Biodesign

基本信息

Format:Hardback 952 pages, 67 Tables, black and white; 192 Halftones, color; 63 Line drawings, color

Publisher:Cambridge University Press

Imprint:Cambridge University Press

Edition:2 Revised edition

ISBN:9781107087354

Published:2 Feb 2015

Weight:2586g

Dimensions:286 x 232 x 44 (mm)

页面参数仅供参考，具体以实物为准

书籍简介

《Biodesign：医疗科技创新流程》是一本全球著名的“手册式”医疗科技创新和创业指南，展现了当今世界医疗科技创新全球化及价值导向的**趋势。全书由医学、工程和商业领域的知名专家一起编写，诠释了医疗科技的创新流程中发现问题和发明技术的过程，并*终如何通过创业实现价值创造而发挥作用。除了关于医疗科技创新的基本理论之外，全书还包括了近70个项目的案例研究，探索创业的成功之道与失败原由，并配有入门指南章节以帮助读者从真实的案例中学习和领悟。本书已经在全球100多所大学和研究机构使用，极大地促进了全球医疗科技领域的创新教育，希望此次中文版的出版也能推动中国医疗科技产业的创新和创业。

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 most relevant point in the text from within the ebook.

• A step-by-step guide to successful medical technology innovation, now in color, rewritten to reflect recent trends of 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

• Nearly seventy case studies on innovative products from around the world explore successes and failures, provide practical advice, and enable readers to learn from real projects

目录

Preface

Focus on value

Global perspectives

Process insights

Part I. Identify: Stage 1. Needs Finding:

1.1 Strategic focus

1.2 Needs exploration

1.3 Need statement development

Case study

Stage 2. Needs Screening:

2.1 Disease state fundamentals

2.2 Existing solutions

2.3 Stakeholder analysis

2.4 Market analysis

2.5 Needs selection

Case study

Part II. Invent: Stage 3. Concept Generation:

3.1 Ideation

3.2 Initial concept selection

Case study

Stage 4. Concept Screening:

4.1 Intellectual property basics

4.2 Regulatory basics

4.3 Reimbursement basics

4.4 Business models

4.5 Concept exploration and testing

4.6 Final concept selection

Case study

Part III. Implement: Stage 5. Strategy Development:

5.1 IP strategy

5.2 R&D strategy

5.3 Clinical strategy

5.4 Regulatory strategy

5.5 Quality management

5.6 Reimbursement strategy

5.7 Marketing and stakeholder strategy

5.8 Sales and distribution strategy

5.9 Competitive advantage and business strategy

Case study

Stage 6. Business Planning:

6.1 Operating plan and financial model

6.2 Strategy integration and communication

6.3 Funding approaches

6.4 Alternate pathways

Case study

About the author team

Image credits

Glossary

Index.

作者简介

Paul G. Yock, Stanford University, California

Paul Yock is the Weiland Professor and Founding Co-Chair of the Stanford Department of Bioengineering, with a joint appointment in Cardiovascular Medicine and courtesy appointments in Mechanical Engineering and Operations, Information, and Technology in the Graduate School of Business. He founded and directs the Program in Biodesign, a unit of Stanford's Bio-X initiative that focuses on invention and technology transfer related to biomedical engineering. He is internationally known for his work in inventing, developing, and testing new devices, including the Rapid Exchange™ angioplasty/stent system, which is now the primary system in use worldwide, and the Doppler-guided access system known as the Smart Needle™ and PD-Access™. Dr Yock has cofounded several medical technology companies, including Cardiovascular Imaging Systems, acquired by Boston Scientific.

Stefanos Zenios, Stanford University, California

Stefanos Zenios is the Charles A. Holloway Professor at the Graduate School of Business, Stanford University and the director of its Center for Entrepreneurial Studies. An innovative educator, he was the first to introduce courses on the interface between medicine, engineering, and management in the MBA curriculum, and he is the lead architect of Startup Garage, a popular experiential elective on forming new startups. His pioneering research on maximizing the benefits of medical technology to patients when resources are limited has influenced policies in the US and Europe. Dr Zenios is the co-founder of Konnectology.com, a website funded by the National Institutes of Health to help kidney patients find transplant centers.

Josh Makower, Stanford University, California

Josh Makower has dedicated his life to the creation of medical technologies that improve the quality of life for patients. He is the CEO and Founder of ExploraMed Development, LLC, a medical technology incubator, through which he has founded several healthcare companies, including Acclarent, acquired by J&J, TransVascular, acquired by Medtronic, EndoMatrix, and GI Reflux, acquired by C. R. Bard. He is also a Venture Partner with New Enterprise Associates, where he supports investing activity in the medical device arena. Dr Makower holds over 200 patents for medical devices in the fields of orthopedics, ENT, cardiology, general surgery, drug delivery, and urology. He serves as a Consulting Professor of Medicine at Stanford University Medical School and co-founded Stanford's Biodesign Innovation Program.

Todd J. Brinton, Stanford University, California

Todd J. Brinton is a Clinical Associate Professor of Medicine (Cardiovascular) and Consulting Associate Professor of Bioengineering at Stanford University. He is also an interventional cardiologist at the Stanford University Medical Center and the Palo Alto VA Hospital. His clinical practice focuses on general cardiovascular disease and complex coronary interventions. Dr Brinton is also a clinical investigator for new interventional-based therapies for coronary disease and heart failure. He has served as the Fellowship Director for the Biodesign Program since 2006, through which he has mentored numerous innovators in the biodesign innovation process. He also serves as the co-director of the graduate courses in Biodesign Innovation and the Biodesign Executive Education Program at Stanford. He is co-founder of BioParadox and Shockwave Medical, both venture-backed medical device companies, where he is a member of the board of directors and directs clinical development and strategy.

Uday N. Kumar, Stanford University, California

Uday N. Kumar is the Founder, President and CEO of Element Science, Inc., a company focused on the treatment of sudden cardiac death, that he started during his time as an Entrepreneur-in-Residence at Third Rock Ventures, LLC. He also is a co-founder and board member of Qurious.io, Inc., a healthcare information technology company, a co-founder and board member of Sympara Medical, Inc., a company developing a novel therapy for hypertension, and the founder of iRhythm Technologies, Inc., a company focused on developing cost-effective new devices and systems for cardiac rhythm monitoring. He served as a board member and Chief Medical Officer of iRhythm from founding through broad commercialization of its Zio® Patch cardiac monitoring device. Dr Kumar currently serves as a Consulting Associate Professor of Bioengineering at Stanford University and is the Fellowship Director of Stanford's Global Biodesign Programs.

F. T. Jay Watkins, De Novo Ventures, California

Jay Watkins has extensive experience founding and funding healthcare companies. He is a Managing Director with De Novo Ventures and an active individual investor and advisor to emerging medtech companies. He serves as a Lecturer in Management at the Graduate School of Business, Stanford University. Previously, Mr Watkins was on the Guidant management committee and served as president of several divisions, including the Minimally Invasive Surgery Group, and Heart Rhythm Technologies. While President of the Cardiac and Vascular Surgery Group, he initiated the development of a minimally invasive vein harvesting technology, which has been used to treat almost two million patients worldwide. He also has served as an executive with multiple start-up companies, a consultant with McKinsey and Company, and co-founder and founding CEO of Origin Medsystems, a venture funded medical technology start-up acquired by Eli Lilly and Company.

Lyn Denend, Stanford University, California

Lyn Denend is the Associate Director for Curriculum of the Biodesign Program at Stanford University, responsible for the development of written and multimedia curricular materials to support Biodesign courses and initiatives. Previously, Ms Denend worked at the Stanford Graduate School of Business (GSB) as the staff director for the school's Program in Healthcare Innovation, where she specialized in research related to the challenges of global health innovation. She also authored a variety of papers and teaching materials as part of the GSB case writing office. Prior to joining the Stanford community, Ms Denend was a management consultant with Cap Gemini Ernst and Young.

Thomas M. Krummel, Stanford University School of Medicine, California

Thomas M. Krummel is Professor/Chair, Department of Surgery at Stanford University. He has served in leadership positions in all of the important surgical societies, has mentored over 200 students, residents, and postdocs, and is the recipient of more than $3 million in research grants. He is Co-Director of the Stanford Biodesign Program. Dr Krummel has been a pioneer and innovator throughout his career. He has received two Smithsonian Information Technology Innovation Awards for work in the application of information technology to simulation-based surgical training and robotics. He remains an active start-up consultant with three successful exits and nine in the pipeline.

Christine Q. Kurihara, Stanford University, California

Christine Q. Kurihara is Senior Associate Director of Global and Communication for the Biodesign Program at Stanford University, responsible for overseeing the Biodesign Global Fellowship Programs, global relationships, and providing support to Stanford students, fellows, and faculty working on device projects based on global needs. She also manages all IT, web projects, marketing, and communications for the program. Ms Kurihara joined Biodesign after an 11-year career with Stanford in the area of media services. In her previous role, she spearheaded media development efforts for an on-campus service unit, where her team produced websites, online courseware, video and broadcast products. Prior to running Media Solutions, she coordinated the first Stanford University website.