Bringing Relief Home: Developing a Market-Ready Dry Eye Solution

Currently, millions of people from all across the world are suffering from dry eye. It’s a health condition that can cause irritation, discomfort, and blurred vision. For providing complete relief, a new wave of innovative treatments is emerging.

Wearable medical devices are at the forefront of these treatments. Please check out this blog and follow the journey of a company that has transformed its dry eye treatment prototype into a market-ready, FDA-approved wearable medical device:

Taking an Eye Treatment Prototype to Market

As a leading name in eye technology,  this company has a promising prototype for a dry eye treatment device. Their vision is to develop a wearable solution that applies heat to the eyelids and stimulates the production of natural tear lubricants. However, a hurdle remained: transforming the prototype into a wearable medical device adhering to rigorous safety and regulatory standards.

Lack of Expertise in Medical Device Design

Without in-house expertise, the company could not navigate the complexities of medical device design and FDA approval.  They needed  an engineering partner with a thorough understanding of electronic device design and the stringent regulations governing medical devices.

Finding a Partner for Success in Wearable Technology Development for Healthcare

Voler Systems has extensive experience in wearable medical device design and development. With its  technical know-how and regulatory expertise, it is dedicated to bridging the gap between prototype and market.

A Collaborative Approach from Concept to Reality

Voler Systems’ engineers worked closely with the company to transform their prototype into a completely functional medical device. They provided the following solutions:

• Redesigning the electronics— Engineers meticulously redesigned the device's electronic components for optimal system performance, safety, and reliability.
• Developing control software – Engineers  created the custom firmware to manage the device's functionality and user experience.
• Risk management –Engineers performed a comprehensive risk analysis to identify and mitigate potential safety hazards associated with the device.
• Verification and validation – Engineers  created a rigorous testing protocol to verify the device's effectiveness and compliance with FDA regulations. They also compiled extensive documentation to support the 510(k) premarket notification process.

Developing a Life-Changing Medical Device

The collaborative effort between Voler Systems and the company yielded an outstanding outcome. The redesigned device secured FDA approval on the first submission, while saving valuable time and resources and featured a robust design, making it ideal for mass production. Ultimately, this wearable device translates to bringing relief to millions suffering from dry eye conditions.

Transforming Ideas into Impact with the Voler Systems

This success story showcases how Voler Systems' expertise empowers medical device companies to bring innovative prototypes to market. Our commitment to technical excellence, regulatory know-how, and unwavering dedication to quality standards help us to create impactful solutions that improve people's lives.

When you want to transform your vision for wearable technology into a reality, contact Voler Systems. Let us help you navigate the path from prototype to market as smoothly as possible.