{"title":"System Design Approach to Medical Device Development","authors":"M. Wehde","doi":"10.1109/ISSE49799.2020.9272015","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272015","url":null,"abstract":"Many life saving devices come with significant risk which must be mitigated through a defined system design process. A seamless integration of the design and development process and the safety risk management process will allow devices to be safety used on humans. The development process is described in ISO 13485, the international standard for the development of medical devices. ISO 14971 is the international standard for the evaluation of the safety risk of a medical device. A system engineering approach to the design of medical devices provides a holistic approach to ensuring these devices are safe for their intended use. Universities and companies hoping to use their devices in clinical trials on patients are required to follow a well-defined process incorporating design and development planning, design input, design output, design review, design verification, and design validation. The safety risk management process must be carefully overlaid on top of this standard development process. This paper will describe acceptable development processes, including agile and evolutionary design. It will also describe the methodology used to develop devices intended for clinical trials on patients, prior to commercialization. It will briefly describe the requirements of clinical trials performed on humans and will cover the key elements of the safety risk management process.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"45 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122749042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Improving OPM Conceptual Models by Incorporating Design Structure Matrix","authors":"G. Sobol, D. Dori","doi":"10.1109/ISSE49799.2020.9272243","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272243","url":null,"abstract":"We combine Object-Process Methodology (OPM) with Design Structure Matrix (DSM) and its Multi Domain Matrix (MDM) extension to capitalize on the potential synergies of these two approaches to model-based systems engineering. OPM can provide a very detailed system model, but it is limited in examining the system as a whole, especially when the system is large and complex. DSM, which provides a matrix representation of the system, lists all the elements and shows relations between model elements. This matrix is amenable to matrix manipulation like clustering and partitioning, enabling the evaluation of relations among model elements. We follow a methodical five-step approach for applying DSM to analyze and improve complex OPM system models. Dedicated preprocessing algorithms have been developed and applied to eliminate states from objects and flatten the hierarchical OPM model while maintaining its semantics. The resulting DSMs and DSM variations of an OPM model are then analyzed, this can be achieved by domain experts who can get ideas or suggestions to improve the model based on quantitative metrics. After examining outcomes of clustering or partitioning algorithms on the DSM, the modularity of the model can be improved, yielding possible gains for the system under development.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"9 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114135376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Integrated Design Methodology for Improved System Manufacturability","authors":"A. Kurgan, P. Maggiore, A. Golkar","doi":"10.1109/ISSE49799.2020.9272211","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272211","url":null,"abstract":"System prototypes and technology demonstrators are usually designed for one-time manufacturing. Issues related to later phases of the lifecycle start to appear when prototypes are consolidated into a product baseline. It is, therefore, beneficial for systems engineers to account for later phases of the project starting from its early stages, such as concept design and evaluation. We present a quantitative methodology with human decision-makers in the loop based on the design for manufacturing considerations, to support systems engineers in bridging the gap between the design phase and later phases of the lifecycle of the development of a complex system. The developed methodology consists of three phases main stages: “product definition and production context identification,” “design alternatives investigation,” and “analysis,” considering critical manufacturing phases and parameters. This paper demonstrates the proposed methodology on a case study of the design of a medical device for wheelchair support. Our approach allowed us to reduce the cost and time of production by 18.3 and 16.8 percent, respectively, by identifying areas of improvement of the design that accounted for manufacturing and assembly considerations. In the paper, we discuss the advantages and limitations of our approach and identify possibilities for future work in the area.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"49 2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124179640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B. Tekinerdogan, Kaan Özcan, Sevil Yagiz, Iskender Yakin
{"title":"Systems Engineering Architecture Framework for Physical Protection Systems","authors":"B. Tekinerdogan, Kaan Özcan, Sevil Yagiz, Iskender Yakin","doi":"10.1109/ISSE49799.2020.9272215","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272215","url":null,"abstract":"A physical protection system (PPS) integrates people, procedures, and equipment for the protection of assets or facilities against theft, sabotage, or other malevolent intruder attacks. In this paper we focus on the architecture modeling of PPS to support the communication among stakeholders, analysis and guiding the systems development activities. A common practice for modeling architecture is by using an architecture framework that defines a coherent set of viewpoints. Existing systems engineering modeling approaches appear to be too general and fail to address the domain-specific aspects of PPSs. On the other hand, no dedicated architecture framework approach has been provided yet to address the specific concerns of PPS. In this paper, we present an architecture framework for PPS (PPSAF) that has been developed in a real industrial context focusing on the development of multiple PPSs. The architecture framework consists of six coherent set of viewpoints including facility viewpoint, threats and vulnerabilities viewpoint, deterrence viewpoint, detection viewpoint, delay viewpoint, and response viewpoint. We illustrate the application of the architecture framework for the design of a PPS architecture of a building.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"2018 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114698212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Elspas, Jacob Langner, Michael Aydinbas, Johannes Bach, E. Sax
{"title":"Leveraging Regular Expressions for Flexible Scenario Detection in Recorded Driving Data","authors":"P. Elspas, Jacob Langner, Michael Aydinbas, Johannes Bach, E. Sax","doi":"10.1109/ISSE49799.2020.9272025","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272025","url":null,"abstract":"For the development of Advanced Driver Assistant Systems (ADAS) and Automated Driving Systems (ADS) large amounts of driving data are collected. Storing, processing and analyzing this data requires significant efforts. For these efforts to pay off, data must be made accessible and reusable for different development phases from specification to testing. However, raw measurement data can largely vary in format, configuration and comprehensiveness. Adding meaningful, semantic labels to the data, also called data enrichment, is a promising way to improve searchability and to compute aggregating statistics over large databases. In this work we identify challenges and define requirements for data enrichment of real world measurement data for ADAS and ADS. We suggest a framework as a general and modular processing pipeline to tackle common challenges of real world data. Within this framework we support Boolean expressions to reduce multivariate time series to states of interest. Finally regular expressions are used as a deterministic method to identify semantically meaningful sequences. We demonstrate the flexibility of this approach by detecting lane change and cut-in maneuvers. The proposed methods prove to be well suited for robust maneuver detection with varying durations.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"93 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116001657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Genetic Algorithm Based Fuzzy Cognitive Map Concept Relationship Determination and Sigmoid Configuration","authors":"Turan Goktug Altundogan, Mehmet Karaköse","doi":"10.1109/ISSE49799.2020.9272216","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272216","url":null,"abstract":"Fuzzy cognitive maps take the features of a problem or a system as a concept to solve a problem or to model real world systems. Here, the positive or negative relationships between the concepts of fuzzy cognitive map are expressed with fuzzy weights, and the proposed solution or cognitive construction of the system model is completed. Previously, many different perspectives have been proposed in the literature for FCM weighting. Some of them utilize an expert group to determine the relationships between concepts, some using Hebbian-based methods, some using population-based meta-heuristic optimization methods, and some FCMs use different supervised computational intelligence methods. For FCMs that use supervised learning techniques in weight determination and updating, it is not possible to provide a data set with system-related conceptual relationships. Data sets for systems or problems generally contain the values that the concept values take over time. In this study, it is aimed to bring the cognitive weights corresponding to the concept values of the raw data sets of the systems to be expressed with FCM by a genetic algorithm based method. The method tested on different scenarios has a very high performance.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"130 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130865913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"System Design and Simulation of a Human Electric Hybrid Vehicle in AVL CRUISE","authors":"Mehmet Ali Ongun, U. Kiran, A. Sakalli","doi":"10.1109/ISSE49799.2020.9272232","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272232","url":null,"abstract":"In this paper, system design of a series-parallel human powered hybrid electric vehicle, namely Human Electric Hybrid (HEH), is presented and the system is validated by AVL CRUISE simulations. The proposed powertrain architecture and working principles of operating modes are presented from systems engineering point of view. The powertrain layout consists of two electric machines, a bicycle pedal controlled by human, mechanical elements (gear, clutch, and transmission), power electronics and control units. To simulate our proposed powertrain system within a realistic simulation environment, a vehicle model is constructed in AVL CRUISE. As the scope of simulations, all vehicle operating modes are tested over a pre-defined driving cycle. The simulation results show that the superiority of the proposed powertrain layout is exploited not only in the achievement of various operation modes like a full hybrid passenger car, but also the effectively contribution of the human power as propulsion source.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"94 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116072374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Agent Based Cybersecurity Model for Business Entity Risk Assessment","authors":"Lirim Ashiku, C. Dagli","doi":"10.1109/ISSE49799.2020.9272234","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272234","url":null,"abstract":"Computer networks and surging advancements of innovative information technology construct a critical infrastructure for network transactions of business entities. Information exchange and data access though such infrastructure is scrutinized by adversaries for vulnerabilities that lead to cyber-attacks. This paper presents an agent-based system modelling to conceptualize and extract explicit and latent structure of the complex enterprise systems as well as human interactions within the system to determine common vulnerabilities of the entity. The model captures emergent behavior resulting from interactions of multiple network agents including the number of workstations, regular, administrator and third-party users, external and internal attacks, defense mechanisms for the network setting, and many other parameters. A risk-based approach to modelling cybersecurity of a business entity is utilized to derive the rate of attacks. A neural network model will generalize the type of attack based on network traffic features allowing dynamic state changes. Rules of engagement to generate self-organizing behavior will be leveraged to appoint a defense mechanism suitable for the attack-state of the model. The effectiveness of the model will be depicted by time-state chart that shows the number of affected assets for the different types of attacks triggered by the entity risk and the time it takes to revert into normal state. The model will also associate a relevant cost per incident occurrence that derives the need for enhancement of security solutions.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114270777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Binder, Katharina Polanec, Franz Schweiberer, C. Neureiter, G. Lastro, A. Lüder
{"title":"Using a model-based engineering approach for developing Industrial Internet of Things applications","authors":"C. Binder, Katharina Polanec, Franz Schweiberer, C. Neureiter, G. Lastro, A. Lüder","doi":"10.1109/ISSE49799.2020.9272026","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272026","url":null,"abstract":"A new trend in the manufacturing sector, better known by the term “Industry 4.0”, will influence all areas and increase the complexity of production processes, product development, maintenance and disposal. The integration of information and communication technologies (ICT) and the advantages of the Industrial Internet of Things (IIoT) will result in automation processes aiming to optimize efficiency or reduce expenses. However, this results in the emergence of on-demand manufacturing as well as the provision of personalized goods and services, produced in the context of shortened innovation cycles. However, the downside of this trend is the uprising complexity that appears when engineering such systems. Thus, the Reference Architecture Model Industry 4.0 (RAMI 4.0) has been developed by several German associations in order to cope with the complexity of such cross-disciplinary systems. However, at the current point of view, this framework is exhibiting a gap between the architectural model and actual industrial applications. Thus, this paper introduces an approach proposing Round-trip Engineering (RTE) of previously modeled industrial system components. In order to do so, first the information and communication architecture is modeled according to the specifications of RAMI 4.0 and by utilizing OPC UA. Subsequently, the modeled components are generated and applied with the help of FREDOSAR, an open-source system architecture aimed for the application in such a complex system. In the end, data exchange between RAMI 4.0 and the industrial application is established by realizing a bidirectional interface, which is evaluated with a typical industrial case study.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"92 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127001408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"When Mini-AES Meets Machine Learning: Practice and Experience","authors":"Xian Liu","doi":"10.1109/ISSE49799.2020.9272227","DOIUrl":"https://doi.org/10.1109/ISSE49799.2020.9272227","url":null,"abstract":"It is interesting to investigate the decryptability of machine learning methodology for a compact block cypher: Mini-AES. In the present work, we design a neural network with three hidden layers and a moderate number of neurons. Trained by a moderate number of random pairs of plaintext and ciphertext, this neural network can successfully decrypt Mini-AES.","PeriodicalId":112760,"journal":{"name":"2020 IEEE International Symposium on Systems Engineering (ISSE)","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134217546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}