More about Human Factors Engineering...

User research 

  • Literature reviews 
  • Observations of intended users in their environments of use (contextual inquiries, AAMI TIR 51:2014)
  • Individual and group interviews
  • Benchmark studies and expert reviews of predecessor and competition devices
  • Review of HFE design principles ("heuristic analysis")
  • Identification of known use-related problems
  • User profiles
  • Use environment descriptions
  • User needs and preferences

Risk control, specify and design

  • Hazard analysis
  • Function analysis
  • Task analysis (including PCA analysis)
  • Use-related failure modes and effects analysis (u-FMEA)
  • Fault tree analysis
  • Report on hazards
  • Function allocations
  • Task flow diagrams
  • List of potential use errors, associated levels of risk, and risk control measures
  • Translate user needs and preferences into user interface specification
  • Adapt HFE guidelines to suit given device
  • Develop graphical user interface structure
  • Develop visual style
  • Develop screen templates
  • Develop preliminary, refined, and final designs
  • Build interactive prototypes of increasing visual and functional fidelity
  • Develop a style guide to help ensure hardware, software, and document design consistency
  • Update style guide on a continuing basis


  • Conduct expert reviews
  • Conduct advisory panel/board reviews
  • Conduct cognitive walkthroughs of early, low-fidelity models/sketches
  • Conduct formative usability tests
  • Conduct summative usability test, with associated documentation (plan, protocol, data collection, report)
  • Analysis of human factors validation test results, use issues root cause analysis and residual risks assessment
  • Conduct HFE studies during clinical studies


All those study outputs and reports form an important part of the Usability Engineering File; the Usability Engineering file can be written in a format that is compatible with either IEC 62366-1:2015 or the FDA Human Factors Engineering Report format, depending on which format is appropriate for the chosen markets.


  • Audit, reviews of usability engineering files
  • Integrating human factors into design control processes
  • Training, mentoring

Working together

Multiple options are possible:

  • To manage the entire human factors engineering activity for a given project
  • To run any specific item of the above list
  • To update files with post-production data
  • To create initial usability engineering file for legacy products

Please contact Tessier Biomedical Consulting by email or call +33 6 5881 8544