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.
|Original language||English (US)|
|Title of host publication||Software Engineering in Health Care - 4th International Symposium, FHIES 2014 and 6th International Workshop, SEHC 2014, Revised Selected Papers|
|Editors||Michaela Huhn, Laurie Williams|
|Number of pages||17|
|State||Published - 2017|
|Event||4th International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2014 and 6th International Workshop on Software Engineering in Health Care, SEHC 2014 - Washington, United States|
Duration: Jul 17 2014 → Jul 18 2014
|Name||Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics)|
|Other||4th International Symposium on Foundations of Health Information Engineering and Systems, FHIES 2014 and 6th International Workshop on Software Engineering in Health Care, SEHC 2014|
|Period||7/17/14 → 7/18/14|
Bibliographical noteFunding Information:
This work has been partially supported by NSF grants CNS-0931931 and CNS-1035715.
by NSF grants CNS-0931931 and CNS-
© Springer International Publishing AG 2017.