Open Forum: Applying Human Factors Engineering (HFE) to Drug-Device Combination Products Q&A

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: Applying HFE to drug-device combination products Q&A

There are many important nuances in regulators’ expectations for applying human factors engineering (HFE) throughout the development of combination products, which are therapeutic or diagnostic products that integrate drugs, devices and/or biological components. Teams developing these products often have practical questions about how to structure, execute and document their HFE activities to align with regulators’ rapidly evolving expectations.

Webinar date

April 30, 2026

Topics discussed

In this open forum webinar, experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team address questions on applying HFE to drug-device combination products, covering topics such as:

Conducting use-related risk analyses and identifying critical tasks
Selecting appropriate user groups and sample sizes, including justifying proxy participants in cases of a rare end-user population
Planning and executing formative and HF validation tests

Andrea Sutton: Research Director, HFR&D; A board-certified human factors professional, Andrea Sutton leads and oversees research activities required to meet...

Allison Strochlic: Senior Research Director; Allison was one of the Emergo by UL, Human Factors Research & Design team’s co-founders in 2005.

Layne Hartman: Senior Human Factors specialist; Layne Hartman is a Senior Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team.