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Developing Medical Devices from Abstract State Machines to Embedded Systems: A Smart Pill Box Case Study

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Software Technology: Methods and Tools (TOOLS 2019)

Part of the book series: Lecture Notes in Computer Science ((LNPSE,volume 11771))

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Abstract

The development of medical devices is a safety-critical process, because a failure or a malfunction of the device can cause serious injuries to the patients whom use it. The application of a rigorous process for their development reduces the risk of failures since validation and verification activities can be performed in a objective, reproducible, and documentable manner. In this paper we present an approach based on the Abstract State Machine (ASM) formal method. Starting from the model, validation and verification (V&V) techniques can be applied. Furthermore, by step-wise refinement, a final model can be obtained, which can be automatically translated to code. The process is applied to the smart pill box case study. Starting from the ASM model, we generate code for the Arduino platform after the application of V&V activities. Furthermore, we introduce regulation (IEC62304) and guidelines (FDA General Principles of Software Validation) that support the developer in medical software development. In particular, we explain how ASMs formal process can be compliant with them.

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Notes

  1. 1.

    http://asmeta.sourceforge.net/.

  2. 2.

    https://www.arduino.cc/.

  3. 3.

    The specifications are available at https://foselab.unibg.it/asmeta/PillboxASM.zip.

  4. 4.

    http://nusmv.fbk.eu/.

  5. 5.

    https://it.mathworks.com/products/simulink.html.

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Authors and Affiliations

  1. Department of Economics and Technology Management, Information Technology and Production, University of Bergamo, Bergamo, Italy

    Andrea Bombarda, Silvia Bonfanti & Angelo Gargantini

Authors
  1. Andrea Bombarda
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  2. Silvia Bonfanti
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  3. Angelo Gargantini
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Corresponding author

Correspondence to Angelo Gargantini .

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Editors and Affiliations

  1. Innopolis University, Innopolis, Russia

    Manuel Mazzara

  2. IUT de Blagnac , Blagnac, France

    Jean-Michel Bruel

  3. Innopolis University, Innopolis, Russia

    Bertrand Meyer

  4. Ivannikov Institute for System Programming, Russian Academy of Sciences, Moscow, Russia

    Alexander Petrenko

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Bombarda, A., Bonfanti, S., Gargantini, A. (2019). Developing Medical Devices from Abstract State Machines to Embedded Systems: A Smart Pill Box Case Study. In: Mazzara, M., Bruel, JM., Meyer, B., Petrenko, A. (eds) Software Technology: Methods and Tools. TOOLS 2019. Lecture Notes in Computer Science(), vol 11771. Springer, Cham. https://doi.org/10.1007/978-3-030-29852-4_7

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  • DOI: https://doi.org/10.1007/978-3-030-29852-4_7

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