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Exploring Methods for Assessing Design Differences Between Generic Drug-Device Combination Products and Reference Listed Drugs

Tuesday, April 23, 2024 (1:00 PM - 2:00 PM) (EDT)


Alternative methods to conduct comparative use human factors studies to assess design differences remain relatively unexplored. This webinar discusses research that investigated potential alternative methods to evaluate user interface design differences between generic drug-device combination products when compared to its reference listed drugs and provides recommendations based on those findings.



David Hirning
Director, Human Factors, Human Factors/New Product Development

David has more than 25 years of experience in Human Factors, with over 13 years of experience leading and/or working on a broad range of medical device Human Factors projects. He served in a range of roles during his medical device tenure, including a Sr Principal Human Factors Engineer, Principal Project Manager, and Quality System Internal Auditor/Management Representative.

The products he has been responsible for range from very simple eye dropper devices through combination devices, negative pressure wound therapy, diabetic treatment devices, diagnostic and surgical devices, ventilators, IV pumps, x-ray machines, and more. In his current role, David actively oversees and mentors Battelle’s Medical Device Human Centric Design Team and the New Product Development team (Mechanical Engineers, Electrical Engineers, Software Engineers, System Engineers, and of course Human Factors Engineers). He has worked with both the US FDA and International Regulatory agencies for the approval and post-market evaluation of medical devices throughout the world.

Tuesday, April 23, 2024 (1:00 PM - 2:00 PM) (EDT)
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