{"product_id":"medical-device-design-for-six-sigma-a-road-map-for-safety-and-effectiveness-hardback-9780470168615","title":"Medical Device Design for Six Sigma; A Road Map for Safety and Effectiveness (Hardback) 9780470168615","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eMedical Device Design for Six Sigma\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eA Road Map for Safety and Effectiveness\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eBasem Said El-Haik (Author), Khalid S. Mekki (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470168615, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 23 May 2008\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e560 pages\u003cbr\u003e24.1 x 16.3 x 3 cm, 0.907 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"The book is well-written and the authors use well versed descriptions, easy to read figures and tables, and industry-related examples and case studies to explain what can be very complex concepts and processes. This book would be a valuable resource for anyone in the field of medical device design.\" (\u003ci\u003eDoody's Book Reviews\u003c\/i\u003e, October 2008)\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eThe first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle\u003c\/b\u003e  \u003cp\u003e\u003ci\u003eMedical Device Design for Six Sigma: A Road Map for Safety and Effectiveness\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eIntegrates 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\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eCovers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eProvides a detailed, step-by-step implementation process for each DFSS tool included\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eCovers the structural, organizational, and technical deployment of DFSS within the medical device industry\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eIncludes a DFSS case study describing the development of a new device\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003ePresents a global prospective of medical device regulations\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eProviding 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eForeword.\u003c\/b\u003e  \u003cp\u003e\u003cb\u003ePreface.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Medical Device Design Quality.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction.\u003c\/p\u003e \u003cp\u003e1.2 The Essence of Quality.\u003c\/p\u003e \u003cp\u003e1.3 Quality Operating System and the Device Life Cycle.\u003c\/p\u003e \u003cp\u003e1.4 Evolution of Quality.\u003c\/p\u003e \u003cp\u003e1.5 Business Excellence: A Value Proposition.\u003cbr\u003e \u003c\/p\u003e \u003cp\u003e1.6 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Design for Six Sigma and Medical Device Regulation.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction.\u003c\/p\u003e \u003cp\u003e2.2 Global Perspective on Medical Device Regulations.\u003c\/p\u003e \u003cp\u003e2.3 Medical Device Classifi cation.\u003c\/p\u003e \u003cp\u003e2.4 Medical Device Safety.\u003c\/p\u003e \u003cp\u003e2.5 Medical Device Quality Management Systems Requirements.\u003c\/p\u003e \u003cp\u003e2.6 Medical Device Regulation Throughout the Product Development Life Cycle.\u003c\/p\u003e \u003cp\u003e2.7 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Basic Statistics.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction.\u003c\/p\u003e \u003cp\u003e3.2 Common Probability Distributions.\u003c\/p\u003e \u003cp\u003e3.3 Methods of Input and Output Analysis.\u003c\/p\u003e \u003cp\u003e3.4 Descriptive Statistics.\u003c\/p\u003e \u003cp\u003e3.5 Inferential Statistics.\u003c\/p\u003e \u003cp\u003e3.6 Normal Distribution and Normality Assumption.\u003c\/p\u003e \u003cp\u003e3.7 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 The Six Sigma Process.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction.\u003c\/p\u003e \u003cp\u003e4.2 Six Sigma Fundamentals.\u003c\/p\u003e \u003cp\u003e4.3 Process Modeling.\u003c\/p\u003e \u003cp\u003e4.4 Business Process Management.\u003c\/p\u003e \u003cp\u003e4.5 Measurement Systems Analysis.\u003c\/p\u003e \u003cp\u003e4.6 Process Capability and Six Sigma Process Performance.\u003c\/p\u003e \u003cp\u003e4.7 Overview of Six Sigma Improvement.\u003c\/p\u003e \u003cp\u003e4.8 Six Sigma Gose Upstream: Design for Six Sigma.\u003c\/p\u003e \u003cp\u003e4.9 Summary.\u003c\/p\u003e \u003cp\u003eAppendix 4A: Cause-and-Effect Tools.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Medical Device Design for Six Sigma.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction.\u003c\/p\u003e \u003cp\u003e5.2 Value of Designing for Six Sigma.\u003c\/p\u003e \u003cp\u003e5.3 Medical Device DFSS Fundamentals.\u003c\/p\u003e \u003cp\u003e5.4 The ICOV Process in Design.\u003c\/p\u003e \u003cp\u003e5.5 The ICOV Process in Product Development.\u003c\/p\u003e \u003cp\u003e5.6 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Medical Device DFSS Deployment.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction.\u003c\/p\u003e \u003cp\u003e6.2 Medical Device DFSS Deployment Fundamentals.\u003c\/p\u003e \u003cp\u003e6.3 Predeployment Phase.\u003c\/p\u003e \u003cp\u003e6.4 Deployment Phase.\u003c\/p\u003e \u003cp\u003e6.5 Postdeployment Phase.\u003c\/p\u003e \u003cp\u003e6.6 DFSS Sustainability Factors.\u003c\/p\u003e \u003cp\u003e6.7 Black Belts and the DFSS Team: Cultural Change.\u003c\/p\u003e \u003cp\u003e6.8 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Medical Device DFSS Project Road Map.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction.\u003c\/p\u003e \u003cp\u003e7.2 Medical Device DFSS Team.\u003c\/p\u003e \u003cp\u003e7.3 Medical Device DFSS Road Map.\u003c\/p\u003e \u003cp\u003e7.4 Software DFSS ICOV Process.\u003c\/p\u003e \u003cp\u003e7.5 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Quality Function Deployment.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction.\u003c\/p\u003e \u003cp\u003e8.2 History of QFD.\u003c\/p\u003e \u003cp\u003e8.3 QFD Fundamentals.\u003c\/p\u003e \u003cp\u003e8.4 QFD Methodology.\u003c\/p\u003e \u003cp\u003e8.5 HQQ Evaluation.\u003c\/p\u003e \u003cp\u003e8.6 HQQ 1: The Customer’s House.\u003c\/p\u003e \u003cp\u003e8.7 HQQ 2: Translation House.\u003c\/p\u003e \u003cp\u003e8.8 HQQ 3: Design House.\u003c\/p\u003e \u003cp\u003e8.9 HQQ 4: Process House.\u003c\/p\u003e \u003cp\u003e8.10 Application: Auto 3D.\u003c\/p\u003e \u003cp\u003e8.11 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 DFSS Axiomatic Design Method.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction.\u003c\/p\u003e \u003cp\u003e9.2 Axiomatic Method Fundamentals.\u003c\/p\u003e \u003cp\u003e9.3 Introduction to Axiom 1.\u003c\/p\u003e \u003cp\u003e9.4 Introduction to Axiom 2.\u003c\/p\u003e \u003cp\u003e9.5 Axiomatic Design Theorems and Corollaries.\u003c\/p\u003e \u003cp\u003e9.6 Application: Medication Mixing Machine.\u003c\/p\u003e \u003cp\u003e9.7 Application: Axiomatic Design Applied to Design Controls.\u003c\/p\u003e \u003cp\u003e9.8 Summary.\u003c\/p\u003e \u003cp\u003eAppendix 9A: Matrix Review.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 DFSS Innovation for Medical Devices.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction.\u003c\/p\u003e \u003cp\u003e10.2 History of the Theory of Inventive Problem Solving.\u003c\/p\u003e \u003cp\u003e10.3 TRIZ Fundamentals.\u003c\/p\u003e \u003cp\u003e10.4 TRIZ Problem-Solving Process.\u003c\/p\u003e \u003cp\u003e10.5 Ideal Final Result.\u003c\/p\u003e \u003cp\u003e10.6 Building Suffi cient Functions.\u003c\/p\u003e \u003cp\u003e10.7 Eliminating Harmful Functions.\u003c\/p\u003e \u003cp\u003e10.8 Inventive Principles.\u003c\/p\u003e \u003cp\u003e10.9 Detection and Measurement Concepts.\u003c\/p\u003e \u003cp\u003e10.10 TRIZ Root Cause Analysis.\u003c\/p\u003e \u003cp\u003e10.11 Evolution trends in Technological Systems.\u003c\/p\u003e \u003cp\u003e10.12 TRIZ Functional Analysis and Analogy.\u003c\/p\u003e \u003cp\u003e10.13 Application: Using Triads to Predict and Conceive Next-Generation Products.\u003c\/p\u003e \u003cp\u003e10.14 Summary.\u003c\/p\u003e \u003cp\u003eAppendix 10A: Contradiction Matrix.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 DFSS Risk Management Process.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction.\u003c\/p\u003e \u003cp\u003e11.2 Planning for Risk Management Activities in Design  and Development.\u003c\/p\u003e \u003cp\u003e11.3 Risk Assessment Techniques.\u003c\/p\u003e \u003cp\u003e11.4 Risk Evaluation.\u003c\/p\u003e \u003cp\u003e11.5 Risk Control.\u003c\/p\u003e \u003cp\u003e11.6 Postproduction Control.\u003c\/p\u003e \u003cp\u003e11.7 Summary.\u003c\/p\u003e \u003cp\u003eAppendix 11A: Robust Design Failure Mode and Effects Analysis.\u003c\/p\u003e \u003cp\u003e11A.1 Parameter Diagram.\u003c\/p\u003e \u003cp\u003e11A.2 Robust Design FMEA Elements.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Medical Device Design for X.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction.\u003c\/p\u003e \u003cp\u003e12.2 Design for Reliability.\u003c\/p\u003e \u003cp\u003e12.3 Design for Packaging.\u003c\/p\u003e \u003cp\u003e12.4 Design for Manufacture and Design for Assembly.\u003c\/p\u003e \u003cp\u003e12.5 Design for Maintainability.\u003c\/p\u003e \u003cp\u003e12.6 Design for Serviceability.\u003c\/p\u003e \u003cp\u003e12.7 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 DFSS Transfer Function and Scorecards.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction.\u003c\/p\u003e \u003cp\u003e13.2 Design Mapping.\u003c\/p\u003e \u003cp\u003e13.3 Design Scorecards and the Transfer Function.\u003c\/p\u003e \u003cp\u003e13.4 Transfer Function Mathematics.\u003c\/p\u003e \u003cp\u003e13.5 Transfer Function and Optimization.\u003c\/p\u003e \u003cp\u003e13.6 Monte Carlo Simulation.\u003c\/p\u003e \u003cp\u003e13.7 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Fundamentals of Experimental Design.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction.\u003c\/p\u003e \u003cp\u003e14.2 Classical Design of Experiments.\u003c\/p\u003e \u003cp\u003e14.3 Factorial Experiment.\u003c\/p\u003e \u003cp\u003e14.4 Analysis of Variance.\u003c\/p\u003e \u003cp\u003e14.5 2\u003ci\u003ek\u003c\/i\u003e Full Factorial Designs.\u003c\/p\u003e \u003cp\u003e14.6 Fractional Factorial Designs.\u003c\/p\u003e \u003cp\u003e14.7 Other Factorial Designs.\u003c\/p\u003e \u003cp\u003e14.8 Summary.\u003c\/p\u003e \u003cp\u003eAppendix 14A.\u003c\/p\u003e \u003cp\u003e14A.1 Diagnostic Plots of Residuals.\u003c\/p\u003e \u003cp\u003e14A.2 Pareto Chart of Effects.\u003c\/p\u003e \u003cp\u003e14A.3 Square and Cube Plots.\u003c\/p\u003e \u003cp\u003e14A.4 Interaction Plots.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Robust Parameter Design for Medical Devices.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction.\u003c\/p\u003e \u003cp\u003e15.2 Robust Design Fundamentals.\u003c\/p\u003e \u003cp\u003e15.3 Robust Design Concepts.\u003c\/p\u003e \u003cp\u003e15.4 Application: Dynamic Formulation.\u003c\/p\u003e \u003cp\u003e15.5 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Medical Device Tolerance Design.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction.\u003c\/p\u003e \u003cp\u003e16.2 Tolerance Design and DFSS.\u003c\/p\u003e \u003cp\u003e16.3 Worst-Case Tolerance.\u003c\/p\u003e \u003cp\u003e16.4 Statistical Tolerances.\u003c\/p\u003e \u003cp\u003e16.5 Taguchi’s Loss Function and Safety Tolerance Design.\u003c\/p\u003e \u003cp\u003e16.6 High- vs. Low-Level Requirements’ Tolerance Relationships.\u003c\/p\u003e \u003cp\u003e16.7 Taguchi’s Tolerance Design Experiment.\u003c\/p\u003e \u003cp\u003e16.8 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Medical Device DFSS Verifi cation and Validation.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction.\u003c\/p\u003e \u003cp\u003e17.2 Design Verifi cation Process.\u003c\/p\u003e \u003cp\u003e17.3 Production Process Validation.\u003c\/p\u003e \u003cp\u003e17.4 Software Validation.\u003c\/p\u003e \u003cp\u003e17.5 Design Validation.\u003c\/p\u003e \u003cp\u003e17.6 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 DFSS Design Transfer.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction.\u003c\/p\u003e \u003cp\u003e18.2 Design Transfer Planning.\u003c\/p\u003e \u003cp\u003e18.3 Process Control Plan.\u003c\/p\u003e \u003cp\u003e18.4 Statistical Process Control.\u003c\/p\u003e \u003cp\u003e18.5 Process Capability.\u003c\/p\u003e \u003cp\u003e18.6 Advanced Product Quality Planning.\u003c\/p\u003e \u003cp\u003e18.7 Device Master Record.\u003c\/p\u003e \u003cp\u003e18.8 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Design Change Control, Design Review, and Design\u003c\/b\u003e \u003cb\u003eHistory File.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction.\u003c\/p\u003e \u003cp\u003e19.2 Design Change Control Process.\u003c\/p\u003e \u003cp\u003e19.3 Design Review.\u003c\/p\u003e \u003cp\u003e19.4 Design History File.\u003c\/p\u003e \u003cp\u003e19.5 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Medical Device DFSS Case Study.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction.\u003c\/p\u003e \u003cp\u003e20.2 DFSS Identify Phase.\u003c\/p\u003e \u003cp\u003e20.3 DFSS Characterize Phase.\u003c\/p\u003e \u003cp\u003e20.4 DFSS Optimize Phase.\u003c\/p\u003e \u003cp\u003e20.5 DFSS Verify\/Validate Phase.\u003c\/p\u003e \u003cp\u003e20.6 Summary.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eGlossary: DFSS Terminology.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix: Statistical Tables.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eReferences.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIndex.\u003c\/b\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Other branches of medicine [\u003ca title=\"See our other books on Other branches of medicine\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Other%20branches%20of%20medicine%20%5BMM%5D%22\"\u003eMM\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley-Interscience","offers":[{"title":"Brand New","offer_id":52257147879704,"sku":"9780470168615","price":132.59,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470168615.jpg?v=1781277645","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/medical-device-design-for-six-sigma-a-road-map-for-safety-and-effectiveness-hardback-9780470168615","provider":"Freshly Printed Books","version":"1.0","type":"link"}