A pharmaceutical company was evaluating potential options for a combination drug and injection device for a highly viscous drug. The viscosity of the drug made it difficult to inject by hand. In order to improve safety and reduce hand fatigue, they needed to modify the flanges or thumb pad on the syringe. There were custom-made and commercial-off-the-shelf (COTS) options available. They came to Battelle for help in deciding which one would be most likely to be accepted by their end users.
Battelle conducted an early formative assessment study to compare the usability of the COTS and custom-made options. We collected observational and survey data from nurses who were given the opportunity to try different combinations of COTS and custom modifications in a controlled environment. For each option, we observed how hard the device was to hold and manipulate, how hard it was to depress the plunger and the length of injection time. We also gathered data on hand fatigue as well as other subjective comments from the nurses.
The data from our study was used to identify the optimal combination of COTS and custom components. They were able to balance user needs and preferences against costs and development schedules in order to make the best business decision. By conducting this study early in the development process, they reduced the risk that they would need to make expensive changes later in development.