Speaker Abstract: S-25
Whole Product Life Cycle
Alford Taylor, M.S., Center for Devices & Radiological Health/FDA
This presentation will offer an engineer's perspective on the Critical Path dimension of "industrialization," or how one gets from the prototype stage to successful commercial production of a new medical product.
Product developers, under the watchful eyes of regulators, must make hundreds or thousands of decisions concerning the design of the product and its associated production and servicing processes. While decisions made during the early part of the product life cycle have an enormous continuing impact on the safety and effectiveness of the product, new questions continue to arise throughout the product's useful life. At every juncture, developers and regulators alike must grapple with the question of "How good does it have to be?" The presentation will offer a pragmatic working answer to this question, and illustrate how this answer has been applied in real-world situations. While the focus of the presentation is on medical devices, the underlying principles are applicable to all medical products. Indeed, many of the practices that we employ on a day-to-day basis have been "borrowed" from other industry sectors.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf