What “AI agents” mean in MedTech (practical, not hype)
Grounded definitions, system boundaries, and where agents create real value under QMS.
Research notes
Publishing the playbook
Essays and working notes on bringing AI agents to regulated products. Each post includes ready-to-use frameworks plus prototypes that pressure-test the approach.
Coming soon
Initial topics on deck
Draft outlines; prioritize by subscriber interest.
Designing consent for AI-assisted features
User journeys, copy, and logging patterns that maintain clarity and compliance.
Minimal pattern for PHI-safe logging
Event models, retention rules, and immutable records aligned to audit needs.
Agent handoffs that preserve traceability
Reviewer checkpoints, approval gates, and rationale capture without slowing delivery.
Risk controls for LLM features: a PM checklist
From requirements to monitoring—controls teams can actually implement.
Newsletter
Follow along on Substack
Follow along on Substack. Expect practical templates and walkthroughs—not fluff.