News and Insights

by  Arathi Sethumadhavan The team at Core Human Factors headed to the bowling alley for some bonding! What better way to provide team support and motivate each other?

By Timothy Visich We  partnered with Merck & Co., Inc and Samsung Bioepis and conducted a  simulated-use  comparative study on two autoinjectors used for the treatment of rheumatoid arthritis (RA). Rheumatoid arthritis (RA) is often treated by effective biologics delivered in different types of injection devices. RA patients, who are often limited in dexterity capabilities, are sometimes prescribed self-injection devices to deliver injections on themselves. Using an injection device for self-delivery can be a hard task for RA patients to complete, and even painful depending on the device being used. Recently, Merck & Co., Inc and Samsung Bioepis have developed the Brenzys autoinjector with the goal of improving the self-injection experience for RA patients. Brenzys (left) and Enbrel (right) While delivering a biosimilar of etanercept (Enbrel), the Brenzys device offers the following advantages: Eliminates the need for pressing down on an injection ...

By Naomi Cherne I was recently on an online forum for a touchscreen product because I was frustrated by a problem I kept having and the lack of any means to solve this problem (hey, did you know that toddlers like to touch interactive screens?). The company had a “feature suggestion” forum for its products and, sure enough, there was a post requesting a touchscreen lock feature. I clicked through to add my support for the request, and was confronted with pages and pages of ire. It seemed that the company had quickly released a new feature that met the original poster’s need but was not a touchscreen lock, and had marked the post as “Solved”. Hundreds of posters begged to differ, offering up use scenarios where the lack of a touchscreen lock prevented the intended use of the product, as well as a stream of anger towards the company, statements that they had returned the product, and descriptions of the competitor products they planned to purchase instead. When people could not ...

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!