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 Y. STROCHLIC Research Director of Human Factors Engineering (HFE) Underwriters Laboratories
Allison Y. 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 B.S. in Human Factors at Tufts University and her M.S. in Human Factors in Information Design at Bentley University.
MICHEALl 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, Mr. 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.
Mr. 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.
Selling Devices vs. Selling Drugs: Implications for UX KOREY JOHNSON
Historically, the molecule or the drug has been the hero of a combination product. After all, the drug is what treats the disease. But in a market becoming more and more saturated by generics and bio-similars, delivery devices are increasingly important as differentiators that can have incremental improvement on the end users’ quality of life. Manufacturers are responding by devoting resources to develop not only next-generation drugs, but also next generation devices – many of which are increasingly interconnected in systems of devices. This is a trend for which medical devices are actually lagging behind other industries but a clear direction nonetheless. As manufacturers move in this direction, it is increasingly important for them to consider the human factor in the development of those next generation devices.
As Vice President at GfK, Korey Johnson manages the global Healthcare UX practice. Johnson works closely with medical device manufacturers to plan and manage programs of human factors research that lead to the design of safe and effective medical devices.
Since joining GfK, Johnson has managed and conducted research in many therapeutic areas and with many devices, including injection devices, infusion pumps, diagnostic devices and imaging devices.
Johnson has an M.S. in Human Factors Psychology from the University of Idaho and a B.A. in Psychology from Lewis and Clark College.
Life and Death and Devices: Lessons from the Creation of a Critical Care Physician DR. JORDAN BONOMO
This presentation will briefly describe the training of a modern "resuscitationist” and emergency physician through the indelible lessons taught in residency and fellowship. From the perspective of medical devices we call upon daily, we’ll follow a critically injured patient through the pre-hospital helicopter EMS environment, the Emergency Department, the unique care received in the OR and ICU and ultimately organ donation. This journey will focus on the vast arsenal of equipment involved in critical care and resuscitation and the challenges clinicians face daily in providing high-level, high-stakes critical and resuscitative care. This journey includes mindful debate of the cost of medicine and the failings of ultra-early prognostication. We will touch on newly developed strategies of using advanced resuscitation devices to increase organ donation and the future of the interface between devices and the ethics of dying (and living) in the modern world of ultra high-speed medicine.
Case Study 5 | Concept Synthesis (sub session of Infection Control in the Hospital Workshop) JOE CESA
The group will use a collaborative charrette session to ideate and rapidly capture ideas into an actionable design proposal based on prioritized requirements from previous sessions - Contextual Inquiry and Insight Translation. Attendees will participate in activities to conceptualize, build upon, prioritize and refine many ideas into a single synthesized concept idea. This output will be utilized for further design refinement, development and prototyping during the Interaction Design session.