Design Researcher
Real-World Validation: In-Home Medical Device Study
Conducted contextual inquiries in patients' homes across four cities to validate that real-world injection practices matched laboratory safety standards, supporting FDA compliance while managing complex logistics and recruitment challenges.
The Challenge
Most medical device usability research happens in controlled laboratory settings. While this approach effectively identifies critical use errors, it misses the rich contextual factors that influence how people actually use devices in their daily lives.
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A pharmaceutical client wanted to understand: How do patients really use injection devices in their home environments, and what design opportunities exist beyond what we see in the lab?
My Role
Teammates
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Supported extensive preparation phase involving safety protocols, legal documentation, and multi-city logistics
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Drafted discussion guide, screener, consent forms, NDAs, and adverse event reporting requirements
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Developed template for documenting naturalistic injection behaviors and environmental factor
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Research Lead
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2 UX Researchers
What we learned
The research revealed that home environments actually equally safe, and even more confident injection practices than lab settings—directly contradicting initial assumption.s
Impact
Our topline report detailed how patients leveraged their home environments in sophisticated ways that couldn't be replicated in lab settings—kitchen counters offered stability while bathrooms provided better lighting for visual confirmation.
These findings directly informed design recommendations including: revised Instructions for Use (IFUs) that accommodate multiple injection environments and training materials that help users build personalized routines rather than prescribing rigid procedures