Overview

The demand for ventilators to treat COVID-19 patients is predicted to far surpass the available supply (and in many regions, it already has). While efforts are underway to increase ventilator production, current estimates indicate that this will be insufficient to meet the coming need, forcing medical professionals to make decisions about which patients are allocated a ventilator and for how long. The sobering reality is that time is short and days matter. 

Objective

Our goal is to design, validate, and produce a tool for medical professionals—a lowest complexity required ventilation device for the COVID-19 crisis that is deemed safe by experts in the field (as made clear in the FDA Emergency Use Authorization (EUA), on March 24, 2020). Intended to complement existing solutions, this device is meant to be neither a first choice replacement for high end ventilators nor a last-resort, DIY solution.

Approach

We are carrying forward the MIT E-Vent team’s proof of concept, translating their proven system architecture into a user-validated, regulatory approved design to be produced by manufacturers who know how to build a medical device the right way. In keeping with their vision, we will be publishing updates and sharing files as we make progress so that anyone capable of carrying it forward can do so. Given the urgency of the need, our team is defining the system architecture to meet anticipated requirements, lifecycle testing several varieties of BVMs, such as AmbuBags, and understanding the evolving regulatory landscape. We are currently seeking minimum requirements from the FDA under Emergency Use Authorization and aligning development efforts to meet those as quickly as possible.

Rationale

Forecasted COVID-19 case-surge timelines and shortages of supplies and personnel in the healthcare industry called us to immediate action. Our team surveyed potential project opportunities ranging from using our own facility to assemble 3D printed N95 masks, to resupplying critical PAPR components, to an interchangeable solution for the shortage of hospital ventilators. Established suppliers and manufacturing teams appear to be accelerating production capabilities in efforts to meet new demands of PPE and highly functional ventilators. We are driven by the goal to provide overwhelmed healthcare providers with a means to deliver the necessary level of care for all incoming patients. By rapidly engaging our community, we made an educated decision to move forward with the Aether Project based on the confluence of key factors:

  • Our combined-team’s capabilities
  • Guidance of medical professionals identifying ventilators, specifically an AmbuBag-based solution, as the best route to reach the greatest number of patients in the midst of healthcare facilities exceeding capacity
  • The release of the open-source, clinically-driven and animal-tested MIT E-Vent design
  • Committed funding to accelerate the discovery of a path to respond to the current pandemic
How can you help?

Our primary focus is on moving quickly. If you have feedback or additional information regarding content included in this post or future updates, please share it with us via this form and we will respond as we are able. We will list specific needs as they are identified, initially below and in a separate, designated post to follow.

Current needs:
  • FDA Regulations: with regard to approval of ventilators under the current Emergency Use Authorization. We are currently seeking understanding of the EUA space and what testing requirements are. We are especially interested in speaking with anyone else who is currently navigating this landscape or has successfully done so already.
  • Bag Valve Mask (BVM) data: lifecycle test data and global supply availability information
  • User insight: Physicians, respiratory therapists, clinicians, and nurses experienced with caring for patients using ventilators. Input is needed to ensure our design and intended application is executed in a way that makes a difference.
  • Financial resources: Our team’s technical, medical, and manufacturing resources found financial resources to contribute to addressing this global problem. If you’d like to add your financial resources to this effort, please reach out to us.
Contact

Our team is reachable via this form

Team

We are a collective of companies and subject matter experts dedicated to using our relevant backgrounds to tackle the needs of this project. Knowing a team is stronger than the summation of its members, we each bring complementary experiences creating medical devices. Members of our team have designed user experiences, translated them into products through systems, mechanical and electrical engineering, guided companies through quality management and regulatory compliance, and navigated the complexity of supply chain and manufacturing. We are working in parallel to drive workstreams forward in an accelerated, coordinated effort.
Among the parties involved in this effort are Dragon Innovation, Greenlight Guru, and Prodct, LLC..
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Disclaimer and Copyright

  • This project is based on the open-source designs of the MIT E-Vent team, and we will continue to publish our work so that others may carry it forward as well.
  • All parties continuing this work must individually verify and validate designs and attain regulatory approval.
  • No material on this site is intended to provide medical advice. The correct use of a ventilator could save lives; bad use of such a device could cause death to a patient. The device must be used exclusively by or under the direct supervision of a qualified healthcare professional.
  • We will be submitting a specific variant of the Aether design to the United States FDA for review under the Emergency Use Authorization (EUA) authority.
  • The Department of Health and Human Services (DHHS) has declared liability immunity for medical countermeasures against COVID-19.

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