A pharmaceutical manufacturer was interested in collecting data to inform the development of a large-volume autoinjector and its accompanying IFU and labeling.
A pharmaceutical manufacturer was interested in conducting a usability test for a large volume autoinjector platform device currently in development. The study was conducted to inform final platform design and accompanying materials, including instructions for use (IFU), with an emphasis on assessing the ability of patient participants to depress prefilled syringes with placebo of differing viscosities.
We conducted 90-minute usability sessions with adult patients with rheumatoid arthritis and/or polymyalgia rheumatica and their healthcare providers. Participants completed two injection tasks, the second requiring use of the IFU to ensure comprehensive evaluation of platform materials, and then completed a series of knowledge tasks. When time permitted, patient participants completed a force assessment using prefilled syringes with placebo of differing viscosities.
We provided recommendations for the design of the device and its IFU and labeling based on participant performance and feedback. Study findings and recommendations for the design of the device and its associated IFU and labeling were documented in a topline report and a full report and submitted to the manufacturer.