• 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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  • Kathy King Joins Human Factors MD

    Human Factors MD is pleased to announce that Kathy King has joined the company as a Research Associate. Kathy brings a diverse background to our company. She has over a decade of experience conducting cognitive psychology research as well as teaching psychology at the college level, including research design courses. Kathy started her human factors […]

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  • Tim Reeves Interviewed for AAMI News

    Tim Reeves, Senior Technical Director and Founder of Human Factors MD, was interviewed for the article “What Does It Mean to Design for Failure?” in the October 2019 issue of AAMI News. He provides his thoughts on the importance of understanding how design failures can negatively impact medical device use and why manufacturers should consider […]

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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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  • 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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