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

Today, major healthcare companies are investing heavily into various AI-powered devices. For example, Zimmer Biomet and the New York City-based Hospital for Special Surgery recently inked a three-year deal to create the HSS/Zimmer Biomet Innovation Center for Artificial Intelligence in Robotic Joint Replacement. “The collaboration aims to develop decision support tools—powered by data collection and machine learning — to assist surgeons planning and predicting outcomes for robotic-assisted joint replacements.” Additionally, Johnson & Johnson have gone on record saying that they see “a huge opportunity to harness data, machine learning and artificial intelligence to help drive decision-making at all levels of healthcare.” As artificial intelligence starts playing a larger role in the modern healthcare space, a critical question will need to be answered: Are AI-powered solutions products or services?
Continue Reading Is Your Artificial Intelligence a Service or a Product?

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?