Human Factors

Human Factors & Usability Engineering

Human-centered design is core to our process. Gilero uses human factors engineering to improve the design of medical devices and combination products, ensuring they can be operated safely in real-world conditions.

Our seasoned human factors and usability engineering experts help clients meet the user requirements, business objectives, and regulatory expectations for their medical and drug delivery device projects. We conduct user research early on to collect actionable data that can be applied to medical device design throughout the entire product lifecycle—from early user research at the outset of concept development through the formative and summative human factors studies required for regulatory submission. Most of these studies can be conducted on-site in our human factors observation suite. By making user needs, abilities, and experience the focus of our research, we help our clients deliver devices to market that are not only safe and effective, but are also more likely to be a commercial success.

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Gilero’s Human Factors Services

  • HFE planning
  • Contextual inquiry
  • Focus groups
  • Anthropometry
  • Ethnographic research
  • Heuristic analysis
  • Participatory design sessions
  • Task analysis
  • Use-related risk analysis (URRA)
  • Use failure modes and effects analysis (uFMEA)
  • Formative usability studies
  • Summative usability studies
  • Label comprehension studies
  • Comparative analysis
  • Threshold analysis
  • Instructions for use (IFU)
  • HFE/UE summary reports

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