Device outcomes endpoint inclusion in IDE protocols recommended by Medtronic exec.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE HEALTH, ECONOMIC OUTCOMES ENDPOINT INCLUSION IN IDE PROTOCOLS recommended by Robert Thompson, manager of Medtronic's health policy and research division, at a managed care conference sponsored by the Institute for International Research Nov. 13-15 in Washington D.C. Although FDA looks at safety and effectiveness rather than outcomes data, Thompson said that manufacturers conducting outcomes studies for marketing purposes should include them as "secondary objectives" in investigational device exemption protocols because it is the most efficient method of obtaining the data.