Human Factors Engineering (HFE) and Usability Testing for Medical Devices


  • What is Human Factors Engineering?
  • What are the benefits of HFE for medical devices?
  • Must we obtain specific certifications to comply with US FDA HFE requirements?

Human factors engineering is part art, part science, and a regulatory imperative for medical device companies. HFE is an essential step toward minimizing use errors and designing a commercially successful product. To meet FDA expectations, manufacturers seeking device clearance in the US should adhere to HFE guidance and prioritize usability testing. Our team can assist you with a range of HFE research, prototyping, and testing services to help you optimize the design, usability, and marketability of your product.

Medical device user interface design and research

User research and evaluation are the best ways to ensure your device meets FDA guidelines for HFE. Performing user research early in the design process is optimal because it leads to a richer understanding of the factors controlling the quality of user interactions with your product. We can perform research using a variety of methods, including:

  • user observations;
  • interviews, including contextual inquiries, one-on-one, and group;
  • and benchmark tests.

Research informs our user interface design and prototyping activities. We can build prototypes of complex devices and software applications to mimic controls, indicators, product form, and digital displays.

Medical device usability testing, design audits, and forensic analysis

We can also assess the human factors suitability of an existing prototype or a device already on the market. We modify our assessment approach depending on the nature of the product, your schedule, and your budget. Assessments include:

  • Usability testing. Involves a full evaluation of your device’s interactive characteristics and measures project performance by objective means.
  • Heuristic analysis. Includes an independent design review of your product to identify design shortcomings and prioritize the resolution of these discrepancies.
  • Design audits and critiques. Determines if a product's user interface adheres to established design practices as described in multiple standards. A design critique provides quick feedback on a product's human factors strengths and opportunities for improvement.
  • Forensic analysis. Involves a variety of assessments that support accident investigations, including in-depth analyses to determine HFE factors contributing to an adverse event, instructions and warnings assessments, and anthropometric analysis.

Our team can help you optimize the design and usability of your device

Our human factors specialists can help with every stage of the design process, from planning and research to prototype evaluation. We help manufacturers meet the FDA’s HFE expectations that pertain to the assurance of device safety and effectiveness, as well as enhance products by increasing their usability and appeal. Here’s how we can help:

  • Develop an HFE program within your existing product development process that satisfies current regulations and standards.
  • Design user interfaces that not only enable safe and effective user interactions, but also are perceived as usable and appealing.
  • Conduct formative and summative (i.e., validation) usability tests according to best practices and informed by extensive experience.
  • Produce a complete HFE design history file that includes end-products cited in applicable standards, as well as an HFE report for submission (as needed) to regulators.
  • Conduct gap analyses to determine if a manufacturer has performed all of the requisite HFE activities and produced the necessary end-products.
  • Guide your interactions with regulatory bodies, including attending meetings (e.g., Pre-IDE and Type C meetings with FDA).
  • Design labels and IFUs that enable and enhance the user’s ability to engage with the product effectively and safely.

Please contact us for more information on how we can help you design truly great medical devices that comply with US FDA HFE requirements.

Common HFE and usability testing questions

Can medical product manufacturers meet the FDA’s expectations by conforming to the IEC HFE standard?

Not entirely. FDA recognizes the IEC standard, suggesting that it provides useful HFE guidance. However, in February 2016, FDA published its own HFE guidance titled "Applying Human Factors and Usability Engineering to Optimize Medical Device Design." This 45-page document describes a comprehensive set of HFE activities that manufacturers should perform before seeking clearance for a final product. In February 2016, the FDA also published a “List of Highest Priority Devices for Human Factors Review.” Combination product manufacturers should reference the draft guidance “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.”

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