The Medical UI design field recently received assistance from the FDA in the form of a publication title “Applying Human Factors and Usability Engineering to Medical Devices.” This is a guidance document helping those in the medical device and medical user interface industry in developing the proper human factors and usability engineering methods and practices that minimize the possibility of critical task errors during use.
The revised human factors guidance document encourages incorporation of human factors processes and considerations early in the product’s development, essentially “designing out” potential hazards in a device and its interface system. The belief on the part of the FDA is that these design checks and balances should significantly reduce severe use-related risks that could cause patient harm or impair medical treatment.
Human factors validation—sometimes referred to as summative usability testing—assesses whether the final medial UI solution supports safe and successful use by adhering to the following:
– The test participants represent the intended (actual) users of the device (the test sample size is best determined from the results of the preliminary analyses and evaluations)
– All critical tasks are performed during the test
– The device user interface represents the final design
– The test conditions are sufficiently realistic to represent actual conditions of use