Summative usability validation · Roche · 2023
Validating navify Digital Pathology for FDA submission
A digital pathology system was heading into FDA submission without completed summative usability validation. I planned and ran the study. The system cleared.
- Context
- navify Digital Pathology is the workflow software pathologists use to review and sign out cancer cases — part of Roche Digital Pathology Dx, the whole-slide imaging system Roche was taking through FDA 510(k) clearance.
- Problem
- The submission required summative usability validation conducted to FDA human factors guidelines. The timeline was short and the study had not yet been built.
- What I did
- I recruited 30 participants, ran the sessions, and produced the validation report on the submission timeline — roughly two months end to end.
- Outcome
- Roche Digital Pathology Dx received FDA 510(k) clearance in June 2024.
Role: Led the summative usability validation, navify Digital Pathology (Roche, via Concord).
Context
navify Digital Pathology is the workflow software pathologists use to review and sign out cancer cases — part of Roche Digital Pathology Dx, the whole-slide imaging system Roche was taking through FDA 510(k) clearance. The submission required summative usability validation conducted to FDA human factors guidelines. The timeline was short and the study had not yet been built.
What I did
I came up to speed on the FDA human factors requirements and the clinical workflow, then planned a summative study covering the critical diagnostic tasks across the application. I recruited 30 participants, ran the sessions, and produced the validation report on the submission timeline — roughly two months end to end.
Outcome
Roche Digital Pathology Dx received FDA 510(k) clearance in June 2024. The validation work is part of the clinical evidence published in American Journal of Clinical Pathology (Wharton et al., 2025), which reported that usability testing confirmed completion of all critical tasks required for primary diagnosis, with both studies meeting their predetermined endpoints. I’m named as a contributor in that paper.
Specifics of the protocol and findings are confidential. What’s described here is supported by Roche’s public press release and the published study.
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