New interactive tool, other resources help use regulatory strategy to drive successful business strategy for digital medical product development
The Digital Medicine Society (DiMe) announced free resources for medical product developers to optimize their regulatory strategy and 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, a tool for navigating U.S. regulatory pathways for digital health products - were developed as part of a DiMe's collaborative project, Digital Health Regulatory Pathways.
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 Digital Health Regulatory Pathway project kicked off in June 2022, with a DiMe survey of digital medicine stakeholders. It found that 25% of medical product developers didn't know whether their digital health product should be regulated. Of those surveyed who did know their product should be regulated, 75% reported not knowing the optimal regulatory pathway. The new resources announced today address these challenges by helping innovators understand the key differences between pathways and the commercial benefits to regulatory engagement and
"We believe these resources will help digital health innovators leverage new technologies to advance more accessible and equitable care," said Linda Peters, Vice President of Quality, Regulatory & Safety, Health at Google. "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."
Partners on this project are Abbott, Abbvie, Aetion, American Medical Association (AMA), Amgen, AstraZeneca, the Consumer Technology Association (CTA), the Digital Therapeutic Alliance (DTA), Genentech - a member of the Roche Group, Google, the Harvard-MIT Center for Regulatory Science, Janssen, Otsuka Pharmaceuticals, Rock Health, Sidekick Health, and Tidepool.
Reference: DiMe Launches Free Resources for Medical Product Developers to Better Navigate U.S. Regulations. BOSTON, March 1, 2023 /PRNewswire.