Our client Curative was on the front line fighting the COVID-19 pandemic and needed to manufacture a new COVID-19 detection kit immediately. From our first engagement with the Curative team (on a Sunday), we produced an FDA-compliant unit within a week and ramped up production to meet their immense market need.
Challenge
Manufacturing a new diagnostic device and ramp production to fight pandemic.
The COVID-19 pandemic forced organizations globally to react to imposed changes faster than ever before. That was no different for Evolve and our client Curative. Curative had an urgent requirement unlike anything we had seen. They needed to manufacture an FDA-compliant COVID-19 test to help flatten the curve and save lives. Not only did a working product need to be developed immediately, but the production also had to increase exponentially and be distributed across the US to help achieve governmental testing targets.
How we made it possible
1. Initial engagement and production-grade designs
Curative contacted the Evolve team with an immediate need to manufacture their new COVID-19 testing kit. From the initial request and discussion, Evolve’s NPI team created dozens of iterations. The main components of the build were: specimen tubes, re-agent, bio-hazard bags, cotton pads & cotton swabs. In collaboration with Curative’s engineering team, an FDA-compliant product had been built before the week was out. What could traditionally take most contract manufacturers weeks (or in some cases months), we had completed in just seven days.
2. Mobilizing production
Due to the global pandemic there were worldwide shortages of basic components. This led to a constantly changing supply chain, which we had to embrace to get the testing kits developed as fast as possible. As it soon became apparent that supplies were going to be affected for the foreseeable future, we opted to fill the tubes in our own ISO 8 controlled environment clean rooms. Due to supply chain constraints, the manufacturing teams were supplied with different caps and bottles in different shipments. This lead to automation of line to adjust accordingly to the circumstances.
3.Scaling to mass production
Evolve hired 80 new members of staff across all levels to meet the growing demand for medical devices during the pandemic. Since the project start date, ramp rate over time increased steadily. The scaling was not purely due to volumes, it was made possible by efficiencies and improvements made to manufacturing processes. The growing workforce and efficiencies and automation implemented allowed evolve to ramp up to 36,000 units/day within 10 weeks.
Results
Not only did Evolve deliver on the initial requirement within 7-day during a global pandemic, the ingenuity and perseverance from the teams enabled Curative to ramp up production to 30,000 units/day within 2 months. This fast time to market enabled the Curative to meet the growing demand to provide reliable and rapid COVID-19 testing to help flatten the curve and save lives.