This technical information has been contributed by
Minnesota Rubber and Plastics
Medical Innovations Require Complex Materials
By Lih Fang Chew
Global Vice President Marketing, Quadion LLC
Healthcare is a highly competitive industry, and the demand for consistently high quality, yet affordable products, continues to increase as the industry struggles with higher costs and decreased reimbursement. With these forces firmly entrenched, the medical community has worked hard to enhance specialized products to be more ergonomic and functional. Designs continue to be tweaked, redesigned, and improved. Often, the design has come to the point where the materials are just as important when establishing an industry leading device or instrument.
A Search for the Right Material Often Requires Finding the Right Processor
Material processors are not all alike. Just as material formulations differ, so do the processors. Finding the right materials manufacturer can be a challenge, especially with the mass migration to consolidation in the medical design industry. However, certain experienced and more nimble companies offer the research and development-backed materials, along with the flexibility, that more innovative medical device companies desire in a supplier.
While durable rubber and plastic devices have been used for more than 100 years, over time, the molding of these materials has become highly precise and automated. But providing an efficiently made, molded component or assembly is no longer enough for most medical companies. For that reason, researchers and processors have designed rubber and plastic formulas with inherent characteristics built into the polymers. These characteristics include strength, durability and flexibility.
Over time, many of these advancements still are not enough—quality, clinical performance, infection control liability, and other concerns begin to dominate. As a result, the manufacturing technology pushes the limits on materials design, including these factors:
- Characteristics of the plastics and rubbers
- How these materials interact with fluids and chemicals in their environment
- Whether or not molding operations are done in FDA registered facilities and clean rooms
- Temperature tolerance in extreme conditions, while maintaining all inherent characteristics
- How device design maintains integrity and performance during use
What Drives Innovation and Its Benefits
Industry demands push innovation, and medical device manufacturers rely on component and assembly manufacturers to push the envelope in development so they can offer healthcare professionals the best solution for their application. This comes at a cost—sometimes a high cost. While medical innovations with new materials are exciting, cost is a major factor in the medical device industry. Suppliers, both large and small, struggle with balancing the cost of research and development with the cost to the provider and the patient.
As a result, materials manufacturers are cognizant of this factor when it comes to assisting with device design. A more expensive design without a major clinical benefit will not be specified.
In the 1980’s and 1990’s, there was a large manufacturing transition from metal products to plastic and rubber alternatives due to the availability and relative lower cost of these materials. With that transition nearing completion, finding new ways to make ever more affordable, better plastic and rubber formulations has been a priority. Investing in a quality materials manufacturer relationship can guarantee the company a quality product, but over- investing can be problematic as cost drivers remain crucial.
That said, using a lower quality or poorly developed product may compromise a supplier’s relationship with a customer following a device failure. Finding a middle ground in price, while ensuring quality and clinical performance, is every medical device manufacturer’s goal. What is important to realize while making new material decision with a new processor is the potential for a very successful, long-term partnership.
A Molding Partner with Material Development Expertise
Many times, a supplier will have a design concept in mind, but not the research and development expertise or resources to finalize the design specifications. Materials manufacturers are recognized as industry leaders, first, for their commitment towards research and design in their materials division, and, second, for their long-standing commitment to developing molds and processes for these new materials that ensure long-lasting effectiveness in the medical industry.
Components manufactured by Minnesota Rubber and Plastics contribute to industry-leading devices and brands in the diagnostic, surgical, orthopedic, and interventional markets. A critical part in meeting this demand is the company’s ongoing mission to develop innovative materials. The most recent innovation is Quniton™, a completely new compound formulated to be highly lubricious with many other benefits as well.
Quniton™ Has Arrived
Every so often, a new material is developed that outdoes others in its class because it has multiple benefits beyond those already in the market. That is the case with Quniton. It is a very low-friction material with obvious benefits for the medical device industry. For example, it makes the seals on plungers and vials, equipment, and access devices more secure and smoother to operate. Additional benefits and features of Quniton are well suited for an industry with critical requirements and demands that include:
Compared to existing materials ,such as SBR and NBR, Quniton exhibits excellent resistance against UV aging, making it applicable in devices and equipment that use high-dosage UV light. Because Quniton is saturated (i.e., containing no double bonds) it is inherently protected from degradation caused by exposure to UV light. This is important because UV disinfection is becoming an increasingly popular sanitization method in the medical device industry, due to its ability to reduce hospital “superbugs” and its overall environmental friendliness compared to other sanitization methods.
- A low compression set that means it will maintain its integrity and sealing force;
- UV resistance, a feature especially timely with an increasing number of UV light disinfection equipment on the market;
- Thermal stability in temperatures up to 500 degrees Fahrenheit.
Quniton Differences and Advantages Compared
Quniton exhibits a CoF that is inherently low for the material (<0.25µ), much lower than existing materials, and all without any extra additives. In fact, the static coefficient of Quniton FKM is far lower than its general purpose counterparts. As seen in the graph above, General Purpose FKM-70 has a 1.13 static coefficient, while Quniton General Purpose FKM-70 has a static coefficient of just 0.18. Likewise, General Purpose FKM-90 has a 0.66 static coefficient, while Quniton General Purpose FKM-90 has a substantially lower 0.21 static coefficient.
These numbers indicate a material that reduces wear and abrasion, thus producing a longer life. Quniton is not treated or coated, ensuring that it produces no extractables or leachables, and touts a biocompatibility USP Class VI and ISO 10993-5 certification. Inherent lubricious qualities also allow elimination of wet or dry lubricants required to insert or install a seal, saving cost and providing easier installation.
Insightful Application of New Materials
In the medical industry (and others as well), seals, plugs, and valves are especially subject to wear and abrasion due to repeated material compression and surface-to-surface contact. Quniton is highly suited for these types of plugs, valves, and seals for a number of reasons:
All of the above properties ensure that seals, plugs, and valves ultimately maintain integrity and performance and maintain a longer shelf life, an aspect that is critical to healthcare industry due to cost concerns.
- Its low compression set allows it to maintain its original form and sealing force, retaining integrity throughout the product life cycle.
- Low CoF allows resistance to bonding or sticking to a wide variety of materials, reducing wear and abrasion.
- Stiction is greatly reduced, ensuring negligible degradation when the device is not in use.
- Non-reactivity ensures consistent surface-to-surface contact, preventing wear.
- No micro-cracking or flaking issues, especially considering stretching that can occur during installation.
- Complies with ISO 10993-5.
More Opportunities on the Horizon
Quniton presents a variety of new opportunities for seals in medical powered rotary applications, such as in powered prosthetic devices. Dynamic applications such as these require a material that maintains shape and integrity and is able to endure the repeated compression and rotary movement between joints that many prosthetic devices exhibit.
Quniton is an example of a material in a cost-aware industry that offers education and technical advantages through partnerships. While all processors desire to be the best, only those with supporting technical expertise will achieve this level of excellence.
More information about the use of Quniton is available at mnrubber.com.
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