Usability Testing In FDA’s Crosshairs As Manufacturers Seek Human Factors Buy-In
This article was originally published in The Silver Sheet
Device manufacturers that fail to conduct formative testing early on in human factors efforts run the risk of making devices that don’t interact well with users and ultimately require costly fixes. Formatives are “often essential for achieving acceptable human factors validation testing results, minimizing FDA [pre-market] review time and agency requests for additional information,” says CDRH usability guru Ron Kaye. Meanwhile, a quality assurance official at device-maker Kinetic Concepts describes how his firm uses simulation rooms, and other experts offer advice on engraining human factors concepts into company culture.