Six Sigma for Medical Device Design

Six Sigma for Medical Device Design
Author: Jose Justiniano
Publisher: CRC Press
Total Pages: 152
Release: 2004-11-15
Genre: Science
ISBN: 0203485742

Download Six Sigma for Medical Device Design Book in PDF, Epub and Kindle

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

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
Author: Basem El-Haik
Publisher: John Wiley & Sons
Total Pages: 556
Release: 2011-09-20
Genre: Medical
ISBN: 1118210417

Download Medical Device Design for Six Sigma Book in PDF, Epub and Kindle

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.

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
Total Pages: 732
Release: 2009-08-19
Genre:
ISBN: 0137035918

Download Applying Design for Six Sigma to Software and Hardware Systems Book in PDF, Epub and Kindle

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 in Technology and Product Development

Design for Six Sigma in Technology and Product Development
Author: Clyde M. Creveling
Publisher: Prentice Hall Professional
Total Pages: 1011
Release: 2002-10-25
Genre: Technology & Engineering
ISBN: 0132797240

Download Design for Six Sigma in Technology and Product Development Book in PDF, Epub and Kindle

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.

Design for Six Sigma

Design for Six Sigma
Author: Elizabeth A. Cudney
Publisher: CRC Press
Total Pages: 312
Release: 2016-08-05
Genre: Technology & Engineering
ISBN: 1315352079

Download Design for Six Sigma Book in PDF, Epub and Kindle

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 Six Sigma

Design for Six Sigma
Author: Greg Brue
Publisher: McGraw Hill Professional
Total Pages: 209
Release: 2003-02-22
Genre: Business & Economics
ISBN: 0071425632

Download Design for Six Sigma Book in PDF, Epub and Kindle

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

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author: Richard C. Fries
Publisher: CRC Press
Total Pages: 490
Release: 2005-11-21
Genre: Medical
ISBN: 1420027948

Download Reliable Design of Medical Devices Book in PDF, Epub and Kindle

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
Total Pages: 285
Release: 2005-02-11
Genre: Medical
ISBN: 1040063756

Download Designing Usability into Medical Products Book in PDF, Epub and Kindle

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

Six Sigma for Electronics Design and Manufacturing

Six Sigma for Electronics Design and Manufacturing
Author: Sammy G. Shina
Publisher: McGraw Hill Professional
Total Pages: 394
Release: 2002-04-22
Genre: Technology & Engineering
ISBN: 0071409556

Download Six Sigma for Electronics Design and Manufacturing Book in PDF, Epub and Kindle

* Covers the nuts, bolts, and statistics of implementing Six Sigma in electronics manufacturing--includes case studies and detailed calculations

Design for Six Sigma

Design for Six Sigma
Author: Geoff Tennant
Publisher: Gower Publishing, Ltd.
Total Pages: 242
Release: 2002
Genre: Business & Economics
ISBN: 9780566084348

Download Design for Six Sigma Book in PDF, Epub and Kindle

Six Sigma provides an overarching concept, methodology and the tools to improve quality and customer satisfaction, thereby increasing profitability. This book moves beyond applying Six Sigma to already exisiting products and services to quantifying, designing and measuring success in from the start.Most new ideas are launched on the market without taking customer needs into account. Failings are discovered in the marketplace where products or services then have to be refined and redesigned - indeed perhaps some 80% of new products or services will fail altogether. By using the Six Sigma approach to designing new products and services the chances of failure are greatly reduced. Six Sigma encourages innovation within a controlled framework, leading to better products and services brought to the marketplace more quickly.This book aims to provide a detailed resource of guidance and inspiration covering all the aspects of business strategy, product/service design, project management and execution necessary for the successful introduction of new products and services, all under the auspices of a customer-focused Six Sigma approach. Moreover it provides a tangible way of measuring satisfaction and the success of the new.