Description

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices.  

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Julio Martinez-Clark, CEO and co-founder of Bioaccess, about early feasibility studies in Latin America.

Since 2010, Julio has supported more than 100 Medtech opportunities to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America. 

Some of the highlights of this episode include:

• Julio is a big believer in the potential for medical device companies in Latin America. He explains how U.S. Medtech companies can succeed in Latin America with early feasibility clinical trials and market access entry initiatives.
• Latin America is a good location to conduct easy feasibility clinical trials because U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.
• More companies are coming to Columbia because it is difficult, expensive, and time consuming to recruit patients in the United States and achieve regulatory approval at the FDA.
• Although the FDA implemented its Early Feasibility Studies (EFS) Program several years ago, it does not work well. Trials are still expensive, and it’s still difficult to recruit patients in the United States.
• Patients and physicians in the United States and those in Latin America tend to share a similar culture when it comes to their health and lifestyle.
• However, there are challenges for companies in Columbia, such as language barriers. Documents for regulatory approval need to be translated into Spanish.
• Columbia’s reputation has evolved into a knowledgeable country for companies to visit, feel safe/comfortable, and find patients to conduct trials for quality data.

Memorable quotes from Julio Martinez-Clark:

“U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.”

“The struggle that these companies go through is immense. They find it very difficult, very expensive, and time consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA.”

“The Early Feasibility Studies Program that they implemented about seven, 10 years ago, it hasn’t really worked because of the dynamics of the U.S. system. Trials are still expensive and it’s still difficult to recruit patients in the United States.”

“It’s really a bargain to buy services from a hospital in a country like Columbia.”

“These companies are, in essence, looking for fast regulatory approval, ease of patient recruitment, and cost savings.”

Links:

Bioaccess

Julio Martinez-Clark on LinkedIn

OECD

Pacific Alliance

FDA - Early Feasibility Studies (EFS) Program

ISO 13485

True Quality 2022

The Greenlight Guru True Quality Virtual Summit