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Virtual Engineering Week Schedule Viewer

Virtual Engineering Week is bringing a full week of best-in-class education to the global design, engineering, and manufacturing communities. Join us each morning to hear from medical device industry professionals during the Medtech Mornings series, and in the afternoons to learn from engineering and manufacturing experts in areas like 3D printing, smart manufacturing, packaging, materials and sustainability, and career development.

All times listed below are PST (Pacific Standard Time).

Innovative Design After the FDA Emergency Use Authorization Era

Andrew J. DiMeo, Sr. Ph.D.  (Founder & CEO, CanvasGT)

Date: Friday, December 4

Time: 9:30 am - 10:00 am

Track: MedTech Mornings: Product Design & Development

Vault Recording: TBD

Audience Level: All

US and international organizations took rapid action in efforts to diagnose and treat COVID-19. This unprecedented era of innovation was aided by the FDA’s Emergency Use Authorization (EUA) which removed significant regulatory hurdles on the pathway to commercialization. As this chapter comes to a close, the need for novel medical solutions is not waning. How can medical innovators rapidly accelerate the design process without the benefit of an EUA? Current standard practice is based on a 30-year-old announcement by the FDA. This discussion will provide tools to accelerate medical innovation within the current framework of design while also serving as a call to action for a new guidance document relevant to the current medical innovation ecosystem.