• 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

  • Keep Your Documentation Rolling

    This is the third 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. Now is the perfect opportunity to devote the time that you might normally have spent traveling to observe or prepare for face-to-face research to developing critical […]

    Read More

  • You Don’t Have to Stop Testing

    This is the second 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. COVID-19 has had an unprecedented effect on many companies with telecommuting at an all-time high. With the CDC, the Federal government, and various state governments advising […]

    Read More

  • Don’t Let COVID-19 Stop your Progress

    This is the first 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. The rapid onset of the COVID-19 crisis has many businesses grappling with how to maintain momentum on their development programs, especially as it relates to human […]

    Read More