Integrated Functional and Formal Modeling for Closed-loop Evaluation of Medical Device Software
Zhihao Jiang, Rahul Mangharam

Citation
Zhihao Jiang, Rahul Mangharam. "Integrated Functional and Formal Modeling for Closed-loop Evaluation of Medical Device Software". TECHCON 2014, 8, September, 2014.

Abstract
The safety of medical devices are crucial for patients' health. The percentage of software related recalls rises as the complexity of the software component of the medical devices increases. In traditional software design the safety requirements are evaluated using functional testing and clinical trials which are limited in identifying safety issues. Open-loop testing like functional testing is not effective when evaluating high-level requirements in which the input-output relation of the system is not well-specified. Clinical trials are closed-loop evaluations but are limited in size and cost. Model-based design enables closed-loop evaluation at design stage, which significantly reduce its cost. In this paper we introduce a reconfigurable closed-loop testing platform for implantable cardiac devices which is part of our model-based software design framework. The platform implemented a spatial-temporal heart model which can be reconfigured into different heart conditions which can be used for model-based clinical trials.

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Citation formats  
  • HTML
    Zhihao Jiang, Rahul Mangharam. <a
    href="http://www.terraswarm.org/pubs/358.html"
    >Integrated Functional and Formal Modeling for
    Closed-loop Evaluation of Medical Device Software</a>,
    TECHCON 2014, 8, September, 2014.
  • Plain text
    Zhihao Jiang, Rahul Mangharam. "Integrated Functional
    and Formal Modeling for Closed-loop Evaluation of Medical
    Device Software". TECHCON 2014, 8, September, 2014.
  • BibTeX
    @inproceedings{JiangMangharam14_IntegratedFunctionalFormalModelingForClosedloopEvaluation,
        author = {Zhihao Jiang and Rahul Mangharam},
        title = {Integrated Functional and Formal Modeling for
                  Closed-loop Evaluation of Medical Device Software},
        booktitle = {TECHCON 2014},
        day = {8},
        month = {September},
        year = {2014},
        abstract = {The safety of medical devices are crucial for
                  patients' health. The percentage of software
                  related recalls rises as the complexity of the
                  software component of the medical devices
                  increases. In traditional software design the
                  safety requirements are evaluated using functional
                  testing and clinical trials which are limited in
                  identifying safety issues. Open-loop testing like
                  functional testing is not effective when
                  evaluating high-level requirements in which the
                  input-output relation of the system is not
                  well-specified. Clinical trials are closed-loop
                  evaluations but are limited in size and cost.
                  Model-based design enables closed-loop evaluation
                  at design stage, which significantly reduce its
                  cost. In this paper we introduce a reconfigurable
                  closed-loop testing platform for implantable
                  cardiac devices which is part of our model-based
                  software design framework. The platform
                  implemented a spatial-temporal heart model which
                  can be reconfigured into different heart
                  conditions which can be used for model-based
                  clinical trials.},
        URL = {http://terraswarm.org/pubs/358.html}
    }
    

Posted by Barb Hoversten on 15 Sep 2014.
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