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As device companies seek to distinguish themselves in an ultra-competitive environment, materials offer opportunities for product differentiation and innovation.
How?
By utilizing technologies and selecting materials that are not only cost-efficient, but provide the properties required for high-performance orthopaedic devices, including (but not limited to) desired mechanical performance, thickness, porosity and bone in-growth potential.
“For more mature product segments such as hips and knees, it appears that the industry has consolidated its thinking around implant design, and the next avenue of innovation opportunity is found with materials (and after that, manufacturing),” explains Dave Anderson, Commercial Affairs Lead at SITES Medical, a company that develops orthopaedic technologies/materials and then partners with OEMs to bring them to market.
“The worldwide trend in pricing is downward, yet the demands being placed on implants by patients remain high—thus, there has never been a more important time to offer implant materials that are best-in-class in terms of performance, but at a lower cost. For less-mature product segments there are still many opportunities for design enhancement, and materials with design flexibility can enable them.”
The three companies we highlight below either have new materials/product offerings that we wanted to bring to your attention, or have had a material utilized in a recently-launched orthopaedic product. Each company was asked questions about their materials, the OEMs that they work with, what segment of the market they hope to corner, how their technologies respond to current industry trends and any expected 2019 challenges they want to share with OEM partners.
SITES Medical
Interviewed: Dave Anderson, Commercial Affairs Lead
Material: OsteoSync™ Ti porous titanium scaffold
Application: OsteoSync Ti is a porous bone in-growth technology. In preclinical testing, it demonstrated two to five times the bone volume in-growth of 3D-printed materials. It can be fabricated in various thicknesses and can attach to metals (titanium, cobalt chrome, zirconium) and polymers (UHMWPE, PEEK, PCU). The material has application in spine (e.g. interbody fusion devices) and joint reconstruction (hip, knee and shoulder). In addition, OsteoSync Ti can be used as a coating or standalone implant. It is also a robust and easy to clean material, which enables the SITES automated make-to-order manufacturing method.
OsteoSync Ti Material
Status: More than ten products utilizing OsteoSync Ti have received FDA 510(k) clearance (sourced from FDA.gov).
OEM customers: Alphatec Spine, Arthrex, Nanovis, NeuroPro, Xtant Medical (sourced from FDA.gov). We are working with six OEMs in spine, three in joint replacement, and are in active discussions with eleven more OEMs for the provision of OsteoSync Ti.
Priority market segment: The highest need for innovation in high-performance, lower-cost ingrowth materials are spine and large bone joint replacement.
Trend: Compared to inpatient hospital settings, outpatient surgical centers and ambulatory surgery centers receive reduced procedure reimbursement from payors, and as a result, are focused on sourcing high-performance implant systems at a lower cost as well as technologies that enable greater perioperative efficiency. Fully-cementless implant systems utilizing OsteoSync Ti respond to this need. These systems eliminate the need for bone cement, saving not only cost, but O.R. time.
What one significant challenge will materials suppliers face in 2019, of which OEMs should be aware? With increased demand for typical implant raw materials, costs are expected to go up. SITES Medical will be impacted by these increased prices, but we are confident that we can keep overall costs down. OEMs can also pursue forward purchases of raw materials to lock in prices.
Solvay Specialty Polymers
Interviewed: Dane Waund, Global Marketing Manager, Healthcare
Material: Ixef® PARA (polyacrylamide) polymer
Application: Ixef PARA is a biocompatible polymer with strength and stiffness properties that are comparable to those of cast metals and alloys at ambient temperatures. The polymer offers a highly-rigid yet injection-moldable alternative to metal for orthopaedic instrumentation, allowing for efficient mass production. Its use can reduce both the cost and weight of instrument kits.
Solvay Ixef PARA
Status: Gamma-stabilized, biocompatible healthcare grades of Ixef PARA were introduced under the Ixef GS label in 2009. In 3Q18, Ixef PARA was utilized as an alternative to stainless steel in a single-use instrument kit for minimally invasive spinal fusion procedures, launched by Innovative Surgical Designs.
OEM customers: Innovative Surgical Designs, Instratek (purchased by Stryker in 2016), Intelligent Implant Systems, Reign Medical.
Priority market segment: OEMs that specialize in single-use applications or offer parallel options of reusable or single-use kits with their implants. Currently used in spine, extremities, trauma and large joint.
Trend: Ixef PARA materials enable orthopaedic applications to be converted to plastics, supporting a cost/benefit ratio that is suitable for single-use instrumentation price points. We also share our OEM customers’ growing concerns about plastic environmental pollution. Solvay is launching several corporate initiatives to introduce and create “cyclical economies” with downstream customers and partners. We are interested in collaborating with partners to find and implement actionable solutions to reduce waste and minimize both the carbon footprint of orthopaedic products and the consumption of potable water.
What one significant challenge will materials suppliers face in 2019, of which OEMs should be aware? Counterfeiting and the use of industrial-grade materials for instrument and implant applications have become real concerns for us. Specifically, the substitution of industrial-grade polymers for their strictly quality-controlled, biocompatible, chemically similar counterparts has always been a risk for OEMs that use these materials in their products. That risk has only grown over the past five years with cost reduction pressures, globalization of supply chains and increased regulatory complexity. We’re taking proactive steps with our supply chains to help OEMs reduce these risks, for example standardizing and clearly branding the limited contact and implant grade products that we supply, and licensing specific partners to produce or distribute our healthcare materials.
Superior Polymers
Interviewed: Jeffrey Johnson, President
Material: Magnolia PEEK & PEEK HA (hydroxyapatite) + Fi (carbon fiber)
Application: Magnolia PEEK is used in implantables, specifically those that are in contact with bodily fluids or tissue for more than 24 hours. It is manufactured in a cGMP clean room production facility that incorporates cGMP design for medical applications. Magnolia PEEK HA + Fi was created to allow forbony in-growth and to outperform Unfilled PEEK. The issue with PEEK HA is that you lose strength by adding HA to the PEEK. This causes devices to be weaker than your typical, Unfilled PEEK and can cause damage to the devices. With Magnolia Peek HA + Fi, we are adding hydroxyapatite, but gaining the strength back by adding carbon fiber.
Status: One product utilizing Magnolia PEEK has received FDA 510(k) clearance; Magnolia PEEK HA + Fi expected to be on market by 3Q19.
OEM customer: Zavation uses Magnolia PEEK in its interbody devices for lumbar fusion.
Priority market segment: Broad orthopaedic, focus on spine.
What one significant challenge/trend will materials suppliers face in 2019, of which OEMs should be aware? Titanium is a hot topic. The issue is and always will be is its incompatibility with diagnostic images crucial for visualizing changes to bone formation. PEEK was the answer for that, but it is inert. OEMs started searching for a combination and went back to titanium. Now, we are seeing new designs and formulations coming out (PEEK HA, HA + Ti, porous, coated, etc.) and we expect to see OEMs return to these formulations, as they are getting the best of both worlds.
Rob Meyer is ORTHOWORLD’s Senior Editor.
