An evidence-informed guide to patient-pathway value, reimbursement, strategic fit and acquisition readiness Most healthcare-app founders believe they are building a product. A future buyer may be looking for something entirely …
-
-
Germany gives pharmaceutical companies unusually rapid access to a major European market. A newly authorised medicine can generally enter reimbursed use while its comparative benefit and long-term reimbursement amount are …
-
Receiving FDA clearance or approval is one of the defining moments in a medical technology company’s life. It is also the point at which many companies discover that regulatory success …
-
UK RWE can support EU market access, but only when clinical, economic and payer evidence is translated for local HTA decisions. The UK remains one of the strongest environments in …
-
Biotechnology sponsors entering Europe are facing a quieter but more important access shift than many realise. It is easy to describe this shift as procedural. The European Union has introduced …
-
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 …