A Model-Based Approach to Comprehensive Risk Management for Medical Devices

The European medical technology industry consists of around 27,000 companies, more than 95% of them small and medium-sized enterprises (SMEs), with over 675,000 employees [MEDT17]. In the European Union (EU) alone, medical devices constituted by far the biggest part of the medical technology (MedTech) sector with a market of 95 billion euros in annual sales in 2015 [EURO15].The European medical technology industry consists of around 27,000 companies, more than 95% of them small and medium-sized enterprises (SMEs), with over 675,000 employees [MEDT17]. In the European Union (EU) alone, medical devices constituted by far the biggest part of the medical technology (MedTech) sector with a market of 95 billion euros in annual sales in 2015 [EURO15]

A Review on Application of Model Based Systems Engineering to Manufacturing and Production Engineering Systems

Increasing complexity in today’s manufacturing and production industry due to the need for higher flexibility and competitiveness is leading to inconsistencies in the iterative exchange loops of the system design process. To address these complexities and inconsistencies, an ongoing industry trend for organizations to make a transition from document-centric principles and applications to being model-centric is observed. In this paper, a literature review is presented highlighting the current need for an industry-wide transition from document-centric systems engineering to Model-Based Systems Engineering (MBSE). Further, investigating the tools and languages used by the researchers for facilitating the transition to and the integration of MBSE approach, we identify the most commonly used tools and languages to highlight the applicability of MBSE in the manufacturing and production industry

Development of New Model-based Methods in ASIC Requirements Engineering

Requirements in the development of application-specific integrated circuits (ASICs) continue to increase. This leads to more complexities in handling and processing the requirements, which often causes inconsistencies in the requirments. To better manage the resulting complexities, ASIC development is evolving into a model-based process. This thesis is part of a continuing research into the application and evolution of a model-based process for ASIC development at the Robert Bosch GmbH. It focuses on providing methologies that enable tracing of ASIC requirements and specifications as part of a model-based development process to eliminate inconsistencies in the requirements. The question of what requirements are and, what their traceability means, is defined and analysed in the context of their relationships to models. This thesis applies requirements engineering (RE) practices to the processing of ASIC requirements in a development environment. This environment is defined by availability of tools which are compliant with some standards and technologies. Relying on semi-formal interviews to understand the process in this environment and what stakeholders expect, this thesis applies the standards and technologies with which these tools are compliant to provide methodologies that ensures requirements traceability. Effective traceability methods were proven to be matrices and tables, but for cases of fewer requirements (ten or below), requirement diagrams are also efficient and effective. Furthermore, the development process as a collaborative effort was shown to be enhanced by using the resulting tool-chain, when the defined methodologies are properly followed. This solution was tested on an ASIC concept development project as a case study

Supporting ISO 26262 with SysML, Benefits and Limits

International audienceThis article deals with the issue of deploying efficiently the ISO 26262: the new standard in automotive systems development. The directives enclosed in this norm demands the establishment of a product lifecycle fully integrating the safety assessment activities. To tackle this subject, this paper explores the way of setting up Model-Based Design methodology to express and organize the concepts manipulated during the ISO 26262 process. This attempt is founded on the use of SysML and on the creation of a profile dedicated to ISO 26262 development context. We provide an introduction to Model-Based Design paradigm and its appli-cation in a safety relevant context. An overview of ISO 26262 is given, followed by the description of an on-going project on the subject. Modeling propositions are formulated and the use of diverse SysML diagrams are mapped on the automotive safety lifecycle process

Digital Twin: towards the integration between System Design and RAMS assessment through the Model–Based Systems Engineering

The design of a safety-critical system requires an effective prediction of its reliability, availability, maintainability and safety (RAMS). Anticipating the RAMS analysis at the concept design helps the designer in the trade-off of the system architecture and technologies, reduces cost of product development and the time to market. This action is rather difficult, because the RAMS analysis deals with the hazard assessment of system components, whose abstraction at concept level is never simple. Therefore, to integrate the system design and RAMS assessment, a clear path to follow is required. The paper investigates how the Model Based Systems Engineering (MBSE) supports this task and drives the system reliability allocation, through the functional and dysfunctional analyses. The implementation of the proposed approach needs to set up the tool chain. In the industrial context it must be compatible with practices, standards and tools currently used in product development. Defining a suitable process of integration of tools used for the System Design and the Safety Engineering is a need of industry. Therefore, this task is also discussed, in this paper, dealing with some examples of industrial test case

Ares Upper Stage Processes to Implement Model Based Design - Going Paperless

Computer-Aided Design (CAD) has all but replaced the drafting board for design work. Increased productivity and accuracy should be natural outcomes of using CAD. Going from paper drawings only to paper drawings based on CAD models to CAD models and no drawings, or Model Based Design (MBD), is a natural progression in today?s world. There are many advantages to MBD over traditional design methods. To make the most of those advantages, standards should be in place and the proper foundation should be laid prior to transitioning to MBD. However, without a full understanding of the implications of MBD and the proper control of the data, the advantages are greatly diminished. Transitioning from a paper design world to an electronic design world means re-thinking how information gets controlled at its origin and distributed from one point to another. It means design methodology is critical, especially for large projects. It means preparation of standardized parts and processes as well as strong communication between all parties in order to maximize the benefits of MBD

MBSE Applied to an Aerospace ‘Force Fighting’ Application

International audienceThe aerospace industry is a domain where system engineering, and in particular Model Based System Engineering (MBSE), has been adopted extensively. Based on a feedback of the ongoing development of a technical use case, this paper provides a high level view of MBSE state-of-the-art and current state-of-practice as provided through the Dassault Systèmes (DS) Product Lifecycle Management (PLM) solutions

Challenges of implementing MBSE in industry: a tool vendor experience

Model Based Systems Engineering (MBSE) offers a systematic approach to address the challenges faced by industries in developing complex systems. However, the full implementation of MBSE Process, Methods, and Tools (PMT) in industry remains a challenge. This paper focuses on the implementation of the 3DEXPERIENCE MBSE toolchain by Dassault Systèmes Industrial Service (DSIS), introduces the typical challenges observed during the MBSE implementation process and categorizes them into five types. Based on industrial best practices and service experiences, the paper proposes multiple solution elements to overcome these challenges. These elements emphasize stakeholder support, establish an experience-based MBSE capability, enrich MBSE capabilities to solution bricks, create an implementation plan and validate through proof of concepts. The interdependency between solution elements allows efficient implementation and realization of short-term benefits. The paper concludes by discussing the value and applicability of the proposed solution elements, highlighting their potential for the industrial practice. The chapter closes with an outline of future steps to mature and advance the solution elements

An architectural description for the application of MBSE in complex systems

The design of a complex warship is a multi-disciplinary effort which often encounters major challenges, particularly with respect to integration across interfaces in the System of Systems (SoS). In principle, the goal of Model Based Systems Engineering (MBSE) with respect to system design is to provide a means of capturing and communicating the system design in a structured, consistent, and coherent fashion; that can be easily assessed by engineering teams and quickly analysed using queries and toolsets. The focus of this paper is to investigate the potential to achieve a consistent description, identify a viable methodology that minimises mismatch in requirements and to avoid an extended design lifecycle. This study highlights the need to develop a generic Architectural Description (AD) that is based on a common ontology which would clearly define the fundamental tenets of applying state-of-the-art Architectural Frameworks (AFs) in naval ship design. An investigation on the effectiveness and accuracy of a graph-based approach is needed to assess whether it is possible to create a ‘Rosetta stone’ for AFs, which links any two or more different model viewpoints in different AF’s using the approach

Developing Executable Digital Models with Model-Based Systems Engineering – An Unmanned Aerial Vehicle Surveillance Scenario Example

There is an increase in complexity in modern systems that causes inconsistencies in the iterative exchange loops of the system design process and in turn, demands greater quality of system organization and optimization techniques. A recent transition from document-centric systems engineering to Model-Based Systems Engineering (MBSE) is being documented in literature from various industries to address these issues. This study aims to investigate how MBSE can be used as a starting point in developing digital twins (DT). Specifically, the adoption of MBSE for realizing DT has been investigated, resulting in various literature reviews that indicate the most prevalent methodologies and tools used to enhance and validate existing and future systems. An MBSE-enabled template for virtual model development was executed for the creation of executable models, which can serve as a research testbed for DT and system and system-of-systems optimization. This study explores the feasibility of this MBSE-enabled template by creating and simulating a surveillance system that monitors and reports on the health status and performance of an armored fighting vehicle via an Unmanned Aerial Vehicle (UAV). The objective of this template is to demonstrate how executable SysML diagrams are used to establish a collaborative working environment between multiple platforms to better convey system behavior, modifications, and analytics for various system stakeholders