Materials play a prime role in advancing orthopedics, especially given the industry’s focus on device solutions that positively impact patient outcomes, reduce procedural cost, and support an aging population. Materials and their corresponding characteristics can significantly impact the efficacy of the devices they are made into and should be considered at the starting point of device manufacturing. Understanding trends, challenges, and changing regulations allow medical device designers and manufacturers to identify gaps in the materials landscape and explore opportunities paramount to device evolution.
Last month, Carpenter Technology assembled diversified representation from OEM, contract manufacturing, and other industry expertise to discuss orthopedic macro trends impacting material needs.
- Brent Marini, Medical Strategic Business Developer, Carpenter Technology
- Gaurav Lalwani, Ph.D., Medical Applications Development Engineer, Carpenter Technology
- Gordon Hunter, Ph.D., Principal Manager of Materials Science, Smith+Nephew
- Chuck Hansford, Director of the Advanced Development Center of Excellence, Tecomet
- Dale Tempco, Medical Device Consultant
The panel provided critical insight and practical advice on the impact of EU medical device regulations and the use of cobalt-containing materials, the emergence of robotic and minimally invasive procedures, and the advancement of additive manufacturing.
Presence of cobalt in materials
The landscape of the industry is changing with the new European Union medical device regulations (EU MDR). OEMs and contract manufacturers have been focusing on risk mitigation, regulatory compliance, design control, and device history record.
While it’s difficult to predict how the market will react to labeling changes, placing a limit of 0.1% on cobalt in stainless steel alloys (such as 316L) would ensure that it is not present at a level that would require special labeling of those devices for EU markets.
Carpenter Technology is one of the first to officially introduce low-cobalt stainless steel products to the market. The company continues to participate in public forums, including ASTM, and work closely on material standards impacted by the new regulations. Carpenter Technology is also innovating alternative materials for regulation compliance, as well as optimal quality and patient outcomes.
Minimally invasive and robotic surgical techniques
Minimally invasive surgery (MIS) and robotic-assisted procedures present unique challenges due to finer features and tighter toleranced devices. Instrument designs have become more intricate. We’ve also seen a shift in interest toward single-use and patient-specific instrumentation.
As parts get smaller and more complex, material choices and manufacturing technologies become ever more crucial.
Materials must be extremely stable during machining, as residual stress will throw parts off. Manufacturing methods will need to evolve to keep up with surgical technique advancements.
There is a steep learning curve for how to handle powder, how to handle an additively manufactured product during subsequent processing, and what issues may arise with the products in service. Very thin sections and fatigue-critical part applications are a particular challenge with additive manufacturing (AM).The industry has turned to Ti64 as a leading AM solution because it provides:
- Less stiffness and greater biocompatibility than most alternative implant alloys
- High tensile strength and corrosion resistance
- A potential reduction in scrap from milling of cast and wrought materials
New materials will be rare for implants except in niche applications, whether produced by AM or other processes. However, the advancement of stainless steel material is gaining interest in orthopedic instrument development. Over the next 3 to 5 years, we expect to see a focus on 400 series stainless steel parameter development.
You can also reach out to the Carpenter experts by getting in touch below with any questions!