• Lean On (Your Formatives)

    By Corinna Proctor, MS The FDA and ANSI/AAMI/IEC 62366-1 provide guidance on the device design process and where human factors formative studies fit in, and what is expected. If the agency sees your submission with no Formative usability work, your submission may be ‘flagged.’ After many years in the business, we are still seeing go-to-market […]

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  • Tips for Designing Effective Medical Equipment Reprocessing Instructions

    by Eric F. Shaver, PhD The last five years have seen increased focus on the importance of adequately reprocessing reusable medical equipment. One medical device specifically – duodenoscopes – has garnered much of the attention due to the challenges associated with its’ complex design. In fact, this year alone the FDA has sent out two […]

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  • Applied Human Factors in Medical Device Design

    Human Factors MD is pleased to have contributed to a new book covering the application of human factors to medical device design. Tim, Christina, Eric and Liz authored chapters on Root Cause Analysis and Human Factors Validation Testing of Combination Products. Our Root Cause Analysis chapter outlines a framework for understanding the causes of errors […]

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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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  • 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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