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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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5.2 Research and Development Strategy

Introduction
Initial prototyping of the chosen concept has shown that it is technically feasible and can address what users want. But now the solution has to be made real. Successive iterations must lead to a device that is safe, performs effectively in humans, and can be efficiently manufactured. Thousands of hours will be spent on engineering and testing, as expensive equipment and scores of raw materials are used to produce a final product. This is R&D.
In the medtech field, research and development (R&D) typically refers to the scientific and engineering work required to take a concept from an early-stage prototype to a user-ready final device.1 Whereas early prototyping focuses on proving the general ...

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