Abstract
The development of a medical device is a complex process. It requires the integration of a range of diverse disciplines, activities, and regulatory requirements, all of which must be achieved to ensure that the final result is a safe, effective and competitive product.
While much of the information required in the process of device development is already in the pubic domain, it is scattered throughout many documents and not easily assimilated by the busy design engineer. The author of this recently published volume, an employee of a major medical equipment manufacturing company, is clearly aware of the problem. He has used his extensive experience of the process to bring together the necessary information in a convenient and easily accessible format.
The subject material is presented in some twenty-eight chapters, dealing in turn with the basic concepts of reliability, medical device regulation and standards, product specification and definition, testing and data analysis, and a discussion of issues around manufacturing and maintenance. The style is highly structured and concise, with extensive use of bullet points and tables. There is considerable emphasis on the problems associated with the use of software in medical devices, a subject currently receiving much attention as we approach the millennium. Each chapter includes a useful list of source material, although the specific contribution of each is not always made clear.
This book will appeal to designers of medical equipment as it contains a wealth of both factual information and guidance on how to apply it. At one point the author discusses the role that trade secrets play in protecting competitive advantage; perhaps in writing a book such this he has disregarded his own advice.