Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This 2008 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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Editorial Reviews
Review
"This book is packed with useful details on all aspects of launching a new biomedical company. I highly recommend it to anyone contemplating a new venture"
Hanson Gifford, biomedical device entrepreneur and co-founder of The Foundry
"Dr. Mehta's book is a comprehensive and practical overview of all the steps and challenges to successfully develop and commercialize a product from idea to income. His points are illustrated with real life examples throughout. Students and professionals alike should read this book!"
Jim Mullen, CEO Biogen-Idec and past President of the Biotechnology Industry Organization
"The book covers all the things that matter but are never written down in a comprehensive text."
Carmichael Roberts, General partner at Northbridge Partners, Vice Chairman, WMR Biomedical and cofounder of Surface Logix
"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
"Shreefal Mehta's book provides insights and important information about the major steps entrepreneurs must take as an idea progresses through the various steps of commercialization. This text is a must for anyone developing a new medical product."
Joseph Bronzino, Editor-in-Chief of The Biomedical Engineering Handbook (CRC Press, 3rd Edition, 2006), and recipient of the IEEE Millennium Medal for "his contributions to biomedical engineering research and education"
"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."
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."
Dr. Henk van Houten, Senior Vice President Philips Research, Program Manager Healthcare
"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
"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.
"In Commercializing Successful Biomedical Technologies, biomedical academic and entrepreneur Shreefal Mehta highlights the key issues that must be understood to improve the chance of bringing biomedical technology innovation to market...Mehta does an excellent job of identifying and organizing the major issues associated with biomedical technology commercialization in a framework that students, researchers and entrepreneurs can understand."
Michael R Bielski, Nature Biotechnology
Hanson Gifford, biomedical device entrepreneur and co-founder of The Foundry
"Dr. Mehta's book is a comprehensive and practical overview of all the steps and challenges to successfully develop and commercialize a product from idea to income. His points are illustrated with real life examples throughout. Students and professionals alike should read this book!"
Jim Mullen, CEO Biogen-Idec and past President of the Biotechnology Industry Organization
"The book covers all the things that matter but are never written down in a comprehensive text."
Carmichael Roberts, General partner at Northbridge Partners, Vice Chairman, WMR Biomedical and cofounder of Surface Logix
"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
"Shreefal Mehta's book provides insights and important information about the major steps entrepreneurs must take as an idea progresses through the various steps of commercialization. This text is a must for anyone developing a new medical product."
Joseph Bronzino, Editor-in-Chief of The Biomedical Engineering Handbook (CRC Press, 3rd Edition, 2006), and recipient of the IEEE Millennium Medal for "his contributions to biomedical engineering research and education"
"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."
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."
Dr. Henk van Houten, Senior Vice President Philips Research, Program Manager Healthcare
"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
"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.
"In Commercializing Successful Biomedical Technologies, biomedical academic and entrepreneur Shreefal Mehta highlights the key issues that must be understood to improve the chance of bringing biomedical technology innovation to market...Mehta does an excellent job of identifying and organizing the major issues associated with biomedical technology commercialization in a framework that students, researchers and entrepreneurs can understand."
Michael R Bielski, Nature Biotechnology
Book Description
An indispensable guide for professionals, entrepreneurs and students in biomedical technology development, teaching how to translate technology into useful patentable inventions and commercial products. Guiding the reader through the practical aspects of the commercialization process, it is an ideal accompaniment to a capstone design course in engineering and biotechnology.
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5 of 5 people found the following review helpful:
5.0 out of 5 stars
Outstanding overview of the complexities of commercialization,
This review is from: Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices (Hardcover)
I am using this text in a commercializing biomaterials course and highly recommend it to graduate students and post-docs who want to enter the world of start-up biotechnology. I think it would also be very helpful to junior faculty who are thinking about commercializing their research. It is brilliantly constructed to walk you through the basics of taking your research from the bench to bedside and the challenges you are going to face along the way. I also found the author's use of vignettes and specific examples very helpful to illustrate complex points. This book won't write your business plan for you but should help you do your market analysis and give you the questions to ask when you initiate disclosures to your university's Technology Transfer office. Highly recommended.
1 of 1 people found the following review helpful:
5.0 out of 5 stars
Outstanding Text for Understanding Commercialization Strategies,
This review is from: Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices (Hardcover)
We have used this text at the University at Buffalo School of Management Center for Entrepreneurial Leadership in a program called High Tech CEL for the past two years. The program was developed to help early stage life sciences companies find a pathway to commercialization. This text is a valuable tool that takes sometimes complicated pathways and represents them in easy to understand language and diagrams that almost anyone can follow. Shreefal Mehta does a great job of distilling tons of material down into a tight compact text that can be used as both a textbook and a reference guide. Everyone involved in the life sciences industries should have one copy on their desk and couple more on their office shelves to hand out. Highly recommended!
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Inside This Book
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Key Phrases - Statistically Improbable Phrases (SIPs):
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genomic health, reimbursement path, product commercialization plan, biomedical product development, first baseline visit, reimbursement planning, development plan rights, market research steps, device development process, referral chain, infused drugs, discrepancy investigation, medical specialty group, vitro devices, medical device design, quality system regulation, nucleic acid tests, predicate device, product development planning, biological drugs, biomedical products, biologic drugs, reimbursement process, adequate reimbursement Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Cosmetic Act, Angiotech Technology, Production Profits Industry Market Intellectual New, Regulatory Manufacture Reimbursement, Head Check, Biotechnology Industry Organization, Apple Computer, Marrow Tech, Code of Federal Regulations, Harvard Business School Press, Boston Scientific, Kalorama Information, Licensed Field of Use, Federal Food, Department of Justice, Social Security Act, Discovery Clinical Manufacture, Clinical Laboratory Improvement Amendments, Prentice Hall, Manufacturing Box, Apple Corps, European Union, Aspect Medical Systems, The Orange Book Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
genomic health, reimbursement path, product commercialization plan, biomedical product development, first baseline visit, reimbursement planning, development plan rights, market research steps, device development process, referral chain, infused drugs, discrepancy investigation, medical specialty group, vitro devices, medical device design, quality system regulation, nucleic acid tests, predicate device, product development planning, biological drugs, biomedical products, biologic drugs, reimbursement process, adequate reimbursement Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Cosmetic Act, Angiotech Technology, Production Profits Industry Market Intellectual New, Regulatory Manufacture Reimbursement, Head Check, Biotechnology Industry Organization, Apple Computer, Marrow Tech, Code of Federal Regulations, Harvard Business School Press, Boston Scientific, Kalorama Information, Licensed Field of Use, Federal Food, Department of Justice, Social Security Act, Discovery Clinical Manufacture, Clinical Laboratory Improvement Amendments, Prentice Hall, Manufacturing Box, Apple Corps, European Union, Aspect Medical Systems, The Orange Book Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Surprise Me!
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