Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

Basem S. El-Haik and Khalid S. Mekki, Wiley Interscience, 2008, 528 pp., $148.50 (book).

The title of this volume does not reflect the amount of material El-Haik and Mekki cover. The first four chapters provide grounding in the evolution of Six Sigma, global perspectives on medical device regulations, how to define quality in terms of medical devices and a thorough review of the basic statistical methods needed to understand the technical chapters that follow.

The authors have chosen to focus on the U.S. Food and Drug Administration (FDA) and the design controls related to FDA regulations. The book is exhaustive in describing the process of medical device design, starting with a description of the roles and responsibilities in deploying a Six Sigma medical device design team and discussing strategic and tactical methods used.

The middle chapters of the book focus on the project roadmap and phases of design for Six Sigma (DFSS), first from a high-level overview, proceeding to specific phases and then the seven lifecycle development stages. The reader moves to quality function deployment and how it is used to transfer customer needs into the design. This is important because the authors discuss sustainability issues and how to prevent problems from arising before the design becomes operational.

The last third of the book moves the reader through the most important aspects of risk management and how to translate the information in the book to a generic design template for continued robust design development and design verification before launching a product.

Finally, design review in light of federal regulations is discussed, and a case study is presented. An all-encompassing handbook for integrating Six Sigma and medical device design, this book would be a great addition to the bookshelves of technical staff in the medical device industry.

Reviewed by I. Elaine Allen
Babson College
Wesllesley, MA

Combination Products: Regulatory Challenges and Successful Product Development

Smita Gopalaswamy and Venky Gopalaswamy, CRC Press, 2008, 264 pp., $139.95 (book).

This book is an excellent summary and source of information for addressing the myriad issues involved in combination product (CP) development, regulation, quality control and pre and post launch. A CP is the integration of at least two FDA-regulated components: drugs, medical devices or biologics.

The authors provide practical and easy-to-understand product development approaches that can be used regardless of level of expertise. This book will be useful to anyone considering marketing any type of FDA-regulated product.

Each development scenario goes through the six domains of the lifecycle: innovation, customer needs, product function, design, processing and postmarketing with the appropriate modifications for the product type. A 360-degree viewpoint is used, and few aspects are not mentioned for consideration. Discussion of requirements is thorough and as direct as possible given the multiple product possibilities.

Particularly noteworthy are the voice of the customer analysis and DFSS cascade. Regulatory expectations are provided for each step for the United States, European Union, Canada, Japan, China and India, with guidance to the involved agencies’ departments and their interactions.

The table of contents, bibliography and index are well organized and make finding specific topics simple. Numerous tables summarize huge volumes of information in an easily understood and practical manner.

The authors have done a superb job of distilling their considerable years of experience and consulting work into an easy-to-read format. If there is anything to object to in this book, it is that while there are many examples given, the authors will never be able to cover each and every reader’s specific issues.

Each person responsible for a domain in the CP lifecycle should be required to read and have a copy of this book. It will definitely increase efficiency and eliminate a lot of wasted time spent searching for answers or direction.

Reviewed by Marc A. Feldman
Solvay Chemicals

100% Leadership: Guidelines To Be An Effective Leader

Gabriel Hevesi, with editors Tracy S. Epley and Collin R. Mcloughlin, Enna Inc., 2008, 150 pp., $21.99 (book).

Hevesi, a former managing partner of Brazil-based management consulting firm Target Ltd., draws on his 50-plus years of front-line business management experience in three countries to provide yet another guide to leadership that joins the already burgeoning library of works on this topic.

Hevesi organizes his material into 16 succinct, tersely cogent chapters on common leadership issues, such as communication, team building, planning and risk taking, efficiency, decision making and global business. His intent is to make the information useful, and he includes opposing systems, theories and opinions to provoke readers into thinking about the material and adjusting it to fit their own situations and help them solve their own problems.

Hevesi’s many years of first-hand responsibility in leadership positions help connect these ideas with readers who may have grown tired of the management-consultant psychobabble that, unfortunately, fills our shelves.

His sound ideas are well organized, and his concern for others bearing the burdens of leadership is genuinely evident. I recommend this book for anyone newly appointed to the role of management in any organization.

Reviewed by Dale Farris
Groves, TX

Achieving Class A Business Excellence: An Executive’s Perspective

Dennis Groves, Kevin Herbert and Jim Correll, 2008, John Wiley & Sons, 385 pp., $45 (book).

Greg Sanders is our hero in this fictitious story of a journey to lead a company using the book The Oliver Wight Class A Checklist for Business Excellence. Sanders is brought in to save a chronically ill cosmetic product division, which is failing in its customer service.

The whole story is a skillful description of the problems an executive encounters and how to deal with them while also trying to achieve class A status.

The class A concepts are introduced through coaching lectures and personal guidance by the character Roxanne Barnes, a consultant brought in to help this company.

Just like all fairy tales, Sanders guides the division to achieve class A status and is promoted to CEO.

The book is written from a top executive’s perspective, providing a solid roadmap on how to use integrated business management throughout conversion processes. The class A concepts provide another approach with the required strategy, information and tools to achieve class A status, filling in the gap Six Sigma does not adequately address. I recommend this book for all senior managers and Six Sigma practitioners.

Reviewed by Shin Ta Liu
Lynx Systems
San Diego

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