by Hunter Futo
Participating to challenge(s): Evaluation and Validation of Open Source Solutions, Covid19 Prevention, OpenCovid19 - Grant Review Round 5
- Short Name: #BasicRespirator
- Status: Active/Ongoing
- Project maturity: Proof of concept
- Looking for collaborators: ✅
- Grant information: Received €3,695€ from the OpenCOVID19 Grant Round 2/5 on 05/21/2021
Note for reviewers: The full application for Round 5 is in the "Documents" section, as well as my previous application from April 2020 for my initial round of funding.
Problem & Background
Healthcare workers have been on the front lines in a yearlong fight against a global pandemic. Amnesty estimates that at least 17,0001 have died worldwide. In the US alone, over 570,0002 have been infected and over 3,5003 of them have lost their lives.
N95 respirators are necessary to keep front line workers and patients safe from airborne transmission of diseases. They require considerable testing, certification and strict regulatory compliance. The companies that have cleared these hurdles manufacture designs with similar materials and supply chains. This and many other factors created a shortage of N95 respirators that we still haven't recovered from. And while 70% of healthcare workers worldwide are women4 and many are people of color, most PPE is designed to fit European white men.5
Elastomeric half mask respirators are typically manufactured using injection molded silicone and plastic and can be sterilized and reused repeatedly. They accept replaceable cartridges with disposable filter media and achieve a tight seal on the face, but are not designed specifically for healthcare use. They have an intimidating look, are heavy to wear, and can cause sweating, bruising and sores.
Disposable filtering facepiece respirators use the filter media itself as the mask. Surgical versions are used in clinical settings to prevent 2- way transmission of infectious viruses via aerosolized infectious droplets. While they are lightweight, comfortable and cheap, it is difficult to establish a good face seal and they generate excessive environmental waste.
1 “Mapping health worker deaths from COVID-19,” Amnesty International, Sept. 3, 2020
2 Erdem H, Lucey DR. Healthcare worker infections and deaths due to COVID-19: A survey from 37 nations and a call for WHO to post national data on their website. Int J Infect Dis. 2021;102:239-241. doi:10.1016/j.ijid.2020.10.064
3 “Our key findings about US healthcare worker deaths to date,” The Guardian, Feb. 10, 2022
4 Mathieu Boniol, Michelle McIsaac, Lihui Xu, Tana Wuliji, Khassoum Diallo, and Jim Campbell, Gender Equity in the Health Workforce: Analysis of 104 Countries (World Health Organization, 2019).
5 "Personal protective equipment and women" TUC, Apr. 2017
Solution Summary in Simple Terms
There is a gap in the market for a reusable surgical N95 respirator that is as comfortable as a disposable mask, yet provides the tight seal and adequate protection of an elastomeric respirator. Such a device would ideally fit the majority of front line workers, be easy to sanitize, use an alternative supply chain, cost less per use and generate minimal environmental waste. This is the criteria I used to design the Basic Respirator.
Even though the device is designed for healthcare use, it can also work for other industries and the general population. Whether we are exposed to airborne pathogens, toxic chemicals, wildfires or pollution, this device can help slow the spread of transmission and protect our lungs and health.
Solution Summary in Technical Terms
The facepiece is made from a woven fabric with a waterproof coating so it's lightweight, breathable and flexible. A soft rubber gasket along the inside edge forms a tight seal against the face, even while making facial expressions or talking. A disposable N95 or other filter can be inserted into the mask and uses considerably less filter media than a disposable mask. All seams and openings are waterproofed.
The 5 available sizes are made to fit headforms developed by NIOSH in 2009. These headforms are intended to fit 95% of the US workforce and incorporate data from fit test panels, 3D head scans and 21 anthropometric measurements of 3997 subjects.6
6 Ziqing Zhuang, Stacey Benson & Dennis Viscusi (2010) Digital 3-D headforms with facial features representative of the current US workforce, Ergonomics, 53:5, 661-671, DOI: 10.1080/00140130903581656
State of advancement of the project
- Created initial prototype made from Tyvek
- Delivered prototypes to local hospitals to help with shortages
- Awarded €500 euro grant from JOGL
- User research and qualitative interviews with nurses and first responders
- Modified design to use fabric and added magnetic harness
- Won COVID-19 Hackathon w/ VHA Innovation Ecosystem
- Revised design to achieve better fit and breathability
- Developed mobile AR app
- Presented design at the annual VHA innovation conference with ~1700 registrants
- Shipped 20 devices to healthcare, EMS and front line workers for long-term user testing
- Winter 2020: Won a grant from the VHA for further R&D
- Qualitative fit testing
- AFFOA (MIT) takes interest in project and sponsors initial round of lab testing
- Shipped devices to UMass Lowell for lab testing
- Establish high level strategy for certification & FDA approval with regulatory strategist
- ATOR labs takes interest in project, provides design feedback and sponsors respiratory testing
- Appeared on bipartisan television news program about the federal government to promote project
- Pitched design to angel investors, VC, accelerators, DoD and innovation leaders in the public & private sectors
- Identified potential manufacturer for production of facepiece
- Identified potential manufacturer for meltblown filter media
- Identified manufacturer to make samples
- Designed UX pilot & research study for healthcare facilities
- Large Los Angeles healthcare network expresses interest in project for pilot testing
- Recruit local hospitals and healthcare workers to take part in the study
- Create fixtures needed for BFE, pressure drop & liquid barrier penetration lab testing
- Revise design based on NIOSH respiratory guidelines
- Ship samples to respiratory testing lab provider
- Revise design based on results from lab tests
- Recruit microbiologist & data scientist to assist w/ study
- Collect and organize data
- Manufacture samples for additional lab & user testing
- Wet lab testing for sterilization and durability
- User interviews, measurement & fit checks of healthcare workers at local hospitals
- Interview other supply chain stakeholders
- Analyze data
- Draft paper of research results
- Publish results & findings
Basic Respirator by Hunter Futo of Electric Church, Inc. is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
Note about licensing and project transparency
The Basic Respirator was intended as an open source project, but open licensing terms are incompatible with devices that are to be FDA approved. The cost for such approval can run into the hundreds of thousands and would force me to seek outside investment. I've chosen to restrict the licensing terms until I find a legal and regulatory strategy that would enable me to keep the designs as open as reasonably possible, but still allow me to obtain outside investment for certification, FDA approval and manufacturing and deliver a device that is proven to be safe and effective. I am keeping my design process open and publishing frequently on social media so that others can learn from the project to create a respirator design of their own and I plan to publish any relevant findings from the proposed UX pilot and research study.