Title: A workflow for design and evaluation of embedded control systems in medical devices

Authors: Lukas Pielawa; Melina Frenken; Andreas Hein

Addresses: Health Department, OFFIS, Oldenburg, Germany ' Health Department, OFFIS, Oldenburg, Germany ' School of Medicine and Health Sciences and Health Department, OFFIS, University of Oldenburg, Oldenburg, Germany

Abstract: The recent development of more and more autonomous medical devices facilitates unsupervised treatment and thereby saving of costs for healthcare. While flawless control software is needed for such life-critical systems, no specific development processes are established in the medical domain. The here presented approach founds on the functional simulation of system components and their virtual integration as well as modelling of the decisive parts of the physiology influenced by the device. Additionally, a virtual execution platform is integrated enabling to develop the embedded control software and evaluate it online to the functional simulation. Finally, the coupling to an assertion engine for semi-formal verification allows validation of the system's behaviour and its compliance with requirements, specified as assertions. The utilisation of this proposed methodology is demonstrated on the control development for an autonomous dialysis system. The applicability is evaluated and insights gained through its utilisation exemplary demonstrate its benefits.

Keywords: personalised healthcare; development workflow; simulation; autonomous dialysis; control engineering; assertion-based verification; cyber-physical systems; CPS; embedded control; medical devices; unsupervised treatment; healthcare technology; system components; virtual integration; modelling; physiology.

DOI: 10.1504/IJBET.2013.058446

International Journal of Biomedical Engineering and Technology, 2013 Vol.13 No.3, pp.257 - 269

Received: 17 May 2013
Accepted: 27 Oct 2013
Published online: 27 Sep 2014 *

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