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When we started Formlabs nine years ago, I couldn’t have predicted that we’d go from manufacturing 3-D printers and developing resins to producing medical equipment to fight a pandemic. But as we heard about shortages of essential medical devices and products needed to provide lifesaving care in the wake of the novel coronavirus, I realized Formlabs could help.
Hospitals and clinicians were already using Formlabs 3-D printers and resins to create 3-D printed parts such as physical models of patients’ anatomies from CT/MRI data and surgical guides for oral surgery. As the need for more medical equipment became clear, we began working with our current medical partners as well as many others across the country to support their needs. Our primary response was focused on test swabs because the demand for the COVID-19 test kit components had far outpaced the supply of the two main factories — one in hard-hit northern Italy and one in Maine — that typically produce the swabs.
The development of 3-D printed swabs to test for the coronavirus — which are now approved to use on patients — offers a guide on how to produce these supplies quickly, efficiently and with clinical validation.
We worked with Northwell Health, a New York area health-care network, and University of South Florida (USF) Health on the design and production of the coronavirus test swabs in mid-March as cases began rapidly spreading across the country. A team at USF Health created the initial design, and we began developing prototypes and securing materials for a 3-D-printed alternative to the version now in short supply.
The result is a 3-D printed swab that is a flexible stick with a bristled end that is inserted deep inside a patient’s nose and swept around to collect samples that stick to or wick up the bristles. The swab also has a breaking point that allows it to be easily placed in a vial and capped for testing in a lab.
One weekend, working through the night
The design and prototype for the swabs were developed over one weekend with clinicians from USF Health and 3-D printing experts from Formlabs working through the night. The 3-D-printed swabs were then tested by clinicians at Northwell Health, USF Health, and Tampa General Hospital for patient safety and comfort over the following week. It is important the medical devices that we supply to health-care professionals on the front lines of fighting this pandemic work effectively and don’t put workers or their patients at risk.
Now that initial clinical trials are complete, Formlabs is starting to produce these swabs at scale in our Ohio-based printing facility southeast of Toledo. With close to 200 3-D printers on-site, we will be able to produce up to 100,000 swabs a day at peak capacity. We are currently ramping up production and will be at this capacity in the coming weeks.
More hospitals may use the swabs
These swabs are currently being used on patients at Northwell Health, USF Health and Tampa General. Formlabs has sent additional samples of these swabs along with relevant documentation to other hospital systems experiencing shortages so they can be evaluated for use. USF Health has posted a WIRB application to allow other sites to join its protocol (WIRB # 20200779, Protocol 3DSWAB001) and add to the existing body of knowledge.
Formlabs and its hospital partners have FDA clearance through the recently announced Policy for Diagnostic Tests for COVID-19 related devices, which classifies the swabs as Class 1 Exempt devices, meaning they are exempt from the typical regulatory requirements. As long as the swabs are manufactured at FDA-registered facilities with Good Manufacturing Practice (GMP) in place, like Formlabs’ Ohio ISO-13485-certified facility, and the design has been tested and validated by the hospitals’ institutional review boards (IRBs), they are compliant.
Formlabs adheres to a wide range of required sterilization, regulatory, safety, biocompatibility and manufacturing standards and produces sterilizable, surgical-grade plastics for use in medical and dental applications.
We recognize that 100,000 test swabs a day isn’t enough to test for coronavirus across the United States. However, 3-D printing easily enables a local approach to manufacturing because the swab designs can be easily shared online across the country and the world, meaning faster delivery. Producing critical components locally cuts down on the time it takes to get these devices in the hands of medical personnel. By producing these components locally, say in New York City or in San Francisco, delivery time is cut in half so hospitals have access to more test swabs faster.
By turning to 3-D printing to improve production processes, shorten supply chains and localize manufacturing, health-care providers will be able to quickly and efficiently gain access to the supplies they need to combat COVID-19. It’s inspiring to see the 3-D printing community come together to offer assistance to hospitals in need. At Formlabs, we are proud to help our partners who are fighting this pandemic on the front lines.
Also read:Here’s how 3-D printing can help in the fight against the coronavirus
Max Lobovsky is co-founder and CEO of Formlabs, a Somerville, Mass., company that makes professional desktop 3-D printers. Follow him on Twitter @MaxLobovsky.
