DIY-ing the eclipse, DIY-ing health
A CD, polarised sunglasses, and a homemade risk assessment — what DIY-ing the 2026 eclipse taught me about how we all DIY our own healthcare too.
On "human in the loop" and automation bias
A widely circulated exchange about AI and military targeting raises a question every QARA professional should sit with: does "a human makes the final decision" really resolve anything when review time is a glance? Plus what's missing from the EU AI Act's high-risk categories, and new Commission guidance for health AI.
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 price tag on being a woman
Menstruation costs the average person £20,359 over a lifetime — before contraception, birth, or menopause even enter the picture. Layered onto a persistent gender pay gap, this isn't a private budgeting problem. It's a structural cost that deserves the same scrutiny as any other health inequity.
Optimised for the optimised
Health tech has never had more data or more capital — yet population health outcomes haven't moved. This article looks at why the wellness-to-medical staged strategy is harder than it looks, and what regulation, funding data, and public health theory tell us about who we're actually building for.
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.
Plasters Vs Period Products
Why are tampons regulated differently than plasters? Discover the critical gap between "hygiene products" and Class I Medical Devices (MDR). From ISO 13485 quality standards and biocompatibility testing to the FDA’s Class II classification, we explore why medical-grade manufacturing—like Daye’s cleanroom production—is essential for menstrual safety.
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.
