\’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

Agenda

5:00 – 5:30 pm: Networking

5:30 – 6:30 pm: Talk and Q&A