Usability Testing of Medical Devices

Usability Testing of Medical Devices
Author: Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publsiher: CRC Press
Total Pages: 378
Release: 2010-12-20
Genre: Medical
ISBN: 9781439811849

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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 re

Usability Testing of Medical Devices Second Edition

Usability Testing of Medical Devices  Second Edition
Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic
Publsiher: CRC Press
Total Pages: 0
Release: 2015-12-18
Genre: Medical
ISBN: 1466595884

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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.

Usability Testing of Medical Devices

Usability Testing of Medical Devices
Author: Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publsiher: CRC Press
Total Pages: 477
Release: 2015-12-23
Genre: Medical
ISBN: 9781466595897

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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 h

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design
Author: Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publsiher: CRC Press
Total Pages: 844
Release: 2010-12-13
Genre: Technology & Engineering
ISBN: 9781420063516

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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

Medical Device Use Error

Medical Device Use Error
Author: Michael Wiklund,Andrea Dwyer,Erin Davis
Publsiher: CRC Press
Total Pages: 267
Release: 2016-01-06
Genre: Medical
ISBN: 9781498705806

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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

Medical Device and Equipment Design

Medical Device and Equipment Design
Author: Michael E. Wiklund
Publsiher: CRC Press
Total Pages: 402
Release: 1995-02-15
Genre: Technology & Engineering
ISBN: 0935184694

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The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design
Author: Mary Beth Privitera
Publsiher: Academic Press
Total Pages: 371
Release: 2019-06-15
Genre: Science
ISBN: 9780128161647

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Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method

Designing Usability into Medical Products

Designing Usability into Medical Products
Author: Michael E. Wiklund,Stephen B. Wilcox
Publsiher: CRC Press
Total Pages: 376
Release: 2005-02-11
Genre: Medical
ISBN: 9781420038088

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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.