Origin, the developer of the leading open platform for additive mass manufacturing, is an instrumental additive manufacturing leader collaborating with Beth Israel Deaconess Medical Center (BIDMC) to find a better solution for manufacturing COVID-19 test swabs. Over the last two weeks, Origin has quickly shifted its resources from being a 3D printer manufacturer to become a medical device manufacturer and has started production to address the massive shortage of COVID-19 test kit supply.
Health experts have said widespread testing for COVID-19 is the best way to track and trace the spread of the virus, yet America is desperately behind. Test swabs are difficult to manufacture and require design features and qualities that include a mix of stiffness + flexibility, biocompatibility, autoclavability, and specimen capture and carrying efficacy. Traditional test swab production is currently limited to only a couple of factories in the world.
BIDMC, an academic medical center affiliated with Harvard Medical School, selected Origin’s 3D-printed test swab to be part of a clinical trial to evaluate it for efficacy and safety. Origin’s 3D-printed swab passed a rigorous initial clinical evaluation for human factors, materials testing, and PCR compatibility, and we expect that full results of the clinical trial will be published shortly.
“The nation’s need for rapid and widespread testing for COVID-19 has been hampered by a widespread shortage of the swabs needed for testing,” said Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories at BIDMC, who has led a multi-disciplinary effort to resolve the shortage and is overseeing the clinical evaluations of 3D-printed swabs at BIDMC. “Innovations in 3D printing hold real promise for our collective efforts to diagnose and treat COVID-19, as well as to flatten the transmission curve.”
Origin’s test swabs are considered an FDA Class 1 Exempt Device. In addition to BIDMC’s clinical testing, Origin’s swabs have gone through rigorous testing with the US Army, Origin material partners, universities including UCLA, and independent medical labs.
Origin designed the swabs using the nTop Platform to rapidly iterate many different versions for BIDMC to evaluate, allowing them to quickly hone in on the best design elements for clinical efficacy and patient comfort. Origin worked closely with its Open Material Network to identify the proper medical grade material and to quickly refine optimal processing conditions.
Origin is also part of a new industry consortium called PrintedSwabs.org, which is bringing together the efforts of the 3D printing industry with academia and medical enterprises to supply millions of 3D printed COVID-19 test swabs.
Source: Company Press Release
