Workshop B: Navigating FDA Guidance: Practical Threat Modeling & Security Architecture for Medical Devices

Interactive, scenario-based working session combining short expert framing talks with small-group exercises. Attendees work through a realistic device scenario and leave with a reusable threat modeling and security design framework

• Step-by-step walkthrough of how to build a regulator-ready threat model and map real cybersecurity risks to concrete security architecture decisions for a connected medical device
• Practical guidance on linking threats, controls, and verification evidence so cybersecurity work is clearly traceable and defensible in FDA submissions
• Attendees leave with a repeatable framework and documentation approach they can apply immediately to strengthen their own device security design and reduce regulatory pushback

Speakers:

Andrew O’Keeffe

Executive Director - Global Digital Quality

Olympus

Lukas Futera

Platform Principal & Security Architect

Roche