Transforming a Complex Stent Delivery Catheter for Scalable Manufacturing

Case Study: Robust Manufacturing of a Complex, High-Precision Medical Device

Overview

In collaboration with a leading OEM, SMC Ltd. successfully developed and validated a peripheral stent delivery catheter that required delicate handling, miniature precision, and robust manufacturing processes. This project highlights SMC’s ability to solve complex engineering challenges while maintaining the highest standards of quality and reliability.

The Challenge

This project presented several technical and manufacturing challenges that required creative problem-solving and deep engineering expertise:

  • Highly intricate device incorporating miniature components and delicate materials
  • Need for a redesign to enable robust, scalable manufacturability
  • Complications in processing radio-opaque materials
  • Custom tooling required for complex overmolding operations
  • Sub-assembly, packaging, and handling of fragile components
  • Strict quality assurance and verification protocols

The Solution

SMC applied its cross-functional expertise in design for manufacturability, precision tooling, and automation to develop an end-to-end production process. Key solutions included:

  • Transitioned from manual gluing and assembly to robust over-molding of miniature features
  • Designed custom tooling features to support precise overmolding and reduce risk of component damage
  • Integrated custom-built equipment to enable secondary processing and reflow capabilities
  • Managed the requirements and logistics of multiple component suppliers
  • Developed specialized downstream packaging methods to minimize handling and protect the device through final delivery

The Results

SMC delivered a validated, manufacturable stent delivery catheter that met all OEM requirements while ensuring product integrity and scalability. The collaboration led to:

  • Increased manufacturing robustness and repeatability
  • Reduced risk of component damage during assembly
  • Streamlined handling and packaging processes
  • High product integrity maintained from production through shipping
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