Notes from Scarlet's digital health summit
A day of genuinely open debate on digital health regulation: why the risk of not approving a solution deserves as much weight as the risk of approving one, what duty of care looks like at consumer-platform scale, and whether continuous deployment can ever fit inside traditional regulatory review.
New Zealand: an under-explored SaMD frontier
New Zealand still regulates medical devices under a 1981 law never built for software — meaning most low-risk SaMD can reach market today with a simple, free notification and no pre-market review. Here's what that window looks like, how long it lasts, and why it pairs naturally with Australia.
Australia as a first GTM for SaMD
Australia's TGA released fresh SaMD guidance in early 2026 — and it's a case study in what good regulation can look like: plain-language self-assessment, genuine low-risk carve-outs, and enforcement that actually backs the framework. Here's why it's often my recommended first market for digital health founders.
Translating your device into "regulatorese"
Struggling to translate your device into "regulatorese"? Our collaborator Erica Perrier of Evidentia Consulting built a free AI tool around three deceptively simple questions — what does it do, who is it for, how does it work. I tested it on fertility devices: here's what it nailed, what it missed, and why those three questions matter more than they sound.
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.
Quantum: The Regulatory Frontier That Will Catch Us Off Guard
Quantum computing is revolutionizing medical device development, but regulatory frameworks aren't ready. Companies like Algorithmiq are achieving 100x precision improvements in cancer therapy using quantum-generated synthetic data—yet FDA's 2025 AI/ML guidance doesn't address quantum validation challenges. How do you validate data you can't reproduce classically? Regulatory science needs quantum-aware frameworks now, before quantum-AI medical devices reach the clinic.
Beyond the EU-US paradigm
The global medtech regulatory landscape is shifting away from the traditional EU-US duopoly. The UAE now offers approval timelines 30-50% shorter than US and EU markets, while Mexico and Nigeria introduced comprehensive digital health regulations in 2023 and 2025. Canada, Australia, the UK, and Brazil are implementing bold reforms—from the UK's AI Airlock regulatory sandbox to Brazil's platform tracking over 500 registered software medical devices. This analysis explores strategic implications for medtech companies choosing between the Anglosphere, BRIC nations, Middle East markets, and emerging economies for regulatory submissions.
Crans-Montana, a compliance perspective
In the wake of the devastating NYE fire in Crans-Montana, this post reflects on the critical role of compliance and individual accountability in preventing national tragedies, reminding us that regulation is only a burden until the moment it becomes our last line of defense.
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.
