Orthopedics Case Studies

Case Study: Advancing a Minimally Invasive Treatment for Vertebral Fractures

A handheld device and controller unit designed for the treatment of vertebrae weakened or fractured as a result of osteoporosis.

The system stabilizes the injured vertebra through the injection of high-viscosity bone cement, with increased precision enabled by an articulating distal end. This minimally invasive approach helps restore stability and supports improved quality of life for patients.

Industry

Orthopedics

Impact

  • Designed and developed the handheld device and controller unit.
  • Developed a newly formulated bonecement, mixing and injection system.
  • Contributed to regulatory submission documentation.
  • Supported successful U.S. regulatory approval and subsequent market launch.

Challenge

The client sought to develop a novel more effective and user friendly system for stabilizing osteoporotic vertebral fractures. The device needed to deliver high-viscosity bone cement with precision while remaining safe, effective, and minimally invasive for patients.

Solution

As a contract developer and manufacturer, our team collaborated with the client from early design through regulatory approval. We:

  • Led the design and development of the handheld device and controller unit.
  • Collaborated with the manufacturer to optimize the innovative new bonecement (PMMA) formula.
  • Established manufacturing processes for critical components, including cleanroom production.
  • Supported preparation of documentation for U.S. regulatory approval.
  • Transitioned the system to commercial launch following FDA clearance.
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