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Background <p>Medical device development (MDD) is a highly intricate process. The dynamic nature of regulatory frameworks further complicates the MDD process. As medical technologies continue to evolve, regulatory systems introduce increasing challenges that must be addressed through the development lifecycle to ensure safe medical devices. </p> Objective <p>This study aims to identify challenges in implementing regulations in medical device development.</p> Methodology <p>A bibliometric analysis of 124 papers was conducted to investigate research gaps in the field of medical device development. We analyzed literature from Scopus, PubMed, IEEE Xplore, and Google Scholar using VOSviewer to identify regulatory barriers in medical device development, methods and technologies that address these challenges and assess their integration with design and operational aspects. </p> Results <p>The analysis reveals underexplored regulatory dimensions such as regulation complexity, costs, innovation, requirement elicitation and collaboration issues. </p> Conclusion <p>Our findings highlight the need to simplify regulatory compliance using advanced tools which can enhance the safety and efficiency of medical device development processes.</p>

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Implementing regulations in medical device development: a bibliometric review of challenges

  • 期刊论文

  • 发表日期：

    2026年5月11日

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  • Rupinder Kaur,
  • Anjali Awasthi

摘要

Background

Medical device development (MDD) is a highly intricate process. The dynamic nature of regulatory frameworks further complicates the MDD process. As medical technologies continue to evolve, regulatory systems introduce increasing challenges that must be addressed through the development lifecycle to ensure safe medical devices.

Objective

This study aims to identify challenges in implementing regulations in medical device development.

Methodology

A bibliometric analysis of 124 papers was conducted to investigate research gaps in the field of medical device development. We analyzed literature from Scopus, PubMed, IEEE Xplore, and Google Scholar using VOSviewer to identify regulatory barriers in medical device development, methods and technologies that address these challenges and assess their integration with design and operational aspects.

Results

The analysis reveals underexplored regulatory dimensions such as regulation complexity, costs, innovation, requirement elicitation and collaboration issues.

Conclusion

Our findings highlight the need to simplify regulatory compliance using advanced tools which can enhance the safety and efficiency of medical device development processes.