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Neuromodulation Device

Spinal Cord Stimulation System

Led program for development of an advanced SCS system for chronic pain management.

  • Objective

    Class III approval, enhanced patient control.

  • Client

    Confidential

Services Provided

  • Concept Development

    Conducted market research and consultations with pain specialists to identify critical device features.

  • Design & Prototyping

    Developed and tested multiple prototypes to optimize electrode configurations and control systems.

  • Pre-DV Testing

    Engaged in extensive bench and animal testing to validate device safety and performance.

  • DV Testing

    Conducted verification tests to ensure that all components functioned correctly and met safety standards.

Support Focus

  • Quality Management System

  • Regulatory Submission

  • Packaging Design

  • Risk Documentation

  • Usage, Safety & Compliance Labeling

photo of an operating room taken with wide angle lens, rendered in black and white

Outcomes

  • 60% average pain reduction

  • FDA clearance in 11 months

  • $8 million revenue in the first year