Navigating the regulatory frameworks that ensure the safety and efficacy of medical devices can be challenging, especially across different regions. These frameworks often require redundant testing, slowing down the process of getting innovations to patients.

翻译：确保医疗器械安全性与有效性的监管框架往往难以把握，尤其是在不同区域之间。这些框架通常要求重复性测试，从而延缓了创新成果惠及患者的进程。