MOM blueprint for scalable and secure medtech greenfield manufacturing

Ypsomed is an internationally active manufacturer of innovative medical delivery systems such as injection and infusion systems. To build additional production capacity, the company is investing in a new high-tech manufacturing facility with a high degree of automation. This greenfield factory is intended not only to meet current demand but also to serve as a blueprint for further sites, whilst simultaneously fulfilling the high regulatory requirements of the medical technology sector.

Before the project began, the IT/OT landscape in the existing plants was heterogeneous and not future-proof. At the same time, the new production facility was to see a significant increase in the level of automation in manufacturing and logistics, and vertical integration was to be expanded through new production processes. This led to a considerable increase in technical and organisational complexity – particularly due to additional IT assets and rising IT security requirements. Added to this was a very ambitious schedule, as urgently needed additional production capacity had to be made available quickly.

Together with Ypsomed, adesso developed a comprehensive Manufacturing Operations Management (MOM) blueprint for the future smart factory. To this end, the existing plants were first analysed, best practices identified and potential for improvement highlighted. On this basis, a smart factory vision was created with clearly defined factory and digitalisation goals. Building on this, the functional and technical requirements for the systems were derived, a consistent integration concept from the ERP level down to the plant was designed, and a future-proof IT/OT reference architecture was conceived. A roadmap and a rough IT cost estimate are preparing the ground for the subsequent implementation of the concept.

• Analysis of existing plants and derivation of best practices for the new greenfield production facility
• Definition of a smart factory vision and the associated factory and digitalisation goals
• Functional and technical requirements analysis for MOM, production, logistics and quality
• Development of an end-to-end integration concept from ERP to the machine
• Design of a scalable IT/OT reference architecture for the smart factory
• Creation of a roadmap for the step-by-step implementation of the IT/OT concept
• Rough estimate of IT costs to prepare for the implementation project

With the developed MOM blueprint, Ypsomed now has a clear vision of what a Smart Factory specifically entails in the context of medical delivery systems. All relevant components of the Smart Factory – including a shortlist of suitable solutions – are described transparently. The jointly defined MOM process serves as the ‘single source of truth’ for further planning and implementation. The holistic integration concept prevents silo thinking and ensures that the factory functions as an integrated system, whilst the clear separation of tasks and functionalities across the systems sustainably reduces complexity and operational overheads. This enables Ypsomed to implement the planned capacity expansions efficiently, safely and in compliance with regulations, and to roll out the concept to further sites in the future.