DiMe Launches Resources to Boost Commercial Success of Digital Health Technologies
BOSTON, March 18, 2025 – The Digital Medicine Society (DiMe), in collaboration with the Peterson Health Technology Institute (PHTI), ZS Associates, and other industry leaders, has unveiled new resources designed to assist digital health technology (DHT) developers in navigating Integrated Evidence Plans (IEP).
These open-source tools aim to help DHT developers generate robust, fit-for-purpose evidence that aligns with the requirements of various decision-makers, thereby increasing the likelihood of commercial success. This initiative comes at a crucial time, with evolving regulatory demands, emphasizing the need for DHT developers to adopt a proactive, evidence-based approach to innovation.
The IEP toolkit provides a structured and transparent framework aimed at simplifying the navigation of evidentiary requirements and market access complexities. It helps to reduce risk and speed up the commercialization process, ultimately paving the way for wider adoption.
This project addresses a key priority identified in the 2023 Digital Health Industry Regulatory Needs Assessment: to streamline best practices between regulatory requirements, decision-making, and the needs of downstream payers and purchasers.
“Even after receiving FDA authorization, many DHTs face challenges in achieving widespread adoption due to unclear evidentiary needs and strategy misalignments. Commercial success remains uncertain without addressing the needs of downstream stakeholders, including payers, providers, and health systems,” said Smit Patel, Program Director at DiMe.
“The resources launched today address this by creating a coordinated and flexible strategy that meets the needs of stakeholders across the board, leading to a faster time-to-market and increased adoption.”
This work follows DiMe’s work on U.S. Digital Health Regulatory Pathways for DHTs and the Evidence DEFINED framework to promote the use of IEPs in DHT development.
The new resources include:
- IEP Toolkit: A detailed roadmap for developing evidence plans, featuring best practices, templates, checklists, and case examples.
- Stakeholder Map: A guide that identifies decision-makers influencing DHT adoption and their specific evidence requirements throughout the product lifecycle.
- High-Quality Evidence Checklist: A comprehensive checklist for DHT developers to ensure their evidence generation aligns with the needs of decision-makers.
“We are proud of our partnership with DiMe and a great cross-industry team to build unprecedented resources that will help all companies, big and small, develop evidence 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 currently leading several important projects that focus on digital measures for the safe and effective use of technologies to improve patient care. These include initiatives focused on continuous glucose monitoring to expand market access for effective diabetes therapies and treatments and also on defining digital measures for common mental health disorders. This aims to advance the use of objective endpoints in assessing treatment effectiveness.
About the Digital Medicine Society
DiMe is a global non-profit organization and professional home for the digital medicine community. DiMe focuses on solving the most pressing digital medicine challenges by developing clinical-quality resources on a quick timeline and sharing these insights and knowledge via open sources and educational programs.
