Usability Testing of Medical Devices Second Edition

Author: Michael E. Wiklund, P.E.
Publisher: CRC Press
ISBN: 9781466595897
Release Date: 2015-12-23
Genre: Medical

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.

Handbook of Human Factors in Medical Device Design

Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Release Date: 2010-12-13
Genre: Technology & Engineering

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 Software Verification Validation and Compliance

Author: David A. Vogel
Publisher: Artech House Publishers
ISBN: 1596934220
Release Date: 2011-01
Genre: Medical

Here's 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 a much broader, higher-level picture than other books in this field, this book helps professionals think critically about software validation -- to build confidence in their software's safety and effectiveness. The book presents validation activities for each phase of the product 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, and in compliance with regulations.

Handbook of Usability Testing

Author: Jeffrey Rubin
Publisher: Wiley
ISBN: 0471594032
Release Date: 1994-04-29
Genre: Computers

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

Design Controls for the Medical Device Industry Second Edition

Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 9781466503557
Release Date: 2013-11-12
Genre: Medical

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.

Medical Device Use Error

Author: Michael Wiklund
Publisher: CRC Press
ISBN: 9781498705806
Release Date: 2016-01-06
Genre: Technology & Engineering

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.

Contextual Inquiry for Medical Device Design

Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 9780128018743
Release Date: 2015-05-29
Genre: Technology & Engineering

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 and Ergonomics in Health Care and Patient Safety Second Edition

Author: Pascale Carayon
Publisher: CRC Press
ISBN: 9781439830345
Release Date: 2016-04-19
Genre: Technology & Engineering

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.

Handbook of Human Factors Testing and Evaluation

Author: Samuel G. Charlton
Publisher: CRC Press
ISBN: 9780805832907
Release Date: 2001-12-01
Genre: Technology & Engineering

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.

Quantifying the User Experience

Author: Jeff Sauro
Publisher: Morgan Kaufmann
ISBN: 9780128025482
Release Date: 2016-07-12
Genre: Computers

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

Reliable Design of Medical Devices

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 1420001019
Release Date: 1997-01-30
Genre: Medical

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.

Game Usability

Author: Katherine Isbister
Publisher: CRC Press
ISBN: 9781498759571
Release Date: 2015-09-15
Genre: Art

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.

Moderating Usability Tests

Author: Joseph S. Dumas
Publisher: Elsevier
ISBN: 0080558275
Release Date: 2008-04-09
Genre: Computers

Moderating Usability Tests provides insight and guidance for usability testing. To a large extent, successful usability testing depends on the skills of the person facilitating the test. However, most usability specialists still learn how to conduct tests through an apprentice system with little formal training. This book is the resource for new and experienced moderators to learn about the rules and practices for interacting. Authors Dumas and Loring draw on their combined 40 years of usability testing experience to develop and present the most effective principles and practices – both practical and ethical – for moderating successful usability tests. The videos are available from the publisher's companion web site. Presents the ten “golden rules that maximize every session’s value Offers targeted advice on how to maintain objectivity Discusses the ethical considerations that apply in all usability testing Explains how to reduce the stress that participants often feel Considers the special requirements of remote usability testing Demonstrates good and bad moderating techniques with laboratory videos accessible from the publisher’s companion web site

Medical Device Design

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

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

Beyond the Usability Lab

Author: William Albert
Publisher: Morgan Kaufmann
ISBN: 0080953859
Release Date: 2009-12-21
Genre: Computers

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