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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