Allergan TrueTear Intranasal Device Manufacturing Case Study

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Allergan TrueTear Intranasal Device Manufacturing Case Study

Case study of Flex's contract manufacturing partnership with Allergan to scale TrueTear, the first intranasal neurostimulating device for dry eye treatment.

Published

June 4, 2026

Read time

3 min read

Source

Details how Flex applied Design for Manufacturability (DFM) and Design for Reliability to transition TrueTear from pilot and clinical builds to commercial production. Covers FDA clearance achieved in 18 months, process validation, hydration cycle optimization, and scale-up to projected 3 million units annually at the Gushu, China facility.

Key takeaways

Flex managed DFM and process engineering for a novel intranasal neurostimulator requiring precise hydration control.

Program achieved FDA clearance in 18 months and immediate production of 60,000 units post-approval.

Single supplier handled disposable tip, durable device, and commercial scale-up through acquisition transition.

Higher cavitation molds, fluid dispenser automation, and tray/sleeve equipment supported volume ramp.

Projected annual volume of 3 million units manufactured at Flex's ISO 13485 and FDA-registered Gushu facility.

Market overview

SCR methodology note

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Important consideration

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