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Priorities for product development groups introducing a new medical devices are clear. Demonstrate clinical efficacy. Get it to market quickly. Produce a high quality device at the lowest total cost. Traditionally these priorities are addressed in series. First, “proof-of-concept” models are fabricated and evaluated in the lab. Once the clinical concept is set, the goal is to get devices representative of the final form, fit and function into human clinicals as quickly as possible. Finally the design is validated and transferred to production. The curse of success is that momentum carries the device into the market with a “prototype” design which was perfect for clinical evaluations but is expensive and inconsistent to manufacture. A panel of experts and practitioners will discuss how to design process where a multi-disciplinary team address manufacturing, supply chain and cost issues in parallel to the design team early in development.
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