bg电子娱乐场麓s and Origin麓s first FDA compliant, sterile, 3D printed nasopharyngeal test swab now shipping
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 鈥(NP) swab test, which collects viral material from inside a person鈥檚 nasal cavity. Globally, there are very few companies that manufacture the swabs commercially, and all are overwhelmed with demand. In collaboration with Origin, bg电子娱乐场 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鈥檚 material development systems.
Traditionally, the swabs are made from multiple materials and adjoined prior to sterilization and packaging. Working cooperatively with Origin, bg电子娱乐场 supplied knowledge and technology to help design a swab that could be 3D printed at scale.
鈥淔rom inception, the vision behind bg电子娱乐场鈥檚 Open Materials Platform was to enable collaboration all along additive manufacturing鈥檚 value chain,鈥 says Ken Kisner, Head of Innovation - 3D Printing at bg电子娱乐场. 鈥淲orking 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.鈥
Origin鈥檚 programmable photo polymerization 鈥(P3) technology enabled the company to test different materials, print parameters, and designs in parallel 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 collect a reliable and sufficient sample.
The development effort also leveraged bg电子娱乐场鈥檚 Albert software platform, which accelerates the innovation of new products by determining the materials that are utilized. With its ability to access Loctite鈥檚 vast material and post-processing knowledge and data, Albert allowed bg电子娱乐场 to recommend the best performing material for the NP swab application.
鈥淣asal swabs are actually very complex instruments,鈥 says Nick Talken, CTO of Albert Software at bg电子娱乐场. 鈥淭he head of the swab utilizes a detailed lattice structure that鈥檚 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 bg电子娱乐场鈥檚 Albert Software, we were able to quickly match the best Loctite material for this specific application.鈥
Leading the effort, Origin also collaborated with Beth Israel Deaconess Medical Center 鈥(BIDMC) on the swab鈥檚 development. BIDMC conducted a rigorous initial clinical evaluation for human factors, materials testing and ensured that the final product would be compatible with the polymerase chain reaction 鈥(PCR) method that is used in laboratories to test for COVID-19.
鈥淏y working collaboratively and utilizing each other鈥檚 technologies, we identified, optimized and scaled the manufacturing process to bring an application to market extremely fast,鈥 says Chris Prucha, Founder and CEO at Origin.
Origin鈥檚 NP swab is classified as a sterile device and is considered a finished medical product. This means it must adhere to 鈥渃urrent good manufacturing practices鈥 鈥(cGMP) which are regulations enforced by the FDA and documented in the Code of Federal Regulations 鈥(title 21, part 820.) Both bg电子娱乐场 and Origin collaborated to conduct testing and validate each step in the sterilization process, which includes Ethylene Oxide 鈥(EtO) and autoclave sterilization. They also performed mechanical testing and intensive packaging validation which determined the product鈥檚 FDA compliant shelf life.
Furthermore, the NP swabs are 100% traceable and contain a digital thread that can be traced back to the manufactured base chemistries, which were produced using Albert software. Origin鈥檚 sterile NP swabs are currently shipping to leading healthcare facilities, government institutions, and independent testing centers in the U.S. and several other countries.
Discover how the two companies were able to design, develop, validate and scale the NP Swab in this upcoming deep dive webinar with Origin CEO, Chris Prucha and Ken Kisner, Head of Innovation 鈥 3D Printing at Henke on June 26, 2020. Register under:
About Origin
Based in San Francisco, CA, Origin is pioneering the concept of Open Additive Manufacturing, a new way to build based on open materials, extensible software, and modular hardware. Origin One, the company's manufacturing-grade 3D printer, uses programmable photopolymerization to precisely control light, heat, and force among other variables to produce parts with exceptional accuracy and consistency. The company works with a network of material partners to develop a wide range of commercial-grade materials for its system, resulting in some of the toughest and most resilient materials in additive manufacturing. The company was founded in 2015 and is led by alumni from Google and Apple. Investors include Floodgate, DCM, Mandra Capital, Haystack, Stanford University, and Joe Montana. Learn more about Origin here: