Navigating Constraints: A Lightweight Systems Engineering Journey in Pharma and Medical Devices

This contribution shares the experience of supporting a pharmaceutical component supplier in re-engineering requirements for a novel solution built on legacy elements. While the client operates in a B2B context and delivers sub-components to system manufacturers, the final product is aimed at end users — a level of the value chain where the client holds no direct influence but faces increasing expectations for compliance and integration readiness.

To address this, a lightweight systems engineering approach was adopted, focused on identifying critical gaps and enabling structured development without overburdening existing processes. Key activities included eliciting internal knowledge through cross-functional workshops, defining system and sub-system requirements from fragmented legacy documentation, and interpreting regulatory constraints at the appropriate abstraction level.

Validation planning was tailored to those areas where the client could meaningfully support downstream integration, despite lacking visibility or control over the full system. The selection of a scalable requirements management tool and early preparation for variant handling added long-term value.

This experience demonstrates how a lightweight systems engineering approach enabled tangible project progress. It uncovered overlooked requirements, built consistent knowledge within the core team, and created a structured foundation for supporting future integration — even in a complex, distributed development context.