Medical Device Design: Innovation from Concept to Market, 2nd Edition describes the entire process of developing a medical device. Although the book does not cover the clinical research stage of development in depth, it is invaluable for understanding the larger context, especially for researchers coming from drug clinical research. Newcomers will find that, while safety is an issue for both drugs and devices, devices can harm a lot more people than just the patient. Another difference from the drug clinical research field is that medical devices do not go through the standard three phases that occur in drug testing; in many cases, they can skip clinical trials entirely.
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