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Neuromodulation Device

Movement Disorders

Led program for development of implantable device for reduction in Parkinson disease symptoms and essential tremors.

  • Objective

    Improve motor function, FDA Class III approval.

  • Client

    Confidential

Services Provided

  • Concept Development

    Conducted focus groups and surveys with patients and healthcare providers to inform product requirements.

  • Design & Prototyping

    Created multiple prototypes to test various configurations of stimulation algorithms and electrode design

  • Pre-DV Testing

    Completed mechanical and electrical testing on prototypes to ensure functionality and safety.

  • DV Testing

    Conducted thorough verification against design specifications and product requirements to ensure robustness and reliability.

Support Focus

  • Quality Documentation 

  • Labeling Development 

  • Regulatory Submission

  • Packaging Design 

  • Usage, Safety & Compliance Labeling

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

Outcomes

  • 60% reduction in tremor severity

  • FDA approval in 12 months

  • $5 million revenue in the first year