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Cybersecurity and the Medical Device Product Development Lifecycle.

Richard W Jones1, Konstantinos Katzis2

  • 1School of Engineering, University of Warwick, U.K.

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Summary
This summary is machine-generated.

Securing connected medical devices against cyber threats demands integrating cybersecurity throughout the product development lifecycle. This approach reinforces safety risk management for robust medical device protection.

Keywords:
CybersecurityLife-cycleMedical devicesRisk Management

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Area of Science:

  • Biomedical Engineering
  • Cybersecurity
  • Healthcare Technology

Background:

  • Connected medical devices are increasingly vulnerable to evolving cyber threats.
  • Existing cybersecurity measures often lack a lifecycle approach.
  • Integrating cybersecurity with safety risk management is crucial.

Purpose of the Study:

  • To review current guidance on medical device cybersecurity within the product development lifecycle.
  • To emphasize a continuous lifecycle approach for medical device cybersecurity.
  • To highlight the synergy between cybersecurity and safety risk management.

Main Methods:

  • Literature review of existing guidance documents.
  • Analysis of cybersecurity integration within product development lifecycles.
  • Examination of complementary roles in safety risk management.

Main Results:

  • Current guidance often addresses cybersecurity in silos rather than as an integrated lifecycle process.
  • A continuous lifecycle approach is essential for effective medical device protection.
  • Cybersecurity integration complements and reinforces safety risk management.

Conclusions:

  • A proactive, lifecycle-integrated cybersecurity strategy is vital for medical devices.
  • Regulatory and industry guidance needs to evolve to support continuous cybersecurity.
  • Enhanced collaboration between cybersecurity and safety teams is recommended.