FDA Clearance for Medical AR Device

A Case Study in Optical Engineering for AR Medical Devices

As a leading provider of optical engineering services, we were recently approached by a medical device company seeking assistance with optical measurements for their Augmented Reality headset. This article explores the journey from initial inquiry to successful FDA approval, highlighting the challenges faced and the creative solutions implemented along the way.

Optical Medical Product Inquiry

The project began when a medical device company with a unique AR device contacted Joya Team to inquire about performing optical measurements for their system. Immediately, we set up a technical meeting to discuss the project in more detail.

FDA Approval Request for AR device

During the initial meeting, it became clear that the company was seeking FDA approval for their system's use in medical procedures. The FDA review team had posed many important questions, particularly regarding the system's optical performance and display, and required engineering answers within a tight timeframe.

Despite their efforts, the company's initial attempt to address the FDA's questions fell short. Recognizing the complexity of the task, they sought expertise in the field of optical metrology and optical system engineering. They needed to understand the FDA team's questions thoroughly and address them accurately, professionally, and swiftly. This led them to engage with us, based on our knowledge and experience in optical engineering and our ability to provide comprehensive solutions to challenging problems in the field.

Optical Metrology for Augmented Reality

What initially seemed like straightforward optical measurements quickly evolved into a detailed response to FDA requirements. We worked very closely with the company's V&V and engineering team to establish optical measurement systems, perform complex calculations, and meticulously document results.

One of the main challenges faced was the need to construct measurement systems within tight timeframes. Despite these constraints, we suggested precise and efficient ways to set up rapid measurement systems.

The optical metrology conducted during the test included a range of measurements, including photometry, colorimetry, and imaging assessments such as MTF, resolution, field of view, and distortion analysis. Each of these tests required specific measurement equipment and distinct setups to ensure accurate and comprehensive data collection.

Photometry measurements were essential for quantifying the intensity of light emitted by the device, providing critical insights into its overall performance, efficiency and Contrast ratio. Colorimetry tests were employed to assess the device's color accuracy and consistency, crucial for applications requiring precise color rendering.

Imaging measurements, including MTF, resolution, field of view, and distortion analysis, offered valuable insights into the device's imaging capabilities.

Each of these measurements required specialized equipment tailored to the specific parameters being evaluated. Additionally, the setup for each test had to be specifically designed to ensure accurate and reliable results. This comprehensive approach to optical metrology ensured that the device's performance was thoroughly evaluated across a range of key metrics, facilitating informed decision-making and optimization of its design and provide answers to the FDA team.

AR product Testing Setup using Photometer (The image was blurred to protect customer and system confidentiality)

Optical Measurements Challenges

Optical measurements often require specialized devices, which can be both expensive and not readily accessible. For wearable devices, like AR headsets there are additional challenges due limited space and the need for precise positioning of measurement equipment on the system's exit pupil. To address this challenge, we leveraged our network by borrowing equipment from colleagues and other AR companies known to possess such devices. This approach enabled us to swiftly assemble alternative measurement setups, facilitating precise optical measurements.

Furthermore, our expertise in optical prototyping proved to be invaluable. We rapidly constructed optical testing setups, enabling us to build optical benches swiftly while maintaining high testing accuracy. This capability ensured that we could meet stringent testing requirements without compromising on accuracy.

AR product Testing Setup using Camera (The image was blurred to protect customer and system confidentiality)

Detailed FDA Reports

After successful testing of many optical parameters of the optical system, we documented the tests in comprehensive reports submitted to the FDA's center. These reports were crucial in demonstrating compliance with FDA requirements.

Successful FDA Testing and Clearance

After a few months of rigorous testing, the medical device company received confirmation that their product had successfully passed the FDA's testing and obtained approval for use in medical procedures.

Conclusion

This case study exemplifies the importance of optical engineering in the medical device industry and highlights the critical role that Joya Team played in helping their client navigate the complex process of FDA approval. Through creative problem-solving and technical expertise, we were able to assist the company in achieving its goal of bringing a new medical device to market, in few weeks. This task looked almost impossible, as it required us to fully characterize and validate the design of an optical device that was previously unfamiliar to us within a tight timeframe. We were thrilled to learn that after a few weeks of rigorous optical testing, the medical device company received confirmation that their product had successfully passed the FDA's testing and obtained approval for use in medical procedures.

Optical Engineering in Medical Field

As we move forward, it's essential to continue exploring new technologies and methodologies in optical engineering. Collaboration between companies like Joya Team and medical device startups and technology companies may be key in developing innovative solutions that improve patient care and safety.

In conclusion, the successful FDA approval of the AR medical device is a testament to the value of optical engineering in the medical field and in Augmented Reality. Our expertise and dedication played a crucial role in this achievement, highlighting the importance of collaboration and innovation in bringing new medical technologies to market.

Ready to transform your AR medical device's journey to FDA approval?

Reach out to us and let our optical engineering expertise navigate the complexities, address crucial FDA questions, and optimize your device for groundbreaking healthcare innovation.