Lukas Futera
Principal Architect - Platform Security 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
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
Wednesday 22nd July 2026
Building a Living Threat Model: Integrating Security Architecture and Operations Through Agentic Systems
2:00 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
