Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum

Med Device Online

With a global digital health market — comprising health technology, mobile devices, software applications, and analytics — projected to swell from $71.4 billion in 2017 to $379 billion by 2024, a range of startup and long-established medtech, pharmaceutical, and IT companies are vying for market shares. The United States commanded $30.5 billion worth of the global market in 2017, while Germany was the European Union’s leading digital health market.

Innovators targeting these two regions must not only have differentiating technologies, they must understand the regulatory ”rules of the road” — including, among other things, clarity whether their product is considered a regulated medical device, diagnostic, or combination product, an understanding of the requirements for wireless capability, and the sense to avoid common mistakes. Namely, they must keep pace with changing regulatory expectations in the same way they do with technology changes, exercising diligence in creating and following a prudent and effective regulatory strategy, while anticipating the potential need to shift course as industry drivers change.

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