Sparo Labs’ Abby Cohen on Getting FDA Clearance for Wing
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Earlier this month, WashU-bred biotech company Sparo Labs, headed up by co-founders Abby Cohen and Andrew Brimer, learned their Wing device gained FDA clearance.
Wing hooks a sensor to a smartphone to measure the fastest speed and maximum volume someone is able to exhale in one second. Results are shown on the smartphone screen with an explanation of how the lungs are faring in that moment. This allows the user to avoid potential triggers or anticipate attacks rather than waiting until an asthma attack takes place.
We caught up with Cohen this week about the process of gaining FDA clearance and what’s coming next for the STL startup.
Congratulations on getting FDA clearance! Did your team know you were finding out when you did, or was it a surprise?
With FDA, it’s always kind of a black box, so they don’t necessarily have set times they have to adhere to. But the way the process works, you submit applications initially and there is slower back and forth as they start the review.
But then by the end, you’re finishing up any formatting issues or any last questions they have. So we had an idea that it was coming in the last month when there was a lot more back and forth.
But the actual day that we going to get that notification we didn’t know. So that was a great day to open our inboxes and see that.
Talk a little about the process; how long did it take from submission to result?
The FDA’s purpose is to validate technology that can be used for health-related purposes. They want to make sure that if you’re marketing something for someone to manage their asthma, you can actually fulfill that promise. So you have to put together a ton of documentation.
In total, our application was about 1,200 pages of documentation. That everything from testing of the hardware, so file compatibility testing to make sure that the materials you use don’t react poorly with someone, to electrical safety testing to make sure that with the use of the product there is no way someone could get shocked, all the way to performance testing of the product to make sure it’s actually accurate and precise.
From the software side, you’re documenting that the software does what it actually needs to do to meet the needs of a patient for a specific purpose. Then we’re showing that what we built meets those requirements and expressing and explaining the full design of the products to the FDA so they understand how everything fits together.
It’s kind of all the way from the thought process of the development to actual implementation and testing. It was about six months from submission to actually getting clearance.
But then of course all of our development before that is really what takes most of the time. The back and forth with them was to make sure there wasn’t any other testing they needed or any questions that they have, making sure they’re really able to evaluate the technology to make sure it works effectively.
What was the most challenging aspect of the whole process?
I think the most challenge aspect was probably waiting. Because we know our product so well and we’re giving someone thousands of pages of documentation that they have to review and there’s not necessarily a significant amount of discussion with them upfront.
You really give it to them and it’s pretty hands-off while they review it. We have all the information in our heads and on paper, and a lot of the questions we could have answered right then and there but instead, we have to create more formalized responses after they wade through it and collect their own questions for us.
So I think the waiting game is the most challenging and an entrepreneur and in a startup environment because you’re always trying to do things as quickly as possible.
Aside from being helpful for asthma sufferers, Wing can be used by athletes as a training tool and even musicians with wind instruments. Were you ever tempted to shift the main usage of Wing to recreational so the clearance process wouldn’t be so strenuous?
We’ve seen a lot of interest from a lot of people, from athletes that are interested in measuring their lungs to patients with cystic fibrosis to people with asthma to COPD. There’s a lot of value to be had across the board.
For us, when it comes to asthma and other respiratory conditions, more of that medical purpose, there’s such a significant need. The potential to save someone’s life by taking the right medication at the right time, and knowing that value that we can provide, that’s why we express that it can be used for specifically medical purposes.
It really is that very important and valuable piece and we wanted to make sure we could provide that data and that function in a way people feel confident using it. That’s where FDA clearance comes in. It’s really a testament to how our product works and its accuracy.
What happens next? When and where will people be able to buy the product?
Our team is gearing up for production and launch. At this point in time, we are anticipating launching this fall as allergies kind of ramp-up.
That will be on our website initially. Then we’ll also be working with partners in the lung or healthcare space to develop pilot programs with people who maybe can’t necessarily afford it.
Long term goals would be to make sure than anyone who needs Wing has access to it.