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.

Designing Usability into Medical Products

Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 9781420038088
Release Date: 2005-02-11
Genre: Medical

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.

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
ISBN: 9781596934238
Release Date: 2010
Genre: Biomedical engineering

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."

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.

Handbook of Usability Testing

Author: Jeffrey Rubin
Publisher: John Wiley & Sons
ISBN: 9781118080405
Release Date: 2011-03-10
Genre: Computers

Whether it's software, a cell phone, or a refrigerator, your customer wants - no, expects - your product to be easy to use. This fully revised handbook provides clear, step-by-step guidelines to help you test your product for usability. Completely updated with current industry best practices, it can give you that all-important marketplace advantage: products that perform the way users expect. You'll learn to recognize factors that limit usability, decide where testing should occur, set up a test plan to assess goals for your product's usability, and more.

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

The Medical Device R D Handbook

Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 9781420038354
Release Date: 2005-11-21
Genre: Medical

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.

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

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.

Don t Make Me Think

Author: Steve Krug
Publisher: Pearson Education
ISBN: 9780321648785
Release Date: 2009-08-05
Genre: Computers

Five years and more than 100,000 copies after it was first published, it's hard to imagine anyone working in Web design who hasn't read Steve Krug's "instant classic" on Web usability, but people are still discovering it every day. In this second edition, Steve adds three new chapters in the same style as the original: wry and entertaining, yet loaded with insights and practical advice for novice and veteran alike. Don't be surprised if it completely changes the way you think about Web design. Three New Chapters! Usability as common courtesy -- Why people really leave Web sites Web Accessibility, CSS, and you -- Making sites usable and accessible Help! My boss wants me to ______. -- Surviving executive design whims "I thought usability was the enemy of design until I read the first edition of this book. Don't Make Me Think! showed me how to put myself in the position of the person who uses my site. After reading it over a couple of hours and putting its ideas to work for the past five years, I can say it has done more to improve my abilities as a Web designer than any other book. In this second edition, Steve Krug adds essential ammunition for those whose bosses, clients, stakeholders, and marketing managers insist on doing the wrong thing. If you design, write, program, own, or manage Web sites, you must read this book." -- Jeffrey Zeldman, author of Designing with Web Standards

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.

Usability Testing Essentials

Author: Carol M. Barnum
Publisher: Elsevier
ISBN: 0123785537
Release Date: 2010-10-29
Genre: Computers

Usability Testing Essentials provides readers with the tools and techniques needed to begin usability testing or to advance their knowledge in this area. The book begins by presenting the essentials of usability testing, which include focusing on the user and not the product; knowing when to conduct small or large studies; and thinking of usability as hill climbing. It then reviews testing options and places usability testing into the context of a user-centered design (UCD). It goes on to discuss the planning, preparation, and implementation of a usability test. The remaining chapters cover the analysis and reporting of usability test findings, and the unique aspects of international usability testing. This book will be useful to anyone else involved in the development or support of any type of product, such as software or web developers, engineers, interaction designers, information architects, technical communicators, visual or graphic designers, trainers, user-assistance specialists, and instructional technologists. Provides a comprehensive, step-by-step guide to usability testing, a crucial part of every product’s development The fully updated four-color edition now features important usability issues such as international testing, persona creation, remote testing, and accessibility Follow-up to Usability Testing and Research (9780205315192, Longman, 2001), winner of the highest-level award from the Society for Technical Communication

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