Lih Fang Chew / Global Vice President Marketing, Quadion LLC

Minimally invasive surgeries have become faster, easier, and less costly using the latest trocar designs. They could incorporate specialized seals molded of the newly formulated Quniton elastomer formulated just for these endoscopic applications.

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. Designers continue tweaking, redesigning, and improving their work. The design often comes to a point where the materials are just as important when establishing an industry leading device or instrument

The right material often requires finding the right processor

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 look for 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.

Research and elastomer development by Minnesota Rubber and Plastics results in seals that may improve endoscopic procedures. These duckbill seals (named for their apparent shape) are molded from specially formulated Quniton compound. It is highly lubricious and very pliable with good memory so that it stretches properly and holds shape around the inserted instrument during the procedure.

Despite such advancements, they 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 factors such as the:

• Characteristics of the plastics and rubbers
• How the 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

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 applications. This comes at a cost – sometimes a high one. Cost is a major factor in the medical device industry. Large and small suppliers, 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 balancing 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 and manufacturer relationship can guarantee the company a quality product. But over-investing can be problematic because 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 successful, long-term partnership.

A molding partner with material development expertise

Many times a supplier will have a design concept in mind, without the research and development expertise or resources to finalize the design specifications. Materials manufacturers, such as Minnesota Rubber and Plastics, are recognized as industry leaders, first, for their commitment towards research and design in their materials division, and second, for their long-standing commitment at developing molds and processes for these new materials that ensure long-lasting effectiveness in the medical industry.

Components from the company contribute to industry-leading devices and brands in the diagnostic, surgical, orthopedic and interventional markets A critical part in meeting this demand is its ongoing mission to develop innovative materials. The most recent innovation is Quniton, a completely new compound formulated to be highly lubricious and with many other benefits.

Why the preceding was important

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.

Medical syringe technology continues to evolve for better function with plungers and caps molded of specially formulated Quniton by Minnesota Rubber and Plastics. The material is highly lubricious which reduces stiction and that lets care providers more easily administer services to patients. Quniton may offer extended shelf life to pre-filled syringes because it can maintain lubricity and sealing force throughout the product life span.

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 ideal for an industry with critical requirements and demands that include:

• A low compression set that means it will maintain its integrity and sealing force.
• UV resistance, a feature especially timely with anincreasing number of UV light disinfection equipment on the market.
• Thermal stability in temperatures up to 500°F.

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.