Six Sigma for Medical Device DesignSix Sigma for Medical Device Design



For designers of medical devices, the FDA and ISO requirements are extremely stringent.

Author: Jose Justiniano

Publisher: CRC Press

ISBN: 9780203485743

Category:

Page: 152

View: 355

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 SigmaMedical Device Design for Six Sigma



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 ...

Author: Basem El-Haik

Publisher: John Wiley & Sons

ISBN: 9781118210413

Category:

Page: 528

View: 600

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 DesignSix Sigma for Medical Device Design



For designers of medical devices, the FDA and ISO requirements are extremely stringent.

Author: Jose Justiniano

Publisher: CRC Press

ISBN: 9781135506742

Category:

Page: 152

View: 441

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 DevicesReliable Design of Medical Devices



The basis of Six Sigma is measuring a process in terms of defects. The statistical concept of Six Sigma means your processes are working nearly perfectly, ...

Author: Richard C. Fries

Publisher: CRC Press

ISBN: 9781420027945

Category:

Page: 504

View: 635

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.

Reliable Design of Medical Devices Third EditionReliable Design of Medical Devices Third Edition



20.1 DESIGN FOR SIX SIGMA (DFSS) DFSS.is.an.approach.to.designing.or.redesigning.product.and/or.services.to.meet. or. exceed. customer. requirements. and.

Author: Richard C. Fries

Publisher: CRC Press

ISBN: 9781439894910

Category:

Page: 501

View: 718

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.

Software Design for Six SigmaSoftware Design for Six Sigma



Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness, 1st Ed., Wiley-Interscience, New York. El-Haik, Basem, S. and Roy, D. (2005).

Author: Basem S. El-Haik

Publisher: John Wiley & Sons

ISBN: 9781118074411

Category:

Page: 532

View: 996

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.

Plastics in Medical DevicesPlastics in Medical Devices



Dr. Sastri is a certified Six Sigma black-belt with expertise in Six Sigma® and Design for Six Sigma. His areas of expertise include FDA and ISO quality ...

Author: Vinny R. Sastri

Publisher: Elsevier

ISBN: 9780815520283

Category:

Page: 352

View: 935

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.

Medical Device DesignMedical Device Design



I have mentioned Six Sigma (or 6σ) numerous times in this text. There is little doubt that this is the section where it is introduced properly.

Author: Peter J Ogrodnik

Publisher: Academic Press

ISBN: 9780123919434

Category:

Page: 376

View: 326

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

Biomedical DevicesBiomedical Devices



Suppl 209; http://www.ncbi.nlm.nih.gov/pubmed/24872391; 2011. [7] El-Haik BS and Mekki MS. Medical device design for Six Sigma.

Author: Tŭgrul ?zel

Publisher: John Wiley & Sons

ISBN: 9781118478929

Category:

Page: 208

View: 979

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

Medical Device DesignMedical Device Design



We meet the D4X (Design for X) family of tools when we come to product realization (that ... I have mentioned six sigma (or 6s) numerous times in this text.

Author: Peter J. Ogrodnik

Publisher: Academic Press

ISBN: 9780128149638

Category:

Page: 538

View: 189

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

Combination ProductsCombination Products



Regulatory Challenges and Successful Product Development Smita ... In one of the author's earlier publications, Six Sigma for Medical Device Design, ...

Author: Smita Gopalaswamy

Publisher: CRC Press

ISBN: 1420064517

Category:

Page: 264

View: 922

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner. Specifically, this text explores the process from start to finish, establishing a workable design and development plan complete with relevant definitions. It reviews FDA and other regulatory expectations and covers resource requirements, manufacturing pitfalls, post-launch compliance requirements, and agency audits and challenges. Drawing on the experience and expertise of two leaders in their respective fields, Combination Products boasts the credentials of Dr. Smita Gopalaswamy, a 20 year veteran of technical consulting responsibilities in medical device, biologics, and pharmaceutical industries as well as combination products, along with the support of Dr. Venky Gopalaswamy, an expert in business improvement methodologies such as six sigma, lean, and change management, to provide a comprehensive assessment of the field and an efficient and effective approach to the creation and implementation of combination products.

Six Sigma for Electronics Design and ManufacturingSix Sigma for Electronics Design and Manufacturing



Written by an acknowledged Six Sigma quality expert with a flair for clear, succinct writing – and priceless hands-on new product development and manufacturing experience -- Six Sigma for Electronics Design and Manufacturing includes eye ...

Author: Sammy G. Shina

Publisher: McGraw Hill Professional

ISBN: 9780071409551

Category:

Page: 364

View: 297

* Covers the nuts, bolts, and statistics of implementing Six Sigma in electronics manufacturing--includes case studies and detailed calculations

Design of Biomedical Devices and SystemsDesign of Biomedical Devices and Systems



ANSI/AAMI/ISO–14971-2000, Medical Devices—Application of Risk Management to Medical Devices. Brue, G. and R. G. Launsby, Design for Six Sigma.

Author: Dragan Primorac

Publisher: CRC Press

ISBN: 9781466569140

Category:

Page: 515

View: 412

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.

Using the Pharmaceutical LiteratureUsing the Pharmaceutical Literature



Justiniano JM, Gopalaswamy V. Six Sigma for Medical Device Design. 1st ed. Boca Raton, FL: CRC Press Inc., 2004. First book available on applying Six-Sigma ...

Author: Sharon Srodin

Publisher: CRC Press

ISBN: 9780849374524

Category:

Page: 344

View: 901

Gathering information of critical importance for professionals in the pharmaceutical and medical device industries, this guide provides a comprehensive overview of key resources, such as databases, on-line directories, reports, and periodicals-providing at-a-glance guidance and collection development tools for information professionals in this field. Each chapter corresponds to a key stage or component of the drug development processin a typical pharmaceutical company and covers the types of information typically required at that particular phase.

Plastics in Medical DevicesPlastics in Medical Devices



In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and ...

Author: Vinny R. Sastri

Publisher: William Andrew

ISBN: 9780323265638

Category:

Page: 336

View: 276

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices. Unique coverage of medical device regulatory aspects, supplier control and process validation. Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.

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



Medical device design for six sigma. John Wiley & Sons. doi:10.1002/9780470264003 Freeman, L. J., Ryan, A. G., Kensler, J. L. K., Dickinson, R. M., ...

Author: Alor-Hernández, Giner

Publisher: IGI Global

ISBN: 9781522501312

Category:

Page: 674

View: 677

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.

Lean SigmaLean Sigma



Ian has a strong product development background and codeveloped SBTI's Lean Design, Lean Sigma, KSigma (accelerated Lean Sigma), and Healthcare ...

Author: Ian Wedgwood PhD

Publisher: Pearson Education

ISBN: 0132712830

Category:

Page: 320

View: 580

The Practical, Easy-to-Use Guide to Lean Sigma Problem-Solving Lean Sigma delivers results–if you use the right tools and techniques. In Lean Sigma: A Practitioner’s Guide, Dr. Ian Wedgwood captures best-practice Lean Sigma experience from multiple projects and industries, helping any professional identify the solution that will work best–and implement it. Wedgwood’s exclusive "project roadmaps" present the fastest, most effective route to solving a wide range of problems–and explain why those solutions make sense. His "discovery roadmaps" help you identify potential Lean Sigma projects, even in processes where there are no obvious targets. Whether you’re a Green Belt, Black Belt, Master, Project Champion, Sponsor, Deployment Leader, or consultant, this book will help you use Lean Sigma to solve far more problems, far more rapidly, and far more effectively.

Lean Six SigmaLean Six Sigma



168 ◾ New International Lean Six Sigma Applications Recently, Lean Thinking and ... design has become a popular topic in the medical device, semiconductor, ...

Author: Terra Vanzant Stern, PhD

Publisher: CRC Press

ISBN: 9781498739610

Category:

Page: 280

View: 944

A hybrid methodology, Lean Six Sigma (LSS) is designed to accommodate global challenges and constraints by capitalizing on Six Sigma and Lean Thinking. LSS incorporates best practices from programs such as the International Organization for Standardization (ISO), Capability Maturity Model, and Total Quality Management. International Lean Six Sigma practitioners must understand the dynamics of LSS, along with its cultural aspects and regulations. Lean Six Sigma: International Standards and Global Guidelines, Second Edition provides this understanding. The book assumes that the overall goal of operational excellence is to ensure that organizational tasks and activities are being performed to the best of their process capabilities. It defines continuous improvement as activities that support and empower environments to make flexible decisions that lead to ongoing improvement and effectiveness. Coverage includes: New global LSS standards International implementation of process improvement programs New international LSS applications International Lean Six Sigma areas of competency The book defines many of the terms popularized by process improvement programs, such as center of excellence and business transformation. It documents these practices and explains how to perform future activities in accordance with the recorded practices. Exploring international approaches to Lean Six Sigma, it details the new ISO Standard for Six Sigma and also addresses the role of project management in LSS. Illustrating the synergies between Lean and Six Sigma and how they partner with other process improvement programs and initiatives, this book is an ideal study guide for those preparing to take the LSS Black Belt certification exam.

Design of Experiments for Chemical Pharmaceutical Food and Industrial ApplicationsDesign of Experiments for Chemical Pharmaceutical Food and Industrial Applications



The Six Sigma methodology has been adopted by companies in the medical device sector as an approach to quality improvement, especially where producing high ...

Author: Carrillo-Cedillo, Eugenia Gabriela

Publisher: IGI Global

ISBN: 9781799815204

Category:

Page: 429

View: 742

Statistics is a key characteristic that assists a wide variety of professions including business, government, and factual sciences. Companies need data calculation to make informed decisions that help maintain their relevance. Design of experiments (DOE) is a set of active techniques that provides a more efficient approach for industries to test their processes and form effective conclusions. Experimental design can be implemented into multiple professions, and it is a necessity to promote applicable research on this up-and-coming method. Design of Experiments for Chemical, Pharmaceutical, Food, and Industrial Applications is a pivotal reference source that seeks to increase the use of design of experiments to optimize and improve analytical methods and productive processes in order to use less resources and time. While highlighting topics such as multivariate methods, factorial experiments, and pharmaceutical research, this publication is ideally designed for industrial designers, research scientists, chemical engineers, managers, academicians, and students seeking current research on advanced and multivariate statistics.

Essentials for the Improvement of Healthcare Using Lean Six SigmaEssentials for the Improvement of Healthcare Using Lean Six Sigma



The medical devices industry generated more than $230 billion in 2007, and that number is ... including the Lean approach and the Six Sigma approach.

Author: D.H. Stamatis

Publisher: CRC Press

ISBN: 9781466500716

Category:

Page: 463

View: 175

Essentials for the Improvement of Healthcare Using Lean & Six Sigma is all about real and immediate quality improvement. Written by D.H. Stamatis, a renowned expert in organizational development and quality, the book addresses concerns that can be ameliorated with minimal government intervention. Detailing immediate paths for improvement fundamental to primary care, hospitals, and managed care, the book: Introduces much-needed mechanics of change, including transitioning from hierarchical groups to interactive inclusionary teams Focuses on customer satisfaction as a key indicator of quality Explains how Lean and Six Sigma tools can be readily applied to healthcare Spotlights primary care, including how to define and redesign its process and develop better metrics Presents IT applications that will improve billing, documentation, and patient care Examines Malcolm Baldrige National Quality Award criteria as it applies to healthcare Illustrates quality improvements and best practices through real world case studies Includes a companion CD with Six Sigma forms and formulas, Lean improvement tools, and other quality tools and worksheets Whether you think advances in technology and medicine, coupled with freedom of choice, makes the U.S. healthcare system the best in the world, or whether you believe growing costs, regulatory morass, and a tort-obsessed culture drop it to the bottom; it is evident that the processes currently employed and the subsequent defensive medicine philosophy that has resulted will not be able to meet the future demands of our aging society. Through Six Sigma and Lean, this text moves the focus from reactive controls to the proactive efficiency required to implement real and sustainable quality improvements that will allow us to forge a system that is all about wellness.