BARDA Announces Phase 2 Finalists of the Mask Innovation Challenge

Ten innovative concepts for next-generation masks to protect against airborne threats have been named the finalists of Round 2 in Phase 2 of the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH), and the National Institute of Standards and Technologies (NIST) Mask Innovation Challenge.

In December 2021, BARDA’s Division of Research, Innovation, and Ventures (DRIVe), NIOSH, and NIST partnered to announce the launch of Phase 2 of the Mask Innovation Challenge: Building Tomorrow’s Mask. The goal of Phase 2 is to accelerate the development of the next generation of respiratory protective devices to protect the public from a variety of airborne threats.

The goal of the Mask Innovation Challenge, overall, is to support the development of evidence-based and scientifically validated mask designs for future pandemics and public health emergencies, while striving to support sustained innovation for masks. The competition is designed to reduce the barriers to testing by providing access to federal laboratories during the prototyping process. By providing access to these facilities and expertise, the challenge finalists will be able to address common barriers to mask wearing, such as comfort, poor breathability, and glasses fogging, while striving for improved designs and novel materials.

Using the ambitious performance and design criteria specified in the Moonshot Target Product Profile (TPP), 10 unique teams were selected as the Phase 2, Round 2, finalists. These finalist teams include novel designs from academic institutions, small and large businesses, and a few previous Phase 1 winners.

SHOOTING FOR THE MOON WITH HUMAN-CENTERED DESIGN

Phase 2 of the Mask Innovation Challenge aims to enable rapid prototyping by providing access to federal government respiratory protection experts at NIOSH and NIST laboratories. Each of the teams will be competing for a portion of the available $400,000 cash prize that will be awarded in early Fall 2022 during the final round of testing, termed the Final Mask Face-Off.

The Phase 2 finalists and the descriptions of their concepts are:

• 4C Air, Inc.: The BreSafe Transparent mask is a semi-transparent face mask that utilizes 4C Air, Inc.’s patented BreSafe nanomaterial. The mask was designed to provide high levels of filtration and breathability with a controlled amount of transparency to suit different levels of filtration and communication needs.
• Air99, LLC: Leveraging the principles of origami to improve upon fit, breathability, and aesthetics of existing masks, the Air99 team created a mask that was designed to provide high filtration efficiency and a self-conforming fit, and to reduce fogging on eyeglasses and muffling of voices.
• Air Flo Labs, LLC: Flo Mask Pro is a reusable, elastomeric mask for adults. Leveraging 100+ 3D facial scans across multiple ethnicities, two mask size options provide a tailored fit for over 90% of the world's adult population. Interchangeable filters allow users to choose between a Pro Filter, offering approximately 99% filtration, or an Everyday Filter which aims to be 3x more breathable than most masks.
• ClearMask, LLC: This transparent mask advances filtration and full-face visibility to provide protection and clear communication for all. The ClearMask was also designed to ensure that it can be mass produced, packaged, and shipped at a low cost, making it accessible to a wide range of potential users and organizations.
• Georgetown University: This “smart mask” was composed of nanoporous metallic foams that are lightweight yet robust, can be easily cleaned and reused, and are intended to provide deep submicron particulate filtration. The mask’s specially tailored nanostructures are designed to be comparable to the efficiency and breathability of face masks, with the potential for also neutralizing viral pathogens or toxic gases.
• Global Safety First, LLC: Wanting to craft a simple solution, the ReadiMask team developed their design over many years, entailing extensive materials research, working with the U.S. Defense Logistics Agency (DLA), and human factor prototyping. The latest model is the ReadiMask 365, a strapless design that utilizes a cutting-edge, flexible, nano fiber filter and a medical adhesive, intending to create a new level of protection not only for the wearer, but also those around them.
• Levi Strauss & Co.: This mask was engineered to have a form that can be easily manufactured by any basic garment factory. The mask activates the existing and underutilized apparel supply chain as an alternative resource to make high-performance, low-cost mask– with no new equipment, training, or start-up costs.
• Matregenix, LLC: The team created a transparent nanofiber mask with the potential for high filtration efficiency and low breathing resistance. The mask aims to provide a high level of protection with a minimum barrier to communication.
• SEAL Lab: The Smart, Individualized, Near-face, Extended Wear (SINEW) Mask is a new type of personal respiratory protection which features a perimetral gap filter that removes particles and does not come in contact with the skin of the wearer’s face. The Sinew mask was designed to use electrohydrodynamic technology to overcome flaws of traditional respirators while maintaining the same degree of protection.
• StaySafeNow, Inc.: The Harvard-based team developed a reusable and cost-effective clear mask that is intended to reduce the spread of respiratory viral pathogens by blocking the two-way transmission of high-velocity jets of viral droplets. Researchers from Brigham and Women’s Hospital also designed a mechanism for easy switching of the filter for optimal protection and the clear shield to be inclusive for those with hearing difficulties or communication disabilities.

REMOVING BARRIERS IN TRANSLATING CONCEPTS FROM THE DRAWING BOARD TO PHYSICAL PROTOTYPING AND TESTING

Designing a well-designed and validated mask is not an easy endeavor. The undertaking requires a team with diverse expertise, financial support, and many months – if not years – of research and development, followed by rigorous product testing. In many cases, access to testing facilities and equipment is often a huge obstacle to small businesses and early-stage entrepreneurs. Over the past year, the Mask Challenge Team has had the privilege of interacting with entrepreneurs attempting to break into the personal protective equipment (PPE) sector and listening to their experiences, successes, and struggles. Informed by these insights, the Mask Challenge Team designed Phase 2 with the innovators in mind and aimed to reduce developmental barriers by providing access to federal testing laboratories and expertise while encouraging these groups to develop concepts that are as ambitious as possible. Through partnerships at NIOSH and NIST, Phase 2 of the Mask Innovation Challenge provides access to critical laboratory testing needed to assess and understand filtration efficiency, breathability, fit, and comfort.

At NIST, mechanical engineer and fluid dynamics expert Matthew Staymates will use advanced imaging techniques to visualize how air flows through and around the masks of the 10 finalists. For instance, fluid flow visualization techniques such as schlieren imaging, in combination with high-speed videography, can show airflow dynamics and reveal air leaks when a person who is wearing a mask breathes, talks, and coughs. In addition, fog illumination techniques produce semi-quantitative data on filtration efficiency of different mask materials. These visualization techniques provide unique insights into mask performance, and Staymates will share the data he produces with the finalists so they can use it to improve their designs.

Experts from NIOSH will evaluate the breathability (pressure drop), filtration efficiency, and simulated thermal comfort of the 10 finalists’ prototypes with machine testing. They will also evaluate the prototypes for mask fit using advanced manikin headforms that are modeled from data collected from the U.S. workforce. In the final rounds of testing, the prototypes will also be evaluated on a sweating thermal manikin for simulated thermal comfort during moderate-intensity walking. In all, the tests from NIOSH and NIST will together provide a holistic assessment of the fit, function, and comfort of the masks, and provide the finalists with critical data needed to advance their designs.

REIMAGINING THE FUTURE OF MASKS

In the coming months, the 10 finalist teams will have many opportunities to engage with experts at BARDA, NIOSH, and NIST and refine their concepts. Following a four-month redesign period in the summer, the finalists will resubmit their reimagined prototypes for the Final Mask Face-Off in late summer 2022. The final round of testing in the Final Mask Face-Off will include a re-evaluation of filtration efficiency, breathability, and tolerability, as well as another round of visualization imaging to reassess fit. Following this testing, the top two winning designs will receive $150,000 each, with two runners-up each receiving $50,000.

“This competition has spotlighted some really impressive innovations,” said Matthew Staymates. “These finalists highlight how this next generation of masks is moving beyond what we think of as a traditional mask to new spaces involving transparency, better breathability, and better fit and comfort.”

“Finding new ways to support entrepreneurs and innovators is really important for mask and PPE development,” said Sandeep Patel, Director of DRIVe. “Smaller companies often face enormous challenges trying to access laboratory testing services or manufacturing to successfully commercialize a new product. For us to provide this level of support to the Phase 2 Finalists is uniquely collaborative and we look forward to seeing their improved prototypes at the end of the challenge.”

Phase 2 of the Mask Innovation Challenge and the 10 finalists equally represent the commitment to providing better respiratory protection options to the general public. In the coming months, BARDA, NIOSH, and NIST look forward to accelerating the development of the most promising mask designs by facilitating their access to experts and laboratory testing.