Case #00521

PROBLEM:
Infusion pump manufacturer needed their patient controlled analgesia infusion pump to support connectivity to a hospital-wide medication management system. With these enhancements, the system needed the ability to read real-time status and event data from the infuser and automatically program therapy settings on the infuser.

SEP SOLUTION:
SEP provided the software design and development team for an effort to enhance an existing patient controlled analgesia infusion pump (a class IIb medical device). This effort involved defining software requirements, developing communication protocols, high-level and detailed software design, coding, unit testing and formal software verification. The project required interfacing and integration with two other components of the overall hospital system architecture. SEP worked directly with our customer’s medical and marketing personnel to define the software requirements for the infuser enhancements. Use Cases were utilized to effectively communicate proposed device operation to a cross-functional team as part of the requirements analysis process. Significant user interface functionality was defined for the device to support the added functionality. Human factors issues were addressed during this requirements analysis and definition phase. SEP was responsible for all technical software documentation used for the 510(k) submission.