Presentation
Some assembly required: Unique considerations for applying human factors to medical devices as a system
SessionSystems (MDD4)
DescriptionThere is a lot to consider when it comes to applying human factors to any medical device during development, regardless of the apparent complexity of the device. What can seem like a daunting task in planning and execution becomes that much more intimidating when thinking about the application to a system of devices versus a singular device. For example, take the application of human factors to a large volume infusion pump that also includes a dedicated IV set and drug library. Each of these components could potentially exist on their own, but what considerations should you take when assessing how they will function together? Or, similarly, consider the application of human factors for an insulin management system that combines a delivery device, blood glucose measurement device, and software intended to monitor and control the system overall. Each component of the system presents its own set of tasks and risks, which might further evolve as they interface with one another within a larger coordinated system.
Although the same human factors tenets apply regardless of device or system complexity, some additional planning of the “bigger picture” is required when thinking about application to a system of devices. This presentation will focus on the application of human factors to systems of communicating devices and the unique considerations they require as compared to a singular medical device. We will examine key steps in the application of human factors through the lens of these types of systems and provide guidance for how to approach each step. Specifically, we will discuss how to approach task and risk analyses, execute usability evaluations throughout development, and document the application of human factors for regulatory authorities.
Rather than focus on one type of system in particular, our presentation will rely on our experience supporting manufacturers in applying human factors to a variety of medical device systems. We will explore how these attributes of medical systems manifest during all phases of development, up to and including HF validation.
Although the same human factors tenets apply regardless of device or system complexity, some additional planning of the “bigger picture” is required when thinking about application to a system of devices. This presentation will focus on the application of human factors to systems of communicating devices and the unique considerations they require as compared to a singular medical device. We will examine key steps in the application of human factors through the lens of these types of systems and provide guidance for how to approach each step. Specifically, we will discuss how to approach task and risk analyses, execute usability evaluations throughout development, and document the application of human factors for regulatory authorities.
Rather than focus on one type of system in particular, our presentation will rely on our experience supporting manufacturers in applying human factors to a variety of medical device systems. We will explore how these attributes of medical systems manifest during all phases of development, up to and including HF validation.
Event Type
Oral Presentations
TimeTuesday, March 269:00am - 9:30am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices