Beyond Biomaterials: Integrated Services for Medical Device Innovation
Accelerate development, reduce technical and regulatory risk, and bring innovative medical devices to market faster through Evonik's integrated biomaterials, development, manufacturing, and regulatory expertise.
Accelerating Medical Device Development with RESOMER® Expertise
Developing innovative medical devices requires balancing technical performance, regulatory expectations, manufacturing scalability, and commercialization timelines. Evonik helps medical device companies navigate these challenges by combining biomaterial expertise, development services, and manufacturing support within a single integrated organization.
As the manufacturer of the RESOMER® portfolio of medical-grade bioresorbable polymers, Evonik supports medical device companies with a broad range of value-added services designed to simplify development, reduce risk, and accelerate commercialization. From initial material selection through process optimization and regulatory submission, our multidisciplinary teams help transform innovative concepts into market-ready medical devices.
Unlike organizations that provide either biomaterials or development services, Evonik combines both within a single development ecosystem. As the manufacturer of RESOMER® medical-grade bioresorbable polymers, we provide direct access to experts in polymer chemistry, processing, analytical testing, quality systems, and commercialization support throughout the product lifecycle.
Whether you are developing orthopedic implants, cardiovascular devices, tissue engineering solutions, drug-device combinations, wound care products, or advanced surgical technologies, our technical specialists collaborate closely with your team to overcome development challenges and shorten time to market.
Our teams support the development of a wide range of medical technologies, including:
· Orthopedic fixation devices, anchors, screws, and regenerative implants
· Cardiovascular and structural heart technologies
· Drug-device combination products and controlled-release platforms
· Tissue engineering and regenerative medicine solutions
· Wound management and surgical products
· Soft tissue reinforcement meshes and films
· Emerging bioresorbable device applications
While many organizations can provide individual services, few offer the integrated biomaterials expertise, development support, and manufacturing capabilities required throughout the entire product lifecycle.
Why Partner with Evonik?
From concept development through commercialization, Evonik provides integrated support designed to help customers reduce risk, accelerate timelines, and improve development efficiency.
· Decades of RESOMER® bioresorbable polymer expertise
· Integrated support from concept through commercialization
· Analytical, testing, and process development capabilities
· Regulatory and quality system expertise
· ISO-certified and GMP-compliant manufacturing operations
· Custom polymer and component manufacturing solutions
A Development Partner Throughout the Entire Product Lifecycle
Medical device innovation involves numerous technical and regulatory hurdles. Our integrated support model enables customers to access specialized expertise at every stage of development.
A comprehensive understanding of material performance is essential for successful device design. Our analytical laboratories provide in-depth characterization of bioresorbable polymers, components, and finished devices.
Services include:
· Polymer characterization and material analysis
· Mechanical performance testing
· Stability and degradation assessments
· Failure analysis and troubleshooting
· Material comparison studies
· Customized analytical methods
These capabilities help manufacturers generate critical data to optimize device performance, validate material selection, and support development decisions.
Speed is critical in medical device development. Our prototyping services enable fast iteration cycles, allowing development teams to evaluate concepts, refine designs, and generate proof-of-concept devices more efficiently.
Benefits include:
· Accelerated design evaluation
· Reduced development timelines
· Early-stage performance assessment
· Support for preclinical development activities
· Faster transition toward clinical readiness
This approach helps innovators make informed decisions before investing in large-scale manufacturing.
For customers seeking specialized manufacturing support, we provide the production of high-quality medical device components using advanced polymer and textile processing technologies.
Our expertise includes:
· Bioresorbable fibers and textiles
· Customized medical device components
· Process transfer support
· Pilot and small-scale production
· Manufacturing feasibility assessment
These services allow developers to access proven manufacturing capabilities while focusing internal resources on innovation and product strategy.
Successful product development requires more than material supply. Our application development teams work alongside customers to address practical challenges associated with bioresorbable medical devices.
Support may include:
· Material selection guidance
· Device design recommendations
· Processing strategy development
· In vitro performance evaluation support
· Manufacturing transfer activities
· Technical troubleshooting
By integrating material science and application knowledge, we help customers identify efficient pathways from concept to commercialization.
Material selection decisions can have significant implications for global regulatory strategy, submission success, and long-term product lifecycle management. Early access to technical documentation, quality system expertise, and material-specific knowledge can support development planning and reduce potential delays during regulatory review processes. As regulatory requirements continue to evolve, access to reliable material documentation and experienced technical support becomes increasingly important for successful submissions.
To support regulatory submissions worldwide, we maintain extensive technical documentation for the RESOMER® portfolio and provide a strong quality framework aligned with medical device industry expectations.
Our support includes:
· Material documentation packages
· Technical dossiers and Master File support
· Quality management expertise
· GMP-compliant manufacturing environment
· ISO-certified production processes
· Regulatory consultation for material-related questions
This foundation helps streamline customer regulatory activities while reducing documentation burden during product development and approval.
Not every medical device application can be addressed with a standard polymer solution. Our Contract Manufacturing Organization (CMO) services enable customers to access tailored polymer development and manufacturing capabilities.
Areas of support include:
· Custom polymer synthesis
· Polymer design and optimization
· Scale-up manufacturing
· Process development
· Medical device component production
· Rapid prototyping and pilot production
In addition to RESOMER®, our expertise extends to specialized medical-grade materials including Endexo®, VESTAKEEP®, Vecollan®, and Biocellic+, providing developers with a broad toolbox of advanced biomaterial solutions.
Why Medical Device Companies Choose RESOMER®
For decades, medical device innovators have utilized RESOMER® biomaterials across a broad range of bioresorbable and implantable medical device applications. This experience enables Evonik to support customers with established material knowledge, technical expertise, and practical development insights from concept through commercialization.
Medical device innovators partner with Evonik for more than access to high-quality bioresorbable polymers. They gain a development partner with expertise spanning material science, analytical testing, process development, manufacturing scale-up, quality systems, and regulatory support.By combining medical-grade bioresorbable polymers, application expertise, analytical capabilities, and manufacturing services under one roof, we help customers:
· Reduce development complexity
· Mitigate technical and regulatory risks
· Accelerate product development timelines
· Improve manufacturing readiness
· Generate critical performance data
· Bring innovative medical devices to market faster
Advancing the Next Generation of Bioresorbable Medical Devices
The journey from concept to commercial medical device requires trusted expertise at every step. With RESOMER® bioresorbable polymers and Evonik's comprehensive development services, medical device manufacturers gain a collaborative partner committed to advancing innovation, performance, and patient outcomes.
Ready to accelerate your development program? Connect with a RESOMER® technical specialist to discuss material selection, process development, manufacturing scale-up, regulatory support, or custom biomaterial solutions for your next medical device innovation.
