Challenge:  

The client sought to address safety concerns with their previously FDA-approved handheld endoscopic device, which initially featured an aluminum tip. Due to the risk of the aluminum tip becoming excessively hot and potentially causing burns or tissue damage, the client decided to replace it with a plastic tip. The challenge was to conduct thorough Design Validation Testing to ensure the durability and safety of the updated device. Additionally, the client needed to confirm that the device met user needs and usability standards, while also ensuring that the device aligned with FDA requirements. 

Solution: 

ClariMed conducted comprehensive Design Validation for the client's handheld endoscopic device, focusing on durability testing. We tested the new plastic tip for durability under simulated use conditions.

Leveraging our extensive experience in human factors, we were given the continuity to assist the client in the most effective way possible. This foresight ensured the client’s Design Validation was not only thorough but also aligned with FDA requirements and potential future validation.

As one of ClariMed’s longstanding clients, our deep understanding of their products and processes allows us to identify bottlenecks and streamline our work. This familiarity not only makes our services more efficient but also helps in incrementally reducing costs. Our ongoing collaboration ensures that we can provide tailored solutions that align perfectly with their needs, optimizing both time and resources.

Results: 

Our Design Validation service provided the client a multitude of benefits, including: 

• FDA Compliance: The rigorous testing ensured the device met FDA requirements, aiding in the approval process, which is currently underway. 

• User-Centered Design: The Design Validation process thoroughly analyzed the device’s durability, which helps it to meet user needs and usability standards. 

• Future-Ready: The client is now better prepared for potential Validation Studies with this device or similar ones, which will lead to a bigger probability of success for next stage validation.

Overall, ClariMed’s Design Validation service is a deliverable that offered lasting benefits for the client’s development of the medical device. Our expertise in human factors, along with our ability to work across different time zones and industries, makes our service suitable for any company, regardless of size or location.

Conclusion: 

By starting the Design Validation process early with ClariMed, the client ensured that usability and user needs remained at the forefront of their durability testing, aligning with FDA expectations and requirements.

Learn more about our Design Validation Services.