Postmarket Surveillance and Anomaly Detection for Medical Devices

What are some of the biggest cybersecurity risks medical devices face after they hit the market?

This episode dives into the challenges of postmarket surveillance for medical devices. Christian and Trevor discuss vulnerabilities that emerge after deployment, how manufacturers and hospitals handle updates, and why continuous security testing is essential. They also cover penetration testing and the evolving regulatory landscape for medical device cybersecurity.

Key points:

• The importance of postmarket surveillance in medical device cybersecurity.

• How vulnerabilities in third-party libraries can create security risks.

• The FDA’s push for over-the-air (OTA) updates and the associated attack vectors.

• The necessity of a Coordinated Vulnerability Disclosure (CVD) system.

• Why hospitals struggle with unpatchable medical devices in their networks.

• The role of Software Bill of Materials (SBOM) in monitoring supply chain security.

• How penetration testing identifies new threats even after a device is launched.

• How attackers exploit known vulnerabilities in medical devices.

• The misconception that cybersecurity is a one-time effort rather than an ongoing process.