Author: Elaine Whitmore
Written in clear and understandable terms, this book tells readers, with little or no scientific background, exactly what needs to be done for the successful development and commercialization of health care products regulated by the FDA, specific to medical devices, biologics, and drugs. Helpful references include a glossary, an abbreviations list, and a list of useful contacts. Contents: Special Challenges in Health Care Product Development; Planning for Quality: Design Controls; Models and Metaphors: Health Care Product Development and Organization; Components of Product Development Planning: The Product Development of Portfolio Management, Technology Assessment, and Technology Forecasting.
