Enhancing Systems Thinking, MBSE and Cross-Team Collaboration in Regulated Industries on example of Novartis

Traditionally the development of drug products in combination with devices for administration and transportation (combination product) results in conflicting requirements of development teams. Based on totally different educational and work-cultural backgrounds, conflicts often arise because of different domain specific languages. Furthermore, different interpretations of combination products throughout various stages of their lifecycle often cause confusion and disagreements.
To bring the different teams together it is crucial to enhance Systems Thinking to enable cross-team collaboration of different design domains and build bridges. At Novartis an approach based on Model-Based Systems Engineering (MBSE) is utilized to enhance Systems Thinking based on stakeholder-specific view on the product. This allows to provide required information in the language of involved stakeholders and at the same time ensure consistency of the system specification.
This presentation will highlight insights gained while defining and deploying stakeholder-specific viewpoints to enhance cross-team collaboration and build bridges. Different exemplary measures will be depicted based on the current status at Novartis and a mapping to an acceptance model for change management will be presented. Additionally, a short example of a procedure for implementation of a stakeholder-specific viewpoints will be given.