Article

30 Nov 2018, by Mark Crawford, Contributing Writer

Featuring DSM bioceramics, biocomposites, collagen and UHMWPE

Material properties are foundational for medical devices to achieve effective clinical outcomes. Decades ago, orthopedics almost exclusively focused on metal. Over the last 10 years, material options have shifted toward polymer-based components, including polymer/metal hybrids and disposable polymer instruments.

Material science continues to rapidly evolve to meet the needs of disruptive new technologies such as additive manufacturing and 3D printing. Advanced injection molding can handle a wider range of polymers for key product applications. New or enhanced materials provide engineers with more options for creative medical device designs, higher functionality, and improved patient outcomes. Digital patient care and embedded electronics are also driving innovation in medical materials.

Despite these exciting advances, however, orthopedic OEMs tend to remain very conservative when it comes to choosing materials for their implants and instrumentation. Adoption of new materials tends to only happen when a new design requires some level of functionality that incumbent materials simply cannot offer. Given the effort, risk, and cost involved with validating new materials, designers generally only consider materials that enable “need-to-have” rather than “nice-to-have” product features.

More recently, this resistance is starting to fade. OEMs must embrace new materials to stay on the cutting edge of technology and remain competitive. As demand increases for smaller, more complex, and more functional devices with highly specific engineered material properties, medical device manufacturers (MDMs) must keep up with material science. Products made with advanced materials help meet end-user demands for improved patient benefits, product safety, and cost controls. Other considerations for material selection are biocompatibility, resistance to sterilization/decontamination, longevity of mechanical properties, and color variation for color coding.

Materials commonly used in orthopedic products include metals and metal alloys, biostable plastics, bioabsorbable polymers, biocomposite polymers/ceramics, bioceramics, collagen, and extracellular matrices. With all these options to consider, and new materials with highly specific properties being announced on a regular basis, MDMs rely heavily on their contract manufacturers (CMs) and material providers for the up-to-date knowledge and expertise they need to make informed decisions about materials.

Matching the right material to the right device to the right procedures is a key element in the product development and commercialization process. “Ultimately, the best device solutions come when manufacturers and materials suppliers work hand in hand with one another to create product and process efficiency,” said Bing J. Carbone, president of Modern Plastics, a Shelton, Conn.-based provider of high-performance plastics.

What OEMs Want

OEMs want to make devices that deliver better and more reliable outcomes. They are intensely focused on driving down costs however they can, which often involves material-related strategies. Using cost-effective materials that exhibit the precise properties required for the application is critical for success. Materials impact both performance and cost through their ease of use (design for manufacturability), durability, longevity, and regulatory acceptance.

OEMs are intent on improving clinical outcomes by using materials that work more naturally within the body, such as biocomposite materials for soft tissue fixation devices. Stronger biocomposite materials are being developed to overcome challenges with device failure in hard bone; faster resorbing materials allow for more predictable absorption and bone remodelin

This new focus has created a shift away from metal and plastic permanent implants to products manufactured from materials such as biocomposites, bioceramics, and collagen that promote or facilitate the biologic basis of healing and bone/soft tissue remodeling. “The goal is to create implants that not only provide a very strong structural repair, but over a period of time absorb into the body and go away after the healing has taken place,” said Kevin Cooney, director of product marketing for DSM Biomedical, an Exton, Pa.-based global solutions provider in biomedical science and regenerative medicine. “Long term, the patient is left with strong underlying native tissue with no implant left behind. This really is where medicine is going, and our goal is to be at the forefront of these innovations.”

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