Managing Change in Global Medtech Regulation: A Tale of Two Systems

article image
ARTICLE SUMMARY:

US and European regulators are moving in opposite directions. How should the medical device industry cope?

In psychology, cognitive dissonance results from trying to maintain contradictory beliefs or positions simultaneously because humans prefer internal consistency. Welcome to the current state of global medical device regulation, particularly in the US and Europe. I recently attended two US medtech conferences and both featured sessions on international medical device regulation harmonization, a topic that has been under discussion for years. Yet, at the same time, we are seeing perhaps the clearest divide ever between the US and Europe since Pangaea split, with their respective regulatory regimens rapidly moving in opposite directions.

This article is restricted to subscribers only.

To continue reading, select one of the options below:

Existing Subscriber?

Sign In to continue reading.


Need Multi-User Access?

Gain access for your entire organization.

Get Quote Check to see if your company already has access

Subscribe to Market Pathways:

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Subscribe to Market Pathways
Subscribe to ELITE Strategist

Become an ELITE Strategist and unlock access to both MedTech Strategist and MTS Market Pathways.

Subscribe to Elite

Questions?

We're here to help! Please contact us at: