The Center collaborates with industry and academic partners to jointly develop regulatory science resources that are shared in the public domain. Examples of such collaborations are highlighted below.
Digital Health Regulatory Pathways
CRS contributed to an exciting industry collaboration led by the Digital Medicine Society (DiMe) to develop free resources to help digital product developers and founders optimize their regulatory strategy to drive the development of high-quality, trustworthy digital health products that best meet their commercial goals and the needs of patients. The resources – including U.S. RegPath, the world’s first tool for navigating U.S. regulatory pathways for digital health products – were developed as part of a DiMe collaborative project, Digital Health Regulatory Pathways.
“Digital health solutions offer enormous promise to address some of the most pressing and persistent challenges in healthcare but to fully realize the benefits of novel digital offerings, concomitant innovation in regulatory science and education for a new group of health technology leaders is necessary. Dr. Ariel Stern and CRS played an integral role in the development of these new, action-oriented resources,” said Smit Patel, Associate Director for DiMe.
A survey of digital medicine stakeholders in 2022 found that 25% of medical product developers didn’t know whether their digital health products should be regulated. Of those surveyed who did know their product should be regulated, 75% reported not knowing the optimal regulatory pathway.
A fit-for-purpose regulatory strategy that includes a bespoke timeline and approach to if, when, and whether to seek regulatory oversight offers end users, patients, and clinicians confidence about the tools and products they are using. It can also improve market access, support payment strategies, and optimize the impact on patient care and outcomes. Finding ways to help innovators navigate regulations and incorporate a robust regulatory strategy into their business plans is critical to addressing some of the most pressing and persistent challenges in healthcare.
The new resources became available March 1, 2023 and can be accessed for free on the DiMe website here.