Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a relatively mainstream activity. Most companies have figured out the basics of what they need to do and how to do it. Now, the challenge for medical device manufacturers is to apply HFE efficiently and effectively.
This webinar will guide you toward a better HFE approach with answers to these questions:
• Is there value in establishing an in-house HFE team? Does the answer depend on company location, size, and the number and type of products?
• Should in-house HFE teams conduct summative usability tests or engage consultants to run them?
• Is it worth investing in learning tools (e.g., user manual, quick reference guide, “Get Started” guide, online simulations)?
• How many rounds of formative usability testing is enough?
• Should we build our own usability test laboratory or rent?
• Where should an HFE team reside in the organizational hierarchy?
• How much user research is necessary when developing a global product?
ABOUT THE PRESENTER
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.