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Medical Device

Chronic Pain Management

Led program for development of a neurostimulation device for chronic pain using targeted electrical impulses.

  • Objective

    Non-invasive treatment, FDA Class II approval.

  • Client

    Confidential

Services Provided

  • Concept Development

    Conducted user research and market analysis to define product requirements.

  • Design & Prototyping

    Developed initial prototypes using rapid prototyping techniques to iterate on electrode designs and stimulation parameters.

  • Pre-DV Testing

    Conducted bench tests to validate electrical performance and biocompatibility, followed by animal studies for safety assessment.

  • DV Testing

    Performed testing to ensure device performance aligned with predefined product requirements and specifications.

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

  • 55% average pain reduction

  • FDA clearance in 10 months

  • $4 million revenue in the first year