Maritime vessels are complex systems that generate and require the utiliza-tion of large amounts of data for maximum efficiency. Designing, develop-ing, and deploying maritime systems in a digital world requires rethinking how people interact and utilize technology to improve the development process. However, while different technologies have been deployed with various levels of success the current challenge is not generating data but be-ing able to harmoniously integrate different data streams into the decision-making process. To this purpose, a development framework to support changeability has been identified as being necessary for the development of next generation value-added vessels. This work incorporates literature and industry interviews to develop a framework for changeable system devel-opment. The contribution of this paper is the establishment of a develop-ment framework for changeability that can be integrated into the Systems Engineering development approach to improve decision making through the inclusion of data driven feedback loops.

A continuous digital thread is not yet fully supported by the product lifecycle tools. A particular discontinuity appears between Model-Based Systems Engineering (MBSE) and Product Lifecycle Management (PLM) solutions and methodologies. Seamless data exchange is an essential element to achieve system components integration, that would support positive emergence and prevent negative ones. A significant integration challenge lies at the heart of MBSE and PLM solutions, since the former facilitates system conceptual design, while the latter focuses on detailed design. However, these two domains are missing common language elements and concepts. We foresee that this could be facilitated through better interface management definition, as one of the most critical integration processes which contains information about both behavior and form, thus, links conceptual and detailed design. In our paper, we propose to use a Design Structure Matrix as a supporting tool to achieve a continuous digital thread, necessary for Digital Engineering solutions. To verify this approach, an aircraft bleed-air system was used as a use-case. We demonstrate that this method can effectively enrich the interface management and control processes through the analysis of metaphors for interface representation proposed by the conceptual design language and product mock-up.

The complexity of innovative products is increasing due to implementation of emerging technologies and rise in system complexity because of greater system and software functionality and inter connectivity, to address the challenge, multiple engineering disciplines must be well-coordinated in product lifecycle management tools. Complexity of novel products have also demanded the establishment of life cycle spanning development from the conceptualization till product realization. The application of MBSE inside PLM tools to keep requirements-in-loop becomes paramount for timely decision support. Unfortunately, keeping a requirements traceability within product development is still a challenge. In aerospace domain, due to innate complexity results in huge number of mission critical requirements which need to be verified and validated to make well informed design decisions throughout the product development process. In this paper, we have proposed a method to implement MBSE using RFLP approach in PLM tool using a Cubesat case study, to keep requirements-in-loop during initial phase of product development.

The steady growth of life expectancy calls for a new view on the importance of MedTech combination product development. One can envision that to keep a higher quality of life, more people would require some form of therapy depending on their individual state of health. This would require more medical devices of different types and complexity to be designed for specific drugs. However, from a holistic perspective, several challenges emerge in the development of drug-device combination products. An additional layer of complexity appears due to the increasing complexity of the MedTech devices, as they interact with the other systems and products in the design environment. This paper discusses those potential challenges and proposes ways to mitigate them. The primary focus of this work is on the drug delivery systems, such as autoinjectors.

Data generated throughout the product development lifecycle is often unused to its full potential. Knowledge-Based Engineering (KBE), through the capture, management, and effective reuse of design knowledge, aims to develop strategies to reduce the time and cost of product development. While KBE methods have been deployed in different sectors, using different commercial solutions, scholars still point to various shortcomings of these solutions. This paper focuses on the process and challenges an organization faces through the digital transformation for integrating KBE processes and how a Digital Twin (DT) platform can serve as the core technical infrastructure for a Knowledge-Based System (KBS). A Portuguese company redesigning its Power Transformer (PT) development processes is used as a case study.