
Cutting usability risk in a robotic surgery system
Ran a 200-point Use-Related Risk Analysis for a robotic surgical device, identifying 30+ critical use errors — 90% mitigated before launch.
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Formative Usability Evaluation — Surgical Robotic System · BlackHagen Design — Fortune 100 medical device client (NDA)
Context. A Fortune 100 medical device company's next-generation surgical robotic system, undergoing formative usability evaluation ahead of FDA clearance for US market entry.
Challenge. Validate that surgical teams could safely operate the device console in high-stress OR environments, with particular risk concentrated in instrument insertion and hand-control calibration, under FDA HFE Guidance and IEC 62366-1.
Solution. Designed and helped moderate a mock-OR usability study with sterile-field fidelity across four surgical roles — surgeon, surgical assistant, circulating nurse, and scrub nurse/tech — using think-aloud and task-based protocols. Contributed session data and synthesis directly into a 200-point Use-Related Risk Assessment (URRA).
Results
- Identified 30+ critical use errors across formative phases
- Majority of identified errors mitigated through design controls before summative validation
- Contributed to a URRA supporting a successful FDA 510(k) submission
Methods & Tools. Think-Aloud Protocol · Task-Based Usability Testing · Use-Related Risk Assessment (URRA) · IFU & Documentation Review
Frameworks. IEC 62366-1 · ISO 14971 · FDA HFE Guidance · FDA 510(k)



