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A New Voler Systems Case Study

Transforming a Dry Eye Treatment Prototype into a Market-Ready, FDA-Approved Wearable Medical Device

Customer Introduction

This company produces eye technology for the treatment of eye diseases. It had a new proof-of-concept prototype for dry eye treatment and wanted to market it as a medical device. It needed help doing the design under medical design controls and preparing the device for FDA approval.

Problem/Goal

• Lack of knowledge in designing an electronic medical device.

  The company had built a proof-of-concept prototype and needed an electrical engineering expert to create a wearable medical device that applies heat to the eyelids to improve the flow of oil that naturally lubricates the eye.

• Requires 510(k) approval from FDA

  The device will meet 510(k) approval from the FDA to be legally marketed in the United States as a medical device treatment for dry eyes and verify proof of its meeting high safety and effectiveness standards.

• Significant manufacturing obstacles

  The medical device will be designed for scalability or mass production.

The latest stop of the Voler Networking Series took place in Vienna, Virginia last week, just outside Washington DC.

Twenty execs spanning an interesting mix of industries and backgrounds (MedTech, IIoT, Software Security, Consumer Electronics, Acoustics Engineering, Defense etc) got together for an enjoyable evening of conversation and networking.

We’re thrilled to announce our next two stops on the Voler Systems Networking Tour 2023:

📍 Indianapolis 🗓️ Monday, September 25th
📍 Chicago 🗓️ Tuesday, September 26th.

Are you ready to unwind and connect? Join us for a fun, relaxing evening with your favorite drink in hand, delicious food, and engaging conversations with like-minded individuals passionate about networking. 🍷🍴🗣️

Please send Miguel Adao a note and he will be sure to send you a calendar invite.

We would like to invite you to join Voler's partner Edge Impulse at the premier edge AI event for the real world, with presentations and demonstrations from top technology leaders and innovators.

Imagine is an annual gathering of edge AI industry leaders, visionaries, and researchers, discussing the latest developments and solutions in machine learning with an invite-only audience of 200+ business executives and decision-makers.

Please let Miguel Adao know if you would like to attend and we'll get you a VIP invitation to this event.

Voler has helped many premier clients turn device ideas into reality. Whether you are looking for Medical Device or Wearable Technologies, Industrial IoT Device Designs, Electronic Support, Hardware/Firmware/Software, Wireless, Sensors, Motion Control, Microprocessors or FPGA Development, Voler can help you along the journey – always with a focus on keeping risks low, and keeping projects on-time, on-budget, and easy to manufacture.