San Francisco company Origin is one of a handful of 3D printing companies that set out to develop and mass produce 3D printed nasopharyngeal testing swabs for COVID-19 diagnosis. This effort was a direct response to a lack of conventional swabs; stores of the traditional swabs, only produced by a select group of companies around the globe, were rapidly depleted as countries around the world ramped up COVID-19 testing.
Origin’s swab, which is now being mass produced and has support from Stratasys for deployment, was developed in collaboration with the Beth Israel Deaconess Medical Center (BIDMC) as well as chemical giant Henkel, which recently drew the veil on its participation in the important healthcare project. The company says it worked closely with Origin to conduct biocompatibility and mechanical testing at its facility in Concord, California and provided a range of 3D printable medical-grade photopolymers for Origin’s high-speed layerless stereolithography technology.
“From inception, the vision behind Henkel’s Open Materials Platform was to enable collaboration all along additive manufacturing’s value chain,” said Ken Kisner, Head of Innovation, 3D Printing at Henkel. “Working together with Origin, we were able to develop a product which is very effective as its mass-produced counterparts. With the constraints commercial medical suppliers are facing, this presents a significant opportunity for the 3D printing industry to demonstrate its capabilities, beyond prototyping.”
Origin’s Programmable Photo Polymerization (P3) technology enabled it to test various 3D printing materials, as well as print parameters and swab designs to find the best solution. The resulting swab, which is now in use, is based on an intricate lattice design, optimized for collecting samples from the nasopharyngeal passage as well as for patient comfort.
The development process also utilized Henkel’s Albert software platform, which streamlines the development of new products by determining what materials are best suited for a given application. The software has access to a broad portfolio of materials, including Henkel’s Loctite products, and integrates post-processing data.
“Nasal swabs are actually very complex instruments,” explained Nick Talken, CTO of Albert Software at Henkel. “The head of the swab utilizes a detailed lattice structure that’s designed to maximize the amount of virus collected. The whole thing has to be flexible and strong, not to mention safe for medical use. With the help of Henkel’s Albert Software, we were able to quickly match the best Loctite material for this specific application.”
From there, the 3D printed swab was evaluated by BIDMC, which conducted initial clinical evaluation for human factors and materials testing, to ensure that the swab was compatible with the polymerase chain reaction (PCR) process used in labs for COVID-19 testing.
Fast forward to today, and Origin’s nasopharyngeal swab is classified as a sterile device and is offered as a finished medical product, meaning it must adhere to current good manufacturing practices (cGMP) enforced by the FDA, and documented in the Code of Federal Regulations. Henkel adds that it helped Origin to test and validate the sterilization process for the nasal swab, which includes Ethylene Oxide and autoclave sterilization. Mechanical testing was also performed to validate the product’s packaging and shelf life.
The Origin nasal swabs, which are being marketed by Stratasys to healthcare providers and other testing centers in the U.S., are 100% traceable thanks to a digital thread that goes all the way back to the manufactured base chemistries. A webinar detailing the entire nasal swab development process will be hosted by Origin and Henkel on June 26, 2020.