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Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk

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Medical device startups often overlook non-technical risks. This study identifies these gaps and proposes a framework to improve risk management for successful product development and regulatory compliance.

Keywords:
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Area of Science:

  • Medical Device Development
  • Risk Management
  • Regulatory Compliance

Background:

  • Current medical device risk management primarily focuses on technical risks (product, usability, process), neglecting crucial business and project risks.
  • Start-ups in this sector face resource limitations, impacting their ability to manage complex risks effectively.
  • Existing regulations and standards emphasize technical risk, leaving a gap in addressing broader business and project-related risks.

Purpose of the Study:

  • To investigate the risk management practices of medical device start-ups.
  • To identify the types of risks currently addressed and those overlooked in their development processes.
  • To propose a comprehensive risk management framework tailored for start-ups.

Main Methods:

  • Qualitative interviews were conducted with seven medical device start-ups.
  • Grounded theory was employed to analyze interview data.
  • Project Management Institute's risk categories were used to assess coverage of non-technical risks.

Main Results:

  • Significant gaps were identified in risk identification, particularly concerning non-technical risks.
  • Lack of involvement from appropriate teams and other procedural weaknesses were highlighted.
  • Current practices often fail to cover essential business and project risks.

Conclusions:

  • A user-friendly risk management framework is proposed to assist start-ups.
  • The framework aims to enhance the identification and management of both technical and non-technical risks.
  • Successful, safe, and regulatory-compliant medical device production can be facilitated by adopting this framework.