June 20, 2024

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5 Innovative Ways To Bring DHTs To Market Successfully

By Megan Coder and Smit Patel, Digital Medicine Society (DiMe)

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Digital health technologies (DHTs) offer enormous promise to address pressing and persistent healthcare access, equity, affordability, and patient outcome challenges. A critical step for DHTs that qualify as a medical device toward patient access is demonstrating safety and effectiveness through achieving the appropriate level of regulatory authorization from the FDA.

In 2023, the FDA authorized the highest number of novel medical devices in the Center for Devices and Radiological Health’s (CDRH) 40+ year history. However, regulatory authorization is only the first step on a medical device’s journey to reaching patients, caregivers, and clinicians. Once devices receive authorization, it takes an average of 5.7 years to establish nominal coverage. Long timelines delay patient access to novel DHTs, stifle the development of innovative technologies, and negatively impact DHT developers’ ability to survive in a competitive market. While a large number of companies have successfully received FDA market authorization for their innovative products, unfortunately to date, many still face obstacles to broad patient access. Despite promising advancements in reimbursement, M&As, and changing business models, many struggle to survive in today’s marketplace.

Opportunities To Advance Regulatory Alignment With Downstream Decision Makers

Last summer, the Digital Medicine Society (DiMe) convened a series of workshops and surveys to identify key opportunities for advancing digital health through regulatory action. The digital health industry regulatory needs assessment report highlighted (1) FDA alignment with downstream payer decision makers and (2) clear alternate pathways to market, especially for truly novel digital health products, as the top two opportunities to advance the field of digital health. The report demonstrates that, while regulatory success is necessary, it is insufficient for commercial success. Without downstream alignment between DHT developers, regulators, and payers, patients cannot access these important medical devices.

Strategies And Success Stories Of Bringing DHTs To Market

Real-world examples demonstrate how developers embarking on their path to market must balance navigating the regulatory pathway with optimizing opportunities for downstream patient access and commercial success. Key strategies behind the successful market entry of these products include:

  1. Diversify commercialization pathways for product market entry.

Given slow Congressional action on digital health reimbursement, digital health product reimbursements have not yet become mainstream for public and private payers in the U.S. With limited pathways to commercialization, companies like AppliedVR and JOGO are finding creative ways to deliver products to patients.

Following FDA authorization, AppliedVR worked with the Centers for Medicare & Medicaid Services (CMS) to include RelieVRx, an FDA-authorized virtual reality  treatment for chronic lower back pain, in the existing Medicare Part B benefit category for durable medical equipment (DME). In March of 2023, CMS established 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 engaged in frequent conversations with FDA about pathways and ways to navigate the evolving payment and coding landscape.

  1. Consider new models for AI/ML-enabled medical devices.

The prolific growth of innovative AI-products can pose unique regulatory challenges when balancing product safety and effectiveness with the iterative nature of AI-based software. Caption Health received the first FDA-authorized cardiac ultrasound AI software clearance under the FDA’s breakthrough program with a Predetermined Change Control Plan (PCCP). This program allows developers to make certain changes to an iterative product without new regulatory submissions, thus saving time and money.

  1. Move from an individual product to an integrated platform approach.

Following the FDA clearance of multiple condition-specific product solutions, Empatica developed a full-stack integrated condition-agnostic platform that could be deployed for both research or clinical care and would support integration with third-party algorithms. Conversations with FDA helped them evaluate their strategy to combine regulatory and business needs and pursue the best regulatory path to support patient care. In 2024, the U.S. market is trending toward connected care, and as companies develop regulatory and business strategies, adopting a platform approach can enable greater DHT use and integration.

  1. Innovate in markets that solve for underserved, high-patient needs.

It is hard to innovate in the pediatric market due to high development costs and limited commercial market size. Developing DHTs for children comes with anatomical and physiological differences from those of adults, requiring specialized design and testing for products to ensure compatibility and effectiveness. Despite these challenges, Gabi smartcare received priority market authorization with a waived application fee for introducing a product for pediatric use in the U.S. This allowed them to collaborate with 30+ children’s hospitals across the U.S.

  1. Pursue druglike evidence for digital health where necessary.

Click Therapeutics successfully navigated the FDA process through a methodology akin to that used for drug approval, demonstrating high evidence rigor and market innovation in their approach. This allowed them to utilize a novel commercial model to pair its digital therapeutic for patients with major depressive disorder with no reported treatment-related adverse events in the trial alongside a leading antidepressant medication.

Recent FDA Initiatives To Keep Pace With Industry

As the field of digital medicine continues to evolve, FDA is working to keep pace with industry, iterating on their regulatory approaches. To support developers at the forefront of innovation and simultaneously build out the regulatory infrastructure necessary for the digital era of healthcare, FDA has taken numerous measures including:

  • Building internal capacity: FDA’s Super Office provides a model designed to promote collaboration, ensure patient safety, urge legislative progress, and support patient access to high-quality, safe, effective, and innovative products.
  • Adopting a collaborative approach: FDA launched its Total Product Life Cycle Advisory program (TAP) pilot to de-risk the medical device “valley of death” and spur more investment in and rapid development of innovative medical devices that are critical to public health. To date, 60 products have been enrolled in TAP.
  • Promoting equity: FDA launched Home as a Health Care Hub to address patient needs by moving more care into the home setting.
  • Supporting therapy advancements: The agency is developing the Prescription Drug Use-Related Software regulatory framework for software functions associated with the use of a prescription drug or a prescription drug-led, drug-device combination product.
  • Enabling AI innovation: FDA is working on inter-agency divisions on AI/ML and, through May 2024, has authorized 882 AI/ML-enabled devices.
  • Focusing on security: FDA is working to ensure developers comply with cybersecurity of medical devices requirements.

DHTs have unlimited potential to advance health and improve lives, but developers’ ability to bring new products to market and realize their value is contingent on regulatory and downstream decision makers being able to keep up with the pace of innovation and enable patient access to safe and effective technologies. FDA has demonstrated its intent to support and now it’s time for industry to share learnings, leverage existing policies and practices, encourage public payers like CMS to keep stride, and work together to bring new innovations to the patients who need them.

About The Authors:

Megan Coder, PharmD, MBA, is vice president, product & policy, at the Digital Medicine Society (DiMe), where she leads a portfolio focused on digital health technology policy, product assessment, and real-world impact. Prior to her time with DiMe, Coder was the executive director and founder of the Digital Therapeutics Alliance (DTA). Through thought leadership, international standard development, and global policy collaborations, she led industry efforts to establish digital therapeutics (DTx) as a new category of medicine. Trained as a pharmacist, she graduated from the University of Wisconsin—Madison and completed an executive residency in association management & leadership with the American Pharmacists Association.

Smit J. Patel serves as the 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 is an advisory board member for Brown-Lifespan Center for Digital Health and serves on advisory committees for digital health programs at the Association of Community Cancer Centers (ACCC), American Pharmacists Association (APhA), and HealthXL. Patel earned his doctorate in pharmacy from The Ohio State University. He currently holds a faculty position for the Digital Health Innovation Certificate Program at the Brown University School of Professional Studies. Additionally, he is a Global Shaper at the World Economic Forum, a Forbes 30 under 30 scholar, a TEDx speaker, and MIT-Harvard Health Innovation alumnus.

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