Twists and Turns on the Winding Road of Digital Therapeutics: From Product Development to Approval to Access

Clinical Researcher—April 2023 (Volume 37, Issue 2)


Joel Morse, MBA


The pandemic has produced a series of seismic shifts across broad aspects of our lives, upending so much of what we had previously taken for granted. One example in healthcare is the sudden growth of digital therapeutics (DTx). DTx revenue in the U.S. is expected to reach $11.2 billion by 2030, while the global DTx market is projected to reach $56 billion in just two year (up from a forecast of $9 billion). Much of this growth can be traced back to the start of the pandemic, when the U.S. Food and Drug Administration (FDA) fast-tracked several DTx products to provide options for an increased number of patients with anxiety and depression at a time when traditional, in-person treatment methods were less available. In April 2021, too, the FDA loosened regulations surrounding approval of digital mental health tools to hasten their time to market.

Facing Challenges and Making an Impact

Today, the uses of DTx have expanded beyond mental health and their benefits are making a lasting impact across therapeutic areas, demographics, and pandemic limitations. Innovation across the DTx sector represents a critical new frontier for healthcare and an important opportunity to provide patients with a new kind of modern care. Further, as more of Generation Z enters the healthcare marketplace, these progressive approaches can expect to be welcomed with open arms. For a generation that often conducts much of its daily activity on smartphones and puts a high premium on convenience, healthcare companies that prioritize digital and embrace innovation will be more likely to see success.

Unfortunately, however, innovations relating to the commercialization of DTx have lagged those of the digital products themselves. Instead of coming to market with relative ease, many DTx have been mired in processes that were originally designed for more traditional therapeutics, such as drugs, and ill-suited for the products that are being developed by DTx companies.

“One of the exciting things about new technology as well as one of the challenges is that it really opens up new ways to develop products and then to commercialize them,” said Mike Rosenbluth, PhD, CEO at Swing Therapeutics, a DTx company founded in 2019. “The question we need to ask is how we adapt those processes for the new intervention. A lot of the processes of developing a drug are not relevant for what we’re doing in DTx.”

Thankfully, there are early signs of an evolution taking place in the development and commercialization of DTx, starting with the utilization of decentralized clinical trials (DCTs). DCTs saw a major uptick when COVID-19 struck, and sponsors had no other choice but to conduct their studies remotely. Even as pandemic restrictions lifted, the benefits of DCTs remained. For instance, hybrid and decentralized trials improve patient enrollment both in speed and in diversity by allowing sponsors to target patients without geographic limitations. Well-crafted digital engagement can reach potential participants where they regularly engage with content, capturing their interest and seamlessly bringing them into the vetting process. As a result, DCTs are often more effective at obtaining highly engaged participants that better represent the patient population than the traditional, brick-and-mortar trials.

DTx in Development

Swing Therapeutics is trialing two DTx products for the treatment of fibromyalgia, a chronic pain condition. “We’re working to expand access to clinically validated treatments to help patients when and where they need it,” explained Rosenbluth. “Right now, there are over 10 million people in the U.S. with fibromyalgia yet only about 5% have access to behavior therapies, so we are working to get this product out to all patients in need.”

Since the therapeutics being studied are digital, a decentralized trial is a natural fit. Fundamentally, a DTx is software rather than a pill or injectable, so there is no physical distribution of medicines. There are no physical logistics—no shipping, storing, chain of control, cold storage, or biohazards, plus endpoints can be captured within the DTx application itself, making DCTs ideally suited for DTx studies whether seeking regulatory approval or consumer and payer confidence. Further, because a DTx is also the data collection device, manufacturers often save costs from not needing extra technologies like an electronic patient-recorded outcome to capture data in a clinical trial. DTx trials also benefit from the many other documented advantages of a DCT, including those related to patient recruitment and enrollment.

In the Swing study, for example, the company leveraged a virtual site and was able to recruit on average 10 times the number of enrolled participants vs. those recruited from each of the study’s 22 other traditional sites that started recruiting at the same time. Without geographic restrictions, the virtual site could recruit nationwide, and the convenience of a decentralized trial incentivized more patients to enroll and participate in the comfort of their own homes, rather than in traditional clinical settings outside their comfort zone.

Concerns that the lack of face-to-face contact puts virtual sites at a disadvantage seem to be unfounded, based on the Swing study. “Actually, I would say that the [DCT patients have] been more engaged in terms of their participation than [those at] other sites in our study,” Rosenbluth said.

There is also the added benefit of reaching participants who might be new to the clinical study process, and a better representation of the population who might benefit from the new therapeutic. “In a lot of clinical trials, there is a database where you can find a narrow set of people who are active trial participants rather than someone who might be more representative of the overall population and participating for the first time,” added Rosenbluth.

Aiming for Approval and Beyond

Yet even with these positive developments, the overall processes required to commercialize DTx products remains frustrating, and gaining FDA approval, an already arduous process, is hardly the final hurdle toward achieving success. Instead, it is often just the beginning; DTx companies are then faced with a series of potentially crippling obstacles, from the battle for visibility and market access, to tackling payer- and reimbursement-related issues. Companies also face systemic institutional challenges that include steep learning curves and a lack of awareness from many healthcare providers, who often have entrenched practices about the traditional therapies that they prescribe to their patients.

A traditional pharmaceutical company might spend between $200 million and $300 million to launch a new product, bolstering it with expensive initiatives such as wide-ranging patient support programs, enormous sales and marketing teams, and comprehensive advertising strategies. For the vast majority of DTx companies, such elaborate and expensive product launches are simply not possible. As a result, innovative therapies that might have already cost millions of dollars to research and develop often never successfully reach their markets. This is an unfortunate and unnecessary failure that ultimately leaves patients with fewer options.

For DTx companies to be profitable, or even sustainable, the path to commercialization must be altered and streamlined. DTx companies can help themselves by providing strong, evidence-based data on the efficacy of their therapeutics as well as by developing innovative and less costly ways of educating and enabling physicians to prescribe digital therapeutics and get reimbursed. “We’re committed to evidence development and demonstrating that our products are clinically effective,” Rosenbluth said. “The industry needs to build on a solid foundation of evidence so that digital therapies can be adopted as standard of care.”

Paving the Way for Access

Swing’s cognitive behavioral therapy mobile application, known as Stanza, is commercially available under the FDA’s Enforcement Policy for Digital Health Devices. In addition to being available by prescription, Stanza is available through Swing Care™, an affiliated, physician-owned telemedicine clinic established by Swing Therapeutics to enable broader access to its product and place it in the context of a holistic care pathway. “We are working to find patient-centered ways to provide widespread access to our product and the holistic care patients need. We expect to expand Swing Care to more areas of the country in 2023,” concluded Rosenbluth.

The various pivots that were necessitated by the pandemic over the last few years offer a clear road map for how we can begin to take innovative approaches toward leveling the playing field of healthcare—from developing new therapeutics to ensuring equitable market access. Decentralized approaches and new technologies are the lynchpin, but require close collaboration with regulators, physicians, sponsors, payers, and patients. Without taking bold steps now, we risk potentially muting the impact of important new therapeutics and preventing critical care from reaching those who need it the most.

Joel Morse

Joel Morse, MBA, ( is Founder and CEO of Curavit, a virtual contract research organization that designs and executes decentralized clinical trials. Previously, he founded C3i, a business process outsourcing healthcare provider.