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…

Read More

CleanCision™ Wound Retraction and Protection System receives FDA Clearance!

CleanCision™ .jpg

UserWise is proud to announce that Prescient Surgical’s CleanCision™ Wound Retraction and Protection System has received FDA 510(k) clearance! UserWise worked closely with Prescient Surgical in conducting Human Factors testing to minimize potential use errors associated with the use of CleanCision™. Learn more about CleanCision™ here

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...

Read More

Experts Weigh In: Consider Human Factors and Usability Early in Development for Success

Experts Weigh In: Consider Human Factors and Usability Early in Development for Success

UserWise’s Shannon Clark recently participated in an expert panel discussion hosted by the San Francisco Bay Area Biomedical Engineering Society focusing on important questions that companies encounter when trying to apply Human Factors and Usability for Medical Devices. A variety of questions, originating from the audience and from the experts own experience, were deliberated and answered throughout the night. The common theme that emerged from this panel was that human factors is now being recognized as an essential part of the medical device development process...

Read More

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...

Read More

Informing the Next Generation of Engineers

Shannon Clark’s recent talk at Santa Clara University informed prospective engineers on the importance of human factors and usability testing. Professor Gerardo Noriega’s classroom included the next generation of Santa Clara University bioengineers, as well as a handful of local startups. The audience was lead through how early implementation of human factors in the design process can reduce potential risk and cost through the product’s lifecycle.

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