News and Insights

Core Human Factors will be attending a workshop exploring  the use of human factors methods to improve patient safety . This workshop is hosted by the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine. Come meet Director Christopher Kim MD at the April workshop and find out how  Core Human Factors  can help you implement  human factors methods  to identify and mitigate issues that can lead to safety hazards for patients and others, such as caregivers and healthcare providers.

Core Human Factors will be attending the  HFES Healthcare Symposium  in Boston, MA on March 26th to 28th, 2018. Come meet CEO Adam Shames, Senior Director Jennifer Soosaar PhD, and Associate Sam Sye BA and BS. Sam Sye will be presenting a poster on maximizing participant buy-in during simulated-use studies. You can visit the poster from 4:30 – 6:00 pm on March 27th. Explore how  Core Human Factors  can help you  research and develop your products ! Interested in career opportunities? We are always looking for talented people to join our team. Come chat with us to see what opportunities we may have now or in the future!

Core Human Factors is happy to announce that CEO Adam Shames will be speaking at the  510k Workshop for Medical Devices  in Las Vegas on March 19th, 2018. He will be discussing how to design and conduct  human factors studies  for 510k submissions. More information about this event can be found  here . Learn how Core Human Factors can help you design and conduct  human factors studies .

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...