Medical Device Design For Six Sigma

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Medical Device Design for Six Sigma

Author : Basem El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118210417
Total Pages : 556 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Medical Device Design for Six Sigma by : Basem El-Haik

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.

Six Sigma for Medical Device Design

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 1135506744
Total Pages : 113 pages
Book Rating : 4.1/5 (355 download)

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Book Synopsis Six Sigma for Medical Device Design by : Jose Justiniano

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.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

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.

Applying Design for Six Sigma to Software and Hardware Systems

Author : Eric Maass
Publisher : Pearson Education
ISBN 13 : 0137035918
Total Pages : 732 pages
Book Rating : 4.1/5 (37 download)

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Book Synopsis Applying Design for Six Sigma to Software and Hardware Systems by : Eric Maass

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.

Design of Biomedical Devices and Systems, 4th edition

Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 0429786050
Total Pages : 709 pages
Book Rating : 4.4/5 (297 download)

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Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Design for Six Sigma

Author : Greg Brue
Publisher : McGraw Hill Professional
ISBN 13 : 0071425632
Total Pages : 209 pages
Book Rating : 4.0/5 (714 download)

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Book Synopsis Design for Six Sigma by : Greg Brue

Download or read book Design for Six Sigma written by Greg Brue and published by McGraw Hill Professional. This book was released on 2003-02-22 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Medical Device Design

Author :
Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 369 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by :

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

Software Design for Six Sigma

Author : Basem S. El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118074416
Total Pages : 553 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Software Design for Six Sigma by : Basem S. El-Haik

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.

Designing Usability into Medical Products

Author : Michael E. Wiklund
Publisher : CRC Press
ISBN 13 : 1040063756
Total Pages : 285 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Designing Usability into Medical Products by : Michael E. Wiklund

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

Design of Biomedical Devices and Systems Second edition

Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 1439878072
Total Pages : 424 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Design of Biomedical Devices and Systems Second edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This

Design of Biomedical Devices and Systems

Author : Dragan Primorac
Publisher : CRC Press
ISBN 13 : 146656914X
Total Pages : 494 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Design of Biomedical Devices and Systems by : Dragan Primorac

Download or read book Design of Biomedical Devices and Systems written by Dragan Primorac and published by CRC Press. This book was released on 2014-07-29 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.

Implementing Design For Six Sigma: A Leader'S Guide (With Cd)

Author : Nil
Publisher : Pearson Education India
ISBN 13 : 9788131707265
Total Pages : 258 pages
Book Rating : 4.7/5 (72 download)

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Book Synopsis Implementing Design For Six Sigma: A Leader'S Guide (With Cd) by : Nil

Download or read book Implementing Design For Six Sigma: A Leader'S Guide (With Cd) written by Nil and published by Pearson Education India. This book was released on 2007-09 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Six Sigma Software Quality Improvement

Author : Vic Nanda
Publisher : McGraw Hill Professional
ISBN 13 : 0071700633
Total Pages : 635 pages
Book Rating : 4.0/5 (717 download)

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Book Synopsis Six Sigma Software Quality Improvement by : Vic Nanda

Download or read book Six Sigma Software Quality Improvement written by Vic Nanda and published by McGraw Hill Professional. This book was released on 2011-03-08 with total page 635 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proven techniques for improving software and process quality with Six Sigma This practical, in-depth guide explains how to apply Six Sigma to solve common product and process improvement challenges in the software and IT industry. Six Sigma Software Quality Improvement covers Define, Measure, Analyze, Improve, and Control (DMAIC), Lean Six Sigma, Design for Six Sigma (DFSS), and Define, Measure, Analyze, Design, and Verify (DMADV). Featuring more than 20 success stories from Motorola, IBM, Cisco, Seagate, Xerox, Thomson Reuters, TCS, EMC, Infosys, and Convergys, the book offers first-hand accounts of corporate Six Sigma programs and explains how these companies are successfully leveraging Six Sigma for software process and quality improvement. The success stories reveal how: Motorola minimized business risk before changing business-critical applications TCS improved fraud detection for a global bank Infosys improved software development productivity for a large multinational bank IBM reduced help desk escalations and overhead activities EMC improved development productivity Motorola realized significant cost avoidance by streamlining processes and project documentation Xerox achieved high-speed product development Seagate reduced application downtime and improved availability to 99.99% Cisco successfully reinvented its Six Sigma program Convergys injected Six Sigma into the company's DNA Thomson Reuters' Six Sigma program gathered significant momentum in a short time Six Sigma was successfully applied in many other projects for defect reduction, cycle time reduction, productivity improvement, and more

Lean Six Sigma for Hospitals: Improving Patient Safety, Patient Flow and the Bottom Line, Second Edition

Author : Jay Arthur
Publisher : McGraw Hill Professional
ISBN 13 : 1259641090
Total Pages : 400 pages
Book Rating : 4.2/5 (596 download)

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Book Synopsis Lean Six Sigma for Hospitals: Improving Patient Safety, Patient Flow and the Bottom Line, Second Edition by : Jay Arthur

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

Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries

Author : Dyadem Press
Publisher : CRC Press
ISBN 13 : 0203009681
Total Pages : 143 pages
Book Rating : 4.2/5 (3 download)

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Book Synopsis Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries by : Dyadem Press

Download or read book Guidelines for Failure Mode and Effects Analysis (FMEA), for Automotive, Aerospace, and General Manufacturing Industries written by Dyadem Press and published by CRC Press. This book was released on 2003-03-03 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examines why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers learn how to use FMEA throughout the life cycles of their product to improve customer satisfaction and assure safety and regulatory compliance. They will obtain sound advice on selecting a study team, setting up and conducting a study, and analyzing the results. Other topics include Failure Mode, Effects, and Criticality Analysis, Risk Management Planning, Advanced Quality Planning, Product Quality Control Plans, and Dynamic Control Plans.

Handbook of Medical Device Design

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1000693872
Total Pages : 795 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Handbook of Medical Device Design by : Richard C. Fries

Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Medical Device Safety

Author : G.R Higson
Publisher : CRC Press
ISBN 13 : 1420033980
Total Pages : 278 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Medical Device Safety by : G.R Higson

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