Medical Device Design for Six Sigma Book

Medical Device Design for Six Sigma


  • Author : Basem El-Haik
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Genre: Medical
  • Pages : 528
  • ISBN 10 : 9781118210413

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Medical Device Design for Six Sigma Excerpt :

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Six Sigma for Medical Device Design Book
Score: 3
From 2 Ratings

Six Sigma for Medical Device Design


  • Author : Jose Justiniano
  • Publisher : CRC Press
  • Release Date : 2004-11-15
  • Genre: Science
  • Pages : 152
  • ISBN 10 : 9780203485743

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Six Sigma for Medical Device Design 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

Reliable Design of Medical Devices Book

Reliable Design of Medical Devices


  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release Date : 2005-11-21
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781420027945

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Reliable Design of Medical Devices 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.

Software Design for Six Sigma Book

Software Design for Six Sigma


  • Author : Basem S. El-Haik
  • Publisher : John Wiley & Sons
  • Release Date : 2010-08-06
  • Genre: Computers
  • Pages : 500
  • ISBN 10 : 9780470877838

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Software Design for Six Sigma Excerpt :

Medical Device Design Book

Medical Device Design


  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2012-12-17
  • Genre: Technology & Engineering
  • Pages : 376
  • ISBN 10 : 9780123919434

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Medical Device Design 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

Plastics in Medical Devices Book

Plastics in Medical Devices


  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release Date : 2010-03-05
  • Genre: Technology & Engineering
  • Pages : 352
  • ISBN 10 : 9780815520283

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Plastics in Medical Devices 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.

Biomedical Devices Book

Biomedical Devices


  • Author : Tugrul Özel
  • Publisher : John Wiley & Sons
  • Release Date : 2016-09-13
  • Genre: Science
  • Pages : 208
  • ISBN 10 : 9781119267058

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Biomedical Devices Excerpt :

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Design for Six Sigma Book
Score: 4
From 1 Ratings

Design for Six Sigma


  • Author : Greg Brue
  • Publisher : McGraw Hill Professional
  • Release Date : 2003-02-22
  • Genre: Business & Economics
  • Pages : 180
  • ISBN 10 : 9780071425636

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Design for Six Sigma 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

Design of Biomedical Devices and Systems Book

Design of Biomedical Devices and Systems


  • Author : Dragan Primorac
  • Publisher : CRC Press
  • Release Date : 2014-07-29
  • Genre: Medical
  • Pages : 515
  • ISBN 10 : 9781466569140

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Design of Biomedical Devices and Systems 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.

Biomedical Product and Materials Evaluation Book

Biomedical Product and Materials Evaluation


  • Author : P.V. Mohanan
  • Publisher : Woodhead Publishing
  • Release Date : 2022-01-22
  • Genre: Medical
  • Pages : 806
  • ISBN 10 : 9780128241738

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Biomedical Product and Materials Evaluation Excerpt :

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Handbook of Research on Managerial Strategies for Achieving Optimal Performance in Industrial Processes Book

Handbook of Research on Managerial Strategies for Achieving Optimal Performance in Industrial Processes


  • Author : Alor-Hernández, Giner
  • Publisher : IGI Global
  • Release Date : 2016-05-03
  • Genre: Business & Economics
  • Pages : 674
  • ISBN 10 : 9781522501312

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Handbook of Research on Managerial Strategies for Achieving Optimal Performance in Industrial Processes Excerpt :

Competitive advantage is a key factor to the success of any business in modern society. To achieve this goal, effective strategies for process improvement must be researched and implemented into an organization. The Handbook of Research on Managerial Strategies for Achieving Optimal Performance in Industrial Processes examines optimization techniques for improved business operations and procedures in the industrial sector. Highlighting management techniques, innovative approaches, and technological tools, this publication is an essential reference source for professionals, researchers, consultants, upper-level students, and academicians interested in the advancement of knowledge in industrial communities.

Medical Device Design Book

Medical Device Design


  • Author : Peter J. Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2019-10-30
  • Genre: Technology & Engineering
  • Pages : 538
  • ISBN 10 : 9780128149638

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Medical Device Design Excerpt :

Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Applying Design for Six Sigma to Software and Hardware Systems Book

Applying Design for Six Sigma to Software and Hardware Systems


  • Author : Eric Maass
  • Publisher : Pearson Education
  • Release Date : 2009-08-19
  • Genre: Technology & Engineering
  • Pages : 456
  • ISBN 10 : 9780137035915

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Applying Design for Six Sigma to Software and Hardware Systems 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

Design of Biomedical Devices and Systems  4th edition Book

Design of Biomedical Devices and Systems 4th edition


  • Author : Paul H. King
  • Publisher : CRC Press
  • Release Date : 2018-10-03
  • Genre: Medical
  • Pages : 508
  • ISBN 10 : 9780429786068

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Design of Biomedical Devices and Systems 4th edition 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

Guidelines for Failure Modes and Effects Analysis for Medical Devices Book

Guidelines for Failure Modes and Effects Analysis for Medical Devices


  • Author : Dyadem Press
  • Publisher : CRC Press
  • Release Date : 2018-06-28
  • Genre: Technology & Engineering
  • Pages : 190
  • ISBN 10 : 9780203490112

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Guidelines for Failure Modes and Effects Analysis for Medical Devices Excerpt :

Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.