The Objective

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.

Key Considerations

  • Defining the Representative User: We help you move beyond generic profiles. Whether your device is for a scrub tech in a high-stress OR, a patient with limited dexterity at home, or an EMT in a moving vehicle, we define the physical, cognitive, and emotional attributes of your user.
  • Environmental Stressors: A device that works in a quiet office may fail in a loud, dimly lit emergency room. We analyze environmental variables, lighting, noise, protective gear (gloves/goggles), and workspace constraints, to ensure the design is resilient.
  • Indications for Use (IFU) Alignment: The Indications for Use (IFU) and the Context Of Use (COU) dictate your HFE requirements.

FAQ

How do you define a 'representative user' for medical device HFE?

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.

 

What is involved in researching users?

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.

 

When should user research begin?

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.

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