Patient safety comes first
Every decision we make is filtered through the question: does this protect the patient using the device?
When commercial pressure, deadlines, or convenience collide with a real safety question, patient safety wins. We escalate hazards early even when it slows a submission or an engagement.
Situation: A pen-tester finds an unauthenticated BLE command that can silence an infusion pump alarm two days before the client's FDA submission deadline.
Immediately notify the client's PM and cybersecurity lead, add the finding to the risk register with a clinical hazard analysis, and recommend a submission hold or targeted mitigation - even though it delays the client's launch.
Downgrading the severity so the finding fits into the residual risk table and the deadline stays intact.
Situation: A client asks us to remove a Critical CVE from the SBOM report because the affected component is 'not really exploitable'.
Keep the CVE, document the exploitability rationale under ANSI/AAMI SW96, and let the FDA reviewer see the reasoning.
Silently deleting the row to make the report look cleaner.
