Presentation
Determining Minimal Environmental Fidelity for Simulated Use Studies
SessionPoster Session 2
DescriptionSimulated-use environments are essential to the successful execution of formative and validation studies for medical devices. Simulated-use environments replicate real-world contexts and are critical for evaluating safety, usability, and workflow integration of evaluated devices. As actual use environments become increasingly complex, there is a growing need to understand how to effectively and minimally simulate complex, variable environments during usability studies to evoke authentic use behavior.
This poster highlights key processes and practical steps to streamline the process of achieving the minimal environmental fidelity required for representative simulated-use environments. The aim is to support Human Factors Engineers in designing cost-effective studies that yield valid and actionable insights. A secondary objective is to encourage the expansion of research in diverse healthcare contexts.
A practical framework to define, enhance, and iterate will be exhibited to support the definition of minimal environmental fidelity based on answering two main questions:
(1) What tasks fall within the manufacturer’s scope and responsibility to ensure patient safety?
(2) What standardized environmental elements should be included, and what aspects of the simulation should remain flexible to reflect real-world variability?
The first step of this framework is to define the goals of the study, the intended users and participants, the intended use environment, the tasks to be evaluated, and the acceptance criteria of each task. Notably, this phase intends to uncover nuances of which tasks fall within the manufacturer’s scope to address, and where the boundary lies between manufacturer responsibility and site-specific governance to ensure patient safety. Additionally, the definition phase aims to target what elements of the intended use environment can be standardized, and which must remain flexible to reflect real-world variability. Lastly, the definition phase includes a preliminary estimation of key items and props with which users may have to interact during the execution of study tasks.
The second phase of the framework leverages tools and techniques that can be used to enhance the realism of the simulated environment and elicit real-use behavior. These include strategies for cognitive priming, scenario variation, and unobtrusive monitoring to support naturalistic observation of behavior, increasing the immersion of participants in the simulation.
The final iteration phase allows the human factors engineer to continuously challenge their assumptions by testing and iterating their proposed simulated use environment through cross-functional collaboration, engaging with intended users, and multiple rounds of testing the simulated use environment.
The proposed framework for achieving minimal environmental fidelity will be illustrated through examples of minimally representative simulated environments (i.e., sterile processing department). Participant reactions to the minimally represented environment will be shared, and the adequacy of fulfilling the study scope and purpose will be discussed. This will demonstrate how targeted fidelity combined with cognitive priming, purposeful questioning, and unobtrusive monitoring methods evoked authentic user behaviors during simulated device tasks.
This poster provides a clear framework for determining minimal environmental fidelity aligned with the specific characteristics of the study device and intended objectives. Through practical, cost-efficient tools and illustrative examples, it facilitates the creation of simulated-use environments that are both effective and scalable. Designed for entry and mid-level Human Factors Engineers, the content delivers immediately applicable insights that enhance study design and execution. Attendees will be empowered to make evidence-based decisions regarding environmental fidelity, navigating the trade-offs between realism, cost-efficiency, and regulatory compliance. The broader impact of this poster is its capacity to catalyze further research across diverse healthcare contexts by offering a methodologically sound and economically viable approach adaptable to a wide range of intended use environments.
This poster highlights key processes and practical steps to streamline the process of achieving the minimal environmental fidelity required for representative simulated-use environments. The aim is to support Human Factors Engineers in designing cost-effective studies that yield valid and actionable insights. A secondary objective is to encourage the expansion of research in diverse healthcare contexts.
A practical framework to define, enhance, and iterate will be exhibited to support the definition of minimal environmental fidelity based on answering two main questions:
(1) What tasks fall within the manufacturer’s scope and responsibility to ensure patient safety?
(2) What standardized environmental elements should be included, and what aspects of the simulation should remain flexible to reflect real-world variability?
The first step of this framework is to define the goals of the study, the intended users and participants, the intended use environment, the tasks to be evaluated, and the acceptance criteria of each task. Notably, this phase intends to uncover nuances of which tasks fall within the manufacturer’s scope to address, and where the boundary lies between manufacturer responsibility and site-specific governance to ensure patient safety. Additionally, the definition phase aims to target what elements of the intended use environment can be standardized, and which must remain flexible to reflect real-world variability. Lastly, the definition phase includes a preliminary estimation of key items and props with which users may have to interact during the execution of study tasks.
The second phase of the framework leverages tools and techniques that can be used to enhance the realism of the simulated environment and elicit real-use behavior. These include strategies for cognitive priming, scenario variation, and unobtrusive monitoring to support naturalistic observation of behavior, increasing the immersion of participants in the simulation.
The final iteration phase allows the human factors engineer to continuously challenge their assumptions by testing and iterating their proposed simulated use environment through cross-functional collaboration, engaging with intended users, and multiple rounds of testing the simulated use environment.
The proposed framework for achieving minimal environmental fidelity will be illustrated through examples of minimally representative simulated environments (i.e., sterile processing department). Participant reactions to the minimally represented environment will be shared, and the adequacy of fulfilling the study scope and purpose will be discussed. This will demonstrate how targeted fidelity combined with cognitive priming, purposeful questioning, and unobtrusive monitoring methods evoked authentic user behaviors during simulated device tasks.
This poster provides a clear framework for determining minimal environmental fidelity aligned with the specific characteristics of the study device and intended objectives. Through practical, cost-efficient tools and illustrative examples, it facilitates the creation of simulated-use environments that are both effective and scalable. Designed for entry and mid-level Human Factors Engineers, the content delivers immediately applicable insights that enhance study design and execution. Attendees will be empowered to make evidence-based decisions regarding environmental fidelity, navigating the trade-offs between realism, cost-efficiency, and regulatory compliance. The broader impact of this poster is its capacity to catalyze further research across diverse healthcare contexts by offering a methodologically sound and economically viable approach adaptable to a wide range of intended use environments.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices