To initiate the project, teams from 2 of Vention’s US catheter manufacturing facilities collaborated to document best practices from each site and determine which processes to use for the transfer to Costa Rica. Team members analyzed lessons learned from previous transfers and built a plan to mitigate risk.
- Laser bonding
- Marker band positioning/swaging
- Split die bonding
- UV bonding
- Balloon catheter functional testing using a hydraulic burst/leak tester
The team used Design for Manufacturability (DFM) principles to analyze processes, implementing one-piece flow and standardizing the manufacturing process to make it less susceptible to operator variability. The team also conducted a rigorous, 3-week training process including Verification of Effectiveness to ensure consistent procedures among operators.