Services
Our services
Human Factors Insight provides human factors and usability engineering services to the medical device industry. Our services range from early stage user research all the way through to submission support.
1. Human factors strategy & integration
Developing and integrating an adequate human factors engineering (HFE) strategy will ensure the medical device is designed according to an iterative, human-centered approach.
- Human Factors Program Plan / Usability engineering plan: Develop an adequate HFE program plan including a roadmap of HFE activities to ensure compliance with notified bodies, HFE standards, and improve overall product development processes.
- Gap analysis: Conduct a gap analysis to understand whether there are any evident gaps in terms of HFE work that has been performed, and HFE work expected by FDA and IEC 62366.
2. User research
Integrate human factors design principles by conducting user research that is compliant with regulatory standards including IEC 62366 and FDA’s guidance on human factors.
- Use Specification: Develop user profiles and use environment descriptions to gain a deeper understanding of the medical device users and its expected use environment conditions.
- User Interface Specification: Develop user interface requirements to ensure the medical device is designed according to established human factors design principles and standards.
3. Risk management analysis
Conduct risk management activities in accordance with ISO 14971 to identify and reduce use-related risks that have a potential to cause harm.
- Task analysis: Systematically break down the device into a set of sequential use-steps.
- Known problems analysis (KPA): Analyse and document use-related problems with predicate and comparable devices.
- Risk analysis: Develop and maintain a use-related risk analysis to identify and reduce use errors that have a potential risk to cause harm.
4. Formative evaluations
Conduct formative evaluations to discover a product’s strengths, opportunities for design improvement, and timely mitigate potential use errors.
- Formative usability test: Evaluate a partial or complete device (e.g., labelling, user documentation, device prototype) by conducting a formative usability test with representative participants.
- Expert review / design critique: 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.
5. Summative evaluation
- Human factors summative validation usability test: Validate whether intended users can safely and effectively use a production-equivalent device without a significant risk of committing potentially harmful use errors.
6. Submission support
- Human Factors Engineering (HFE) Report: Develop a comprehensive HFE report which summarises all HFE activities in a clear, concise, and compelling manner that is compliant with FDA.