Evonik stands as a leading supplier of biomaterials for the medical device market, such as RESOMER® and VESTAKEEP®, recognized for its unwavering commitment to innovation and quality. In the orthopedic sector, manufacturers face numerous challenges when developing new products, including stringent regulatory hurdles that vary by region, a shortage of commercially available biocompatible materials with a wide range of properties, and a need for increasingly complex device designs. This landscape necessitates innovative solutions that deliver a compelling value proposition, not only addressing these challenges but also while enhancing patient outcomes and ensuring patient safety. By fostering collaboration and customization while simplifying complexity throughout the supply chain, Evonik is strategically positioned to significantly advance orthopedic device development.

Evolution of the Orthopedic Market

The orthopedic market has undergone a profound transformation over the past few decades. Historically, the industry relied heavily on traditional materials that, while effective, often came with inherent limitations regarding processability and performance.

“In earlier decades, manufacturers were constrained to using only the ‘approved’ materials available, with minimal scope for modification due to uncertainties surrounding material properties and regulatory pathways. However, as the industry has evolved, there has been a marked shift toward customizing these well-characterized materials to enhance device performance for specific applications, all while prioritizing patient safety,” said Ryan Heniford, Director of Global Sales & Business Development for Medical Devices at Evonik Health Care.

Modern advancements have ushered in a new era of composite materials and innovative solutions that break free from the constraints of the past. The rise of personalized medicine has further accelerated this evolution, prompting the orthopedic market to shift from a one-size-fits-all approach to a more tailored methodology. While polymers such as PLLA, PLDLA, and PEEK have long been staples in orthopedic repair implants due to their well-characterized in-vivo performance and regulatory acceptance, they are now being utilized as the foundation for material customizations aimed at improving biocompatibility, durability, and bone integration properties. These customizations not only enhance the functionality of the implants but also align with the growing demand for personalized medical solutions that cater to individual patient profiles, thereby maximizing the efficacy of treatment and minimizing potential risks.

As the orthopedic landscape evolves, manufacturers are increasingly challenged to adapt to rapidly changing technologies and patient needs. This necessitates a proactive approach to innovation, where companies like Evonik can play a crucial role in helping customers stay ahead of the curve through customization.

“By offering tailored solutions that address specific clinical challenges, Evonik empowers manufacturers to develop cutting-edge orthopedic devices that meet the unique demands of today’s healthcare environment,” said Ryan Heniford.

The Role of Customization in Orthopedics

The orthopedic market is experiencing a paradigm shift toward a patient-centered approach, driven by the rise of value-based care. This transition has led to a notable decline in the use of generic devices, favoring instead the development of procedure-specific devices tailored for particular surgical protocols. Consequently, the biomaterials that form the backbone of implantable orthopedic devices must be customized to accommodate the expanding design variations that stem from this trend, ensuring that each device not only meets regulatory standards but also enhances patient safety and satisfaction.

Evonik excels in translating customer requirements at the device level—such as mechanical properties, degradation profile, surface behavior, and drug elution kinetics—into materials that meet those specifications. There are numerous ways to customize base materials to achieve desired properties. For instance, in the case of bioresorbable osteoinductive devices, optimizing both the concentration and morphology of the inorganic component (such as hydroxyapatite [HA], beta-tricalcium phosphate [b-TCP], or biphasic calcium phosphate [BCP]) relative to the bioresorbable polymer matrix (like PLLA or PLDLA) can significantly enhance bone regeneration while maintaining a minimum strength to mitigate the risk of premature device failure. This careful balance is critical to ensuring that devices not only perform effectively but also uphold the highest standards of patient safety.

Another compelling example involves the customization of PEEK, a well-established material traditionally very difficult for 3D printing in medical device applications. Through a significant collaborative effort with a leading 3D printer manufacturer, Evonik has successfully developed VESTAKEEP® i4-3DF PEEK in filament form. This innovation allows customers to print patient-specific implantable devices using commercially available 3D printers, thereby enhancing their ability to bring unique orthopedic solutions to the market. This not only improves device efficacy but also minimizes the risk of complications associated with ill-fitting implants.

Specialized Processing Support

As biomaterials become increasingly customized to meet stringent design requirements, the development effort required to identify the processing conditions necessary for achieving precise outcomes must not be overlooked. Customized materials often introduce complexities that can challenge traditional processing methods. For example, bioresorbable polymers, widely utilized in orthopedic repairs in the form of screws, pins, and anchors, present unique processing challenges, particularly for melt processing techniques like extrusion and injection molding. Even minor variations in processing conditions can dramatically affect the performance of the final device, potentially impacting patient safety and device efficacy.

Evonik is uniquely equipped to address these challenges. According to Ryan Heniford, “Evonik is set up to prototype, develop, and scale customized bioresorbable polymers. We can characterize these materials along with the required processing conditions quickly and efficiently via our RESOMER® Select process. This approach capitalizes on our extensive experience with the RESOMER bioresorbable polymers platform, allowing us to create new materials tailored to exacting requirements. Bring your idea to us, and we can help you bring it to life.” This proactive approach not only accelerates the development cycle but also ensures that patient safety remains a top priority throughout the design and manufacturing process.

Furthermore, Evonik collaborates closely with Original Equipment Manufacturers (OEMs), Contract Manufacturing Organizations (CMOs), and Medical Device Companies (MDCs) to deliver biomaterials and components in forms that seamlessly integrate into the device manufacturing process. This collaborative approach ensures that the transition from material development to final product manufacturing is smooth and efficient, reducing time-to-market and enhancing overall product quality. By prioritizing safety and efficacy in every step of the process, Evonik helps to mitigate risks associated with device failure and adverse patient outcomes.

Adapting to Changes in the Orthopedic Industry

As the orthopedic industry continues to evolve, manufacturers must remain agile and responsive to emerging trends, such as advancements in minimally invasive surgical techniques, the integration of digital technologies, and the increasing emphasis on patient-centric care. These changes necessitate a shift in how orthopedic devices are designed, produced, and delivered, requiring manufacturers to rethink their strategies and embrace innovation.

Evonik is at the forefront of this transformation, providing the expertise and resources necessary for customers to adapt to these changes effectively. By leveraging its global footprint of and extensive knowledge of biomaterials and processing technologies, Evonik can assist manufacturers in developing devices that not only meet current market demands but also anticipate future needs. This foresight is critical in a rapidly evolving industry where staying ahead of the curve can significantly impact a company’s success.

Evonik continues to invest in new technologies that bring innovative new biomaterials to market that complement and advance the state of the art for device design, including Vecollan® recombinant collagen-like peptides, biocellic® biosynthetic nanocellulose, RESOMER® bioresorbable polymers, and Endexo® surface modifying additives, which together can offer innovators a variety of biomaterial options upon which to further customize and innovate.

Summary

Evonik leverages an extensive knowledge base of materials and processing information to help customers navigate the complex challenges of the orthopedic market. In today’s competitive landscape, merely having a unique or novel product is insufficient; a holistic solution is essential—one that encompasses a robust supply chain capable of delivering value throughout the product lifecycle while ensuring the highest standards of patient safety.

By actively listening to its customers and seeking solutions, Evonik seeks to reduce the complexity of the supply chain for our customers through close collaboration with partners throughout the supply chain and world-class materials processing support. By providing more than just materials, Evonik positions itself as a strategic partner in the orthopedic market, driving innovation and ultimately improving patient outcomes. Through this commitment to collaboration, customization, and comprehensive support, Evonik is not only shaping the future of orthopedic devices but also enhancing the quality of care for patients worldwide. By prioritizing efficacy and safety, Evonik continues to lead the way in developing solutions that not only meet but exceed the expectations of healthcare providers and patients alike, ensuring that the orthopedic industry remains at the cutting edge of medical technology.