Why Do U.S. Medtech Trials Go Abroad?

Inside this conversation

Julio G Martinez-Clark is a pioneer in the world of clinical research for medical devices, and we spoke about why so many American innovations never get tested on American soil first. As the founder and CEO of Bioaccess, the only U.S.-based CRO dedicated to first-in-human trials in Latin America, Julio brings an insider’s perspective on how to save medtech startups from trial-related dead ends.

Did you know that most U.S. medical device startups look outside the U.S. to test their innovations first? “Because the uncertainty of the FDA, the difficulty of recruiting patients, and the costs associated with these trials force these companies to go overseas,” Julio explains. The destinations? Colombia, Panama, Dominican Republic — not just for affordability but for speed. “The savings in time and cost in Latin America can be substantial—about 70% faster approvals and up to 70% cost savings.”

We explored:

• Why the FDA approval timeline is a bottleneck for startups
• How Latin America became the "go-to destination" for first-in-human trials
• What makes sites in Colombia, Chile, Panama, and the Dominican Republic so attractive for medtech founders
• How Bioaccess virtually recruited and treated patients during the pandemic when U.S. teams couldn’t travel
• Why speed-to-data is the lifeline for medtech companies with impatient investors

Julio also shared how his team built a 20-year legacy out of a University of Miami spin-off, backed by world-class cardiologists like his brother Pedro Martinez-Clark and mentor Dr. William O'Neill. “We were able to set up different cameras in the operating room… so the team from different parts of the United States via Zoom was able to guide the local investigator.”

Takeaways for founders and innovators:

• You don’t need to wait 12 months for a greenlight when you can have it in 30-60 days.
• Latin America offers “geographical proximity, same time zone, and also because it's a lot faster and easier and cheaper to recruit patients.”
• Remote trials are real: "We recruited over 30 patients this way, actually.”

If you're developing a breakthrough medical device and can't afford a year-long waiting game, this episode is a must-listen.

Episode description from the official 21CE podcast feed. This text is the show notes, not a full transcript.