COVID-19 Pandemic

Formlabs is dedicated to helping the medical community address the COVID-19 epidemic and associated supply chain shortages with 3D printing technology. We have many customers in the healthcare space already using Formlabs’ products to test applications for COVID-19 related projects, and recently launched the Formlabs Support Network for COVID-19 Response. This is an initiative to match healthcare organizations and providers with Formlabs customers who are willing to use their printers and volunteer their time to help address critical supply chain shortages and other healthcare needs. We are working closely with health systems, government agencies, and our network of over 1,500 volunteers to help design, prototype, and produce parts to be tested and potentially adopted by clinicians.

Page Last Updated: March 25, 2020, 9:50am EDT

CategoryComponentClinical partner/ testerClinical Steps CompletedCurrent StatusClinical Uses to dateWhat's Next
Test KitsNasal swabsUSF Health and Northwell Health (NY)Emergency IRB approval, PCR test pass, ID sign off and pathologyFDA Class I Exempt status0Awaiting clinical protocol and final printable files
VentilatorsTubing splitter (1 to 2, 3, and 4 patients)Northwell HealthPassed lab testing with standard tubing (2)Awaiting final files and clinical protocols0Files and instructions made available later this week
Facial ShieldAdjustment strapSeveral // Budmen (3)Awaiting initial feedbackPrototypes printed0Awaiting clinical input
Respiratory mask (adapter)Scuba mask conversion to PPETwo leading hospitals in the US (4)Lab testingLab testing0Next round of lab testing
Surgical Masks and RespiratorsN95 respirators and masksSeveral hospitalsSuccessful printing. Clinical fit failureTemporarily on hold0N/A(5)

1 Clinicians at USF Radiology, Northwell Health 3D Design and Innovation Lab, and others
See writeup below for additional information and disclaimers
Budmen mask
4 Two open-source projects led by physicians and researchers from leading hospitals in Boston and the Bay Area
5 Based on clinical opinions and technical feasibility analysis, Formlabs does not recommend 3D printing masks or respirators, including N95s. To make your own N95 respirator using off-the-shelf parts that are traditionally available to the medical community, please watch this video from Boston Children’s Hospital with recommendations and read the position from another hospital leader in our FAQs section below.

Formlabs Support Network for COVID-19 Response

Formlabs is aware of many hardware projects that seek to address global healthcare-related supply shortages around the world. We are reaching out to our incredible community to connect those in need with those who have engineering, clinical, and 3D printing resources to offer. 

You should fill out this form if either of the following apply:

You or your organization is working on COVID-19 related projects and need access to 3D printed parts, or

You or your team have access to Formlabs manufactured 3D printers and are willing to volunteer your time and equipment in the fight against COVID-19.

We will do our best to connect available Formlabs printers and relevant services to the people who need them most.

 

Join the 1500+ volunteers who signed up last week alone.

Sign Up Here

Current Focus Areas

Formlabs has fielded hundreds of requests, evaluated dozens of potential applications for 3D printed products, and is now supporting a handful of projects with high-impact potential. The current priority areas were selected based on clinical demand, technical feasibility, and regulatory implications. Priority areas for focus include test kit swabs, ventilator splitters, and face shields. Once designs have been tested and validated by the medical community, Formlabs has the resources available to scale production to tens of thousands of parts per week. We are ready to engage our internal resources and community of skilled volunteers to produce parts for healthcare providers all over the world.

Below are the key projects that Formlabs is spearheading, with guidance from medical thought leaders and physician innovators.

Test Kit Swabs

Problem

There is a nationwide shortage of the nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians are beginning to design and test their own swabs as quickly and safely as possible.

NP swabs are flexible sticks with a bristled end that are inserted into the nose to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles. The swab is then placed into a vial that contains a culture medium. Swab sticks have an intentionally weak point 7-8cm from the bristled tip, which allows the stick to be broken to the correct length so that the vial can be capped before it is transported to a laboratory for testing.

Solution

Currently we are printing and optimizing swab designs co-created by doctors at USF Health and Northwell Health, as well evaluating designs from other leading hospitals. The entire swab is printed as one piece. 

Validation Status

Formlabs has printed samples of the test swab using our biocompatible, autoclavable Surgical Guide Resin. These samples have passed a variety of tests at USF Health, which has received an Emergency IRB approval as well as authorization from regulatory, infectious disease, and virology, among others.

As of this writing (at the time posted on the top of this page), the FDA considers these swabs a Class I Exempt device and states that manufacturers should be FDA-registered and listed, and have all information, on request, for GMP. Formlabs will produce swabs in its FDA-registered, ISO 13485 certified facility in the United States. Further, the FDA recommends, but does not require, flocking of the swab, meaning that 3D printing of the entire swab as a single piece is acceptable.

Conversion Kits

Dr. Alex Stone and Dr. Jacqueline Boehme from a leading hospital in Boston

Problem

Front-line providers are running out of personal protective equipment (PPE). At many hospitals, there is a very limited supply of PPE remaining. PPE includes face masks and/or respirators (e.g. N95 masks) and face shields. In addition, the typical forms of PPE are disposable and more durable solutions are needed given the limited supply. Moreover, most PPE is designed to be used for minutes at a time, not for an entire day.

Solution

Adapting a full face snorkel mask to fit a filter already in use for breathing circuits and in hospitals. Because this filter is reusable, and unavailable/unknown to the general public, it will be less at risk to be taken from providers treating ill patients.

Validation Status

Dr. Alex Stone and Dr. Jacqueline Boehme from a leading Boston hospital are currently testing and validating designs for: seal, breathability, fogging, and ability to communicate with other physicians while wearing it.

 

Ventilator Splitter

Problem

As the number of patients in critical condition grows, mechanical ventilation is required to provide sufficient oxygen into the lungs and body. Ventilator machines are limited in supply, and hospitals can run out of machines faster than they can order new devices.

Solution

Adding an adapter to one ventilation system to be used with more than one patient can help expand capacity. These adapters allow for two, three, or four patients with similar needs and conditions to potentially use one ventilator.

The 3D Design and Innovation Lab at Northwell Health has provided Formlabs with STL files that fit standard tubing. These files allow for a HEPA filter to be placed at each end then connecting patient vent tubing.

Note

We recommend Clear Resin or Surgical Guide Resin for the final product of ventilation splitters. Photos are of Draft Resin.

Validation Status

Northwell Health has conducted lab testing and states that while this would allow one to split a ventilator in a life or death situation there are certain caveats one need to be aware of.

Patients need to be similar in height, IBW, lung dynamics, and both be COVID-19 +. Also, heavy sedation / paralytics to eliminate asynchrony, and tandem weaning.

Northwell is currently writing clinical protocols. Neither Northwell Health, nor the CDC, have studied ventilation splitting on human patients.

While there is the new capability to ventilate multiple patients for a short period of time without utilizing front line clinical staff, patients likely need to be similar in height, weight, lung dynamics, COVID-19 carrier status.

 Please watch Dr. Charlene Babcock explain how to modify a ventilator, and the risks involved.

 

Face Shields

Problem

Face shields are personal protective equipment (PPE) devices that are used for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are in short supply, with some hospitals reusing disposable units or improvising solutions from commercial products not intended for this use.

Solution

Formlabs is prototyping and evaluating several 3D printed and non-3D printed designs in parallel to determine effectiveness and near-term scalability. Current focus is on producing parts onto which a shield may be mounted and tightened, emulating existing designs such as from Halyard Health and McKesson. The shield itself is not being 3D printed and may be available from traditional manufacturers and medical suppliers.

Validation Status

Prototypes are being sent to various hospitals around the US for evaluation and testing.

 

Frequently Asked Questions

Formlabs has received hundreds of inquiries regarding how 3D printing can help the current crisis. Here are answers to some of the most common questions we have received. 

Question: What can I 3D print right now that can help in the fight against COVID-19?

Formlabs is actively working with numerous healthcare systems, government agencies, and universities to figure out the highest impact role 3D printing can play in the current crisis.

This process has two important phases:

  1. The first phase is to work directly with these organizations to test and validate actual 3D printed parts for medical use. This is actively happening across COVID-19 test kits and materials, PPE, and medical equipment. We are working quickly to have designs and parts validated and approved.
  2. The second phase is to begin printing these parts. Formlabs will use our internal printers, and reach out to the hundreds of people who have volunteered through the Formlabs Support Network to solicit their help in printing these parts.

As of now we are in the first phase. There are currently no approved parts yet available for mass printing. As soon as we reach phase two, we will notify everyone. If you have not already, please join the Formlabs Support Network.

Question: Is Formlabs or any other 3D printing company able to print N95 respirator masks?

As of this writing, Formlabs does not recommend 3D printing N95 or other respirator masks. Please see the following statement from the Director of a 3D Printing Lab within one of the largest health systems in the United States, which represents our opinion well.

“N95 masks are the one of the many forms of PPE that our frontline healthcare providers rely on to protect themselves from airborne pathogens. As one can imagine due to the current outbreak, demand for these masks have gone through the roof and supply chains have not been able to keep up. While I applaud the maker community for trying to assist the overloaded healthcare system right now, I would caution the fabrication of “hacked masks”. Unfortunately the resolution required to create an N95 far outweighs the resolution of our 3D printers. For example the COVID-19 virus is thought to be ~125 nm and in order to block it properly, the filter should have an appropriately small pore size. As per the FDA “The 'N95' designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles.” I do not feel comfortable providing a mask to a frontline provider without thoroughly vetting it. Additionally, the mask must create an airtight seal which is almost impossible to achieve with ridged plastic. I truly wish we had a simple solution to create these much needed masks in house, however with the current technology in my 3D lab, the solution remains elusive.”


For additional information about possible alternatives to surgical filtering facepiece respirators, please see this February 2020 document from 3M, and the latest from 3M here.

Question: What is the initial response to the Formlabs Support Network for COVID-19 Response?

The community response to the Formlabs Support Network for COVID-19 has been tremendous. Within the first 48 hours of the network going live, we received nearly 500 responses from individuals and organizations offering their assistance.

Question: In general, how can 3D printing be used to help with the COVID-19 epidemic?

There are several ways 3D printers can be used to address COVID-19. Most requests we are receiving from hospitals fall into four categories:

  1. Testing. 3D printed parts can be used to develop components of test kits, such as swabs, needed to diagnose COVID-19
  2. Personal Protective Equipment. While directly printing N95 masks is not recommended, there are several components of masks which could be 3D printed to protect both the public and healthcare professionals. Several are being tested as we speak.
  3. Medical Equipment. This includes ventilators, respirators, spare parts, etc.
  4. Accessories. This includes arm activated door latches, foot pulls, nasal swabs, etc.

Question: Why is Formlabs not already printing parts?

While we appreciate the overwhelming response to the Formlabs Support Network for COVID-19, we do not yet have medically-validated parts that can be printed. We ask for our community's patience while we go through appropriate validation. We must do everything we can to ensure that whatever is produced is safe for use in a real-world health care setting. We will notify everyone as soon as we have designs approved for printing.

Question: Will Formlabs supply instructions or STL files for parts to print?

As soon as any of the projects above have received clinical approval we will provide STL files, along with instructions and clinical protocols to our community partners specifying how they can join in printing.

 

Formlabs’ Customers in the News

Our users continue to amaze us with the innovative and groundbreaking ways they are using 3D printing to advance their industry: the healthcare field is no exception. Several Formlabs customers are already making headlines for using Formlabs' products in the fight against COVID-19.

One example of this is Mologic, a diagnostic testing company based out of the United Kingdom that was recently given a grant by the UK government for COVID-19 research. Mologic is using Formlabs’ printers to rapidly prototype COVID-19 test kits.

"Mologic currently uses the Form 2 3D printer for the prototyping of all of its test devices as the system is easy to use, has a wide range of useful materials, and is quick. The production of high quality detailed parts is invaluable to the speedy device development and the fact we can produce parts in a matter of hours enables us to progress quickly from testing towards the tooling stages." 

"For the development of the Covid-19 test, we would primarily use our Formlabs 3D printer to generate prototype devices to enable us to quickly progress with testing, providing the team with enough devices for the initial stages of the development process. This speeds up the generation of tooling for the final device design and enables a quicker overall delivery of the test into the manufacturing stages and release."

Adrian Walker, Lead Biomedical Engineer, Mologic

 

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Disclaimer

Formlabs has created this website and has become involved in varying degrees with the projects described here during a global medical crisis.  Formlabs is working on many projects to address global healthcare-related supply shortages around the world, but in trying to mitigate these shortages, patient safety is still Formlabs’ top concern. We must remind those who are helping to alleviate these shortages that masks, swabs, face shields, and other 3D printed products intended to prevent or treat COVID-19 are medical devices. These devices must be safe for their intended purpose and anyone considering the manufacturing of these products should consider the following items:

  • Formlabs is a manufacturer of 3D printing materials capable of fabricating finished devices according to their labeling and any other product manufactured from these materials should be verified and validated according to their intended purpose.

  • You may be fabricating a device that does not have the required regulatory approvals and clearances. If you are fabricating devices, follow the guidelines on the label for each material.  You may seek to obtain reliable regulatory advice. 

  • Please consider local regulations, material safety data sheets, software capabilities, sterilization requirements, and institutional requirements before 3D printing medical devices.

  • Regulatory agencies (such as the FDA) may consider expedited review of manufacturing information and/or premarket submissions.

Formlabs cannot warrant that any products not manufactured by Formlabs are suitable for their intended purpose.