Quidel Sofia^® 2 Fluorescent Immunoassay Analyzer

Quidel Sofia® 2: Rising to the challenge in a time of urgent need.

At the height of the COVID-19 pandemic, one question was on much of the world’s minds: “What can we do to help?” For Quidel, a manufacturer of diagnostic devices for the healthcare industry, the answer was simple — get more of the Sofia^® 2 Fluorescent Immunoassay Analyzers out to the world, making as many Sofia^® SARS Antigen FIA tests available as possible.

But a simple answer isn’t necessarily a simple task.

As COVID-19 was spreading across the globe, the surging demand for medical devices, supplies and protective equipment was squeezing healthcare supply chains. Shortages began cropping up in all areas of the global supply chain. Which means the medical and diagnostic devices that were so crucial to identifying, treating and fighting COVID-19 — devices like the Quidel Sofia^® 2 — would only become more difficult to produce.

It was against this backdrop of increasingly urgent need and critical supply shortage that Quidel turned to Plexus to help get their potentially life-saving Sofia^® 2 into as many frontline hands as possible. Together, we were all in — ready to do whatever it would take to mobilize our resources, build the necessary supply chain and design the manufacturing process to ramp up from hundreds of Sofia^® 2 per week to thousands, in as short a time as possible.

The key to rapidly scaling Sofia® 2: collaboration and communication.

The partnership was up against the clock. There were real people counting on these devices every minute. This timeline was not set internally to meet business goals, but was driven externally by how fast the COVID-19 virus was spreading. Quidel’s Sofia^® 2 rapid test devices needed to get to market, and fast.

To achieve this, Quidel and Plexus established a leadership steering committee that met weekly to discuss progress and find solutions to project challenges. It was a clear demonstration of the communication and integration of our two companies at the leadership level. And it set the precedent for how the project and manufacturing teams would collaborate throughout the process.

Even in this fast-paced environment, it was essential that the daily project team was aligned for success. To ensure a seamless integration of the two teams, a transition team managed timeline and leveraged communication best practices across the multiple workstreams involved in bringing the Sofia^® 2 to market. This included establishing clear benchmarks that we needed to meet before moving on to the next project activity. The Quidel and Plexus teams also met daily to update the project plan in real time based on recent progress. This ensured that the project would be completed in an accelerated timeframe while meeting quality and safety standards.

“The Quidel Team was first to market and quick to ramp production of our Sofia^® SARS rapid antigen test strips to detect transmissible levels of coronavirus in 15 minutes, but we needed to bring our Sofia^® 2 fluorescent immunoassay analyzer capacity to a scale commensurate with the enormous testing volume and the urgent public-health need,” said Douglas Bryant, president and CEO of Quidel Corporation. “We were in a war with COVID-19, and we needed a force multiplier.”

“We found our ideal partner in Plexus,” Mr. Bryant continued. “The Plexus Team worked with us in lockstep — from planning and procurement to manufacturing and quality control. Their entire operation was safe, secure and swift. The excellence and dedication Plexus brought to the effort enabled Quidel to better fulfill our mission to democratize access to accurate and affordable COVID-19 testing and support our healthcare heroes on the front lines of the pandemic fight.”

The industrial operators at our Neenah, Wisconsin, facility developed a clear plan to maximize productivity and decrease downtime. Each step of the manufacturing process had owners responsible to keep manufacturing efficient. Manufacturing engineers knew the importance of setting up the line to adhere to COVID-19 protocols. Quality engineers made sure that every device met stringent standards. And industrial operators understood the importance of reducing unnecessary machine or operational downtime.

With Quidel’s device expertise and the proven manufacturing and supply chain solutions Plexus brought to the table, we were able to form a highly successful collaboration. And the alignment of purpose was the key to it all. Healthcare professionals were depending on these devices to provide patients with accurate COVID-19 test results to determine the appropriate care. Every team member understood the urgent need to make this project a success.