• VULCAN-5 VENTILATOR PROJECT

    A DEFENSE INNOVATION STORY

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  • CorVent Ventilator Wins FDA Approval

    CorVent Ventilator obtained EUA from U.S. FDA for use in a hospital or similar clinical environments and was determined to meet required criteria for safety and performance.

THE STORY

In March 2020, as hospital beds around the country filled up with patients suffering from respiratory distress due to COVID-19, the U.S. Department of Defense (DoD) launched the Hack-a-Vent Challenge and assembled a rapid-reaction team to execute the effort. Two months later, five distinct, low-cost, ventilators were ready for production and submitted for FDA approval.

“We set out to identify a viable solution to address the projected ventilator shortage, and we got a whole lot more than we bargained for in the process” – Lt Col Audie Murphy, DoD COVID-19 JATF

The challenge solicited crowdsourced ventilator designs and seven days later, the DoD received 172 submissions.  In the two days that followed, Defense clinicians and engineers completed all their assessments in Vulcan, yielding five final designs for rapid development. Vulcan is sponsored by the U.S. Special Operations Command. The prototype ventilators matured and successfully completed a rigorous process to demonstrate that they not only can resuscitate a non-compliant lung, but can also be postured for mass production. The highlights of the project do not stop there. In fact, here are a few noteworthy examples – all in less than 60 days:

  • Open collaboration and ‘coopetition’ among two large businesses, two small businesses, and one Government Lab to rapidly mature 5 distinct designs.
  • Re-purposing of  commercial technology, including marine diving equipment, for medical application.
  • Cross-country transport and successful testing of prototypes in the midst of severe COVID-19 restrictions on mobility.
  • Infusion of private venture capital into at least one design
  • The productization of a Government design and its partnering with commercial manufacturing.
  • Open-sourcing of several designs and one technology transfer to an academic institution.
  • The U.S. FDA Emergency Use Authorization of the CorVent RESPOND 19 Ventilator for use in a hospital, or similar clinical environments.

Despite the extraordinary circumstances surrounding COVID-19, the DoD executed this project with unprecedented agility, breaking through traditional barriers and inspiring its partners to deliver critical innovation at the speed of relevance.

THE TEAM

A multidisciplinary team with requisite expertise in rapid innovation, critical medical care, product engineering, regulatory compliance, supply chain engagement, and Government acquisition.

THE PROCESS

User-Centered Design

A process driven and informed by practicing critical care doctors with ICU usability and emerging COVID-19 patient insights in focus.

Agile Development

Daily scrums driving rapid prototyping spirals with real-time collaboration on data and insights across teams

Evidence-Based Approach

Expert-driven and data-driven process with rigorous testing and usability inputs to inform rapid maturation and manufacturability

THE PLATFORM

Vulcan Technology Domain Awareness is a technology scouting platform, sponsored by USSOCOM, and used by diverse communities of practice to accelerate the delivery of innovative solutions to the national security enterprise. Vulcan is a fully networked solution on GovCloud(US) with end-to-end workflows supporting ecosystem engagement and collaborative scouting of technology solutions.