Human Factors & Usability Engineering in Medical Devices

by | Apr 12, 2019 | FDA, Medical Devices, Quality Systems, Risk Management

Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device?  If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be important decisions for an organization.

A final validation study before release of the device may not take long to execute, sometimes this can be done in as little as a day. Yet leading to the execution of the study there can be a large body of work that begins early in the product development process. With a product development process being integrated with Usability / Human Factors Engineering, inputs into the final validation protocol can be generated as the device matures as it goes through the product development process. Some inputs that could be considerations in a final validation may include:

  • Intended User Profile
  • Intended Conditions of Use
  • Intended Use Environment
  • Operating Principle
  • Device User Interface(s)
  • Primary Operating Functions
  • Evaluation of tasks related to safety
  • Perception, Cognitive and Action analysis
  • Learning decay considerations
  • Identification of hazards related to use error
  • Mitigation and control of hazards related to use error
  • Learning from Formative study
  • Sample size considerations

With so many considerations going into a final or summative study, the processes used to guide a product development team need to be designed to manage the activities associated with the many HFE considerations.  The documentation of considerations and how their relationships with each other within a quality system are important to not only guiding a team to the proper execution of a final validation study, but the generation of the final Usability / Human Factors report.  The report is to contain not only the results of the final study but also covering the inputs that were used to develop and ensure the protocol, including Users and Use Cases used, were appropriate for the validation of the device.

A systematic approach for a manufacturer to understand which HFE requirements to apply to their device and how to manage those requirements is needed early in the product development process. Having the device inputs and risks identified as early as possible during product development is necessary for successful Usability / Human Factors Validation testing.

Having trouble building your risk management program? Give us a call at 248-987-4497 or email us at

Matthew Ward

Matthew Ward

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This