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Neuromodulation Device

Sleep Disorder

Led program for development of a device for obstructive sleep apnea (OSA) treatment through hypoglossal nerve stimulation.

  • Objective

    Improve comfort and effectiveness, FDA Class II approval.

  • Client

    Confidential

Services Provided

  • Concept Development

    Gathered patient feedback and conducted market analysis to define product features and requirements.

  • Design & Prototyping

    Developed prototypes focusing on ergonomic design and stimulation efficiency, incorporating user feedback at each stage.

  • Pre-DV Testing

    Conducted performance tests to assess device functionality and patient safety.

  • DV Testing

    Ensured compliance with design specifications through rigorous testing of prototype performance.

Support Focus

  • Quality Management System

  • Regulatory Submission

  • Packaging Design

  • Risk Documentation

  • Risk Documentation

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

Outcomes

  • 60% reduction in apnea-hypopnea index (AHI)

  • FDA approval in 10 months

  • $6 million revenue in the first year