One of the largest and most rapidly expanding segments of medical technology today, digital therapeutics are set to revolutionize healthcare as we know it, tremendously increasing access to high-quality treatment while vastly widening the scope of clinicians' ability to provide for their patients. Though personal fitness devices and health applications have cluttered the consumer market and muddied the waters of digital healthcare for many years, DTx therapies have emerged as groundbreaking solutions to some of the medical field's most pressing demands; while satisfying patients' growing desires for more personalized, comprehensive healthcare, they have stepped forward to lessen the load on providers struggling with overburdened systems and insufficient treatment capabilities.
Payers and regulators, too, have recognized the power and potential of digital therapeutics, increasingly adopting pay-for-performance and value-based care models that allow for novel contracting and commercialization schemes directly feeding DTx innovation. Things like performance-based roll-out scenarios and provider-piloted trials enable unprecedented data collection, leading to the generation of feedback loops continuously fueling advancement. Indeed, the healthcare marketplace may be more conducive to innovation today than ever.
Challenges and Approval
Still, digital therapeutics face unique challenges both during development and when seeking regulatory approval, including overcoming the skepticism of patients and providers who, as consumers, have for decades been bombarded with generic health apps espousing unsubstantiated claims and producing no verifiable results. To overcome this stigma, upcoming DTx therapies must be not only of exceptionally high quality but meet a high burden of proof with documented outcomes to verify their efficacy and encourage adoption, particularly among physicians, who are key gatekeepers in the arena. Further, these cutting-edge products must contend with still-developing regulatory pathways that are often vaguely defined and vary from one global market to the next.
Fortunately, the FDA has taken steps to expedite the digital therapeutics approval process and adapt the regulatory procedure to better suit the changing model of healthcare that DTx represents. The Breakthrough Devices Program, created as part of the 21st Century Cures Act, optimized regulatory procedures for new technologies aimed at unmet and poorly met medical needs, providing a needed modernization to requirements that created numerous innovative opportunities. Yet, it was insufficient to address the FDA's most pressing question: how can a platform be appropriately regulated when constantly evolving?
For now, their relatively simple answer is to scrutinize the developer instead. Recognizing the impracticality of requiring individual approval for every new version of a software product, under the Digital Health Software Precertification Program, the FDA evaluates organizations' infrastructure and established quality processes, providing blanket approval to the software of companies compliant with standards, eliminating the need for constantly repeated approval cycles. With this, developers can move along with new device iterations far more rapidly and freely than the traditional pathways allow.
Used in the prevention, management, and treatment of a wide range of conditions spanning mind and body, digital therapeutics are high-quality software products that employ evidence-based methods to simplify and enhance the management of symptoms and the execution of care. Distinguished from commercial personal health devices by their strong scientific backing, DTx therapies are prescribed by medical professionals, deployed as part of established treatment plans, and often subject to regulatory oversight the same as any other medical device. When used in conjunction with medications, devices, and other types of therapy, these applications promote safety, efficacy, and compliance while vastly expanding providers' diagnostic capabilities, generating superior outcomes, and enabling more effective preventative care. Used independently, they may even come in lieu of pharmacological interventions altogether; some have shown promise in mental health and pain management applications as viable alternatives to medication, while others have cropped up as novel treatments to otherwise unaddressed conditions, such as tinnitus.
Whether employed alongside or independently of more conventional treatment methods, DTx therapies:
- Usually involve some form of behavioral or psychotherapy.
- Integrate directly with electronic prescribing, dispensing, and medical record-keeping platforms.
- May be paired with devices, sensors, and other medical wearables.
- Demonstrate measurable outcomes.
- Can be prescribed by clinicians and covered by insurance providers.
- Generate data creating a feedback loop for the continual improvement of patient care.
Classified according to their relationship to traditional treatment methods, therapeutics under the DTX umbrella generally fall into one of three categories: standalone, augmented, or complementary.
Standalone DTX applications serve to deliver therapeutic interventions independent of any alternative treatments digitally; though they may be prescribed alongside other methods, they do not rely on them for efficacy and, in some cases, may even be enough to supplant them entirely. Capable of addressing a vast array of conditions, they are currently most prevalent in mental health applications.
Conversely, augmented DTX applications deploy digital therapies alongside prescribed pharmacological interventions to bolster existing treatments' effectiveness and improve management. Helpful in enhancing outcomes in complex, non-linear care plans, augmentative digital medicines are currently most often prescribed to treat chronic conditions such as diabetes.
Complementary DTX applications are also used with conventional treatments, providing digital therapies designed to complement existing interventions by improving patients' capacity for self-management and care. Rather than augmenting a particular treatment or course thereof, complementary applications take a more holistic approach by addressing conditions along with their relevant health factors, influencing behavior to create more favorable conditions for ideal treatment outcomes. As such, they can be most commonly found treating conditions heavily influenced by lifestyle, such as obesity and hypertension.
Whether aimed at supporting or supplanting traditional pharmacological interventions, DTx therapies are invaluable modern-day solutions to age-old medical problems, improving access and quality across the field. While this fact has, for the most part, been recognized by industry stakeholders and regulators, it remains that the individual digital therapy product has several more hoops to jump through to reach commercialization and adoption than the average medical device or application.
To hear more about DTx solutions, the questions they pose to regulators, and how developers can navigate them, visit the MIDI Innovation Vault.