Ephi Most
Director - Software Quality Program Medtronic
Over 20 years of experience with numerous orthopedic and medical device companies. Developed robotic testing system for knee biomechanics investigations. Perform statistical analysis on various medical devices and biological systems. Experience in quality control process as applied to software and medical devices, including, but not limited, to requirements generation, design specifications, risk analysis, and verification and validation protocols and reports. Proficient in risk analysis techniques such as hazard analysis, FMEA (software, design, and process). Experienced with the following guidelines (partial list) 21 CFR part 820; 21 CFR part 11; ISO 13485; EN 60601; ISO 14971; EN 62304.
Seminars
A collaborative simulation where participants design and test autonomous AI agents, exploring how goals, constraints, and decision making logic shape system behavior.
- Teams confront a realistic scenario where an autonomous AI agent can write code, review PRs, run tests, and respond to cyber threats, forcing them to decide what actions they’re truly comfortable delegating
- Participants break into governance style groups (engineering, V&V, regulatory, cybersecurity, and patient safety) to define guardrails around autonomy, validation, documentation, risk, and oversight across the SDLC
- Live “curveballs” expose failure modes and challenge assumptions, culminating in a cross-discipline debate on what to allow, forbid, or reconsider, revealing blind spots and making agentic AI risks tangible
- Decide whether autonomous AI agents are advantageous in comparison to classic AI/ML models (such as Co-pilot)
Closing Question: In 5 years, which of today’s ‘absolutely not’ decisions will sound overly cautious?
