Medical Device Design for Six Sigma: A Road Map for Safety and EffectivenessBasem S. El-Haik, Khalid S. Mekki. Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness . John Wiley & Sons, Inc.. 2008. 525$112.00. ISBN: 978-0-470-16861-5.

Abstract

Six sigma has a long history outside of healthcare. As a measurement standard, it can be traced back to the 1920s, when Walter Shewhart demonstrated that three sigma from the mean is the point where a process requires correction. Since then, many global companies have adopted the six sigma principles, successfully improving processes and gaining significant financial benefits. Over the past few years, six sigma started to find its place in the healthcare environment, addressing some of the most common challenges, such as patient safety, market growth, resource utilization, and technology optimization, as well as medical device design.As Medical Device Design for Six Sigma addresses the application of six sigma principles to medical device design, it provides a platform for creating a safe and effective healthcare environment for everyone who comes in contact with medical devices. The book does a wonderful job addressing these underlying principles in an academic approach, as opposed to a practical, hands-on approach that clinical engineers (CEs) and biomedical equipment technicians (BMETs) would be engaged in on a daily basis and thus benefit from most.Audience: The book covers a wide range of topics on creating the necessary foundations for better medical device design, and CEs working in product research and development, quality six sigma professionals, and others in related fields will be able to reap the most benefits. The book's review of the six sigma principles provides a solid base for identifying and later implementing improvement strategies that are related to systems and processes involving medical equipment in a hospital environment. Examples could include alarm communication via medical wireless telemetry between technicians and nursing staff, and radio frequency identification (RFID) operations to monitor where patients are located and what the status of their treatment is in an emergency care department.Features: The book presents a good overview of the design for six sigma (DFSS) methodologies and emphasizes the need to integrate the appropriate methodologies early on in the medical device development cycle to reap potential benefits.Chapters 5–8 provide an interesting description of the DFSS process, including deploying the process as related to medical devices and the necessary tools to ensure successful outcomes. In some healthcare institutions, CEs and BMETs get involved in process improvement initiatives; thus, this content could still be relevant and applicable beyond just medical device design.The remaining chapters of the book cover theoretical approaches to six sigma with a multitude of mathematical equations and case studies that do not necessarily have a direct correlation with medical devices used in hospitals. The concluding case study is probably one of the better studies in the book in terms of its applicability to medical devices used in hospitals, though it is again rich in mathematical and statistical assessment. The glossary on DFSS terminology is very helpful and a good addition to the book.Assessment: The book is a long and often difficult read due to its high percentage of theoretical content to illustrate the six sigma principles, making it more suitable as an academic textbook or reference for engineers working in product development, process improvement, or quality. Between the theory, equations, and other statistical and mathematical complexities, the book includes some interesting case studies on medical devices, but not all are directly applicable to medical devices used by CEs and BMETs on a regular basis. Putting some of the theoretical complexities aside, the book provides valuable material on the application of six sigma to support the medical device development cycle.