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Panel: Driving Innovation: Getting Innovative Products Through FDA


Eri Hirumi (Regulatory Affairs Specialist, Eri Hirumi Consulting)


Grant Bennett (Chief Executive Officer, Brandwood Biomedical)

Michael Hoffman (Deputy Director, Division of Neurological and Physical Medicine Devices, FDA)

Location: 210D

Date: Thursday, February 8

Time: 3:45pm - 4:30pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

Getting innovative medical devices through the regulatory pathway is no easy task. In this session, you’ll hear from disruptors that managed to do it. Part 2 of this discussion will focus on examples and case studies of those with digital health products, or other new devices, who are moving the needle on innovation with in a regulated environment.

Topics to be covered include:

  • Case studies from companies that successfully brought digital health products and other new devices to market
  • Challenges faced by disruptive devices
  • Exploring innovative regulatory strategies
  • Strategies for minimizing the regulatory burden on innovative devices