Medical Device Design for Six Sigma
Medical Device Design for Six Sigma

Author: Basem El-Haik

Publisher: Wiley-Interscience

Published: 2008-04-25

Total Pages: 564

ISBN-13:

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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.

Six Sigma for Medical Device Design
Six Sigma for Medical Device Design

Author: Jose Justiniano

Publisher: CRC Press

Published: 2004-11-15

Total Pages: 152

ISBN-13: 0203485742

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For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Design for Six Sigma in Technology and Product Development
Design for Six Sigma in Technology and Product Development

Author: Clyde M. Creveling

Publisher: Prentice Hall Professional

Published: 2002-10-25

Total Pages: 1011

ISBN-13: 0132797240

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This book addresses many new topical areas for the development of 6 Sigma performance. The text is structured to demonstrate how 6 Sigma methods can be used as a very powerful tool within System Engineering and integration evaluations to help enable the process of Critical Parameter Management. The case studies and examples used throughout the book come from recent successful applications of the material developed in the text.

Applying Design for Six Sigma to Software and Hardware Systems
Applying Design for Six Sigma to Software and Hardware Systems

Author: Eric Maass

Publisher: Pearson Education

Published: 2009-08-19

Total Pages: 732

ISBN-13: 0137035918

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The Practical, Example-Rich Guide to Building Better Systems, Software, and Hardware with DFSS Design for Six Sigma (DFSS) offers engineers powerful opportunities to develop more successful systems, software, hardware, and processes. In Applying Design for Six Sigma to Software and Hardware Systems, two leading experts offer a realistic, step-by-step process for succeeding with DFSS. Their clear, start-to-finish roadmap is designed for successfully developing complex high-technology products and systems that require both software and hardware development. Drawing on their unsurpassed experience leading Six Sigma at Motorola, the authors cover the entire project lifecycle, from business case through scheduling, customer-driven requirements gathering through execution. They provide real-world examples for applying their techniques to software alone, hardware alone, and systems composed of both. Product developers will find proven job aids and specific guidance about what teams and team members need to do at every stage. Using this book’s integrated, systems approach, marketers, software professionals, and hardware developers can converge all their efforts on what really matters: addressing the customer’s true needs. Learn how to Ensure that your entire team shares a solid understanding of customer needs Define measurable critical parameters that reflect customer requirements Thoroughly assess business case risk and opportunity in the context of product roadmaps and portfolios Prioritize development decisions and scheduling in the face of resource constraints Flow critical parameters down to quantifiable, verifiable requirements for every sub-process, subsystem, and component Use predictive engineering and advanced optimization to build products that robustly handle variations in manufacturing and usage Verify system capabilities and reliability based on pilots or early production samples Master new statistical techniques for ensuring that supply chains deliver on time, with minimal inventory Choose the right DFSS tools, using the authors’ step-by-step flowchart If you’re an engineer involved in developing any new technology solution, this book will help you reflect the real Voice of the Customer, achieve better results faster, and eliminate fingerpointing. About the Web Site The accompanying Web site, sigmaexperts.com/dfss, provides an interactive DFSS flowchart, templates, exercises, examples, and tools.

Design for Six Sigma
Design for Six Sigma

Author: Elizabeth A. Cudney

Publisher: CRC Press

Published: 2016-08-05

Total Pages: 312

ISBN-13: 1315352079

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Design for Six Sigma (DFSS) is an innovative continuous improvement methodology for designing new products, processes, and services by integrating Lean and Six Sigma principles. This book will explain how the DFSS methodology is used to design robust products, processes, or services right the first time by using the voice of the customer to meet Six Sigma performance. Robust designs are insensitive to variation and provide consistent performance in the hands of the customer. DFSS is used to meet customer needs by understanding their requirements, considering current process capability, identifying and reducing gaps, and verifying predictions to develop a robust design. This book offers: Methodology on how to implement DFSS in various industries Practical examples of the use of DFSS Sustainability utilizing Lean Six Sigma techniques and Lean product development Innovative designs using DFSS with concept generation Case studies for implementing the DFSS methodology Design for Six Sigma (DFSS) enables organizations to develop innovative designs. In order to redesign an existing process or design a new process, the success is dependent on a rigorous process and methodology. DFSS ensures that there are minimal defects in the introduction of new products, processes, or services. The authors have compiled all of the tools necessary for implementation of a practical approach though innovation.

Design for Lean Six Sigma
Design for Lean Six Sigma

Author: Rajesh Jugulum

Publisher: John Wiley & Sons

Published: 2010-01-06

Total Pages: 321

ISBN-13: 0470631694

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Design for Lean Six Sigmais the only book that employs a "road-map" approach to DFSS, which allows corporate management to understand where they are in the process and to integrate DFSS methodology more fully into their overall business strategy. This is a similar approach to that used by Forrest Breyfogle in his successful book: "Implementing Six Sigma, 2E". This approach will allow corporate management to understand where they are in the process and to integrate DFSS methodology more fully into the overall business strategy. Another important aspect of this book is its coverage of DFSS implementation in a broad range of industries including service and manufacturing, plus the use of actual cases throughout.

Design for Six Sigma
Design for Six Sigma

Author: Greg Brue

Publisher: McGraw Hill Professional

Published: 2003-02-22

Total Pages: 209

ISBN-13: 0071425632

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THE BRIEFCASE BOOKS SERIEs Now translated into 11 languages! This reader-friendly, icon-rich series is must reading for all managers at every level All managers, whether brand new to their positions or well established in the corporate hierarchy, can use a little "brushing up" now and then. The skills-based Briefcase Books series is filled with ideas and strategies to help managers become more capable, efficient, effective, and valuable to their corporations. DESIGN FOR SIX SIGMA Six Sigma has revolutionized the ways in which companies meet and beat today's stringent quality expectations. But achieving Six Sigma results first requires Six Sigma building blocks. Design for Six Sigma unveils a systematic methodology for enabling the design of products, services, and processes to meet Six Sigma quality levels. Designed to be easily read and implemented, this concise Briefcase Book shows managers at all levels how to include Six Sigma at the earliest stages of virtually any manufacturing process. Here are DFSS's techniques for: Optimizing the design process to achieve Six Sigma performance Integrating Six Sigma from the outset of new product development Self-examinations, explanatory sidebars, and chapter-ending checklists

Service Design for Six Sigma
Service Design for Six Sigma

Author: Basem El-Haik

Publisher: John Wiley & Sons

Published: 2005-08-19

Total Pages: 300

ISBN-13: 0471744700

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A roadmap to consistent, high-quality service for anyorganization A service is typically something created to serve a payingcustomer, whether internal or external. Some services consist ofseveral processes linked together while others consist of a singleprocess. This book introduces Design for Six Sigma (DFSS), aneasy-to-master, yet highly effective data-driven method thatprevents defects in any type of service process. The particularfocus of this publication is service DFSS, which leads to what theauthors term "a whole quality business," one that takes a proactivestance and gets things right the first time. Not only does thewhole quality business produce a high-quality product and offerhigh-quality services, but it also operates at lower cost andhigher efficiency, throughout the entire life cycle, than itscompetitors because all the links in the supply chain areoptimized. Following a detailed overview that sets forth the basic premise andkey concepts of service DFSS, the authors offer all the informationand tools needed to take advantage of service DFSS within their ownorganizations, 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 andexecution process * Full discussions of all the key methods involved in service DFSS,including axiomatic design, design for X, the theory of inventiveproblem solving (TRIZ), transfer function, design scorecards, andTaguchi's method * Practical, illustrative examples that demonstrate how the theoryis put into practice * Assistance in developing the necessary skills in applying DFSS inorganizational settings Problems and their solutions are provided at the end of eachchapter to help readers grasp the key concepts they need to moveforward in the text. Acclaro DFSS Light(r), a Java-based softwarepackage that implements axiomatic design processes discussed inChapter Eight, is available for download from an accompanying Wileyftp site. Acclaro DFSS Light(r) is a software product of AxiomaticDesign Solutions, Inc. This book is ideal as a reference to service DFSS for corporateexecutives, quality control managers, and process engineers, or asa complete training manual for DFSS teams. It is also a superiortextbook for graduate students in management, operations, andquality assurance.

Reliable Design of Medical Devices
Reliable Design of Medical Devices

Author: Richard C. Fries

Publisher: CRC Press

Published: 2005-11-21

Total Pages: 490

ISBN-13: 1420027948

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As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Designing Usability into Medical Products
Designing Usability into Medical Products

Author: Michael E. Wiklund

Publisher: CRC Press

Published: 2005-02-11

Total Pages: 285

ISBN-13: 1040063756

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Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o