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Patient Flow Monitoring Systems: Investigation of Alternatives Read chapter Read first chapter

2017 | OriginalPaper | Chapter

From Requirements to Code: Model Based Development of a Medical Cyber Physical System

Authors : Anitha Murugesan, Mats P. E. Heimdahl, Michael W. Whalen, Sanjai Rayadurgam, John Komp, Lian Duan, Baek-Gyu Kim, Oleg Sokolsky, Insup Lee

Published in: Software Engineering in Health Care

Publisher: Springer International Publishing

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Abstract

The advanced use of technology in medical devices has improved the way health care is delivered to patients. Unfortunately, the increased complexity of modern medical devices poses challenges for development, assurance, and regulatory approval. In an effort to improve the safety of advanced medical devices, organizations such as FDA have supported exploration of techniques to aid in the development and regulatory approval of such systems. In an ongoing research project, our aim is to provide effective development techniques and exemplars of system development artifacts that demonstrate state of the art development techniques.
In this paper we present an end-to-end model-based approach to medical device software development along with the artifacts created in the process. While outlining the approach, we also describe our experiences, challenges, and lessons learned in the process of formulating and analyzing the requirements, modeling the system, formally verifying the models, generating code, and executing the generated code in the hardware for generic patient controlled analgesic infusion pump (GPCA). We believe that the development artifacts and techniques presented in this paper could serve as a generic reference to be used by researchers, practitioners, and authorities while developing and evaluating cyber physical medical devices.

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previous chapter Building Semantic Causal Models to Predict Treatment Adherence for Tuberculosis Patients in Sub-Saharan Africa
next chapter Demonstrating that Medical Devices Satisfy User Related Safety Requirements
Footnotes
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In Fig. 4, the connections between components are abstracted for visual clarity.
 
Literature
1.
2.
Cofer, D., Gacek, A., Miller, S., Whalen, M.W., LaValley, B., Sha, L.: Compositional verification of architectural models. In: Goodloe, A.E., Person, S. (eds.) NFM 2012. LNCS, vol. 7226, pp. 126–140. Springer, Heidelberg (2012). doi:10.​1007/​978-3-642-28891-3_​13 CrossRef
3.
FDA. White Paper: Infusion Pump Improvement Initiative, April 2010
4.
Gunter, C.A., Gunter, E.L., Jackson, M., Zave, P.: A reference model for requirements and specifications. IEEE Software 17(3), 37–43 (2000)CrossRef
5.
Hammond, J., Rawlings, R., Hall, A.: Will it work? [requirements engineering]. In: Fifth IEEE International Symposium on Requirements Engineering, Proceedings, pp. 102–109 (2001)
6.
Heimdahl, M.P.E., Duan, L., Murugesan, A., Rayadurgam, S.: Modeling and requirements on the physical side of cyber-physical systems. In: Second International Workshop on the Twin Peaks of Requirements and Architecture, May 2013
7.
Heimdahl, M.P.E., Rayadurgam, S., Visser, W., Devaraj, G., Gao, J.: Auto-generating test sequences using model checkers: a case study. In: 3rd International Workshop on Formal Approaches to Testing of Software (FATES 2003) (2003)
8.
Joshi, A., Miller, S.P., Heimdahl, M.P.E.: Mode confusion analysis of a flight guidance system using formal methods. In: Proceedings of 22nd Digital Avionics Systems Conference (DASC 2003), vol. 1, p. 2-D. IEEE (2003)
9.
Kim, B.G., Ayoub, A., Sokolsky, O., Lee, I., Jones, P., Zhang, Y., Jetley, R.: Safety-assured development of the GPCA infusion pump software. In: Proceedings of the International Conference on Embedded Software (EMSOFT), pp. 155–164, October 2011
10.
Knight, J.C.: Safety critical systems: challenges and directions. In: Proceedings of the 24th International Conference on Software Engineering, pp. 547–550. IEEE (2002)
11.
Leveson, N., Pinnel, L.D., Sandys, S.D., Koga, S., Reese, J.D.: Analyzing software specifications for mode confusion potential. In: Proceedings of a Workshop on Human Error and System Development, pp. 132–146 (1997)
12.
13.
McMillan, K.L.: Circular compositional reasoning about liveness. Technical report 1999–02, Cadence Berkeley Labs, Berkeley, CA 94704 (1999)
14.
Miller, S.P., Tribble, A.C., Whalen, M.W., Heimdahl, M.P.E.: Proving the shalls: early validation of requirements through formal methods. Int. J. Softw. Tools Technol. Transf. 8(4), 303–319 (2006)CrossRef
15.
Miller, S.P., Whalen, M.W., Cofer, D.D.: Software model checking takes off. Commun. ACM 53(2), 58–64 (2010)CrossRef
16.
Murugesan, A., Rayadurgam, S., Heimdahl, M.P.E.: Modes, features, and state-based modeling for clarity and flexibility. In: Fifth International Workshop on Modeling in Software Engineering, May 2013
17.
Murugesan, A., Rayadurgam, S., Heimdahl, M.P.E.: Using models to address challenges in specifying requirements for medical cyber-physical systems. In: Fourth workshop on Medical Cyber-Physical Systems, April 2013
18.
Murugesan, A., Sokolsky, O., Rayadurgam, S., Whalen, M., Heimdahl, M.P.E., Lee, I.: Linking abstract analysis to concrete design: a hierarchical approach to verify medical CPS safety. In: International Conference on Cyber-Physical Systems (ICCPS) 2014, April 2014
19.
Murugesan, A., Whalen, M.W., Rayadurgam, S., Heimdahl, M.P.E.: Compositional verification of a medical device system. In: ACM International Conference on High Integrity Language Technology (HILT). ACM, November 2013
20.
Nuseibeh, B.: Weaving together requirements and architectures. Computer 34, 115–117 (2001)CrossRef
21.
Pajic, M., Mangharam, R., Sokolsky, O., Arney, D., Goldman, J., Lee, I.: Model-driven safety analysis of closed-loop medical systems. IEEE Trans. Ind. Inform. PP, 1–12 (2010). In early online access
22.
Rajan, A., Whalen, M.W., Staats, M., Deng, W., Heimdahl, M.P.E.: The effect of program and model structure on the fault finding ability of MC/DC test suites. In: Proceedings of Int’l Symposium on Software Testing and Analysis (ISSTA) (2008, submitted). http://​crisys.​cs.​umn.​edu/​ISSTA08.​pdf
23.
24.
Sha, L., Gopalakrishnan, S., Liu, X., Wang, Q.: Cyber-physical systems: a new frontier. In: Machine Learning in Cyber Trust, pp. 3–13. Springer, New York (2009)
25.
Staats, M., Gay, G., Whalen, M.W., Heimdahl, M.P.E.: On the danger of coverage directed test case generation. In: 15th International Conference on Fundamental Approaches to Software Engineering (FASE), April 2012
26.
Whalen, M., Murugesan, A., Rayadurgam, S., Heimdahl, M.: Structuring Simulink models for verification and reuse. In: Proceedings of the 6th International Workshop on Modeling in Software Engineering (2014)
27.
Whalen, M.W., Gacek, A., Cofer, D., Murugesan, A., Heimdahl, M.P.E., Rayadurgam, S.: Your what is my how: iteration and hierarchy in system design. IEEE Software 30(2), 54–60 (2013)CrossRef
Metadata
Title
From Requirements to Code: Model Based Development of a Medical Cyber Physical System
Authors
Anitha Murugesan
Mats P. E. Heimdahl
Michael W. Whalen
Sanjai Rayadurgam
John Komp
Lian Duan
Baek-Gyu Kim
Oleg Sokolsky
Insup Lee
Copyright Year
2017
Book
Software Engineering in Health Care

Print ISBN: 978-3-319-63193-6

Electronic ISBN: 978-3-319-63194-3

Copyright Year: 2017

DOI
https://doi.org/10.1007/978-3-319-63194-3_7

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