The Benefits of Clinical Trials in Latin America for Medtech Startups
Aired On: June 17, 2025
Julio Martinez-Clark, co-founder and CEO of contract research organization (CRO) bioaccess® joins hosts Michael Roberts and Scott Zeitzer to discuss why Latin America is a great place for clinical trials for medical devices. Julio explains how both the startup and the patients benefit from studies conducted in Latin America, and what startups should be thinking about as they get ready to begin first-in-human studies.
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In this Episode
- 02:59 The Role of CROs in Clinical Trials
- 06:03 Benefits of Clinical Trials in Latin America
- 08:52 Challenges for Startups in Clinical Research
- 12:13 Perceptions of First-in-Human Trials
- 14:50 Advice for Startups in MedTech
- 17:57 Navigating Clinical Trials and Regulations
Quotes From This Episode
It is just hard for a regular patient in a Latin American country to have access to the system and to be treated with dignity. So when you come in as the sponsor of the clinical trial or a CRO that is acting on behalf of the sponsor, offering through the investigator a clinical trial to the patient, they love it. They wanna be part of it because they’re gonna have fast access to a medical innovation, and they’re gonna have fast access to the system.
Julio Martinez-Clark
The FDA is risk averse. So they don’t wanna get involved with these high risk clinical trials. They wanna make sure nothing’s gonna happen to any patient, so they give you all these high requirements. The red tape is extremely high, because everybody wants to protect their jobs.
Julio Martinez-Clark
The key message is there are options in Latin America and not only Latin America, there are countries that are very, very friendly to clinical research at this point. That if you submit something, they’re gonna review it and you’re gonna get a site activated in less than eight weeks, which is a record in the United States right now, is almost impossible. So there are options and there are options even closer to home.
Julio Martinez-Clark
