This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using open coding and Natural Language Processing (NLP) techniques. The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (A) Regulatory language complexity, (B) Intricacies within the regulatory process, (C) Global-level complexities, (D) Database-related considerations, and (E) Product-level issues. The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.

翻译：本研究探讨了医疗器械行业中监管事务的复杂性——这是影响市场准入与患者护理的关键因素。通过定性研究，我们收集了专家见解以理解导致这种复杂性的因素。研究涉及对28名医疗器械公司专业人员的半结构化访谈，这些人员专注于监管事务的各个领域。访谈内容采用开放式编码和自然语言处理（NLP）技术进行分析。研究结果揭示了监管环境中复杂性的主要来源，分为五个领域：（A）监管语言复杂性、（B）监管程序内在复杂性、（C）全球层面复杂性、（D）数据库相关考量，以及（E）产品层面问题。参与者强调需要制定策略以简化监管合规流程、加强监管机构与行业参与者之间的互动，并构建适应快速技术进步的可调整框架。研究指出，强调跨学科合作与提升透明度对于在医疗器械领域建立连贯且有效的监管程序至关重要。