Program Management
Customers new to Freudenberg Medical often come to us after facing significant program management challenges that have impacted timelines and budgets.
Shifting project scopes, evolving regulatory requirements, supply chain disruptions, and the coordination of multiple development stages all require careful oversight and clear communication. Without strong cross-functional collaboration, early risk identification, and disciplined project execution, even small delays or design changes can cascade into costly setbacks.
Balancing technical innovation with efficient, well-structured program management is critical to ensure products are delivered on time, within budget, and meet the highest quality standards.
Driving Value Through Integrated Program Management
At the core of our approach is the belief that successful program management goes beyond timelines, it’s about delivering lasting value throughout the entire product lifecycle. Our vertically integrated model combines materials science, advanced manufacturing, and in-house design and development, all within a single organization. This structure enables faster decision-making, improved quality control, and reduced program risk.
Our seasoned, cross-functional teams, including experts in engineering, manufacturing, quality, and regulatory affairs, work in close partnership with customers from concept to commercialization. By identifying risks early and aligning on goals, we ensure smoother execution and stronger outcomes.
With this seamless, transparent collaboration, we help accelerate innovation, manage costs effectively, and bring high-performance medical devices to market with speed and confidence.
Standardized Gate Process
Freudenberg Medical employs a well-defined, standardized stage gate process to ensure seamless technology transfers and accelerate the introduction of new products.
A comprehensive process assessment proactively identifies risks and sets clear expectations, keeping projects on schedule and within budget. Standardized validation methodology ensures consistency and compliance across all Freudenberg Medical sites.
Our in-house expertise and best practices help bring products to market faster:
- Design for Manufacturability: Enhances product quality and enables efficient scale-up production.
- Lean Systems Expertise: Optimizes resources, manufacturing processes and layouts for maximum efficiency.
- New Product Introduction (NPI): Streamlines the transition of new customer products into production.
Freudenberg Medical's Stage Gate Process
We recognize the importance of applying these principles across all 12 global manufacturing sites, and have embedded a unified and harmonious program management framework within Freudenberg Medical. This ensures scalability, with consistent and compliant protocols observed across all sites. KPIs are introduced to measure progress and real-time feedback loops are implemented to suggest improvements to improve planning and validation processes.
Periodic phase reviews with customers also encourage accountability and hold the global team to the highest standards.
Quality and program management are inseparable in the development of safe, effective medical devices and components. Our cross-functional teams embed quality at every stage—driving better decisions, earlier risk mitigation, and reliable outcomes. By aligning robust quality systems with disciplined program execution, we go beyond compliance to deliver value to our customers and, most importantly, to patients.
Michael Kilday
VP Quality Assurance & Regulatory
