Flex and Allergan Team Up for Treating Dry Eyes with a Nasal Neurostimulating Device
ProductTrueTear® neurostimulation device
ServicesSketch-to-Scale®, Design for Reliability, Design for Manufacturing, Product Introduction
“Flex forged a very strong working relationship with the members of our team. With great people who are willing to work together, they made the difference and stretched to produce this innovative product.”
— Chris Stivers, Program Lead, Manufacturing, Allergan
We demonstrated that we could take an innovative and complex design, and bring it to success within Allergan’s required timelines.
We worked with Allergan and provided our Sketch-to-Scale® solution that incorporated Design for Reliability (DfR), Design for Manufacturing (DfM), and new product introduction expertise. We collaborated with the Allergan team to develop the product, usher it through FDA clearance, and scale manufacturing to bring the device to market.
On the development side, we had to manage the unique hydration process essential to maintain the right moisture level for TrueTear®. We designed the device’s fluid dispenser automation, the equipment for trays and sleeve, and the disposable tip; key to delivering the electrical pulses.
During the pilot phase, our Design and Engineering facility in Dallas delivered on time for the clinical trial, which led to our engagement for the durable portion of the product. We scaled, validated, and provided documentation for the FDA filing.
When planning for commercial production, Allergan recognized the value of a partner like Flex that specializes in contract manufacturing and can quickly scale to mass manufacturing as needed. Not only was our expertise in PCBA, assembly, and process engineering vital, but our team was also able to master management of a new manufacturing process.
Allergan chose us for this project based on our experience in developing products for FDA submission and our ability to meet tight deadlines.
Together, we were able to produce an innovative, state-of-the-art technology and bring it quickly and successfully to market.
Ultimately, we demonstrated that we could take a new, innovative, and complex design and bring it to success within Allergan’s necessary timelines.
We obtained clearance followed by immediate production of 60,000 units.
After receiving FDA clearance in April 2017, TrueTear® was introduced to ophthalmologists and is now being produced in Flex’s Gushu, China facility.
Conceptualize, design, and test ideas through co-innovation. Rapid prototyping shortens the distance to a viable, quality product.
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