The use of digital therapeutics (DTx) is on the rise. Fueled by shifting models of care as a result of the coronavirus pandemic, the DTx market is expected to reach $10.62 billion by 2025. While DTx offer unique opportunities within the life science product industry, the rapid evolution of these technologies pose numerous regulatory challenges and guidance remains in flux. Despite these challenges, tech companies – including “The Big 5” of Google, Amazon, Meta, Apple, and Microsoft – are shifting focus to healthcare and accelerating innovation in the health tech field. With research and development advancing rapidly, sponsors and biopharmaceutical, medical device, and diagnostic companies, as well as organizations in the tech industry, are well-positioned to play a key role in shaping regulations while they are still being defined.
From a regulatory point of view, digital therapies are considered within the Software as a Medical Device (SaMD) category. A medical device is defined as “a software that is used, alone or in combination, for medical purposes but that does not act in the human body through pharmacological, immunological or metabolic ways.”
Although FDA has published some guidance documents, the DTx landscape remains dynamic.
Since digital therapies are non-invasive, the collection of safety data and burden of adverse events may be less cumbersome in DTx trials. However, the regulatory process for DTx and device trials pose unique challenges as well. Although these trials may be smaller than drug trials, diverse endpoints require unique approaches to study blinding, randomization, and control group set up.
SaMD products also present a unique challenge when it comes to regulation. Although FDA has published some guidances, the landscape remains dynamic. As the FDA guidance adapts to the speed of technology, the parameters of regulation and enforcement are not yet clearly established. The cadence of the FDA’s traditional regulatory approach is seemingly incongruent with the agile, iterative, and dynamic nature of software development.
The FDA approach is modernizing to adapt itself in order to properly evaluate and regulate SaMD products. However, as N.A Patel and A.J. Butte noted in their 2020 article, Characteristics and Challenges of the Clinical Pipeline of Digital Therapeutics, “a dedicated FDA regulatory framework for software-as-a-medical-device (SaMD) products remains in flux.” In 2017, nine companies joined the FDA’s Digital Health Software Precertification Pilot Program to help the FDA build, revise, and assess a new framework to provide a reasonable assurance of safety and effectiveness throughout the total product lifecycle of digital health software. Currently, all products that require clearance or approval are proceeding through existing regulatory processes. Simultaneously, the agency is internally testing different approaches through its pilot program that may facilitate more streamlined development and review of digital health technology products in the years to come.
Amidst the shifting landscape, a window of opportunity currently exists, particularly for early adopters, for new ideas and approaches. Sponsors and companies operating in the DTx sphere should adhere to existing guidances, but also recognize the changing conditions of DTx regulation. DTx companies should be unafraid to present new ideas and new approaches as guidance is developed with the FDA, and work with an experienced advisory partner to create their product development strategy, navigate FDA filings, and help mitigate risk.
Pearl Pathways is uniquely equipped to execute innovative go-to-market strategies for digital therapeutics. We understand the nuances that differentiate DTx from other therapeutic products. The seasoned experience and size of our team results in regulatory strategies, quality systems, and clinical development programs that are highly specialized for each individual product. Contact us today to start a conversation.