching this and they wanna learn more about bio access, how do they connect? How do they learn more?
Well, our website is bio access LA. For Latin america.com, bio access a.com or LinkedIn. I’m very active on LinkedIn. I have over 30,000 followers. Just Google bio access or, just enter bio access on, on LinkedIn or Google or my name. I always on podcasts, I write articles about the industry and, and, and topics related to clinical trials overseas.
So I’m easily searchable on LinkedIn or Google. Fantastic. And for everybody listening, just so you know, we’ll definitely put the links in the show notes so you can just click on the links and head right on over. And speaking of the audience, if this is your first time with Mission Matters and you haven’t done it yet, be sure to hit that subscribe or follow button.
This is a daily show. Each and every day we’re bringing you new content, new ideas, and hopefully new inspiration to help you along the way on your journey as well. So again, hit that subscribe or follow button. And Julio, appreciate on the show. Thank you, Adam for having me here. It was a pleasure.