ABSTRACT
The Human Factors Engineering / Usability Engineering (HFE/UE) process is designed to provide a structured methodology to identify, assess, and determine controls/mitigations for use-related risk. Following the HFE process allows a manufacturer to not only reduce overall combination product risk, but to design a user interface that supports safe and effective use, along with generating the evidence to support such conclusions in regulatory submissions. This chapter explores the HFE process framework, Use-Related Risk Analysis (URRA), the type of data generated, regulatory review, and – through a series of case studies- highlights challenges faced and best practice considerations for HFE through development and lifecycle management in the combination products space.
