In episode #63 of The Cool Parts Show, we explore how the medical device manufacturer Curiteva is utilizing advanced 3D printing technology to produce spinal implants from PEEK material. This represents a groundbreaking advancement in medicine, enabling more complex designs and improving bone integration.
Introduction to Curiteva and 3D printing in medical devices
Curiteva is a leading innovator in the medical device industry, particularly in the development of spinal implants using advanced 3D printing technologies. A key material in their products is Polyether ether ketone (PEEK), known for its exceptional strength, biocompatibility, and similarity to human bone, making it ideal for spinal implants.
However, PEEK is notoriously difficult to 3D print, which poses a significant challenge in creating implants with the necessary porosity for bone integration. Curiteva has overcome these challenges with their proprietary techniques, setting a new standard in the field.
PEEK (Polyether Ether Ketone) is a high-performance thermoplastic polymer that belongs to the polyaryletherketone (PAEK) group. It is renowned for its exceptional mechanical properties, including high strength, heat and chemical resistance, and wear resistance. These characteristics make PEEK an ideal material for various industries, especially in the medical and aerospace sectors.
3D printed medical parts with PEEK material
In the medical field, PEEK is widely used to manufacture implants, such as spinal implants, due to its high biocompatibility and mechanical properties that closely resemble human bone.
This helps to minimize the risks associated with implants and enhances their integration into the patient's body. PEEK is also resistant to biodegradation and does not cause adverse reactions when used long-term in the body.
Curiteva’s Fused Strand Deposition (FSD) process
Curiteva has developed a unique 3D printing method known as Fused Strand Deposition (FSD), which allows them to print PEEK with precision and consistency. The FSD process offers significant advantages, including the ability to create porous structures that enhance osseointegration, allowing the bone to grow into the implant for better stability and long-term success. The breakthrough of this technology was marked by the FDA clearance of Curiteva’s first 3D-printed cervical spine implant, a milestone that demonstrated the safety and efficacy of their innovative approach.
Peek material 3D printed cervical spine implant parts
Expansion to lower lumbar implants
Building on their initial success, Curiteva has expanded their product line to include implants for the lower lumbar spine, which recently received FDA clearance. This new line features a broader variety of shapes and sizes compared to the cervical spine implants, with over 1,300 different configurations.
The approval process for these implants was significantly faster, taking only 57 days, compared to the 18 months for the cervical implants. This rapid approval is a testament to the trust in Curiteva’s technology and process. The adoption of these implants has been impressive, with over 500 surgeons using them to treat thousands of patients, highlighting their impact on the medical community.
PEEK is also used in skull implants
Curiteva’s manufacturing facility tour
The manufacturing of these cutting-edge implants takes place at Curiteva’s state-of-the-art facility in Huntsville, Alabama. This facility is a hub of innovation, housing a range of advanced manufacturing technologies, including five-axis milling, wire EDM, and, most notably, Curiteva’s proprietary 3D printers.
These 3D printers, developed in-house, are in a clean room environment, ensuring the implants meet the highest standards of quality and sterility. The facility currently operates nine 3D printers for production, with a tenth used for research and development, reflecting Curiteva’s commitment to continuous improvement and innovation.
End-to-End manufacturing process
The production process at Curiteva is highly integrated, covering all steps from material preparation to final packaging. It begins with the preparation of PEEK filament, which is carefully dried and loaded into the 3D printers. After printing, the implants undergo a series of post-processing steps including support removal, cleaning with isopropyl alcohol (IPA), and annealing to relieve stress.
Additional machining is performed to drill holes and add necessary features, followed by assembly where titanium locator pins are inserted for X-ray visibility. The implants then receive an external coating of hydroxyapatite, which promotes bone growth into the implant. The final steps include laser marking, sterile packaging, and inventory management, all within the clean room environment to maintain sterility and quality.
Inside the 3D printed PEEK material implant
Efficiency and low-waste production
Curiteva’s manufacturing process is not only innovative but also highly efficient, with only 2% of the PEEK material wasted during production. This is a significant improvement over traditional manufacturing methods, which typically involve more extensive machining and, consequently, higher material waste. The low-waste process is not only more cost-effective but also environmentally friendly, making it a model of efficiency in medical device manufacturing.
Future scaling and production goals
As demand for their implants continues to grow, Curiteva is planning to expand their production capacity by adding 20 more 3D printers to their clean room environment. This expansion will enable them to meet the increasing needs of the medical community while maintaining their commitment to quality and innovation. Curiteva’s vision for the future includes scaling up production to keep pace with the rising demand for their groundbreaking implants, ensuring that more patients can benefit from their life-changing technology.
Medical Device Manufacturing Support in Vietnam
Vinnotek is a leading medical device manufacturing support company in Vietnam, playing a crucial role in advancing the modern healthcare industry. As the official partner of Nikon SLM Solutions, the world's leading metal 3D printing company, Vinnotek proudly offers cutting-edge 3D printing solutions that meet the stringent demands of the medical sector.
In addition, Vinnotek provides a wide range of materials tailored to different 3D printing machines, ensuring optimal performance and production efficiency, thereby assisting businesses in creating high-quality medical products.
Contact Vinnotek today to explore advanced manufacturing solutions and enhance the quality of your medical products!
Read more: 3D METAL PRINTING: A REVOLUTION IN THE MEDICAL FIELD
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