Skip to primary menu Skip to main content Skip to footer content

Neuromodulation Device

Chronic Pain & Epilepsy

Led program for development of a device for targeted stimulation of neural pathways for chronic pain and epilepsy.

  • Objective

    Class II approval.

  • Client

    Confidential

Services Provided

  • Concept Development

    Identified unmet clinical needs through interviews with patients and medical professionals to inform product requirements.

  • Design & Prototyping

    Employed an iterative design process, producing prototypes to assess different stimulation waveforms and electrode placements.

  • Pre-DV Testing

    Conducted extensive bench testing to evaluate performance metrics and biocompatibility.

  • DV Testing

    Performed comprehensive testing to verify the device’s compliance with safety and efficacy requirements.

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

  • 45% reduction in seizure frequency

  • FDA clearance in 8 months

  • $4 million revenue in the first year