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Bridging the Bio-Electronic Interface with Biofabrication
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Adding wisdom to 'smart' bioelectronic systems: a design framework for physiologic control including practical

Aysegul Gunduz1, Enrico Opri1, Ro'ee Gilron2

  • 1Department of Biomedical Engineering, University of Florida Gainesville, Gainesville, FL 32611, USA.

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|April 19, 2021
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Summary
This summary is machine-generated.

This perspective explores risk management in automated physiological control loops. It details design frameworks and risk areas, using a brain-machine interface as an example for safe, adaptive operation.

Keywords:
bioengineeringclosed-loop deviceselectroceuticalsneuromodulationneuroprosthesissmart implants

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Area of Science:

  • Biomedical Engineering
  • Control Systems
  • Medical Device Design

Background:

  • Physiological control loops are increasingly automated.
  • Ensuring safety and managing risk is critical for user needs.
  • Historical medical device failures highlight the importance of risk assessment.

Purpose of the Study:

  • To provide an overview of risk consideration in physiological control loops.
  • To introduce a framework for designing safe, semi-to-fully automated controllers.
  • To illustrate risk concepts with examples and a case study.

Main Methods:

  • Literature review and perspective synthesis.
  • Analysis of historical medical device case studies.
  • Design overview of an adaptive bidirectional brain-machine interface.

Main Results:

  • Identified key risk areas in automated physiological control.
  • Presented a framework for designing risk-aware closed-loop controllers.
  • Demonstrated the application of design principles through a brain-machine interface example.

Conclusions:

  • Effective risk consideration is essential for safe automated physiological control.
  • A systematic approach to risk management enhances the reliability of closed-loop systems.
  • Adaptive bidirectional brain-machine interfaces offer a promising application for these design principles.