Developing the 3D-Print Knit Maskº — Scientifically Better

September 8,2020 UPDATE

With guidelines from the CDC and state authorities strongly recommending public use of face masks to help prevent transmission of the coronavirus, we are making 3D Print-Knit Maskº and filter inserts available for consumer purchase. We began developing Mask° in March with our partners at Nimbly Made, and with the support of your donations, we’ve been able not only to donate thousands of protective masks to healthcare professionals, but also to create a comfortable, functional, and reusable mask for personal use.

The Maskº filter elements have been independently tested by Nelson Labs to provide 95% Bacterial Filtration Efficiency (BFE).

Our 3D Print-Knit Maskº is now in its second generation based on the feedback from thousands wearers, for improved for comfort and ease of use with our filters. Our Apollo Maskº is a new addition to our offering with our signature, Apollo fabric for warmer climates and active use.

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Update as of April 14, 2020

Hi there,

It’s been quite the busy past two weeks here, and I wanted to check in and share an update on the progress of our Mask Donation program. A huge thanks to everyone who has supported the initiative, with amazing direct donations and through our 20% pledge of all proceeds. With your help, as well as the generosity of several of our partners and supply chain, we’ve been able to take decisive action on providing much-needed masks to healthcare professionals.

Here’s a look at how far we’ve come:

$104,725 raised through donations
35,000 N95-equivalent respirators and surgical masks produced prepared for shipment from our factory.We just completed production of 30,000 respirators and 5,000 surgical masks - and with the support of our logistics partners, we’re flying them in ASAP to hospitals in need.
3,000 face masks donated to Boston Medical Center and other area hospitals. These masks arrived two weeks ago, and were put to immediate use on the front lines.
1,500 3D Print-Knit Masks° Produced and counting…Every 7 minutes, a Mask° comes off the machine - by our partners at Nimbly Made and Andari. We’ve simultaneously been laser cutting HEPA filters to fit. These Masks° will be deployed at Harvard Vanguard Medical in the next few days.

Even as we shift to delivery of masks, we’re continuing our work on research, development, and production of our Masksº and innovation in the production development of PPE for now and the future.

Thank you,
Gihan and the Ministry of Supply Team

Developing the Maskº

In Short Supply

Due to the surge of COVID-19 cases and a lack of short-term production capacity, there is currently a shortage of Personal Protective Equipment (PPE) for medical professionals dealing with the virus first-hand. Doctors across the US and the world are clamoring for a rapid response to this critical shortage. The Centers for Disease Control (CDC) defines three levels of care given limited PPE as Conventional, Contingency, and Crisis Capacity. As the stock of masks, respirators and eye protection runs low, hospitals are now following CDC Crisis Capacity guidelines.

According to the WHO, the transmission of the virus particles is through close contact with respiratory droplets created during events such as coughing.

The virus can spread directly from person to person when a COVID-19 case coughs or exhales producing droplets that reach the nose, mouth or eyes of another person. The United Nations World Health Organization (WHO)

This is of particular concern for healthcare professionals working in close contact with patients, who need Personal Protective Equipment (PPE) such as masks and respirators.

We’re from Boston, a hub of the healthcare sector. Many of our family and friends work in the field directly—and inspired by our namesake, the Ministry of Supply, which designed, procured and deployed equipment and gear to the front lines in WWII—we believe this is our call to action to procure and produce equipment that can support healthcare professionals and front-line workers.

Understanding the Types of Masks

There are three primary types of masks as defined in further detail by the Food and Drug Administration (FDA)

Face Masks: This can include a variety of generic masks that cover the nose and mouth, that may or may not meet liquid or filtration efficiency levels
Surgical Masks: These masks are FDA Regulated, Class 2 devices that cover the nose and mouth and are designed to provide liquid barrier protection and filtration
Respirators: These are normally regulated by the FDA and NIOSH (National Institute for Occupational Safety and Health), and provide 95% filtration efficiency of particles greater than 0.3 microns and create a 100% fit seal around the nose and mouth

When none of these are available the CDC allows the use of homemade masks (such as bandanas and scarves) by healthcare providers. But it is recommended that they are used in conjunction with a face shield. Unfortunately, typical fabrics used in rudimentary masks are not highly effective. Something better must be developed.

Regulation and Recommendations During a Public Health Emergency by the FDA & CDC

Due to the shortage of respirators and masks, both the CDC and FDA are rapidly adapting guidelines during this public health emergency by providing options for certifications and allowing for alternate masks to be deployed to stimulate availability of PPE respectively.

Per the CDC, use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators are expected to provide protection to workers.

In settings where N95 respirators are so limited that routinely practiced standards of care for wearing N95 respirators and equivalent or higher level of protection respirators are no longer possible, and surgical masks are not available, as a last resort, it may be necessary for HCP to use masks that have never been evaluated or approved by NIOSH or homemade masks. CDC

Creating the 3D Print-Knit Maskº

We sought to create a face mask within the FDA COVID-19 Face Mask Public Health Guidelines that could be provided when primary options are no longer available.

Design: Decouple Fit and Filtration for Washability and Ease of Production

Our partners at Shima Seiki developed an open-source, 3D-Knit program for masks, which we’ve modified and improved with Nimbly. The face mask has a pocket for a replaceable filter element. The intent is to decouple the mask frame, which determines the fit and comfort of the mask, from the filtration component. This allows us to separate construction processes so that we can utilize techniques that are more efficient: such as computerized knitting and die-cutting. Filters can be replaced as needed and can be produced more easily through simpler production techniques.

Experts

First, we assembled a team of advisors — we worked with MakerHealth, which has a network of prototyping facilities that doctors and nurses use to prototype and improve medical devices. Working with them we learned how to produce for a real-world environment.

We also worked with our long-time partner Skylar Tibbits at MIT Self-Assembly Lab to create design iterations built around 3D-knitting where we’ve worked on advanced knit materials.

We also worked with Dr. Dorothy DeGuzman, a physician at the Ventura County Medical Center and Dr. Kelly Advani to user-test, iterate and improve the fit and usability of the mask.

Materials

Yarn: Utilizing our 3D-Print Knit process, we were able to quickly iterate new prototypes in hours and test the shaping of several different yarn combinations, but ultimately landed on viscose for breathability, softness and a dry microclimate.

Filter Pocket: For the filter media pocket, we were guided by advisors in the field to High Efficiency Particulate Arrestance (HEPA). These filters are currently recommended for air purification. Thanks to our work with interlinings for suits and shirts we were very familiar with various non-woven fabrics. That same knowledge guided us in determining a comfortable structure.

Manufacturing

We are using the computerized knitting process to knit masks with our partners at Nimbly that require minimal post-processing time, which enables rapid production. A single mask can be knitted in under 9 minutes. This also allows 3D shaping to create structures for the mouth and nose, for a more comfortable fit.

The Process:

Here are some behind the scenes images of the development process.

Over the coming days, we’ll be moving into production of the Maskº, so that we can begin making donations to healthcare professionals in need.

Disclaimer: The Ministry of Supply 3DPK Mask° is not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.

Sources (Linked): WHO, CDC, FDA, NEJM, NIH