It can be hard even for some healthcare professionals to imagine products like a prescription video game to manage ADHD. But that’s exactly what FDA-approved Endeavor by Akili does.

Digital health solutions like these aren’t just a new healthcare trend. These evidence-based, on-demand, health interventions are fundamentally redefining our relationship to health.

But digital therapeutics (DTx) still have some way to go before we can see them scale to universal levels. Below a few of the key barriers standing in the way of DTx and how they can be overcome.

Stumbling Blocks

  • FDA/Regulatory Approval. The most important hurdle. The majority of other DTx barriers are lowered when this is achieved.
  • Patient education. Many patients don’t even know DTx exists. Creating awareness about these products and educating about their benefits is essential.
  • Product separation. DTx providers need to take strides to distinguish themselves from OTC health and wellness products.
  • Data collection. Providers need to find easier ways to collect patient data accurately.
  • Integration with traditional therapies. DTx needs to keep Biopharma on their side by integrating and supplementing existing therapies rather than trying to replace them entirely.

Regulatory Approval

The path to the success of any healthcare product is enshrined in FDA and other regulatory-body approval. It is how you secure not only physician buy-in but also payer support.

With traditional biopharmaceuticals, this pipeline may be challenging, but it is well-established and clear enough. But as an entirely new class of medicine, digital therapeutics doesn’t have the same framework to work with.

Moreover, since digital therapeutics vary immensely, they often need to be evaluated on a case-by-case basis. Though this will remain a challenge for at least the next few years, the path is getting clearer. To start, the growing number of FDA-approved digital therapeutics is already creating a system of predicates that will help more products follow suit.

Moreover, regulatory bodies are becoming increasingly inclined to evaluate digital therapeutics in new ways that reflect these technologies instead of through the traditional clinical trial process. The FDA is working on the Digital Health Precertification (Pre-Cert) Program and already reached pilot mode. This is more in line with the software iteration cycle that these tech breakthroughs are built on and shows regulators’ willingness to create new models.

Patient Education

Because of COVID-19, more people are aware of digital health technologies than in the past. But DTx providers still need to do a better job of getting the word out there about what the health gains their products offer.

How many people with children struggling with ADHD would be thrilled to learn about a product like Akili’s Endeavour? The same is also true in every DTx niche. Unfortunately, it’s a little bit of a chicken and egg scenario.

With some companies waiting to overly spread the news about themselves until FDA-approval but larger acceptance but this can get easier when more people are using the product.

This is where the industry needs to work together better to raise awareness about the immense potential DTx will deliver to patient health outcomes and their pocketbooks.

Separating DTx From OTC Products 

There is definitely a place for OTC products that share overlapping features with DTx. Sleep trackers, fitness apps, brain games, and other wellness solutions are valuable for improving health.

In many ways, they can and should coexist. It’s also possible for an OTC to receive regulatory approval. Happify is one such example of a digital health solution headed in that direction. The app encourages mindfulness and has tens of thousands of downloads. They’ve been undoubtedly successful, but the developers also recognize the product can only exist in a certain niche, so they’ve also begun pursuing regulatory approval. By achieving this, they’ll be able to secure not only physician buy-in but also payer support better guaranteeing their long term financial stability.

So the question is, what’s DTx and what isn’t? That can be not easy for even providers to answer. For now, DTx providers whose products have received FDA or other approval, need to emphasize it.

The cognitive training app Constant Therapy is one example of a digital health provider who takes great lengths to do this. They’ve developed a clinically proven cognitive therapy. But on the surface, it looks similar to any of countless “brain games” you can download in the App Store.

So Constant Therapy has taken upon themselves to show what marks their solution different and effective, so people know they’re getting evidence-based therapy. They not only have links to clinical studies and other information on the website, but have published numerous blog pieces, articles and other media to further distinguish themselves. Other DTx providers should similarly take these steps, which will have the additional benefit of spreading awareness about DTx to more people.

Data Collection

The success and growth of DTx relies on data collection. The data determines the course of therapy and product personalization and how developers can refine their products over time.

However, the problem now is much of the collection process is dependent on the individual user’s willingness to log the data manually—and we all know how well that goes. People forget, or they just don’t want to do it.

Automatic data collection needs to become standard on DTx products. But this is easier said than done. While your Apple Watch can easily log your steps or heartbeat, getting blood glucose levels is another thing entirely.

DTx providers have already stepped up to these challenges. In the short term, voice assistants will fill this role to simplify the data collection process and actively remind patients to record health updates. In the next few years, we’ll also see the emergence of more passive tracking technology that will shift the collection burden away from users.

Integration With Traditional Therapies

Many DTx ventures rely directly on support from biopharma companies. DTx promises “beyond the pill” therapeutics interventions. DTx specifically works to fill treatment voids that biopharmaceutics cannot. Likewise, it also works very well in conjunction with therapies.

For example, one of the most successful digital therapeutic products has been the diabetes management application Bluestar. Bluestar drives adherence and helps deliver better outcomes working alongside traditional insulin therapy.

This is a key way for DTx to begin scaling across healthcare. These integrated therapies not only help drive the best possible patient outcomes but don’t overly disrupt the traditional business model and potentially lose the invaluable support of Big Pharma.

The DTx Roadmap to the Future

For such an early-stage market, DTx boasts an incredible potential to revolutionize the practice of medicine. It has the support of Big Pharma and Big IT along with access to capital and the dynamic spirit needed to innovate truly. Moreover, it already has achieved significant regulatory wins creating the space it needs to grow.

Now DTx providers must double-down on education, focusing on the approval pathways, and integrating with existing therapies. By doing so, DTx will be able to empathize with integral stakeholders and build the trust needed to overcome barriers and achieve the healthcare transformation we all are hoping for.