Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices

Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices

Paperback

By (author) Shreefal S. Mehta

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  • Publisher: CAMBRIDGE UNIVERSITY PRESS
  • Format: Paperback | 360 pages
  • Dimensions: 170mm x 242mm x 22mm | 600g
  • Publication date: 30 April 2011
  • Publication City/Country: Cambridge
  • ISBN 10: 0521205859
  • ISBN 13: 9780521205856
  • Edition statement: Reissue
  • Illustrations note: black & white illustrations, black & white line drawings, black & white tables, figures, charts
  • Sales rank: 494,616

Product description

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.

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Review quote

Review of the hardback: 'This text covers the commercialization of life science technologies in the areas 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.' Paul Yock Director of the Stanford Program in Biodesign and Professor at Stanford Graduate School of Business and School of Medicine Review of the hardback: '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.' Carmichael Roberts Vice Chairman, WMR Biomedical and cofounder of Surface Logix (a private company in Boston) Review of the hardback: '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 developing a new medical product.' Joseph Bronzino Editor-in-Chief of The Biomedical Engineering Handbook (2006) and President of Biomedical Engineering Alliance and Consortium Review of the hardback: '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 from ideas to income. 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 Review of the hardback: '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.' Hanson Gifford Biomedical device entrepreneur and co-founder of The Foundry Review of the hardback: 'This book is a must for starters in the industry and for people who have collected different pieces of the puzzle through scattered sources and need to organize it in their minds to put it in perspective.' Atul Gupta MIT Sloan School MBA candidate and Kauffman Foundation intern Review of the hardback: 'Real life issues experienced by life sciences product development teams are described in the book. Key hurdles along the commercialization path are clearly organized and will help the reader navigate multiple business functions and disciplines to take a product to market. Dr Mehta's book is on my table as a handy reference and overview of the business and product development challenges involved in the health care industry. Young scientists, engineers and even experienced executives involved in the health care industry should read this book.' Christoph Hergersberg Global Technology Leader, Biosciences, General Electric Global Research Center Review of the hardback: 'Venture philanthropists, venture capitalists, state organizations, and angel investors involved in building new life sciences-based ventures can use this book to inform their investment decision making process. Dr Mehta's comprehensive book helps funding organizations and entrepreneurs identify the companies and technologies most likely to succeed.' Lesa Mitchell Vice President, Advancing Innovation, the Ewing Marion Kauffman Foundation Review of the hardback: 'Dr Mehta's book is an excellent guide on how to overcome obstacles in commercializing innovative medical technologies. It covers market research, intellectual property rights, business models, and regulatory affairs. Of note are the real life examples, the extensive discussion of Intellectual Property Rights in relation to business models, and that of interaction with the FDA for innovative projects.' Henk van Houten Senior Vice President Philips Research, Program Manager Healthcare Review of the hardback: 'The 'How-To Bible' for launching a product - If I had to recommend one great book to get you started on the road to launching a product, then begin with Commercializing Successful Biomedical Technologies.' Joe Sasenick Washington Biotechnology & Biomedical Association Review of the hardback: 'Shreefal Mehta's book highlights the right questions to ask in order to truly understand the impact of reimbursement and health economics, too often ignored in product development, on new devices, drugs, and biologicals.' Parashar Patel Vice President, Health Economics & Reimbursement, Boston Scientific Review of the hardback: '... Mehta does an excellent job of identifying and organising the major issues associated with biomedical technology commercialisation in a framework that students, researchers and entrepreneurs can understand.' Nature America, Inc.

Table of 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.