Cybersecurity for connected devices: FDA guidance, threat modeling, and why Stryker is a wake-up call

The FDA's cybersecurity guidance has teeth now. For connected medical devices, security isn't a feature you bolt on before submission. It's a design input that affects your 510(k), your post-market obligations, and your liability exposure if something goes wrong in the field.

In this session from the Greenlight Guru Software Enabled Devices Virtual Summit, a cybersecurity expert walks through what the current FDA guidance actually requires, how threat modeling works in practice for medical devices, and what the Stryker incident tells us about where the industry's real gaps are.