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Abstract
Human factors has grown in popularity in the medical device industry since the introduction of FDA’s Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design in 2011. However, human factors and ergonomics has been practiced since the 1940’s and adopted by various industries, regulated and unregulated, to improve user safety and satisfaction. Over the last 70+ years, many manufacturers in industries like aerospace, aviation, automotive, and consumer goods have incorporated human factors into their product design controls. Nevertheless, many medical device manufacturers still treat human factors as a singular step (validation testing) in the regulatory submission process. Leveraging the diverse experience, we aimed to identify human factors practices that have proven successful in non-medical industries that are not commonly practiced in the medical device industry, possible reasons these practices are not used by medical device manufacturers, and recommend possible solutions. Our discussions revealed four human factors practices that are not commonly used in the medical device industry, reasons the medical device industry may be slow to adopt human factors, and potential solutions for each.
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