Even for healthcare professionals, it can be difficult to imagine a product like a video game prescription to manage ADHD. The FDA-approved Endeavor By Akili is a prescription video game that helps manage ADHD.
These digital health solutions aren’t a mere trend in healthcare. These on-demand health interventions, which are based on evidence, fundamentally redefine our relationship with health.
Digital therapeutics (DTx), however, still has a long way to go to reach universal scale. Here are some of the main barriers to DTx, and how they can overcome.
Stumbling Blocks
- FDA/Regulatory Approval. This is the most important obstacle. When this hurdle is overcome, the majority of other DTx obstacles are lowered.
- Patient Education. Many people don’t know DTx even exists. It is important to create awareness of these products and educate patients about their benefits.
- Separation of products. DTx providers must take steps to differentiate themselves from OTC products.
- Data collection. Data collection is a challenge for providers.
- Integration of traditional therapies DTx must keep Biopharma at their side, by integrating existing therapies and enhancing them rather than replacing them.
Regulatory Approval
FDA approval and other regulatory bodies are the key to success for any healthcare product. This is the only way to ensure not just physician support but also payers.
This pipeline is not only well-established, but also very clear. Digital therapeutics, as a new class of medicine does not have the same framework.
Since digital therapeutics are so diverse, they need to be assessed on an individual basis. This will be a challenge at least for the next few decades, but the road is becoming clearer. The growing number of FDA approved digital therapeutics has already created a system that will allow more products to follow suit.
In addition, regulatory bodies are increasingly inclined to evaluate digital therapies in ways that reflect the technologies rather than through the traditional trial process. The FDA has already entered pilot mode with its Digital Health Precertification Program. This model is in line with software iteration cycles that are the foundation of these technological breakthroughs and shows regulators willingness to create new models.
Patient Education
Due to COVID-19 more people now know about digital health technologies. But DTx companies still have a lot of work to do in order to get the word out about the benefits their products can offer.
How many parents of children with ADHD would be delighted to hear about a product such as Akili’s Endeavour. It’s the same in all DTx niches. It’s unfortunately a bit of a chicken-and-egg scenario.
Some companies wait to spread the word about their products until FDA approval, but it is easier once more people use the product.
The industry must work together to better raise awareness of the enormous potential DTx can deliver for patient health outcomes as well as their wallets.
Separating DTx from OTC Products
It is clear that OTC products with features similar to DTx have a place. Other wellness solutions, such as brain games, fitness apps and sleep trackers are also valuable in improving your health.
They can and should coexist in many ways. It is also possible that an OTC will receive regulatory approval. Happify, a digital solution for health that is headed in this direction, is an example. The app promotes mindfulness, and it has been downloaded by tens thousands. The app has been a huge success, but developers are aware that the product is only suited for a specific niche. They have therefore begun to pursue regulatory approval. This will allow them to gain not only the support of physicians, but also payers.
What is DTx? Even providers may find it difficult to answer. DTx suppliers whose products have been approved by the FDA or another agency must emphasize this for now.
Constant Therapy, a cognitive training app, is an example of a provider in the digital health industry who goes to great lengths for this. They have developed a cognitive therapy that has been clinically tested. It looks like any other “brain game” that you can find in the App store.
Constant Therapy is a company that has made it their mission to demonstrate what makes Constant Therapy’s solution unique and effective so that people can be assured they are receiving evidence-based treatment. Constant Therapy has not only published links to clinical studies, articles, and other information, but also blog posts, videos, and other media, to help them stand out. These steps should be taken by other DTx providers, as they will also help to spread awareness of DTx.
Data Collection
Data collection is essential to the success and growth of DTx. Data is used to determine the direction of therapy, product personalization, and how developers can improve their products.
We all know that the manual data entry is a very difficult task. They forget or don’t care.
DTx’s products must be equipped with automatic data collection. This is much easier said than accomplished. Apple Watches can easily track your heartbeat or steps, but obtaining blood glucose levels requires a different approach.
DTx providers are already addressing these challenges. Voice assistants are expected to fill this role in the near future, simplifying the data collection and reminding patients to update their health status. In the coming years, we will also see a rise in passive tracking technologies that will take the burden of data collection off the users.
Integrating Traditional Therapies
DTx projects rely on the direct support of biopharmaceutical companies. DTx promises therapeutic interventions “beyond pills”. DTx works specifically to fill treatment voids biopharmaceutics can’t. It also works well with other therapies.
Bluestar, for example, is a diabetes management app that has proven to be a very successful digital therapeutic product. Bluestar helps improve outcomes and adherence when used in conjunction with traditional insulin therapy.
This is a crucial way for DTx’s to start scaling across the healthcare industry. These integrated therapies help to drive the best patient outcomes, but they don’t disrupt the traditional business models and could lose the valuable support of Big Pharma.
The DTx Roadmap to Future
DTx has a tremendous potential for revolutionizing medicine, even though it is a market in its early stages. Big Pharma and Big IT support it, and they have access to capital. They also possess the spirit of innovation and are willing to invest. It has also already achieved important regulatory victories, creating the space needed to grow.
Now DTx providers need to double down on education. They must focus on the approval pathway and integrate with existing therapies. By doing this, DTx can empathize and build trust with key stakeholders to overcome obstacles and achieve the healthcare revolution we all hope for.
