Client Profile

A top-tier global Medical Device Manufacturer and Pharmaceutical company operating in a complex, regulated environment while also expanding through mergers and acquisitions.

Business Challenge

The client faced significant challenges in implementing and maintaining a global Product Lifecycle Management (PLM) initiative within its Medical Device sector. The objective was to harmonize processes, gain efficiencies, and realize cost savings through a centralized PLM shared services solution. The multi-year project scope included onboarding over 18 operating companies, managing millions of records, and supporting thousands of users globally. With an ongoing program roadmap, additional operating companies continue to be onboarded onto this strategic platform. The implementation methodology for this project follows the Scaled Agile Framework (SAFe) using SAFe Lean-Agile Principles.

The Solution

As a long-term strategic partner, our consulting team fulfilled the following key roles to support the PLM systems consolidation initiative:

1. Data Migration:

• Provided dedicated teams of Data Migration Leads, Testers, and Scrum Masters to successfully deliver complex data migration workstreams.

• Migration scope included millions of documents, parts, CAD drawings, and their complex relationships.

• Developed integrations with Learning Management Systems and multiple other enterprise systems.

• Managed migration projects using the SAFe Scrum approach, utilizing Jira Align and Confluence tools.

2. Base Business Management:

• Supported the harmonized PLM system, which serves multiple operating companies and thousands of users.

• Provided a Scrum Master and several Test Leads to manage and test the production backlog of bugs and issues using the SAFe Kanban approach.

• Deployed new releases to the production environment every 4–6 weeks to ensure system stability and continuous improvements.

3. Special Projects:

• Assigned senior Scrum Masters to manage several emerging initiatives following the SAFe Scrum approach, including:

• Extracting PLM data into materialized views and staging it in a regulatory database to enable robust data analytics and reporting.

• Leading a new AI team to implement automated functionalities, such as Natural Language Processing (NLP) to streamline and automate the change-checking process.

Proven Results

By leveraging our expertise in data migration, system management, and emerging technologies, we played a crucial role in the successful execution of the client’s digital transformation and PLM consolidation strategy. Our partnership ensured improved system efficiency, streamlined processes, and a scalable roadmap for future growth within the organization’s PLM ecosystem.

Business Benefits & Value Provided:

• Operational Efficiency: Reduced manual efforts and accelerated data migration, ensuring minimal business disruption and optimized system performance.

• Cost Savings: Achieved significant reductions in operational costs by consolidating multiple PLM systems into a single harmonized platform.

• Enhanced Compliance & Reporting: Strengthened regulatory compliance by enabling better data management and real-time analytics, providing a robust foundation for audits and inspections.

• Agility & Scalability: Implemented a flexible and scalable PLM framework that accommodates future acquisitions and business growth.

• Innovation & Automation: Introduced AI-driven automation capabilities, enhancing data validation, change management, and overall system usability.

• Improved User Experience: Delivered an intuitive, user-friendly PLM platform with streamlined workflows, ensuring higher adoption rates and user satisfaction.

Through our strategic partnership, the client was able to transform its PLM landscape, driving innovation, efficiency, and long-term success in a highly regulated industry.