On Tuesday, the Food and Drug Administration approved a 3D-printed coronavirus testing swab for use in hospitals. The swab design was a collaboration among Formlabs, a Boston-based 3D-printer manufacturer; New York’s Northwell Health; and University of South Florida Health.
Formlabs will mail its first shipments of swabs by the end of the week, healthcare director Gaurav Manchanda told Built In. These will be sent from the company’s Ohio production facility, which can print up to 150,000 swabs per day on its fleet of more than 250 3D printers.
The new swabs will help healthcare providers ramp up coronavirus testing, which is lagging in the United States. We have administered fewer tests per capita than many other countries amid the ongoing outbreak.
At a local level, though, that’s already changing. As of Monday, New York State — the epicenter of the American pandemic — was testing 16,000 people a day, according to Governor Andrew Cuomo. This translates into more testing per capita, Cuomo said, than was done in China or South Korea, two noted success stories in controlling the virus.
Manchanda sees the newly approved swabs making a “major dent” in the U.S.’s remaining testing supply shortage.
Formlabs will be printing more than enough swabs to supply all of New York State each day. The company plans to ship swabs across the country, and send only a fraction of them to its collaborators in New York and Florida. Both institutions can print their own swabs on in-house 3D printers.
Each swab is “about the size of a coffee stirrer,” Manchanda said, with ridged bulbs at the top and bottom to aid sample collection. The design was optimized so that 3D printers could each create 300 swabs in one pass.
Thus far, the swab design has received emergency internal review board approvals from both of its healthcare provider partners, and Class I Exempt status from the FDA. That means the agency has deemed it a low enough risk, and a critical enough device, that it doesn’t need to undergo testing beyond its creators’ initial lab tests.
Though Northwell and USF Health have a shared patent pending on the swabs, given the crisis at hand, they plan to share the design with other institutions.
Those may include hospitals and other medical-grade printing facilities with idle machines, like dental labs and surgery centers, Manchanda said. Criteria around which institutions can print the swabs are still a work in progress.
“I think this will play a meaningful role in testing for COVID-19,” he said of the newly approved swab design. “At this point there aren’t any competing [3D-printed] alternatives.”
