Customer Introduction

This pioneering bioelectronic medicine company specializes in developing wearable therapies that provide personalized neuromodulation for treating movement disorders. Their flagship product delivers targeted electrical stimulation to alleviate essential tremors, a condition that affects millions worldwide. To refine and optimize their device for market launch, the company partnered with Voler Systems for advanced firmware development and regulatory documentation.

Problem/Goal

• Lack of firmware for therapy activation
  
  Develop firmware to control stimulation waveforms and timing to ensure precise activation of therapy and effective neuromodulation.
• Inconsistent therapy comfort
  
  Implement a breath-synchronized feature to pause stimulation during inhalation, improving comfort and treatment efficacy.
  
• Regulatory compliance challenges
  
  Provide robust design control documentation and verification to meet FDA regulatory requirements and secure market approval.

Solution

Voler Systems provided expert engineering support to finalize the device's firmware, optimize its functionality, and facilitate regulatory approval:

• Created embedded firmware to activate and control the device's stimulation waveform, ensuring precise therapy timing.

• Integrated a piezoelectric sensor to detect inhalation, allowing the device to automatically pause stimulation, thereby improving patient comfort automatically.

• Developed a software application to collect and display real-time device data for diagnostic and research purposes.

• Delivered comprehensive regulatory documentation to support the FDA submission process.

Results & Benefits

• Developed a fully functional firmware solution to activate and control therapy features, ensuring precise neuromodulation.

• Integrated breath-synchronized therapy to pause stimulation during inhalation, enhancing patient comfort and treatment efficacy.

• Enabled real-time data collection with a Bluetooth system, allowing clinicians to capture and analyze diagnostic insights.

• Provided comprehensive design control documentation to support FDA submission, leading to regulatory approval and a successful product launch.

Inspiration

Voler Systems is committed to driving innovation in wearable medical devices by providing expert engineering solutions that bridge the gap between concept and commercialization. By partnering with this bioelectronic medicine leader, Voler helped bring groundbreaking neuromodulation therapy to market, improving the lives of those affected by essential tremors.

"Voler has great resources, low overhead, and high accountability. As a result, I know what you are doing, and you are good at what you do."

Contact Voler Systems today to see how our engineering expertise can accelerate your medical device development and regulatory success.