Digital therapeutics (DTx) represents a collection of technologies, products, and services across healthcare and wellness. More specifically, DTx delivers evidence-based therapeutic interventions that prevent, manage, or treat medical disorders and can either supplement or supplant existing treatments for a variety of diseases and conditions. DTx differs from diagnostics, telehealth, and other digital health products, as DTx products must be approved by regulatory entities. Proof of concept is at the core of their models, as DTx products not only have to be driven and backed by evidence but must also be able to prevent and/or manage a disease or disorder.
As COVID-19 proliferated across the globe, forever changing the way we interact in both physical and digital environments, combined with a growing mental health crisis and surging prevalence of chronic conditions around the world, the DTx space is now projected to reach $56 billion by 2025. DTx has the potential to disrupt traditional pharmaceutical markets, and big pharma and medical device companies must decide whether to embrace this technology or potentially lose market share to DTx startups in a rapidly expanding market.
What is DTx and How Does it Work?
The Digital Therapeutics Alliance (DTA) is the leading international organization on thought leadership in the DTx space, providing patients, clinicians, and policymakers with the necessary tools to evaluate and utilize DTx products — including ethics, best practices, and product categorization.3 According to the DTA, all products claiming to be a digital therapeutic must:
- Prevent, manage, or treat a medical disorder or disease;
- Produce a medical intervention that is driven by software;
- Incorporate design, manufacturing, and quality best practices;
- Engage end users in product development and usability processes;
- Incorporate patient privacy and security protections;
- Apply product deployment, management, and maintenance best practices;
- Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals;
- Be reviewed and cleared or certified by regulatory bodies as required to support claims of risk, efficacy, and intended use;
- Make claims appropriate to clinical evaluation and regulatory status; and
- Collect, analyze, and apply real-world evidence and/or product performance data.
