Steps in Device and Drug Pathway Development: Clinical Trials, Similarities, and Differences
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Bringing a new medical device or drug from benchtop to bedside is a long and arduous process and is very expensive. This chapter describes the stages of development for new medical devices and drugs and describes each while comparing the similarities and differences between the two with a focus on clinical trials. Much of this comes from a long personal history of direct involvement in medical device trials, in addition to writing a 510(k) and an IDE.
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