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MDD18 - Lights, Camera, Action: Setting the Stage of your Simulated Use Environment
DescriptionWhen preparing for a human factors study there are many things to take into consideration. It can be easy to get so caught up in the study methodology that a key factor is overlooked…the simulated-use environment. A representative environment sets the scene for a study participant and prompts them to be in the mindset as if they were in a real-life scenario. It can seem simple to place objects in a study room to “simulate” an environment, and oftentimes this may be just fine, but it is our position that this activity should be rooted in a higher-level understanding of the use specification, characteristics of the environment that could affect use, and other related variables (e.g., stress levels, PPE, etc.).

On occasion, the agency has been known to comment on human factors validation test protocols due to insufficiently representative simulated use environments. Therefore, finding the perfect balance between accurately representing an environment while not drawing attention away from evaluating the device is crucial. In this poster, we will reflect on well-done simulated use environments, common mistakes we have seen, and tips and tricks to successfully simulate your use environment (without breaking the bank) and mitigate against the thing every human factors professional dreads when writing their reports: the study artifact.

Our poster will focus on the following themes:

1. Define the Intended Use Environments: What factors about the use environment(s) could impact device use, and therefore you should care about simulating in your study? What things can you ignore? Do you have to simulate multiple environments in one study or is one satisfactory? Our approach is to greatly leverage the use specification and use-related analysis.
• The first step is understanding use specifications. Before creating a simulated-use environment, it’s vital to deeply grasp the intended use of the device or system. This includes where and how it will be used, the tasks users will perform, and environmental factors affecting user behavior. This understanding forms the basis for crafting an environment that mimics real-world application.
• Use-related risk analysis plays a pivotal role in shaping the design and execution of usability studies. By identifying and understanding potential risks associated with a product’s use, usability studies can be tailored to evaluate these risks in realistic and relevant simulated-use environments (i.e., are people under stress, are they in a loud environment, etc.).

2. Balancing Realism and Budget: How real does your simulated environment need to be? Finding the right balance between realism and budget is key. While you want the environment to be as realistic as possible, you also need to maintain control over variables during testing and not break the bank in the process. We’ll provide some advice on this. (Hint. You probably don’t need a fully outfitted operating theater for most studies).

3. Mitigating for Potential Study Artifacts: No matter how well you simulate a use environment in a study, if the participants have no context, or the simulated-use environment does not feel “familiar” to some degree, you may see study artifacts crop up in your findings, which can distract from the real use problems (i.e., “I didn’t wash my hands because I didn’t notice the sink in the corner”). It is crucial that participants understand the purpose of the study, the context of use, and relevant details about the environment that help them feel immersed so that they can act as naturally as possible.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Tracks
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives