Update: April 23, 2020

Throughout the development of the Aether ventilator, the team monitored the progress of the outbreak. Though we started in response to dire predictions of ventilator shortages in the United States, current models show both a reduced need for ventilators and an earlier end to the need in this country. Our most optimistic manufacturing schedule would not yield ventilators before more capable models arrived and the need ended; as a result, the team has ceased operations. However, we recognize that our work may be useful for those seeking to develop ventilators for other regions where the need is still predicted to exist. In this post, we’ve recapped the work we’ve done and the work yet to do, and provided a link to relevant files.

Summary of Work

As mentioned in our previous post, we started development by conducting research into ventilators, their modes and uses, and the features expected by expert users such as respiratory therapists and clinicians. We explored the guidance presented by regulatory standards (specifically IEC 60601 and ISO 80601) and expert users, and conducted research into 510k submissions of similar devices. When developing the device architecture, we started with the MIT E-Vent design and explored ways to improve component life and safety. We developed a system diagram to identify the subsystems and components needed to satisfy the requirements. To understand the failure modes of resuscitator bags, we developed a life cycle rig to simulate their loading. As a foundation for further development, we built a simple prototype of the mechanism.

The team made progress on many fronts, from requirements and the system architecture, to the mechanical and electrical designs, to test rigs and manufacturing plans and sourcing. Much of this work has been distilled into the content below. The system architecture, and the details of the mechanical, electrical, and firmware designs, were all in development and incomplete when the decision was made to cease development efforts. The rigs were left in nearly operational states, but did not generate significant information. The team had developed short- and long-term plans for fabricating, assembling, and distributing the Aether ventilators using ISO 13485 approved contract manufacturers, but did not engage in any agreements.

Remaining work includes determining, from the preliminary list of requirements we had developed, which would need to be satisfied for the device to be safe and effective. The details of the mechanical, electrical, and firmware designs still need to be completed, validation tests identified and run, and manufacturing and distribution partners fully engaged. The body of work needed to build a submission to the FDA for approval of a medical device still needs to be built, including complete requirements tracing from user needs to verified requirements.

Content

Work completed to date is available in this Dropbox folder.

Please note: The development of the Aether ventilator was interrupted when it became clear that the timeframe for fabrication no longer met the need. As a result, the content presented here is incomplete—it does not represent a completed design, and significant work remains on all phases: requirement definition, rig design and testing, system architecture, electrical, mechanical, and firmware design, verification and validation testing, component and system manufacturing, distribution plans, and documentation to support an FDA submission. The work is presented here to allow anyone willing and able to carry it forward. Below is a summary of the content. All CAD is a pack-n-go export from SolidWorks 2019 and each folder is self-contained.

Files
  • Aether Test Rig – this folder includes the mechanical CAD and actuator datasheets for a rig intended to test the life of ambubags.
  • Aether Drive Train Breadboard – this folder contains the mechanical CAD for a simple rig intended to demonstrate the operation of the basic drive train. This rig would be the foundation for future work as additional features were developed.
  • Aether EE Development Plan – this PDF presents the early plan by the electrical group to develop an electrical architecture that would meet the system requirements.
  • Aether ID Concept – this folder contains CAD implementation of the ID as it was being developed – it is not complete.
  • Aether Motor & Power Calcs – this is a spreadsheet calculating the motor and power needs for the device.
  • Aether System Diagram – this shows the current state of the system block diagram with notes on specific items indicating additional work. The notes do not represent all the additional work that would be needed to consider the diagram complete.
  • Aether System Requirements – this PDF present the current state of a trace matrix of the system requirements with notes. This document is not complete.
  • Aether Top Level – this folder contains the CAD of the system at an early stage, just starting to implement the ID.
  • VDC 4915 and 9474915432 – these are two documents specifying the motor that the team had chosen for the device. The criteria were heavily skewed toward operational life and safety and sourcing; cost was a secondary concern.
Acknowledgements

We want to send a special thank you to everyone who reached out to offer their support and to the extraordinary team that came together on this project:

  • Scott Miller at Dragon Innovation, for volunteering his time to develop manufacturing plans (short-term, long-term, domestic, and overseas), tap into his sourcing network, and bring valuable insights from clinical experts.
  • Devon Campbell at Prodct, LLC, for guiding us through the regulatory landscape and for exercising his expansive network on the project’s behalf
  • Jon Speer at Greenlight Guru, for volunteering his company’s QMS system, his network, and his own personal time
  • Stephen Fowler, Respiratory Therapist, for providing invaluable expert user feedback and insight into the use and operation of ventilators, all while battling at the front lines of this pandemic
  • Josh Rose and Adrian Bischoff for their design and engineering expertise
  • The MIT E-Vent team for starting this race
  • And finally, all the engineers and staff at Cooper Perkins who volunteered their time and effort to this project at a trying time

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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.

Use of Cooper Perkins Name
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