The Economics of MedTech Innovation: Balancing Patient Safety with Economic Growth (Routledge Studies in the Economics of Innovation)

In an era where medical technology advances rapidly yet faces mounting regulatory hurdles, this book explores the critical interplay between patent law and regulatory frameworks that shapes the future of healthcare.It examines a fundamental problem in European medical technology innovation: the disconnect between patent protection periods and increasingly lengthy regulatory approval processes, demonstrating that Europe's current system forces companies to abandon breakthrough innovations in favor of incremental improvements.It compares the European Union’s Medical Device Regulation with the United States’ integrated patent-regulatory system, revealing how temporal misalignment between approval and protection discourages investment in complex medical devices.The book develops the first quantitative model linking patent-regulatory interaction and innovation effort in medical devices and demonstrates empirically, through Monte Carlo simulations and elasticity analysis, a significant impro