Customer Introduction

This client is a leading innovator in pain therapy medical devices, specializing in treating complex neurological and structural back pain conditions. Its products are known for premium therapeutic efficacy, incorporating advanced waveform technologies for spinal cord stimulation. The client sought Voler Systems' expertise to overcome engineering challenges, reduce failure rates, and enhance device functionality and user experience.

Problem/Goal

• The implantable device was too large.
  
  Achieve significant device miniaturization without compromising waveform precision, battery life, or therapeutic effectiveness.
• Bluetooth firmware had critical issues that resulted in unreliable communication between the implanted device and the patient's mobile app.
  
  Develop robust Bluetooth firmware to enable seamless connectivity and precise control of therapy.
  
• Poor contact of electrodes used to stimulate nerve endings.
  
  Enhance the reliability of electrodes to ensure consistent and effective nerve stimulation over time.
  
• Device relied on traditional batteries, leading to limited lifespan and a bulky design that required frequent recharging.
  
  Design innovative energy solution that eliminates the need for permanent batteries while maintaining device functionality and ease of use.
• Documentation lacked critical elements needed for regulatory submission.
  
  Prepare comprehensive design documentation to ensure alignment with regulatory standards and expediting the approval process.

Solution

Voler Systems delivered comprehensive solutions by leveraging years of medical device expertise:

• Designed compact circuit boards and optimized layouts to reduce the overall size of IPGs without sacrificing therapeutic performance.

• Resolved Bluetooth communication issues, enabling seamless connectivity between devices and smartphone apps for therapy customization.

• Identified and addressed electrode failure modes, enhancing reliability and therapeutic consistency.

• Designed an external power transfer system using a handheld charging wand, eliminating the need for permanent batteries while ensuring continuous device operation.

• Prepared portions of the Design History File (DHF) for FDA submission, ensuring compliance with stringent medical device standards.

Results & Benefits

• Enhanced device functionality by delivering premium waveform precision and energy efficiency in a smaller package, maintaining the client’s market leadership.

• Reduced implant size and enabled easy therapy adjustment through an intuitive app, increasing patient adoption.

• Significantly decreased electrode failure rates through innovative design adjustments, increasing reliability of the device.

• Eliminated bulky battery designs with a user-friendly, wireless charging system, simplifying the charging solution.

• Streamlined regulatory approval with comprehensive design documentation for regulatory readiness.

Inspiration

Voler Systems takes pride in its partnership with this leading neurological medical device innovator. This collaboration exemplifies Voler Systems’ dedication to enabling groundbreaking advancements in pain therapy while supporting the client’s mission to improve patients’ lives.

"Voler Systems has been instrumental in our success, offering unparalleled engineering support and innovative solutions that keep us ahead in a competitive market."

Contact Voler Systems today to learn how our tailored engineering solutions can bring your medical device to life and ensure regulatory compliance.