Conceptualizing and developing a new medical device, getting regulatory approval, and bringing a device to market takes years and requires investing millions of dollars. Industry experts agree that successful companies follow a structured, phased approach to medical device product development. In particular, as part of this structured, phased approach, careful attention and planning during the early concept development stages of a project prevents costly and time-consuming re-work later on. Case studies illustrate the challenges that can arise when failing to follow disciplined processes in the earliest stages of development and the success that can be achieved when following good processes.
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