Regulatory success begins with a deep understanding of the user and their environment. Before a single CAD model is built, we define the "Context of Use." This ensures that the HFE scope is accurately aligned with your Indications for Use, preventing "scope creep" and ensuring your testing is defensible.
A representative user is an individual who mirrors the actual population intended to use the device. This includes clinical professionals, lay caregivers, and/or patients themselves. HFE protocols must account for their typical age, education level, physical capabilities, and prior experience with similar technologies.
User Research is a broad field that can include contextual inquiry, procedure mapping, task analysis, and lots of user observation. It's crucial to document the findings of this research and show how the user can confidently interact with a new device.
As early as possible in the project. It’s wise to seek out stakeholders and receive input before prototypes have even been fabricated. The earlier a model can be put into hands of users, the more information can be gathered to confirm or redirect development effort.