
Cutting usability risk in a robotic surgery
Contributed to formative usability testing for an FDA-regulated robotic surgical device, co-drafting a 200-point URRA that surfaced 30+ critical use errors, 90% mitigated before US market launch.
Brief overviewHide overview
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. Supported a mock-OR usability study with sterile-field fidelity across four surgical roles: surgeon, surgical assistant, circulating nurse, and scrub nurse/tech. Contributed to participant screener development, in-session observation, and initial drafting of the Use-Related Risk Assessment.
Results
- Captured session data that helped surface 30+ critical use errors across formative phases
- Majority of identified errors mitigated through design controls before summative validation
- Observations 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)









