Commercializing Digital Therapeutic Solutions: Key Lessons Learned to Watch

Transforming a great idea into a Digital Therapeutics (DTx) app that works in healthcare’s complex ecosystem can be painstakingly difficult.

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.