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不止是繁文缛节：探索医疗器械监管事务中的复杂性

More than red tape: exploring complexity in medical device regulatory affairs.

作者信息

Han Yu, Ceross Aaron, Bergmann Jeroen

机构信息

Department of Engineering Science, University of Oxford, Oxford, United Kingdom.

Department of Technology and Innovation, TEK, University of Southern Denmark (SDU), Odense, Denmark.

出版信息

Front Med (Lausanne). 2024 Jul 31;11:1415319. doi: 10.3389/fmed.2024.1415319. eCollection 2024.

DOI:10.3389/fmed.2024.1415319
PMID:39144660
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11322972/
Abstract

INTRODUCTION

This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care.

METHODS

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 a mix of qualitative coding and natural language processing (NLP) techniques.

RESULTS

The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (1) regulatory language complexity, (2) intricacies within the regulatory process, (3) global-level complexities, (4) database-related considerations, and (5) product-level issues.

DISCUSSION

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.

摘要

引言

本研究调查了医疗器械行业监管事务的复杂性，这是影响市场准入和患者护理的关键因素。

方法

通过定性研究，我们寻求专家见解以了解导致这种复杂性的因素。该研究对28名来自医疗器械公司、专门从事监管事务各方面工作的专业人员进行了半结构化访谈。这些访谈采用定性编码和自然语言处理（NLP）技术相结合的方式进行分析。

结果

研究结果揭示了监管领域复杂性的关键来源，分为五个领域：（1）监管语言的复杂性，（2）监管过程中的错综复杂之处，（3）全球层面的复杂性，（4）与数据库相关的考虑因素，以及（5）产品层面的问题。

讨论

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，并为快速的技术进步制定适应性框架。该研究强调跨学科合作和提高透明度，得出结论认为这些要素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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/73b9224f74e9/fmed-11-1415319-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/8a422e614d4e/fmed-11-1415319-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/73b9224f74e9/fmed-11-1415319-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/8a422e614d4e/fmed-11-1415319-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/42e04fb331f6/fmed-11-1415319-g002.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50d1/11322972/73b9224f74e9/fmed-11-1415319-g007.jpg

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