Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.
• A robust product development plan is provided through a step-by-step model, from concept to regulated, commercially viable product • Highlights key business issues taking into account critical business aspects, such as budgetary impact, time constraints and quality control in the development cycle • Includes learning points and exercises as well as practical case studies and contributions from industry
Contents
Foreword; Glossary; 1. Biomedical device and drug design industry and markets; 2. Markets of interest and market research steps; 3. Intellectual property and licensing; 4. Product development; 5. Regulatory pathway; 6. Manufacturing; 7. Reimbursement and distribution; Appendices: A. General sources of information (websites, associations); B. Alphabet soup of regulatory bodies, regulations and standards; Index.
Reviews
‘The text provides a systematic introduction to the field that is well suited for the classroom, with clear organization and appropriate weighting of the many subtopics. The book should also help industry engineers and managers as well as life science entrpreneurs to better understand the full range of steps required to develop a medical product and to understand the broader context of the health technology industry.' Paul Yock, Stanford University
‘The book looks like it will be very important and interesting. The outline lists all the sorts of things that matter but are never written down in a comprehensive text.’ Dr Carmichael Roberts, Vice Chairman, WMR Biomedical and cofounder of Surface Logix (a private company in Boston)
'Shreefal Mehta's book is very timely for it provides insights and important information regarding the major steps entrepreneurs must take as an idea progresses through the various steps of commercialization … Consequently this text is a must for anyone engaged in this process.' Joseph Bronzino, Professor of Applied Science at Trinity College, Hartford
'This new text covers the commercialization of life science technologies widely, ranging across the spectrum of pharmaceuticals, biotechnologies, medical devices and diagnostics and spanning the development process from invention through marketing and sales. Shreefal Mehta writes clearly and with a practical bent, using case examples and drawing on his own substantial industry experience to help chart a path through the complex landscape of new product development. The text provides a systematic introduction to the field that is well suited for the classroom, with clear organization and appropriate weighting of the many subtopics. The book should also help industry engineers and managers as well as life science entrpreneurs to better understand the full range of steps required to develop a medical product and to understand the broader context of the health technology industry.' Paul Yock, Stanford University
'Dr Mehta covers the evolution of products in the biomedical industry from ideas to income. The book is a comprehensive and practical overview of all the steps and challenges required to successfully develop and commercialize a product. Throughout the text he illustrates his points with real life examples. This is a text that should be broadly read by students and professionals alike!' Jim Mullen, CEO of Biogen Idec
‘Launching a new biomedical company is a complex undertaking, and this book is packed with useful details on all aspects of the startup process. I highly recommend it to anyone contemplating a new venture.’ Gifford Hanson, The Foundry
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