Russ Branaghan, Research Collective: "Demystifying the FDA’s Human Factors Guidance"

As part of FDA approval, a new medical device must follow guidelines for “Human Factors,” which address design and encompass usability and ergonomics. Because medical devices are so diverse, manufacturers often struggle to understand how the guidelines apply to their own product. At this talk, Dr. Russell Branaghan, Founder/President at Research Collective will describe strategies to help companies (1) improve their time to market and overall design through early implementation of human factors, and (2) pass their human factors validation test for FDA clearance.

Specifically, you will learn:

  • An understanding of usability testing and its role within the field of human factors

  • How to improve overall product design and speed to market by implementing human factors into design controls

  • Strategies to pass a human factors validation test on the first attempt

  • The importance of including in their human factors strategy all of the tasks impacted by the device use (device setup, instructions for use, cleaning, disposal, etc.)

  • The first step a manufacturer should take after receiving a deficiency letter that mentions a lack of human factors

  • The future of post-market usability surveillance

Where & When

Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Tuesday, September 11

Agenda

5:00 - 5:30 pm: Networking

5:30 - 6:30 pm: Talk and Q&A

About the Speaker

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Dr. Russell J. Branaghan is founder and scientific advisor at Research Collective. Russ enjoys teaching, mentoring and research as a Professor of Cognitive Psychology and Human Factors at Arizona State University and as a long-standing Visiting Professor at Northwestern University. Russ is also integrated in the human factors arena, where he currently serves as Chair of the Human Factors and Ergonomics Society Product Design Technical Group, on the Editorial Board of the Journal of Human Factors, and on the Advisory Board for Mayo Clinic’s Center for Innovation. An avid researcher and writer, Russ has authored over 40 articles and one book. He also served an appointment as the Managing Editor of User Experience Magazine. With over 20 years of industry experience and consulting to over half of the Fortune 100, Russ brings his expertise and vision to Research Collective.