Customer Introduction

This innovative medical technology startup aimed to address sleep apnea by developing an electronic stimulator designed to rouse individuals when they stop breathing during sleep. The goal was to create a device capable of providing a safe and effective solution for treating sleep apnea. Partnering with Voler Systems, the startup sought engineering expertise to advance its project through early-stage development and FDA pre-submission requirements.

Problem/Goal

• Developing a functioning design framework.
  
  The startup will have a detailed and precise block diagram to define the electronic stimulator's architecture and functionality.
• Lacked accurate device specifications.
  
  Configure calculations for stimulation levels and battery life to ensure efficacy and usability.
  
• Needed assistance in regulatory preparation.
  
  Align with FDA requirements and have comprehensive documentation for a pre-submission meeting.
  

Solution

Voler Systems provided expert engineering and regulatory support, delivering the following solutions:

• Created a block diagram to clearly outline the stimulator’s functional architecture.

• Conducted thorough calculations to determine stimulation intensity and estimated battery life to guide design considerations.

• Prepared detailed regulatory documentation, ensuring readiness for the FDA pre-submission meeting

Results & Benefits

• Received a positive FDA Pre-Submission result, with the device considered safe and approved to proceed as a Class II medical device under the 510(k) pathway.

• Provided clear documentation and a solid design framework, gaining confidence in advancing to the subsequent phases of development.

• Ensured the startup met critical regulatory milestones early in the process, creating regulatory readiness for subsequent phases.

Inspiration

Voler Systems is proud to support groundbreaking medical innovations that tackle significant health challenges. Voler empowered the startup to navigate complex development and compliance requirements by providing tailored engineering and regulatory services.

Contact Voler Systems today to learn how our engineering solutions can help your medical device innovation succeed while meeting stringent regulatory standards.