Aerated Saline-based Contrast Medium Injection System
CooperSurgical contracted the Center for Advanced Medical Learning and Simulation (CAMLS) and BH to provide turn-key services developing a new Air Bubble-Based Infuser (ABBI®) to evaluate tubal patency using ultrasound versus X-ray. ABBI was to utilize ultrasound with a saline and air bubble contrast media to safely evaluate tubal patency in the office. The echogenic air bubbles produced by ABBI flow continuously through the cornua, fallopian tubes and fimbriae to confirm patency, or pool in the event of tubal occlusion. The CAMLS/BH team was provided the predicate device and IP strategy, and instructed to fast-track the project to pilot production and 510k clearance.
The team initiated the project by conducting Contextual Inquiry (CI) in parallel with predicate device review and output characterization to determine how to provide a strategy on substantial equivalence. Both tasks provided critical design input requirements for ABBI. The CI study concluded that useful functionality should be added to ABBI that was not part of the predicate, but at minimal added unit cost to ensure market advantages. Thereafter, a technical study evaluated make:buy decisions for fluidic components and a feasibility prototype fabricated to ensure output equivalence to the predicate device.
Once the feasibility and costing/logistics study was complete, the design team was provided internal component layouts with which to conceptualize study models for ABBI. These were evaluated via a user-preference study and a final configuration selected for Alpha prototype development. Additional formative studies confirmed the suitability of the final design which was then accelerated into tooling and pilot production with the qualified contract manufacturer. Great effort was made to streamline the V&V process and this resulted in 510K clearance in just 70 days. The outsourced team produced the first 5,000 production units for CooperSurgical, with the likelihood of winning a long term manufacturing contract.
Duration- 18 months