5 innovative ways to successfully bring DHT to the market

Authors: Megan Coder and Smit Patel, Society for Digital Medicine (DiMe)

Digital health technologies (DHTs) offer enormous opportunities to address pressing and persistent challenges related to healthcare access, equity, affordability and patient outcomes. A critical step for DHTs to qualify as a patient access medical device is to demonstrate safety and effectiveness by achieving the appropriate level of regulatory approvals from the FDA.

In 2023, the FDA approved the largest number of novel medical devices in the more than 40-year history of the Center for Devices and Radiological Health (CDRH). However, regulatory approval is only the first step in a medical device’s journey to reaching patients, caregivers and physicians. Once a device is authorized, it takes an average of 5.7 years to establish nominal range. Long time frames delay patient access to new DHTs, inhibit the development of innovative technologies, and negatively impact the ability of DHT developers to survive in a competitive market. While many companies have successfully received FDA marketing approval for their innovative products, unfortunately many still face barriers to broad patient access. Despite promising advances in reimbursement, mergers and acquisitions, and changing business models, many companies are struggling to survive in today’s marketplace.

Opportunities to better align regulations with decision-makers downstream

Last summer, the Society for Digital Medicine (DiMe) convened a series of workshops and surveys to identify key opportunities to improve digital health through regulatory action. The Digital Health Industry Regulatory Needs Assessment report highlights (1) FDA alignment with downstream payment decision makers and (2) clear alternative routes to market, particularly for truly novel digital health products, as the two most important growth opportunities in the field of digital health. The report shows that while regulatory success is necessary, it is not enough to achieve commercial success. Without further agreements between DHT developers, regulators and payers, patients will not have access to these important medical devices.

Strategies and success stories in bringing DHT to market

Real-life examples demonstrate how developers entering the market must balance navigating the regulatory path with optimizing opportunities for downstream patient access and commercial success. The key strategies behind the successful launch of these products include:

Diversify your product’s commercialization paths to market.

Given Congress’ slow action on digital health reimbursement, digital health reimbursement has not yet become mainstream for U.S. public and private payers. With limited commercialization paths, companies like AppliedVR and JOGO are finding creative ways to bring products to patients.

Following FDA approval, AppliedVR worked with the Centers for Medicare and Medicaid Services (CMS) to include RelieVRx, an FDA-approved virtual reality-based treatment for chronic low back pain, in the existing Medicare Part B benefit category for durable medical equipment (DME). In March 2023, CMS assigned the HCPCS Level II code E1905, expanding access to the therapy. Similarly, JOGO-related provider services are reimbursed by Medicare and payers under four CPT codes.

Both of these companies have had frequent conversations with the FDA about paths and ways to navigate the changing payment and coding landscape.

To consider new models Down AI/ML-enabled medical devices.

The prolific development of innovative AI-based products can create unique regulatory challenges in balancing product safety and effectiveness with the iterative nature of AI-based software. Caption Health received the first approval for FDA-cleared artificial intelligence software for cardiac ultrasound under the FDA’s groundbreaking Pre-Planned Change Control Plan (PCCP) program. This program allows developers to make certain changes to the iterative product without having to submit new regulatory applications, thereby saving time and money.

Move fromn individual product to an integrated platform approach.

Following FDA approval of multiple disease-specific product solutions, Empatica has developed a comprehensive, integrated, condition-agnostic platform that can be deployed in both research and clinical care and supports integration with third-party algorithms. Discussions with the FDA helped them evaluate their strategy for combining regulatory and business needs and selecting the best regulatory path to support patient care. In 2024, the U.S. market will move toward connected care, and as companies develop regulatory and business strategies, adopting a platform approach may enable greater use and integration of DHT.

Innovate in markets that meet underserved patient needs.

It is difficult to innovate in the pediatric market due to high development costs and limited commercial market size. Developing DHT for children involves anatomical and physiological differences from adults, requiring specialized product design and testing to ensure compatibility and effectiveness. Despite these challenges, Gabi smartcare received priority marketing approval with a filing fee waiver to introduce the product to children in the US. This has enabled collaboration with over 30 children’s hospitals across the United States.

Search for a cure–as needed, such as evidence for digital health.

Click Therapeutics successfully navigated the FDA process using a methodology similar to that used for drug approval, demonstrating a rigorous evidentiary approach and market innovation. This enabled them to use a novel commercial model to combine a digital medicine for patients with major depressive disorder, for whom no treatment-related adverse events were reported in the study, with a leading antidepressant.

The FDA’s latest initiatives to keep pace with the industry

As the field of digital medicine continues to evolve, the FDA strives to keep pace with the industry by constantly changing its regulatory approach. To support developers at the forefront of innovation while building the regulatory infrastructure necessary for the digital era of health care, FDA has taken numerous actions, including:

Building internal capacity: : The FDA Super Office provides a model to promote collaboration, ensure patient safety, and urge legislation progressand supporting patient access to high-quality, safe, effective and innovative products.

Adopting a collaborative approach: : The FDA has launched a Total Lifecycle of Product (TAP) Advisory Program pilot to reduce risks associated with the “valley of death” for medical devices and to spur greater investment and rapid development of innovative medical devices that are critical to public health. So far, 60 products have been registered in TAP.

Promoting equality: The FDA launched Home as a Health Care Center to meet patient needs by bringing more care home.

Supporting therapy progress: The Agency is developing a regulatory framework for prescription drug use software for software functions related to the use of a prescription drug or a product that is a combination of a prescription drug and a device.

Enabling AI innovation: : The FDA is working on interagency AI/ML divisions and has authorized 882 AI/ML-enabled devices by May 2024.

Focusing on safety: The FDA is working to ensure that developers meet cybersecurity requirements for medical devices.

DHTs have unlimited potential to improve health and lives, but the ability of their developers to bring new products to market and realize their value depends on whether regulatory and decision-makers downstream can keep up with the pace of innovation and enable patients to access safe and secure effective technologies. FDA has shown a willingness to support, and now is the time for industry to share lessons learned, build on existing policies and practices, encourage public payers like CMS to keep pace, and work together to deliver new innovations to patients who need them.

About the authors:

Megan Coder, PharmD, MBA, is vice president of product and policy at the Digital Medicine Society (DiMe), where she leads a portfolio focused on digital health technology policy, product evaluation, and real-world impact. Prior to joining DiMe, Coder was the Executive Director and Founder of the Digital Therapeutics Alliance (DTA). Through thought leadership, the development of international standards, and global policy collaboration, she has led the industry’s efforts to establish digital therapeutics (DTx) as a new category of medicine. A pharmacist by training, she graduated from the University of Wisconsin at Madison and completed an executive internship in association management and leadership with the American Pharmacists Association.

Smit J. Patel is Associate Program Director at the Digital Medicine Society (DiMe). His work focuses on applied approaches to the safe, effective, ethical and equitable use of digital technologies to advance clinical research, clinical care and public health. He serves on the advisory board of the Brown-Lifespan Center for Digital Health and serves on the digital health advisory committees of the Association of Community Cancer Centers (ACCC), the American Pharmacists Association (APhA), and HealthXL. Patel earned his doctorate in pharmacy from The Ohio State University. He currently holds a faculty position in the Digital Health Innovation Certificate Program at Brown University School of Professional Studies. Additionally, he is a Global Shaper at the World Economic Forum, a Forbes 30 Under 30 Fellow, a TEDx speaker, and an MIT-Harvard Health Innovation graduate.