Medical Device Link.

WEB EXCLUSIVE: BOOK REVIEW

The objective of this book is to describe the principles, methodologies, and deployment of design for Six Sigma (DfSS) and to illustrate how DfSS can be used in the medical device industry. As the authors claim, this is the first book that attempts to provide a road map and relationship between design for Six Sigma and medical device design and development. The main focus of this book is design and is geared toward those working in research and development as well as design and engineering. It is written for an intermediate to an advanced audience. Basic knowledge in statistical techniques and analysis is required. The book covers two main topics: 1) quality and medical device regulations and 2) design for Six Sigma.

Quality and Medical Device Regulations. The first couple of chapters begin with an overview and chronology of quality and an explanation of the medical device regulations (21 CFR Part 820, Quality Systems Regulation, and ISO 13485, Medical Devices—Quality Management Systems). In Chapter 2, there is a nice matrix describing the relationship between the regulations, a typical product development life cycle, and design for Six Sigma. The last three chapters describe the latter stages of medical device design with respect to the regulations, from verifying and validating a design to design changes, and finally design transfer to operations.

Design for Six Sigma. Sandwiched in between the chapters on the regulations is a description of the design for Six Sigma process. These chapters can be read almost exclusively by anyone who needs to understand the DfSS process, principles, methodologies, and tools used for the design and development of any product. The authors detail their DfSS process, which they term ICOV (Identify, Characterize, Optimize, Verify/Validate): identifying the user and customer needs, developing concepts and characterizing the design, optimizing the design, and finally verifying and validating the design. Standard tools like quality function deployment (QFD), axiomatic design, TRIZ (the Russian acronym for theory of inventive problem solving), and risk analysis are covered in separate chapters. The book also contains chapters on basic statistics, design of experiments, tolerance design, and robust parameter design with a few medical device examples. Diagrams, flow charts, tables, and mathematical equations illustrate the concepts quite well. The last chapter provides a high-level case study of a medical device design from product requirements to design verification.

This book is a useful reference for practitioners involved in the design and development of products and devices. It is not written to be a how-to book and does not provide the reader with a step-by-step approach on how to apply the DfSS tools in medical device design. The flow between chapters to illustrate the relationship between the DfSS principles and medical device design, quality, and regulations could have been better organized. However, the book succeeds in providing an excellent overview of design for Six Sigma methodologies and has made a worthy attempt to show the importance and value of this process in the medical device industry.

Published by Wiley (Hoboken, NJ); Price: $140.00; ISBN: 0470168617.