News and Insights

By Patricia Anderson A medical device recall is action taken to remove or correct a problem with a device on the market because it contains some defect, poses some risk to users, or otherwise violates regulatory law. Naturally, manufacturers go to great lengths to prevent recalls from happening with all the research conducted before a device ever comes to market. However, you may wonder exactly how recalls work – both in the US and outside the US. While countries handle recalls differently, this article contains an overview of three examples of how countries handle recalls: recalls in the UK, the EU and the US. In the UK: Recalls in the UK are conducted and regulated by The Medicines and Healthcare products Regulatory Agency (MHRA), which is a government organization that was established in 2003. Prior to this, the MHRA existed as aspects of two separate organizations, Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The role of the MHRA in medical device...

By Naomi Cherne In a courageous parenting move, my parents not only encouraged the question “why?” but also taught that an unaccompanied “because” (as in “Because I said so!”) was not an acceptable answer. We children embraced this cognitive tool, much to the chagrin of babysitters.  There was much to learn, and each answer raised new questions.  Why do I have to wear mittens? Why is it cold outside? Why is it winter? Years later, not much has changed: people are still paid to undergo my “why” barrage. However, these people are no longer overwhelmed babysitters; they are participants in usability studies and their answers help improve product designs. Generally speaking, a typical goal of a  usability study  is to get people to try to use a product or system (let’s say a new mitten design), and to understand why they took any unintended actions (let’s say wore it inside-out). Researchers ask questions to uncover root causes (for example, that the outer fabri...

By Sam Sye A key step in designing any human factors study is to define the intended user groups. User groups are determined by unique demographic characteristics that may impact how a particular user interacts with a given medical device. These characteristics may include age, gender, education level, medical literacy, prior experience with similar products, or any number of other factors. Every human factors study requires determining which of these characteristics are relevant, and subsequently, how these might be represented appropriately in a study. At the surface, it is logical that study participants should be representative of real-life end users. How else could one determine if safety mitigations and product designs facilitate treating patients safely and effectively? However, medical and pharmaceutical companies must wear many hats. On one hand, they have a responsibility to develop safe and useful products that promote health and alleviate suffering. On the other, a...

By Arathi Sethumadhavan The employees at Core Human Factors unleashed their inner Picasso, engaging in creative thinking and socializing at Paint Nite. Results were some spectacular masterpieces!

By Patricia Anderson Paper prototyping is a simple way to get complex and valuable insight into your user interface. It is a user-centric design technique that can be an effective means of early usability testing. The typical application is software of some sort, be it an app, website, or other software interface. To create paper prototypes, different screens are typically sketched on a series of papers that can be manually navigated by switching the piece of paper you’re looking at. These sketches are usually made without extensive work going into choosing the “final” fonts, colors, or images. Rather, they may have the words, buttons, placeholders for pictures, text boxes and other elements arranged as they might be arranged in the final version to test the readability and understandability of the screens, and how well users can navigate between screens.   Usabilitygeek.com  compiled a list of some of the largest benefits to paper prototyping: User involvement at a...

By Arathi Sethumadhavan and Patricia Anderson  Instructions for Use (IFU) is a frequently discussed and debated topic in the Health Care Human Factors world. How to test them? What do they mitigate? What should be in them? Often, companies despair when it comes to their device’s IFU because it seems like users never bother to read the IFU. So, what is the point in pouring time and resources into developing, testing and validating them? While it is true that many users opt not to read IFUs, they are nevertheless hugely important. “Good” IFUs versus “bad” IFUs make a huge difference not only in user experience, but also in how users perform with products. Think about your own experience with “good” and “awful” instructions. Although few people enjoy building Ikea furniture, their instructions have been appreciated because they are easy to follow, easy to use, and are multilingual because they actually include very few words at all (if any). On the other hand, most of us have e...

By Arathi Sethumadhavan In my last blog post, I wrote about the common usability misconceptions that Philip Kortum identified in his   latest book . In this blog, I will discuss the usability metrics that the author has identified and provide my impressions on the suitability of these metrics to evaluate products. Effectiveness –Effectiveness is the ability of a user to perform a task. –Was the user able to complete the task without any difficulties? Did the user struggle initially but was finally able to complete the task? Was there a use error but did the user recover without any help? –During a usability evaluation, researchers typically capture errors of omission, errors of commission, out of sequence errors, and close calls. Effectiveness can be a useful metric to understand user interactions with a plethora of products from consumer products to medical devices. For example, is the user able to use a microwave to warm his or her food? Were the buttons on th...