Human factors consulting services
Human Factors Insight provides human factors and usability engineering consulting services to the medical industry. Our services range from early stage user research all the way through to submission support.
Human factors strategy & integration
Develop and integrate an adequate human factors engineering (HFE) strategy to ensure your medical device is designed according to an iterative, human-centered approach. This does not only ensure regulatory compliance with ANSI / AAMI / IEC 62366-1, ISO 14971, ISO 13485 and FDA, but also ensures you develop a product which is safe, effective, and appealing.
User research
Integrate human factors design principles by conducting user research that is compliant with regulatory HFE standards including IEC 62366 and FDA’s guidance on human factors engineering. Develop a use specification that thoroughly describes the intended users, uses, and use environment conditions.
Use-related risk management
Conduct use-related risk management activities in accordance with ISO 14971 to timely identify and reduce use-related risks that have a potential to cause harm. Develop a task analysis to break down the device into a set of sequential use-steps. Conduct a known problems analysis to analyze and document use-related problems with predicate or comparable devices. Develop and maintain a robust use-related risk analysis (URRA) to identify and reduce use errors that have a potential risk to cause harm.
Formative usability test
Conduct a formative usability test to discover a product’s strengths, opportunities for design improvement, and timely mitigate potential use errors that could lead to costly redesigns and product recalls.
Conduct a design critique / expert review to evaluate a partial or complete device (e.g., labelling, user documentation, device prototype) to understand its strengths and opportunities for design improvement based on established HFE design principles and professional expertise.
Summative usability test
Conduct a summative usability test (i.e., human factors validation test) to validate whether intended users can safely and effectively use a production-equivalent device without a significant risk of committing potentially harmful use errors.
Submission support
Develop a comprehensive Human Factors Engineering (Usability Engineering) report which summarizes all HFE activities in a clear, concise, and compelling manner that is compliant for regulatory submission.