Redefining Innovation and Quality: The Bridge from Consumer Goods to Medical Devices

Redefining Innovation and Quality: The Bridge from Consumer Goods to Medical Devices

Eric Pettes, Bose Health


This week’s IpX True North Podcast episode features Eric Pettes, Director of QA/RA for Bose Health, as he shares with IpX President Joseph Anderson the Bose journey of expansion into the medical device industry with their development of the world’s first direct to consumer hearing aid. Eric and Joe discuss:

  • Building a quality management system and Bose’s enterprise-wide commitment to quality as a process-based approach 
  • Bose’s growth into Class 1 and Class 2 medical devices, the challenges of meeting regulatory states’ requirements, and receiving approval for a Class 2 device
  • The innovation from an over-the-counter hearing aid device that provides freedom, privacy, affordability and functionality for those in need with the support of a user-friendly application 
  • The dedication behind launching a new product with a 90-day implementation period and 15 workstream teams while simultaneously entering a new market with the support of Bose’s unique system for traceability and senior executives
  • The Bose shared vision for the future and commitment to making a difference for its workforce and consumers

Learn more about Bose and their products by visiting their website.

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