• Dear FDA

    By Eric F Shaver, PhD Earlier this month, the Human Factors and Ergonomics Society (HFES) held the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future in San Diego, California. The event was well attended by researchers, practitioners, industry representatives, and students from around the world with an interest in […]

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  • The Plunger Blues

    By Christina Mendat, PhD This is the third in a six-part series on prefilled syringes where we address some issues we’ve encountered in our multiple client engagements. What’s in a plunger you may ask? A lot more than one may think. A plunger is a plunger right? So, how do you set the dose? Some […]

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  • Size Does Matter for Syringe Flanges

    By Christina Mendat, PhD This is the second in a six-part series on prefilled syringes where we address some issues we’ve encountered in our multiple client engagements. Not all flanges are created equally. One place we often don’t see human factors used enough is when selecting a particular off-the-shelf component. A good feature to solicit […]

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  • On-Syringe Labeling

    By Christina Mendat, PhD Prefilled syringes seem to be taken for granted when it comes to human factors evaluations and testing. However, it has been our experience (working on multiple prefilled syringes) that these combination products have more to them than meets the eye. This is the first of a six-part series on prefilled syringes […]

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  • Real Device Labeling for Real People

    By Heather Colbert On September 29th and 30th, 2015, the FDA hosted a public workshop on “Medical Device Patient Labeling.” The workshop was organized by the Center for Devices and Radiological Health (CDRH) with participation by FDA staffers from the Center for Drug Evaluation and Research (CDER). The purpose of the workshop was to discuss […]

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  • IEC 62366-1:2015 – More Than A Checkbox

    By Eric F Shaver, PhD Introduction In February, the International Electrotechnical Commission (IEC) published IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices, which revised and replaced both the IEC 62366:2007 and IEC 62366 Ed 1.1:2014. That same month the Association for the Advancement of Medical Instrumentation (AAMI) and the American […]

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  • FDA Offers New HF Guidance

    By Tim Reeves, PhD CHFP Introduction This past June 2011 marked the release of a new guidance document from the FDA titled Applying Human Factors and Usability Engineering to Optimize Medical Device Design. It is the first new guidance on human factors from the Agency in more than 10 years and it marks a significant […]

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  • Usability Bench Test™

    By Tim Reeves, PhD CHFP Our Usability Bench Test™ provides a quick and cost-effective evaluation of potential usability issues with a software application or medical device user interface. The Bench Test can be performed at the earliest stages of your product’s development, while there is still an opportunity to introduce effective design solutions. Solves These […]

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  • Formative Usability Testing

    By Tim Reeves, PhD CHFP The simplest, most effective way to understand how to improve your product is to watch people use it. Human Factors MD conducts Formative Usability Testing for clients to evaluate the usability of their medical software or device design. We put early product concepts or design prototypes into the hands of […]

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  • Human Factors and the QSR

    By Tim Reeves, PhD CHFP As a manufacturer, you are required by FDA to demonstrate how human factors considerations were met during your product’s development. To assist manufacturers in understanding the regulations, FDA issued several guidance documents to support its human factors initiative, including Do It By Design: An Introduction to Human Factors in Medical […]

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