admin 22nd August 2025

A leading global manufacturer of Class II and III medical devices approached Katalyst Engineering to address a critical challenge: streamlining and scaling their Product Lifecycle Management (PLM) operations. With engineering teams split between the U.S. and EU, the client needed to relieve their core engineering talent from time-consuming administrative and compliance-related PLM tasks. Their vision was clear — enable faster innovation and regulatory readiness without compromising quality.

Project Scope

The client sought a strategic partner to optimize their CAD updates, Engineering Change Orders (ECOs), BOM management, DHF maintenance, and documentation control. The goal was to:

• Reduce documentation turnaround time by up to 40%
• Improve BOM-to-CAD-to-DHF synchronization for accuracy and efficiency
• Ensure audit-ready traceable documentation across all product records
• Free U.S./EU teams to focus on product innovation and regulatory submissions

Katalyst Engineering’s Design Approach

1. Building an Offshore Excellence Team

Katalyst Engineering formed a dedicated offshore engineering team with specialized expertise in medical device compliance and PLM best practices. This approach ensured seamless collaboration with the client’s core engineering teams while providing cost-effective scalability.

2. ECN Management in Windchill

We centralized the creation and management of Engineering Change Notices (ECNs) within Windchill PLM software, ensuring full version control and easy retrieval of historical data.

3. Standardization & Traceability

To eliminate inconsistencies, Katalyst implemented traceability matrices and standardized templates for CAD models, BOMs, and ECO documents. This step significantly reduced errors and made cross-team collaboration smoother.

4. Onshore-Offshore Collaboration Model

By maintaining real-time design intent validation with both offshore and onshore teams, we ensured that all updates were accurate, regulatory-compliant, and production-ready.

5. Advanced CAD/BOM Management

Leveraging Creo for CAD updates and Windchill for BOM control, we achieved consistent alignment between design and manufacturing data — a critical factor in avoiding costly rework and compliance failures.

Deliverables Achieved

• Fully updated CAD Models and 2D Drawings
• Multi-level Bill of Materials (BOMs)
• ECNs created and approved within reduced timelines
• Documentation discrepancies resolved across multiple PLM tools

Value Delivered to the Client

30–40% Reduction in Documentation Turnaround

By optimizing ECN processing, CAD/BOM synchronization, and DHF updates, we drastically cut the approval cycle time, helping the client meet tight regulatory submission deadlines.

Regulatory Readiness with Zero Compromise

The audit-ready, traceable documentation model ensured compliance with FDA, EU MDR, and other global medical device standards, reducing the risk of compliance-related delays.

Freed Engineering Time for Innovation

By offloading compliance-heavy tasks to Katalyst’s offshore team, the client’s U.S./EU engineers could focus on R&D, new product development, and strategic initiatives.

Cost-Effective Scaling

With the offshore model, the client gained cost efficiency while maintaining high-quality outputs — enabling them to scale documentation support without proportional cost increases.

Why Katalyst Engineering?

With decades of experience in medical device engineering, PLM optimization, and offshore collaboration models, Katalyst Engineering empowers manufacturers to work smarter, not harder. Our PLM solutions are designed to deliver measurable ROI, whether through faster market entry, reduced compliance risk, or enhanced product quality.

Conclusion

This collaboration demonstrates how strategic PLM outsourcing with Katalyst Engineering can drive speed, compliance, and efficiency for regulated industries like medical devices. By combining technical expertise with process discipline, we enabled the client to achieve faster product cycles, improved compliance, and cost savings — a blueprint for future-ready PLM operations.

Ready to streamline your PLM? Contact Katalyst Engineering today to explore how we can help your business accelerate innovation while maintaining regulatory excellence.