TESTIMONIALS

‘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, Chief Scientific Officer and co-founder of Sequenom, Inc., Professor Emeritus of Biomedical Engineering at Boston University and the Director of the Center for Advanced Biotechnology at Boston Univ.

“This is one of my go-to resources to better understand biomed tech dynamics”

• Brian Nickerson, Senior Associate Dean, Icahn School of Medicine Mt Sinai and Senior Evaluation Lead, Institute of Translational Sciences (NIH CTSA)

“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, serial entrepreneur and co-founder of The Foundry

“The book covers all the things that matter but are never written down in a comprehensive text.”

• Carmichael Roberts, CoFounder and Partner, Material Impact, previously Northbridge Partners, serial entrepreneur, Board member and trustee at Duke University Health System, Chairman of the Board of the Consumer Technology Association, 2022.

“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. This book won’t write your business plan for you but will give you the questions to ask when you initiate disclosures to your university’s Technology Transfer office. Highly recommended.”

• reviewer on Amazon.com

“We have used this text at the University at Buffalo School of Management Center for Entrepreneurial Leadership in a program called High Tech CEL. 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. 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!”

• H. Ulbrich, review on Amazon.com

“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!”

• James Mullen, Exec Chair at Editas Medicine, past CEO of Biogen-Idec, Patheon and past President of the Biotechnology Industry Organization

“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

“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 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, (previously) Vice President, Health Economics & Reimbursement, Boston Scientific

“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, Ex-VP Research at ThermoFisher, Global Technology Leader, Biosciences, General Electric Global Research Center

“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

“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