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This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly one hundred videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the mo

本書詳細闡述了藥品和醫療器械等生物醫學產品的研發和產業化流程，包括市場分析、產品開發、知識產權保護，以及法規註冊等方面的要求。本書還提供了豐富的案例，重點解讀每一步的研發流程。本書將有助於生物科技領域的工程技術和商務人員高效地規劃相關產品的產業化進程，同時也可以作為生物醫學工程專業的關鍵課程教材，提供產品開發和商務開拓領域的必備技能。