Smart Molding International 2-2020

medical application 20 smart_molding international 2/2020 T raditionally, the swabs are made from multiple materials and ad - joined prior to sterilization and packaging. Working cooperatively with Origin, Henkel supplied knowledge and technology to help design a swab that could be 3D printed at scale. “From inception, the vision behind Henkel’s Open Materials Platform was to enable collaboration all along addi - tive manufacturing’s value chain,” says 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 suppli - ers are facing, this presents a significant opportunity for the 3D printing industry to demonstrate its capabilities, beyond prototyping.” Origin’s programmable photo polym - erization (P3) technology enabled the company to test different materials, print parameters, and designs in paral - lel to find an optimal solution in just a few days. The final clinically validated swab utilizes an intricate lattice design to collect the virus sample. It balances patient comfort with the ability to col - lect a reliable and sufficient sample. The development effort also lever - aged Henkel’s Albert software platform, which accelerates the innovation of new products by determining the ma - terials that are utilized. With its ability to access Loctite’s vast material and post-processing knowledge and data, Albert allowed Henkel to recommend the best performing material for the NP swab application. “Nasal swabs are actually very com - plex instruments,” says 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. Thewhole thing has to be flexible and strong, not to mention safe for medical use. With the help of Henkel’s Albert Software, wewere able to quickly match the best Loc - tite material for this specific application.” Leading the effort, Origin also col - laborated with Beth Israel Deaconess Medical Center (BIDMC) on the swab’s development. BIDMC conducted a rig - orous initial clinical evaluation for hu - man factors, materials testing and en - sured that the final product would be compatible with the polymerase chain reaction (PCR) method that is used in laboratories to test for COVID-19. “By working collaboratively and utiliz - ing each other’s technologies, we iden - tified, optimized and scaled the manu - facturing process to bring an application to market extremely fast,” says Chris Prucha, Founder and CEO at Origin. Origin’sNP swab is classifiedas a sterile device and is considered a finishedmedi - cal product. Thismeans itmust adhere to “current good manufacturing practices” (cGMP) which are regulations enforced by the FDA and documented in the Code of Federal Regulations (title21, part 820.) Both Henkel and Origin collaborated to conduct testing and validate each step in the sterilization process, which includes Ethylene Oxide (EtO) and autoclave sterilization. They also performed me - chanical testing and intensive packaging validation which determined the prod - uct’s FDA compliant shelf life. Henkel www.henkel.com Origin www.origin.io With the onset of the COVID-19 pandemic, the demand for medical supplies, including testing kits has outpaced supply. The primary protocol involves conducting a nasopharyngeal (NP) swab test, which collects viral material from inside a person’s nasal cavity. Globally, there are very few companies that manufacture the swabs commercially, and all are overwhelmed with demand. In collaboration with Origin, Henkel is leveraging its ability to carry out biocompatibility and robust mechanical testing at its facility in Concord, California, and has provided a range of 3D printable medical photopolymers designed for use on Origin’s material development systems. Henkel and Origin collaborate to help meet demand for COVID-19 NP swabs Several iterations of an intricate lattice designs were evaluated that would act like a brush to collect adequate samples needed for COVID-19 testing