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
Reducing The Surface Friction Of Medical Devices - A New Functional Application For A Commercial Biomaterials Surface Modification Technology
Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.
The Market For 3D Printed Bioresorbable CMF Plates And Other Complex Devices Is Being Redefined By New GMP-Grade Filament Material
The adoption of 3D printing technologies for implantable medical devices has been relatively slow and largely confined to metal-based implants traditionally used for hip, knee, and spine reconstruction applications. This has been due to challenges in sourcing the right biocompatible materials, validating processes, and adhering to quality and regulatory requirements.
Isabel Wahl, Head of Evonik’s RESOMER development lab, discusses a new bioresorbable copolymer combining mechanical strength with rapid degradation for wound healing and pediatric devices.
The convergence of modern 3D printing technologies such as selective laser sintering (SLS), fused filament fabrication (FFF), and bioplotters with a new generation of custom bioresorbable polymers in powder, filament, and granule is revolutionizing what’s possible in the development of bioresorbable medical device parts.
Prevention Of Thrombus Accumulation On Vascular Access Products Can Have Positive Impact On Patient Outcomes And Healthcare Costs
Thrombus accumulation on blood contacting-devices such as catheters, vascular stents, or hemodialyzers can lead to device failure or serious complications and has a significant impact on patient care, quality of life, and overall healthcare costs. The functional properties of Endexo additive technology can modify the surfaces of blood-contacting devices to reduce adhesion and activation of blood components, thereby significantly reducing thrombus formation, associated complications, and overall costs.
A GMP Implantable Grade Bioresorbable Polymer Powder Breakthrough For The 3D Printing Of Medical Devices Using SLS Technology
Recent innovations with Selective Laser Sintering (SLS) systems and bioresorbable polymers are redefining opportunities for the 3D printing of medical devices with complex geometries across a range of application areas. SLS systems utilize a high-powered laser to selectively melt and fuse powder particles of a bioresorbable polymer in a layer by layer process to manufacture a final implantable medical device part. Depending on the part geometry, these systems can typically print geometries as small as 0.4 mm with a tolerance of +/- 0.25 mm.
How To Utilize Extrusion To Optimize Processing And Supply Of High-Quality Tubes For Use With Stents, Scaffolds, And Other Medical Devices
This interview with Dr. Thiago Borges covers how to utilize extrusion to optimize the processing and supply of high-quality tubes for use in stents, scaffolds, and other medical devices.
Reducing Bacterial Adhesion And Biofouling On Medical Device Surfaces: An Interview With Jeannette Ho
This interview with Jeannette Ho, the head of surface modification at Evonik, discusses opportunities for medical device companies to leverage a passive, stable, and durable technology platform to reduce bacterial adhesion and biofouling.
The production of recombinant collagen made via fermentation-based processes addresses the market need for collagen that is safe, sustainable, reproducible, and acceptable to consumers.
In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S., we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.
A New Recombinant Collagen Platform Is Poised To Enhance The Safety, Performance And Acceptability Of Medical Devices
Collagen is one of the industry’s most important biomaterials. To address market needs for solubility, biocompatibility, processability, sustainability and scalability, Evonik has developed a new recombinant collagen technology platform. Prospective medical device customers seeking product samples for feasibility studies or development programs can contact Evonik for further information.