Human Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for medical products and reduce use-related risks. In this article from Cell & Gene, Kymanox experts, Tara (Daugherty) Long, Senior Human Factors Engineer, QuynhNhu Nguyen, MS, Director, Human Factors, and Millie Shah, PharmD, BCPS, Associate Director, Human Factors, discuss the importance of using a risk-based approach for the HFE process.