Key Human Factors Drive Design for Disposables, Test Kits and IFUs

Bring to mind your last straight-out-of-the-box experience with a disposable medical device of any kind. Without a doubt, everyone has experienced the same frustrations: ambiguous instructions printed too small to read easily, and difficult assemblies that simply don't match up with human capabilities. As an industry and a profession, medical product developers have vast knowledge on how human beings perceive and process information and on how human hands work. Surprisingly, not much of that knowledge manages to inform the design of medical disposables, test kits, and instructions for use (IFUs). With an eye toward higher functionality and usability in disposables, test kits, and IFUs, this article reviews fundamental factors critical to successful design plus common oversights that lead to design disasters.