Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition should be mindful of four common AI failure modes: AI functional errors, software rot, unexplained programming glitches, and the ever-present human factor.
Continue Reading 4 Common Ways That AI Driven Medical Devices Can Fail
A couple of years ago, the FDA articulated its expectations for the ways device manufacturers should address cybersecurity premarket. More recently, FDA released a complementary draft guidance.
Continue Reading FDA’s New Draft Guidance on Postmarket Cybersecurity Programs for Medical Devices
My colleague, Amy Foust, and I were recently discussing steps that medical device manufacturers can take to limit liability before a system security breach occurs. As if medical device companies didn’t have enough to worry about, the news this year has been replete with stories about software vulnerabilities and successful hacks of medical devices with integrated operating software.
Continue Reading How Secure is Your Medical Device?