Uncovering Regulatory Affairs Complexity in Medical Products: A
  Qualitative Assessment Utilizing Open Coding and Natural Language Processing
  (NLP)
Yu Han Aaron Ceross Jeroen H. M. Bergmann
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.