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.

Transform your ideas into commercial products through this updated second edition, with real-world case studies and industry tips.

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

This guide is written for biomedical innovators seeking to improve the lives of patients by translating innovative technologies into medical technologies. The contents are focused primarily on business principles that have been distilled from hundreds of projects as part of the Coulter Foundation's Translational Partners Program and Coulter Translational Reward Awards. To date, the Foundation has funded more than 600 projects, which in the first 11 years have raised close to $6 billion in funding.The course Concept to Clinic: Commercializing Innovation (C3i), offered by the National Institutes of Health (NIH), forms the basis of this Guide. This course has helped hundreds of university innovators, engineers, clinicians, and scientists learn how to commercialize the technologies they have developed in a very demanding market. The C3i program is based on the Coulter commercialization process, an approach to biomedical research translation developed and continuously refined by the Foundation in collaboration with its academic partners across the country.

This guide is written for biomedical innovators seeking to improve the lives of patients bytranslating innovative technologies into medical technologies. The contents are focusedprimarily on business principles that have been distilled from hundreds of projects as part ofthe Coulter Foundation's Translational Partners Program and Coulter Translational RewardAwards. To date, the Foundation has funded more than 600 projects, which in the first 11 yearshave raised close to $6 billion in funding.The course Concept to Clinic: Commercializing Innovation (C3i), offered by the NationalInstitutes of Health (NIH), forms the basis of this Guide. This course has helped hundredsof university innovators, engineers, clinicians, and scientists learn how to commercialize thetechnologies they have developed in a very demanding market. The C3i program is basedon the Coulter commercialization process, an approach to biomedical research translationdeveloped and continuously refined by the Foundation in collaboration with its academicpartners across the country.