Publications

Here are some links to some of our technical papers and presentations on human factors in design, as well as our recent books.

Books

Medical Device Use Error Root Cause Analysis

by Michael Wiklund, Andrea Dwyer, and Erin Davis

Medical Device Use Error Root Cause Analysis

This book offers practical guidance on how to methodically discover and explain the root cause of a use error (mistake) that occurs when someone uses a medical device. From home-use products to devices used in clinical environments, the text presents case studies that show how root cause analysis leads from understanding a use error's causes and consequences to the development of design-based preventions. Using clear illustrations and simple narrative explanations, the text covers the fundamentals, language, and regulatory expectations of root cause analysis.

Usability Testing of Medical Devices, Second Edition

by Michael Wiklund, Jonathan Kendler, and Allison Strochlic

Usability Testing of Medical Devices

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 a device 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. The book 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.

Since publication of the first edition, the FDA and other organizations and agencies 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 include guidance pertaining to new FDA and IEC requirements, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.

Handbook of Human Factors in Medical Device Design

Edited by Matthew Weinger, Michael Wiklund, and Daryle Gardner-Bonneau

Handbook of Human Factors in Medical Device Design

Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single, consolidated 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. The book then focuses on applied design issues, offering guidance on the design of specific devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance distills professional judgment extracted from the contributing authors? years of experience in applied analysis and design.

Designing Usability into Medical Products

By Michael Wiklund and Stephen Wilcox

Designing Usability into Medical Products

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.

Anesthesia Informatics

J. Stonemetz and K. Ruskin (editors), Chapter 5 – Ensuring Usability Through Human Factors Engineering, by Michael Wiklund and Jonathan Kendler.

Designing Usability into Medical Products

Wiklund’s and Kendler’s contribution to Anesthesia Informatics introduces readers to the human factors of software applications and discusses how future anesthesia information management systems can be designed to maximize usability and appeal while reducing the chance of use error.

Medical Instrumentation: Accessibility and Usability Considerations

J. Winters and M.F. Story (editors), Chapter 16 – Human Factors Standards for Medical Devices Promote Usability, by Michael Wiklund.

Designing Usability into Medical Products

Wiklund’s contribution to Medical Instrumentation offers his perspective on today’s human factors standards as they relate to making medical devices more accessible to individuals with physical impairments. He points out that medical instruments that accommodate people with physical impairments are often more useful and pleasing to the user population as a whole, reflecting the underlying principle of universal design.

Webinars

Human Factors Approaches to Ensuring Safe Medical Devices

An AAMI Webinar moderated in November 2008 by Michael Wiklund and Jonathan Kendler

Design engineers, quality system managers, risk managers, and compliance officers have a responsibility to their employer, the clinician user, and the public to ensure that their medical device products are safe and effective.  It is for this reason that medical device professionals must have a solid understanding of FDA regulations, possible hazards resulting from design flaws, and detailed steps to conduct and validate usability tests.  To educate industry professionals on human factors concepts, AAMI offered a new three-part webinar series that provided participants with the opportunity to increase the safety and efficacy of their medical device products. Source: AAMI.

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