Overcoming the Challenges of Getting Digital Therapeutics to Market

The FDA’s recent landmark decision to formally acknowledge and regulate digital therapeutics (DTx), with the 510(k) clearance of DeepWell DTx’s biofeedback software development kit (SDK), marks a significant turning point for the healthcare industry.  The agency’s new stance further legitimizes the technology and opens the door for innovation, appropriate regulation, and more extensive adoption of these therapeutic tools. The newly cleared SDK is a translational engine that connects media to the reimbursement stream via digital therapeutics. 

Born of the concept that media can be medicine, digital therapeutics exploded onto the scene with promises of digital drugs, massive reach, and untapped market potential, but after a lot of big hype, DTx got stuck. We’re now seeing a way through the fundamental challenges holding the industry back and are excited to be positioned in the middle of it all. 

The challenges of DTx were not easily addressed. The FDA’s regulatory framework and approval process, built to manage software as a medical device (SaMD), made very good sense for an implantable medical device but couldn’t bend appropriately to the dynamic nature of an effective digital therapeutic. By these guidelines, media developers looking to produce a DTx medical device had a hard time understanding how to follow the approval process.

Getting DTx reimbursed was another obstacle. Assuming DTx companies could get through the regulatory process to the point where they had a viable therapeutic on the market, there was still no guarantee of getting paid. To get the therapy in the hands of a patient, it first had to be prescribed by a doctor, after which most health insurers, lacking any monetary motivation to do so, would decline to provide reimbursement, making DTx financially unviable for both providers and patients.

Perhaps most important of all was the challenge of meeting the need for compelling products that patients would adhere to. With the restrictive regulatory framework and rigid ideas of what constitutes a “therapy,” DTx were generally doomed to be unimaginative and unengaging medical devices devoid of incentivization.  

With all these barriers in place, it was challenging to get DTx recognized as a powerful option for mental and physical health treatment. However, despite all this, the landscape is changing, and doing so quickly. Fueled with a greater understanding of what makes media medicinal, new regulatory pathways, and viable payment options, it looks like the world of DTx is on its way to being a very legitimate and effective market. 

What’s happening at the moment is a recognition of the global mental health emergency and current resource constraints. The FDA clearance for DeepWell as a ‘toolkit’ allows media creators to connect media to the reimbursement stream that’s coming next year for digital mental health.

The global mental health crisis we’re currently experiencing has shone a light on a huge unmet need. A critical shortage of mental health professionals and a general lack of accessibility and affordability of care means that many innovative solutions will be needed to address the overwhelming issues we are facing worldwide. The recent FDA decision moves us all one step closer to meaningfully addressing the issue, at scale.

Media as medical devices using DeepWell’s technology can be available to consumers over the counter (without a prescription and by doctors’ orders as appropriate) on all media platforms. The new codes proposed by the Centers for Medicaid and Medicare Services will provide monetary incentives for development and adoption by both providers and patients. The accessible nature of DTx, combined with the transformational power of media, now has the potential to positively impact millions of struggling individuals and families.

With the SDK inside or adjacent to their media as a highly effective therapy, creators can bring immersive, transformational content to patients on an accelerated timeline. It’s a compelling pathway to medicinal media that the FDA is comfortable with and facilitates previously unimagined levels of accessibility to care.