Global Medical Device Company (Orthopedics)

  • Summary
    SanaVita Medical sources raw materials and performs packaging process validation for new biodegradable orthopedic device.
  • Challenge
    A global medical device company had recently acquired the technology for a biodegradable scaffold designed to restore natural range of motion in patients following joint resurfacing, tissue reinforcement, and tendon and ligament repair procedures.

    The company needed a qualified organization capable of extruding polymers from sensitive yet durable raw materials, as the device needed to be engineered with a biocompatible synthetic fiber that could mimic the strength and elasticity of normal tissue. The ideal partner would also complete the packaging process validation to meet the scheduled market launch of the device.
  • Solution
    With expertise in process optimization, paired with the polymer extrusion capabilities of its partner company Secant Group—known for its transformative, nextgeneration biomaterials, structures, and textile designs—SanaVita Medical was the clear choice for the client’s project.

    An FDA-registered contract manufacturing organization (CMO), SanaVita partners with medical device manufacturers and life science companies to bring innovative solutions to market with flexible, customized production capabilities.

    Working closely with the client, Secant Group’s engineering and scientific teams extruded the porous polyurethane-based yarn and knit it into numerous mesh-textile specifications. Upon meeting the specifications, SanaVita advanced the project to the production verification and optimization stages followed by the packaging process validation for the final medical device.
  • Result
    The client launched an effective device on time and worked with SanaVita to scale up production volumes to meet high demand in an extremely competitive tissueregeneration market. Following this successful collaboration, the client hired SanaVita to handle process development work for a second-generation textile-based device.