|
![]() |
|||
|
||||
OverviewFull Product DetailsAuthor: Shreefal S. MehtaPublisher: Cambridge University Press Imprint: Cambridge University Press (Virtual Publishing) ISBN: 9780511791345ISBN 10: 0511791348 Publication Date: 05 September 2012 Audience: Professional and scholarly , Professional & Vocational Format: Undefined Publisher's Status: Active Availability: Available To Order ![]() We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsForeword; 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.ReviewsReview 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. 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. '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 '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) '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 '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 '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 '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 '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 '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 '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 '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 '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 '... 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. Author InformationShreefal 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. Tab Content 6Author Website:Countries AvailableAll regions |