Human factors engineering advancements in the medical device industry

Human Factors Engineering (HFE) has become a cornerstone in the medical device industry, driven by stringent international standards and U.S. FDA guidance over the past 15 years. Once considered a “nice to have,” HFE is now a regulatory expectation, ensuring the safety, effectiveness, and usability of medical devices.

In recent years, HFE has grown in importance as medical device companies are also now required to comply with other standards — including IEC 62366-1 — that mandate HFE principles throughout the entire product lifecycle. This means that early in the design phase, medical device companies must fully evaluate and mitigate potential use issues that could cause harm.

Jennifer Samproni, Chief Technology Officer of Health Solutions, Flex, answered questions for Medical Product Outsourcing (MPO) as they explored the advancement of HFE and implications for medical device manufacturers. Jennifer discusses the importance of early and frequent user engagement in the development process, highlighting that the approach allows for iterative design improvements, minimizing costs and ensuring successful summative testing. She also emphasizes that late-stage usability issues often lead to costly design changes.

Jennifer highlights recent HFE successes, including enhancing dose window magnification on injection pens, improving UI layouts for imaging software, and refining error messages on displays. Finally, she explores how emerging technologies like AI and augmented reality are also being evaluated for user trust and reliability, crucial for their adoption in diagnostics and imaging.