Secure by Design: Medical Device Threat Modeling

Threat modeling is a cornerstone of “secure by design” development. As connected medical devices become more complex and integrated, manufacturers must move beyond reactive cybersecurity measures and systematically identify risks before they become vulnerabilities. This whitepaper outlines the principles, frameworks, and methods of threat modeling in medical device development — bridging established safety practices like FMEA and FTA with cybersecurity frameworks like STRIDE and CVSS. It illustrates how threat modeling supports FDA, Health Canada, TGA, and ANSM expectations, and provides a practical roadmap for integrating the process into existing quality and risk management systems.

Medical device manufacturers face growing regulatory and customer pressure to embed cybersecurity into the product development lifecycle.

Threat modeling offers a structured, repeatable approach to identifying potential cyber risks — analogous to how FMEA identifies failure points in safety risk management. It connects clinical safety with technical security, ensuring confidentiality, integrity, and availability are preserved across the device ecosystem. This whitepaper helps MDMs and HDOs understand when, why, and how to apply threat modeling to strengthen compliance, protect patients, and reduce product risk.

• Threat modeling extends ISO 14971-style safety risk management into cybersecurity.
• Regulatory agencies now expect MDMs to apply threat modeling to manage system-level risk.
• STRIDE and CVSS provide scalable frameworks to analyze and prioritize threats.
• Diagrams (DFDs/UML) are essential tools for visualizing data flow and attack surfaces.
• Continuous, collaborative threat modeling builds trust, reduces recall risk, and meets FDA expectations for “secure by design.”