B2 Mask - Breathe99

COVID-19 has had a devastating impact on global health with over 8 million reported cases and 439,487 deaths globally (WHO, 2020). The use of Personal Protective Equipment (PPE) has been unanimously suggested by governments and international bodies to flatten the exponential growth curve of the pandemic and save lives. The spike in PPE demand, coupled with supply chain shortages resulted in worldwide challenges to equip healthcare workers and the public with high-quality PPE. 

The solution that Breathe99 suggests is the B2 Mask: a comfortable reusable mask that filters 99% of common airborne contaminants and significantly reduces filter waste and cost. The mask went through four years of human-centered design and development, which resulted in a low-cost, low-waste alternative to disposable facemasks. If scaled globally, the B2 can be an easy-to-use, durable alternative to N95-masks for the wider public, easing the healthcare sector shortage while empowering and protecting our communities at-large.

The specific problems that Breathe99 is trying to solve in response to COVID-19 are the following: 

1. The shortage of high-quality PPE for the public, i.e: masks that provide excellent protection but also feature human-centered design features that boost user compliance

2. PPE shortages for vital healthcare workers necessitating conservation strategies on behalf of the public (FDA, 2020)

3. Alternatives such as cloth masks that have flooded the market due to shortages, are academically proven, in randomised control trials, to be considerably less effective than medical-standard masks (MacIntyre et al, 2015)

4. Equitable access to high-quality PPE for under-resourced populations is yet to be achieved, as donations are still the only way to protect communities who cannot afford or access this, rendering them particularly vulnerable

5. Environmental hazards from the so-called ‘COVID waste’ and disposable PPE, which is polluting the planet at an alarming rate

Breathe99’s solution lies on (a) providing a durable, reusable respirator mask with highly efficient changeable, low-waste filters, whose production is fast and scalable, and (b) making these accessible to everyone, through a Get One-Give One donation system. 

The B2 Mask is a lightweight, reusable respirator that removes 99% of common contaminants down to .1 micron and significantly reduces filter waste and cost. 

It has 3 components: 

1. The facepiece: a flexible, patent-pending facepiece made from FDA-compliant materials. The novel designs flexible seal geometry and the flex-hinge design can accommodate a wide range of face shapes and folds in half for easy storage. The ergonomic design is both comfortable and protective, achieving an airtight seal against the face, with a fit factor above 100 during normal motion. Safe to wash by hand/dishwasher. 

2. The filters: B2 Mask filters 99% of airborne contaminants down to .1 micron under normal everyday breathing conditions. The layers of the B2 filters trap particles by physical filtration with a micron-sized mesh, and by electrostatic attraction to a charged layer. Filters may be used for one day up to one month, depending on the preferences and exposure of the user.

3. The fabric overlay: an interchangeable, adjustable, machine/hand washable and breathable textile component which secures the facepiece to the wearer. The overlay’s modularity allows for easy integration of future aesthetic and functionality features. Current exploration includes droplet protection and healthcare specific launder-able/disposable textiles.

Demo Video: https://www.kickstarter.com/projects/breathe99/the-b2-mask-innovative-respiratory-protection

Key target populations whose lives could be impacted by the B2 Mask, in the COVID-19 context:

• People with underlying health conditions who are at higher risk if infected, such as the elderly, people with respiratory conditions, immunocompromised, etc.

• City dwellers and daily commuters who cannot avoid crowded, urban places 

• Travellers who run the risk of contracting/spreading the disease during their trip

• High-contact essential workers, like key-industry, grocery store workers and people in customer-facing roles 

• Caregivers to vulnerable individuals 

Through our donations, we want to impact the lives of communities that are either lacking access to PPE or are disproportionately more vulnerable to the spread of the disease. Examples include: migrant workers, the homeless, and black and other minority populations. Indirectly, we are also having an impact on the healthcare sector by providing an alternative to N95 masks for the public.

The B2 Mask is the product of four years of human-centered design work, refined through valuable user feedback captured in China, Korea, and the United States. We have also received valuable feedback from our 4,163 Kickstarter early-adopters to improve our large-scale first production round. 

Breathe99 aligns with the Challenge’s pursuits as follows: 

• We are a tech-based, innovative solution, pertaining to the ‘slowing’ and ‘tackling’ aspects of the covid outbreak, achieved through the design, production and donation of the B2 Mask. 

• We are empowering the global community in the near term, by releasing the B2 as a ‘prevention and mitigation’ tool that could significantly slow the spread of COVID-19 if scaled quickly.

• As a Public Benefit Corporation we have a long-term vision to make public health goods accessible to everyone, an Impact outcome aligned with the Challenge’s efforts to nurture social entrepreneurs instigating change.

The B2 Mask is the first reusable respirator that combines human-centered design with an impact-oriented business model (think Warby Parker meets TOMS). The result is a mask that people actually want to wear both for functional and social purposes.

Other players in the mask space include 3M and Honeywell - the industry stalwarts - who produce ‘traditional’ disposable masks and encountered supply chain bottlenecks due to inefficient design and manufacturing operations. There are smaller “lifestyle” competitors, such as Airinum, RZ Mask, AusAir, Respro, and Airpop. However, we believe positioning PPE as a fashion statement or lifestyle product undermines the important public health questions that surround these technologies. That is why registering as a Public Benefit Corporation seemed like the best way to nest our innovative solution inside the social context it pertains to.

With the right scale, Breathe99 could disrupt the industry standard, by keeping the same high degree of protection of medically-used N95s with the sustainability, comfort, and design of a consumer product. The mask’s re-usability and disposable filters are key to this, exemplifying the B2 Mask’s ‘platform approach’ to respiratory protection. The flexible facepiece can be loaded with various types of filters, which can be changed to fit the application. Additionally, the fabric overlay is endlessly customizable which opens the door for self expression and even custom-branded masks. 

The core technologies at the heart of B2 Mask are the elastomeric facepiece and the high-efficiency polypropylene filters. 

The patent-pending facepiece features an overmolded design that provides the comfort and protection one would expect from a larger half-face respirator used by painters. Unlike these bulkier options however, the B2 facepiece features a novel flex-hinge design that allows the mask to fold in half - an important feature for daily users who value portability. Our filter platform leverages well-understood filtration media including micron-scale meltblown polypropylene and electrostatically charged spunbond polypropylene.

As our business grows, we will explore using 3D printing for mass customization of masks. This transition will require hefty capital investments and innovation in 3D scanning technologies and manufacturing operations.

On Face-Fit: initial quantitative fit-testing has been performed on several subjects in accordance with the FDA approved Portacount 8038 system. This early bench testing showed B2 Mask achieved a fit factor above 100 during normal motion. To ensure B2 Mask fits a wider range of face shapes and sizes, Breathe99 is partnering with Anthrotech to conduct additional face fit studies with participants that fill the NIOSH panel for face shape and head size, and represent the variance in face shape across populations.

On Filter Efficiency: Our filters use the same materials that are commonly used to make N95 respirators. Breathe99 is working with its filter manufacturer to test filtration performance using an industry-standard TSI 8130 flow testing system. We are also working with a research partner at the University of Minnesota Mechanical Engineering Department, providing us third-party validation that our particle filtration efficiency is similar to N95 respirators (graphs available upon request- an overview can be found here: https://www.kickstarter.com/projects/breathe99/the-b2-mask-innovative-respiratory-protection/posts/2850156). Our regulatory application process will include testing at the nationally recognized Nelson Labs. 

We are happy to provide the MIT Solve Challenge committee with a B2 Mask prototype, along with the necessary documentation on our test results. 

Our Assumptions: 

• Facemask use in public is one of the key measures to reduce COVID  transmission (WHO, 2020)

• Academic evidence indicates that mask-wearing reduces the transmissibility per contact by reducing transmission of infected droplets in both laboratory and clinical contexts and is most effective when user compliance is high (Howard et al, 2020)

• The general public lacks training or care to properly wear a mask, which gives a false sense of security (Yeung et al, 2020)

• Not all facemasks have the same filtration effectiveness (MacIntyre et al, 2020) 

• Face-masks are essential public health goods, under pandemic circumstances, and they should not be a privilege but available at-large and equitably

Our Inputs: 

• A lightweight facemask that is easy to use, store, wash and reuse

• One that offers high filtration of airborne contaminants, hence high levels of respiratory protection for the individual wearer and his/her entourage, via the frequent change of filters

• Filters that are low-cost, can be produced at scale and reduce waste

• A platform of donations, whereby B2 Mask consumers empower their fellow-citizens who cannot afford PPE

Our Outputs (immediate, trackable results of our work): 

• Protecting B2 mask-wearers from spreading and/or contracting COVID-19

• Increasing compliance of facemask use

• Giving access to facemasks to communities who would be otherwise not protected

• Reducing the burden on the healthcare system 

• Leaving much needed single-use PPE, such as N95 masks for healthcare workers 

Our Outcomes (long-term goals): 

• Making public health good accessible to everyone 

• Nurturing healthier communities 

• Providing the world with a mitigation and prevention tool against future epidemics

• Providing urbanites with a facemask that reduces exposure to a

• Contributing to a cleaner planet 

We are currently serving 11,571 early adopters who trusted the technology of the B2 Mask and pledged one through our Kickstarter and Indiegogo campaigns. Out of these, we can support approximately 1,500 donations, from backers who supported our early donation model by pledging a higher amount. Our goal is to progressively increase the ratio of donations and achieve an 1-for-1 model by Q1 of 2021.

By the end of 2020, we expect to provide the B2 Mask to approximately 50.000 users if we maintain our current capacity. This number can increase significantly if we secure further funding which would allow us to increase our production capacity and serve more people (especially in international contexts). By mid-2021 - when the burden of COVID hopefully eases - we are forecasting the production of 250,000 - 300,000 masks. In the post-pandemic world, we plan to continue serving the facemask market where PPE shortages exist and in locations where airborne contaminants are a daily hurdle (e.g: high pollution cities). Our 5-year projections of users range in the region of 1mil-2mil users.   

We acknowledge that given the urgency of the pandemic, we can only increase our impact by increasing fast and effectively in scale, which can only be done with the right funding partners, who would also need to support our philanthropic mission to help us maximise our societal contribution -- this is something we hope to achieve through MIT Solve. 

Our 2020 goals: 

• Become FDA-approved, so that we can succinctly support the wider public, frontline healthcare workers and those most at risk. To achieve this, Breathe99 plans to undergo NIOSH-certified testing and apply for FDA Emergency Use Authorization as a filtering facepiece respirator in summer 2020.

• To become the de facto standard for daily respiratory protection against the virus and other airborne contaminants. In order to achieve this, we need to ensure scale of our production, increase our customer reach while also bolstering our donation model to serve as many under-resourced populations as possible, now that they most need our contribution.

• We will not cease catering for our customer demands and further improving the B2 based on feedback we have already received from our early adopters. Indicatively, we have initiated product improvements such as the introduction of multiple mask sizes and fabric overlay colours, as well as the release of a kids size B2 Mask and a UV-light travel case.  

Our 5-year goal is to shift from just the B2 Mask to building a portfolio of high-quality public health goods, accessible to everyone through a 1-for-1 platform. We envision a world in which sustainable, ergonomic, and functional public health goods are in the hands of everyone who needs them. We are not just a ‘mask company’ - we are a public health goods company en route to realizing our true public benefit purpose to supply valuable public health goods to those in need.

Financial 

• We are in need of significant capital investment to expand our production lines and achieve rapid scale to maximize our impact, given the urgency of the pandemic

• Scale is necessary to reduce our cost of goods sufficiently to realize our goal of a  1-for-1 impact business model

• Funding partners who share our double bottom-line (commercial and social goals) and are willing to support us in realising it

Technical/Supply constraints: 

• Optimising facepiece shape for best seal across a range of demographics 

• Further improving breathability and filtration efficiency of filter material (material research) 

• Overcoming barriers to sourcing filtration materials which are in high demand

• Achieving a well-operating, smooth supply chain that can produce large volumes

• Overcoming long lead times and disruptions to the supply chains due to the effects of the pandemic

Market barriers 

• Shipping internationally due to regulatory restrictions in some markets

• Other incumbent facemask companies who have already achieved strong market shares in other territories and erect barriers to entry

Cultural

• Barriers to adoption of facemasks and need to change perceptions around facemask wearing

• Concerns around compliance to adequate facemask use for maximum protection

Legal

• Patent and trademark protection 

• Establishing a full Quality Management System to record all of our design and manufacturing process in compliance with medical device manufacturing standards

• Regulatory compliance (FDA & NIOSH approval) to make the B2 verified PPE for healthcare workers 

• Legal barriers in certain markets such as the cost of complying to GDPR policy to be able to ship in Europe

Financial 

• We have partnered with the Venn Foundation, to raise $120k via a PRI and donor advised funds to capitalize our business

• We were accepted at the Impact Hub, as well as the Walleye Tank by Mayo Clinic initiative, enlarging our connections cycle to source additional social impact investment 

Technical/Supply constraints: 

• We are conducting additional face fit testing, to optimise the seal for diverse users

• We continue carrying out material research, to identify and source more effective or lower cost filters 

• We identified an additional, new overlay supplier who could achieve larger volumes at lower cost

• We cherrypick trustworthy suppliers and shipping partners to ensure timely delivery of the B2 Mask

Market barriers 

• We get legal expertise to kickstart us with regulatory matters with regards to entering new markets

• We are closely monitoring the emergence of similar offerings and how they establish in certain markets and will strategize accordingly 

Cultural

• We educate our users via our communication platforms about  facemask use best practices, hoping to gradually change perceptions about facemask compliance

• We created a visual guide on ‘how to use the B2’ and a comprehensive guide for filter changes to facilitate users to exercise informed judgment on how often the filters should be changed 

Legal

• We are using a digital Quality Management System with ready-made templates and best practice guidelines to help us efficiently come up to speed

• After shipping of our first production round, we are ready to submit our application for FDA and NIOSH approval

We are a founding team of six. 4 full-time staff and 2 part-time contractors.

• Max Bock-Arronson - CEO, Design Engineer 

• Coleman Rollins - COO , Software

• Julia Duvall - Soft Goods Product Lead

• Alison Lee - Filter Expert & Product Manager

• Emma Gavala - Impact & Marketing Lead 

• Derek Mathers - Director of Business Development

Breathe99 is at a unique advantage because we have been developing a better respirator for the last 4 years. Unlike other teams rushing to produce solutions, we’ve refined B2 Mask through major iterations using a human-centered design approach built on user feedback captured in China, Korea, and the United States.

We are a nimble group of ex-googlers, nanotechnologists, and design engineers with over 10 years of experience in the medical device industry. The B2 was born out of our co-founder Max’s own pain-point and impact opportunity identification, when studying in Singapore in 2013, and realising the inadequacy of existing options for ambient air pollution protection. Since then, he worked as design engineer, developing everything from surgical instruments to heart valve implants, as well as manufacturing processes including injection molding for aesthetic components. Coleman came to skyrocket Max’s respirator mask prototype by employing his developer skills and setting our digital and crowdfunding B2 platforms. Julia bolstered the team with her expertise as a Soft Goods Engineer, with past experience in designing wearable technology and functional clothing for human space flight with NASA, while Alison is our nanotechnology expert dealing with all-things-filters! Derek brings his regenerative medicine and 3D-bioprinting background combined with his acumen to accelerating sales and adoption of impactful technologies and forging partnerships with Fortune 500 companies. Lastly, Emma is an ex-Googler catering for all-things-marketing while also being an LSE-alumni with background in economic development and public policy, hence currently leading our Social Impact efforts.

Our partnerships are key for the acceleration, adoption and impact of the B2 Mask both in terms of ensuring sourcing of primary materials and uninterrupted production as well as gaining visibility and constant advice on how to best serve our social goal and have the maximum impact possible, given our resources. Currently these are the following: 

• Suppliers: Protolabs, MME Group, TPI Custom Solutions, Superior Felt & Filtration, Liberty Packaging, Exceleron Medical

• Software: Greenlight Guru, Crowdfunding platforms (Kickstarter & Indiegogo)

• Impact: Venn Foundation (Minnesota-based nonprofit public charity on a mission to unleash the full power of Program-Related Investments (PRIs) to achieve charitable impact), Impact Hub (world's largest network focused on building entrepreneurial communities for impact at scale)

• Other organisations: We have been proudly accepted at MN Cup and Walleye Tank by University of Minnesota and Mayo Clinic for our innovative solution for the COVID-19 fight

Our business model rests on the premise that: we are using the commercialization of our B2 Mask technology as a key revenue stream and funding mechanism (our ‘how’)  to serve our social mission (our ‘why’). Our value proposition is two-fold: (a) superior respiratory protection for our consumers, whom our technology empowers to protect themselves and their entourage, assuming facemasks lower COVID transmission, according to overwhelming academic and publicly available evidence and (b) the direct value added to the communities we opt to donate to, who would not otherwise have access to high-quality PPE, hence suffering from higher COVID penetration and potentially higher mortality. 

Our key activity is the B2 production and our key resources include our team’s expertise, design and superior material sourcing to most effectively execute our dual type of intervention: the roll-out of our superior respiratory product, along with a platform of much-needed donations. The former benefits key segments such as people with underlying health conditions and frontline workers, while the latter impacts vulnerable communities at risk. 

Our key partners include anything from our core suppliers to our crowdfunding platforms that acted as a pivotal customer-acquisition channel, soon to be replaced by our own ecommerce platform and retail partnerships. 

Our biggest expenditure is investing in the supply chain and capital infrastructure and logistics that ensure high-quality B2 production and timely distribution, hence partly our surplus will be reinvested in this direction to achieve economies of scale, while the rest will be dedicated to expanding our donations’ reach.

Our existing Revenue Streams are the following: 

• We are currently self-sustaining through early sales of B2 Masks. However, our goal is not just to sustain ourselves but to charge the optimal B2 price that accommodates both a good margin for our financial sustainability, plus serving our donations. This is done through: 

  • Direct to Consumer

    • Crowdfunding platforms (ending soon)

    • Own website and e-commerce platform

    • Retail channels, physical and digital (to be added soon)

  • Organisational sales

    • Large enterprises

    • Healthcare organisations

    • Governments

• Recurring revenue from filter sales to existing B2 users

• Additional revenue stream from up-selling extra features of the B2 (e.g.: fabric overlays and travel case)

• Grants, donations and subsidies are still valuable as an extra cash injection for Breathe99 to solely canalise on our impact program

Breathe99 is a Public Benefit Corporation with a dual mission of commercialising our innovative public health goods while simultaneously funding our social impact. From that perspective, financial sustainability is key to help us fulfil our mission, hence our revenue model above should serve this ‘integrated’ social enterprise structure. It is our founding premise that our business activities from the sales of the B2 Mask should always overlap with our core social program (our donations to under-resources communities and those most at risk). Seen as such, our core business at this phase (sales of the B2) is merely created as a funding mechanism to fill in the impact gap that our organization has identified and wishes to serve -- equitable access to PPE.

COVID-19 made the B2 Mask exceptionally relevant and we are proud that we already had a robust solution ready for tackling and mitigating such a pressing global issue. However, we transitioned remarkably fast from a concept and prototype venture, into a fully-fetched, early-stage start-up, with a ready-made pilot, already in large-scale production, obtaining a beachhead market of 11,571 early adopters within only 2 months, while also enlarging our core team which is now summing up 6 talents. These constitute massive changes for our small team, which had to tackle numerous challenges in a very short amount of time, including the responsibility of bringing the B2 to the market and sourcing all materials needed under pandemic conditions. We are applying to MIT Solve because we are convinced its community can guide, advice and educate us on how to prioritize and align our double bottom-line with regards to the following challenges we face:

• How to cater for spikes in customer demand due to the pandemic while harmonising this with our existing capabilities. Potentially expanding these through the right partnerships and funding partners to achieve rapid scale

• How to solidify our early donations impact and how to increase our reach to additional target segments and beneficiaries

• How to develop a concise, realistic and trackable donations model and impact reporting system

We are already tackling many of our supply, logistics and market barriers but we still need vital intangible resources of the MIT Solve community to enhance our social business model.

Advice on the Social Business Model Canvas: digging deeper into the specifics of our social business model to fully realise our social mission while attaining financial sustainability.

Product/Service Distribution: Advice from other Solvers and MIT Faculty on prioritising donations based on maximum impact. Help in defining our ‘donation criteria’ such as affordability, need, vulnerability and lack of access

Funding: potential funding partners who share our social mission and also bring their expertise on how to best divert these funds to enhance impact

Board members or advisors: experts willing to mentor our small team on the ongoing challenges we face

Marketing, media & exposure: collaborating with the right partners for social impact marketing, that will enable us increase awareness about facemask wearing and compliance, along with the need for equitable distribution of PPE to those most vulnerable

We would be honoured to partner with the bright community of MIT Solvers, Faculty and partner organisations. In order to achieve the optimal partnership, we trust in the evaluation committee’s ability to match us with the right human capital who would be willing and able to share best practices and help us advance our commercial activities along with our social impact. These include but are not limited to:

• Previous MIT Solvers who faced similar challenges to ours, so as to get informed by their decisions and actions, prevent any mistakes we can foresee and get inspired by their trajectories. Additionally, look into the opportunity of cross-collaboration with other solutions to boost our joint impact, address new market opportunities together and amplify our reach

• MIT academic faculty whose expertise could help us advance our product design, capabilities and features, to enable our solution to better serve its existing target segments and further expand towards impact opportunities we might have missed. Also, faculty ready to challenge the assumptions of our Theory of Change, while helping us improve our logic model by posing tough questions 

• Social impact organisations offering advisory services on sustainability reporting and/or getting the B Corp certification

• Anyone of the above who could connect us to donation partners who could help us make the most informed decision on who our donation recipients should be and how we can reach them and distribute the B2 to them in the fastest and most effective way possible