User-Centered Design
A process driven and informed by practicing critical care doctors with ICU usability and emerging COVID-19 patient insights in focus.
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172 Submissions received from Government, industry, academia, and individual innovators
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DoD engineering team completes initial review in Vulcan and downslects 22 submissions
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DoD medical team completes clinical assessment in Vulcan to recommend 5 submissions to prototype phase
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Daily video scrums with 40+ team members, weekly sprints, and multiple testing rounds
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Usability study in operational environment and extensive EUA package preparation for all 5 designs
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A manufacturing challenge in Vulcan and pilot manufacturing analyses
1. COLLECTION:
- The challenge was designed, from the outset, by end-users, namely medical doctors from the Defense Health Enterprise.
- The Vulcan platform was engaged for the rapid discovery and assessment of crowdsourced ventilator designs from a diverse community of innovators.
2. ASSESSMENT:
- A DoD engineering team in coordination with Clinical experts reviewed all 172 submissions in Vulcan and down-selected to 22 viable designs.
- A DoD clinical team, which included critical care physicians, assessed the screened designs in Vulcan and selected 5 solutions for further maturation, testing, and pilot manufacturing.
3. DEVELOPMENT:
- The DoD COVID-19 JATF quickly mobilized a team led by the Wright Brothers Institute (WBI), to implement an agile development process for the Vulcan-5 Prototypes.
- The teams entered rapid Dev-Test-Dev spirals with daily scrums moving each prototype closer to target protocols for bench and animal testing.
4. TESTING & USABILITY:
- Ventilator prototypes underwent artificial lung testing, as well as extensive animal testing over the course of two phases at USUHS: Phase 1 (Compliant) and Phase 2 (Non-Compliant).
- The Team conducted usability testing at Walter Reed Medical Center with UX reviews from Critical Care, Anesthesiology, and Respiratory Therapy practitioners.
5. EUA & MANUFACTURABILITY:
- In parallel, the team engaged both Emergency Use Authorization (EUA) and pilot manufacturing processes in close coordination with FDA and AFLCMC.
- A Build-a-Vent challenge was also launched to align innovative manufacturing solutions with Vulcan-5 prototype designs.
