Medicines are “essential goods”, why not devices?
Medicines get reduced VAT as "essential goods," devices don't. A look at how Swissmedic's funding gap traces back to 2002 and 2021.
Top nominated!
A year of weekly LinkedIn posts on medtech regulation just earned a "top new voice" nod — and it's got me thinking about why manual, deliberately human writing still cuts through an increasingly AI-saturated feed. Plus my personal top-10 list of medtech voices worth following.
The next strategic frontiers of medtech
Where should medtech and femtech companies focus their international expansion efforts after establishing EU and US market presence? This article analyses eight high-potential markets across four global regions — Anglosphere, East Asia, MENA, and Latin America — ranked against three strategic criteria: ROI and medtech infrastructure, femtech readiness, and regulatory alignment with international harmonisation frameworks including MDSAP and CE Mark mutual recognition agreements. Whether you are mapping your next regulatory strategy or building a market entry roadmap, this evidence-based analysis offers a practical starting point — with an honest look at what the data says and where gut instinct still has a role to play.
PFAS: wait-and-see Vs precautionary principle
When data is limited, do you default to safety or wait for proof of harm? This post explores the widening regulatory gap between the US and EU regarding PFAS - the "Forever Chemicals."
FDA’s new guidance on general wellness
This post critiques the widening regulatory gap between the US and EU following the FDA's new wellness guidance, highlighting how lower barriers for bold health claims in the US may sacrifice essential quality drivers and complicate global strategies for startups.
MDR/IVDR proposal for simplication
This post highlights the European Commission's groundbreaking proposal to overhaul and simplify the MDR and IVDR frameworks, promising more proportionate rules for low-risk devices, reduced administrative burdens for SMEs, and a modern, digital-first approach to medtech regulation in the EU.
What can we learn from… Canada?
This post explores the "Canadian Technology Accelerator" model for international expansion, sharing insights from a bilingual FemTech panel in Paris on how high-potential startups - like PCOS-focused mentee Élan Healthcare - can leverage diplomatic networks and local mentorship to navigate global regulatory compliance.
