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ORIGINAL RESEARCH article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1415319
This article is part of the Research Topic Regulatory Science and Meta Science as Components of Regulation of Medical Products and Practices View all 3 articles

More than Red Tape: Exploring Complexity in Medical Device Regulatory Affairs

Provisionally accepted
Yu Han Yu Han *Aaron Ceross Aaron Ceross Jeroen Bergmann Jeroen Bergmann *
  • University of Oxford, Oxford, United Kingdom

The final, formatted version of the article will be published soon.

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

    Keywords: medical devices, regulatory affairs, regulation, Complexity, Natural Language Processing, Topic modelling, Open coding, qualitative analysis

    Received: 10 Apr 2024; Accepted: 10 Jul 2024.

    Copyright: © 2024 Han, Ceross and Bergmann. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Yu Han, University of Oxford, Oxford, United Kingdom
    Jeroen Bergmann, University of Oxford, Oxford, United Kingdom

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.