Life-saving idea to open-source license and FDA approval in less than 30 days
1. IDEA
Stephen Richardson, UMN cardiac anesthesiologist, sees a need for a low-cost ventilator. His design doesn’t require pressurized oxygen or air supply. Instead, it uses “Ambu” bags that paramedics employ to manually resuscitate patients. His friend Jim McGurran, who works for MGC Diagnostics, brings the idea to life in a red toolbox.
2. PROOF OF CONCEPT
The next day (March 16, 2020), Richardson meets Art Erdman, founding director of the Earl E. Bakken Medical Devices Center (BMDC) that’s part of the UMN Institute for Engineering in Medicine (IEM).
BMDC
Prof. Hubert Lim is current director of the Earl E. Bakken Medical Devices Center
IEM
Prof. John Bischof leads IEM, within the medical school.
3. PROTOTYPES & TESTS
Erdman gathers his lab supervisors—then mechanical engineering students Aaron Tucker (Ph.D. ’23), Steve Thomalia (Ph.D. ’20), Cara Piazza (Ph.D. ’23), and John Huss (Ph.D. ’19)— plus medical doctor Enio Perez, who was enrolled in the BMDC Innovation Fellows Program.
Their mission:
⊲ How do we convert this toolbox into an FDA-approved device?
⊲ How can we scale up production, as fast as possible?
⊲ How do we set up a supply chain for all the components?
Tucker spends 30 days making five prototypes and running the more advanced models through six clinical tests with the medical school.
“We got some publicity locally in the Star Tribune, KARE 11, and other local television stations. As soon as that happened, everyone said, ‘What can I do?’” —Art Erdman
4. SCALE-UP PRODUCTION
Within two weeks, 70 volunteers—University of Minnesota College of Science and Engineering undergrads already familiar with the 9,000 sq. ft. Bakken Medical Devices Center facilities—built the first 25 units there.
5. COMMERCIALIZE
The University of Minnesota Bakken Medical Device Center team, Steve Richardson, and the University of Minnesota Office of Technology Commercialization (OTC) meet with industry partners on the Twin Cities campus.
6. FDA APPROVAL
On April 14, 2020 the U.S. Food and Drug Administration grants Emergency Use Authorization to what-is-now-known as the Coventor.
The Coventor—the first of its kind to be approved during the COVID-19 pandemic—is compact and relatively inexpensive to manufacture and distribute.
7. WHERE ARE COVENTORS TODAY?
More than 100 open-source files ordered worldwide (z.umn.edu/cov-license). Nonprofit Scalpel at the Cross continues to use the Coventor in Peru, Honduras, India, and Guinea.