The pandemic has set ablaze the white-hot market for Digital Therapeutics (DTx), which “deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders1.” In 2020, a digital research firm projected the global DTx market to hit nearly $9 billion by 2025; a year later, its 2025 DTx forecast had increased to $56 billion2.
One of the few bright spots of 2020 was how quickly and effectively healthcare providers embraced technology to remotely engage and manage patients, especially those with chronic conditions that account for the lion’s share of US healthcare spending. As a result, providers and payers are seeking more DTx solutions to improve patient care and management while enabling oversight between clinical visits. Pharma and device companies also are investing heavily in co-developing DTx companion solutions for their medicines and products, including apps for clinical research.
Though the fervor fueling this explosive growth is understandable, developers should recognize that DTx is not just another plug-and-play algorithm. In fact, its developmental process is strikingly similar to time-intensive pathways for new medicines. DTx solutions require clinical research and testing, regulatory approvals and specialized expertise to integrate the technology into clinical workflows and patients’ lives.
Transforming a great idea into a DTx app that works in healthcare’s complex ecosystem can be painstakingly difficult. Based on our 10 years of experience developing both a DTx platform (our diabetes connected-care platform hosts several DTx apps) and a DTx app for long-term insulin management, we want to share our learnings about the challenges associated with developing and commercializing DTx innovations.
The Big Picture
In practical terms, DTx solutions empower patients, clinicians and payers with intelligent, easily accessible and data-rich tools to address a wide range of conditions. They can be used independently or in concert with medications, devices, or other therapies and are especially effective for treating complex disease states that can benefit from constant monitoring and therapeutic adjustments. For example, pharma companies are pairing DTx with Remote Patient Monitoring (RPM) and Digital Companion (DC) tools to improve patient engagement, adherence and outcomes,
According to the Digital Therapeutics Alliance (DTA), the goal of DTx products for treating or managing a disease or improving a health function is to deliver therapeutic interventions based on clinical evidence with clinical endpoints used to support any product claims3.
Clinical Studies, Regulatory Oversight
As this statement indicates, DTx is worlds apart from the countless digital health apps flooding the market. Instead of just supporting wellness activities or encouraging patient behaviors or alerting physicians or patients of changes in a patient’s condition, DTx apps intervene in the care regimen. In many cases, this will involve automating decisions based on individual physicians’ specific clinical recommendations or using rules-based algorithms to replicate elements of established practice guidelines.
Numerous DTx apps are in development for the wildly popular insulin injector pens to direct diabetes patients to select dosing levels based on their CGM (continuous glucose monitor) or BGM (blood glucose monitor) data over the previous 12 hours. For example, an insulin dosage system can analyze a Type 2 diabetes patient’s fasting blood glucose levels and recommend dose adjustments based on a physician’s pre-configured treatment plan and/or published clinical guidelines. This frees the patient from having to manually enter their fasting glucose and can quickly and easily deliver optimal doses without involving the physician. Consistent, personalized dosing can help slow disease progression since fewer than 50% of patients on long-acting insulin are able to achieve their target glycemic outcomes4.
Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. The FDA designates DTx products as Software as Medical Device (SaMD), which, until recently, were considered Class I (low to moderate risk) devices. In 2018, however, the FDA authorized marketing for the first Class II (moderate to high risk) SaMD, a fully interoperable continuous glucose monitoring system5.
Companies planning to commercialize DTx products must be rigorously diligent in their preparations to conduct clinical trials and present scientific evidence. Based on an FDA guidance document on SaMD clinical evaluation, this evidence should demonstrate:
– A valid clinical association between your SaMD output, based on the inputs and algorithms selected, and your SaMD’s targeted clinical condition
– Your SaMD’s ability to correctly process input data to generate accurate, reliable, and precise output data
– The ability of your SaMD data to achieve your intended purpose in your target population in the context of clinical care6
For example, to gain FDA approval of an app for patients with Type 2 diabetes, a randomized clinical trial was conducted to compare an app-based self-titration tool with a paper-based titration tool combined with diabetes educator support. Although patients in both study groups showed higher insulin dose and significantly improved glycemic control after 16 weeks, the group with the DTx app demonstrated a greater proportion of self-monitored blood glucose (SMBG) readings between the target range of 70-180 mg/dL and fewer SMBG readings >250 mg/dL7.
Actualizing DTx Apps in Healthcare’s Complex Ecosystem
To guide and expedite DTx development, companies need to understand all the factors that will affect how well these solutions will be accepted and used in the real world. This starts by recognizing the various needs and concerns of the interconnected components that play a critical role in patient care and management, including physicians, clinicians, hospitals, payers, devices, information systems and, most importantly, the patients themselves.
Questions to ask during the development (or selection) of DTx solutions might include:
– What can we do to make them fit seamlessly into clinicians’ workflows and help them easily find the information they need?
– Are they compatible with the multiple apps and devices (e.g., fitness trackers or disease-specific monitoring devices) patients already use in their daily lives?
– Will the DTx be readily adopted and used by all segments of the patient population?
– Can data from the app be easily integrated in the EHR?
– What are payers’ specific data requirements?
– How effectively does the app engage patients in their own self-care and incentivize desired self-care behaviors?
An often overlooked and underestimated aspect of actualizing DTx is the influential role physicians play in facilitating their adoption and use. Simply put, patients trust their physicians and are much more likely to join disease management programs recommended by their doctors.
Therapeutic Alliances to Create a ‘Circle of Care’
DTx solutions usually work best when part of a collaborative, therapeutic alliance among the key participants involved in patient care and management. Ideally, these solutions will help connect patients, providers and data to create a “circle of care” to optimize health outcomes.
The right partnerships can facilitate and strengthen these connections while supporting the adoption and use of DTx apps on robust, interoperable platforms. When evaluating such platforms, DTx developers and users should consider:
– How easily clinics and care teams can access, share and gain insights from patient-generated data and other sources, including the patient’s EHR
– The richness and size of the real-world datasets
– How quickly such platforms can launch DTx apps and devices worldwide
– Their ability to integrate with multiple devices so that providers can choose the right device based on the patient’s insurance and/or personal needs and preferences
– Evidence indicating that other platform apps were able to achieve sustainable improvements in patients’ conditions
– The platform’s ability to scale and expand into adjacent conditions as needed
The opportunities for DTx solutions to automate patient care decisions are abundant. Here are key things we have learned, which hopefully can help DTx developers successfully commercialize their innovations and prosper in the fast-growing market.
– The connection between patients and physicians is where care happens and needs to be strengthened, not disintermediated.
– Since the FDA considers DTx a Class II SaMD device, the pathway to market authorization can be arduous and requires specialized expertise.
– A global strategy is essential to ensure DTx products meet various countries’ regulatory and reimbursement requirements.
– Never underestimate the complexity of the healthcare ecosystem and the interplay among stakeholders, especially payers. Market access can be just as challenging as DTx development.
– Gain a deep understanding of all the human behaviors (patients and providers) associated with your DTx solution.
– Since DTx addresses systemic problems in patient care and management, it is vitally important to get all stakeholders working together to solve them
About Zach Henderson, MBA
Zach Henderson is Chief Commercial Officer at Glooko, where he leads the company’s global growth and is responsible for all commercial efforts, including the company’s work with its key strategic partners and revenue generation initiatives. He came to Glooko from LexisNexis Health Care and Elsevier, where he served as VP of Strategy, Alliances, and Data Sourcing and was responsible for the creation and development of a strategic alliance program of go-to-market and enablement partners, the negotiation of strategic partnership deals, and the integration of new business acquisitions
About Komathi Stem, MS
Komathi Stem is a biomedical engineer and chief operating officer at Glooko, where she is leading the evolution and scaling of the connected care platform to meet the rising post-COVID19 market demand for telehealth and virtual trials. She has more than 25 years of experience spanning start-ups to global pharma/biotech companies across multiple therapeutic areas and phases for biologic and small molecule drugs. She has extensive experience in the use of real-world data from EHRs, connected devices, and mobile apps to execute virtual and/or decentralized clinical trials and support remote patient monitoring.
1. Digital Therapeutic Alliance website. Understanding DTx – Digital Therapeutics Alliance (dtxalliance.org) Accessed July 25, 2021.
2. Digital Therapeutics Report: Latest DTx market trends and companies in growing digital health sector. Insider Intelligence, July 29, 2021. Digital Therapeutics (DTx) Market in 2021: Companies & Trends (insiderintelligence.com) Accessed August 6, 2021.
3. DTx Product Categories, Digital Therapeutic Alliance. DTA_FS_DTx-Product-Categories_010521.pdf (dtxalliance.org) Accessed August 5, 2021.
4. García-Pérez LE, Alvarez M, Dilla T, Gil-Guillén V, Orozco-Beltrán D. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther. 2013;4(2):175-194. doi:10.1007/s13300-013-0034-y. Adherence to Therapies in Patients with Type 2 Diabetes (nih.gov) Accessed August 7, 2021.
5. FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices. FDA website, March 27, 2018. FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices | FDA Accessed August 27, 2021.
6. Software as a Medical Device (SAMD): Clinical Evaluation. Guidance for Industry and Food and Drug Administration Staff. FDA website, December 8, 2017. Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug Administration Staff (fda.gov) Accessed August 8, 2021.
7. 202-OR: Basal Insulin Digital Titration App vs. Enhanced Paper Titration Tool: A Randomized Control Study ATHENA PHILIS-TSIMIKAS, ADDIE L. FORTMANN, ALESSANDRA BASTIAN, ARATI KANCHI, RICARDO ABAD, TONG SHENG, LINDA PARKS, MICHAEL GREENFIELD and MARK A. CLEMENTS. Diabetes Jun 2020, 69 (Supplement
202-OR; DOI: 10.2337/db20-202-OR 202-OR: Basal Insulin Digital Titration App vs. Enhanced Paper Titration Tool: A Randomized Control Study | Diabetes (diabetesjournals.org) Accessed August 31, 2021.