An Intensive Look at Methods for Identifying Potential Use Errors

Mitigating use-related risks in medical devices and combination products

To demonstrate safe and effective use of medical devices and combination products, it is incumbent upon manufacturers to identify and mitigate use-related risks during product development. A key step in the use-related risk analysis process is to identify potential use errors or – more simply put – to identify all the mistakes a user could make when interacting with a product.

Human Factors webinar presenters

Michael Wiklund, Leader, Life Science Industry Practice, UL Solutions

Michael Wiklund serves as Leader of UL Solutions' Life Sciences Industry Practice. He is currently responsible for analyzing customers’ needs and connecting them with advisory service providers. Previously, he served as General Manager of Emergo by UL’s Human Factors Research & Design (HFR&D) team. Over a four decades career, his research, design, and evaluation work has focused on products and systems as diverse as televisions and heart lung machines; aircraft instrumentation and mascara applicators; lawn mowers and stepladders; wheelchairs and lucid containers, swimming pool warnings and sports car company websites. 

Michael is a board-certified human factors professional. He is also a Professor of the Practice at Tufts University, where he has taught human factors for 30+ years and focused the human factors program on the application of human factors to medical technology.  

He has been a major contributor to several standards on human factors across multiple industries. Michael has written multiple books on various human factors topics designing for safe use, designing simple instructions, writing user interface requirements, conducting usability test, determining the root cause of use errors.

Erin Davis, associate research director, Emergo by UL

Erin Davis is an Associate Research Director in Emergo by UL's Human Factors Research & Design (HFR&D) team. She earned her MS in human factors engineering from Tufts University and her BS in biomedical engineering from Marquette University. During her undergraduate studies, Erin served as a systems engineering and human factors co-op at Baxter Healthcare and interned with the FDA. At Emergo by UL, Erin develops and implements HFE programs and leads projects requiring expertise in user research, design, and usability testing of medical devices. She is a co-author of Medical Device Use Error - Root Cause Analysis.