Ryan Douglas, co-founder and chair of DeepWell Digital Therapeutics (DTx), says the device developer and its partners have broken through the three major challenges that have so far stymied the field of digital therapeutics.

“Digital therapeutics got stuck. … After the big hype and the trough of despair, we’re on our way back up to the reality of what’s going to happen here,” Douglas said in an interview with Medical Design & Outsourcing. “And at the moment, DeepWell is going to sit right in the middle of that.”

DeepWell recently won FDA 510(k) clearance for its biofeedback software development kit (SDK), which DeepWell and video game developers can use in over-the-counter therapies for stress reduction and hypertension. (Read more about how the technology works at MassDevice.)

Douglas discussed the three big challenges for digital therapeutics — creating compelling products for patients, getting them through the FDA and securing payments — and how they’ve been solved with the help of the Digital Therapeutics Alliance (DTA), a group that includes Cognito Therapeutics and Pfizer among its members. (The following quotes have been lightly edited for space and clarity.)

1. The digital therapeutics patient challenge

Douglas: “The first fundamental problem we saw with digital therapeutics is something we’ve seen in med device for a very long time. We believe because we know what’s good for you, when we tell you to do it, you will do it. Experts in media have been highly therapeutic for 50 years from the video game industry and the media creation industry. The ability to wield media to the point that you can change someone’s perception about themselves and about reality is a specialty — and we didn’t utilize it in digital therapeutics. We took something that wasn’t fun and tried to make engaging by gamifying it. We got somebody into the computer lab and told them they couldn’t change anything. They didn’t get to build a fundamental engagement loop. Instead, they would just throw badging, scoring and social at the secondary game mechanics, and go, ‘We’re gamified, this should be fun now.’ It’s actually been completely the opposite of fun. Look at something like Fitbit. When you’re doing great, going for your walks every day, it’s telling all your friends you’re a superhero. That’s not when you need the help. The day that you lay on the couch is when you need the help, and that’s exactly when all it tells you is, ‘You suck,’ which you already knew that day. It’s the complete opposite of the incentive model that we’ve seen be so effective in digital media. Digital media is insanely compelling, but we didn’t bring any of that to it.”

2. The digital therapeutics regulatory challenge

Douglas: “If you think about digital therapeutics from the FDA’s perspective, they look at it like software as a medical device (SaMD), and where did SaMD come from? Things you put in people’s hearts. They want a set piece of hardware that never changes and a set piece of software that’s verified and validated — stick those together and nothing’s going to change. The problem is that we want to deliver this to folks in the mobile environment, where there are about 1,300 active devices that are updating their software all the time and morphing and changing. For the media to be compelling, you must be dynamic and shifting and changing. We want it to move. The agency said no to all that. I was just with Google’s former chief game designer, Noah Falstein, and he was a big part of designing what Akili Interactive was designing. They knew the game wasn’t everything they wanted it to be, but they were six years into clinicals and stuck in all these positions and so mired down in $30 million worth of work with the FDA, they couldn’t change it. That was a fundamental stuck point that DeepWell has overcome.”

3. The digital therapeutics reimbursement challenge

Douglas: “Let’s say you figured out how to get a therapy to be gamified in a way that was compelling and you could get it through the FDA. Build it and someone will come. But nobody came. There was nowhere to get paid for all this. When Corey McCann’s last message came out from Pear Therapeutics on his way out the door after SPACing for $1.6 billion, raising $400 million and all this crazy stuff going on, he noted payers do not have to pay for clinically viable therapies, even if they have been proven to be effective. You should know that before you take $400 million of people’s money, do a SPAC and all this, because you literally took our industry and it went poof. Everybody got hit. The Digital Therapeutics Alliance has kicked butt with Congress, they’ve worked to get people to understand that we’ve got these reimbursement codes coming in for mental health. You’ve got the Section 1905 reimbursement coming in for pain — that is running right now, AppliedVR is doing it. We’re going to see this progression. Even with the immediate clearance that DeepWell has, the HSA reimbursements are coming in. They’re even touching hardware at this point, so if you’ve got an accessory to a medical application, you can submit that. People are being successful with their HSAs.”

What’s next?

DeepWell launched in 2022 and has remained mostly self-funded as it worked toward this FDA 510(k) clearance, Douglas said.

“We figured out how to do this in a compelling manner, we figured out how to do it in a way that the agency is going to be comfortable with and that will support that compelling manner and accessibility to care, and there’s a way to get paid that’s right here on the horizon,” Douglas said.

DeepWell plans to pursue more indications, with potential for treating pain, anxiety and depression before more specialized treatments, Douglas said

FDA clearance of DeepWell’s SDK will not only make it easier for media developers to bring the technology to patients, but also provides a predicate for a similar approach by other digital therapeutics developers.

“You don’t have to work with DeepWell. You don’t have to be DeepWell,” Douglas said. “We’re so proud to have set this precedent and allow other people to be able to use this as a reference device, because remember, it’s not just your indication for use that you use with a predicate device. You’re also looking for technical references. … That’s exactly how we progress in this market. We grow off of each other’s work. I applaud Pear and Akili for pushing through the way they did, but they didn’t do it as medical device experts.”