“The digital health industry is a heterogeneous, innovative, and dynamic sector. More importantly, it is continuously changing. Regulatory processes aren’t the limiting factor for digital innovation. Rather an optimal regulatory strategy is a critical part of successful product and business strategy.”

“Across the ecosystem, there is confusion and apprehension about the regulation of health technology products. The RegPath tool is unique because it provides a clear roadmap for innovators to successfully navigate the complex regulatory landscape in the U.S.”

“Digital therapeutics (DTx) use software to directly treat, manage, and prevent diseases, and are therefore subject to regulatory oversight to support product claims of risk, efficacy, and intended use. Over the last ten years, FDA’s CDRH division has diligently worked with manufacturers to assess and validate DTx products. These new resources – developed in partnership between FDA and industry leaders – provide further clarity on these critical regulatory pathways.”

“We believe these resources will help digital health innovators leverage new technologies to advance more accessible and equitable care. We’re proud to have worked with DiMe and other leading digital health innovators to develop unprecedented resources that can support the innovation ecosystem, speed commercial success, and create more comfort for end users.”

“With the increasing role of software-based medical products, they are becoming ubiquitous and an important part of the fabric of technological advancements in healthcare. As a leader in bringing digital health products [particularly Software as a Medical Device (SaMD)] into a traditional drug-focused life sciences industry, it is more important an ever to collaborate and showcase SaMD development and its regulatory implications. Having various types of tools like the ones by DiMe’s RegPath will not only foster innovation in the field of SaMD, but will help thrive!”

“We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers. As we anticipate a tightening of funding for digital innovators, the importance of selecting optimal regulatory pathways for individual products and product portfolios becomes critically important to ensure market access, trust, and adoption.”