Nov 4, 2019

Incorporating human factors engineering (HFE) into medical device development is more than a regulatory requirement. It also serves a manufacturer’s commercial interest by helping to create products that ensure good user experiences for patients and healthcare professionals.

Those were among the key take-aways from a presentation by Emergo by UL’s Michael Wiklund, General Manager for Human Factors Research & Design, at a workshop attended by 79 medical device professionals in Seoul, South Korea on October 11, 2019. 

The workshop included an introduction to HFE, a review of the US Food and Drug Administration’s HFE expectations, and a discussion of key HFE activities including user research, user interface requirement development, use-related risk analysis and usability testing.

“There is a natural flow of HFE activities leading to safer, more effective medical device designs,” Wiklund said. “The right approach can both meet FDA’s expectations and blend well with traditional, engineering-focused approaches to product development.”




  • Andrew Micek