Category: Medical Device Industry

Today’s complex high-tech devices continue to cause cybersecurity vulnerability issues, but it’s the medical devices that live on or inside patients, like implants and pacemakers, that are posing a special challenge for the healthcare industry. The problem arises when those medical devices are recalled and the manufacturing company must track down each device to notify a patient of the potential risk.

The faster a new medical device is approved, the sooner it’s likely to be recalled, according to a new research letter published in JAMA Internal Medicine. While the authors admit the data and findings have limitations, two conclusions they draw are startling: Medical devices approved by priority review were twice as likely to be recalled.

First and foremost, we hope you and everyone close to you are well. We’re living through an unprecedented time and hopefully you’re able to find some calm and maintain connections. Like each of you, we’ve been working through the COVID-19 crisis, encouraging workers to follow the recommendations of federal, state and local health officials. But as crisis management professionals, we also can’t help but think about the long game.

While U.S. product recalls were relatively flat from the second to third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unregulated categories.  Part of that pressure on regulators is a result of past handling of product safety issues.

The product recall by Denver-based marijuana cultivator Bonsai Cultivation reminds us all of the unique regulatory dynamic facing the cannabis industry. In this case, the cultivator – working with state officials – pulled marijuana products off the market because they may contain elevated yeast and mold counts. The recall followed a Denver Department of Public Health & Environment examination of dried marijuana samples.