In late August, NASA announced that its FDA-approved VITAL respirators entered mass production in Brazil .
VITAL, which stands for Ventilator Intervention Technology Accessible Locally, was developed specifically for use with COVID-19 patients.
"We consulted directly with doctors who were treating patients in the hospital," said Leon Alkalai, one of the leaders of the ventilator project and manager of JPL Office of Strategic Partnerships, in an earlier Tech Briefs article.
The technology has since been licensed to 28 companies globally, including Brazil.
The NASA-developed ventilator has fewer parts than a traditional, high-end ventilator and can therefore be built faster and maintained more easily. Many of the VITAL components are currently available to potential manufacturers through existing supply chains.
The pneumatic version of the device, which will be built in Brazil under the name VIDA, uses pressurized oxygen or air from hospital sources. Like all ventilators, VITAL requires patients to be sedated and an oxygen tube inserted into their airway to breathe.
NASA had received more than 100 applications for a license to build and distribute the ventilator.
In a live Tech Briefs presentation called COVID-19: The New Design Paradigm and Emerging Technologies, an attendee asked Alkalai about the decision to offer licenses rather than develop a publicly accessible design:
"How and when did you decide to approach the U.S. Food and Drug Administration (FDA)? And how did you decide go down the licensing pathway as opposed to, say, open-source?"
Read Alkalai's edited response below.
Leon Alkalai, NASA JPL: These are two questions that really address a key decision point in this project.
We started on March 16. On Day 3 of the project, our team caucused on whether we needed to get FDA approval or not. At the time, we were looking at a lot of open-source designs. There were some from the University of Florida, Oxford, and a bunch of groups coming up with designs that were not planning to go through FDA approval.
We actually did an informal poll. We called a few hospitals and some of our friends. We asked if they would use a ventilator device that was not FDA-approved, and the answer was clearly no. So, even though it seemed like a "mission impossible," we decided that we had to work with the FDA to get approval.
On Day 3, I called [Emergency Coordinator at FDA] Dr. James Lee, and he was very responsive. He answered my email right away. We scheduled a call. On that same day, he offered to help. He assigned Dr. Brandon Blakely to work with our team. They participated in all of our design reviews and helped us through the process.
Midway through the project. we did another analysis of whether to consider open-source or not. We did some polls and called manufacturing companies, advisors, and consultants, and they warned us about open-source systems like this, mainly from a supply-chain point of view. They indicated that were concerns and risks that people and companies could possibly disrupt the supply chain. So, if a certain product was open-source, they could go out and buy critical parts, artificially raise the price, and so on. This was a big concern to us.
We opted to go down the licensing approach, which frankly is more complicated. There is more involvement of JPL, and a process that has to go through Caltech. Licensing required IP filings, patents, and a lot of things that had to be done in a very short amount of time. We defined the licensing criteria, We issued a call. We received proposals. All of those proposals had to be reviewed, and then we picked [about] 30 companies that have the capability to manufacture and build these ventilators.
We're very happy with how it's going now right now. We're having a workshop with our licensees. This was a tough decision, but I think the likelihood of this ventilator actually going into a hospital and being used on a patient is far more likely than [if NASA went] open-source.
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