Improving Medical Device Complaint Management with Human Factors

Improving Medical Device Complaint Management with Human Factors

In this blog post we discuss how best to integrate Human Factors Engineering with Complaint Management. The content from this post was presented at a poster session at the Human Factors Engineering Society’s Human Factors and Ergonomics in Health Care Conference…

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Experts Weigh In: Common Pitfalls to Avoid in Usability Testing

Experts Weigh In: Common Pitfalls to Avoid in Usability Testing

This is the second installment in the series of posts summarizing the Panel Discussion on Usability Testing and the Human Factors product submission process, which included UserWise's CEO, Shannon Clark. In this post, we address the question:

What are pitfalls to avoid when conducting usability testing for a medical device?

Numerous considerations for conducting usability validation testing were named by both the panel and the audience, the most important pitfalls to avoid include...

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Shannon Clark's latest Article on Human Factors and Usability Testing

Human Factors Engineering, an important facet of product development focused on minimizing or eliminating human error through the design of a medical product, is now becoming one of the most critical stages in the design process for medical devices. Shannon Clark, CEO of UserWise, has written an in-depth article on Human Factors and Usability Engineering for Medical Devices that has been...

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Out-of-the-Box Medical Device Safety

Executive Summary: Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications related to IEC 62366-1. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced through human factors engineering by conducting usability studies related to the out-of-the-box experience.

Read the full paper here

Cognitive Bias in Usability Testing

Executive Summary: Cognitive bias is the tendency to subconsciously change ones actions or thought process based on someone else’s comments or behavior. It is important to consider cognitive bias when performing a usability study because it can significantly alter or impair the validity of the results. While cognitive bias cannot always be entirely eliminated, identifying key cognitive biases to which usability study results are particularly susceptible is the first step to mitigating them. Once experimenters are alert to these subtle traps, they can consider approaches that sidestep the biases and greatly improve the accuracy and overall effectiveness of a usability study.

Read the full paper here