Global Medical Device Company (Orthopedics)

A large global medical device manufacturer invented a new textile structure to improve the performance of one of their orthopedic devices.

One of the critical parameters identified for the component was that it must exceed a specific tensile load in two discrete regions. The dimensional characteristics specified for the component were especially important for the width and thickness in order to make delivery of the device minimally invasive.

The client approached Secant Group to help develop the new structure and design the component. The client chose Secant because of its advanced fiber- and textile-forming technology and deep experience with implantable fabrics. 

Secant Group’s team of engineers utilized its unique manufacturing capabilities to add sealed edges, holes, and reinforcement zones to the textile, therefore producing a value-added component. The custom machinery Secant developed made it possible to achieve the specified thickness, width, and tensile properties with both braid and woven technologies. The design parameters were conducive to either a braided or woven fabric. So, to provide flexibility, Secant designed both while adhering to volume, operational capability, and process requirements.

Because the device had to be manufactured by an FDA-registered contract manufacturing organization (CMO) that could assemble several components into the finished device, Secant Group worked with its partner company SanaVita Medical to provide a cost-effective, turn-key solution.

Several years after implementation, the project met many of its major milestones, including 510K approval, successful human implanted studies, and commercial launch.