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MedTech · Robotic Surgery
Mock-OR validation for a next-generation surgical robot
30+ critical use errors identified before design freeze.
Context
Leading medical device manufacturer developing a next-generation surgical robot for minimally invasive procedures.
Challenge
Validate that surgeons could safely operate the device console in high-stress OR environments, with particular focus on critical use errors in instrument insertion and hand-control calibration.
How we helped
Identified critical use errors in surgical workflows. Designed a mock-OR protocol with sterile-field fidelity to surface real-world pain points. Supported summative validation aligned to IEC 62366-1 and ISO 14971.
The impact
- •Identified 30+ critical use errors across formative phases
- •Majority of identified errors mitigated through design controls
- •Supported successful FDA 510(k) submission with HFE/UE file
Methods
- Think-Aloud Protocol
- Task-Based Usability Testing
- Use-Related Risk Assessment (URRA)
- IFU & Documentation Review
- Mock-OR Study
Tools
Specific tools are not listed for this engagement.
Standards & research foundations
- IEC 62366-1
- ISO 14971
- AAMI HE75
- FDA HFE Guidance
- FDA 510(k)
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