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As expected based on FDA’s priorities for 2016, the Agency recently released the final guidance document on human factors and usability engineering. The document, titled “Applying Human Factors and Usability Engineering to Medical Devices,” finalizes the draft guidance on the subject released in 2011 and officially overrides “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” issued in 2000.
The update finalizes FDA’s stance that device manufacturers should consider human factors testing as part of a “robust design control subsystem.” When risk analysis for a device indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm, manufacturers should submit human factors data in their premarket submissions.
Two other documents were released with the final document. The first was a draft guidance, “List of Highest Priority Devices for Human Factors Review,” including over 15 types of devices that should include human factors data in premarket submissions. An exception exists when the submission does not involve any changes to users, user tasks, user interface or use environments from those of predicate devices.
Robotic surgery devices made the list – seemingly the only item pertinent for orthopaedic device manufacturers. However, if a type of device is not on the list, it doesn’t mean you’re off the hook for submitting data to FDA, says Ed Israelski, Ph.D., Private Consultant and Co-Convener of the IEC and ISO Joint Working Groups on Usability Engineering Standards.
“The fact that your device may be omitted from the current version of that list doesn’t mean you don’t have to do your human factors [in your premarket submission],” Israelski says. “You have to do a thorough risk analysis, looking at users and your tasks. You have to do historical analysis of use errors for some of the products, then risk analysis and iterative design with formative evaluations. In the validation final study, you have to rationalize user groups and say how many make sense. There are no statistical criteria – we didn’t expect FDA would change their mind on that – it’s qualitative.”
It’s highly likely that you’ll observe use errors in your validation study, says Israelski.
“Your job is to look at each one of those use errors that occur during the validation study and explain them,” he says. “Can you do more about them in design? If not, is the residual risk that remains acceptable compared to the benefit of the product?”
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.
Testing, design and people requirements for performing human factors studies are often the most difficult for device companies, due to lack of resources and guidance understanding. However, FDA and international governing bodies expect continued scrutiny of the topic. This is evidenced by the second guidance document that FDA released during its announcement.
The second draft guidance is titled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” When final, it will represent FDA’s thinking on when and how manufacturers should perform human factors studies for combination products for investigational or marketing applications.
This document provides examples of such products and recommends ways to approach human factors studies for them, focusing on challenges, including:
- The timing and sequencing of human factors studies as they relate to the overall development and study of a combination product
- How human factors studies compare to other clinical studies
- When changes to a combination product call for new human factors studies to be conducted
- When to use simulated-use versus actual-use human factors studies
- What information to provide to FDA, and when, to ensure timely feedback for human factors studies
The comment period for this draft guidance ends on May 3, 2016. In addition to seeking input on the guidance, FDA is requesting that stakeholders submit examples of combination products in their comments and state whether they believe human factors studies are necessary, as well as those challenges and development risks that may arise if these studies are conducted before, during or after clinical studies for combination products.
In the final guidance for human factors, FDA clarified that simulated use studies are the norm and it would be rare to require actual use studies in a clinical study, according to Israelski.
“That may be required in rare circumstances where you can’t simulate all the conditions, especially the ones that concern safety,” he says.
Changes from the 2011 draft guidance to the recently-released final guidance are minor, and have a small impact, Israelski says.
This includes slight changes to the report format that FDA wants (listed in Annex A) and small changes to definitions. Specifically, the report format is now eight sections instead of seven, and the conclusion section is in the front rather than the last section.
