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Doody's Review ServiceReviewer: James K Plemmons, PhD (The Citadel)
Description: This comprehensive book covers the full spectrum of activities associated with medical device design. With a focus on development, the authors address the specific steps needed to obtain absolute excellence in the design of medical devices using the proactive design for six sigma (DFSS) methodology of identify, characterize, optimize, and verify/validate (ICOV). In addition, many powerful process tools and techniques are introduced to increase the effectiveness of ICOV, including axiomatic design, design of X, theory of inventive problem solving (TRIZ), and transfer function and score cards.
Purpose: This book provides the philosophical, organizational, and technical aspects of delivering medical device quality by understanding and following best known practices. The deployment and execution processes associated with medical device DFSS are provided in great detail with examples, tables, and figures. Each phase of the medical device DFSS roadmap is presented with a detailed step-by-step implementation for the methods commonly associated with medical device DFSS. This book exceeds any expectations users or medical device firms might have in implementing medical device DFSS.
Audience: It is intended for individuals or medical device design teams seeking a superior development process, from idea generation to the finished product and use by the customer. Although intended for medical industry professionals, this is an extremely useful book for anyone seeking seeing to understand or to improve their own medical device design processes.
Features: Chapters include a historical scan of DMAIC methodology and medical device quality, followed by the fundamentals, deployment, and implementation of a DFSS project roadmap. There is extensive coverage of the ICOV phases at a high level using the seven life-cycle development stages of idea creation, voice of the customer and business, concept development, preliminary design, design optimization, verification, and launch readiness. The concluding chapters build upon this by adding innovative problem-solving methods, incorporating risk management and robust design techniques into the medical device DFSS development process, and institutionalizing DFSS knowledge and design change control. The final chapter presents a case study on the development of an automatic dissolving and dosing device (Auto 3D).
Assessment: The book is well written and the authors use well versed descriptions, easy to read figures and tables, and industry-related examples and case studies to explain what can be very complex concepts and processes. This book would be a valuable resource for anyone in the field of medical device design.