Digital Medicine Society Report Benchmarks Industry Needs for Regulatory Science and Policy Innovation

Industry leaders align on recommendations for FDA strategic initiatives to support continued US leadership in digital health product innovation

BOSTON, Aug. 29, 2023 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) released findings from a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers. 86 industry experts from 66 organizations spanning the digital health product development market participated in a series of three workshops and an industry benchmarking survey. The resulting report has been shared with the Food and Drug Administration's (FDA) Digital Health Center of Excellence in support of their commitment to medical device innovation to protect and promote public health.

To date, FDA's Center for Devices and Radiological Health (CDRH), which houses the Digital Health Center of Excellence, has released 24 guidance documents with digital health content. But the pace of digital health innovation is relentless and accelerating. Under exciting new leadership from an industry veteran, the Digital Health Center of Excellence is optimally positioned to embrace the promise of digital medical products to help address some of the most pressing and persistent challenges in healthcare. Regulatory strategies that are fit-for-purpose for the digital era have the potential to promote high-value innovation that improves health outcomes, equity, and economics, while ensuring that the U.S. is the home to the leading digital health innovation economy in the world.

DiMe's report outlines the top industry needs to provide clear direction on where regulatory advancements can have the greatest impact.

"We were proud to host leading digital health product innovators from across all sectors of the industry to benchmark their needs for regulatory advancement to improve lives," said Jennifer Goldsack, CEO of DiMe. "Digital health industry innovators are committed to providing the necessary evidence that demonstrate that cutting edge technologies are safe and effective for patients. They are seeking clarity from and collaboration with their FDA counterparts and are confident in the Agency's positioning and commitment to drive global best practice in digital health product innovation and ensure that the U.S. market remains at the forefront of medical product regulation in the digital era of health."

The industry identified 10 opportunities for the FDA to advance regulatory science and policy to support the product, portfolio, and organizational goals of the digital health industry, with the following three being the highest priority:

1. FDA alignment with downstream payer decision makers
2. Clear alternate pathways to market, especially for truly novel digital health products
3. Better communication and coordination between FDA divisions, cross-center clarity, and consistency in interpretations

"Incorporating industry-wide needs and best practices will help position FDA to effectively meet the needs of innovators while protecting the safety and building the trust of patients and consumers," said Megan Coder, VP Product and Policy at DiMe. "In our dynamic ecosystem, fit-for-purpose regulatory innovations will continue to enable expanded patient care opportunities in the US, particularly as DiMe aligns our portfolio of research, education, and the development of product evaluation frameworks to meet the needs of our industry colleagues." 

DiMe is committed to advancing regulatory science and digital health product innovation. Click here to learn more about DiMe's upcoming project, Integrated Evidence Plans (IEP) for Digital Health Products. This new project will contribute important resources to support the report's top industry need. DiMe's Digital Medicine Academy also recently released a new course, Unlocking Regulatory Success for Digital Health Product Developers, to help inform why and how a good regulatory strategy is essential to a good business strategy.

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)