Healthcare is a highly competitive industry that demands consistently high-quality, yet affordable products. That means the industry struggles with higher costs and decreased reimbursement. With these forces firmly entrenched, the medical community has worked hard to enhance specialized products so they are more ergonomic and functional. Designers continue tweaking, redesigning, and improving their work. If the device is to be considered industry-leading, material selection becomes critical.
The right material often requires finding the right processor
Just as material formulations differ, so do their processors. Finding the right material manufacturer can be a challenge, especially with increasing consolidation in the medical-design industry. However, certain experienced and more nimble companies offer the research & development-backed materials, along with the flexibility, that more innovative medical device companies look for in a supplier.
Over the last 100 years, the molding of durable rubber and plastic devices has become highly precise and automated. But providing an efficiently 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 has resulted in a particular seal that may improve endoscopic procedures (catheter components are another potential application). Duckbill seals (named for their apparent shape) are molded from a specially formulated Quniton compound. It is highly lubricious and pliable with good memory so it stretches properly and holds shape around the inserted instrument during the procedure.
Despite these advances, quality, clinical performance, infection-control liability, and other concerns begin to dominate. As a result, manufacturing technology pushes the limits on material design, including factors such as:
- Characteristics of the plastics and rubbers
- How the materials interact with fluids and chemicals in their environment
- Whether 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 drive innovation. Medical device manufacturers rely on component and assembly manufacturers to push the development envelope so they can offer healthcare professionals the best solution for their applications. This comes at a cost – sometimes a high one. It is no surprise that cost is a major factor in the medical device industry. Large and small suppliers struggle balancing the cost of research and development with the cost to the provider and patient.
As a result, material manufacturers are cognizant of this balance 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, a large manufacturing transition pushed designs from metal to plastic-and-rubber alternatives due to the availability and relatively lower cost of the materials. With that transition almost complete, finding new ways to make ever more affordable, better plastic and rubber formulations has been a priority. Investing in quality materials and manufacturer relationships can ensure a quality product. But over-investing can be problematic. On one hand, it generates cost drivers. On the other hand, using a lower quality or poorly developed product can lead to device failure that could compromise a supplier’s relationship with a customer. Finding a middle ground in price, while ensuring quality and clinical performance, is every medical device manufacturer’s goal. It’s important to recognize, while making a new material decision with a new processor, the potential for a successful, long-term partnership.
A partner with material development expertise
A supplier will often have a design concept in mind, but lack the R&D expertise or the resources to finalize design specifications. Materials manufacturers, such as Minnesota Rubber and Plastics, are recognized as industry leaders for their commitment to research and design. Such leaders also have a long-standing commitment to 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 of meeting this demand is an ongoing mission to develop innovative materials; the most recent innovation is Quniton, a completely new compound.
Slippery material offers new possibilities for seals, catheters, and more
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, a low-friction material with obvious benefits for the medical device industry.
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.
The material also makes the seals on plungers, vials and access devices more secure and smoother to operate. Additional benefits and features of Quniton are ideal for an industry with requirements including:
- A low compression set, meaning it will maintain its integrity and sealing force;
- UV resistance, a feature especially timely with an increasing number of UV disinfection technologies on the market;
- Stability in temperatures up to 500°F.
Compared to existing materials such as SBR and NBR, Quniton exhibits excellent resistance to 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 more widely used in the medical device industry, due to its ability to reduce hospital “superbugs” and because of its overall environmental friendliness compared to other sanitization methods.