Regardless of a medical product’s complexity, manufacturers have many considerations when it comes to applying human factors during development. Applying human factors to a whole system of medical products versus a singular product might seem even more intimidating. Furthermore, additional complexities might emerge when applying human factors to a system of products where all products or components are new and require regulatory submission (a “new” system), as compared to a system with at least one new product designed to be used with one or more existing products on the market (a “mixed” system). For example, the application of human factors might vary for a new infusion pump system that includes a large volume infusion pump with a dedicated IV set and drug library, versus an insulin management system that combines a newly developed “smart tracker” attachment and new smartphone app with a pre-existing pen-injector. Each component of these systems presents its own set of tasks and risks, which might further evolve as they interface with one another in a larger coordinated system. Below, we outline various considerations when applying human factors to these systems, including: developing task and risk analyses, conducting usability testing and creating documentation.
Developing human factors task and risk analyses
As with any other medical product, the task and risk analyses are key documents for a system of medical products. Creating these documents is an iterative process running in parallel to product development and usability testing activities.
For completely “new” systems, you should thoroughly document tasks, risks and mitigations for each component of the system as you would for any other single medical product, while keeping in mind tasks related to interaction points among the system components. Conversely, for “mixed” systems, it might be unnecessary to analyze components that have already successfully undergone validation. Rather, prioritize analyzing any new components and new tasks, while also thinking about how both previously validated and new components impact or mitigate against each others’ potential use errors.
Regardless of the type of system, task and risk analyses should capture how errors and risks can propagate across the system of products and avoid focusing on each component of the system in isolation.
Applying HF to System-Based Medical Products | Emergo by UL
Some Assembly Required: Unique Considerations for Applying Human Factors to a Medical Products System
Emergo by UL human factors specialists discuss how to apply human factors engineering to medical products as a system.
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