Precision Surgical Device Engineering to Support Rapid Commercialization

Case Study: Accelerating a Complex Surgical Device from Concept to Production

Overview

SMC partnered with a surgical device developer to support the manufacturing and scale-up of a complex balloon kyphoplasty system used in minimally invasive spinal procedures. The device required precision molding, careful material handling, and robust process development to support both clinical performance and manufacturability. SMC delivered an integrated solution that addressed tooling, molding, and production readiness for this highly specialized medical device.

The Challenge

Balloon kyphoplasty devices present unique manufacturing challenges due to their complexity, tight tolerances, and performance-critical components. This project required SMC to support a sophisticated surgical system while ensuring consistency, quality, and scalability.

  • Manufacturing a complex balloon kyphoplasty device for spinal surgery applications
  • Managing tight tolerances and delicate materials critical to device performance
  • Developing a robust molding process capable of repeatable, high-quality output
  • Supporting the surgical device developer’s need for a reliable, scalable manufacturing partner
  • Ensuring the device design could transition smoothly from development into production

The Solution

SMC applied its expertise in precision medical molding and process development to create a manufacturable, production-ready solution. By collaborating closely with the surgical device developer, SMC ensured that tooling, materials, and processes were aligned with both performance and scale requirements. SMC’s solution included:

  • Custom tooling design and development tailored to the balloon kyphoplasty device’s geometry and material requirements
  • Precision molding processes developed to maintain tight tolerances and functional integrity
  • Close collaboration with the customer to optimize manufacturability while preserving clinical performance
  • Manufacturing workflows designed to support repeatability, quality, and scalability

The Results

The final outcome was a stable, production-ready manufacturing process that supported the surgical device developer’s goals for quality, reliability, and future growth. Results achieved included:

  • Successful transition of a complex balloon kyphoplasty device into production
  • Improved manufacturing consistency and repeatability
  • A scalable process capable of supporting future volume increases
  • A trusted manufacturing partnership supporting ongoing device development
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