DiMe Launches Education Course on Regulatory Strategy for Digital Health Innovators

Curriculum Will Position Product Developers to Build a Robust Regulatory Strategy to Strengthen Business Strategy, Differentiate Products, and Avoid Regulatory Risks 

BOSTON, July 25, 2023 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) launched a new education course for individuals, "Unlocking Regulatory Success for Digital Health Product Developers,'' as part of its growing Digital Medicine Academy. The Academy, which features education courses on topics across the digital medicine spectrum, launched in August 2022 as a one-stop shop for digital medicine education and training.

This new course will teach product developers why and how to build robust regulatory strategies that will in turn strengthen their organization's business strategy, differentiate their products, and build trust among their consumers in today's competitive digital health market. Specifically, learners who complete the course will be able to:

• Identify whether digital health products in their portfolio are likely to be regulated and through which mechanisms.
• Build a regulatory strategy, sufficient knowledge to implement that strategy, and be positioned to advance the success of their digital health product portfolios.
• Develop evidence-based, high-quality products and reduce the dependency on regulatory consultants.

"The digital health market has matured dramatically. Investors are now more deliberate about where they are placing their bets, and end users are much more discerning. We see payers, physicians and patients all seeking signals of quality and trustworthiness in the companies they partner with and the products they choose to use," said Jennifer Goldsack, CEO of DiMe. "This course is a critical resource to arm product developers with the information they need to effectively navigate regulations that can make or break the commercial success of their product portfolio."

The Unlocking Regulatory Success for Digital Health Product Developers course is an online, self-directed course featuring a combination of DiMe experts and guest faculty from Rock Health, Epstein Becker Green, Strategy Health, and Caption Health. Topics addressed include:

• A fit-for-purpose regulatory strategy is good business strategy
• Demystifying the regulatory landscape
• Crafting a fit-for-purpose regulatory strategy
• Staying ahead of the curve: Building for adaptability
• You're developing a regulated product: Now what?
• The impact: How robust regulatory strategies build trust

"Fit-for-purpose regulatory strategy is good business strategy. As digital health has grown, we're seeing new companies pushing innovation and operating in a gray area. With regulation maturing, it's now critical to develop regulatory strategy to inform business and marketing approaches, and ensure improved patient outcomes, safety, and efficacy," said Sari Kaganoff, General Manager, Consulting, Rock Health.

Individuals who take the course will also gain access to the broader DiMe community, which will help them continue to grow their expertise, leadership, and network in digital health. Those who successfully complete will receive a certificate of completion and an official badge for their LinkedIn profile.

DiMe's Digital Medicine Academy also features Fast Track to Digital Clinical Trials: Pharma Edition for pharmaceutical organizations, Digital Health Ethics for individuals, and new courses coming soon.

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)