Instructions for use (IFUs) and quick reference guides (QRGs) often play a critical role in ensuring the safe and effective use of medical devices. These documents not only help novice users perform tasks correctly, but also help experienced users stay on track with tasks performed infrequently, including those associated with emergencies and those associated with device troubleshooting. Accordingly, it is worth the investment to develop high-quality IFUs and QRGs. This case study will review the steps to effective IFU and QRG development, including developing a vision of how the intended users will interact the documents, developing a document design specification and then progressing through an iterative process of design and usability testing to optimize the documents. The case study will conclude with the review of a sample QRG for an infection control device.
Usability testing is central to producing a medical device that is safe and effective, as well as commercially successful. This is why many countries have established regulations and uphold consensus standards calling for usability testing. Moreover, many countries call for manufacturers seeking regulatory approval of a given medical device to submit evidence that the device is not subject to potentially harmful use errors; evidence that comes from conducting a so-called summative usability test. This case study will review the steps associated with conduct a summative usability test, including deriving user tasks from a use-related risk analysis, identifying distinct user groups and test participant characteristics and collecting performance data (e.g., task failures, use errors, close calls, difficulties). The case study will conclude with a demonstration usability test of an infection control device.
ALLISON STROCHLIC Research Director of Human Factors Engineering (HFE) Underwriters Laboratories
Allison Strochlic represents UL (Underwriters Laboratories), where she serves as research director of the organization's human factors engineering (HFE) practice. She manages and contributes technically to user research, user interface design and usability testing work on various medical devices and pharmaceutical products. Strochlic is co-author of Usability Testing of Medical Devices and several technical papers focused on applying HFE to medical device development. She is a part-time lecturer at Tufts University. She earned her BS in Human Factors at Tufts University and her MS in Human Factors in Information Design at Bentley University.
MICHAEL WIKLUND Underwriters Laboratories General Manager of Human Factors Engineering (HFE)
Michael Wiklund represents UL (Underwriters Laboratories), where he serves as general manager of the organization's human factors engineering (HFE) practice. A certified human factors professional, Wiklund has helped clients develop high-quality user interfaces for medical devices ranging from over-the-counter devices to surgical instruments to diagnostic workstations. He has made substantial contributions to human factors standards for medical devices. His recent publications include Usability Testing of Medical Devices, Handbook on Human Factors in Medical Devices and Designing Usability into Medical Products. He teaches courses on human factors in medical technology and software user interface design at Tufts University.
Many development teams dread the thought of performing risk assessment, as it appears tedious and non-creative. While both are potentially true, strategic implementation of risk assessment helps teams to think creatively about how to solve use risks that could cause harm.In this workshop, Continuum’s Sean Phillips will consider key aspects of ISO 14971:2012 Application of Risk Management to Medical Devices. Reviewing inputs from the infection control case study, participants will explore how top-down hazards analysis and bottom-up application failure modes and effects analysis (FMEA) tools are created. The team will then identify potential use errors that could cause harm and explore potential design mitigations. In closing, Phillips will discuss the benefits and challenges of implementing risk assessment early in development programs.
SEAN PHILLIPS Principal, Human Factors Engineer Continuum Advanced Systems
For over 20 years, Sean Phillips has led discovery and human factors research across pharmaceutical, diagnostic and surgical verticals. He has presented at human factors conferences, as well as IDSA and academic meetings. Phillips is a principal human factors engineer at Continuum’s Advanced System. Prior to joining Continuum, he led research teams at Rocket and Radius consultancies near Boston, as well as Gold Peak Industries in Hong Kong and Laerdal Medical Corporation in Norway. He received a Masters in Human Centered Design from Illinois Institute of Technology and a BFA in Sculpture from the University of Tulsa.