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Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf
For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do
Medical Device Design for Six Sigma by Basem El-Haik,Khalid S. Mekki Pdf
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.
Reliable Design of Medical Devices by Richard C. Fries Pdf
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.
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
Design for Six Sigma in Technology and Product Development by Clyde M. Creveling,Jeff Slutsky,Dave Antis Pdf
This book addresses many new topical areas for the development of 6 Sigma performance. The text is structured to demonstrate how 6 Sigma methods can be used as a very powerful tool within System Engineering and integration evaluations to help enable the process of Critical Parameter Management. The case studies and examples used throughout the book come from recent successful applications of the material developed in the text.
Design for Lean Six Sigma by Rajesh Jugulum,Philip Samuel Pdf
Design for Lean Six Sigmais the only book that employs a "road-map" approach to DFSS, which allows corporate management to understand where they are in the process and to integrate DFSS methodology more fully into their overall business strategy. This is a similar approach to that used by Forrest Breyfogle in his successful book: "Implementing Six Sigma, 2E". This approach will allow corporate management to understand where they are in the process and to integrate DFSS methodology more fully into the overall business strategy. Another important aspect of this book is its coverage of DFSS implementation in a broad range of industries including service and manufacturing, plus the use of actual cases throughout.
Design for Six Sigma by Elizabeth A. Cudney,Tina Kanti Agustiady Pdf
Design for Six Sigma (DFSS) is an innovative continuous improvement methodology for designing new products, processes, and services by integrating Lean and Six Sigma principles. This book will explain how the DFSS methodology is used to design robust products, processes, or services right the first time by using the voice of the customer to meet Six Sigma performance. Robust designs are insensitive to variation and provide consistent performance in the hands of the customer. DFSS is used to meet customer needs by understanding their requirements, considering current process capability, identifying and reducing gaps, and verifying predictions to develop a robust design. This book offers: Methodology on how to implement DFSS in various industries Practical examples of the use of DFSS Sustainability utilizing Lean Six Sigma techniques and Lean product development Innovative designs using DFSS with concept generation Case studies for implementing the DFSS methodology Design for Six Sigma (DFSS) enables organizations to develop innovative designs. In order to redesign an existing process or design a new process, the success is dependent on a rigorous process and methodology. DFSS ensures that there are minimal defects in the introduction of new products, processes, or services. The authors have compiled all of the tools necessary for implementation of a practical approach though innovation.
Design for Six Sigma by Greg Brue,Robert Launsby Pdf
THE BRIEFCASE BOOKS SERIEs Now translated into 11 languages! This reader-friendly, icon-rich series is must reading for all managers at every level All managers, whether brand new to their positions or well established in the corporate hierarchy, can use a little "brushing up" now and then. The skills-based Briefcase Books series is filled with ideas and strategies to help managers become more capable, efficient, effective, and valuable to their corporations. DESIGN FOR SIX SIGMA Six Sigma has revolutionized the ways in which companies meet and beat today's stringent quality expectations. But achieving Six Sigma results first requires Six Sigma building blocks. Design for Six Sigma unveils a systematic methodology for enabling the design of products, services, and processes to meet Six Sigma quality levels. Designed to be easily read and implemented, this concise Briefcase Book shows managers at all levels how to include Six Sigma at the earliest stages of virtually any manufacturing process. Here are DFSS's techniques for: Optimizing the design process to achieve Six Sigma performance Integrating Six Sigma from the outset of new product development Self-examinations, explanatory sidebars, and chapter-ending checklists
Reliable Design of Medical Devices, Third Edition by Richard C. Fries Pdf
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.
Applying Design for Six Sigma to Software and Hardware Systems by Eric Maass,Patricia D. McNair Pdf
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.
Designing Usability into Medical Products by Michael E. Wiklund,Stephen B. Wilcox Pdf
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 of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools, present case studies of user-friendly medical technologies and corporate human factors programs, and supply related resources for medical design professionals. The book conveys an in-depth understanding of the user-centered design process, covers design methods for FDA compliance, and offers guidance on performing a variety of hands-on user research, user interface design, and user interface evaluation. The authors make a compelling case for treating the user's needs and preferences as a top design priority, rather than an afterthought. They demonstrate that high-quality customer interactions with systems and products leads to effective medical diagnosis and treatment, increases the physical and mental well being of patients and caregivers, and leads to commercial success in a crowded marketplace.
Author : Paul H. King,Richard C. Fries,Arthur T. Johnson Publisher : CRC Press Page : 725 pages File Size : 41,5 Mb Release : 2018-10-03 Category : Medical ISBN : 9780429786051
Design of Biomedical Devices and Systems, 4th edition by Paul H. King,Richard C. Fries,Arthur T. Johnson Pdf
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
Service Design for Six Sigma by Basem El-Haik,David M. Roy Pdf
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.
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