MyMask Movement

Jesse Chang, MyMaskMovement executive lead and co-founder: 

Jesse is the head of digital manufacturing for Stanley X, the innovation arm of Stanley Black and Decker. Through years of experience at Amazon and also starting up a robotics vision company, Jesse has expertise in the fields of computer vision, applied machine learning, and 3D. In his prior role with Amazon, Jesse oversaw Amazon’s effort to create the world’s largest library of 3D models for Augmented Reality as the Head of 3D Content, which is now the industry’s largest library of 3D models. Jesse holds a JD and MBA from Northwestern University and a BA of economics and international relations from Claremont McKenna College. 

 Due to the ongoing COVID-19 pandemic, there is a recognized demand for protective masks given the inadequate supply globally. This shortage has created hazardous conditions (i.e. ill-fitting N95 respirators, reusing soiled respirators, and even using a mere cloth covering) for front-line medical workers and increases the risk of infection for both patients and professionals. MyMask Movement aims to create digitally manufactured, reusable personalized masks which allows medical professionals to switch out filters and sterilize masks whenever they need to. Our supply chain is completely indigenous and can scale up to the production of 1 million masks a week, which will enable us to provision both frontline workers and the general public both domestically and globally.

MyMask Movement has two goals – to solve the fit problem of N95 respirators and relieve the PPE shortage.

N95 respirators have a filtration efficiency of 95%; however, to achieve this filtration efficiency, every user worldwide must fit into one of fifteen mask shapes. In order to achieve an airtight seal, masks must be pulled extremely tight, creating an uncomfortable and potentially painful fit after long hours of wear. 

In the past few months, COVID-19 has quickly become a pandemic, infecting millions and killing hundreds of thousands. This medical emergency caused a worldwide shortage of PPE and major instabilities in the supply chain. Six months later, the pandemic rages on in the US, and PPE remains scarce. 

Currently, there is a 4 to 6 month backlog in PPE orders and dramatic inflations, with prices tripling and counterfeit supplies. N95s and surgical masks are rationed even when available. N95 masks are limited for use only in aerosol-producing procedures, and medical workers are forced to go without adequate protective gear for other procedures such as basic testing and treating non-severe patients. This improper protection from the virus and other procedures places medical workers at high risk for working hard and saving lives.

MyMask Movement aims to create reusable personalized masks, which allow medical professionals to switch out filters and sterilize masks whenever they need to. The MyMask app uses photometric, photogrammetric, and structured light depth-sensing technology to create a 3D printable model of a mask personalized to an individual's face. The resulting personalized fit enables a tighter seal which loose-fitting protection, such as surgical masks and bandanas, cannot provide (what our front-line workers have resorted to using out of desperation). After the model is sent to an industrial-grade laser sintering 3D printer and the resulting custom-fit mask is paired with a filter and straps, the mask is ready to be worn and is intended to withstand repeated sterilization in-between wears.

MyMask Movement’s primary mission is to save as many lives as possible as fast as possible by relieving the PPE shortage. Due to the ongoing pandemic, every individual worldwide is encouraged to wear masks to prevent the spread of the virus. We are a movement, actively promoting proper mask usage and taking steps to ensure corporate safety through contacting large companies and offering advice to prevent the spread. 

Beyond the pandemic, we want to provide better fit, custom, reusable respirator masks to medical workers to not only improve comfort but also reduce waste. 

Our team consists of medical workers, software engineers, lawyers, product developers, and students. With these perspectives, we are actively learning and researching to understand the needs of healthcare workers and the general public. We have given out our prototypes to over 100 healthcare workers to test our scaling and fit algorithm to ensure the quality of the mask. 

The COVID-19 pandemic exposed two problems with the PPE market – the fit problem and the instability of the supply chain. As corporations scramble to provide masks to their numerous employees and individuals find creative alternatives for masks, we have noticed a false sense of security spreading among individuals. Masks are worn improperly or distributed with false promises. Beyond designing our personalized respirator, we have taken steps to connect with corporations, like Walmart, and propose mask distribution and use methods to implement within their community. 

When the COVID-19 pandemic hit the US and our PPE supply rapidly decreased, the whole nation was in danger, particularly healthcare workers. 

My little brother and his wife recently had a newborn son, my very own nephew. I was ecstatic to have a new member of the Chang family. However, both my little brother and sister-in-law work in the ICU at high risk helping COVID patients recover. Everyday, they went home to their newborn son, took off their soiled N95 mask, sprayed it down with Lysol, and wore it again the next day at work. I was disgusted and extremely worried for this new family – my family. 

With my background in digital 3D manufacturing and the rise in 3D printed medical devices, I began thinking of solutions. With my good friends Cole Herskowitz, a software engineer and start-up founder, and Dr. Stanley Liu, a Stanford surgeon and assistant professor for facial reconstruction, we gathered a superstar team to create MyMask Movement.

Six months into the COVID-19 pandemic, some parts of the US are just beginning to hit peaks in new number of daily cases. A few days ago, my little brother called me saying his hospital only has a 19 day supply of face masks left and no more respirators left for any of the hospital workers. The end of this pandemic is nowhere in sight, yet my younger brother, sister-in-law, and countless other healthcare personnel are risking their lives every day in the hospital to help patients recover from COVID, perform life saving surgeries, deliver newborn babies, etc. 

The least I could do is use my skill set to help provide protection to some healthcare workers and continue the battle against COVID-19. The length of this pandemic and the continuous shortage of PPE has only further emphasized the US’s lack of preparation for a global pandemic, and this project has the potential to relieve the current shortage and prevent future shortages.

3D is my life’s work and what I’m best at. As previously mentioned in my bio, I worked as the Amazon Head of 3D Content for 3 years and worked in the 3D industry for the last decade. When I heard about the crisis, even though I didn’t know much about medicine and the industry, I knew a lot about 3D and its potential as a solution.

My experience in the 3D industry enabled me to assemble a world class team of volunteers and supporters and a network of contacts with work in the medical field. Together, we have achieved so much with this project in just four months, and with this momentum, I’m extremely hopeful to be able to deliver MyMask Movement to you and solve the current fit and supply problem in the mask industry.

At Amazon, I became the head of 3D content against all odds and in the face of extreme adversity in a high pressure, low margin of error workplace culture. Though I started off as a product manager, I was able to ascend quickly because of persistence. Of my entire cohort that started with me, 33% were gone in the first year, 33% were gone in the second, and 33% were gone in the third. When I first started, my manager told me that only half would make it past the first year, and he didn’t believe I would be in the half that made it. After my three years, not only did I earn the highest performance ratings, but also I launched AR view from the ground up, which is the world’s largest augmented reality feature. 

More generally, as someone with a learning difference who almost flunked out of middle school, I’ve been able to get where I am today by the grace of God and sheer grit and determination.

At the start of this pandemic, I had two people working on this – my buddy Cole and I. In a matter of 4 months, we’ve been able to go from a mere idea to a full blown movement with over 100 volunteers, an alliance of 8 different tech companies, and a Fortune 500 sponsor. The achievements of this organization are not my own, but rather a reflection of the caliber of the people who have joined this organization and have become greater than the sum of the individual parts. I am humbled by the ability to be the servant leader of this movement.

MyMaskMovement can quickly and efficiently enable 3D scans of the faces of frontline medical professionals. These scans are used to produce custom-fit 3D printed masks that conform to the face and produce tighter seals, while also preserving the necessary comfort for prolonged use. These masks are currently able to withstand 150 consecutive sterilizations, with potentially unlimited general cleaning ability. The personalization, fit, comfort, and massive reuse potential are all unique game-changers to the mask industry both during the crisis and after it. 

We are also focusing on providing for under-resourced communities that might not have access to PPE in the first place. For instance, “Operation Moldaw” is currently in the process of providing 100 masks to the healthcare workers at the Moldaw Retirement Homes who currently rely on rationed surgical and fabric masks. MyMaskMovement is also expanding globally to have the greatest impact. “Operation Simba” is MyMaskMovement’s international plan to distribute over 800 masks to front-line medical workers in Kisumu, Kenya. After this, we will expand to Zambia and South Africa and throughout the African continent. In Canada, infrastructure has been built to allow for national printing and distribution of the mask as soon as it has received approval from the Canadian government, with the capacity to print 25,000 masks per month. 

Current needs and requirements for PPE are not being met. N95s and surgeon masks are being rationed even when available. Medical workers are forced to re-use masks, leading to an unsafe situation for both workers and patients. This ongoing shortage creates hazardous conditions for frontline medical workers and increases the risk of infection for both patients and professionals. The faster the infection curve rises, the quicker local health care systems and medical professionals will be overloaded beyond their capacity to treat and assist people. MyMask Movement aims to create reusable personalized masks which allows medical professionals to switch out filters and sterilize masks whenever they need to.

MyMask Movement focuses on frontline medical workers to attempt to flatten the curve in the most efficient way. MyMask Movement uses depth sensing technology and 3D scanning technology to create digitally manufactured, reusable masks. We have submitted an application for Emergency Use Authorization from the FDA, which allows non-regulated organizations to manufacture and distribute medical devices during medical emergencies. The team aims to gain NIOSH respirator approval and FDA clearance by August 2020, so our product is viable beyond the medical emergency. 

 The current workflow pipeline for MyMask Movement requires access to a FaceID equipped iPhone or tablet. However, we eventually want to untether ourselves from Apple’s facial scanning technology and develop a novel 3D face scanner using just a screen and camera. This will broadly expand access to custom 3D printed masks, particularly for medical workers in financially constrained medical institutions that do not have immediate access to 3D sensor-equipped devices. 

Currently, we have given out over 300 prototype testing masks to our team of volunteers and healthcare personnel. In one year, we hope to give masks approved masks to over 100,000 HCP in Canada and the US. In five years, we hope to give masks to each HCP in the US and Canada.

Within the next year

• Gain full respirator FDA and NIOSH authorization so MyMask can be used beyond the current medical emergency. 

• Become first FDA authorized 3D scanning generative design application.

• Create Quality System guidelines that any digital manufacturer worldwide can follow to produce our mask. 

• Partner with Kenyan Ministry of Health, Kenya Medical Research Institute, and a South African 3D printing company to indigenously produce custom mask frames for HCP. 

• Develop a mask pairing algorithm that fits the standard 15 sizes of N95 respirators on HCP’s face and gives an educated starting point for fit testing. 

• Raise 5 million dollars in funding

In the next 5 years

• Decentralize and democratize supply chain to make PPE more equitable and accessible 

• Decrease unit mask cost from $50 to $2-5 by using hybrid technique with injection molding and additive manufacturing

• Create a commercial agreement and decentralized network of printers and distributors in each major region of the world (Africa, Asia, Central America, North America, South America, Oceania, The Caribbean, and Europe) 

• Partner with the US government to create supply chain alternative to augment national PPE stockpile with additive manufacturing

• Democratize access to technology by decoupling dependency on iPhone X and partnering with Northwestern University 

• Start a pilot program with National Security Innovation Council or equivalent govt agency for national PPE stockpile

MyMask Movement has been providing masks to healthcare personnel and members of our team for free. 

• Our goal is to provide as many of these masks as possible free of cost, which requires financial funding.

• Our application and product is bound to iPhone X’s facial recognition technology, which greatly narrows our reach. However, only select individuals have access to an iPhone X, and obtaining an iPhone X in different regions of the world has proven to be a challenge.

• Respirator FDA and NIOSH approval has many legal intricacies and testing requirements.

• Unit cost of each mask is expensive ($50 in the US and $10 in southern Africa) 

• Finding local manufacturers and suppliers that are qualified to produce medical devices 

• Secure SBIR grant funding from National Science Foundation, which would bring in $256,000

• Apply to NIH research and development grants and contract corporate investors, like Stanley Black & Decker

• Work with Northwestern University professor, Dr. Oliver Cossairt, and his research to change technology from iPhone X software to 3D scanning with simply a screen and a camera

• Hired an FDA consultant to navigate through the intricacies of quality, design, and production guidelines development

• Collaborate with Canadian government and DormaLabs to complete NIOSH testing, free of cost

• Combine injection molding and additive manufacturing to significantly reduce unit cost of each mask

• Implement Quality Systems at various manufacturers worldwide and periodically audit manufacturers to ensure medical device quality

MyMask Movement currently partners with:

DormaLabs on prototyping and NIOSH testing as well as product design and development.

Kenya Medical Research Institute on providing PPE to frontline health officers and research on COVID-19 transmission dynamics and social implications.

Stanford University on research and development in its COVID Research Pipeline

Northwestern University on developing facial scanning technology with only a screen and camera

Our mission is to save as many lives as fast as possible by providing PPE to frontline healthcare workers. In order to get our product to market faster, we fuel our mission through B2B and B2C channels as a public B-corp. This enables us to press forward with our mission while having revenue-generating contracts with commercial partners like Stanley Black and Decker and Walmart. 

In the healthcare market, we provide custom-fit PPE to frontline healthcare workers at no cost to them, so they can continue the fight against pandemics like coronavirus. 

To generate revenue, we partner with medical institutions (e.g., Mass Gen) in a B2B model to provide custom-fit PPE for their non-frontline healthcare staff. The value proposition to the healthcare market is that our masks are custom-fit, providing a 100% sealed fit, and that we have a continual supply of digitally manufactured PPE available even when regular N95 masks run out of stock.

In the B2B market, we provide mask fit analysis, personalized custom-fit masks, and risk area assessments for companies with essential workers in retail stores, warehouses, and restaurants (e.g., Walmart, Target, Starbucks). We provide preventative services and products for these businesses to avoid COVID-19 infections, which subsequently reduces staff turnover and closing facilities.

In the B2C market, we sell personalized custom-fit masks to the public via commercial partners (e.g., Stanley Black and Decker, Home Depot). We leverage previous purchase history to identify the customer segments who would benefit most from custom-fit masks. 

In order to maintain financial sustainability, MyMask Movement plans to shift from a nonprofit organization to a benefit corporation and receive funding from various sources listed below.

1. Finance donations of masks through generating revenue from commercial distribution partners 

2. Finance donations of masks through raising funding from private and public foundations (i.e. JJJ Foundation) 

3. Grants (i.e. National Science Foundation SBIR/STTR and NIH Grant) 

4. Raise private funding for benefit corporation and corporate sponsors like Stanley Black & Decker

5. Operate at unit cost of $50 and create a subscription model for $30 every month for 12 month minimum contract

• Stanley Black and Decker subsidized production and prototyping costs for first year - $25,000

• John Irwin Foundation – $30,000
  

• National Science Foundation SBIR/STTR grant in review – value of $256,000

• Apply to various NIH grants and seek donations from foundations

• Secure Stanley Black & Decker as a minor equity holder

• Commercialize and sell mask frames to companies

• Sell our mask with a subscription model for $30 a month, including the mask frame and reusable cassette filter to generate revenue to supply other healthcare workers with free masks

$4000 ASTM Fluid Resistance Testing

$5300 for 88 masks required for NIOSH Testing

$200 for NIOSH Application Fee

$50,000 for FDA Consultant 

$30,000 for Marketing 

Total: $87,500 + as many masks to donate as possible (mask unit cost: $50)

MyMask Movement’s primary mission is to save as many lives as fast as possible, which begins with the individuals saving lives every day and helping the most vulnerable. We are trying to supply as many of our masks to frontline workers as possible. The FDA and NIH recently updated policies on masks allowed in hospitals, requiring them to be approved by the FDA under Emergency Use Authorization and NIOSH for respirator approval. However, this requires thousands of dollars in funding, as seen in the previous question. The Elevate Prize can help overcome the regulation barrier, and greatly expedite our progress with the help of The Elevate Prize's remarkable network of advisors and programs to bring our masks into hospitals as fast as possible.

Mentorship/Coaching; Board Members or Advisors

MyMask Movement is under a 501c3 nonprofit organization, YouMask Inc. While our team consists of all-star lawyers, surgeons, software engineers, startup founders, and additive manufacturers. However, when it comes to running a nonprofit, mentorship and advisors would definitely be extremely helpful.

Marketing, Media, Exposure

Our primary audience is hospitals, so we can provide masks to frontline workers. MIT Solve’s help in gaining exposure and improving our media presence would increase our reach to hospitals would greatly support us in serving frontline workers and donating masks.

We would like to partner with an ISO 13485 approved organization who can help with packaging and distribution of our masks. 

The partner we have in mind is Primo Medical Group, who can accelerate our FDA approval process because of their ISO certification and expertise in packaging and distribution of medical devices.