Real-world data is reshaping medtech — but at what cost?

DOTmed May 2, 2025
DJ Fang

Data is changing the way medtech companies operate, not just in how devices are built but also in how they’re approved, regulated, and launched in global markets. Real-world data and AI tools are becoming a key part of regulatory operations, helping teams build evidence, manage submissions, and meet compliance requirements across different regions.

This shift is reshaping investment and hiring across the industry, with companies building out data infrastructure, regulatory technology, and AI capabilities to support these demands. But as the use of data grows, so does regulatory risk. Companies are facing new pressures to manage privacy, security, and compliance, particularly when operating across markets with different rules on data use.

Data is reshaping regulatory workflows

Regulatory processes in medtech...

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