The customer’s team had developed some designs internally, but asked the Vention team to come up with its own ideas after studying the competitor’s product. The result was a collaborative design that included the best features of both teams’ designs.
Because of the challenges of reaching the anatomy, the design required varying characteristics along the length of the device. As a femoral access catheter, it required stiffness in the proximal end for pushability, and flexibility in the distal end to access the cerebral artery. The resulting design was extremely complex: The outer jacket consisted of 2 materials with 9 durometer or dimensional transitions along a tapered shaft. The device was reinforced with an alternating-pitch nitinol coil with 19 discrete pitch changes. This required the development of a new shape setting process and customized machinery that could produce a pitch change every few millimeters along the length of the device.
The Vention team first built proof-of-concept prototypes for the more challenging distal end of the device, then built complete device prototypes and collaborated with the customer to evaluate the designs in benchtop anatomical models and cadaver studies. The team was able to iterate very quickly. Within the first few months, team members made more than 15 iterations with various durometer and pitch transitions to find the optimal balance of stiffness and flexibility. Vention applied a Design for Manufacturability (DFM) mindset and process, making key design changes up front that would enable lower-cost manufacturing.
Vention also effectively managed the supply chain from design and development through manufacturing transfer. The team generated component specifications, chose vendors from the customer’s preferred supplier list, ordered all materials, received and inspected materials, and managed all suppliers.
After design verification, Vention quickly ramped up to manufacture 2500 of each device for design validation. No machinery capable of manufacturing the alternatingpitch nitinol coil was commercially available within the timeline. So within 6 weeks, the Vention team designed and built a custom coil-winding machine that increased throughput and provided increased process control. As capacity continued to ramp up, Vention built 2 additional coil winders within a few weeks to meet the customer’s needs. The Vention team smoothly transferred manufacturing to the customer, who was so happy with the coil winders that it purchased 2 additional machines to support its manufacturing line.
In addition, the Vention team generated and managed all manufacturing documentation to support the customer’s FDA submission, including process flow diagrams, material traceability, process failure mode effects analysis (PFMEA), and lot history records to support validation testing performed by the customer.