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A pharmaceutical manufacturer wanted to use an existing connected system mobile app with a pediatric population.
The FDA requested verification that the app would work with this new pediatric patient population.
The initial study was to identify major showstoppers (if any) and if using the existing mobile app was possible with these patients.
We were to uncover any environmental, scenario, and logistic considerations that are different for the user group.
We simulated at-home environments in a lab setting, including a mock living room, bedroom, and bathroom.
Our preliminary research revealed that working with pediatrics with this particular diagnosis required a heightened level of moderator sensitivity as the patient may not be aware of their diagnosis.
We learned our simulated in-home setup supported data collection; patients and caregivers adapted well to the simulated environments.
We also learned to include a kitchen in future studies as there was a tendency for patients and/or caregivers to utilize these areas when prepping the medication.