By Sean Fenske, Editor-in-Chief

Many trends are driving innovation in the orthopedic sector. This includes the rise of robotic surgical systems, the expansion of data-based assist devices, and the growing number of procedures shifting to the ASC environment. Another trend, however, is the persistent interest in harnessing more natural healing solutions. Orthobiologics is the main segment involved in this effort.

Orthobiologics draw from various technology fields to ensure success. One of the primary needs is unique materials to formulate these products. Whether the material must deliver a therapeutic element, dissolve in place as it is replaced by natural bone or tissue, or be reabsorbed over time, choosing the right option is crucial.

Given this challenge, it’s important to partner with a company that can share its materials expertise to help ensure the best outcome. With this in mind, Ryan Heniford, Director of Global Sales & Business Development for Medical Devices at Evonik Health Care—a segment of Evonik Industries AG—addressed several questions about the company’s biomaterials in the following Q&A.

Sean Fenske: As materials are often the first step in development, let’s start there. Can you speak to the biomaterials Evonik provides?

Ryan Heniford: Evonik is at the forefront of biomaterials innovation, offering a diverse range of advanced materials specifically tailored for orthopedic applications. Our portfolio includes RESOMER® biodegradable polymers, which are particularly suitable for temporary implants that gradually degrade in the body, reducing the need for secondary surgeries. For instance, RESOMER® can be used in applications such as composite screws or scaffolds for bone regeneration, where controlled degradation is crucial for the healing process. Additionally, Vecollan®—a novel collagen-like protein—provides a non-animal-derived alternative to collagen, making it ideal for use in orthobiologic applications such as bone, cartilage, tendon, and ligament regeneration. Our processing capabilities encompass a variety of methods, including extrusion, injection molding, and 3D printing, enabling the production of customized orthopedic implants that meet specific anatomical requirements.

Fenske: How do these biomaterials address the increasingly complex designs of orthopedic devices?

Heniford: As orthopedic devices become increasingly intricate, Evonik’s biomaterials are engineered to meet these evolving challenges head-on. For example, RESOMER® polymers can be customized to achieve specific mechanical properties and degradation rates, making them suitable for complex geometries found in modern orthopedic implants. The ability to tailor these properties allows manufacturers to design implants that can better mimic the mechanical behavior of natural bone and/or align the degradation rate to the healing process. Moreover, with our expertise in additive manufacturing, we can produce highly customized structures that incorporate advanced design features, such as porous structures that enhance osseointegration and reduce weight without compromising strength.

Fenske: What advantages do the materials provide for orthopedic device applications?

Heniford: Evonik’s biomaterials offer several distinct advantages for orthopedic applications:

• Biocompatibility: Our biomaterials, including RESOMER® and Vecollan®, are rigorously tested for biocompatibility, ensuring they are safe for use in the human body. For example, RESOMER® polymers have been shown to promote bone regeneration while minimizing inflammatory responses.
• Bioactivity: Our biomaterials are designed to withstand the rigorous demands of orthopedic applications while providing an optimal biologic response. For instance, Vecollan® novel collagen-like protein can be incorporated into existing products to enhance the biologic response without the need for the use of animal-derived proteins.
• Customization: We understand every patient is unique. Our biomaterials allow for customization in terms of degradation rate, chemical functionality, and mechanical properties, enabling the development of patient-specific implants that enhance surgical outcomes.
• Processability: The versatility of our biomaterials facilitates various manufacturing techniques, including injection molding, extrusion, and 3D printing for highly customized solutions. This flexibility helps reduce lead times and streamline the manufacturing process.

Fenske: As so much of medical device development is customized to the application, how does Evonik address this need as a services company and through its biomaterials?

Heniford: At Evonik, we recognize that the development of medical devices often requires a tailored approach. Our team collaborates closely with OEMs to provide customized biomaterials and processing solutions. For example, we work with clients to select the right RESOMER® formulation based on the specific mechanical and degradation properties required for their application. Our experts are involved from the initial concept stage through to product design, ensuring our solutions align perfectly with the client’s needs. This collaborative approach not only enhances the effectiveness of the final product but also accelerates time-to-market.

Fenske: What value-added services are available to customers outside of the biomaterials themselves?

Heniford: Beyond our next-generation biomaterials, Evonik provides a range of value-added services designed to support our customers throughout the development process:

• Technical Support: Our team offers in-depth consultation during the development process, assisting with material selection, design optimization, and troubleshooting.
• Manufacturing Process Optimization: We help clients streamline their manufacturing processes, which can lead to significant cost savings and improved efficiency. For instance, we can provide insights on optimizing injection molding parameters to reduce cycle times.
• Access to R&D Resources: Clients have the opportunity to leverage our extensive R&D capabilities, including access to cutting-edge technologies and expertise in biomaterials research, to explore innovative solutions tailored to their specific challenges.

Fenske: Does Evonik aid with aspects that affect the OEM customers beyond the material and its processing? For example, can you help with regulatory submissions or validating related processes like sterilization?

Heniford: Yes, Evonik goes beyond providing materials and processing expertise to support OEM customers in various aspects of medical device development. We also assist with regulatory submissions, guiding clients through the complex landscape of compliance in the medical device industry. This includes helping to prepare documentation and data packages required for regulatory approvals. Additionally, we assist with validating processes such as sterilization, ensuring our clients’ products meet all necessary safety and efficacy standards before they reach the market.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Heniford: At Evonik, we believe innovation and collaboration are essential to advancing the orthopedic device manufacturing landscape. We are committed to being a trusted partner, not only by supplying high-quality biomaterials like RESOMER® and Vecollan®, but also by offering the expertise and support necessary to bring innovative devices to market. We encourage orthopedic device manufacturers to engage with us to discuss their specific challenges and explore how our solutions can enhance patient outcomes and streamline development processes. Together, we can push the boundaries of what is possible in orthopedic device design and manufacturing.

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