• Safety Information Components

    By Eric Shaver, PhD This is the second in a multipart series on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in device labeling. The research literature on safety information, specifically warnings, identifies four components (signal word, identification of the hazard, information on how to avoid the hazard, and consequences for […]

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  • Safety Information in Device Labeling

    By Eric Shaver, PhD This is the first in a multipart series on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in device labeling. Companies face mounting pressure to design and develop higher quality device labeling that meets the requirements of users. These pressures originate from several sources. First, over the […]

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  • Passive Needle Features (Sharps Protection)

    By Christina Mendat, PhD This is the fourth in a six-part series on prefilled syringes where we address some issues we’ve encountered in our multiple client engagements. An increasing number of prefilled syringes are being developed with a sharps protection feature. An example is depicted in the figure below.  The prefilled syringe is placed into […]

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  • Human Factors Testing and Clinical Research

    By Tim Reeves, PhD CHFP This month, I had the pleasure of giving an invited presentation at the 25th Annual Meeting of the Society of Clinical Research Associates (SOCRA) in Montreal, Canada. Over 1,000 people attended the three-day event. My presentation focused on the role of human factors testing in the development of combination products, […]

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  • Limitations of Stand-Alone Symbols in Labeling

    By Eric Shaver, PhD With the publishing of the FDAs Use of Symbols in Labeling final rule earlier this year, many companies are looking to incorporate “stand-alone symbols” (symbols without corresponding explanatory text) in medical devices labeling. This is understandable because symbols have the potential to: increase the salience of labeling, rapidly communicate important information, […]

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  • FDA Allows Stand-Alone Symbols on Labeling

    By Vince Velocci, MS As of June 15, the FDA has revised device labeling regulations to allow for “stand-alone symbols” on labels and labeling in general and additionally for the symbol statement “Rx only” on prescription devices. WHY The industry has asked for and been granted the ability to use stand-alone symbols consistent with those placed on […]

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  • Auto-Injectors, Nurses, and Mental Models

    By Tim Reeves, PhD CHFP Over the years we have run numerous usability studies with auto-injectors. And while auto-injectors provide significant usability advantages over more traditional syringes, from pre-set dosing to built-in sharps protection, we’ve certainly seen our share of users struggle to use these devices both safely and effectively. Curiously, those who sometimes have […]

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  • 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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