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.
An indispensable guide to the commercialization process of drug, diagnostic and device biomedical technology.
Shreefal S. Mehta is Clinical Associate Professor of Biotechnology Management and Biomedical Engineering, Rensselaer Polytechnic Institute and Vice President, Business and Corporate Development, Cytopia Inc. He received his PhD in Biomedical Engineering from University of Texas Southwestern Medical Center in 1995. He was CEO and co-founder of Myomatrix Therapeutics, a cardiovascular pharmaceutical startup and recipient of the '40 under 40' award for rising business leaders in New York. He has been a reviewer for the NSF Biotechnology Commercialization SBIR Review panel.
'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, Director of Biodesign Program and Professor of Operations at Stanford Graduate School of Busines, 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, Editor-in-Chief of The Biomedical Engineering Handbook (CRC Press, 3rd Edition, 2006) and President of Biomedical Engineering Alliance and Consortium '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, serial entrepreneur and CEO of The Foundry 'This text is an excellent reference guide for any Biotech/med entrepreneur. It is the most comprehensive collection of required knowledge of the various aspects of this industry. The anecdotal case studies are highly valuable in driving home key points throughout the text. I will highly recommend this book to starters in this industry and for people who have collected different pieces of the puzzle through scattered sources over years and need to organize all that in their minds to put it in perspective.' MIT Sloan School MBA candidate and Kauffman Foundation intern '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
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