Design & Development
Proprietary processes, proven results.
We collaborate closely with customers to develop breakthrough medical devices that are robust, safe, effective, and cost-efficient. Using advanced tools like digital modeling and digital twin technology, we optimize designs, simulate real-world performance, and accelerate time to market.
From early-stage ideation through process validation and volume production, we provide end-to-end support across the entire development spectrum. As a contract development and manufacturing organization (CDMO), we combine deep technical expertise with clinical acumen and vertically integrated manufacturing to deliver innovative solutions that advance patient care.
Combining experienced engineering resources with human factors and industrial design expertise
During the ideation and prototyping phase of the design process, Freudenberg Medical leverages a blend of seasoned engineering talent and industrial design expertise to guide concept development. We emphasize understanding customer needs through thorough research and effective communication tools, crafting clear problem statements to focus innovation.
This phase includes concept generation and selection, supported by bench-top test models and rapid prototyping to bring ideas quickly and accurately to life.
Deep clinical experience developing and manufacturing complex catheter and medical device systems
In the product development phase, we apply extensive clinical acumen to refine concepts and processes for complex catheter and medical device systems. This stage involves iterative testing and prototyping, thorough design verification, and performance evaluation through various engineering analyses, biological studies, and reliability testing.
Additionally, we focus on developing and validating test methods, packaging, sterilization, and material biocompatibility to ensure the final product meets rigorous clinical and regulatory standards.
Our teams are working in clinical and pre-clinical environments and have an unrelenting commitment to quality
In the Design for Manufacturability phase, we emphasize early collaboration between process engineers, customers, and the supply chain to ensure smooth design transfer and reliable production. Our teams apply rigorous quality control and lean manufacturing principles, including tools like 3P, to optimize equipment selection and process characterization well before qualification.
By leveraging extensive experience and internal resources, we focus on delivering defect-free products on time while continuously improving manufacturing efficiency.
Delivering Quality Through a Structured Design Process
Our team uses a multi-phase design process to deliver the best products possible to our customers.
This proven approach helps structure the flow of product development and ensures maximum collaboration at every step. Throughout the process we communicate frequently with our customers, provide consistent and timely production schedules, and thoroughly document each development process.
Expand Innovation Through
Freudenberg Group R&D
Our customers have direct access to the Freudenberg Group R&D Centers in Weinheim, Germany, and Plymouth, Michigan.
Established decades ago, these innovation hubs bring together more than a hundred PhD scientists and researchers with global scientific expertise in material and engineering to accelerate development times and optimize product performance.
Material
Development
Polymer formulation and materials engineering, boosted by AI and domain experience
Product Design
& Development
Data-driven product development through simulation, digital modeling, and digital twin technologies
Aging
Studies
to predict durability, proof compatibility and enhance shelf life
Surface
Technologies
to tailor product performance, antimicrobial properties, controlled release mechanisms, adhesion and bonding of materials
Analytics &
Characterization
Physical, optical, and chemical analytics and characterization capabilities for rapid problem solving and failure analysis
When medical device companies outsource design and development to us, either wholly or in part, they benefit in two ways: They are adding resources to strengthen their teams, and they have access to complementary capabilities and technologies that they lack themselves. This makes it possible for them to bring products to the market faster. With us, customers know they have a partner who always puts the patients first.
Dr. Paul Weafer
Director of Product Development
pre-developed product platform solutions
Speed up time-to-market and cut development costs
Accelerate your development with proven platform technologies. Our portfolio includes steerable catheters in various sizes, introducers for minimally invasive procedures, and hemostasis valves—engineered for performance, reliability, and seamless integration.
Ready for customization, these solutions help reduce risk, save time, and get your device to market faster. Backed by engineering expertise and vertically integrated manufacturing, our platform products provide a strong foundation for next-generation medical innovations.
