Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by Wiley-Interscience. This book was released on 2008-04-25 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.
Download or read book Applying Design for Six Sigma to Software and Hardware Systems written by Eric Maass and published by Pearson Education. This book was released on 2009-08-19 with total page 732 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Software Design for Six Sigma written by Basem S. El-Haik and published by John Wiley & Sons. This book was released on 2011-02-16 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: This proposal constitutes an algorithm of design applying the design for six sigma thinking, tools, and philosophy to software design. The algorithm will also include conceptual design frameworks, mathematical derivation for Six Sigma capability upfront to enable design teams to disregard concepts that are not capable upfront, learning the software development cycle and saving development costs. The uniqueness of this book lies in bringing all those methodologies under the umbrella of design and provide detailed description about how these methods, QFD, DOE, the robust method, FMEA, Design for X, Axiomatic Design, TRIZ can be utilized to help quality improvement in software development, what kinds of different roles those methods play in various stages of design and how to combine those methods to form a comprehensive strategy, a design algorithm, to tackle any quality issues in the design stage.
Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Designing Usability into Medical Products written by Michael E. Wiklund and published by CRC Press. This book was released on 2005-02-11 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Lean Six Sigma for Hospitals Improving Patient Safety Patient Flow and the Bottom Line Second Edition written by Jay Arthur and published by McGraw Hill Professional. This book was released on 2016-09-05 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Simple Steps to Improve Patient Safety, Patient Flow and the Bottom Line A Doody's Core Title for 2021! This thoroughly revised resource shows, step-by-step, how to simplify, streamline, analyze, and optimize healthcare performance using tested Lean Six Sigma and change management techniques. Lean Six Sigma for Hospitals, Second Edition, follows the patient from the front door of the hospital or emergency room all the way through discharge. The book fully explains how to improve operations and quality of care while dramatically reducing costs—often in just five days. Real-world case studies from major healthcare institutions illustrate successful implementations of Lean Six Sigma. Coverage includes: • Lean Six Sigma for hospitals, emergency departments, operating rooms, medical imaging facilities, nursing units, pharmacies, and ICUs • Patient flow and quality • Clinical staff • Order and claims accuracy • Billing and collection • Defect and medical error reduction • Excel power tools for Lean Six Sigma • Data mining and analysis • Process flow charts and control charts • Laser-focused process innovation • Statistical tools for Lean Six Sigma • Planning and implementation
Download or read book Service Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2005-08-19 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Download or read book The Lean Six Sigma Black Belt Handbook written by Frank Voehl and published by CRC Press. This book was released on 2013-07-09 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these seemingly dissimilar approaches to increase production speed while decreasing variations and costs in your organization. Presenting problem-solving tools you can use to immediately determine the sources of the problems in your organization, the book is based on a recent survey that analyzed Six Sigma tools to determine which are the most beneficial. Although it focuses on the most commonly used tools, it also includes coverage of those used a minimum of two times on every five Six Sigma projects. Filled with diagrams of the tools you’ll need, the book supplies a comprehensive framework to help you for organize and process the vast amount of information currently available about Lean, quality management, and continuous improvement process applications. It begins with an overview of Six Sigma, followed by little-known tips for using Lean Six Sigma (LSS) effectively. It examines the LSS quality system, its supporting organization, and the different roles involved. Identifying the theories required to support a contemporary Lean system, the book describes the new skills and technologies that you need to master to be certified at the Lean Six Sigma Black Belt (LSSBB) level. It also covers the advanced non-statistical and statistical tools that are new to the LSSBB body of knowledge. Presenting time-tested insights of a distinguished group of authors, the book provides the understanding required to select the solutions that best fit your organization's aim and culture. It also includes exercises, worksheets, and templates you can easily customize to create your own handbook for continuous process improvement. Designed to make the methodologies you choose easy to follow, the book will help Black Belts and Senseis better engage their employees, as well as provide an integrated and visual process management structure for reporting and sustaining continuous improvement breakthroughs and initiatives.
Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Download or read book Statistical Methods for Six Sigma written by Anand M. Joglekar and published by John Wiley & Sons. This book was released on 2003-09-19 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to achieving business successes through statistical methods Statistical methods are a key ingredient in providing data-based guidance to research and development as well as to manufacturing. Understanding the concepts and specific steps involved in each statistical method is critical for achieving consistent and on-target performance. Written by a recognized educator in the field, Statistical Methods for Six Sigma: In R&D and Manufacturing is specifically geared to engineers, scientists, technical managers, and other technical professionals in industry. Emphasizing practical learning, applications, and performance improvement, Dr. Joglekar?s text shows today?s industry professionals how to: Summarize and interpret data to make decisions Determine the amount of data to collect Compare product and process designs Build equations relating inputs and outputs Establish specifications and validate processes Reduce risk and cost-of-process control Quantify and reduce economic loss due to variability Estimate process capability and plan process improvements Identify key causes and their contributions to variability Analyze and improve measurement systems This long-awaited guide for students and professionals in research, development, quality, and manufacturing does not presume any prior knowledge of statistics. It covers a large number of useful statistical methods compactly, in a language and depth necessary to make successful applications. Statistical methods in this book include: variance components analysis, variance transmission analysis, risk-based control charts, capability and performance indices, quality planning, regression analysis, comparative experiments, descriptive statistics, sample size determination, confidence intervals, tolerance intervals, and measurement systems analysis. The book also contains a wealth of case studies and examples, and features a unique test to evaluate the reader?s understanding of the subject.
Download or read book Quality Beyond Six Sigma written by Ron Basu and published by Routledge. This book was released on 2012-06-14 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six Sigma is a data-driven management system with near-perfect performance that is a statistical target of operating with no more that 3.4 defects per one million chances. Six sigma has both created avid interest and raised concerns among executives and its practioners. This is all very well for multinationals like Motorola or General Electric but how can it help small and medium-sized enterprises or the service industry? How do you ensure that solutions stick? Quality Beyond Six Sigma responds to this challenge and provides a practical implementation of the issues of Six Sigma, Lean Enterprise and Total Quality and aligns the 'hard' sigma message with the softer sustainable 'strategic issues'. The result is FIT SIGMA. The authors utilize major and minor case studies to support principles and learnings of FIT SIGMA and include review examples and self-assessment that underpin the sustainable process. The three major case studies are contributed by General Electric, Dow Chemical and Seagate Technology. Senior Executives and Managers of organizations of all types and sizes, Management Consultants and Students of all disciplines will find this book a stimulating guide to quality and operational excellence.
Download or read book Six Sigma in the Pharmaceutical Industry written by Brian K. Nunnally and published by CRC Press. This book was released on 2007-06-13 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.
