Material selection for medical devices is of critical importance for reducing risk of a failure and hinges on many factors.
Jeff Ellis, PhD
Medical device material failures are common and costly. Fortunately, the risk of these failures can be greatly reduced through better understanding of materials science earlier in the product development cycle, preventing both delays and postmarket issues.
Using data found on the FDA website, our team of researchers concluded that materials were either a major or possible cause of more than 30 percent of medical device FDA recalls in 2013 and 2014. Whether they incite FDA recalls or development setbacks, many of these material failures can be avoided by gaining a better understanding of the materials’ properties and...