From the April 2007 issue of "The Silver Sheet"
After decades of being relegated to an afterthought for some manufacturers, the concept of incorporating human factors into medical device development has finally gained some traction, several FDA officials say.
Usability is becoming such a widely accepted industry concern that it will soon be the subject of a brand new international standard that will give firms advice on how to build and maintain their own human factors programs.
IEC 62366, “Medical Devices – Application of Usability Engineering to Medical Devices,” should be ready for an October or November release, assuming the standard is given the thumbs-up by members of the International Electrotechnical Commission (IEC) when it comes up for a vote in June, says Pete Carstensen, a senior systems and human factors engineer at FDA’s Center for Devices and Radiological Health (CDRH).
Although FDA cannot require manufacturers to implement IEC 62366, Carstensen fully expects the agency to strongly endorse the standard’s usability guidelines.
“I think a lot of companies are not really sure how to go about doing this stuff,” he says, noting that the new standard provides a comprehensive explanation of human factors. “[There are] a lot of informative annexes. I think that will be a big help to them.”
Annexes indeed make up a large portion of the 82-page draft document. In fact, IEC 62366 includes only six full pages of actual requirements, while its nine annexes – ranging from “general guidance and rationale” to “guidance on the usability engineering process” – stretch 62 pages.
“Use errors caused by inadequate medical device usability have become an increasing cause for concern,” the draft standard states. “Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. The design of a usable medical device is a challenging endeavor, yet many organizations treat it as if it were just ‘common sense.’”
IEC 62366 gives manufacturers practical advice on a wide range of human factors issues, including usability verification and validation, the usability engineering process, the identification of hazards, and human factors training of company employees.
Carstensen points out that the standard also directs manufacturers to integrate usability engineering into the design process early.
“The biggest mistake you can make is to wait until the end to do an evaluation in usability testing, because it’s too late. It’s going to cost you a fortune now,” he told “The Silver Sheet.”
This article continues in the April 2007 issue of "The Silver Sheet."
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