Reverse-engineered Woven Textile Component Prevents Supply Disruption of Cardiovascular Device
Background & Challenge
The supply flow of an FDA-approved cardiovascular device was under threat. The polyester yarn used in the device had been discontinued, and the manufacturer that supplied the woven textile component could no longer dedicate resources to investigating a replacement yarn.
As device inventory dwindled, the original equipment manufacturer needed to find a partner capable of creating a replica yarn and woven textile that closely matched the physical properties of the original components. Failing that, the company risked having to make drastic changes to the device to appease regulatory requirements, further increasing the possibility of a disruption in supply.
Our Solution
The client chose Solesis’ team of engineers to tackle the multilayered project by first focusing on the yarn. After a few rounds of polymer extrusion, the team had successfully recreated the yarn and tested various properties of the polymer and the yarn itself, including spin-finish and resin compositions, elongation, yarn strength, denier, breaking tenacity, and shrinkage.
Next, they reverse-engineered the woven textile component based on the original sample. After reaching a consensus with the client on testing methods, the team met the specific requirements for the yarn, such as thickness, flat width, and tensile strength. Within two rounds of prototyping, Solesis’ textile engineers had recreated the original woven component almost exactly.
Results
With a new supply of yarn and woven textile components, the client moved the “restored” device through the regulatory process with minimal changes and resumed sales without disruption.
Spark Your Next Innovation with Solesis
With decades of expertise in biomaterials science, Solesis can help you solve your medical device and delivery system challenges with custom textile and polymer solutions.
