A pharmaceutical manufacturer required a validation study to determine if an autoinjector and its related materials were safe and effective.
A pharmaceutical manufacturer sought to conduct a human factors (HF) validation study of an autoinjector intended for the treatment of atopic dermatitis.
We conducted 45-minute usability testing sessions with adult patients, caregivers, and healthcare providers. Participants were tasked with administering a dose of medication using the autoinjector and administered knowledge task questions to assess their understanding of the instructions for use (IFU) and labeling.
We partnered with the manufacturer to assess the safety and usability of the autoinjector according to the product’s risk assessment (uFMEA). And aligned on key findings in advance of submission to the FDA.