The idea that can change the world: the COVID test stick, through additive manufacturing

In March 2020, when COVID-19 began to overwhelm American medical systems, the University of South Florida, through Dean Dr. Charles Lockwood, MD, MHCM immediately recognized that global supply chains of personal protective equipment, ventilators and testing swabs could be completely overwhelmed. The two major manufacturers of nasopharyngeal swabs, Puritan Medical Products in Maine and Copan Diagnostics in Italy, failed to keep up with demand, and the federal stimulus came too late. The $7 million federal grant given to Puritan Medical Products to expand the plant would take months to repay, and an air shipment of swabs from Copan was not enough to meet the states’ requests.

Dr Lockwood knew that new manufacturing methods would have to solve the situation and saw 3D printing, also known as additive manufacturing, as a solution to the shortage of personal protective equipment, ventilators and, perhaps most importantly, test sticks – and their distribution to the front lines. Knowing this, he co-opted Dr. Summer Decker, an additive manufacturing expert and director of 3D clinical applications in the Department of Radiology at USF Health.

He reached out to Gaurav Manchanda, who, in his role as director of healthcare at Formlabs, has worked with healthcare organizations and regulatory bodies to develop new ways to use 3D printing for prototyping and manufacturing personalized medical devices. When COVID-19 began to overwhelm American healthcare systems, Dr. Lockwood saw the potential of 3D printing to find an urgent solution for the emergency production of personal protective equipment, ventilators and test sticks.

The goal became clear: a 3D printed

With their background and experience in 3D printing for medical applications, Dr. Lockwood, Dr. Decker and Manchanda set out to develop a 3D printed COVID-19 test swab.

Using the Formlabs printers they had relied on for years, Dr. Decker and her 3D lab colleague, Dr. Jonathan Ford, sought to address the pad shortage by providing a turnkey solution that could be used by the many Formlabs printers already in hospitals and medical facilities across the country. The USF team knew they could quickly design a pad for mass production, but to clear regulatory hurdles, establish best manufacturing practices, and reach a broader audience, they turned to Formlabs’ healthcare team.

“Within a few hours of my initial conversation with Dr. Decker, everything was set up and ready to go into production here,” said Manchanda, as he recruited colleagues from across the company with expertise in print optimization, regulatory and quality processes, and decentralized manufacturing operations.

After a frenetic weekend of prototyping, the pads were evaluated by doctors, volunteers tested for comfort and in the lab at Tampa Bay General Hospital, Northwell Health and USF Health for alignment with usage standards.

Decker’s team then contacted USF’s Department of Infectious Diseases to conduct validation testing. They coordinated with the Formlabs team, which was discussing regulatory requirements with the Food and Drug Administration and establishing manufacturing and quality protocols for other healthcare systems that had already requested the file for printing.

At the same time, Dr. Todd Goldstein of Northwell Health, who also helped design and test, quickly conducted clinical trials in nearly 300 patients because New York state was hit hard in March before the virus spread to other parts of the country.

“This is a great example of the incredible impact we can have on people’s lives when teams of experts from academia, healthcare and the tech industry come together,” Dr Lockwood said. “During COVID-19, we couldn’t have any kind of delay, and everyone’s quick, agile, and experienced alignment dramatically improved the United States’ ability to test patients.”

Just 12 days after Dr. Decker’s call to Manchanda, the final design was approved and the 3D file was made available to other health systems through the Formlabs website and forums for COVID-19 response efforts.

Along with the file, Formlabs has developed a validated and detailed workflow with guidance for experienced healthcare users to fabricate 3D rods and ensure the health and safety of patients. «We are grateful that we were able to work as a team to get this solution so quickly, hoping to help many people. The response has been overwhelming,» Dr. Decker said.

As COVID-19 cases increased through April 2020, the need for widespread testing continued. Hospitals, dental labs, and academic medical centers that used their 3D printers for specific surgical models were able to reconfigure their equipment and meet a current and extremely pressing need in their supply chain.

Hospitals across the United States, from Thomas Jefferson Hospital in Philadelphia to the University of Nevada Health Department, have urged faculty to seek guidance on transitioning Formlabs printers from research and patient care departments to wand manufacturing.

Formlabs also contributed to the production of stickstransforming its ISO 13485-certified, FDA-registered manufacturing facility in Ohio from resin production to printing hundreds of thousands of sticks for public use. With the approvals needed to produce medical devices and supplies, Formlabs was able to quickly reconfigure its production lines for printing chopsticks, showing how 3D printing workflows and materials can easily adapt to demand.

The impact of the COVID-19 pandemic required a global and rapid response.

Through collaboration with USF and Northwell, Formlabs co-authored a solution that has been deployed around the world. With its FDA-approved design, accessible equipment, and validated processes, the stick design has enabled the generation of over forty million COVID tests in twenty-five countries. Over the past year, Formlabs 3D printers have continued to be used by governments and healthcare providers to improve testing and patient care. This global solution is just one example of how the agility of 3D printing can bring public benefits.