RespiraWorks continues progress on their full-featured, open-source respirator.
Written by: Tif Ho
The Challenge
Since the first known cases in late 2019, COVID-19 has spread rapidly throughout the world. As of August 13th, the number of cases tops 20M globally, with more than 740K deaths. This means a fatality rate of over 3%. COVID-19 has resulted in more known deaths than several other health outbreaks. For example, the fatality rate of COVID-19 compares to fatality rates of 2% during the 1918 Influenza pandemic and 0.1% for the seasonal flu.
The reason for COVID-19’s high death rate is that it is a multisystem disease, which attacks every part of the body, including the kidneys, liver, heart, brain, and lungs. The disease’s attack on the lungs is especially dangerous, because lung damage causes low oxygen levels, a condition known as hypoxia. This then results in damage to other major organs. In fact, some cases of COVID-19 result in Acute Respiratory Distress Syndrome (ARDS). In ARDS, severe vascular damage to the lungs reduces an individual’s ability to breathe on their own, causing major organ failure and death.
Diagram of Ventilator System
Ventilators are often the difference between life or death for ARDS patients, and can help to reduce the fatality rate by delivering oxygen to those who cannot breathe on their own. Problematically, since the onset of the pandemic, there has been an extreme shortage of ventilators. The reason for this is that ventilators are complex machines that include proprietary components from multiple parts of the global supply chain. As a result, they are costly and take a long time to build. While many organizations have sought to speed up manufacturing and distribution through rapid-build ventilators, these ventilators are often intended as “bridges.” That is, they are meant to be used as a short-term solution until another ventilator is available and thus, are not compatible with patients who require a ventilator for a longer period of time.
The Updated Solution
RespiraWorks was founded as an open-source project for ventilators. Curtis Kline, who is a Cofounder and Project Manager for RespiraWorks, states, “RespiraWorks is a non-profit organization working to rapidly develop, manufacture, and deploy a low-cost and open-source ventilator for communities under-served by the global supply chain.”
The ventilator uses readily-available materials that are found in the automotive supply chain. The use of these materials reduces cost and time to build, and also means that any country with automotive manufacturers can produce the ventilator. As the ventilator has evolved, the team has also incorporated custom materials.
Software considerations.
Asked about RespiraWorks’s mission, Cofounder and Hardware Engineering Lead, Edwin Chiu, says, “The overall mission of RespiraWorks is to radically democratize the ventilator by creating a fully-featured ICU ventilator that will serve an enduring benefit both during the pandemic and beyond it.” Biomedical Engineer, Pallavi Gunalan follows up with, “What makes the ventilator so radically different and able to be democratized is that it is open-source.” Both Chiu and Gunalan emphasize that RespiraWorks is 100% committed to remaining open-source. The open-source design allows for manufacturing and distribution of the ventilator by anyone with the capabilities to do so. Thus, the design is free to use without licensing.
RespiraWorks Updates on CoVent-19 Challenge, India Collaboration, and Oxygen Control
Goals
RespiraWorks’s goals have continued to evolve over time. Their original intent was to design, manufacture, and distribute an open-source, high-quality bridge ventilator for medical centers that serve low-resource communities. In fact, RespiraWorks originally partnered with Hospitalito Atitlán in Guatemala, as a pilot location for the use of their ventilator. However, the team quickly changed directions, moving from a bridge ventilator towards a full-featured ventilator that is intended for ICU use. Chiu explains, “We realized that other teams were already doing great work with bridge ventilators. But bridges are for short-term, and we wanted to know what would happen after, for patients who need a ventilator for longer periods of time. So we decided to design a full-feature, ICU ventilator.”
In deciding to build a full-featured ventilator, the RespiraWorks team came across multiple issues. Firstly, a full-featured ventilator required a longer design time in order to meet safety regulations. This meant that the ventilator would not be ready in time for the first wave of the COVID-19 pandemic. Secondly, the costs associated with the regulatory process were prohibitively high. This meant that manufacturing and distributing the ventilator through RespiraWorks would be difficult.
Electrical diagram.
RespiraWorks addressed these concerns by changing their goals. The team decided to work towards a second wave of COVID-19 that is expected to hit during fall. This gives them to time to work on a higher-quality ventilator design that would be available for use both during the pandemic and beyond. The team also decided to pursue partnerships with manufacturers who could help to shoulder the costs of getting regulatory approval.
Thus, RespiraWorks’s objective has shifted to producing a fully-functional Reference Design that is complete with the necessary design history, risk analysis, and documentation in order to pursue FDA 510(k) approval. The team remains fully committed to making their Reference Design completely open-source so that any organization can use it in order to pursue approval and bring the ventilator to market. Additionally, the team is willing to provide engineering support to as many manufacturing partners as their resources allow.
Pneumatic Diagram
RespiraWorks’ Reference Design is for a full-featured ventilator. This ventilator is intended as a long-term solution for patients who may be on a ventilator for a period of weeks. While RespiraWorks still intends to keep costs low, the team has decided to do so without sacrificing the quality of the ventilator. They have added additional features and decided to forgo the compressed air that many bridges use. As a result, they estimate that the final cost of the ventilator will be under $2,000. This is 10 times less than the price of other full-feature ventilators, which usually cost between $20,000 and $50,000.
Timeline
- March 2020 – RespiraWorks is founded by engineers Edwin Chiu, Ethan Chaleff, Elizabeth Hillstrom, and operations manager Curtis Kline. The team gets started through a GoFundMe page.
- April 2020 – The team finalizes and tests their first prototype, the Alpha Build. During this month, they win Protocol Labs’s COVID-19 Open Innovation Grant.
- May 2020 – The team partners with Foundry M in India and starts working on a Beta Build. During this month, they also acquire 501(c)(3) nonprofit status and receive a CITRIS grant.
- June 2020 – RespiraWorks submits their design to the CoVent-19 Challenge and places 3rd the following month
- July 2020 – RespiraWorks becomes one of the Top 10 Finalists for the COVID-19 Design Innovation Grant.
- August 2020 – RespiraWorks continues to move towards a full feature Reference Design, while partner Foundry M sets an aggressive timeline for advancing towards an August 15th Demo Day.
Progress
Since its founding in March 2020, the RespiraWorks team has remained dedicated to their mission. Their current progress is categorized into five areas:
- Electrical – The team has designed and manufactured a custom Printed Circuit Board (PCB). The PCB is used to connect electrical components for the ventilator. RespiraWorks’s PCB integrates two separate computing elements for real-time control and graphical user interface, along with the supporting sensor and actuator drivers required for the ventilator. The team is in the process of designing the next revision of this PCB, which will allow for a higher level of integration.
- Pneumatic – The ventilator’s air and oxygen control system is able to deliver closed-loop pressure-controlled breathing cycles to a patient, while providing the sensing to measure tidal volume and patient breathing effort. The closed-loop system allows for controlled, time-triggered cycle breaths that are based on and tailored to patient inputs.
- Software – A real-time control system measures patient pressure and breathing effort, and can deliver both machine- and patient- initiated breaths in Pressure Assist Mode. The team also has a working Graphical User Interface (GUI) that controls breathing mode parameters. The GUI allows for greater usability by ventilator technicians through the provision of a live plot of patient breathing data, as well as built-in alarms. The team is currently in the process of refining that control, adding breathing modes, and adding alarms.
- Mechanical – RespiraWorks is on the second interaction of their enclosure design and aims to do a test build with manufactured pieces in September.
- Testing – The team has begun doing basic pressure-controlled breathing cycle tests based on ISO 80601, using an IngMar QuickLung with a simple QuickTrigger for patient breathing effort simulation. They are currently seeking an Ingmar ASL 5000 or equivalent active test lung to do more advanced testing against active patient behavior. To test reliability of the moving parts, particularly ones that were designed by RespiraWorks, the team currently has a setup which has been running the key moving parts of the ventilator for 800+ hours at twice the expected duty cycle of the ventilator. This is equivalent to 100+ days of continuous operation at regular duty cycle.
Upcoming
The RespiraWorks team is working hard towards several goals, which they hope to achieve in the upcoming months. These goals include:
- August – Complete a full build of the enclosed ventilator.
- September – Get all the required documentation in place in order to pursue FDA 510(k) regulatory approval.
- October – Continue further testing and development of regulatory documentation.
How You Can Help
Volunteers
Since its founding, RespiraWorks has grown into a global organization that includes over 200 volunteers from more than ten countries. Volunteers hail from the U.S., the Netherlands, Lithuania, Guatemala, India, Canada, France, and several other countries. Currently, the organization is seeking to add to its team and has open roles for individuals with regulatory experience, software engineers, and electrical engineers.
Partnerships
In early May, RespiraWorks partnered with Foundry M in the Andhra Pradesh MedTech zone in India. The two teams are currently collaborating in order to develop the hardware and software for manufacturing and deployment in India. Since then, they have successfully sourced and tested locally-manufactured hardware components, and are working on producing a demo unit fully assembled in India. Given the success of the Foundry M partnership, RespiraWorks is seeking additional partners to collaborate with on the continued development of the ventilator in local communities. The team is also open to partnerships with manufacturers, who are able to seek regulatory approval for the design prior to building.
Equipment
Additionally, RespiraWorks is looking for access to an active test lung, such as the IngMar ASL5000. This test lung will allow for advanced testing so that the team can ensure that their ventilator meets safety regulations. The team is asking that organizations or individuals who can lend this test lung, please contact Edwin Chiu.
Funding
Finally, the team is fully committed to remaining 100% open-source. In order to maintain their commitment to providing a free and accessible design, RespiraWorks is seeking donations and funding.
Want to volunteer?
Email RespiraWorks recruiter, Erik Peters, at [email protected]. Please include information about your background and interests. Learn about open positions that fit your background or interests, and join the team!
Want to collaborate?
Development and manufacturing partners should email [email protected]. Businesses and organizations seeking to partner on and/or contribute to fundraising efforts can email our fundraising team, Trisha Beltz or Tif Ho.
Want to donate?
Donate at https://respira.works/donate.
Want to learn more?
Learn more about this project on their website, https://respira.works and on GitHub, https://github.com/RespiraWorks
The designs in this article are presented As-Is. The goal is to present designs that can foster further discussion and be utilized in countries that permit this product. These are not finalized designs and do not represent certification from any country. You accept responsibility and release Helpful Engineering from liability for the manufacture or use of this product. This design was created in response to the announcement on March 10, 2020, from the HHS. Secretary of the Department of Health and Human Services (HHS) who issued a declaration pursuant to the Public Readiness and Emergency Preparedness (PREP) Act.
Link to Prep act. :https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx
ALL WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS, IMPLIED AND STATUTORY, ARE HEREBY DISCLAIMED. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED. THIS DEVICE (INCLUDING ANY ACCESSORIES AND COMPONENTS) IS PRESENTED ‘AS IS.’
