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.
1. The biomedical device and drug industry and their markets learning points; 2. Markets of interest and market research steps learning points; 3. Starting up your company; 4. Intellectual property and licensing; 5. New product development (NPD); 6. The regulated market: gateway through the FDA learning points; 7. Manufacturing; 8. Reimbursement, marketing, sales, and product liability learning points.
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