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Provides a foundation for product development planning in the medical device, biologics, and pharmaceuticals industries, from the idea stage to drawing board, research, development, and marketing. Gives an overview of health care product issues, regulatory history, and the current regulatory environment, and presents a tactical model for the product development process and a menu of strategic issues. Intended for all levels of industry; does not require a scientific background. Annotation c. by Book News, Inc., Portland, Or.