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. The webinar will describe a range of methods for identifying use errors, including:
• Conducting research, such as observations, interviews, and usability tests
• Analyzing use errors that have occurred with currently marketed products, such as complaint and known problems reports
• Conducting task analysis and hazard analysis
• Taking a creative, brainstorming approach to reveal use errors not identified by the aforementioned methods
ABOUT THE PRESENTERS:
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.
Michael Wiklund serves as general manager of UL's human factors engineering practice, which includes staff working in the USA, Europe, and Asia. A certified human factors professional, he has a over 30 years of experience in the field, much of it focused on medical technology development. Michael has authored many books on human factors engineering, the latest being the second edition of Usability Testing of Medical Devices and Medical Device Use Error – Root Cause Analysis. In early 2018, AAMI will publish his latest book titled, Writing Human Factors Plans & Reports for Medical Technology Development. He has also contributed extensively to the current AAMI and IEC standards and guidelines on human factors engineering. As Professor of the Practice at Tufts University, he teaches courses on applying human factors to medical technology to meet regulatory and commercial imperatives.