Reliable Design of Medical Devices (Third Edition)

Abstract

If you develop medical devices, you will like Reliable Design of Medical Devices (Third Edition). Don't let the name fool you—this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions.The book also covers related topics, such as risk management, regulations from the U.S. Food and Drug Administration, and the Medical Device Directive. These chapters are particularly useful for developers who already know product design processes, but do not know the regulatory requirements placed on medical devices.Audience: This book is suitable for product development teams. Multiple disciplines are covered: mechanical, electrical, software, human factors, and reliability. In addition, it covers requirements management and even project management.Assessment: There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered. An example can be found in Chapter 3, regarding planning. In this discussion, every phase of the process ends with a bullet point of “document everything.” Rather than simply saying “document everything” once in the narrative, the author reinforces this point at every step.This book also covers topics that are typically not addressed, such as product liability and protecting intellectual property, and it includes discussions about the importance of a good team in project success.Reliable Design of Medical Devices isn't the type of book that you sit down with and read cover to cover. Rather, it is best used as a reference for those new to medical device product development, as well as for a team grappling with a particular issue. Each chapter has a bibliography for additional reading.In terms of easily finding the advice and information you need, the index will prove to be helpful because the chapter titles don't always indicate all that is included within a particular chapter. For example, the discussion about regulatory requirements is found in the chapter on feasibility. To be clear, I'm not faulting the book—there is a lot of information to convey, and there is no single best way to organize that information. Just know that in the few months I've been using the book, I found it most useful to use the index to direct me, rather than flip through the pages hunting for a particular topic.There are some improvements that I would like to see in the next revision to make the book even more useful. For example, the human factors section is mostly about ergonomics, and there is no mention of the existing body of knowledge that has been captured in IEC 62366 and HE 75, and there are no pointers to professional societies such as the Human Factors and Ergonomics Society. Chapter 18 is a repeat of Chapter 5, almost word for word. Unfortunately, the topic of change control is missing from the book.Assessment: This book is like having a product development consultant on your bookshelf, sharing his experience on what does and does not work. The breadth of knowledge is considerable: the table of contents alone is 19 pages long. This book is a good starting point for a wide variety of topics, and if you treat it like a reference book, it will serve you well.