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:
Think about those for a minute. It’s easy for consumers and regulators to blame the companies designing and marketing these products. But the fact is, these findings have little to do with the decisions of the research and development teams or company leadership. Instead it’s the nature of the products – new, groundbreaking devices that meet complex medical challenges.
As noted in a Regulatory Focus article from the Regulatory Affairs Professionals Society, “FDA has long acknowledged that devices that qualify for expedited reviews may take longer to review, as they are often more complex and raise novel scientific issues.” But the goal of the program is to provide patients with faster access to breakthrough devices.
In response to these initial findings, however, there are lessons companies and regulators can act upon. When it comes to actions medical device manufacturers should:
You have your work cut out for you in responding to current customer and patient needs. But you need to add one item to your list: Preparing for a possible recall when patients’ fears and concerns are at their highest.
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