Consequences of Excluding Human Factors Engineering from Medical Device Development
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.
Through this intervention, the device’s usability aspects including user interface design, interaction workflows, and potential use-related risks were systematically analyzed and optimized. This effort mitigated:
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Potential user difficulties during setup, calibration, and data interpretation.
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Ambiguities in interface feedback that could lead to incorrect interpretation of diagnostic information.
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Gaps in demonstrating regulatory compliance for safe and effective device use.
By implementing these usability evaluations, we reinforced the linkage between human factors engineering and risk management under ISO 14971, strengthening the device’s overall safety, performance, and compliance profile.
Solution Implemented:
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Conducting a retrospective use specification to clearly define intended user profiles, use environments, and operational contexts.
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Developing a preliminary task analysis to map critical user interactions, identify potential use-related hazards, and highlight scenarios prone to user difficulty.
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Executing formative usability evaluations with representative users in both simulated and real-world environments to assess interface interactions and identify improvement areas.
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Implementing a user interface redesign with improved visual feedback and intuitive interaction pathways to address identified challenges.
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Revising the Instructions for Use and labeling to ensure consistency with the updated user interface and associated risk controls.
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Planning a summative usability evaluation to verify and validate safe, effective, and compliant use of the final device design, IFU, and labeling.
Benefits Derived:
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User Safety and Risk Reduction – Early identification and mitigation of use-related risks significantly reduced the likelihood of user errors, thereby enhancing patient safety and clinical reliability.
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Product Performance and User Satisfaction – Integration of user-centered design principles improved ease of use.
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Evidence for Risk–Benefit Analysis – The usability data generated through formative evaluations provided objective evidence.
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Design and Development Efficiency – Incorporating user feedback during iterative design stages minimized rework, streamlined development cycles, and optimized resource utilization across engineering and regulatory teams.
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