Calls For Action

The Challenge

Despite calls from government and the medical community for innovation of respiratory protection that encourages compliance and provides source control, the development of affordable and practical face masks and respirators has not advanced for decades. Mainstream safety manufacturershave failed to meet adequate safety measures by refusing to solve the True Design Flaw™ which is apparent in every mask and respirator on the market. that offers both comfort and protection while also being inexpensive.

Development has stagnated because, for mainstream manufacturers, fundamentally fixing the discomfort caused by respiratory protective equipment and providing cost efficient products would mean a significant loss of profit margins. On the other hand, DRAFT™ believes that profits should not come before the health of mankind. We have rising to the challenge and innovated face mask and respirator technology that can provide supreme comfort with long-term wear at a lower price point.

Support for Innovation

Our mission at DRAFT™ is to transform Respiratory EquipmentFrom Tolerable to Comfortable™.Our innovative methods and designs allowfor 99% of exhaled air to be diverted from the breathing cavity, releasing heat and humidity and minimizing themixture of freshand exhaledair

The U.S. government has long called for action and supported top members of the scientific community in development of new methods of protection, especially for health care professionals.

Discovery of the Exhalation Valve Mask to Extend the life of N95 Long hours of wear in infectious outbreaks.
Patent was filed that stated after 2 hours of use in a infectious disease outbreak, healthcare professionals would be at increased risk due to the failure of protection by way of moisture retained in the breathing cavity begins to breakdown the effectiveness of protection. The patent called for the benefit of putting a hole in the front of a N95 and insisting the benefit of a hole on the mask along with a one-way valve was overwhelming value to healthcare professionals even considering failure of value(such as by moisture-it can stick open) as the true value would allow the respirator to last longer with the decrease moisture that is push out by way of
exhalation.
Due to the 1990’s Resurgence of Tuberculosis, What did the U.S. ask the Safety Manufactures to do?
1990’s The U.S. government called on Safety Manufactures to find a more comfortable PPE for long hours of use with infection control for highest safety and comfort in healthcare organizations to treat highly infectious patients.
2003 SARS Epidemic, What did the U.S. ask the Safety Manufactures to do?
During the 2003 SARS epidemic, with outcry from Canada health care professionals had high levels of discomfort and a possible increase in death due to noncompliance.
During 2007, What did the U.S. ask the Safety Manufactures to do?
During 2007sThe U.S. government called on Safety Manufactures to find a more comfortable PPE In 2007, Institute of Medicine articulated 28 recommendations for better respiratory PPE.
In 2009, B.R.E.A.T.H.E. called for respirator designs and manufacturing to construct a new
In 2009, B.R.E.A.T.H.E. called for respirator designs and manufacturing to construct a new respiratory based on the 28 CRADA steps by authority FTTA 15 U.S.C. 3710a.
Due to the COVID-19 Pandemic, What did the U.S. government ask the Safety Manufactures to do on December
17, 2020?
Solicitation to the mask industry was announced by DRIVe created by BARDA, part of ASPR, with HHS in partnership with NIOSH soliciting input on judging criteria and testing methodology for the Mask Innovation Challenge which was being developed for possible RFI early 2021with a financial competition open to the general public and professionals to be aimed to develop a mask that can protect Americans from respiratory pathogens. Solicitation response ended January 15, 2021.
What was the “Purpose” of the Mask Innovation Challenge, told in the U.S. announcement?
BARDA DRIVe is seeking to understand and develop tools such as challenges and prize competitions that the Federal government and others can use to engage a broad range of stakeholders, including the general public, in developing solutions to difficult problems. Challenges and prize competitions rely on competitive structures to drive innovation among participants and usually offer rewards (financial and/or other) to winners and/or finalists. BARDA may use the information submitted from interested parties to develop challenges and prize competitions to address key respiratory device related issues. BARDA DRIVe is not soliciting input on BARDA’s broader R&D efforts on COVID-19 or other programs.
What was the “Background” of the Mask Innovation Challenge, told in the U.S. announcement?
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary of Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) serves the nation by partnering with industry to make available medical countermeasures against a wide range of major threats to our national health security. BARDA and our industry partners have been successful in delivering new therapeutics, vaccines, diagnostics and devices against serious health threats including chemical, biological, radiological, nuclear (CBRN) agents, pandemic influenza and emerging infectious diseases and their sequelae. Respiratory pathogens, including Influenza and Corona viruses, are known to spread by three main routes: mucosal contact of droplets, inhalation of smaller aerosolized particles, and fomite transmission. Multiple publications have now demonstrated the efficacy of surgical masks (and to an extent, cloth masks) in preventing droplets from breaths, coughs, and sneezes from spreading viral articles. These findings form the base of scientific evidence used by public health agencies worldwide for their citizens to wear masks when in public spaces to reduce the spread of the SARS-CoV-2 virus. However, while such masking practices are efficacious in preventing spread, they are less effective at protecting the wearer from infection and identified as a barrier to mask wearing.1

There are significant design barriers that preclude individuals from wearing masks, such as contact dermatitis with prolonged wear, physical discomfort, difficulty communicating (due to impaired speaking and recognition of facial expressions), or breathing. In addition, many commonly-available masks on the market tout unconfirmed protective factors that lack scientific data to support such claims. Thus, there is a need to develop technologies that meet defined performance standards, while providing comfort and durability to the average consumer.

BARDA, in partnership with National Institute for Occupational Safety and Health (NIOSH), intends to launch the Mask Innovation Challenge, in early 2021, subject to the availability of funds and final agency approval. The competition is designed to support the development of improved mask designs and other related technologies that are more comfortable, have improved fit, and meet defined performance 1Centers for Disease Control and Prevention. Scientific Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2 https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html standards including protection to the wearer and also preventing some level of particles from escaping the mask. The competition is anticipated to run for up to one year and offer financial awards and in-kind support services for meeting the challenge goals.

We are particularly interested in your input on the following questions regarding the evaluation criteria and testing protocols for mask
submissions:

What was the “Development of Evaluation Criteria” of the Mask Innovation Challenge, told in the U.S.
announcement?
1. What do you see as the most important criteria to evaluate the effectiveness of a community mask that is to be used by the general public? Examples might include: assurance of consistent fit, comfort, airflow resistance, ability to protect the wearer and stop particles from escaping the mask, cost, etc.
a. In addition, please provide feedback on the following evaluation criteria:
i. Feasibility – Submission demonstrates a reasonable rationale for the design of the mask, intuitive design that can be used without fitting or prior training, and contains components that are easily accessible.
ii. Innovation. Submission advances the state of the art in filtration efficacy, comfort, and utility of masks used by the general public.
iii. Barriers. Submission addresses barriers and limitations of currently available masks and proposed innovations are based on scientific and technical merit.
iv. Design and Desirability: Submission demonstrates how the proposed solution meets the needs of the users and shows how it could integrate into production now or in the future.
What was the “Testing Protocols” of the Mask Innovation Challenge, told in the U.S. announcement?
Please provide feedback to NIOSH on the following questions regarding performance criteria and testing protocols for novel mask designs. Please provide supporting rationale for any suggestions submitted.
1. For the evaluation of novel mask designs in a laboratory setting, what performance criteria would you recommend and how would you structure a test? Examples might include: criteria for evaluation of fit factors, percent allowable particle penetration through the filter material, percent allowable particle concentration escaping the mask, maximum inhalation and exhalation airflow resistance, etc.
2. If BARDA were to require prototypes to be submitted for evaluation, how many individual prototype samples should be evaluated?
3. What other factors or experiences with general-use masks do you consider important to this mask challenge that you want BARDA and NIOSH to be aware of?
What was the “Partnerships” of the Mask Innovation Challenge, told in the U.S. announcement?
1. What sectors or stakeholders should BARDA engage as part of these efforts?
2. If there is an opportunity for sponsorship, is your organization interested in participating as a potential sponsor? If yes, what are the capabilities of your organization in support as a potential sponsor?
3. Would your organization be interested in joining a list of experts that may provide mentorship to challenge winners?
4. Would your organization be interested in serving as a marketing partner and provide marketing and outreach as part of the challenge competition including posting on websites, social media, and other outlets?
What was the “Dates” of the Mask Innovation Challenge, told in the U.S. announcement?
The period for comments begins with the publication of this document. Submissions must be received on or before 01/15/2021 to be considered.
What was the “Submissions” of the Mask Innovation Challenge, told in the U.S. announcement?
Individuals are encouraged to submit responses electronically to DRIVeComments@hhs.gov. Please indicate “Mask Challenge Response” in the subject line of your email. Submissions received after the deadline may not be reviewed. Responses to this notice are not offers and cannot be accepted by the federal government to form a binding contract or issue a grant. Respond concisely and in plain language. You may use any structure or layout that presents your information well. You may respond to some or all of our questions, and you can suggest other factors or relevant questions. You may also include links to online material or interactive presentations. Clearly mark any proprietary information, and place it in its own section or file. By engaging in this process or submitting any information in relation to this RFI, interested parties acknowledge that federal and nonfederal U.S. Government personnel may participate in the process and provide input compliant with applicable law and regulation. All personnel are strictly bound by the appropriate non-disclosure requirements.

Interested parties should not engage in any part of the announcement process if they do not consent to the participation of non-federal consultants as described in this subparagraph. Your response will become government property and the U.S. Government may publish some
of its non-proprietary content.

March 1, 2020 NIOSH study 4 EHMR models-evaluation of elastomeric half mask respirators with filtered
exhalation-TBD
During COVID-19 Pandemic, What did the U.S. announce about the Safety Manufactures Answer to the
Innovation Challenge to have publicized Money Prize Incentive to allow All Americans to try how to make a comfortable mask.
The goal of the contest is to solve the discomfort BUT two rules were to NOT HAVE
i.NIOSH-approved respirators or designs modifying NIOSH-approved respirators. Designs cannot modify already approved NIOSH-respirators and should be complete, independent designs.
ii.FDA-cleared masks or modifications to FDA-cleared masks. Accessory to a NIOSH-approved respirator or FDA-approved surgical mask (to include but not limited to additional filters, ear loop or strap modifications, etc.).
DRAFT™ social enterprise to FIX safety equipment deficiency and change the status quo will bring about further advancements from the very safety manufactures that have refused and delayed in manufacturing adequate life impacting safety equipment for mankind.
Contact your government representative and tell them to legislate HUGE Financial Incentives to protect the disruptive vertical line extension of products eliminated from all forms of respiratory products by way of this breakthrough technology. Act NOW to persuade through protection of solvency the manufacturing of TRUE SAFETY to TECH™ brining Life-Changing Compliance by manufacturing RESPIRTORY EQUIPMENT FROM TOLERABLE TO COMFORTABLE™ and ensure TURE EFFICACY TECHNOLOGY™ to allow TRUE PROTECTION™ from lung and heart damage caused everyday from particulates to infectious disease.

Natural & Bioterrorism Infectious Micro-Organisms

Comfortable Compliance Mitigation Strategies Reducing the Spread of Infectious Disease, Longhaulers, and Deaths to the Global Population.

IS AMERICA READY FOR THIS?

We would be if Big Safety easily modified their complete line of safety mask and respiratory productions lines with our technologies and apparatuses. Call us and we can show you how this can happen today.


WHAT SHOULD PEOPLE DO TO PROTECT THEMSELVES?

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The Big Q & A

The Big Question

How did DRAFT™ create and maintain ownership of its world-and life-changing intellectual property?

The Answer

We developed it ourselves —after experiencing personal discomfort using a respirator while working in construction, our chief engineer innovated a solution that can be produced and sold at an affordable rate. Low costs mean low profits, so the leaders in the mass safety market aren’t interested. We believe safety shouldn’t come at a high price.

Our Solutions

DRAFT™technology diverts expelled air to reduce heat, humidity and moisture on the face and in the breathing cavity. Our method can apply to every form of face mask and respirator, solving obstacles caused by all types of respiratory PPE to lead to increased comfort and compliance.

Our products are appropriate for use in all workplace, public and social settings. Key industries that we are focused on include health care, manufacturing, construction and more.

Direct to Phase II
NIH Grant
Applicant

Join the Effort

Our Product Lines

Our Future Product Lines

  • Disposable cup particulate masks
  • NIOSH N95 Disposable respirators
  • Elastomeric half-face respirators
  • Full-face respirators
  • A reusable mask kit licensed to and adapted by WorldWide Solutions 4Life, a Michigan-based nonprofit that seeks to provide respiratory PPE for citizens of developing nations across the globe.
  • A variety of additional products that impact any method of respiratory protection.

Future Product Line by DRAFT™

Our Products vs. Our Competitors

MASK DISCOMFORT IS CAUSED BY DEAD SPACE

40° F Heat Index Reduction Makes a Difference in Comfort

Competitors Respirators

NO EXALATION VALVE

Competitors Respirator

WITH EXHALATION VALVE

DRAFT PRODUCTS

WITH OR WITHOUT VALVE

Our Next Steps

DRAFT™is ready to take the leap and begin scaling our testing and production to prepare for market launch. We are seeking partnerships and grant funding from government organizations, private foundations, development banks, regional organizations and private investors who share our concern for public health and global safety. Contact Us to earn how you can get involved and take part in the next generation of respiratory protection