TrueTear^® is the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients. TrueTear^® consists of a handheld neurostimulation device with a disposable tip that is inserted into the nasal cavity to induce the production of natural tears, providing a novel and innovative approach for patients with inadequate tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms.

Business objective

Allergan was bringing an entirely new product to market and needed to pilot and build the device to get FDA clearance on an extremely short timeline.

The process was complex since the work had begun under an Allergan acquired company, Oculeve. The transition from Oculeve had to be managed so it did not impact the path to clearance and launch.

Once FDA clearance was received and product awareness increased, Allergan wanted a partner that could quickly scale manufacturing to meet market demand.

Solution

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.

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

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.

Results

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.