Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to reduce use errors and ensure medical devices are safe and effective for their intended users, uses, and environments. As regulatory expectations continue to mature, human factors can no longer be treated as a late-stage checkbox or isolated activity. Instead, it must be integrated
across the entire product lifecycle, from early concept development through post-market surveillance.
This whitepaper outlines the human factors engineering process as defined by international standards and FDA guidance, with a particular emphasis on real-world implementation and the unique challenges associated with reusable and reprocessed medical devices. It is intended to help medical device manufacturers better understand how to build usability into their development processes and avoid common regulatory and post-market pitfalls.