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Successfully bringing digital health technologies (DHTs) to market using robust regulatory strategies

When bringing a DHT to market, digital health developers must ensure it meets all necessary regulatory requirements to enable patient access and maximize its full potential. A robust regulatory strategy ensures that DHTs are safe, effective, and meet the necessary quality standards and trust of patients, clinicians, and payers.

To help you implement strategies that account for the positive impact of US regulatory engagement on your products’ commercial success and patient access, these industry case studies illustrate how organizations have successfully engaged with the FDA to gain the necessary authorizations to bring their digital health products to market.

Leveraging the case studies

Use these case studies to learn best practices and lessons from organizations who have undergone FDA review processes. Build on their successful interactions, decisions, and approaches so that you can better engage with the FDA and downstream payer decision-makers to convey high reliability and marketability – leading to greater capital investment and payer willingness to provide patient access to DHTs.

Improving access to novel virtual reality (VR) therapies for…
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Expanding access to cardiac care with the first FDA-authoriz…
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Defining robust drug-like evidence: Bringing novel software …
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Integrated platform for digitally monitoring health
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Designing a safe and effective pediatric digital health plat…
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From FDA to multiple US market access pathways
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From 2D to 3D: Charting a new course in imaging analytics in…
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Bringing novel AI-powered devices to the US market
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First fully interoperable automated insulin dosing device: F…
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Making behavioral health radically accessible
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Using the success stories outlined in these industry case studies, we have identified five strategies you can use to navigate the FDA regulatory process. Learn from real-world examples that highlight:

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    Diversifying commercialization pathways
  • Addressing unique AI/ML regulatory needs
  • Moving from product solutions to integrated platforms
  • Innovating in underserved markets
  • Pursuing drug-alike evidence for digital health
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Engaging with the FDA early and often will help you minimize potential risks and challenges during your regulatory review process.

Benefits of engaging with the FDA:

Builds trust among patients, clinicians, and payers

Ensures DHT safety, effectiveness, and quality standards 

Learn from the FDA’s vast expertise, credibility, and library of resources

Use these resources to make your interactions with the FDA seamless

DiMe’s Digital Health Industry Regulatory Needs Assessment has paved the way for a strong partnership between industry and government to propel advancements.

READ THE ASSESSMENT

Use DiMe’s Digital Health Regulatory Pathways to optimize your regulatory strategy, drive business success, and meet patients’ needs.

ACCESS RESOURCES

Innovators and industry stakeholders across the healthcare system can use DiMe’s Library of Digital Health Regulations to keep up with the latest regulations and guidances applicable to digital health.

ACCESS THE LIBRARY

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