Overview

Transform your research into commercial biomedical products with this revised and updated second edition. Covering drugs, devices and diagnostics, this book provides a step-by-step introduction to the process of commercialization, and will allow you to create a realistic business plan to develop your ideas into approved biomedical technologies. This new edition includes: Over 25% new material, including practical tips on startup creation from experienced entrepreneurs. Tools for starting, growing and managing a new venture, including business planning and commercial strategy, pitching investors, and managing operations. Global real-world case studies, including emerging technologies such as regulated medical software and Artificial Intelligence (AI), offer insights into key challenges and help illustrate complex points. Tips and operational tools from established industry insiders, suitable for graduate students and new biomedical entrepreneurs.

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9781316510063

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Reviews

'The first edition of the book was one of the first textbooks related to commercialization of biomedical products and it also provided the most comprehensive coverage related to this topic at the time. This second edition is a timely update of this work and also includes content related to starting new ventures.' Juergen Hahn, Professor and Department Head, Department of Biomedical Engineering, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute and Leader of the Biomedical Engineering Society's Council of Chairs 2023 'This long-awaited 2nd edition is a must-read for anyone wishing to successfully lead, manage and support the highly regulated development process for biomedical innovation. The book illustrates in a systematic and structured way the technical and business aspects required for the commercialization of new biomedical technologies. Read this book - and learn from one of the best!' Heidrun Flaadt Cervini, Director and Founder of Center of Advanced Studies on Entrepreneurship in BioMedicine (CASE BioMed), Università della Svizzera italiana, Lugano, Switzerland 'Bringing early-stage life science innovations from the lab to the market, and into the hands of patients, is both critically important and fraught with risk. This book is a comprehensive resource that should help many of these innovations cross the so-called 'valley of death' more quickly and effectively.' Orin Herskowitz, Senior Vice President for Applied Innovation and Industry Partnerships for Columbia University, Executive Director of Columbia Technology Ventures (CTV) and Adjunct Professor at Columbia's Business and Engineering Schools 'It was thrilling to see that a book of this nature and sophistication exists. I wish I had been able to read it before I transitioned from academia to the private sector. It should be required reading for anyone thinking of starting a biotechnology company, and it is a useful reference for many of the subtleties and complexities of this industry that most participants in the past have had to learn from the school of hard knocks.' Charles Cantor, Professor Emeritus, University of Boston

'The first edition of the book was one of the first textbooks related to commercialization of biomedical products and it also provided the most comprehensive coverage related to this topic at the time. This second edition is a timely update of this work and also includes content related to starting new ventures.' Juergen Hahn, Professor and Department Head, Department of Biomedical Engineering, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute and Leader of the Biomedical Engineering Society's Council of Chairs 2023 'This long-awaited 2nd edition is a must-read for anyone wishing to successfully lead, manage and support the highly regulated development process for biomedical innovation. The book illustrates in a systematic and structured way the technical and business aspects required for the commercialization of new biomedical technologies. Read this book - and learn from one of the best!' Heidrun Flaadt Cervini, Director and Founder of Center of Advanced Studies on Entrepreneurship in BioMedicine (CASE BioMed), Universita della Svizzera italiana, Lugano, Switzerland 'Bringing early-stage life science innovations from the lab to the market, and into the hands of patients, is both critically important and fraught with risk. This book is a comprehensive resource that should help many of these innovations cross the so-called 'valley of death' more quickly and effectively.' Orin Herskowitz, Senior Vice President for Applied Innovation and Industry Partnerships for Columbia University, Executive Director of Columbia Technology Ventures (CTV) and Adjunct Professor at Columbia's Business and Engineering Schools 'It was thrilling to see that a book of this nature and sophistication exists. I wish I had been able to read it before I transitioned from academia to the private sector. It should be required reading for anyone thinking of starting a biotechnology company, and it is a useful reference for many of the subtleties and complexities of this industry that most participants in the past have had to learn from the school of hard knocks.' Charles Cantor, Professor Emeritus, University of Boston

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 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 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 entrepreneurs 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 '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 '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) ???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 ???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) 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 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 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 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 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. 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 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 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 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 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 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 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

Author Information

Shreefal Mehta is Executive Chair of Pulmokine Inc, Entrepreneur in Residence at the Lally Center for Technological Entrepreneurship, Rensselaer Polytechnic Institute, and Visiting Faculty at Center of Advanced Studies on Entrepreneurship in BioMedicine (CASE BioMed) Universita Svizzeria Itialia.

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