Prevention Is Better Than Cure: Applying Medical Principles to Medtech Cybersecurity

The Med Device Cyber Podcast · Feb 26, 2026 · 32m

Medical device risk assessments are failing patients, not because the process is too hard, but because nobody doing the assessment has ever been in the room where the device actually gets used.

Medtech quality and regulatory leader Stephen Smith describes sitting in a risk session for a device going into an intensive care unit. Twelve people in the room, and not one had ever set foot in an ICU. If you have never been in the environment your device will operate in, risk identification becomes guesswork, mitigations get written for problems that are not the actual problems, and the device goes…