Development of an injector pen to achieve dose-settable auto inject mechanism.
Ximedica worked to perform feasibility assessment activities for a new pen injection system. The purpose of this initial feasibility effort was to complete a technical evaluation of the device solution and identify any development risks within the program. The objective was to reach an 80% confidence level in the design direction and minimize both technical and program risks ahead of the full development program.
Ximedica generated several concepts for a revised embodiment, developed Solidworks CAD models of designed components and assembly for identified injector pen, fabricated and built several functional prototypes for evaluation of 2 of the 5 dosing versions (upper and lower dose spectrum), developed assembly and test protocols, and generated IFU.
The output of all work efforts was provided to Haselmeier at the completion of the program.