sagepd.com
Fundamental to the effective development of a new medical device is having a clear definition of the clinical need it must meet. The clinical need may be related to improving patient outcomes, or reducing procedure times or costs. Once that need has been established, it’s the responsibility of the medical device development team to generate a product concept that will deliver the intended benefits. This is the objective of the first phase of the medical device development process: The Concept or Feasibility phase.
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