Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This 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.

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.