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Updated: Jul 27, 2025

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Strategies for Medical Device Development: User and Stakeholder Perceptions.

I-Ching Tsai1, Ching-Da Wang1, Peng-Ting Chen1,2

  • 1Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan.

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|June 7, 2023
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Summary

Medical device development requires a structured approach, focusing first on organizational factors, then technical capabilities and environment, and finally user actions. This ensures product safety and effectiveness.

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Area of Science:

  • Biomedical Engineering
  • Health Policy and Management

Background:

  • Medical device development is complex, with user safety and regulatory compliance as critical factors.
  • Inadequate consideration of users, environment, and organizations during design increases risks.
  • Existing research lacks a systematic assessment of key factors influencing medical device development.

Purpose of the Study:

  • To systematically identify and assess key factors affecting medical device development.
  • To establish a model for optimizing medical device development pathways.
  • To provide actionable recommendations for enhancing medical device development strategies.

Main Methods:

  • A comprehensive literature review was conducted.
  • Interviews with medical device industry experts were performed.
  • The Factors Influencing Adoption-New Regulatory Model (FIA-NRM) was developed and applied.

Main Results:

  • Organizational characteristics are foundational for stable medical device development.
  • Strengthening technical capability and the use environment are subsequent priorities.
  • User actions must be considered in the final stages of development.

Conclusions:

  • The FIA-NRM model provides a structured pathway for medical device development.
  • Recommendations focus on strategic resource allocation for safety and effectiveness.
  • Optimized development pathways enhance product safety and user outcomes.