Validate safe and effective use of emergency device

A pharmaceutical manufacturer preparing to submit an emergency nasal mucosal atomization device (MAD) kit for FDA approval needed to validate that both lay users and healthcare professionals could safely and effectively prepare and administer the product in high-stress situations. The study required evaluation across diverse user populations, some familiar with diabetes and injectable glucagon, others with no relevant experience, to simulate real-world emergency conditions.

We led the full validation process, from protocol development and recruitment through testing and reporting. A total of 45 representative users were divided into three groups: two lay user groups (adults and adolescents) and one healthcare provider group. Each lay group included participants with varying familiarity with diabetes and emergency care. The HCP group included EMTs, paramedics, and nurses from emergency, long-term care, and school settings. Each participant completed a 60-minute validation session, which included device setup and administration under simulated emergency conditions, followed by a post-task “de-stress” period, interview, and knowledge assessment. The study design incorporated environmental stressors to realistic emergency use.

Our research validated that the MAD device could be safely and effectively used across all user groups, with no critical use errors observed that could result in serious harm and that could be eliminated or further reduced through modification of the UI design without introducing new risks. Findings were assessed against the product’s risk analysis (uFMEA) and aligned with the manufacturer prior to FDA submission.

This validation study confirmed that the emergency MAD kit met safety and usability thresholds for regulatory approval, demonstrating effective use by both laypersons and HCPs in high-stress emergency scenarios.