• Earlier this month our team had the opportunity to attend the 10th Annual International Symposium on Human Factors and Ergonomics in Health Care and our company was pleased to be the Silver Sponsor of this notable event.  The virtual event took place between April 12th – 16th and featured content in five educational tracks: Medical […]

    Read More

  • Reflections on Human Factors Programs During COVID-19

    2020 was a challenging year for so many around the world, and medical device and pharmaceutical companies were no exception. The needs these companies fill aren’t going away just because COVID-19 showed up. In fact, if the pandemic has taught us anything, it’s that the life-altering and life-saving therapies and products they develop are needed […]

    Read More

  • Frontline Workers Are the Real Heroes

    Human Factors MD would like to give a big shout out and thanks to all of the frontline workers that are facing this global pandemic. They are selflessly placing themselves in the path of this rapidly changing virus on a daily basis. It’s hard to express how thankful we are for their tireless dedication.   Even […]

    Read More

  • Christina Mendat, PhD Speaks at DIA Conference

    Last month, Christina Mendat, PhD, Managing Director for Human Factors MD, was an invited speaker at the annual DIA Combination Products Conference. This virtual event took place on October 15th and 16th and included professionals from regulatory agencies, pharmaceutical companies, and consultancies from around the world.  Christina participated in the Panel Discussion on Human Factors […]

    Read More

  • Pitfall #4: Focusing on Harm in Your URRA

    by Liz Mauer, MHCI This is the fifth in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks. URRAs can be useful tools to help proactively manage use-related risk. Most URRAs have a set of use-related risks and associated harms that range from negligible to serious. Manufacturers can prioritize […]

    Read More

  • Pitfall #3: Developing Your URRA Based On Your User Interface Design

    by Liz Mauer, MHCI This is the fourth in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks. It can be tempting to create your URRA by documenting the steps of use as they appear in the product’s user interface, using the same exact text and sometimes graphics found […]

    Read More

  • Pitfall #2: Not Considering Frequency in Your URRA

    by Liz Mauer, MHCI This is the third in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks. It can be hard to know how to make use of frequency of occurrence ratings when creating URRAs. On the one hand, the FDA (in their 2016 Human Factors Guidance), clearly […]

    Read More

  • Pitfall #1: Using Only One Methodology to Develop a URRA

    by Liz Mauer, MHCI This is the second in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks. While it is considered best practice to identify and characterize use-related risks by employing both empirical and analytical methods, we’ve noticed that when it comes to analytical methods in particular, most […]

    Read More

  • How Risky is Your Use-Related Risk Analysis?

    by Liz Mauer, MHCI This is the first in a multipart series about how to effectively identify, understand, and communicate a product’s use-related risks. It would be hard to understate the importance of a rigorous Use-Related Risk Analysis (URRA) when developing medical devices and combination products. Not only is a URRA necessary to satisfy a […]

    Read More

  • Now is the Time to Make Progress on Your Device Labeling

    This is the fourth post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis. Device labeling (e.g., user manuals, instructions for use (IFU), quick start guides, on-screen instructions, posters, on-device labels, cartons, trays, etc.) is an important component of the […]

    Read More