Health IT, Devices & Diagnostics

Digital health companies highlight value of rigorous validation

At Health Datapalooza this week, Akili Interactive Labs and WellDoc officers talked about validating their "software as a drug" products.

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Digital health is a relatively young area of healthcare, but some companies have been around long enough to prove the value of their technologies in clinical studies over time. That’s also thanks in part to deciding early on to seek FDA clearance for their software as a drug or treatment. In a panel discussion at Health Datapalooza last week, WellDoc Chief Strategy Officer Anand Iyer and Akili Interactive Labs Cofounder and CEO Eddie Martucci offered some insight on how their rigorous approaches have made it easier to demonstrate their products’ value.

WellDoc was formed in 2005 to develop software as a drug before smartphones were around.

“If you want to be a player in this space you have to have evidence — it is a necessary table space,” Iyer said.

In his overview of the business, Iyer said opting to pursue FDA clearance helped the company be more disciplined with its approach by forcing it to derisk and validate its technology early and often. Although its first application for 510(k) clearance took 15 months. The process has gotten easier for updates to the platform.

“Right, wrong or indifferent, the three-letter stamp [of FDA] means a lot to a lot of countries. It means that you have taken the time to go through the patient safety analysis, ensured your data stack is secure and encrypted and understand cybersecurity risk and product malfunction risk.”

Later in the conversation on the topic of long-term studies, Iyer said:

“I don’t think any digital health company has done as many clinical studies published in peer-reviewed journals as WellDoc has,” Iyer said. 

He noted that it’s fascinating to see the long-term impact of its app, which is prescribed by physicians to better manage diabetes as part of its BlueStar program. 

“We are not only seeing reductions in A1c, but also reductions in acute utilization and control, reduced blood-glucose scatter. We have to look at control of extreme out of bound events and we are seeing significant reduction in those.  We saw in one study a 15 percent reduction in acute utilization.”

That’s important because that means fewer people requiring costly hospitalization to get their condition under control.

Akili has a pediatric digital therapeutic for ADHD in Phase 3 clinical trials. It is also intended to be prescribed. Martucci drew parallels between its work and drugmakers and how the pharma industry has helped its business.

“The label [for its lead digital therapeutic] will read ‘for the treatment of ADHD’ — not disease management, not patient engagement, but a direct therapeutically active software platform.”

But when it comes to the challenge of long-term assessment for the impact of taking certain prescription drugs, Martucci said the company seeks to go beyond what pharma companies do. Instead of monitoring the impact of its digital therapeutic for the one month to eight weeks, Martucci noted that a recent study evaluated the impact of its treatment nine months after.

Martucci added that Akili uses the exact same adverse event reporting system as drug companies.

“We can be very smart with how we segment rich data and segment what’s a concern and what’s not a concern.”

Photo: Getty Images

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