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.
The client chose Secant Group, a leading innovator in the development and transformation of next-generation biomaterials, structures, and medical textile designs for restoration of the human body.
Secant Group’s team of engineers tackled the multilayered project by first focusing on the yarn. After a few rounds of polymer extrusion, Secant 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, Secant 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, Secant Group had recreated the original woven component almost exactly.
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.
About Secant Group
Secant Group, LLC designs and develops custom-engineered, next-generation textiles and biomaterials solutions that enable repair, recovery, and regeneration of the human body.
With decades of experience in implantable medical component design, development, and manufacturing, Secant Group gives market leaders confidence to innovate more boldly across medical devices, cell therapy, tissue engineering, and drug delivery to make lifechanging breakthroughs more accessible to more patients with unmet needs.
From prototyping to commercialization, Secant Group is the collaborative, integrated partner of choice in the cardiovascular, neurovascular, orthopedic, surgical, and pharmaceutical spaces.
About SanaVita Medical
SanaVita Medical, LLC provides contract manufacturing and medical device processing services needed to bring innovative solutions to market. From finishing and assembly, packaging and labeling, sterilization management, and regulatory compliance, SanaVita Medical provides vital supply chain services. SanaVita Medical is an FDA-registered contract manufacturer with a robust Quality Management System compliant with ISO 13485. SanaVita’s expert regulatory team is equipped to handle complex projects from both North American and European markets.