Scenario 01
Connected medical devices · post-market surveillance
Continuous evidence for connected medical devices
- Operating problem
- Complaint, service, telemetry, cybersecurity, and adverse-event records often live in separate systems, so a manufacturer rebuilds the safety picture from scratch for each review.
- Possible Native Alpha
- The manufacturer already has legal access to its installed-device telemetry and its quality team’s complaint decisions. Together they could keep a living evidence record competitors cannot recreate from public data.
- Evidence already present
- Device logs, complaint files, service history, risk controls, vulnerability records, CAPA decisions, and prior submissions.
- Smallest credible experiment
- Trace one known field issue from telemetry through complaint assessment, risk management, corrective action, and the current regulatory record.
- Disconfirming evidence
- The records cannot be joined reliably, the telemetry lacks the context a decision needs, or qualified reviewers do not trust the resulting trace.
- Stop condition
- Stop if the pilot cannot reproduce a previously approved safety decision without someone rebuilding it by hand.
- Next decision
- Build the evidence pipeline, narrow its intended use, or stop.
