• Now is the Time to Make Progress on Your Device Labeling

    This is the fourth post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis. Device labeling (e.g., user manuals, instructions for use (IFU), quick start guides, on-screen instructions, posters, on-device labels, cartons, trays, etc.) is an important component of the […]

    Read More

  • Keep Your Documentation Rolling

    This is the third post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis. Now is the perfect opportunity to devote the time that you might normally have spent traveling to observe or prepare for face-to-face research to developing critical […]

    Read More

  • You Don’t Have to Stop Testing

    This is the second post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis. COVID-19 has had an unprecedented effect on many companies with telecommuting at an all-time high. With the CDC, the Federal government, and various state governments advising […]

    Read More

  • Don’t Let COVID-19 Stop your Progress

    This is the first post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis. The rapid onset of the COVID-19 crisis has many businesses grappling with how to maintain momentum on their development programs, especially as it relates to human […]

    Read More

  • 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 […]

    Read More

  • 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 […]

    Read More

  • 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 […]

    Read More

  • 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 […]

    Read More

  • 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 […]

    Read More

  • 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 […]

    Read More