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The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide: Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process for each DFSS tool included Covers the structural, organizational, and technical deployment of DFSS within the medical device industry Includes a DFSS case study describing the development of a new device Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.

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Medical Device Design for Six Sigma

A roadmap to consistent, high-quality service for any organization A service is typically something created to serve a paying customer, whether internal or external. Some services consist of several processes linked together while others consist of a single process. This book introduces Design for Six Sigma (DFSS), an easy-to-master, yet highly effective data-driven method that prevents defects in any type of service process. The particular focus of this publication is service DFSS, which leads to what the authors term «a whole quality business,» one that takes a proactive stance and gets things right the first time. Not only does the whole quality business produce a high-quality product and offer high-quality services, but it also operates at lower cost and higher efficiency, throughout the entire life cycle, than its competitors because all the links in the supply chain are optimized. Following a detailed overview that sets forth the basic premise and key concepts of service DFSS, the authors offer all the information and tools needed to take advantage of service DFSS within their own organizations, including: * Clear and in-depth coverage of the philosophical, organizational, and technical aspects of service DFSS * Step-by-step roadmap of the entire service DFSS deployment and execution process * Full discussions of all the key methods involved in service DFSS, including axiomatic design, design for X, the theory of inventive problem solving (TRIZ), transfer function, design scorecards, and Taguchi's method * Practical, illustrative examples that demonstrate how the theory is put into practice * Assistance in developing the necessary skills in applying DFSS in organizational settings Problems and their solutions are provided at the end of each chapter to help readers grasp the key concepts they need to move forward in the text. Acclaro DFSS Light(r), a Java-based software package that implements axiomatic design processes discussed in Chapter Eight, is available for download from an accompanying Wiley ftp site. Acclaro DFSS Light(r) is a software product of Axiomatic Design Solutions, Inc. This book is ideal as a reference to service DFSS for corporate executives, quality control managers, and process engineers, or as a complete training manual for DFSS teams. It is also a superior textbook for graduate students in management, operations, and quality assurance.

Service Design for Six Sigma

The first book to integrate axiomatic design and robust design for a comprehensive quality approach As the adoption of quality methods grows across various industries, its implementation is challenged by situations where statistical tools are inadequate, yet the earlier a proactive quality system is introduced into a given process, the greater the payback these methods will yield. Axiomatic Quality brings together two well-established theories, axiomatic design and robust design, to eliminate or reduce both conceptual and operational weaknesses. Providing a complete framework for immediate implementation, this book guides design teams in producing systems that operate at high-quality levels for each of their design requirements. And it shows the way towards achieving the Six-Sigma target–six times the standard deviation contained between the target and each side of the specification limits–for each requirement. This book develops an aggressive axiomatic quality approach that: * Provides the tools to reduce conceptual weaknesses of systems using a framework called the conceptual design for capability * Reduces operational weaknesses of systems in terms of quality losses and control costs * Uses mathematical relationships to bridge the gap between science-based engineering and quality methods Acclaro DFSS Light, a Java-based software package that implements axiomatic design processes, is available for download from a Wiley ftp site. Acclaro DFSS Light is a software product of Axiomatic Design Solutions, Inc. Laying out a comprehensive approach while working through each aspect of its implementation, Axiomatic Quality is an essential resource for managers, engineers, and other professionals who want to successfully deploy the most advanced methodology to tackle system weaknesses and improve quality.

Basem El-Haik