By Julio G. Martinez-Clark, CEO, bioaccess
Planned and ongoing medical device clinical trials rose 14% in Q1 2022 globally compared to the last four quarters' average, according to GlobalData’s medical devices clinical trials database. According to a Grand View Research report, the global medical device contract research organization (CRO) market size is expected to reach $12.1 billion by 2028, registering a CAGR of 8.6% from 2021 to 2028. The main drivers of the CRO medical device market include time savings, cost efficiency, and expertise in the area, accelerating the process of devices reaching the market. There are over 6,500 medtech companies in the U.S., primarily small and midsize enterprises.3 More than 80% of these companies have fewer than 50 employees. Typically, the ones with fewer than 20 employees have limited financial resources and minimal to no sales revenue.4,5 Waiting for long-drawn-out ethics and regulatory approval on an early feasibility study (EFS) or a first-in-human (FIH) study could tie up investment dollars and quickly lead a startup company to starvation.
This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. I will address critical success factors and provide recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.