Systems Engineering Methods for Prioritizing Device Testing in the FDA

Abstract

Today, more than 50% of medical devices used in the United States are imported and that number is increasing by 21% per year. It is the responsibility of the Food and Drug Administration to regulate these devices and protect the safety of the American public. As resources are increasingly limited, efforts must be focused to include those medical devices that pose the greatest risk to the public. As part of a Gordon Engineering Leadership Program Challenge Project, this project uses systems engineering methods to maximize the effectiveness of an FDA field lab. A prioritization method based on risk, integer programming model, and modified Failure Modes and Effects Analysis (FMEA) have been designed for this purpose.