Better Materials Will Help Reduce the Medical Device Recall Rate

Even before the widely publicized medical device sterilization failures like the recent UCLA endoscope case, the product recall rate for medical devices has been increasing steadily for the past 15 years. That's one scary statistic. As Design News has reported, the answer lies in both better medical device design and better design of materials, particularly plastic.

The connection between product failures and materials is made clear by an article in our sister publication MDDI, written by a senior research scientist at R&D giant Battelle. According to the author, a recent McKinsey report found that medical device recalls and other "quality events," including lawsuits, cost the medical device industry $2.5 to $5 billion every year.

MORE FROM DESIGN NEWS: The Fallout from the UCLA Sterilization Failure Will be Better Medical Device Design

After conducting its own analysis of medical device recalls, Battelle's data showed that materials performance was a major cause in at least 20 to 30% of recalls. Materials as a secondary cause of failure boosts that number to 50% of cases studied. The reason seems to be that the more complex, advanced materials used in medical device design aren't selected and evaluated carefully enough during product development.

Mitigating Risks of Materials Failures in Medical Devices | MDDI

Ann R. Thryft is senior technology editor, materials & assembly, for Design News. She's been writing about manufacturing- and electronics-related technologies for 25 years, covering manufacturing materials & processes, alternative energy, machine vision, and all kinds of communications.