The Market Access Conundrum in Digital Health: Balancing Rapid, Robust Validation With Integrated Evidence Plans

ISSUE: The widespread adoption of digital health products (DHPs) is hindered by a lack of evidence supporting their clinical value, which is essential for their broad acceptance, commercial success, and improved patient care. However, while product developers have successfully pioneered new regulatory pathways, securing FDA acceptance, market access and the evidentiary needs of downstream decision-makers have been largely opaque. This results in early and substantial investments in evidence generation being overfitted to regulatory decision-makers, missing the opportunity for more efficient and effective studies that address the requirements of all decision-makers. Consequently, this increases the costs of evidence generation, delays broad adoption, frustrates potential buyers and end-users, and can even lead to commercial failures, as seen in some cases this year.

OVERVIEW: In the dynamic arena of digital health, a pivotal debate focuses on the optimal strategy for addressing the evidentiary needs of a diverse range of stakeholders and decision-makers — including payers, purchasers, clinicians, and patients — in the development and deployment of DHPs for broad acceptance. The proliferation of FDA-authorized DHPs has not resulted in broad patient access to their benefits nor commercial viability for many of their developers. The challenge lies in the fact that despite FDA authorization, many DHPs fail to achieve broad patient access or commercial viability. Regulatory acceptance, while necessary, is not sufficient for the success of DHP innovation. It does not guarantee that the benefits of healthcare digitization will impact health, healthcare, and health economics at a large scale. This panel will center around finding the balance with the right strategies, optimized commercial model, and case examples for finding fit-for-purpose strategies for making progress for broad access and acceptance of DHPs.