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Lucid’s forward-thinking vision and commitment to advancing EsoCheck’s potential led the company to seek a partner capable of matching their determination and purpose. Recognizing Sage’s extensive expertise in medical device development, manufacturing, and support of regulatory submissions, Lucid collaborated with Sage to achieve an ambitious set of goals within a highly condensed timeline. Together, the companies achieved a groundbreaking result.

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Challenges: Turning an Impressive Plan into Reality

In July 2018, Lucid’s Chief Technology Officer reached out to Sage with a bold objective: to submit EsoCheck for FDA 510(k) clearance with an extremely tight timeline, an objective that would require incredible work ethic, communication, and focused attention to detail. Lucid’s confidence in their innovative device and their strategic decision to partner with Sage underscored their determination to bring life-saving technology to market quickly.
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Lucid tasked Sage with finalizing design inputs, building fixtures, completing design verification testing, and writing test reports which would be necessary for the FDA submission. This required a collaborative, strategic approach to meet the accelerated timeline while maintaining rigorous quality standards.

From Vision to Submission

Sage’s team immediately initiated the Design and Development phase, working closely with Lucid to refine and document the device design. Sage developed a comprehensive Design History File, test methods, procedures, test fixtures, and conducted design verification testing efficiently, with great precision and reliability.

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“The nature of what we do requires incredible accuracy, so it is critical to get everything right the first time,” said Peter Aliski, Sage’s General Manager.
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Through close collaboration and meticulous planning, Lucid and Sage successfully completed the project by the deadline, resulting in a 510(k) submission to the FDA. Lucid’s clear vision, combined with Sage’s technical expertise, ensured the device met stringent industry standards while addressing the needs of healthcare professionals and patients.

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Flexibility and Collaboration to Expand the Scope of Work

Impressed by Sage’s ability to deliver results under pressure, Lucid expanded the scope of their collaboration. This included supply chain management and manufacturing. Once commercialized, the demand for Esocheck quickly began to rise in the market. Having developed a robust manufacturing process, the Sage team continued to build product to meet existing demand, while simultaneously working in parallel to provide a seamless transfer to a higher volume manufacturer.

“We viewed any challenges as opportunities to continue supporting our client and ensuring their product reached the market,” said Jeff Cerier, President, and Co-founder of Sage.

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Lucid’s initiative-taking leadership and willingness to adapt as the project evolved, paired with Sage’s flexibility and expertise, enabled the partnership to thrive and deliver exceptional results.

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Achieving Success and Industry Recognition

The collaboration resulted in the successful FDA 510(k) clearance for EsoCheck, which is now commercially available to clinicians. In 2020, EsoCheck was named a “Silver” winner of the Edison Best New Product Awards in the “Medical/Dental Testing Solutions” category, a prestigious honor recognizing excellence in innovation, design, and development.

Conclusion

Lucid Diagnostics’ bold vision and commitment to innovation, combined with Sage’s expertise and adaptability, exemplify the power of collaboration in advancing healthcare technologies. By successfully completing testing that supported 510(k) clearance, manufacturing the product, and facilitating the transfer to a high-volume manufacturer, the partnership brought EsoCheck to market on an accelerated timeline. This achievement not only underscores Lucid’s leadership in the medical diagnostics field but also highlights Sage’s proficiency in taking on complex challenges and commitment to advancing patient outcomes.