By Julio G. Martinez-Clark, CEO, bioaccess
The elements that define an early feasibility study (EFS) are: (a) a small number of subjects; (b) a device that may be early in development, typically before the device design has been finalized; (c) a study that provides initial insights into device proof of principle and safety; and (d) a study that does not necessarily involve the first clinical use of a device. Traditionally, an EFS in the U.S. can take about one year to start, which is not competitive with international standards. Despite efforts by the FDA to implement and streamline its EFS program, medtech companies see very little progress in shortening the time from the site dossier packet received to the first patient enrolled (320 days!). The difficulty in recruiting patients and the unpredictable, inefficient, and expensive regulatory process to conduct an EFS or a first-In-human (FIH) study in the U.S. forces medtech startups to conduct outside the U.S. (OUS) research, where trial regulatory hurdles are more favorable than in the U.S., and it is easier and faster to recruit subjects at a lower cost.
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population; its high rate of urbanization; its solid doctor-patient relations; and its ethical, quality, and lower-cost clinical research.
Latin American countries are committed to harmonizing their medical device regulations with international standards. In June 2022, the Pan American Health Organization (PAHO) organized a meeting with the national regulatory authorities (NRAs) from 19 countries of the Americas to jointly develop strategies and exchange initiatives to strengthen the regulation of medical devices in the region. Among the attendees were directors, unit chiefs, reviewers, department managers, and professionals specialized in medical devices from the NRAs of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, El Salvador, the United States of America, Guatemala, Honduras, Mexico, and Uruguay.