Masks (also referred to as “barrier face coverings”) are products worn on the face that provide varying degrees of protection to the wearer and have the potential to filter respiratory secretions from the wearer to help prevent disease transmission to others (i.e., they may provide source control). Many public health agencies worldwide are encouraging their citizens to wear masks when in public spaces in order to reduce the spread of infectious respiratory diseases. However, there remain notable barriers that reduce overall mask usage. These barriers include issues such as contact dermatitis with prolonged wear, physical discomfort, fogging of eyeglasses, and difficulty communicating. In addition, many masks that are currently available tout unconfirmed protective capabilities that lack scientific evidence to support such claims. Overall, there is a need to develop better designs, materials, and technologies that are more acceptable to wearers and that ensure quantified measures of performance.
To address these issues and accelerate the development of the next generation of masks, BARDA and the National Institute for Occupational Safety and Health (NIOSH) have partnered to launch the Mask Innovation Challenge: Building Tomorrow’s Mask. NIOSH is part of the US Centers for Disease Control and Prevention. NIOSH is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. The Mask Innovation Challenge aims to improve the comfort, utility, and protective capabilities of products that are worn during day-to-day activities by the general public when physical distancing is not possible. This competition is designed to support the development of mask designs that meet defined performance standards while also overcoming barriers to use.
The Mask Innovation Challenge seeks to develop innovative and effective designs for mass-producible, low-cost-per-use devices to be worn by the general public in order to provide protection from respiratory disease pathogens. Furthermore, users of these devices should be able to put them on and wear them without extensive fitting procedures or complicated user instructions. Barriers that reduce compliance with mask usage include, but are not limited to:
- Currently available retail devices are often untested, with unknown protective capability.
- Physical discomfort with use, particularly in hot and humid environments.
- Contact dermatitis with extended wear.
- Inability to effectively communicate with others using facial expressions.
- Speech intelligibility.
- Lack of understanding of the device’s features.
- Fogging of eyeglasses during use.
- Difficulty finding a device that is the proper size.
Challenge Structure and Timeline: The challenge will run for a minimum of 6 months and will be divided into two phases, followed by a possible third phase. All respondents are eligible for Phase 1. Participation in Phase 2 is not dependent upon participation in Phase 1; however, winners from Phase 1 will be eligible to receive additional points for consideration in the final judging process for Phase 2.
Phase 1: Design – Respondents will be asked to submit their concepts for a redesigned mask according to the stipulations in this announcement. Up to 40 regional winners (within up to 4 regions) will be selected to move on to the DRIVe Accelerator Network Product Pitch Competition, where they will present their design to a panel of federal and non-federal experts. Of those finalists, up to 10 will be selected to receive the final prize of up to $10,000 each to create a prototype of their concept. Prototypes and physical products will not be tested in Phase 1, but may be eligible for consideration in future phases.
- Innovation Tracks:
- Masks: Designs in this track focus on improving upon already existing designs for masks
- Masks that are selected for testing in future phases may be evaluated against the following criteria:
- Achieve filtration efficiency ≥20% against a sodium chloride (NaCl) aerosol challenge with a count median diameter of 75 ± 20 nm and a geometric standard deviation of 1.86 at a flowrate of 85 ± 4 Lpm. If the specimen lies flat in the filter holder, the flowrate will be adjusted to achieve a face velocity of 10 cm/sec.
- Achieve inhalation airflow resistance of ≤15 mm H2O at a flowrate of 85 ± 4 Lpm. If the specimen lies flat in the filter holder, the flowrate will be adjusted to achieve a face velocity of 10 cm/sec.
- Ability to reduce inward leakage of particles into the breathing zone across the interface of the device and the face. The testing may be performed using people or a manikin headform.
- Other criteria as deemed necessary in later phases.
- Masks that are selected for testing in future phases may be evaluated against the following criteria:
- Other Designs/Technologies: Designs in this track incorporate new technologies and materials that have not yet been included in current mask designs.
- Designs may be judged on an individual basis in future phases by performance testing of prototypes. Because designs may be innovative, new test methods and criteria may need to be developed to evaluate:
- Filtration efficiency.
- Inhalation airflow resistance.
- Ability to reduce inward leakage of particles into the breathing zone across the interface of the device and the face. The testing may be performed using people or a manikin headform.
- Other test methods as deemed necessary depending on the design.
- Designs may be judged on an individual basis in future phases by performance testing of prototypes. Because designs may be innovative, new test methods and criteria may need to be developed to evaluate:
- Masks: Designs in this track focus on improving upon already existing designs for masks
- Prize Purse: Up to 10 Phase 1 winners will receive up to $10K each.
Phase 2: Proof-of-Concept – Challenge participants will be asked to submit their solutions in response to a scenario. Finalists will be invited to submit prototypes for proof-of-concept testing by NIOSH laboratories and other partner laboratories. More details on Phase 2 will be provided by an update to this announcement in the future.
- Prize Purse: Total prize purse of $400,000, divided among 5 winners, to be determined later.
Exclusion Criteria: The following concepts will NOT be accepted for consideration for either design track:
- Prophylactic chemical treatment such as creams, sprays, coatings, drugs, etc. to provide biocidal enhancement. These devices will be excluded because of their potential for skin, eye, and inhalation irritation of the wearer.
- Contact tracing apps and other behavioral change protocols or technology.
- NIOSH-approved respirators or designs modifying NIOSH-approved respirators.
- FDA-cleared masks or modifications to FDA-cleared masks.
- Products already carrying international respirator certifications (e.g., KN95, P2, P3, etc.) or modifications to these products.
- A self-contained breathing apparatus or a supplied-air design that would connect to a stationary air source.
Awards:-
Total Cash Prize Pool
$500,000 for Phases 1 and 2
Prize Breakdown
Phase 1: Up to 10 winners will be eligible to receive up to $10,000 each.
Phase 2: Up to 5 winners will be selected to split a total $400,000 prize purse.
Prize distribution will occur at the sole discretion of BARDA.
Non-monetary Prizes
Participants may be eligible for mentorship opportunities from interested parties. Additional information will be provided through an update to this announcement.
Deadline:- 21-04-2021