Designing and manufacturing a Class III active implantable pump presents multiple challenges. These challenges include selecting materials that are both biocompatible and drug compatible (which are critical in minimizing the risk of immune reaction), deep tissue thrombosis post-implementation, or drug stability.  The processing of these materials should also be taken into consideration (i.e., maintaining cleanliness and reducing contamination). Design miniaturization is crucial to the success of the device, as it addresses patient comfort and enables minimally invasive practices. 

The devices’ durability and reliability are essential for long-term function.  This requires a robust engineering design with secondary backup seals or systems to meet patient safety requirements and regulatory needs. The device was then put through a rigorous test plan(s) to verify and qualify every design input.  Furthermore, power consumption was minimized to extend battery life during the pump communication, programming, and operation processes. Finally, the pump had to be compatible and safe to use alongside other therapies that the patient might need over the product’s lifetime.