10. Clinical Translation, Regulatory Considerations, and Future Perspectives: Challenges in Zinc-Based Biodegradable Materials for Biomedical Applications

Zinc-based biodegradable materials are emerging as transformative solutions in biomedical science, particularly for temporary implants and devices. These materials combine favorable mechanical properties, biocompatibility, and controlled degradation rates, making them ideal for applications such as orthopedic implants, cardiovascular stents, and wound-healing devices. Compared to traditional biodegradable options like magnesium alloys and polymers, zinc offers intermediate corrosion behavior and unique cellular benefits, including antimicrobial properties and tissue regeneration support. However, challenges such as achieving consistent degradation rates, addressing biocompatibility concerns, and overcoming regulatory hurdles must be resolved to unlock their clinical potential. Advanced material engineering strategies, including alloying, surface modifications, and additive manufacturing, are being explored to address these limitations. Furthermore, stringent regulatory frameworks from bodies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand comprehensive safety and efficacy evaluations, including biocompatibility and degradation studies. Collaboration across disciplines—encompassing materials science, clinical research, and regulatory compliance—is essential to advance zinc-based biodegradable materials from research to clinical application. By tackling these challenges and aligning global regulatory standards, these materials can redefine the future of medical implants, ensuring safer and more effective patient care.