Why diagnostic readiness is becoming the next rare disease access barrier For decades, rare disease screening has been shaped by a cautious principle: do not test for a condition unless …
-
-
From national evidence to regional care When Sweden issued a national recommendation for Automated Insulin Delivery systems in adults with type 1 diabetes, the headline could easily have been read …
-
Clinical evidence is becoming more coordinated. Reimbursement is not. Europe is often described as one of the great prizes for high-risk MedTech and IVD companies. In one sense, that is …
-
For many MedTech, IVD, digital health, biotech and pharmaceutical companies, the difficult question is no longer simply whether a technology can reach the market. Regulatory approval remains essential. A CE …
-
Why the best first market is not the biggest one, but the place where value becomes visible fastest Ask a MedTech, IVD, AI or digital health company where it wants …
-
Reframing endometriosis Endometriosis has traditionally been described as a chronic gynaecological condition characterised by the presence of endometrial-like tissue outside the uterus.¹ Its most recognised symptoms include dysmenorrhoea, chronic pelvic …
-
Medical purpose, MiGeL and price discipline From 1 July 2026, Switzerland will introduce reimbursement for selected medical-purpose digital health applications through MiGeL/LiMA. This article explains how companies should approach Swiss …
-
Price Follows the Patient Pathway Healthcare companies often begin their pricing story in the wrong place. They start with the product. They describe the device, the assay, the implant, the …
-
News
France 2026; Why Reimbursement Route Selection Is Now the Strategic Risk for MedTech, IVD, Digital Health and AI Companies
Why choosing the wrong French pathway can damage evidence, pricing, adoption and investor confidence France is one of Europe’s most attractive markets for medtech, diagnostics, digital health and AI. It …
-
In healthcare, evidence only creates value when it answers the question the payer, HTA body, commissioner, hospital, regulator or investor is actually asking. Many healthtech companies do not fail because …