News and Insights

By Patricia Anderson, MSE Preparing proper documentation for an FDA submission can be a lengthy and daunting process. Luckily, when it comes to human factors specific documentation,  Core can help you . An HFE/UE Summary Report is an important part of your FDA submission – it is the culmination of your research, design, and human factors (HF) process that defends your argument to FDA that your medical device or combination product is safe and usable. Although it is called a “summary report,” FDA guidance lists many different sections that go in the report along with lengthy descriptions of what each section should contain. This report is key to getting your product on the market. Imagine that getting your device onto the market is like going to court. In that imagined scenario, you need to argue to the judge (FDA) that your product is innocent (safe and usable) beyond a reasonable doubt. The HFE/UE Summary report is your defense lawyer for your HF process. The report should ...

By Arathi Sethumadhavan Check out our new article published by Med Device Online  here . This article discusses the design and human factors testing of instructional materials for medical devices. Specifically, we discuss the role of instructional materials as part of the product interface, the importance of considering the product’s use, users, and risk profiles when developing the instructional materials, design principles for creating usable instructions, techniques to test the efficacy of instructions, and limitations of instructions in the hands of real-world users. A Guide to Developing Usable Instructions For Use For Medical Devices

By Marc Egeth “ Theory of Mind”  refers to individuals’ cognitive ability to represent other individuals’ mental states. It is the sort of thing that is theorized to be somehow central to the human condition, underlying the ability to take into account other people as thinking, feeling individuals. Psychologists have examined the development of Theory of Mind as it emerges in toddlers and along with biologists have looked at the evolution of Theory of Mind by considering primates, dolphins, birds, and other seemingly smart animals’ ability to take others’ perspectives. A Theory of Mind deficit has been theorized to explain, or at least describe, the social interaction difficulties present in the autism and asperger’s neuro-atypical continuum personalities. A person with deficient Theory of Mind has a hard time understanding other people’s points of view. Some research has pointed to  tradeoffs  where the types of people who are employed to design and develop devices ...

By Christopher Kim Imagine that, a couple of times this past month, you had some difficulty catching your breath after a routine, morning jog. You tell your doctor about it, and after some questions and tests to  assess your lung function, you are diagnosed with exercise-induced asthma. Your primary care physician (PCP) prescribes you a standard, short-acting beta agonist (SABA) in the form of an albuterol inhaler, and now the saga begins! You are asked to schedule a visit with your PCP to follow-up and discuss your treatment plan, and you schedule a visit for next month. In the meantime, your physician tells you to follow the instructions and use the inhaler as a prophylactic prior to vigorous exercise or PRN ( pro re nata  – use when necessary). In the mean time… As Dennis Hopper’s character famously said in one of my favorite movies from the 90’s, “ What do you do, Jack? What do you do?!”  (Speed) With over 18.4 million adults and 6.2 million children in t...

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 ...