MedTech I.Q.

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As reported in the Journal of Medical Devices ... The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance of reimbursement decisions for successful device commercialization require careful planning and strategy-setting, coordinated decisions, and consistent, rigorous business processes...

... While various models may exist in the medical device industry, no comprehensive development model has been published ...

...Stanford University researchers have created an extensive model designed to guide medical-device companies in developing, commercializing and seeking regulatory approval for their products. The model was constructed based on best-practice analysis and in-depth interviews with more than 80 seasoned experts actively involved in the development, commercialization, and regulation of medical devices.

The framework contains five key stages and four decision gates of the product-development process.... The stage-gate process includes the following five phases:

(1) initiation - opportunity and risk analysis,
(2) formulation - concept and feasibility,
(3) design and development - verification and validation,
(4) final validation - product launch preparation, and
(5) product launch and postlaunch assessment.

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