Fall 2022

Medical Device Safety

Dear Colleague,

In this issue of Trends, we discuss the topic of Medical Device Safety.

Our first article addresses the rapidly growing medical device market and its impact on safety and risk assessment methods. The second article compares historical standards for assessing the skin sensitization risk of medical devices to the new methods of testing that are gaining traction. The third article explores new developments in medical device extractables testing. Our guest editorial, contributed by Bill Wustenberg, D.V.M., of Mycroft Medical, LLC, provides a high-level overview of the evolving regulatory landscape of medical device biocompatibility from a historical perspective.

Gradient contributors to this Trends issue include Joel M. Cohen, Sc.D., DABT; Rebecca C. Ticknor, M.S.; and Lindsey K. Borton, M.P.H.

We hope this issue of Trends leaves you with a greater sense of where the science of medical device biocompatibility has been and where it is headed next.

Yours truly,

Chris Long, Sc.D., DABT and Kurt Herman, M.Eng., P.G.

clong@gradientcorp.com      kherman@gradientcorp.com