Editorial Review:

Product Description:
Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at ebiodesign.org.

This is the most comprehensive text I've found in the area of medical device development. I'm often approached by surgeons who are interested in inventing medical devices, and they often lack the business acumen and intellectual property knowledge to make the best decisions. Now I have a resource to direct them to so they protect their interests and drive their inventions to commercialization themselves, without having to rely on someone at a large corporation to give their invention a go/nogo.

Average Rating:

Rating: - A must for any medical device professional
This is the most comprehensive text I've found in the area of medical device development. I'm often approached by surgeons who are interested in inventing medical devices, and they often lack the business acumen and intellectual property knowledge to make the best decisions. Now I have a resource to direct them to so they protect their interests and drive their inventions to commercialization themselves, without having to rely on someone at a large corporation to give their invention a go/nogo.

Rating: - If you are a medical device designer you need this book
This is a book that compiles the most up-to-date and relevant knowledge, gained by real experience, on how to innovate medical devices, by luminaries in the medical device field. This book will save you many multiples of the purchase price in its leading edge insights, and avoided trial-and-error. Ted Kucklick, author, The Medical Device R&D Handbook

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Rating: - A must-have roadmap for aspiring medical device entrepreneurs!
I had the fortune of getting a beta version of this book a year ago. As a surgical resident, I was frustrated daily by the inadequacy of available treatments for patients and shocked by the archaic ways we often deliver health care. I jotted down many ideas and vowed to do better. But, with no business background, the process of taking an idea from concept to market was...scary. My fears were alleviated after reading this book.

Biodesign is more like a worn treasure map - highlighting where some have succeeded and where many others have failed - than a stuffy reference manual. The real-world case studies are particularly illustrative and the collection - compiled over decades - is comprehensive. Each reads like a good short story - filled with complex characters, tense situations, and many satisfying "Ah ha!" moments.

Read it, and the daunting process of medical device innovation will become more tangible. For clinicians struggling to find better solutions for their patients, this book enables them to finally see their ideas to fruition. For engineers, the book demystifies the complex inner workings of the medical device arena. For aspiring entrepreneurs from any background, it lays out in concrete detail all the critical steps one must take during the process of innovating medical technologies - from identifying the unmet clinical need, to evaluating market opportunities, understanding intellectual property, regulatory and reimbursement hurdles, to finding funding and devising a successful business strategy.
This is a unique and incredible resource. I highly recommend it to anyone.

Kevin Chao, MD

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Rating: - Fundamental resource for medical device engineers
As a medical device engineer with experience at both small and large companies, I was skeptical whether one text could be considered a go-to reference for medical device design. After a year of of experience with the beta version of this text, my doubts were allayed. The text is thoughtfully and logically laid out in a step by step approach to designing medical devices. One particularly unique aspect of this book, is that it provides a well-balanced blend of medicine, business and engineering in its approach. This is largely due to the extensive experience of its authors and their collaboration in its creation. The case studies provided in each chapter provide "hands-on" examples of the key information. For me, I found these sections the most interesting and the most inspiring to read. I found myself reading the case studies first and then going back through the rest of the chapter text to pull out additional information.

As I have found with only a handful of my engineering texts ( admittedly, I have shelved my Vector Calculus and PChem texts), I find myself constantly pulling this text off my shelf and referring to it--particularly for the extensive list of resources that are included at the end of each chapter. It has taken so much of the guess work and internet searching out of the equation!

There are so many unknowns and potential pitfalls in the development of medical devices. This text is a key tool to entrepreneurs who would like to avoid and/or prepare for as many of these unknowns as possible!

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Rating: - Essential text for medical devices entrepreneurs and innovators
I am a recent graduate of the Stanford Graduate Student of Business and have worked in the life sciences industry for many years. While at the GSB, I took the 2-quarter BioDesign class which used a beta version of this book as its text. The course - and text - has a rather ambitious aim, namely to explore the medtech entrepreneurial and innovation process and to do so in a cross-functional, comprehensive, and hands-on fashion. As one of the more popular courses at Stanford and one that has resulted in numerous new VC-funded start-ups, I think they have succeeded in this goal.

More so than entrepreneurialism in other industries, starting a new business in medical devices requires bringing together many disciplines and functions, including engineering, medicine, and business. This book takes this comprehensive view of the process. You'll learn about:

* Medical - learn about the clinical trials process for medical devices (e.g. 510k / PMA) ... learn how to put together a clinical development plan & clinical trials plan

* Engineering - learn about prototyping, produce concept definitions, R&D strategy

* Business - learn about doing a market assessment ... how to put together a reimbursement strategy ... how to do a marketing & business plan ... how build your financial models

But more than just looking at the individual disciplines, this text looks at the innovation *process*. That is, it walks through idea/concept creation and screening, researching new clinical need areas, and important early due diligence (i.e. IP searches, researching unmet medical needs, doing a stakeholder analysis). Then, once you have your concept it takes you through developing your early prototype and putting together a development and business plan. Next, it discusses how you will want to go about pitching this to VCs and obtaining funding to implement your product. And finally, it touches on operation issues and exits once your product is launched.

The book is highly readable and is accessible to a wide range of backgrounds and knowledge levels. This is because it was designed to be a text for a course that was taken by b-school students, engineering graduate students, and med school students. Additionally it is very hands-on, and discusses the tangible *things* that need to be done as you go through the start-up innovation process, and includes numerous case studies. Some chapters are rather dense but these can be skimmed until you actual need to reference the material.

On caveat is that, while I think this text can be relevant for people that are interested in innovation and start-ups in biotech or other areas of life sciences, it is clearly targeted to medical devices & medtech.

Being a successful entrepreneur in medical devices requires a thorough understanding of each of these steps in the innovation process and all of the cross-functional disciplines that are involved in bringing a new innovation to market and to patients. This textbook understands this and tackles this topic with that principle in mind.

Related Items:

The Business of Healthcare Innovation

Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices

The Medical Device R&D Handbook

What I Wish I Knew When I Was 20: A Crash Course on Making Your Place in the World

Change by Design: How Design Thinking Transforms Organizations and Inspires Innovation