Material Evidence: Examining Mysterious Medical Design Failures

By Jeffrey Ellis, Battelle

It’s every medical device manufacturer’s nightmare: an unexpected material failure leading to a product recall. Then, the investigation begins. Everything looked great in the lab—what happened to cause the device to fail in the field?

Material failures in medical devices are both common and costly. In 2013 and 2014, materials failures were implicated in 30-40% of FDA recalls. These recalls cost companies tens or hundreds of millions of dollars in direct expenses, stock devaluation and lost sales. In addition, many companies find themselves facing late-stage design changes and product launch delays due to problems with materials found late in the development cycle.

Fortunately, most of these material failures are preventable. Understanding the most common causes of material failures in medical devices can help manufacturers make better design decisions up front and avoid surprises after product launch.