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Full Description
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 improvement in development effort and increase in innovation value. It provides actionable policy guidance for aligning European patent law with regulatory timelines while maintaining high safety standards and offers cross-sectoral insights from renewable energy and biotechnology as benchmarks for successful regulatory-innovation alignment. Further, it addresses an urgent policy debate in the European Union concerning innovation incentives in the health-technology sector. By combining legal analysis, mathematical modelling, and policy evaluation, the book bridges law, economics, and health-technology governance. It provides a policy blueprint for balancing innovation incentives, regulatory efficiency, and patient safety, addressing a structural weakness at the heart of Europe's medtech competitiveness. With its quantitative rigour and policy relevance, the book targets a multidisciplinary readership of academics in law, economics, and innovation policy, policymakers, regulators at European Union institutions, and industry professionals.
Contents
Executive Summary. Preface. Primary Policy Recommendations. Key Terminology PART I: FOUNDATIONS AND REGULATORY CONTEXT 1. Introduction 2. EU and US Regulatory-Patent Frameworks 3. EU vs. US Framework Comparison PART II: QUANTITATIVE MODELLING 4. Visual Analysis of Innovation Incentives Under Alternative Patent Regimes 5. Extension of the Model: Theoretical Framework and Stochastic Methodology 6. Conclusion of the Device SPC Model 7. Phase-Specific SPC Policy Evaluation: Implementation and Empirical Calibration PART III: EMPIRICAL APPLICATIONS 8. Bass Diffusion with Ergodic Extensions for Medical Device Adoption 9. Formal Calculations and Monte Carlo Simulation 10. Practical Examples to Illustrate the Framework PART IV: POLICY ANALYSIS 11. The Political Dimension of Our Findings 12. Global Competitive Context 13. Stakeholder Analysis: Diverse Perspectives on Innovation Policy 14. Integration with Patent Economic Theory Part V: SYNTHESIS AND CONCLUSIONS 15. Recapitulation and Analytical Synthesis of Our Model 16. Observations and Hypotheses Derived from the Model 17. Glossary of Abbreviations 18. Citations and References 19. Institutional & Industry Reports. Appendices
