• Corinna Proctor Joins Human Factors MD

    Human Factors MD is pleased to announce that Corinna Proctor has joined the company as a Technical Director. Corinna has nearly 20 years of experience employed in the field of Human Factors. She has worked in a variety of domains including medical hardware, health IT, and consumer / commercial IT product development. She has expertise […]

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  • Liz Mauer Joins Human Factors MD

    Human Factors MD is pleased to announce that Liz Mauer has joined the company as a Senior Consultant. Liz has over 15 years of diverse experience in human factors research, design, and testing. She has particular expertise in planning, conducting, and analyzing findings from user research studies and translating those findings into directions for useful, […]

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  • 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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  • Tim Reeves Joins AAMI Faculty

    Tim Reeves, our Managing Director, will be among the faculty at AAMI’s upcoming Human Factors for Medical Devices course presented in Arlington, Virginia May 2 through 4 and in Dublin, Ireland June 6 through 8. This three day public course offers participants a comprehensive introduction to human factors as it relates to medical devices. Course […]

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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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