Solving the Challenges of a Complex Cardiac Diagnostic Device

Case Study: Manufacturing an Intricate Atrial Fibrillation Diagnostic Device

Overview

SMC partnered with an OEM to manufacture a highly complex atrial fibrillation vascular catheter capable of detecting 64 AFib signals simultaneously through a global array. The device integrates these signals to deliver cutting-edge cardiac diagnostics, requiring extreme precision, micro-assembly expertise, and tightly controlled material processes.

The Challenge

The Mapping Catheter program presented significant technical and manufacturing hurdles due to the device’s micro-scale circuitry and stringent performance requirements. Key challenges included:

  • Microscopic, high-density circuitry requiring exceptional precision
  • Redesigned device architecture focused on sustainable manufacturability
  • Delicate, highly flexible components requiring skilled manual assembly
  • Materials that demanded narrow, tightly controlled process windows
  • Custom-built programming tools for circuit analysis and verification
  • Documentation-heavy qualification and verification processes essential for device reliability

The Solution

SMC developed and executed a comprehensive manufacturing strategy combining skilled craftsmanship, advanced technology, and scientific material insights. The solution included:

  • A broad-based operator training and assessment program to support highly specialized manual assembly
  • Progressive surface texture modifications to improve performance
  • Advanced welding technology delivering high reliability
  • Micro-soldering processes optimized for copper bonding
  • Customized laser housing for enhanced precision
  • Use of research to refine alloy balance for improved functionality
  • Advanced adhesive application systems to improve quality and repeatability
  • Improved reflow control for consistent, reliable connections
  • A custom-built circuit analyzer to evaluate circuit integrity and ensure robust electrical performance

The Results

SMC’s engineering, materials, and micro-manufacturing expertise enabled the successful commercialization of a highly advanced cardiac mapping catheter. The collaboration delivered:

  • A fully manufacturable, highly intricate device capable of capturing 64 AFib signals
  • Improved assembly reliability and repeatability through advanced welding, soldering, and adhesive systems
  • Enhanced material performance and circuit integrity through controlled processes and custom testing tools
  • A trained, validated assembly workforce equipped to build a device of exceptional complexity
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