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.

这项研究调查了医疗器械行业中的监管事务复杂性，该复杂性是影响市场准入和患者护理的重要因素。通过定性研究，我们寻求专家的见解，以了解导致这种复杂性的因素。研究涉及到对 28 名医疗器械公司的专业人员进行半结构化访谈，涉及到监管事务的各个方面。通过开放编码和自然语言处理（NLP）技术对这些访谈进行了分析。研究结果揭示了监管环境中的五个复杂度来源：（A）监管语言复杂度，（B）监管过程中的复杂性，（C）全球层面的复杂性，（D）数据库相关问题，以及（E）产品层面问题。参与者强调了简化监管合规性、加强监管机构与行业参与者之间互动以及开发适应快速技术进步的可调整框架的需求。强调跨学科合作和增加透明度，研究结论认为这些元素对于建立协调和有效的医疗器械监管程序至关重要。