Open Standard Respirator prototype N95 mask with filter, in white, detached from face covering. (Univ of Massachusetts, Amherst)
22 June 2020. An engineering partnership is designing a 3-D printed medical face mask needed by front-line health care workers, with its specifications soon to be made freely available. The open-source N95 face mask is a product of the Open Standard Respirator project that includes design, engineering, and manufacturing specialists from university labs and industry.
The current Covid-19 pandemic exposed shortages of personal protective equipment, or PPE, needed by health care workers as well as vulnerabilities in the international supply chains providing parts and materials for PPE manufacturers. The workhorse face mask during the pandemic is the N95 respirator, designed to reduce the wearer’s exposure to aerosol particles and droplets. The tight-fitting mask filters out 95 percent of airborne particles while allowing for free breathing, but wearers are advised to discard the mask after each patient encounter, particularly if exposed to secretions from the patient.
Open Standard Respirator is led by biomedical engineering professors Matt Carney of the MIT Media Lab and Philip Brown at Wake Forest University Baptist Medical Center in Winston Salem, North Carolina, and design engineer Aaron Cantrell, a principal with the consulting company Cofab Design in Holyoke, Massachusetts. The Advanced Digital Design and Fabrication, or ADDFab, lab at University of Massachusetts in Amherst is producing the 3-D printed parts for the mask.
The early PPE shortages and supply-chain failures also exposed another flaw in todays medical equipment production process: intellectual property barriers preventing more manufacturers from entering the market to fill the gaps. “Existing designs were locked up behind intellectual property walls,” says Cantrell in a UMass statement, “which prohibited manufacturers who wanted to chip in from producing them. Core to our ethos was an open hardware approach, which allows anyone with the manufacturing capability to license the design, producing a larger ultimate impact.”
The Open Standard Respirator team designed its first N95 model as a reusable mask with separate filter and face covering pieces made in small, medium, and large sizes to make for a better fit. The inhale and exhale filters are designed to use low-cost readily-available materials, instead of proprietary filter materials as found in some commercial masks. And the team says the mask is designed to to be sterilized using procedures meeting CDC’s guidelines. As reported by Science & Enterprise last month, engineering and biology labs at University of South Florida developed an electronic process for sterilizing N95 respirator masks enabling their safe reuse.
ADDFab is producing 3-D printed parts for testing by Cofab Design that will go into the first model prototype. ADDFab’s director David Follette says, “We can use high-end printers to print molds for silicone parts, which have very demanding requirements for accuracy and surface finish.” Being only 15 miles away from Cofab is an advantage, adds Follette. “To get prototypes that quickly from a third party or online service bureau would just be astronomically expensive, and then require overnight shipping.”
The team plans to have its mask compliant with FDA emergency authorization guidance, with its first model prototype mask now being tested at academic labs, and the final design tested later for certification. The project plans to form a not-for-profit organization to oversee marketing and licensing under an open-source hardware model, and continues to look for clinical, funding, and production partners worldwide.
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