Usability Testing of Medical Devices, Second Edition


Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher: CRC Press
ISBN: 1466595892
Category: Medical
Page: 455
View: 2953

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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Usability Testing of Medical Devices


Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher: CRC Press
ISBN: 9781439811849
Category: Medical
Page: 412
View: 3462

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To paraphrase a popular saying, usability testing should be done early and often. However, it doesn’t have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death. The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible. As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.

Usability Testing of Medical Devices, Second Edition


Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher: CRC Press
ISBN: 9781466595880
Category: Medical
Page: 472
View: 4793

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Since the publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this second edition provides updated guidance to medical device manufacturers and other interested readers. Key updates include new requirements, detailed instructions for linking usability test tasks to risk analysis results, and methods for analyzing root causes of use errors that occur during usability tests. The book’s authors are well-known thought leaders in the medical device industry.

Medical Device Software Verification, Validation and Compliance


Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category: Biomedical engineering
Page: 444
View: 3365

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HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

Handbook of Human Factors in Medical Device Design


Author: Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher: CRC Press
ISBN: 9781420063516
Category: Technology & Engineering
Page: 844
View: 6151

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Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.

Handbook of Usability Testing

How to Plan, Design, and Conduct Effective Tests
Author: Jeffrey Rubin
Publisher: Wiley
ISBN: 9780471594031
Category: Computers
Page: 352
View: 4147

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A supremely usable nuts-and-bolts guide for beginners. A daily tool of the trade for specialists. Handbook of Usability Testing gives you practical, step-by-step guidelines in plain English. Written by Jeffrey Rubin, it arms beginners with the full complement of proven testing tools and techniques. From software, GUIs, and technical documentation, to medical instruments, VCRs, and exercise bikes, no matter what your product, you'll learn to design and administer extremely reliable tests to ensure that people find it easy and desirable to use. * Requires no engineering or human factors training * A rigorous, step-by-step approach--with an eye to common gaffes and pitfalls--saves you months of trial and error * Liberally peppered with real-life examples and case histories taken from a wide range of industries * Packed with extremely usable templates, models, tables, test plans, and other indispensable tools of the trade

Medical Device Use Error

Root Cause Analysis
Author: Michael Wiklund,Andrea Dwyer,Erin Davis
Publisher: CRC Press
ISBN: 1498705804
Category: Technology & Engineering
Page: 245
View: 9999

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Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text: Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.

Design Controls for the Medical Device Industry, Second Edition


Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 1466503556
Category: Medical
Page: 205
View: 3203

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The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Designing Usability into Medical Products


Author: Michael E. Wiklund,Stephen B. Wilcox
Publisher: CRC Press
ISBN: 9780849328435
Category: Medical
Page: 376
View: 7481

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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.

Contextual Inquiry for Medical Device Design


Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128018747
Category: Technology & Engineering
Page: 310
View: 4852

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Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology Helps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process

The Medical Device R&D Handbook


Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 1420038354
Category: Medical
Page: 376
View: 4212

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The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur. Highlights Include... An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for Medical Devices Using Medical Illustration in Product Development Introduction to Pre-Clinical Studies Introduction to Regulatory Affairs Assessing Biocompatibility Exclusive Interviews with Key Industry Leaders ...And More This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.

Handbook of Human Factors Testing and Evaluation


Author: Samuel G. Charlton,Thomas G. O'Brien
Publisher: CRC Press
ISBN: 0805832904
Category: Technology & Engineering
Page: 568
View: 1973

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Like the first edition, the revision of this successful Handbook responds to the growing need for specific tools and methods for testing and evaluating human-system interfaces. Indications are that the market for information on these tools and applications will continue to grow in the 21st century. One of the goals of offering a second edition is to expand and emphasize the application chapters, providing contemporary examples of human factors test and evaluation (HFTE) enterprises across a range of systems and environments. Coverage of the standard tools and techniques used in HFTE have been updated as well. New features of the Handbook of Human Factors Testing and Evaluation include: *new chapters covering human performance testing, manufacturing ergonomics, anthropometry, generative design methods, and usability testing; *updated tools and techniques for modeling, simulation, embedded testing, training assessment, and psychophysiological measurement; *new applications chapters presenting human factors testing examples in aviation and avionics, forestry, road safety, and software systems; and *more examples, illustrations, graphics and tables have been added. The orientation of the current work has been toward breadth of coverage rather than in-depth treatment of a few issues or techniques. Experienced testers will find much that is familiar, as well as new tools, creative approaches, and a rekindled enthusiasm. Newcomers will discover the diversity of issues, methods, and creative approaches that make up the field. In addition, the book is written in such a way that individuals outside the profession should learn the intrinsic value and pleasure in ensuring safe, efficient, and effective operation, as well as increased user satisfaction through HFTE.

Reliable Design of Medical Devices


Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9781420001013
Category: Medical
Page: 728
View: 6729

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Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Medical Device Design

Innovation from Concept to Market
Author: Peter J Ogrodnik
Publisher: Academic Press
ISBN: 0123919436
Category: Technology & Engineering
Page: 376
View: 4078

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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

Institutionalization of Usability

A Step-by-step Guide
Author: Eric Schaffer
Publisher: Addison-Wesley Professional
ISBN: 9780321179340
Category: Computers
Page: 276
View: 7069

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"Institutionalization of Usability" shows how to make user-centered design and development a routine practice within an enterprise. Based on Schaffer's extensive experience, the book provides a solid methodology, guiding readers step by step with practical advice on topics such as organizational change, milestones, toolsets, infrastructure, and more.

HANDBOOK OF USABILITY TESTING: HOW TO PLAN, DESIGN AND CONDUCT EFFECTIVE TESTS, 2ND ED


Author: Jeffrey Rubin And Dana Chisnell
Publisher: John Wiley & Sons
ISBN: 9788126516902
Category:
Page: 384
View: 4746

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Market_Desc: · Product Managers· Designers· Developers Special Features: · The authors are leading authorities on product usability testing; they will actively promote the book at conferences and training seminars· The first edition has sold more than 20,000 copies since it first published in 1994; the new book is 30% revised, with 100 new pages· The book covers testing of consumer products as well as software, so it has a very broad target audience· There is no direct competition About The Book: Handbook of Usability Testing, Second Edition, is a nuts-and-bolts guide for beginners, loaded with tips and tricks for effectively testing products of all types. From software, GUIs, and technical documentation, to medical instruments and exercise bikes, no matter what type of product, readers will learn to design and administer reliable tests to ensure that people find it easy and desirable to use. The Second Edition is fully updated---30% revised, with 100 new pages. Chapters are reorganized to reflect more current industry practices, outdated terminology is updated, and more varied examples are provided.

Designing for Older Adults

Principles and Creative Human Factors Approaches, Second Edition
Author: Arthur D. Fisk,Wendy A. Rogers,Neil Charness,Sara J. Czaja,Joseph Sharit
Publisher: CRC Press
ISBN: 9781420080681
Category: Technology & Engineering
Page: 232
View: 4686

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The first edition of Designing for Older Adults: Principles and Creative Human Factors Approaches broke ground as an easily accessible source of information, a primer on designing for older adults. In this second edition, the authors, as any good human factors practitioner would, have considered comments from readers. They have revised and updated each of the original chapters, rearranged some of them for a more natural flow, added a new section of tutorials, and provided updated recommended readings. New in the Second Edition: Two new applications chapters: Transportation and Aging-in-Place New Tutorials section provides hands-on guidance for critical issues Re-organization of Design Guidelines section allows for better flow of topics The new Tutorials section begins by focusing on general issues that need to be considered when involving older adults generally in research and usability studies and more specifically in focus group studies. It elucidates statistical considerations relevant to user testing with older adults and modeling approaches such as task analysis, error prediction, and GOMS analysis. Given the prevalence of multimedia in today’s world, the authors include a tutorial on design considerations for multimedia products in general but especially for older adults. Meet the Needs of Older Adults through Proper Design Reflecting the multidisciplinary nature of the field, this multidisciplinary author team translates a vast array of academic literature into guidelines without losing its strong grounding in science. They discuss the role the field of human factors plays in creating technology that is effective and safe to use. This book provides information specific enough to be immediately applicable yet general enough to be relevant to technologies of the future.

Challenges and Opportunities in Health Care Management


Author: Sebastian Gurtner,Katja Soyez
Publisher: Springer
ISBN: 3319121782
Category: Medical
Page: 393
View: 4349

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This contributed volume draws a vital picture of the health care sector, which, like no other is affected by technology push and stakeholder pull. Innovative product and service solutions emerge, which have to integrate different stakeholders’ interests. This book studies current challenges in health care management from different perspectives. Research articles analyze the situation in the health care sector and present solutions in the following areas: the health care system; hospitals; teams in health care; patients’ perspectives; assessment of technologies and innovations; and toolkits for organizing health care. All these contributions summarize pressing hot topics in the health care sector, analyze their future potential, and derive managerial implications. Outstanding best practices throughout Europe are presented in the case study section of the book. Consequently, the book closes the gap between science and practical application by addressing not only readers from academia but also practitioners working in the health care industry.

Designing Web Sites that Work

Usability for the Web
Author: Tom Brinck,Darren Gergle,Scott D. Wood
Publisher: Morgan Kaufmann
ISBN: 9781558606586
Category: Computers
Page: 481
View: 4888

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Demonstrates Web design fundamentals that consider usability a major design goal, provides advice on incorporating usability considerations in each stage of the design process, and discusses the functionality of e-commerce sites.

Handbook of Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition


Author: Pascale Carayon
Publisher: CRC Press
ISBN: 1439830347
Category: Technology & Engineering
Page: 876
View: 9454

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The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human factors and ergonomics issues such as human error or design of medical devices or a specific application such as emergency medicine. This book draws on both areas to provide a compendium of human factors and ergonomics issues relevant to health care and patient safety. The second edition takes a more practical approach with coverage of methods, interventions, and applications and a greater range of domains such as medication safety, surgery, anesthesia, and infection prevention. New topics include: work schedules error recovery telemedicine workflow analysis simulation health information technology development and design patient safety management Reflecting developments and advances in the five years since the first edition, the book explores medical technology and telemedicine and puts a special emphasis on the contributions of human factors and ergonomics to the improvement of patient safety and quality of care. In order to take patient safety to the next level, collaboration between human factors professionals and health care providers must occur. This book brings both groups closer to achieving that goal.