Validating design in a COVID World: The challenge of physical stimuli in a remote setting
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionIpsos HF/UX partnered with AbbVie in developing a instructions for use and supporting packaging materials for a medication used to treat a chronic medical condition. The human factors work that began in 2018 was scheduled to wrap up by the spring of 2020 ahead of a filing with the FDA. The research had undergone several design iterations and research sprints ahead of the summative round of research to meet the product’s deadline. The unforeseen and unprecedented arrival of the COVID-19 pandemic necessitated a reconfiguration of human factors testing methodology.
The onset of the COVID-19 pandemic at the beginning of 2020 forced businesses in all industries to innovate and pivot with creative strategies. In the realm of human factors and ergonomics for pharmaceutical products, the big challenge of how to test physical stimuli safely arose to the forefront. For pharmaceuticals and medical devices it is critical that one understands how the end user will interact with the physical interface of the product in order to ensure a complete and effective therapy. However, issues of participant safety and safe handling of pharmaceutical products/medical devices must also be considered in order to ensure that the study is being conducted in both a safe and effective manner.
In this presentation we will focus on two major points of interest: potential methodologies to be used in a remote environment and a case study on the method that was used to validate a pharmaceutical product for FDA submission.
First we will discuss potential methodology and explore the pros and cons of each one. Potential methods we will explore include shipping materials to participants, creating a virtual environment for participants to interact with product concepts, and providing a platform for which users can instruct moderators how they would interact with stimuli using an actor as a proxy. We will discuss benefits, logistics, and potential risks identified with each methodology. Each method listed previously taxed participants comprehension, cognitive abilities, and feasibility to complete in different ways. We will conclude this section by explaining why we ultimately chose to conduct a usability study using an actor as a proxy.
Next we will segue into a case study of how we redesigned an in-person study to a remote methodology. This was initially done in response to local shutdowns from COVID-19 that made in-person research not possible, and it included uncovering suitable platforms for testing, designing the appropriate methodology, and lessons learned from the experience. We will detail what made these remote testing factors successful for the purposes of our research.
We will end the talk by discussing the potential of using these methods in a post-COVID world, as there are implications of how these test methods may be useful in recruiting hard to reach populations, may allow for a global reach, and they may serve as precursors to fully immersive virtual testing environments in the future.