Process-driven approach to product launches in MedTech

New product launch workflows in regulated MedTech environments involve multiple interdependent business objects, cross-functional handovers, and formal compliance gates. Existing BPM frameworks address these dimensions separately, with no mechanism for verifying semantic consistency across structural, behavioral, and informational models simultaneously. This thesis applies the MMABP methodology to the country-level NPL workflow at Medtronic's CEE region to test whether cross-model consistency verification can surface process gaps and produce traceable performance indicators. The study follows a single embedded case study design combined with a design science research approach, producing four evaluated artefacts: an MMABP model set, a cross-model consistency assessment, a KPI catalogue, and a Power BI prototype. Model validity was assessed by four subject matter experts. The prototype was tested on a synthetic dataset. The model set comprises a process map, a UML class diagram (13 classes, 14 associations, and 1 composition), nine object life cycle state charts, and a BPMN process flow with six process states. Consistency was verified across five model pairs through eight checks. One temporal inconsistency was identified and corrected. The modelling discipline surfaced five process insufficiencies, independently corroborated by the expert panel, with full or partial recognition across all five gaps. Ten KPIs were derived through two paths: four communication-point KPIs following Řepa (2019a) and six state chart KPIs proposed in this thesis. The prototype received average expert scores of 4.25 - 4.50 across three Likert-based dimensions. The primary contribution is the formalization of state-chart KPI derivation as a systematic complement to MMABP, using the temporal consistency table as a bridge between process states and object life cycles. Four methodological refinements are proposed. The findings are bounded by a single-case design, synthetic data, and a small expert panel, but the analytical framework and the KPI derivation method are designed to be transferable to comparable regulated workflows.