Overview of a Robust Human Factors Engineering Process.

Abstract

All medical device companies perform human factors engineering (HFE) in some capacity. Human factors validation often is required for a medical product to reach market. The type of human factors validation that each device undergoes can be based on the medical device regulatory risk classification, severity of harm associated with the use of the device, or product complexity. Some companies treat the human factors validation process as a check box at the end of product development rather than using the HFE process throughout the product life cycle, which can lead to costly validation tests that generate a multitude of usability issues that need to be fixed, thereby delaying timelines and launch dates and harming a company’s bottom line. Companies that incorporate a robust HFE process into the entire product life cycle find that they have increased product safety and decreased development time. It also results in a competitive advantage in the marketplace. This article provides an overview and introduction to what a robust HFE process looks like.