Over recent decades, Moore’s Law predicting the doubling of microchip processing power potential every two years has driven the integration of transformative technologies across all aspects of our daily lives, from professional to leisure activities.
Devices and software are increasingly being used not just to gather data but also carry out treatment interventions (i.e. therapeutics) based on these data inputs.
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Meanwhile in the healthcare sector, Eroom’s Law (“Moore” spelled backwards) has described the increasing cost of pharmaceutical research and development. This has created a unique opportunity for low- and middle-income countries (LMICs) to leapfrog traditional biopharma and health infrastructure constraints.
In countries where geographic barriers separate rural communities from specialized medical services, and where health worker shortages further limit access to care, digital therapeutics offer a promising pathway toward universal health coverage.
Digital Therapeutics in Digital Health
Digital therapeutics are treatment interventions delivered by a digital technology, which could include a mobile application, computer-based software, or web-based tool.
Under the supervision of a healthcare provider, these can be paired with medications, medical devices, or other therapies to achieve preventive, promotive, or therapeutic outcomes. The digital therapeutic could be a standalone software (Software as a Medical Device) or integrated into medical device hardware (Software in a Medical Device).
While “digital health” is a broader term referring to the use of information and communications technologies across the health system, digital therapeutics are a subset of this field. They often use some combination of data guided user engagement, gamification, cognitive behavioral therapy, coaching, and biofeedback.
In the US, the first known digital therapeutic to receive clearance from the Food and Drug Administration (FDA) was WellDoc’s BlueStar application in 2010, a software application using real-time blood glucose data to support diabetes medication adherence and lifestyle modification. This application received the FDA 510(k) category of clearance, which is used for therapeutics with substantial equivalence to existing products on the market.
Pear Therapeutics reSET application, which treats substance use disorders, was the first to receive “De Novo” FDA clearance in 2017. De Novo clearance is meant for products which are the first of their kind and pose low- to moderate-risk. The award of this type of clearance paves the way for future 510(k) clearances for other products within its therapeutic category.
To illustrate the breadth of indications addressed by digital therapeutics currently on the market, see table 1 below:
| Name | Disorders Addressed |
| Akili Interactive | Attention-Deficit/Hyperactivity Disorder |
| Click Therapeutics | Mental health |
| Fitbit | Activity, sleep, heart health |
| Kaia Health | Musculoskeletal Pain |
| Luminopia | Neuro-visual disorders |
| Mahana Therapeutics | Irritable Bowel Syndrome |
| Noom | Weight management; GLP-1 companion programs |
| Omada Health | Diabetes, hypertension, weight, MSK, behavioral health |
| Oviva | Obesity, weight management |
| Teladoc Health | Diabetes, hypertension, weight management |
| Welldoc Bluestar | Diabetes, HTN, HF, weight, mental wellbeing & sleep |
Table 1: Examples of digital therapeutics by indication. Source.
Digital Therapeutics for LMIC Health Priorities
From their origins in high income settings, digital therapeutics are now proving their value across LMICs.
Mobile applications like MyBelle in Nigeria provide culturally appropriate education, monitoring, and care navigation in local languages for pregnant women, encouraging antenatal attendance, healthier habits, and early detection of conditions like preeclampsia.
For diabetes management, platforms like Zyla in India enable AI-guided, physician-supervised virtual care teams targeting reductions in HbA1c. As India faces one of the world’s largest burdens of diabetes, digital therapeutics offer an opportunity to achieve rapid scale and accelerate impact alongside expanded primary health coverage.
To address the global burden of tuberculosis, applications delivering video Directly Observed Therapy (vDOT) are able to uncouple the schedules of patients and providers using asynchronous, store and forward, treatment supervision.
Examples include miDOT, SureAdhere, and AiCure, which have been deployed across diverse country health system settings around the world. These technologies improve adherence by providing patients with treatment flexibility, privacy, and savings of both the travel costs and time associated with a traditional clinic visit.
| Name | Disorders Addressed |
| Afya pap | Diabetes & Hypertension |
| AiCure | Observing and assisting medication adherence |
| miDOT | vDOTS (for TB) |
| MyBelle | Maternal & Child Health |
| SureAdhere | vDOTS (for TB) |
| Wazi | Mental Health |
| Zyla | Diabetes |
Table 2: Examples of digital therapeutics in LMICs by indication
4 Challenges to Scale
Scaling digital therapeutics faces four major challenges: technology limitations, regulatory obstacles, reimbursement, and user uptake.
1. Technology Limitations
First, the therapeutic potential of digital technology platforms (i.e. software and devices) limits potential indications as compared to pharmaceuticals. Digital technologies may also demonstrate limitations when they are deployed across diverse populations, demonstrating algorithmic or other design related biases.
2. Regulator Obstacles
Regulatory obstacles further inhibit this sector in LMICs and high income settings alike. In countries where regulations do exist related to digital therapeutics, there remains significant variation across national frameworks.
Technology startups must overcome the lack of dedicated therapeutic evaluation methods for digital solutions and uncertainty around medico-legal liability exposure. In spaces where regulations have not caught up with the potential use cases, companies face significant regulatory risk, i.e. what is legal or unregulated today may become illegal tomorrow.
3. Reimbursement Challenges
Reimbursement is another major barrier for digital therapeutics. Demonstrating clinical effectiveness does not guarantee uptake by health systems when payors remain skeptical.
Take the example of Pear Therapeutics. After raising more than $400 million at a $1.6 billion valuation, it could not overcome limitations in securing reimbursement agreements. The company filed for bankruptcy in 2023.
4. User Uptake
Finally, for digital therapeutics to achieve scale, they must expand beyond initial users to reach the wider population.
Everett Rogers’s Technology Adoption Life Cycle highlights this as a challenge across innovation industries, where new products struggle to move past early adopters to the early majority. User concerns around data privacy and cybersecurity, particularly related to sensitive diagnoses like mental health conditions, can limit product viability.
Building trust, ease of use through human centered design, and stakeholder engagement are key drivers of growth. Patients, health workers, payors, regulators, and developers alike must be aligned for these products to grow beyond pilot initiatives.
Challenges to Success
In their study published earlier this year, Pfitzer, et al interviewed staff from seven different digital health therapeutic startups to identify factors linked to success.
Key themes included:
- a clear path to regulatory certification through validation of health impacts,
- a viable business model (e.g. reimbursement and revenue generation), and
- a sales and marketing strategy that raises consumer awareness.
These themes underscore the distinct challenges of scaling digital therapeutics. The obstacles contradict the initial vision that these products could take advantage of the “zero marginal cost” nature of other digital technologies, i.e. once developed, they could scale quickly with minimal additional effort needed per additional user.
The real world experience of scaling these therapeutics, as described via founder essays and peer reviewed perspectives, has proved to be more difficult than expected.
Because many products require a prescription and clinical supervision, scale is constrained by clinician time and interest. Traditional pharma-style marketing campaigns, accustomed to rolling out new pharmaceutical products, have not been as successful in promoting uptake of digital ones.
Deploying across fragmented health systems and negotiating multiple reimbursement agreements is time consuming with no guarantee of success. In practice, the resulting landscape for digital therapeutics appears less similar to a viral mobile game that makes a splashy entrée onto the app store, and more akin to a traditional pharmaceutical product.
Digital Therapeutics Do Have a Future
Despite these headwinds, digital therapeutics are projected to grow to a value of $82 billion by 2035. Advances in artificial intelligence, genomics, and regulatory pathways are widening the potential clinical scope to include oncology, neurological disorders, and rare diseases.
As smartphone and wearable devices become more affordable, digital therapeutics have the potential to deliver care across geographic, economic, and institutional barriers. Achieving this vision requires human-centered design that prioritizes equity, simplifies clinician workflows, and fosters genuine engagement among patients, providers, payors, and developers.
These applications need active partners, not passive users. Before this revolution can scale, it must first be evaluated, negotiated, and reimbursed.
Written by Dr. Biswas Shrestha and Dr. Amit Chandra, physicians and global health specialists.
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