Lukas Futera
Platform Principal & Security Architect Roche
Seminars
Tuesday 21st July 2026
Workshop B: Navigating FDA Guidance: Practical Threat Modeling & Security Architecture for Medical Devices
11:00 am
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
Wednesday 22nd July 2026
Building a Living Threat Model: Integrating Security Architecture and Operations Through Agentic Systems
1:50 pm
- Exploring how to design a supportive, agent-driven security ecosystem that connects threat modeling, platform controls, and real-time security operations into a unified framework
- Moving beyond static, submission-driven threat models toward continuous validation, monitoring, and iterative risk reassessment across the software lifecycle
- Lessons learned from operationalizing this approach to create a more reactive, evidence-backed security posture that strengthens compliance while improving realworld resilience
Wednesday 22nd July 2026
Fishbowl Debate: Assistive vs. Autonomous AI: Where Should Humans Stay in the Loop?
4:30 pm
This dynamic fishbowl debate brings engineers, clinicians, and regulatory leaders into a rotating inner‑circle conversation, creating a rare, real‑time exchange between those designing AI systems, those deploying them, and those overseeing their safety. With audience members stepping into the discussion throughout, the session becomes a living model of the very human‑machine interaction it examines.
- Discuss how assistive, decision‑support, and autonomous AI shift risk, validation, and oversight, enabling attendees to match autonomy levels to the appropriate regulatory and safety strategy
- Examine where AI improves consistency and where it introduces over‑reliance or hidden errors, giving participants clearer judgment on when human review adds safety value
- Explore how claims, labelling, and clinical context constrain autonomy, helping attendees align design decisions with regulatory positioning
- Break down models for “human in the loop,” “on the loop,” and supervisory control guiding teams to design workflows, interfaces, and monitoring that meet regulator and clinician expectations
