Development of bioanalytical devices requires a multidisciplinary team working together. In the current article, the model-based systems engineering (MBSE) methodology is applied for the design of a bioanalytical device, in order to create a unique system model with consistency of model elements and relations. This allows a multidisciplinary team to work together in order to define and develop the overall system, from bio/chemical processes to software, hardware, and mechanics; for example, scientists may express bio/chemical events in the system model in a way that the design engineers understand the process and requirements, learn the constraints, and develop the system accordingly. In the article, a tailored version of the object-oriented systems engineering method modeling method was used together with systems modeling language. The major steps of the modeling method utilized include define problem, define context level, define technical requirements, define logical level, and define physical level. The modeling method developed for the article may be used as a base for the development of bioanalytical devices. There is a market push to develop new bioanalytical devices, such as point of care sensors. It is believed that the transformation of the product lifecycle process from document centric to MBSE will provide a competitive advantage to the life sciences industry.

中文翻译：

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基于模型的系统工程工具进行生物分析设备设计

生物分析设备的开发需要一支跨学科的团队共同努力。在当前的文章中，基于模型的系统工程（MBSE）方法被应用于生物分析设备的设计，以便创建具有模型元素和关系一致性的唯一系统模型。这样一来，跨学科的团队就可以合作，以定义和开发从生物/化学过程到软件，硬件和力学的整个系统。例如，科学家可以通过设计工程师理解过程和要求，了解约束并相应地开发系统的方式来表达系统模型中的生物/化学事件。在本文中，定制版本的面向对象的系统工程方法建模方法与系统建模语言一起使用。使用的建模方法的主要步骤包括定义问题，定义上下文级别，定义技术要求，定义逻辑级别和定义物理级别。为本文开发的建模方法可以用作生物分析设备开发的基础。市场正在开发新的生物分析设备，例如即时护理传感器。人们相信，产品生命周期过程从以文档为中心向MBSE的转变将为生命科学行业提供竞争优势。市场正在开发新的生物分析设备，例如即时护理传感器。人们相信，产品生命周期过程从以文档为中心向MBSE的转变将为生命科学行业提供竞争优势。市场正在开发新的生物分析设备，例如即时护理传感器。人们相信，产品生命周期过程从以文档为中心向MBSE的转变将为生命科学行业提供竞争优势。