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The demand for intricate and customized components such as plates and spacers for spine surgery has grown significantly in recent years and that growth is expected to continue. The North American spinal implant market size was valued at $10 billion in 2022 and is expected to reach $14 billion by 2032. Trends like increased usage of minimally invasive techniques in spine surgery have contributed to the growth trajectory.
Behind the scenes, advanced manufacturing techniques play a crucial role in shaping these innovations in spine surgery and ensuring that they meet the highest standards of performance and safety. As medical device companies launch products in this growing market, they often look for contract manufacturing partners to help them expand production capacity and accelerate product launches. Selecting the right contract manufacturer, however, is no small feat. The unique intricacies of spinal device manufacturing, combined with the critical nature of these products, create a complex landscape that can be challenging to navigate.
At Pulse Technologies, we have proven to be the perfect partner for several spinal implant companies. We differentiate ourselves through our:
- Depth of spinal implant manufacturing knowledge
- Ability to deliver complex precision machining requirements
- Material expertise
- Quality and regulatory compliance
- Innovation-driven culture
Vertical Integration: The Key to High-Quality Spinal Implant Manufacturing
Spinal implants, including plates and spacers, are critical medical devices used to stabilize and support the spine in cases of injury or degenerative conditions. The success of these implants hinges on their precise design, biocompatibility, and mechanical integrity.
- Spinal plates and spacers require high precision to ensure proper fit and alignment within the spine.
- Any deviations in dimensions or alignment can lead to complications during surgery and post-operative discomfort for patients.
- The intricate shapes of spinal plates and spacers can pose challenges in terms of machining and finishing.
- Surface finish is also an important criterion to ensure proper integration with the bone.
Creating high-quality and precise spinal implants requires a vertically integrated approach with multiple advanced manufacturing capabilities under one roof.
Manufacturing processes must be able to replicate complex geometries accurately. This is where knowledge of advanced manufacturing techniques like milling, electrical discharge machining (EDM), turning and lasers that can provide unparalleled precision and versatility is crucial.
Milling involves the removal of material from a workpiece using rotary cutters to achieve the desired shape and dimensions. EDM machines can produce complex and precise shapes, especially in hard materials like titanium. An EDM machine uses electrical discharges to remove material from a workpiece. Laser capabilities are needed for precise welding, cutting, drilling, marking, surface texturing and modification.
Turning is another crucial manufacturing process that can be used to create the basic cylindrical or threaded shape of implants. Let us take the example of spinal screws that often require threads for fixation. Turning can be used to cut these precise threads on spinal screws.
Apart from precision machining, a solid understanding of assembly techniques and finishing processes (blasting, buffing, polishing and deburring) is also required. Depth of material expertise is a key factor as well. In the case of spinal interbody spacers, titanium and PEEK (polyetheretherketone) are commonly employed. This is due to their exceptional mechanical properties and biocompatibility as lumbar spinal fusion outcomes are often related to the achievement of bone fusion.
Knowledge of manufacturing techniques, like anodizing, that play an important role in improving spinal implant performance is essential. Anodizing is an electrochemical process used to enhance the surface properties of materials like titanium to increase biocompatibility, corrosion resistance and improve bone integration.
At Pulse Technologies, we offer end-to-end advanced manufacturing capabilities for spinal device manufacturers all under one roof.
Pulse Technologies: Your Vertically Integrated Partner for Next-Generation Spinal Implant Manufacturing
With a distinguished track record and a commitment to innovation, Pulse Technologies has established itself as a premier contract manufacturer with an unmatched focus on precision and quality. We differentiate ourselves from other contract manufacturers due to:
Unrivalled Precision
One of our strengths is our extensive fleet of cutting-edge machines. These machines are renowned for their exceptional accuracy and multitasking capabilities. We have 44 Swiss turning machines, 32 cutting -edge milling machines, 15 EDMs and 11 laser machines at our facility with a capacity to machine up to 1M spinal implants annually. Our capabilities include:
- The ability to machine complex and intricate components from bar stock
- Twin machining stations with milling spindles capable of reaching up to 40,000 rpm
- High-capacity multi-pallet mill and mill-turn machines up to 7-axis
- Ability to hold tight tolerances and positions during milling up to 0.0002 inch (0.005 millimeters)
- Integration of milling with part assembly for fast yet controlled production processes
- Wire and RAM EDMs for machining tighter tolerances and improved part strength
- EDM tolerances and repeatability up to a .0001-inch standard
- Cutting-edge laser machines for cutting, drilling, welding, marking, surface texturing and modification
- Highly specialized and versatile CNC Swiss turning machines for cutting precise threads on screws
- Precision hole drilling with the ability to create burr free holes and hold tight tolerances
End-to-End Expertise in Spinal Implant Manufacturing
Our team has years of experience in spinal implant manufacturing. We have worked with over 30 spinal implant companies over the years and have manufactured millions of parts. We understand the intricacies and unique challenges that may come up when manufacturing spinal implants. Our vertically integrated approach provides all the below capabilities under one roof:
- Precision machining
- Anodizing
- Etching
- Assembly
- Finishing
- Inspection
Large Production Capacity
With our wide range of equipment, we have the ability to easily meet and ramp up production for spinal implant companies. This is a great benefit for medical device companies as they look to accelerate product launches and ramp up capacity.
Our commitment to efficiency is reflected in our state-of-the-art machinery. The combination of cutting-edge technology and skilled expertise ensures that projects are completed on time, without compromising quality.
Ability to work with Diverse Materials
With our expertise in working with diverse materials (Titanium, PEEK, Cobalt Chrome), we have the versatility to fulfill the specific material requirements of Spinal medical device manufacturers
Robust Quality Systems
At Pulse Technologies, we have robust quality systems in place designed to ensure that every component leaving our facility adheres to the highest industry standards. We are compliant with all governing standards for medical devices (FDA 21 CFR 820 and ISO 13485).
Innovation-Driven Culture
We strive to innovate daily. With a finger on the pulse of technological advancements, we continue to refine our processes to remain at the cutting edge of medical device manufacturing. We are also one of the few contract manufacturers with an in-house R&D team.
Focused on Operational Excellence
At Pulse Technologies, our team is committed to operational excellence. We are well versed with continuous improvement and root-cause-analysis tools like Value Stream Mapping, CAPA, Poka-yoke and FMEA.
Commitment to Sustainability
As an organization, we are also highly committed to sustainability. We were recently awarded the Silver EcoVadis Medal, recognizing our efforts to run both sustainably and ethically. EcoVadis is one of the world’s most trusted rating systems to ensure companies are strong in several categories, including the environment, human labor rights, ethics and sustainable procurement.
The journey to finding the right partner for spinal device manufacturing is a critical one. The precision required for crafting spinal implants, such as plates and spacers, necessitates a blend of advanced machinery, expertise, and a commitment to quality.
When your goal is to develop and launch medical devices that redefine healthcare standards, trust in a partner that shares your commitment to precision, innovation, and quality. Contact Pulse Technologies for a partnership that will meet all your medical device manufacturing requirements seamlessly.
“Pulse Technologies is the ideal contract manufacturing partner for spinal implant companies seeking precision and excellence. Our cutting-edge manufacturing capabilities and in-depth spinal expertise allow us to seamlessly manufacture plates and spacers with the utmost intricacy. We ensure that every piece aligns with the critical needs of our medical device customers. Your vision, combined with our expertise, can forge a partnership that advances the frontiers of spinal healthcare.”
– Steve Trinter, Director, Sales & Marketing, Pulse Technologies
Pulse Technologies at a Glance:
- 30+ years of medical device manufacturing experience
- Industry-leading in-house metrology and testing capabilities
- 70,000-square-foot facility
- 100+ CNC machine tools.
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Want to learn more about our spinal implant manufacturing capabilities? Contact us today.
