Beyond the EU-US paradigm
The recent speech delivered by Canada's Prime Minister at the World Economic Forum prompted me to reconsider my approach to regulatory strategy. Without delving into politics, the address highlighted the extent to which the western world has become US-centric and reliant on American frameworks—a reality that extends fully to the medical technology sector.
This led me to reflect on my own professional practice:
Most of my analysis focuses on comparative regulatory matters between the EU and US.
Most of my medtech clients prioritize EU and US market entry first, and that is what I help them achieve.
Most of my knowledge accumulated over 14 years in healthtech has been built on the default EU-US paradigm.
However, I am far from blind to the strong signals of change emerging on a global level.
Major medtech corporations are beginning to pursue UAE market entry first, given that average regulatory approval timelines are 30%-50% shorter than in the US and EU. Many emerging economies maintain low regulatory barriers for standalone Software as a Medical Device (SaMD) in digital health—large markets such as Mexico and Nigeria only introduced such requirements in 2023 and 2025, respectively. Meanwhile, Canada, Australia, and the UK are taking bold steps to boost health innovation, attract technology companies, and facilitate regulatory compliance.
As former Bank of England Governor Mark Carney stated in his remarks:
"In a world of great power rivalry, the countries in between have a choice: to compete with each other for favour or to combine to create a third path with impact."
"The question is not whether to adapt—we must. The question is whether we adapt by simply building higher walls or whether we can do something more ambitious. The former is easy and ruinous; the latter is difficult and necessary."
This brings me to an important question for the medtech regulatory community.
Beyond the US-EU 'old order', which regulatory focus would you find most valuable for future analysis and guidance?
Anglosphere: Canada, South Africa, Australia, New Zealand
"BRIC" + Japan: Brazil, Russia, India, China, and Japan
Middle East: UAE, Saudi Arabia, Israel
Emerging Markets: Africa, ASEAN, Latin America
I invite you to share your perspective in the poll here
