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: 9963

Continue Reading →

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.

Medical Device Software Verification, Validation and Compliance


Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category: Biomedical engineering
Page: 444
View: 9964

Continue Reading →

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: 9245

Continue Reading →

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.

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: 9745

Continue Reading →

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.

Handbook of Usability Testing

How to Plan, Design, and Conduct Effective Tests
Author: Jeffrey Rubin
Publisher: Wiley
ISBN: 9780471594031
Category: Computers
Page: 352
View: 8138

Continue Reading →

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

Contextual Inquiry for Medical Device Design


Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128018747
Category: Technology & Engineering
Page: 310
View: 573

Continue Reading →

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

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: 2139

Continue Reading →

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.

Handbook of Medical Device Design


Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9780824703998
Category: Medical
Page: 794
View: 4050

Continue Reading →

The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

Medical Device Design

Innovation from Concept to Market
Author: Peter J Ogrodnik
Publisher: Academic Press
ISBN: 0123919436
Category: Technology & Engineering
Page: 376
View: 9532

Continue Reading →

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

Reliable Design of Medical Devices


Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9781420001013
Category: Medical
Page: 728
View: 2799

Continue Reading →

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.

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: 1445

Continue Reading →

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.

Design, User Experience, and Usability: Health, Learning, Playing, Cultural, and Cross-Cultural User Experience

Second International Conference, DUXU 2013, Held as Part of HCI International 2013, Las Vegas, NV, USA, July 21-26, 2013, Proceedings
Author: Aaron Marcus
Publisher: Springer
ISBN: 3642392415
Category: Computers
Page: 622
View: 2725

Continue Reading →

The four-volume set LNCS 8012, 8013, 8014 and 8015 constitutes the proceedings of the Second International Conference on Design, User Experience, and Usability, DUXU 2013, held as part of the 15th International Conference on Human-Computer Interaction, HCII 2013, held in Las Vegas, USA in July 2013, jointly with 12 other thematically similar conferences. The total of 1666 papers and 303 posters presented at the HCII 2013 conferences was carefully reviewed and selected from 5210 submissions. These papers address the latest research and development efforts and highlight the human aspects of design and use of computing systems. The papers accepted for presentation thoroughly cover the entire field of Human-Computer Interaction, addressing major advances in knowledge and effective use of computers in a variety of application areas. The total of 282 contributions included in the DUXU proceedings were carefully reviewed and selected for inclusion in this four-volume set. The 67 papers included in this volume are organized in the following topical sections: cross-cultural and intercultural user experience; designing for the learning and culture experience; designing for the health and quality of life experience; and games and gamification.

Game Usability

Advancing the Player Experience
Author: Katherine Isbister,Noah Schaffer
Publisher: CRC Press
ISBN: 1498759572
Category: Art
Page: 398
View: 4344

Continue Reading →

Computers used to be for geeks. And geeks were fine with dealing with a difficult and finicky interface--they liked this--it was even a sort of badge of honor (e.g. the Unix geeks). But making the interface really intuitive and useful--think about the first Macintosh computers--took computers far far beyond the geek crowd. The Mac made HCI (human computer interaction) and usability very popular topics in the productivity software industry. Suddenly a new kind of experience was crucial to the success of software - the user experience. Now, 20 years later, developers are applying and extending these ideas to games. Game companies are now trying to take games beyond the 'hardcore' gamer market--the people who love challenge and are happy to master a complicated or highly genre-constrained interface. Right about now (with the growth of interest in casual games) game companies are truly realizing that usability matters, particularly to mainstream audiences. If it's not seamless and easy to use and engaging, players will just not stay to get to the 'good stuff'. By definition, usability is the ease with which people can emplo a particular tool in order to achieve a particular goal. Usability refers to a computer program's efficiency or elegance. This book gives game designers a better understanding of how player characteristics impact usability strategy, and offers specific methods and measures to employ in game usability practice. The book also includes practical advice on how to include usability in already tight development timelines, and how to advocate for usability and communicate results to higher-ups effectively.

Quantifying the User Experience

Practical Statistics for User Research
Author: Jeff Sauro,James R Lewis
Publisher: Morgan Kaufmann
ISBN: 0128025484
Category: Computers
Page: 350
View: 8160

Continue Reading →

Quantifying the User Experience: Practical Statistics for User Research, Second Edition, provides practitioners and researchers with the information they need to confidently quantify, qualify, and justify their data. The book presents a practical guide on how to use statistics to solve common quantitative problems that arise in user research. It addresses questions users face every day, including, Is the current product more usable than our competition? Can we be sure at least 70% of users can complete the task on their first attempt? How long will it take users to purchase products on the website? This book provides a foundation for statistical theories and the best practices needed to apply them. The authors draw on decades of statistical literature from human factors, industrial engineering, and psychology, as well as their own published research, providing both concrete solutions (Excel formulas and links to their own web-calculators), along with an engaging discussion on the statistical reasons why tests work and how to effectively communicate results. Throughout this new edition, users will find updates on standardized usability questionnaires, a new chapter on general linear modeling (correlation, regression, and analysis of variance), with updated examples and case studies throughout. Completely updated to provide practical guidance on solving usability testing problems with statistics for any project, including those using Six Sigma practices Includes new and revised information on standardized usability questionnaires Includes a completely new chapter introducing correlation, regression, and analysis of variance Shows practitioners which test to use, why they work, and best practices for application, along with easy-to-use Excel formulas and web-calculators for analyzing data Recommends ways for researchers and practitioners to communicate results to stakeholders in plain English

Institutionalization of Usability

A Step-by-step Guide
Author: Eric Schaffer
Publisher: Addison-Wesley Professional
ISBN: 9780321179340
Category: Computers
Page: 276
View: 2873

Continue Reading →

"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.

Beyond the Usability Lab

Conducting Large-scale Online User Experience Studies
Author: William Albert,Thomas Tullis,Donna Tedesco
Publisher: Morgan Kaufmann
ISBN: 9780080953854
Category: Computers
Page: 328
View: 5214

Continue Reading →

Usability testing and user experience research typically take place in a controlled lab with small groups. While this type of testing is essential to user experience design, more companies are also looking to test large sample sizes to be able compare data according to specific user populations and see how their experiences differ across user groups. But few usability professionals have experience in setting up these studies, analyzing the data, and presenting it in effective ways. Online usability testing offers the solution by allowing testers to elicit feedback simultaneously from 1,000s of users. Beyond the Usability Lab offers tried and tested methodologies for conducting online usability studies. It gives practitioners the guidance they need to collect a wealth of data through cost-effective, efficient, and reliable practices. The reader will develop a solid understanding of the capabilities of online usability testing, when it’s appropriate to use and not use, and will learn about the various types of online usability testing techniques. *The first guide for conducting large-scale user experience research using the internet *Presents how-to conduct online tests with 1000s of participants – from start to finish *Outlines essential tips for online studies to ensure cost-efficient and reliable results

International Encyclopedia of Ergonomics and Human Factors, Second Edition - 3 Volume Set


Author: Waldemar Karwowski
Publisher: CRC Press
ISBN: 9780415304306
Category: Technology & Engineering
Page: 3728
View: 8650

Continue Reading →

The previous edition of the International Encyclopedia of Ergonomics and Human Factors made history as the first unified source of reliable information drawn from many realms of science and technology and created specifically with ergonomics professionals in mind. It was also a winner of the Best Reference Award 2002 from the Engineering Libraries Division, American Society of Engineering Education, USA, and the Outstanding Academic Title 2002 from Choice Magazine. Not content to rest on his laurels, human factors and ergonomics expert Professor Waldemar Karwowski has overhauled his standard-setting resource, incorporating coverage of tried and true methods, fundamental principles, and major paradigm shifts in philosophy, thought, and design. Demonstrating the truly interdisciplinary nature of this field, these changes make the second edition even more comprehensive, more informative, more, in a word, encyclopedic. Keeping the format popularized by the first edition, the new edition has been completely revised and updated. Divided into 13 sections and organized alphabetically within each section, the entries provide a clear and simple outline of the topics as well as precise and practical information. The book reviews applications, tools, and innovative concepts related to ergonomic research. Technical terms are defined (where possible) within entries as well as in a glossary. Students and professionals will find this format invaluable, whether they have ergonomics, engineering, computing, or psychology backgrounds. Experts and researchers will also find it an excellent source of information on areas beyond the range of their direct interests.

Usability testing and research


Author: Carol M. Barnum
Publisher: Longman Pub Group
ISBN: 9780205315192
Category: Computers
Page: 428
View: 4180

Continue Reading →

Built on a solid foundation of current research in the field, Usability Testing and Research provides a comprehensive, up-to-date perspective in this increasingly important area of technical communication. Based on the most current research in the field, this book reflects the most recent developments and studies on this topic available. Sidebars throughout the book catch the attention of the readers and highlight key concepts in the text. A chapter on web testing provides coverage of what is now the hottest area in usability testing. End of chapter discussions and exercises reinforce learning. Frequent examples of planning, conducting, and reporting usability tests present current samples of projects. An appendix on teamwork gives pertinent advice in an area neglected by other texts: building and coordinating cross-functional teams for usability testing. For those interested in usability testing and research.

Medical Devices

Managing the Mismatch : an Outcome of the Priority Medical Devices Project
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category: Medical
Page: 129
View: 8719

Continue Reading →

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Development of FDA-regulated Medical Products, Second Edition

A Translational Approach
Author: Elaine Whitmore
Publisher: ASQ Quality Press
ISBN: 0873898338
Category: Business & Economics
Page: 256
View: 7874

Continue Reading →

Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates.