About the Client
Ambu, a global medical device manufacturer, needed to modernise its Product Lifecycle Management (PLM) infrastructure. With nearly 2,000 users accessing a legacy Agile PLM system, operations were fragmented across disconnected processes and complex workarounds. InspireXT partnered with Ambu to conduct a comprehensive Fit-Gap Assessment , defining a strategic roadmap to migrate to a unified Oracle PLM Cloud environment. The goal was to move beyond isolated system visibility and create a connected operational view where product data, quality processes, and execution decisions flow together seamlessly.
Business Challenges
Fragmented PLM operations directly affect cycle times, compliance, and cost efficiency. At Ambu, product and quality changes were executed with heavy manual intervention, and system overkill suppressed user adoption. At scale, these misalignments compounded:
Process Inefficiencies: Manual approver assignments led to frequent delays, a higher likelihood of routing errors, and sluggish change and quality cycle times.
Compliance Risks: Instances where the Change Analyst and the Approver were the same individual compromised the strict segregation of duties required by standard change management controls.
System Overkill: Users were forced to apply full, complex change orders for minor updates, leading to process fatigue and inefficient document management.
Fragmented Engagement: High volumes of redundant global searches and over 40% of users showing low or no system engagement highlighted the disconnect between the legacy platform and the reality of the business.
What We Did
InspireXT designed a 28-week transformation programme focused on process re-engineering rather than a simple “lift and shift”. Our approach combines deep expertise in PLM across regulated industries with our PLM MigrateXT accelerator to deliver a seamless transition to Oracle PLM Cloud. Key solution elements include:
Selective Process Adoption: Implementing lightweight Document Change Requests (DCRs) for coordinated updates to parts and documents, bypassing the overkill of heavy change orders when unnecessary.
Intelligent Workflow Automation: Deploying automatic approver assignments based on strict business rules (e.g., change type, affected items) and auto-promoting statuses to reduce dependency on manual tracking.
Enterprise Integration: Establishing a connected ecosystem via Oracle Integration Cloud and Azure Data Factory to synchronise PLM in real-time with Profisee, Infor M3, SAP SuccessFactors, and Kallik Veraciti.
Master Data Governance: Utilising the 6-step PLM MigrateXT framework for data extraction, deep column profiling, and automated reconciliation to ensure pristine data fidelity prior to cloud deployment.
Value Delivered
By moving to a connected Oracle PLM Cloud environment, Ambu transforms its product and quality lifecycles into a highly visible, resilient operation:
- Accelerated Cycle Times: Automated task templates and dynamic routing eliminate manual bottlenecks, significantly speeding up time-to-resolution for quality and change cycles.
- Strengthened Compliance: System-enforced segregation of duties, electronic signatures, and automated audit trails ensure rigorous, uncompromised adherence to medical device industry regulations.
- Optimised User Adoption: A modern, cloud-native interface with unified search capabilities reduces cognitive load, driving higher, more meaningful engagement across the global workforce.
- Unified Data Visibility: The PLM MigrateXT framework ensures a clean, validated migration of historical data, providing a single, trusted source of truth that aligns planning, manufacturing, and quality execution without the need for manual reinterpretation.