By Deborah Borfitz 

August 14, 2025 | The big holdup in the development of advanced medical devices seems inevitably to happen at the point where first-in-human clinical trials are to begin, at least if the studies are to be conducted in the U.S. where it can be difficult to find clinical leaders, recruit patients, and bear the overall financial burden of their execution. Many of these technologies are the creation of resource- and expertise-limited startup companies that will of necessity explore options overseas to maintain momentum, according to Julio G. Martinez-Clark, CEO and co-founder of Bioaccess, a Miami-based contract research organization (CRO) focused on accelerating early-phase trial timelines with on-the-ground knowhow in more than 15 countries. 

“Latin America, in my opinion, is the hidden gem of the first-in-human world,” says Martinez-Clark, who encourages medical device startups to consider countries like Panama, El Salvador, Chile, Paraguay, and the Dominican Republic, where trials tend to get approved rapidly. Even Brazil will soon be one of the “hotspots” of medical device research, thanks to a new law streamlining its notoriously lengthy and complex regulatory approval processes.  

Knowing who to talk to is key to quickly setting up and running trials in these geographies, he adds. Bioaccess was born to help young companies match their studies to potential investigators across Latin America. Over the past 15 years, it has come to know the qualified people and regulations of different countries in the region. It has been helping with the ethics and regulatory approvals of early-phase studies in the region. “On the first pass, we sometimes get [ethical] approvals in a record 15 days because we already know what to do.” 

Until Bioaccess came along, startup medical device companies had few places to go for help in executing clinical trials in Latin America, says Martinez-Clark. Bioaccess also now has operations in Australia and the Balkans “just to give our clients more options” in regions with other advantages related to speed and cost, he adds. 

Since its founding in 2010, the company has completed more than 159 regulatory submissions for over 75 medical device trials across close to a dozen therapeutic areas and has grown a team of close to 40 members, he reports. Its network includes more than 150 active clinical research sites globally. 

The Bioaccess story began at the University of Miami, where his brother was then a Harvard-trained interventional cardiologist. Pedro Martinez-Clark, M.D., co-founded the company with his mentor William O’Neill, M.D., who served as chief of interventional cardiology at the University of Miami Hospital. As clinical leaders, they had been assisting several U.S.-based medical device startups in the design of their products and the design and execution of their animal testing and first-in-human trials. 

Initially known as Interventional Concepts, six years in, Julio Martinez-Clark—the company’s one and only CEO—rebranded the company Bioaccess to reflect its expansion into therapeutic areas beyond cardiology, like ophthalmology, neurology, and urology. “We anticipate seeing soon a lot of interventional oncology studies because ... there are now ways to treat [tumors] with devices rather than drugs,” he says. 

Pressure for Speed

Martinez-Clark moved to the U.S. from Colombia in 1995 with a bachelor's degree in electronics engineering from Saint Thomas University in Bogota. He later earned his MBA from Western New England University (Boston). His background includes technical and business positions at global telecom and networking companies such as Lucent and Nortel, he says, in addition to some entrepreneurial ventures in real estate and serving as an IT advisor at John Hopkins Hospital. 

“I was a good fit to lead Bioaccess because [his brother and O’Neill] were just two physicians trying to do clinical trials,” he continues. “They needed a lot of help with regulatory, importation, and contracting matters,” which were more his forte.  

Clients of Bioaccess are generally small startups that have spun out of a U.S. university and raised the necessary funds to develop the team and technology, says Martinez-Clark. They do all the bench testing, animal studies, and early-phase human validation, and then hope to be acquired by one of the bigger players like Boston Scientific, Medtronic, or Johnson & Johnson. 

First-in-human trials for complex medical devices involve high-cost procedures requiring advanced equipment, wires, and implantable components, and there is “the uncertainty of getting these trials approved inside of ... large hospital institutions in the U.S.,” he says. Meanwhile, investors may be breathing down the necks of these startups to speed things up, so they get a quick return on their investment via a sale to a larger medical device company.  

“Time is crucial for these [smaller] companies,” says Martinez-Clark. The reality is that it can easily take five to 10 years and between $10 million to $30 million to advance medical technologies before a startup gets acquired. Hence, they need the most efficient means possible to get their products clinically validated “ethically and with quality.” 

The geographies they consider include Latin America, Australia, New Zealand, the Balkans, Serbia, Kosovo, Montenegro, and even Central Asia (e.g., Kazakhstan), he continues. Up until a few years ago, when they joined the European Union (EU), Poland and Czech Republic were also popular destinations, as was Ukraine, which is of course now devastated by war. 

All of this is a prerequisite to getting the next, bigger round of financing from investors for larger, multi-center clinical studies in the United States with, say, 300 patients rather than five at a single site overseas. Startups also need to start talking to the Food and Drug Administration and strategic investors that might eventually want to purchase them. 

Attractive Options

For startups based in the U.S., part of the appeal of Latin America is simply that it is in the same hemisphere, says Martinez-Clark. The flight time to Colombia, Panama, and the Dominican Republic from Miami is under three hours. Staying closer to “home base” is a significant advantage for startups given the many required meetings and the fact that advanced medical devices often involve an entire surgical team traveling on-site to implant them.  

Despite being on the other side of the world, “Australia has positioned itself as one of the best countries for medical device [and biopharmaceutical] clinical trials because they have a very generous ... tax rebate,” Martinez-Clark says. “Whatever money you invest in your clinical trial in Australia, you are going to get 43.5% back [in check form] ... from the government.” 

Trials also get approved quickly in Australia because the country has much less bureaucracy than in the U.S.—a streamlined process that is likewise available in Panama and a few other Latin American countries—and has “the same English language and a similar culture,” he adds. “There is really no perfect country, but Australia has some good advantages that many companies find attractive.” 

The Balkans and other Eastern European countries that are not yet part of the EU are considerations, especially for startups based on the continent, because the European Union has “very strict regulations” (i.e., notoriously complex Medical Device Regulation) and therefore trials take much longer to get approved than in either Latin America or Australia, says Martinez-Clark. Fast approvals are possible in Serbia and Kosovo, both “sizable countries with streamlined regulations,” he points out. “In Serbia, you can get a trial approved in 60 to 90 days, which is competitive.” 

In addition to having critical on-the-ground connections globally, Bioaccess makes good use of artificial intelligence (AI) to accelerate reviewing and translating documents and assembling regulatory dossier packages, says Martinez-Clark. Their AI tools summarize informed consent forms and lengthy and complex clinical trial protocols into shorter documents using simple language translated in most cases into either Spanish or, in Brazil, Portuguese.    

Landing pages for recruitment are similarly created to accommodate the laws and language of different countries in a way that even someone with the literacy level of a 12-year-old could understand, he says. AI tools are also used to research different investigators and hospitals overseas to find the right match for specific studies. 

Success Stories 

One of the early success stories with running trials in Latin America, with Pedro Martinez-Clark and O’Neill among the investigators, prompted the creation of Bioaccess. Boston-based Mitralign, which was then developing a percutaneous annuloplasty system for mitral valve repair, was losing nine months to EU-related delays in Poland and Germany. By shifting the trial to Colombia, the company achieved an 18-day ethical approval (versus six months), enrolled 11 patients in eight weeks (versus 24-week EU average), and made its ‍EU submission 14 months ahead of schedule. 

More recently, Axoft—a spinoff company from Harvard Labs in Boston—worked with Bioaccess to run a groundbreaking brain-computer interface trial in one of the top hospitals in Panama that received permission to proceed by regulators in a record 60 days, Martinez-Clark reports. The founder and CEO of Axoft is Paul Le Floch, a former Ph.D. graduate student from Harvard, whose research spun out of the university. 

This feat with Axoft was followed this summer by a speedier, 15-day ethical approval in Panama for a trial sponsored by Newrotex, an Oxford University spinoff developing breakthrough nerve regeneration technology out of silk. “We’re about to begin implanting the technology in patients,” says Martinez-Clark. 

A few years ago, Bioaccess entered the peripheral vascular space via a collaboration with Marc Glickman, M.D., chief medical officer of enVVeno Medical Corp., for a study in Colombia of the company’s surgically implanted VenoValve for treating chronic venous insufficiency—the same condition reported to be afflicting President Donald Trump, per the doctor’s recent appearance on Fox News. The device demonstrated safety and efficacy in the phase 1 study, and a pivotal trial in the U.S. is now underway to assess its performance in a larger number of patients. 

Martinez-Clark has been on a mission to fill the “knowledge gap” about first-in-human medical devices since he knew nothing about how to lead a CRO operation for such studies at the company’s founding, he says. An FAQ section on the website segued into his penning LinkedIn articles to address some of the more common questions in greater detail, which the executive editor of a content marketing firm (Life Science Connect) happened to read. 

This led to his becoming a guest columnist for its Medical Device Online website and contributing dozens of articles. When he had trouble finding any relevant information online, he started interviewing people in the know from around the world. That gave him plenty of material for his podcast, Global Trial Accelerators, now with nearly 100 episodes designed to help startup founders save time and money by avoiding mistakes in executing their clinical trials.