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本书是一本介绍医疗器械创新全流程的简明读本,是被广泛用于该领域研究的第一本教科书。本书是在商业、生理学、教育学和设计学领域的专家以及举世闻名的美国明尼苏达大学医疗器械中心的支持下共同完成的。

 

本书从创新机会的发现到样机制作再到台架试验、动物试验以及临床试验,从市场调研到筹集资金再到产品推介,从上市前审批申报到如何纳入医保系统再到上市后监管,从创意笔记到知识产权战略再到商业计划书,包含了工程技术、临床医学、经济学、管理学、法规等众多知识,向读者介绍了医疗器械创新最终取得成功所需要的全部要素,能让读者快速捕捉到自己知识体系的缺失。

 

 

Introduction

The Medical Device Innovation Handbook is a concise introduction to medical device innovation. It is widely used as the first textbook in the study of the field. The book was developed by its authors with support experts in business, in physiology, in education, and in design, and by the world-famous Earl E. Bakken Medical Devices Center at the University of Minnesota.

 

The Medical Device Innovation Handbook is unique in that it introduces its readers to the entire spectrum of elements required to make an innovative new medical device come to a successful end result: producing good therapeutic results for patients and commercial success for its inventors. That is, the book covers the design process, the development process, research in disease states, business assessments, market research, prototyping and bench testing, patenting, clinical trials, Good Clinical Practice, regulatory pathways, insurance reimbursement lanes, and obtaining funding to bring the products into commercial production. No other book attempts to cover the entire life-cycle of medical device development.


医疗器械的临床需求发现与创新流程培训系列课程已开设,详询联系人:沈女士15601753091,同微信。