Smart Molding International 2-2020

medical application 28 smart_molding international 2/2020 O ne of the biggest immediate needs in the fight against the global pandemic known as COVID-19 is simply identifying those who have been infected as early as possible. Globally, the testing kit avail - ability has been vastly inadequate for the large-scale testing needed in order to identify and isolate known cases of the virus and get ahead of its spread within each community both in the United States and across the globe. The traditional manufacturing method for the swabs is tedious and limited, with the final testing swab needing to ex - hibit unique properties of softness and flexibility that are difficult to produce. EnvisionTEC worked with Beth Israel Deaconess Medical Center (BIDMC) to develop a swab design and material to be printed on their bestselling Envision One cDLM 3D printer. The Envision One, launched in early 2019, has been EnvisionTEC’s best- selling 3D printer to date, with over a thousand units currently in use among dental labs, orthodontic practices, uni - versities, medical device manufactur - ers and more. Many of the owners of these units are accustomed to produc - ing medical-grade products, making them the ideal production partners for this enterprise. The Envision One is ca - pable of producing up to 2400 swabs in 24 hours. This leads to a production ca - pacity of EnvisionTEC and its Envision One user network of up to a million swabs per day. EnvisionTEC engineers have designed a collection tip for a flexible nasal swab that has completed testing in an IRB- approved clinical trial for use in this unprecedented time. In order to be given this approval, a rigorous testing procedure was required to be passed. This testing of both the design and the material included sev - eral rigorous mechanical and chemical tests. This was done to ensure that the swabs pick up viral RNApar - ticles and do not interfere with PCA/reagents, that they are chemically safe, that they would bend 180 degrees without breaking, and that the design would be able to safely collect enough virus particles from the nasal passage to effectively test. One of the major advantaged of the EnvisionTEC NP swab is that it contin - ued to performmechanically the same after being sterilized by steam at 270°F at 27 Pa in an autoclave. Other 3D printed swabs have shown deteriora - tion following autoclave procedures. According to Dr. Ramy Arnaout, MD, DPhil, Associate Director of the Clini - cal Microbiology Laboratories at Beth Israel Deaconess Medical Center, “Analytical results were positive, with a high level of concordance with the reference swab and with subjective results showing that [EnvisionTEC’s] swab performed neutrally or better than other test swabs”. During the clinical trials performed by BIDMC, the EnvisionTEC swabs received positive comments from study staff for comfort, flexibility, and ease of inser - tion, which we attribute to the use of EnvisionTEC’s E-Guide Soft material. E-Guide Soft, a biomedical 3D print - ing material from EnvisionTEC, and the EnvisionTEC tampon design have been tested. EnvisionTEC partnered with the Beth Israel Deaconess Medi - cal Center (BIDMC), which performed these tests. EnvisionTEC www.envisiontec.com EnvisionTEC is proud to announce they have successfully completed a clinical trial to use the EnvisionTEC 3D printed Nasopharyngeal (NP) Swabs for COVID-19 testing. EnvisionTEC, as well as a growing number of their Envision One cDLM customers who have also registered with the FDA to take part in this endeavor, have the mass production capabilities to produce up to a million of the desperately needed swabs per day. EnvisionTEC to 3D print mass quantities of nasopharyngeal swabs for COVID-19 testing