Kelly Stanton, director of quality at Qualio, explains why she feels there is a need for an Operation Warp Speed style approach to digital therapeutics in the U.S.
The COVID-19 pandemic has exposed the incredible fragility of the modern world. Still, two developments brought hope during these trying times: the prospect of a vaccine against the virus and the adoption of remote care strategies to stay connected with patients.
While waiting for “Operation Warp Speed” to produce a safe and effective vaccine, providers turned to virtual care in droves. At the height of the pandemic, the industry saw a 63-fold increase in remote consults among Medicare patients and similar spikes in other patient populations. This shift was only possible because of significant regulatory flexibilities.
Without these regulatory changes, most providers would not have had access to the digital tools and technologies to effectively engage with their patients remotely. They would not have discovered the degree to which patients are willing and able to use apps and remote devices to manage their own health. And they might not now be such vocal advocates for additional ways to use breakthrough digital therapeutics to deliver even more efficient, convenient, and effective care.
As the pandemic pushes forward, how can we capitalise on this momentum and integrate digital therapeutics more deeply into the everyday lives of patients?
We can start by learning from the positive outcomes of Operation Warp Speed and developing our own version of this successful public-private partnership. By finding the balance point between speed to market and appropriate regulatory oversight, we can accelerate promising technologies, reduce administrative burdens, and strengthen our healthcare ecosystem to prepare for the new challenges to come.
Enhance collaboration between DTx developers and regulators
Digital therapeutics (DTx) is a broad class of software applications designed to deliver evidence-based healthcare prevention, management, or treatment services to users.
Digital therapeutics are different from the thousands of health apps available in major smartphone stores. Most downloadable apps offer wellness tools, patient education, or personal health monitoring services, but they cannot claim to treat a disease or offer trusted medical advice.
Digital tools that actively treat or prevent health conditions require significant testing and regulatory oversight to ensure patient safety and clinical effectiveness. At the moment, however, only a handful of digital therapeutics are approved by the FDA each year.
The FDA’s Digital Centre of Excellence is still evaluating the digital therapeutics market and designing regulatory guardrails for the emerging field. Unfortunately, that’s a slow and challenging process – and in the meantime, developers are left trying to navigate shifting rules and complete complex submissions with copious amounts of quality data and other important information.
As a result, many developers view the FDA as an obstacle to getting their products into the marketplace. But that shouldn’t be the case.
The FDA itself acknowledges that there are many opportunities to improve the digital therapeutics approval process. They are actively working on doing so, and continue to request industry input and involvement as they establish new guidelines.
Digital therapeutics developers must take them up on this offer. If we participate in the process, we can share actionable insights on what to retain from previous regulatory structures and what components we can discard in the future to enhance and streamline the approval pathway. Collaboration across the industry is essential for creating safer, more effective products and getting them to market faster.
Embracing lean thinking
One of the most notable things coming out of the pandemic is the shared realisation that working harder doesn’t equate to working smarter. As DTx companies look to forge ahead in 2022, they must take time to rethink critical business processes that are ripe for innovation.
This type of lean thinking is best exemplified by recent innovations in clinical trials that took place during the pandemic. No longer are we expecting patients to come into their doctor’s office for testing and data gathering as part of the clinical trial process. Instead, decentralized clinical trials are taking hold. The recent partnership between CVS Health and Medable is a perfect example of the type of lean, innovative thinking that DTx companies will need to get ahead.
DTx leaders need to use an Operation Warp Speed mentality and identify specific business processes that are ripe for change. While this can be a resource intensive and challenging change management process, the time spent upfront on rethinking the way things have always been done is precisely what will separate the leaders and the left behinds in DTx. But one note of caution. Quality must remain a focal point as part of this process of adopting lean thinking and best practices. Speed to market means little if your DTx ends up being recalled.
Actively collaborating in the regulatory process and taking an active role in driving lean thinking and innovation in processes that are long overdue for change will determine which DTx companies forge ahead in 2022 and which fall behind. If we can create an Operation Warp Speed for digital therapeutics, we will take a strong first step toward establishing a new paradigm where innovative digital tools support preventive care over reactive care.
