The EU MedTech Innovation Pressure: Navigating 2026 "Crunch" and EY-DG SANTE Findings For years, the European Union was the global launchpad for EU MedTech Innovation, but recent data suggests a pivotal identity crisis is looming. A "CE Mark" was often the first major milestone for a startup before tackling the FDA. However, the tide has turned. As we move deeper into the mid-2020s, the medical technology landscape is facing a pivotal identity crisis. The recent EY-DG SANTE study , commissioned by the European Commission, has provided the data to back up what many MedTech professionals have been whispering in boardrooms: the regulatory burden of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is creating an "innovation drain." The Data Speaks: Key Findings from the EY-DG SANTE Study The study was designed to monitor the availability of medical devices on the EU market. The results are a wake-up call. According to the ...
The Future of Healthcare: How AI is Revolutionizing the US Pharmaceutical and Medical Device Industry (2025 Edition) The pharmaceutical and medical device landscape in the United States is undergoing its most significant transformation since the digital revolution. In 2025, Artificial Intelligence (AI) is no longer a "future concept"—it is the primary driver of efficiency, safety, and personalized patient care. The numbers tell the story: The global market for AI in healthcare is projected to breach $45 billion by the end of 2025 , with the US market leading the charge. From accelerating drug discovery cycles to navigating complex FDA regulatory frameworks, AI is the new backbone of life sciences. 1. Accelerating Drug Discovery with Generative AI The traditional cost of bringing a new drug to the US market often exceeds $2.6 billion and takes over a decade. AI is slashing these costs by shortening the research phase by years, transforming a process of "trial a...