FDA's first AI-misuse warning letter wasn’t so much about AI
Purolea Cosmetics Lab's FDA warning letter made headlines as the first to cite AI misuse in manufacturing. But strip away the AI angle and the real story is a quality unit that had already collapsed. Part 3 closes a series on why AI regulation isn't leveling the playing field — yet.
The EU AI Act's postponement rewards those who never started
The EU AI Act's high-risk deadline just moved to December 2027. Under Article 111's grandfather clause, companies that never started compliance may get a permanent pass, while those who invested early carry the cost. Part 2 of a series on the disparity AI regulation is creating.
LLMs for health advice get separate treatment
Over 5% of all ChatGPT messages are health-related, and 40 million people ask it health questions daily — yet it isn't regulated as a medical device, while purpose-built health apps are. Part 1 of a three-part series on why AI regulation creates disparity, not just innovation.
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 risk in having too many risks…
Confusing failure modes for risks is one of the most common structural mistakes in medical device risk analysis — and one of the most costly to fix later. This article explains the difference between hazards, hazardous situations, and harm under ISO 14971, why a bloated risk analysis undermines your whole risk management process, and how one simple syntax rule can help you build a cleaner, more actionable document from the start.
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.
