By Tara (Daugherty) Long, Senior Human Factors Engineer, QuynhNhu Nguyen, MS, Director, Human Factors, and Millie Shah, PharmD, BCPS, Associate Director, Human Factors, Kymanox Corporation, Morrisville, North Carolina
Human Factors Engineering (HF/HFE) is the subject of understanding and optimizing how people interact with technology by using psychology and engineering. Its overarching goal is to validate that a medical product and its user interface is safe and effective for its intended users, uses, and use environments. The HFE process is responsible for evaluating the interactions of the end user with a medical product, user interface, including its instructions for use (IFU), labeling, packaging, and/or physical device. HFE also drives forward the implementation of risk mitigations to reduce use-related risks and the associated potential harms. Regulatory bodies, such as the FDA, consider human factors a risk-based discipline, and the HFE process can optimize the medical product’s user interface. Determining the appropriate critical tasks to be evaluated and assessed is crucial to the HFE process but can pose a challenge if not addressed with the appropriate risk-based approach.