Consequences of Excluding Human Factors Engineering from Medical Device Development
7 November 2025
Problem Statement:
During the development of the Near Infrared Spectroscopy (NIRS)–based diagnostic device - a spinal implant sensor system for tissue oxygen monitoring, the team identified a key gap in the process.
Formal usability engineering activities, as required by IEC 62366-1, EU MDR, and FDA Human Factors Engineering guidance, had not been integrated into the design verification and validation phases. Recognizing this critical gap, we identified the omission and initiated corrective actions to integrate comprehensive usability engineering activities in alignment with regulatory requirements.
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