EnvisionTEC COVID-19 Efforts

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The 2020 COVID-19 pandemic has proven to be an opportunity for 3D printing to assist in finding new, innovative ways for healthcare professionals to provide assistance.  A shortage of the necessary diagnostic and treatment supplies has been discovered, and while many businesses have jumped in to help, it is 3D printing that may be able to provide real answers for how to combat the supply chain crisis.

Working hand-in-hand with healthcare leaders, EnvisionTEC has identified several areas where their specific strengths in biocompatible materials and fast, precise 3D printing equipment can help to provide replenishment of stocks as well as new, alternative solutions.

Learn more about these efforts below and find out where you can help, and how we can help you.

Latest Press Releases:

April 20, 2020 – BIDMC-led clinical trial identifies four novel 3D-printed swabs for use in COVID-19 testing – Link

April 15, 2020 -EnvisionTEC to 3D Print Mass Quantities of Nasopharyngeal Swabs for COVID-19 Testing Based on Successful Clinical Trial – Link

March 29, 2020 – EnvisionTEC Partners With Healthcare Community to Battle Global Pandemic – Link

Nasopharyngeal (NP) Swabs

Perhaps the biggest immediate need in the fight against COVID-19 is simply identifying those who have been infected as early as possible.  Testing kit availability has been vastly inadequate, and the medical community has been working tirelessly with the 3D printing community to find a solution to mass-producing the nasopharyngeal collection swabs to alleviate the shortage quickly. EnvisionTEC has been working closely with the Harvard Microbiology Lab within a larger group dedicated to connecting academia with the manufacturing industry to combat this shortage.

To this end, EnvisionTEC engineers have designed a collection tip for a flexible nasal swab.  Brian Nilson, of Nilson Laboratories, 3D printed the final design for testing.  He was able to print 400 of the swabs on his Envision One cDLM 3D printer in two hours.  The testing process is comprised of a ten stage mechanical testing, a two-part absorption test, a biological/chemical testing procedure to ensure the swab absorbs viral RNA particles and does not interfere with PCA/reagents, and a sample collection testing procedure.  To pass, a sample needed to use a material that is approved as chemically safe, would bend 180 degrees without breaking, and the design needed to be able to safely collect enough virus particles from the nasal passage to effectively test.

EnvisionTEC’s NP swabs have undergone IRB testing and approval. Under FDA regulations, an IRB group that has been formally designated to review and monitor biomedical research involving human subjects has the authority to determine that the swabs are suitable for mass production for COVID-19 testing.  EnvisionTEC worked with Beth Israel Deaconess Medical Center (BIDMC) of Boston’s Biomedical Laboratory, to obtain IRB approval. EnvisionTEC has long been committed to providing solutions to its customers and is now preparing to take on the call to action of helping to equip medical professionals with the tools needed to help combat this global pandemic.  With a vast network of thousands of customers eager to help, EnvisionTEC is proud to offer the capability of producing quantities of up to half a million of the swab per day.

To read the full manuscript as published in the Journal of Clinical Biology,  Click Here

Print NP Swabs

These NP swabs are a Class 1 medical device.  In order to print these for use by medical professionals, you must first be registered with the FDA and the swabs must be added to your medical device listing with the FDA.

Click here for instructions regarding this registration and listing.

Once this is done, please email covid19@envisiontec.com in North America and covid19@envisiontec.de in the rest of the world to be added to the list of available manufacturing partners. The protocols being developed for the NP swabs require an Envision One cDLM and a PCA 2000 curing unit.

EnvisionTEC Swab Listing on NIH 3D Print Exchange

Order NP Swabs

NP swabs are available to order. Please email us at covid19@envisiontec.com in North America and covid19@envisiontec.de in the rest of the world for pricing and lead times.

NP Swab Regulatory Information

NP Swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR 880.6025 Absorbent tipped applicator.

The FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR 80720.

EnvisionTEC facilities are registered:

1. EnvisionTEC GmbH Registration Number: 3012389497 (Link)
2. EnvisionTEC Inc. Registration Number: 3009261582 (Link)

NP Swab FDA Listings

Applicator, Absorbent Tipped, Sterile, Product Code KXG

Personal Protection Equipment (PPE)

In order to effectively treat the growing number of COVID-19 patients, healthcare professionals and many other essential workers rely heavily on PPE’s in order to safely maintain their own health.  Many mask designs are meant to be single-use, and with the general public adding to the demand for these items, they are becoming increasingly hard to come by.  Again, 3D printing is an ideal solution, allowing for portions of face shields to be printed and sterilized.  EnvisionTEC has a number of large 3D printers that can quickly and efficiently print these parts in bulk, and many of their customers have been able to answer the call for local needs.

3D Print Face Shields on Envision One

The links below can be used to assist in 3D printing and assembling face shields for interested parties.

Please do not download any files before you have read, acknowledged and agreed to the following Release Waiver

Build files for face shields (8) on the Envision One

Updated build file for face shields (7) on the Envision One – This new, pre-supported design allows for 7 shields to be printed in two hours on the Envision One and includes retention nubs spaced to a standard 3-hole punch to make the production of the screens quicker and easier than previously. Printing in the E materials means this is a long-term hot- and cold-sterilizable product, so does not need to bne disposed of after use.  This shield also has sufficient facial offset to accommodate glasses goggles, and face masks.

Database of PET Film Suppliers

Build files and instructions for 3D printing face shields

Order EnvisionTEC Custom-Made Masks

Dual-material 3D printed custom mask using soft material for the body and an elastomer for the filter area. Both materials are medical-grade and safe for use.

Please email your requirements to covid19@envisiontec.com in North America and covid19@envisiontec.de in the rest of the world.

Minimum order quantity: 2000

Lead time: 2 weeks

3D Print masks:

Please do not download any files before you have read, acknowledged and agreed to the following Release Waiver

Build files for Burbank Mask

Ventilator Splitter

Individual ICU ventilators are critical in the treatment of patients in severe respiratory failure, a symptom of severe cases of COVID-19. It has been determined that the demand for these ventilators will far exceed the current stock on hand.  Manufacturing giants such as Ford and GM have been tapped to assist in the production of these machines, but even with the increased manufacturing capabilities, the process to get these machines ordered and in the hands of the medical professionals who need them could cause delays.  Al Siblani has been working with local hospitals in the Metro Detroit area to provide a functional ventilation splitter that could be 3D printed in a Class 1 material such as EnvisionTEC’s E-Guide. EnvisionTEC is working with the FDA to authorize the use of 3D printed splitters as an emergency solution to allow for multiple patients to receive oxygen from the same ventilator by adjusting the pressure controls on the ventilators to allow for dual-patient use.  By using 3D printing for these accessories, production could be scaled up in locations close to where the need is greatest, allowing for fast reaction to the growing problem and more than double the capacity of current ventilator stock.

To place an order, please email covid19@envisiontec.com in North America and covid19@envisiontec.de in the rest of the world.