Julio G Martinez-Clark: Why Do U.S. Medtech Trials Go Abroad?

A Costly Delay in U.S. Medtech Innovation

Most U.S.-based medical device startups face a daunting truth early on: conducting a first-in-human clinical trial in the U.S. is not only costly—it’s painfully slow. Between the uncertain FDA timelines, recruitment challenges, and financial pressures from investors, many companies find themselves forced to look abroad to validate their innovations.

Julio G Martinez-Clark, CEO of Bioaccess, knows this journey well. As the founder of the only U.S.-based Contract Research Organization (CRO) specializing in early feasibility trials in Latin America, he’s built a bridge between American innovation and Latin American efficiency. In this episode of 21st Century Entrepreneurship, Julio reveals how medtech startups can gain precious speed and insight by partnering south of the border.

The Bottleneck: Why U.S. Startups Look Abroad

“You can’t afford to wait 12 months for a green light when you can have it in 30 to 60 days,” Julio warns. For most medtech founders, clinical trials aren’t just regulatory boxes to check—they’re existential moments. Fast data validates concepts, convinces investors, and guides pivots. Delay can mean death.

U.S. startups often find themselves bogged down by:

• FDA uncertainty

• High costs of trial setup and execution

• Difficulty recruiting patients in time

These obstacles have made Latin America a strategic alternative.

Why Latin America? Speed, Savings, and Shared Time Zones

Countries like Colombia, Panama, and the Dominican Republic are becoming hotspots for early feasibility studies. “The savings in time and cost in Latin America can be substantial—about 70% faster approvals and up to 70% cost savings,” says Julio. With easier patient recruitment, fewer bureaucratic hurdles, and geographic proximity to the U.S., Latin America is often the smartest choice.

Julio’s team at Bioaccess has built a network of trusted research sites from Mexico to Argentina. Their deep regulatory experience means they can navigate approval processes in:

• Panama: 30–60 days

• Dominican Republic: 60–90 days

• Chile: 30–60 days

  
  

Not only are these countries safe and equipped with world-class hospitals, but their medical staff are increasingly familiar with U.S. expectations and technologies.

Pandemic Innovation: Remote Trials Done Right

COVID-19 brought unexpected disruption to cross-border trials. “Patients didn’t want to go to hospitals, and U.S. teams couldn’t travel,” Julio recalls. But rather than halt progress, Bioaccess innovated.

Using telemedicine, virtual interviews, and remote-guided surgeries via Zoom, they successfully recruited and treated over 30 patients. “We set up different cameras in the operating room so the team from the U.S. could guide the local investigator. It worked,” Julio explains.

This model of remote trial coordination now offers a blueprint for decentralized studies—saving companies both money and time.

From University Spin-Off to Latin America’s Go-To CRO

Julio’s journey began over two decades ago at the University of Miami, where his brother Pedro Martinez-Clark trained at Harvard and later collaborated with top cardiologist Dr. William O’Neill. Their early success connecting medtech companies with Latin American investigators led to the launch of Bioaccess as a standalone entity—designed to move faster and scale wider.

Today, Bioaccess employs over 40 collaborators across Colombia, Mexico, Panama, and the Dominican Republic. They’re uniquely positioned to speed up approvals, match companies with ideal investigators, and run smooth early-phase trials across Latin America.

Educational Mission: The Podcast and Newsletter

Beyond hands-on trials, Julio is also on a mission to educate the industry. His company runs the only podcast focused on medtech clinical research in Latin America, featuring U.S. medtech leaders who’ve “been there and done that.” His Medtech Pulse Newsletter offers practical, region-specific insights for founders navigating the early trial phase.

Julio also contributes to Med Device Online, where he writes a regular column—the only recurring feature focused on Latin American clinical research.

Key Takeaways for Founders and Innovators

• Speed is Survival: Latin America offers 30–60 day approval times, compared to a year in the U.S.

• Huge Savings: Trials can be up to 70% cheaper than in the States.

• Remote-Ready: Telemedicine and virtual trial methods are proven to work.

• Built-In Expertise: Bioaccess helps you navigate regional differences, fast.

  
  

Conclusion: Need Speed? Think South

If your medtech startup is stuck at the FDA starting line or burning cash waiting on patient recruitment, Latin America may be your lifeline. With an experienced CRO like Bioaccess, the path to validating your device just got a lot shorter—and smarter.

As Julio puts it: “You don’t need to wait a year to get to first-in-human. Just Google my name—I’m very active on social media and easily findable.”

➡️ Explore Bioaccess services at bioaccessla.com

➡️ Follow Julio on LinkedIn

➡️Subscribe to the Medtech Pulse Newsletter

➡️ Check out Julio’s column on Med Device Online