News and Insights

By: Marissa Docimo, Nicole Stephenson, Jack Giacomini Selecting the right partner to support human factors (HF) research for your medical device or combination product is an important decision. The results of HF work can influence design decisions, regulatory approvals, and, ultimately, user safety. Given the complexity and importance of human factors engineering in the medical device industry, it’s essential to know what to look for when evaluating a proposal for an HF study. This post will walk you through the key criteria to consider when reviewing proposals to ensure you select a partner who can meet your project’s needs, work within your logistical constraints, and support your device’s regulatory approval. It will also help you consider how to evaluate proposals from different partners, and what to look for when selecting the option that best meets your needs. Your vendor support needs and priorities will vary from project to project. When reviewing proposals from multiple vendor

By: Laura Reinert One of the most important aspects of human factors research is making sure you have the right people in the room interacting with your product. How do we find a representative sample?   Participants in your human factors study should represent the intended users of your product so they behave similarly to what you would expect to see in real life. Modern recruitment methods allow for communication with a large variety of people, but how do we know who to include in the study? We use a recruiting screener. What is a recruiting screener?  The recruiting screener is a list of questions to ask potential participants to determine if they are representative users of your product. By asking specific questions, you can decide who accurately represents the intended users of your product and exclude people who do not. The screener also creates a record of how qualified people were found, what worked and what did not, and other important information, all of which could be

By: Allison Kampa and Tyler Oates A couple of our Core IRB reviewers answered common questions about the Institutional Review Board (IRB) process. If you have any questions that are not answered below, or would like more information about Core IRB services, please feel free to reach out to Core IRB through our website ( https://www.corehf.com/services/irb-services ) or via email ( irb@corehf.com ). Q: What are the benefits of having my study reviewed by an IRB? A: An IRB review is useful to ensure that your study is conducted in accordance with Office for Human Research Protections (45 CFR 46) or FDA regulations (21 CFR 50) and that research participants are physically, socially, and psychologically protected from any potential harms they could face while enrolled in the study. Q: What are the types of studies that Core IRB reviews? A: Core IRB specializes in reviewing minimal risk human factors and social/behavioral sciences studies that are conducted in the United States.

By: Rory Klingensmith My Journey to a Medical Human Factors Career Level 1: The Choice In college, we are challenged with the daunting prospect of funneling ourselves into one category that may serve as the biggest part of our identity for the next 40 years – choosing a major. My mom studied nursing and my dad studied civil engineering, but I did not want to work in healthcare or design bridges and buildings. I liked science, math, and solving puzzles (my favorite video game growing up was Portal 2), so I thought, “why not do it all – healthcare and engineering?” This reasoning led me to select biomedical engineering as my major. It was the perfect combination of learning how to help heal people and build things, without having to go to medical school or wear a hard hat.  Level 2: The Inspiration During my studies, I discovered there were prosthetics that could be controlled by the brain’s electrical signals, artificial organs grown from a few cells, catheters that could complete an ao

By: Ryan Bird Brain-computer Interfaces Brain-computer interfaces (BCI) are devices which allow users to communicate with computers via the electrical signals generated by neuronal firing (i.e., brain cell activity). For example, prosthetic limbs can be connected to the brain’s motor cortex (see Figure 1 below) with implantable electrodes, permitting the user to control the prosthesis just as they would any other limb. Although BCIs have been developed and tested in various forms in both human and non-human models for decades (i.e., cochlear implants), recent advances in artificial intelligence and surgical technology are paving the way for incredible medical breakthroughs once thought to be the stuff of science fiction. Figure 1: Motor Cortex Monumental Progress On December 22, 2021, Philip O’Keefe took over the Twitter account of Synchron ¹ CEO Thomas Oxley and posted a very short tweet. “Hello, world! Short tweet. Monumental progress.” It doesn’t appear to be much at first glance,

  By: Jack Sharples The increasing sophistication of AI tools like ChatGPT represents a major development in the usefulness of information on the internet. As experts in human factors consulting, our business runs on using our experience and acumen to guide our clients through the human factors process. We decided to see if ChatGPT “thinks” that their service could replace the real people here at Core Human Factors. It seems that ChatGPT does a great job at explaining why skilled humans haven’t been replaced quite yet, at least in human factors consulting! Check out the questions and responses below, and then go ahead and send us an email to get the conversation started. Can I rely on ChatGPT for medical human factors consulting? As an AI language model, I am not a medical human factors consultant, nor am I a substitute for one. While I can provide general guidance on human factors principles and best practices, I cannot provide specific advice on the design or testing of medical devi

By: Latanya S. H. King, PsyD A quick internet search will yield a definition of psychology as the scientific study of mind and behavior. But unfortunately, many people also assume they know exactly what psychology is, and never look beyond the quick and surface level definition. There are so many aspects of psychology that impact every career field, but often the average person only thinks about therapy. Through this same lens, many college freshmen pursue an undergraduate degree in psychology with the goal of becoming a practicing psychologist that provides various types of clinical treatment. My journey was no different. After earning a Bachelor of Arts in Psychology, a Master of Arts in Counseling Psychology, a Doctorate in Clinical Psychology, and completing post-doctoral requirements, I had accomplished my goal and was working as a Clinical Psychologist and Professor of Psychology. I LOVE clinical psychology. My passion for studying people, their thinking, and their behaviors