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Panel: Driving Innovation: Getting Innovative Products Through FDA

Moderator:

Eri Hirumi (Regulatory Affairs Specialist, Eri Hirumi Consulting)

Panelists:

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