Elastomeric components are some of the most commonly outsourced items for today’s forward-thinking medical device manufacturers. And for good reason: These items are typically responsible for critical fluid transfer and other functionality in devices ranging from infusion pumps to catheters, respiratory devices to IV setups, surgical tools to dental equipment. 

For medical device manufacturers, working with a dedicated component supplier with specialized knowledge in the development and manufacturing of these important parts can help streamline operations and enable the manufacturer to focus on its core competencies, without having to worry about making its own tubing componentry. By outsourcing tubing, manufacturers can more easily meet regulatory requirements, manage costs and increase their speed to market, all while maintaining the necessary quality required to produce essential medical equipment. 

But there are many different considerations to be made when selecting the right elastomer components for end-use medical devices. For example, many different materials are available, including thermoplastic elastomers, silicone, polyvinyl chloride and latex. These are among the most common materials used in medical device production, and they come with their own performance characteristics that make them more (or less) suitable for a given application.

Indeed, solidifying your outsourcing strategy is an important process that can be made easier when working with the right tubing (or other component) supplier who understands the critical needs of your application. With all of this in mind, this article will explore some considerations to make when selecting the right elastomer products for your medical device production. 

Extruded Tubing and Material Choice: A Closer Look

Depending on the specific application, tubing components used in medical devices must typically meet stringent standards for material purity, flexibility, strength and more. Achieving the required performance characteristics is typically dependent on your choice of material. However, generally speaking, medical device manufacturers don’t often maintain in-house expertise when it comes to material selection for tubing componentry. But there are certain things to know that can help contribute to an optimal selection for your needs. 

First, it’s helpful to be familiar with the common choices:

Polyvinyl Chloride (PVC): PVC is a popular choice due to its low cost and versatility, and can be deployed for general fluid transfer applications including oxygen and respiratory tubes, IV tubing, and more. It’s lightweight and can be manufactured with varying degrees of flexibility. It also lends itself well to solvent bonding, making it easier to work with. PVC is a strong choice for applications that require stability and excellent resistance to tears, corrosion, weather, chemicals, impact and electricity. 

However, because PVCs incorporate plasticizers to soften the material—some of which have more recently been classified as carcinogens—PVC faces some limitations based on the product’s intended application. For example, many PVCs are not suitable for use in tubing applications where the product is implanted in a patient.

Thermoplastic Elastomers (TPEs): TPEs combine the properties of plastic and rubber, providing flexibility and strength without needing plasticizers like PVC. TPE tubing is often used as an alternative to PVC in applications where flexibility and chemical resistance are necessary, like catheters and IV tubing. Because TPE is easy to sterilize, offers excellent cleanliness properties and good biocompatibility, TPE tubing is a good choice for many medical applications. 

TPE mimics many of rubber’s most desirable properties, such as flexibility and a soft feel. But high-quality, specialized TPE can exhibit greater resistance to heat or chemicals than rubber, making it a more stable, durable material choice in certain applications. High-performance TPE demonstrates excellent elasticity, flexibility and elongation properties. Depending on the compound, TPE products can also offer good tensile strength and tear resistance. 

Latex: Latex has long been used in the medical industry, offering excellent flexibility and elasticity for applications that require it. Medical-grade latex is generally safe for skin contact and is often chosen for applications that come into prolonged contact with the body. However, as latex allergies became a more common consideration for medical components, manufacturers will typically offer alternatives for patients with latex allergies. Latex is resistant to tearing and puncturing, which makes it suitable for applications requiring reliable, durable parts like catheter balloons and tourniquets.

Silicone: Known for its flexibility, biocompatibility and resistance to high temperatures, silicone is often used in tubing that needs to be soft and pliable, like catheters or respiratory tubing. It’s highly resistant to chemical reactions, making it suitable for prolonged patient contact.

Silicone has a long history of use in medical applications and has often been specified into production designs for its demonstrated reliability. However, there are many applications where silicone may offer greater-than-required performance at a higher cost than an alternative material. For example, high-quality TPE tubing can provide comparable performance at a lower cost in many applications, and can provide some unique advantages of its own.

Ultimately, your choice of component material—be it for tubing or something else—depends on the demands of your application. For medical device manufacturers, it can be helpful to work with a supplier with a depth of knowledge on the different performance characteristics of different materials. For example, a given application might require good pull strength, material memory and returnability, and very tight tolerances—if you’re unsure which material to pursue, your supplier should be able to guide you toward the right choice. 

One additional criterion to consider in material selection is the sustainability profile of your material of choice. Medical device manufacturers—along with manufacturers of all sorts of products around the world—are under increasing pressure to enhance sustainability from every perspective, and even small improvements in materials selection for a large run of products can contribute to significant carbon reduction. Your component supplier should be able to help you evaluate this criterion as well. 

Procuring High-Performance, Specialized Custom Dip-Molded Parts

Another critical type of elastomeric component common to the medical device industry is custom dip-molded latex parts. Dip molding allows for extensive customization, enabling manufacturers to create parts with specific thicknesses, textures and shapes to meet the unique requirements of different medical applications. These are typically highly specialized components used in various medical applications where flexibility, elasticity and soft textures are required.

Some common applications include catheter balloons, latex bladders, surgical gloves and finger cots as well as protective sheaths and covers. For example, custom-shaped latex sheaths are commonly used in medical instruments to prevent contamination and protect the instrument, including tools like ultrasound probes, endoscopes and dental tools, ensuring they remain sterile during use.

To best understand what goes into a high-performance, dip-molded component, it can be helpful to understand the dip molding process from start to finish. First, a metal or ceramic form is designed in the shape of the final part. Typically, this form is custom-made to meet specific design requirements to accommodate unique shapes and sizes. Once the design is finalized and the form is built, it is dipped into liquid latex, which coats the surface of the form in a layer of material. The thickness of the final part can be controlled by adjusting the number of dips, the viscosity of the latex and the dwell time in both the coagulant and the latex. After sufficient thickness has been achieved, the latex is cured to set the shape and grant the final part better durability. 

Following production, medical-grade latex parts commonly undergo stringent quality control checks for consistency, thickness, tensile strength and more. They must meet standards for medical applications, including biocompatibility and FDA guidelines.

For medical device manufacturers, there are some important things to consider when sourcing your custom dip-molded latex parts. One of the most important parts of the process is form design, which not only impacts the performance of the end-use product, but its ability to be manufactured consistently and efficiently. For example, a form must be designed in such a manner that it does not trap air bubbles within the desired latex shape during the dipping process. Elsewhere, points and edges must be considered so that they do not rip or tear the finished product upon removal from the form. 

These may seem like small design considerations, but they have the potential to make or break a run of components for a medical device manufacturer. A form that is resulting in poor quality products may have to be scrapped and redesigned entirely before restarting a new run of components. So, while medical device manufacturers are most typically responsible for the design of the form based on the needs of their application, it can be beneficial to work with a partner who is able to provide these kinds of considerations based on their experience in the custom dip-molding process.  

Other Factors to Consider When Sourcing Elastomeric Components

Whether it’s elastomer components like tubing or custom dip-molded latex products, there are a few essential requirements that medical device manufacturers should look for when outsourcing these critical parts. Some of them include:

ISO 13485 Compliance. This is the medical industry’s optimal medical device quality management system standard, which helps ensure all medical devices meet regulatory compliance and customer needs. Most components suppliers serving the medical industry meet this standard, but it’s important validation. For example, a jack-of-all-trades extrusion house may be able to make TPE tubing, but likely does not maintain compliance to these important criteria.

TAA Compliance. The Trade Agreements Act (TAA) is a federal law requiring products purchased by the U.S. government to be made in the United States or within a designated TAA-compliant country. For medical device manufacturers, this is an important designation for selling to U.S. government-operated facilities like hospitals overseen by the U.S. Department of Veterans Affairs.

Intellectual Property (IP) Assurance. Outsourcing component design and production typically involves sharing proprietary designs, specifications and potentially sensitive IP with suppliers. For medical device manufacturers, this can lead to concerns about unauthorized use or IP leaks, especially when suppliers serve multiple clients, including competitors. Unauthorized IP use can erode a company’s competitive advantage and result in product imitations in the market, not to mention increase the potential for lengthy and costly legal disputes. So, it’s important that your supplier is willing to make strong contractual non-disclosure agreements (NDAs), and is willing to submit to regular IP audits.

Assembly Services. It’s worth investigating whether your outsourcing partner is able to perform additional assembly services for your medical device components. This kind of service can help you streamline your manufacturing processes and get your products to market quicker. 

As component outsourcing becomes an increasingly reliable way for medical device manufacturers to optimize their business operations, it’s important to thoroughly evaluate the materials of your critical componentry, how they are made and what manufacturers are available to source from, and whether those manufacturers meet the high standards of the medical industry. The performance of your products, and the success of your business, depend on it.

Article source:MPO