A dilemma that medical device developers often face is where to launch their products first—whether it’s in Europe, the US, or both. In our experience, the decision of which initial market to target should not be taken lightly and should be guided by more than just the path of least regulatory resistance. Instead, successful launch planning requires device developers to align their product development, regulatory, and go-to-market strategies such that they can demonstrate safety, efficacy, and value in their priority market—or markets—of choice.
In this guide, we explore the regulatory landscapes for medical devices in the EU and US and share tips on building flexibility into market launch by developing a rigorous clinical and regulatory plan that dovetails with an integrated product development and go-to-market strategy.
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