In times of need, manufacturing is driven by a philosophy John Lennon said best, “There are no problems, only solutions.” Today, manufacturers have pivoted to produce the critical supplies and equipment necessary to battle COVID-19 at a rate never seen before. SME’s Humans of Manufacturing Heroes Edition tells the stories of the teams, companies and partnerships adapting to produce the tools needed to fight this global pandemic. Going behind the scenes to share how these once-in-a-lifetime transformations are happening and the people making it all possible.
In response to a pandemic-related plea from a Florida hospital, a newly formed team at Formlabs, a manufacturer of SLA 3D printers and high-end resins, needed only one week to begin printing its very first parts for customers: swabs used to test people for COVID-19.
When doctors at the USF Health Department of Radiology at Tampa General Hospital sounded an alarm on March 17, the company sprang into action. It reconfigured its factory and began running two production shifts, said Gaurav Manchanda, director of healthcare at Formlabs.
Employees not normally involved in production are stepping up to help—because the urgency of the matter is obvious, he added. “The traditional testing swab is out of stock in some health systems and [existing manufacturing] does not meet demand.”
Using about 200 printers, the company can now make as many as 100,000 swabs per day at its facility in Millbury, Ohio, which was already FDA-registered and ISO 13485-certified.
The scene for the COVID-19-focused collaboration was set on March 16 at Tampa General, the official teaching hospital at the University of South Florida Morsani College of Medicine. Summer Decker, director of the 3D clinical applications at USF Health, was called in that day to help plan a trauma-case surgery.
The next day, Charles Lockwood, dean of USF’s medical college, called Decker’s team about local, national and international shortages of nasal swabs needed to test for COVID-19. Could the team 3D print swabs?
Decker and her team called on Todd Goldstein, director of 3D design and innovation at Northwell Health in New York. “They were almost out of nasal swabs,” she said.
Twelve initial designs became two. They tested the designs first on themselves, then using actual viruses in a bench lab at USF Health Department of Internal Medicine.
“The winning design had to not only be mechanically strong,” Goldstein said. “It had to get enough cell samples and fluid to test and it had to be comfortable enough that patients could accept the test.”
A week later, Formlabs received their preliminary design, which could print fewer than 10 swabs at a time, Decker said.
Manchanda and his team wasted no time: “We received the design file one morning,” he said, “the next afternoon, we had the prototypes shipped out.”
Then the hospitals in Florida and New York began clinical trials with patients who volunteered, using both a traditional swab and the AM swab on the same patient, Decker said.
Formlabs’ team worked day and night “across the United States and in Europe, to get this done,” Manchanda said. The team repurposed its Ohio plant from printing samples–such as dentures–to printing the testing swabs.
Working with Northwell and USF, they refined the design and optimized the placement of the swabs on the build platform to increase the yield and success rates, Manchanda said. The company can now create 324 swabs on a single print platform.
To cure as many swabs as possible, Formlabs’ team in Ohio designed a custom jig to hold the swabs during the cure process, set up more auxiliary equipment to complement parts coming off printers and created a clean room facility to provide the necessary resin. With workers from other departments at the Ohio facility supplementing the print farm and creation of surgical resin.
The players stayed in close contact throughout the process, sending “thousands of emails,” Decker said. “It has been wonderful to see all these people working together who normally would not have been working together,” she added.
Formlabs and the hospitals intend to make the plan available to other hospitals and qualified manufacturers.
“Certain hospitals have been asking for millions of swabs,” Manchanda said. “The total demand is over 10 million. We do have printers in stock we could allocate toward the response effort if needed.”
Although the swabs themselves are FDA class 1 exempt devices, they still must be made using FDA-cleared materials in an FDA-approved facility.
“Because of the investments that we made in that facility in Ohio and the materials we’ve been developing for years, we are pretty uniquely positioned to address this need,” Manchanda said. “We have received an overwhelming response from our customers–well over 3,000 have volunteered their time and printers to be a part of this effort. The vast majority are not medical device manufacturers.”
He recommended that manufacturers not currently in the medical device field look to make other parts and devices, such as adaptors to open doors without using one’s hands, that will slow the spread of the virus.
Next for Formlabs: adaptors that can convert CPAP and BiPAP machines to ventilators, and splitters that could allow one ventilator to serve two or more patients.
“We’re working in two-week sprints, trying to pay attention to the immediate needs of the healthcare system,” Manchanda said. “We’re able to bring a new application to market every few weeks."