MedTech PM

I ship compliant, audit-ready medical device software.

I research how AI agents can enhance end-user experience — within ISO 13485, FDA QMSR, HIPAA, ISO 27001 guardrails.

Regulated delivery

Own the full lifecycle across QMS, verification & validation, release management, and post-market monitoring—so teams move fast without breaking compliance.

Audit-first UX

Design interfaces that surface evidence, rationale, and handoffs in-line, making reviews faster for clinicians, auditors, and stakeholders.

AI agent prototypes

Prototypes are built with consent, logging, and reviewer handoffs.

Operating model for AI in regulated products

Practical guardrails, reviewer workflows, and measurement frameworks that keep cross-functional teams aligned.

  • Map risk controls directly to ISO/FDA guidance.
  • Make agent↔human handoffs traceable and reviewable.
  • Close the loop with post-launch monitoring and drift alerts.
Research

Current lines I’m publishing

Short notes first, prototypes next. Each topic ties to measurable impact for clinicians, reviewers, and product teams.

Agent handoffs that preserve traceability

Design patterns to keep humans in the loop without losing speed.

Browse research archive
Newsletter

Latest note

The first essay launches on Substack soon—systems thinking, templates, and realistic guardrails. Subscribe to get frameworks and walkthroughs as they drop.

Coming soon on Substack

The first essay launches on Substack soon—systems thinking, templates, and realistic guardrails. Subscribe to get frameworks and walkthroughs as they drop.

View note outlines