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The Two Mindsets of Successful Medical Device Development

Roger Tang (Senior Vice President, Science, Systems, and Engineering, Triple Ring Technologies, Inc.)

Aaron Joseph (Principal, Sunstone Pilot, Inc.)

Location: 210B

Date: Wednesday, February 12

Time: 4:05pm - 5:00pm

Track: MD&M Conference: Product Development: Effective Strategies for Moving from Engineering to Production

Vault Recording: TBD

Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and lower manufacturing costs while still maintaining regulatory compliance. In this presentation we will describe the core principles of Agile and Lean product development practices and how they are often misunderstood and poorly implemented: It is not one practice or the other, but rather two “mindsets” that need to be applied at the right time in the product development process. Topics covered include:

  • Overcome the systematic shortcomings of traditional “waterfall” or stage-gate linear approaches
  • Improving risk management, usability, and manufacturability for medical devices
  • Strategies for implementing agile and lean strategies to save money, time and be compliant with regulatory requirements

Presentation File

ANA2020_TheTwoMindsetsof_SuccessfulMedicalDeviceDevelopment_Tang.pdf