Over the course of seven years and 1,200 students, the Association for the Advancement of Medical Instrumentation (AAMI)’s Human Factors for Medical Devices course has continued to evolve. This year, the three-day program, which offers an introduction to regulatory requirements as they relate to the discipline of understanding how humans interact with devices, is undergoing another refresh.
The most recent evolution of the course—which is aimed at quality and design engineers, research and development managers, and risk managers—includes an increased focus on combination products and ties in with changes stemming from the Food and Drug Administration’s (FDA) February 2016 guidance document, Applying Human Factors and Usability Engineering to Medical Devices, as well as revisions to ANSI/AAMI/IEC 62366-1, Medical DevicesPart 1: Application of usability engineering to medical devices.
“Many participants were coming to our course with the new guidance in their hands, and we know they want us to be up to date with the FDA’s published position on human factors,” said Bob North, chief scientist at Human Centered Strategies in Colorado Springs, Colo., who directs the course. “We also present material from the newly updated international guidance, IEC 62366, which has undergone an upgrade to make it harmonize more with the FDA’s guidance. The course now has an integrated agenda that includes both of the FDA’s devices and drug centers. We have officials from those FDA centers giving co-presentations in the course now.”
Since 2009, AAMI’s human factors course has seen an increasing number of participants from the pharmaceutical industry—thanks to the increased integration of drugs and devices—which North described as “game changing.” As a result, the course has gradually incorporated the unique human factors requirements for participants seeking clearance on combination products. Today, it includes instructors from the pharmaceutical industry as well.
“The sophistication of our audience regarding human factors has gone up significantly over seven years. They ask questions that are of a much higher level because they already know the basic principles of human factors,” North said. “The exercises have to reflect that, so the emphasis is not just on how to do a risk analysis or design a validation study, but on the subtleties of investigating what the cause of particular use error is and the implication of those errors on the device design.”
The next human factors course will take place Aug. 29-31 in Baltimore, Md. The completely revised program will launch in November and will incorporate additional investigation techniques, including class exercises where participants use data to identify device design flaws.