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.

‘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