New Resources Designed to Advance Commercial Success for Digital Health Technologies

Open-source tools will help developers generate evidence that meets the needs of all decision-makers through integrated evidence plans

, /PRNewswire/ -- Today, the Digital Medicine Society (DiMe), with support from Peterson Health Technology Institute (PHTI) and ZS Associates, along with other leading industry organizations, released resources to help digital health technologies navigate Integrated Evidence Plans (IEP). These new tools focus on helping DHT developers generate fit-for-purpose evidence that meets the needs of all decision-makers, positioning DHTs for commercial success.

During a time of evolving regulatory expectations, it's more important than ever for DHT developers to take a proactive, evidence-based approach to innovation. The IEP toolkit offers a structured, transparent framework to help innovators navigate evidentiary requirements, market access complexities, reduce risk, and accelerate commercial success—providing a clear path to broad adoption.

This project builds on the top priority identified in the 2023 Digital Health Industry Regulatory Needs Assessment: to align best practices between regulatory requirements and decision-making with downstream payers and purchasers.

"Even after gaining FDA authorization, many DHTs still struggle to achieve widespread adoption due to opaque evidentiary needs and misaligned strategies. Without meeting downstream stakeholders needs including payors, providers, health systems, and others, commercial success remains uncertain," said Smit Patel, Program Director, DiMe. "The resources launched today solve this by creating a coordinated and versatile strategy that satisfies stakeholders across the continuum, leading to faster time-to-market and greater adoption."

This work builds on DiMe's successful U.S. Digital Health Regulatory Pathways for DHTs and the Evidence DEFINED framework to advance the use of IEPs for developing DHTs. The new resources include:

1. IEP Toolkit, a comprehensive roadmap for building evidence plans that provides essential best practices, templates, checklists, and case examples.
2. A Stakeholder Map, listing decision-makers who influence the adoption of DHTs and outlining their specific needs for aligning efforts across the product lifecycle.
3. High-Quality Evidence Checklist, a comprehensive checklist for DHT developers to follow when generating high-quality evidence, ensuring they align with the evidentiary needs of the downstream decision makers.

"We're proud of our partnership with DiMe and a great cross-industry team to build unprecedented resources that will help all companies, both large and small, think holistically about evidence development for novel digital solutions," said Maurice Solomon, Principal, Digital & Connected Health, ZS. "This work provides a blueprint for navigating the time, cost, and effort required to generate the right evidence and proof-points to get new digital tools into the hands of clinicians and patients at scale."

DiMe is leading the charge on several important projects focused on leveraging digital measures for the safe and effective use of digital technologies to improve patients' lives. Join us as we focus on continuous glucose monitoring to improve market access for effective diabetes therapies and treatment pathways, and to define a core set of digital measures for common mental health disorders to advance the use of objective, scalable endpoints for assessing treatment effects.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

Media Contact: Carla English, [email protected]

SOURCE Digital Medicine Society (DiMe)