Collaboration for Mass Production of Certified 3D-Printed Nasal Swabs

Production of Medical Devices with Industrial 3D Printing in Europe and North America

The COVID-19 pandemic tested global health care capabilities. Supply chains were disrupted, requiring local agile solutions for certified medical devices. Many companies are collaborating with their local governments to provide critical medical devices such as ventilator components, ICU critical parts, face shields, face mask filters, etc., to fight the shortages.  

In this context, a collaborative R&D consortium was created in March 2020 to develop certified medical devices and ramp up mass production in North America and Europe. This consortium included Aenium Engineering and Burloak Technologies, who worked closely with EOS’ Additive Minds applied engineering team, the Canadian and Spanish health authorities and hospitals, as well as a Spanish genomic laboratory (ITALCyL).

Challenge

The demand for COVID-19 test kits combined with the empty inventory of conventionally manufactured nasal swabs made it clear that additive manufacturing would be the ideal technology for bridging this gap. However, there were challenges that needed to be overcome.

The first challenge was the sampling itself. It is essential for the test swab to preserve the virus’s integrity to allow RNA detection by means of reverse transcriptase real-time PCR. A solution is needed with a porous-specific activated surface on the head plus a highly flexible stick which cannot be manufactured conventionally.

The second challenge was the high demand for a cost-effective solution. Aenium and Burloak developed a model for producing up to 40 000 swabs per day on multiple EOS additive manufacturing systems.

And the third challenge: Nasal swabs are a class IIa medical device, requiring a specific certification for testing and qualification to fulfill medical standards. Therefore, a typically long certification procedure with the pub