ABOUT CHALLENGE

Compete for $350,000 in total prizes and help to improve the health & safety conditions for all respirator users.

Background

The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC) is the federal organization specifically dedicated to generating new knowledge in the occupational safety and health field and transferring that knowledge into practice for the betterment of workers.

The mission of the National Personal Protective Technology Laboratory (NPPTL) is to advance the state of knowledge and application of personal protective technologies. NPPTL conducts scientific research, leads federal and consensus personal protective technology standards and development, approves respirators, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard evaluations.

Problem Statement

Humans come in many shapes and sizes, as do respirators. This results in wide variability of physical dimensions and features of both people and respirators. The ability of a respirator to form a satisfactory seal or barrier between the wearer and the contaminated environment may be significantly affected by these variabilities. If the respirator-user match (fit) is not checked, an unsatisfactory seal/barrier may unknowingly exist. This could allow excessive leakage of airborne contaminants into the wearer’s breathing zone, despite the user wearing a respirator correctly selected for the application. A fit evaluation is used to address this issue and assess whether a specific type, model and size of respirator can adequately fit a specific individual.^[1]

There are issues with the current state of fit evaluation on filtering facepiece respirators (FFRs), especially for those working outside of the U.S. Occupational Safety and Health Administration (OSHA) regulatory oversight.

1. Research and anecdotal information reveal that health workers at doctors’ offices, nursing homes, dental facilities, and home health settings may not conduct initial or annual fit evaluation on a consistent basis due to lack of resources and fit evaluation procedures being impractical to implement widely across an organization
2. From a global pandemic, to wildfire smoke, and air pollution in urban areas; now more than ever the general public is wearing tight fitting respirators without the benefit of a fit evaluation to know if the respirator selected is properly providing the intended level of protection.
3. Under serious outbreak conditions, current approaches to quantitative and qualitative fit evaluations are constrained and lack the ability to efficiently scale.

These problems present an opportunity for innovators to design a respirator fit evaluation solution delivering users real-time information on a filtering facepiece respirators (FFRs) fit.

^[1] INTRODUCTION TO RESPIRATOR FIT EVALUATION, https://tsi.com/getmedia/25c8d870-4544-4ae4-8f24-a13a27819577/Introduction-to-RFT-(ITI-070)-US?ext=.pdf

How to Enter

In order to enter the Challenge, team’s should follow these three steps.

1. Register your team. Each team is required to identify a Team Leader who registers the official Team on the external Challenge site.
2. Attend the informational webinar on February 2, 2023. Register and attend the virtual informational webinar to gain additional information and ask clarifying questions to the Challenge team.
3. Submit a Phase 1 Concept Paper by May 12, 2023. Phase 1 submission materials are due on the external Challenge site by 11:59 PM EDT on May 12, 2023. View the Phase 1 Concept Paper submission details in the Submission Requirements section of this document.

The Challenge will be implemented as a three-phase, $350,000 competition collecting concept papers in Phase 1, building and evaluating prototypes in Phase 2, and sharing end solutions with NIOSH in Phase 3 for evaluation. By the end of the competition, solutions should aim to be market-ready with user-friendly fit evaluation solutions for end users of FFRs.

Phase 1 Contestants will submit a 10-page concept paper. Proposals must be no longer than 10 pages, with up to 2 optional pages for letters of commitment or support.

Phase 1: Concept Paper (10 pages)

Phase 2 contestants will develop verifiable prototypes of their fit evaluation solutions and conduct small-scale evaluations. The findings from their evaluation and prototype development efforts must be documented in a Phase 2 Prototype Demonstration Report and visually captured in a 3-5 minute product demonstration video. The Phase 2 Evaluation Report and Product Demonstration Video will be submitted for Phase 2 judging and evaluation.

Phase 2: Prototype Demonstration Report (5-10 pages or presentation slides).

MS Word or MS PPT are both acceptable deliverable formats.

Phase 2: Prototype Demonstration Video (3-5 minutes)

Videos should be shared via an accessible link such as YouTube or Vimeo. If teams are interested in preserving the privacy of the videos, they can configure the link visibility to be ‘Private’ so that only judges with the correct link can access the video.

To compete for the Phase 3 NIOSH Fit Evaluation prizes, innovators will be required to submit to NIOSH staff a sufficient number of pre-production prototype devices, or their equivalent, along with any ancillary devices, sufficient instructions/procedures for device operation, results interpretation, and any controls for evaluation to NIOSH staff.

The determination of the winners will be made by a panel of judges, as determined by NIOSH, based on the following evaluation criteria.

The determination of the winners will be made by a panel of judges, as determined by NIOSH, based on the following evaluation criteria.

To enter the NIOSH Evaluation Phase, teams will be required to ship a sufficient number of  pre-production final prototypes devices and all required components to a defined NIOSH  facility. After physically receiving the end solutions and all required instructional components, NIOSH will independently evaluate the solution’s performance and provide a report of the results to a judge panel who will make the final decision on Phase 3 prize awards.

Based on the end products received, possible tests may include:

• Verification of submitted results
• Advanced headform fit evaluation
• Bench testing for stated functionality
• Additional tests based on the unique characteristics of an end solution

Innovator grants to the Federal government an irrevocable, paid-up, royalty-free, non-exclusive, worldwide license to reproduce, publish, post, link to, share, and display publicly the submission on the web or elsewhere, and a non-exclusive, non-transferable, irrevocable, paid-up license to practice, or have practiced for or on its behalf, the solution throughout the world. Each Innovator will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Innovator must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Innovator’s rights to the Federal government.

To receive a prize for their submission, Innovators must agree to grant the Federal government a non-exclusive license right to the inventive concept or inventions and patents in all Intellectual Property demonstrated by the winning/award submissions. Full intellectual property rights also remain with the licensor.

• The Prize is open to anyone age 18 or older participating as an individual or as a team.
• Individual competitors and teams may originate from any country, as long as United States federal sanctions do not prohibit participation.
  • See the Sanctions Programs and Country Information | U.S. Department of the Treasury
• If you are a federal employee, your participation in this Challenge is prohibited.
• Submissions must originate from either the U.S. or a designated country (see definition of designated country at https://www.acquisition.gov/far/part-25#FAR_25_003), OR have been substantially transformed in the U.S. or designated country prior to prototype delivery pursuant to FAR 25.403(c).
• Submissions must be made in English. All Challenge-related communication will be in English. You are required to ensure that all releases or transfers of technical data to non-U.S. persons comply with International Traffic in Arms Regulations (ITAR) 22 C.F.R. §§ 120.1 to 130.17. Submissions from outside individuals and non-expert teams are encouraged. All applications will go through a process of due diligence; any application found to be misrepresentative, plagiarized, or sharing an idea that is not their own will be automatically disqualified.
• All ineligible applicants will be automatically removed from the competition with no recourse or reimbursement.
• No purchase or payment of any kind is necessary to enter or win the competition.
• By participating in this Challenge, each participant (whether an individual, group of individuals, or entity) agrees to indemnify the Federal Government against third-party claims for damages arising from or related to Challenge activities.
• Participants shall not use the NIOSH, CDC, or HHS names, logos or official seals in their submissions and must not claim endorsement from those entities.
• Participants agree that CDC may disqualify the submission if, in CDC’s judgment, the program is inconsistent with CDC’s public health mission, may be ineffective or harmful, or any other reason deemed necessary.
• Record Retention and FOIA: All materials submitted to HHS as part of a submission become HHS records and cannot be returned. Any confidential commercial information contained in a submission should be designated in accordance with 45 C.F.R. § 5.41. Participants will be notified of Freedom of Information Act requests for their submissions in accordance with 45 C.F.R. § 5.42.