## 1 Introduction  
The early Product Design phase is considered one of the cornerstones of successful production equipment design. Over time, various design methodologies were created due to how designers gain the specific knowledge they need to understand user requirements and make decisions for the particular use case [1, 2]. From a philosophical standpoint, knowledge and design are inherently related in the form of ontology, the science of things that exist, and epistemology, which is the methodology used to achieve and correctly understand knowledge [3]. [PERSON] [4] found an early definition for Ontology in the context of computer science as an \"explicit specification of a conceptualization\". This term is explained as \"what exists is exactly that which can be represented\". Later, [PERSON] et al. [5] expanded this definition with a domain-specific component: \"an ontology is a formal, explicit specification of a shared conceptualization\". The term \"conceptualization\" hereby stands for \"an abstract, simplified view of the world that we wish to represent for some purpose\", as a general definition for knowledge representation for a specific use case [6]. Following the ideas of these statements, a structured design process starts with something existing (Ontology). It moves into a formalized information flow of reasoning or a cognitive process (Epistemology), resulting in a new situation that becomes Ontology [3]. From a practical perspective, a design process starts with the requirements analysis and resulting requirement list, which act as design guidelines throughout the project. Designers have to distinguish between technical (functional) and non-technical (economical) attributes while working on conceptual designs [7]. Efficiently reusing knowledge to structure and organize information is a relevant topic. Designers with rich backgrounds in the specific area may handle this intrinsically, but faster-changing products and shorter innovation cycles lead to a different situation [8]. Increasingly, design methods for customized products have become necessary due to the impact of Industry 4.0 on many branches. According to [PERSON] et al. [9], these One-of-a-Kind products come with three main obstacles to product design. First, the product development timespan decreases; second, order sizes decrease; and third, product variety in production increases. To overcome these challenges, companies must find a way to reuse historical product knowledge and manage their resources very efficiently. Some researchers have focused on identifying requirements more straightforwardly and precisely through direct communication and information sharing using web technology [9]. The connection between modeling tools and design methods is seen as an enabler for high-quality products that are no longer based on the experience of designers and managers alone, and it opens possibilities like automated design [10]. Scholars have sought to structure design processes and incorporate quality assurance mechanisms for years. One way of doing this is to use Lean principles to bring product knowledge back from production to design, enhancing the manufacturability and testability and thus increasing the product quality [11]. Developing and designing new pharmaceutical devices is a challenging task requiring knowledge from various disciplines. As regulatory impact is a quality assurance method, there are helpful guidelines and tools to achieve compliance. The most recognized technique to support the high-quality development of custom applications is the V-model described in the GAMP 5 guidelines [12]. The core of the V-Model is a strictly regulated process, in which the requirements for a system must first be fully defined in the specification before work can begin in the subsequent phases [13]. According to this model, each specification must be accompanied by a test strategy to ensure that the implementation meets the requirements. The approach in GAMP 5 complements a well-known conceptual design strategy with a risk-based approach.