BIOMATERIAL SOLUTIONS FOR IMPLANTABLE MEDICAL DEVICES

As a global biomaterials leader, Evonik serves as a development partner and solutions provider to many of the world's largest and most innovative medical device companies. Our portfolio of biomaterials, technologies and application services are used by our customers to enhance the bioavailability, safety and performance of their products.

A GLOBAL BIOMATERIALS DEVELOPMENT PARTNER AND SOLUTIONS PROVIDER FOR MEDICAL DEVICES

The implantable medical devices used across application areas including cardiovascular disease, orthopedics and wound healing continue to become more specialized and personalized.  One key enabling factor driving this market evolution is the development of advanced biomaterials that can optimize medical device safety, biocompatibility and performance.  As a global leader for biomaterials with a broad portfolio of products, technologies and services, Evonik has served as a development partner and solutions provider to many of the world’s largest and most innovative medical device companies for more than 30 years.  This portfolio includes a range of bioresorbable polymers, surface modification technologies, and services relating to custom polymer synthesis, and the development and scale-up of medical device parts to match your specific application requirements.

The RESOMER® portfolio of biodegradable polymers for implantable medical devices

RESOMER® is the world’s leading brand of bioresorbable polymers for use with implantable medical devices, with more than 30 years of safety and supply security.  The breadth and versatility of RESOMER® polymers make them ideal for use across a broad range of orthopedic, vascular, wound closure and other medical device applications.  Degradation profiles can span from a few weeks to more than four years.  The portfolio of polymers for medical devices includes a range of standard and custom grades of homo-polymers, copolymers and block co-polymers including lactide, glycolide, trimethylene carbonate, p-dioxanone and ε-caprolactone.  A range of filaments and powders are also available for use in the high-resolution 3D printing of implantable medical devices using Selective Laser Sintering (SLS) and Fused Filament Fabrication (FFF) technologies.

Medical device CMO partner for custom polymer synthesis

Leveraging more than 60 years of market leadership in the design, synthesis, and supply of high-quality polymers, Evonik provides medical device companies with a safe and reliable choice for the contract outsourcing of their proprietary biomaterials.  From our medical device centers of excellence in the U.S. and Germany, we can offer an integrated range of CMO services from initial scale-up through to large-scale commercial production.  When combined with other application development services available, we can serve as a single partner for the production of your proprietary polymer, and the development of the final medical device part until it is in your hands.

Endexo® surface modification technology to improve medical device functionality and safety

Endexo® is a proprietary additive technology that enhances the biocompatibility of medical devices that come into contact with blood, tissue or other biological fluids.  The low molecular weight fluoro-oligomers used in Endexo® are incorporated during the device manufacturing process and migrate to within nanometers of the surface.  By suppressing procoagulant protein conformation, decreasing platelet adhesion and inhibiting platelet activation, the Endexo® technology reduces the risk of thrombotic events.  It also suppresses bacteria adhesion and biofilm formation to reduce infection risk.  Commercially proven and compatible for use with a range of base polymers and manufacturing techniques, Endexo® represents a simple, value-based surface modification technology that is suitable for use across a wide range of medical device applications.

Application technology services for implantable medical device projects

Evonik has decades of expertise in the design and production of functional biomaterials suitable for implantable Class II and III medical devices.  Our Medical Device Competence Center in the U.S. and Application Labs in Germany and China ensure responsive and reliable project execution.  Our technical knowhow and integrated range of services can help to not only reduce complexity but accelerate speed to market and enhance the performance of your medical device.  Services are available for use across a wide range of medical device applications including polymer synthesis and design, polymer processing, feasibility samples including rapid 3D prototyping, analysis and characterization.  Regulatory data and other medical device support is also available.  Fields of expertise include:

• Orthopedic applications such as interference screws, to optimize properties including insertion torque, bone ingrowth, osteo-conductivity and minimize inflammation
• Cardiovascular applications such as bioresorbable stents, to enhance properties including radial strength, ductility and scaffold thickness, or together with surface modification technologies reduce thrombosis and infection risk
• Wound healing applications such as sutures and clips, to provide proprietary solutions to accelerate degradation, increase strength and durability, or enhance dimensional stability
• Additional expertise with dental mesh, soft tissue fillers and tissue engineering scaffolds

Specialized medical device products and services

• RESOMER® Composite with distinct osteoconductive properties to enhance bone fixation devices
• RESOMER® filament, powder and granulate-based biodegradable materials for 3D printing of high-resolution device parts used with medical implants
• Custom-made biodegradable polymers and custom synthesis of proprietary polymers
• Advanced recombinant collagen platform for use with medical implant devices and other healthcare products