Loading. Please wait.
Full Spectrum teamed with a company developing a new multi-channel infusion pump. The program was a government-funded, dual-phase engagement that begins with the development, build, and verification of a proof-of-concept (POC) prototype, with successful demonstration of POC functionality and performance to be followed by a full development and commercialization effort under design control and submitted for FDA approval.
Our client, an early-stage company, was working on a novel fluid management system to get through IDE for clinical trials. Delivery challenges with the existing vendor had already delayed clinical trials and eroded client confidence in the outcome. This is a Class III medical device.
Clients developing, updating, or remediating infusion pumps rely on Full Spectrum expertise. Full Spectrum has focused engineering practices in software and system design, system integration, system compliance, V&V of the system and software, and experience with various infusion pump technologies, including syringe technology, peristaltic, ambulatory, combination delivery devices, and ACE controllers.
Full Spectrum partnered with a client in the late stages of developing a patch pump with companion mobile app and cloud services for chronic disease management.