A shortage of ventilators to treat Covid-19 patients potentially creates such a problem that at least one state has created a statewide plan to determine how scarce critical care resources would be allocated. In the meantime, innovative entrepreneurs are working to fill gaps in life-saving medical equipment, and, in the process, build new businesses.
One example: In less than twenty days, Vent Multiplexor, LLC designed, developed, tested, and gained FDA Emergency Use Authorization for a device that turns one ventilator into two, allowing each "split" to deliver individualized care to each patient. (Existing devices work like a Y-splitter, simply splitting the same output into two feeds--which means each patient receives the same output, regardless of his or her individual needs. In short: What gets delivered may be perfect for me... but not for you.)
How did the startup go from idea to implementation to approval in such a short time?
Brian Beitler and Tim Foldy-Porto, students at Yale University, created the initial design. Dr. Peter Kahn, a mentor to the students (and who now serves as the Medical Director for Vent Multiplexor) called attorney and entrepreneur Todd Higgins.
"Peter says, 'It's smart, it works, and it could save lives,'" Higgins says. "So I got up to speed with where they were, saw they had a raw prototype that worked... and six hours later we filed a patent. That was the first step: To create an intellectual property foundation, and to do it now. That mindset, that sense of not 'later' but 'now,' was the mindset for everything we did for the three weeks. There was never an alternative to 'now.'"
Once the patent was filed the team spent the next three days further developing the prototype while creating a business plan to turn the idea into a product that could be in the market saving lives when it still mattered.
"That was the mission statement, at least in my mind," Higgins says. "Save lives during the pandemic."
That Sunday night, senior leaders -- including the Chief Medical Officer and ICU Director --from Yale New Haven Hospital joined the team on a Zoom call for a product demo.
"Even if you've been doing business for a long time," Higgins says, "it's human nature to look at all these brilliant people and think, 'Do I belong here? And are they thinking the same thing: Wondering how someone like me is involved.'"
Clearly Higgins and the team did belong: The device clearly worked, the lifesaving implications obvious.
And Higgins realized that doctors, for all their knowledge and talent, aren't necessarily entrepreneurs: People who make it their life's work to quickly turn ideas into products.
"It was clear there wasn't really anyone else in a position to drive the execution," Higgins laughs, "so I decided I guess it had to be me." Importantly, the Chief Clinical Officer decided the device should immediately undergo testing and helped create a clinical testing pathway.
Two days later the startup reached an agreement with the hospital on intellectual property, agreeing to make the device for the hospital at cost and crediting Yale New Haven Hospital as a collaborator.
And two days after that, on April 1st, the startup filed an Emergency Use Authorization submission with the FDA. Even though no one on the team had ever completed an EUA submission.
"To extrapolate a broader point," Higgins says, "in many ways an unprecedented crisis is the great equalizer and leveler, because no one really know what they're doing. No one has the playbook, so everyone is a potential participant in finding the way forward.
"It turns out the FDA had assembled an exceptional cross-disciplinary team who were amazing in their support, and in wanting to help make a difference."
During that time, and while the hospital was creating plans to deploy the device on April 7 the device successfully co-ventilated individualized treatment protocols for two patients.
And on April 15, the FDA granted Emergency Use Authorization -- making it 20 days from idea to execution.
According to Higgins, that never would have happened without the combination of the hospital's medical expertise, the startup's enterpreneurial expertise, and the support of the FDA. Pull out any piece, and the whole puzzle would have fallen apart.
"The whole experience has been life affirming," Higgins says. "It shows there are opportunities on the other side of the crisis: To be a part of change, to find different ways to do things...
"There are plenty of people more capable than me, but I deployed the skills I do have. There are a lot of smart people sitting on their intellectual, or strategic, or capital resources... imagine what could be accomplished if everyone deployed the resources they have."
That's what entrepreneurs do: Not only identify but actually fill gaps.
Because making a difference isn't just an opportunity. Making a difference is also a responsibility.