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Human Factors ValidationAs medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing.

  1. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market.
  2. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies.
  3. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies consist of a minimum of 15 participants for each defined user group and must be performed in actual or simulated use environments.
  4. Currently, not all device manufacturers are required to perform Human Factors Validation Testing on their medical devices for FDA clearance. To determine if your device must undergo this testing, review the FDA guidance, “List of Highest Priority Devices for Human Factors Review.” Nevertheless, even if your specific device is not on the FDA’s list, you may still wish to consider conducting Human Factors studies. Human Factors provides many benefits in addition to meeting regulatory requirements, such as increased efficiency, improved usability and potentially improved sales because your device is perceived as being user friendly.
  5. The user interface is comprised of all points of interaction between the user and the device, which includes packaging, labeling, training materials, physical controls and display elements. The entire user interface must be evaluated for safety and effectiveness.
  6. Your study must be developed based on usability FMEA or other risk assessments you have used to evaluate potential use errors. These risk assessments can be integrated into the overall risk management process of the device and referenced in your study plan.
  7. If your users consist of multiple user groups who will interact with the device in different ways, such as physicians and technicians, FDA will require a study to be conducted for each group.
  8. Training provided to study participants must consider the environment in which training would be provided in actual use, including the fact that retention of information learned decays over time. When creating your study protocol, you must also account for participants forgetting what they have learned by providing at least 1 hour between training and performing the study.
  9. If you are a manufacturer outside of the US, or if you intend on marketing your device in the US and abroad, and are conducting Human Factors Validation Testing for FDA clearance, you must conduct your study in the US or US territories with US citizens.
  10. To meet the FDA’s requirements and expectations for your device’s Human Factors documentation, you should follow both IEC 62366-1 and the FDA guidance, “Applying Human Factors and Usability Engineering to Medical Devices.” IEC 62366 is recognized by the FDA, but the FDA’s guidance includes additional requirements that must be met for compliance.

Developing Human Factors Validation Testing is often complex and time consuming, benefitting from the assistance of experienced professionals to ensure everything runs smoothly. From planning the studies to preparing the risk assessments to developing the protocols and conducting the testing, MethodSense can help.

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