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The importance of material choice in manufacturing can’t be overstated – especially in medical manufacturing. Safety, efficacy, and comfort all rely on the correct material, and as material options expand, finding the optimal one becomes more challenging. Much of that expansion involves polymers, which continue to improve in strength, sophistication, and other properties making them excellent candidates for medical implants.
Polymers versus metals
Medical implants are one area of expertise for specialty chemical company Syensqo, which spun out of chemistry solutions provider Solvay in 2023. Syensqo, serving multiple industries including aerospace and automotive in addition to healthcare, develops advanced polymers for medical devices and equipment. While metals such as stainless steel and titanium have been reliable options for medical implants, polymers have more recently offered an alternative with several advantages.
“Polymer materials help to minimize bone density reduction by continuing to stimulate the normal stress surrounding the bone tissue,” says Natalie Dragunat, global marketing manager for healthcare at Syensqo. “They incorporate a bit better into the body than metals. Metal implants can sometimes cause stress shielding, where the presence of the metal implant itself causes changes in the mechanical load of that area of the body, with the metal implant bearing the load, rather than the load being more naturally distributed to the surrounding bone.”
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Polymers also possess radiolucent properties, meaning they’re transparent on X-ray, MRI, and CT scans, allowing medical professionals to better see what’s happening inside the patient’s body. In addition, they’re typically easier to process than metal, with injection molding offering an advantage for high-volume production. Lower-volume parts are extruded into rods which are then machined.
Syensqo has also been working on 3D printing polyetheretherketone (PEEK). PEEK has caused buzz in the manufacturing industry for its strength, comparable to metals such as aluminum and stainless steel; heat resistance; and biocompatibility, making it enticing to medical implant manufacturers. PEEK is especially well-suited for load-bearing applications because of its strength, so it’s become a popular choice for orthopedic implants in the knees, spine, hips, and shoulders. 3D printing the material is highly economical and efficient, so Syensqo is pursuing the technology of 3D printing implantable PEEK material. The company has already released medical grade 3D printable filament in its Ketaspire-branded PEEK and Radel-branded PPSU.
For non-load-bearing applications including cardiovascular and neurovascular access ports, Dragunat suggests flexible, lightweight materials such as implantable polysulfone (PSU) and polyphenylsulfone (PPSU). These have the added benefit of transparency as well as possessing good electrical insulation properties – making them a popular option for wire coating. Syensqo is currently the only supplier of implant-grade PSU and PPSU.
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Polymer manufacturing presents its own challenges – for example, it can’t compete with metal for parts requiring sharp corners. While polymers are the core of its business, Syensqo doesn’t disregard the advantages of metal. Hybrid surgical tools combining the strength and sharpness of metal with the lightweight, ergonomic features of polymers are popular. Syensqo provides simulation services such as computer aided engineering and mold flow analysis to original equipment manufacturer (OEM) design engineers to assess and optimize part performance by choosing the best manufacturing method and material.
Tackling regulatory, sustainability challenges
Simulation is only one type of guidance Syensqo offers its customers.
“We have a vast library of data on chemical resistance and a lot of other data points we use to help the design engineers at these OEMs design their parts, and then we offer robust regulatory support for our customers,” Dragunat says. “We work all over the world with the regulatory bodies in Europe and Asia to offer support in documentation the OEM might need in filing with those agencies and having their devices approved.”
Syensqo is always developing new materials for its catalog, currently comprising more than 170 material brands, but the company doesn’t fool itself or anyone else into thinking of material development – especially in healthcare – as quick or easy.
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“We’re always exploring other materials,” Dragunat says. “Since we serve so many industries, we often explore the possibility of the materials we have translating from one industry to the other. We always choose the most promising technology advances that would help our customers achieve their goals, but we’re also really aware of the challenges and the difficulty of introducing new medical grades. So we always take our time to fully vet any materials we’re working on or we launch.”
For medical implants, Syensqo offers a family of materials called Solviva Biomaterials, which includes Eviva PSU, Veriva PPSU, and Zeniva PEEK.
While Syensqo is technically a new company, its materials, developed under the Solvay brand, have been around for decades. Its Radel PPSU has been used for nearly 35 years in several applications including food service, aircraft, and plumbing in addition to healthcare. In 2023, Solvay launched a mass balance version of Radel and Udel. Mass balance refers to a globally acknowledged industry standard related to tracking and tracing renewable, circular feedstock in products and materials. Sustainability is a priority for Syensqo, which is aiming for carbon neutrality by 2040 and is actively developing a portfolio of sustainable products to offer customers.
Syensqo, in addition to developing thermoplastic composites, also dedicates its focus to the areas of green hydrogen, battery materials, and renewable materials and biotechnology. Now is an exciting time for the company, as well as for other players in the medical manufacturing industry. Despite the typically slow process of approval for new materials and devices in healthcare, new opportunities for polymer development are expanding quickly – and with these opportunities comes the potential for lifesaving technology.
Syensqo
https://www.syensqo.com
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