Manufacturing of Medical Devices with Twin-Sheet Thermoforming

Medical devices play a pivotal role in modern healthcare, aiding in diagnosis, treatment, and patient care. From intricate surgical instruments to patient-friendly wearable devices, the demand for innovative and reliable medical equipment continues to grow.

One manufacturing method that has gained prominence in producing these critical devices is twin-sheet thermoforming. This specialized thermoforming process offers unique advantages, making it an increasingly attractive choice for medical device manufacturers.

Join the professionals from Advanced Plastiform, Inc., our plastic thermoforming company, as we explore how twin-sheet thermoforming is reshaping the medical device production landscape and contributing to healthcare technology advancement.

What is Twin Sheet Thermoforming for Medical Devices?

Thermoforming is a versatile manufacturing process widely employed in various industries, including aerospace, automotive, telecommunications, and more. At its core, thermoforming involves heating a thermoplastic sheet until it becomes pliable and then molding it into a desired shape using a mold or tool. Once the plastic cools and solidifies, it retains the molded shape.

Twin-sheet thermoforming is a variation of the thermoforming process, setting it apart from conventional thermoforming techniques while making it one of the ideal manufacturing processes for the medical industry. In twin-sheet thermoforming, two thermoplastic sheets are heated simultaneously and molded separately before joining to create a single, hollow, three-dimensional part.

Double-Sided Design

Twin-sheet thermoforming allows for complex parts with different designs on each side. This can be especially beneficial for medical devices that require inner and outer surfaces with distinct features or properties.

Increased Structural Integrity

The combination of two sheets creates a hollow structure, offering enhanced strength and rigidity compared to single-sheet thermoformed parts. This structural integrity is valuable in medical devices that need to withstand mechanical stresses or provide support.

Insulation and Encapsulation

The hollow space between the twin sheets can be used for insulation or encapsulation, making it suitable for medical devices requiring thermal or electrical isolation.

What Materials Are Commonly Used in Twin-Sheet Thermoforming for Medical Devices?

Selecting the appropriate materials is a critical aspect of twin-sheet thermoforming for medical devices. The choice of materials directly impacts the device's performance, safety, and compliance with regulatory standards.

Polyvinyl Chloride (PVC)

Polyvinyl chloride is a popular choice for medical device manufacturing due to its versatility, cost-effectiveness, and compatibility with sterilization methods like autoclaving and ethylene oxide (EtO) sterilization. It is used in applications ranging from medical packaging to tubing and drainage systems.

Polycarbonate

Polycarbonate offers exceptional strength and impact resistance, making it suitable for medical devices that require durability and protection. It is commonly used for device housings, face shields, and surgical instrument handles.

Acrylonitrile Butadiene Styrene (ABS)

Acrylonitrile Butadiene Styrene combines strength with ease of processing, making it an excellent choice for medical device components, especially those requiring structural integrity and impact resistance.

Polypropylene

Polypropylene is lauded for its resistance to moisture and chemicals. It is used in medical devices where compatibility with bodily fluids and sterilization is essential, such as in laboratory equipment and disposable medical products.

Design Considerations for Medical Devices

Designing medical devices through twin-sheet thermoforming involves a unique set of considerations to ensure both functionality and compliance with regulatory standards. Here are some of the necessary considerations for creative plastic parts and pieces for medical devices.

Material Selection

Begin by selecting materials that align with the device's intended use and requirements. Materials should be biocompatible, chemically resistant, and capable of withstanding sterilization methods.

Geometry and Complexity

Twin-sheet thermoforming allows for intricate designs, including undercuts, hinges, and multiple surface textures. However, it's crucial to balance complexity with manufacturability and ease of assembly.

Wall Thickness

Uniform wall thickness is essential for structural integrity. Varying thicknesses can lead to weak points or uneven performance. Ensure that the chosen materials are suitable for achieving consistent wall thickness.

Durability and Impact Resistance

Depending on the medical device's application, consider the need for durability and impact resistance. Reinforce critical areas, such as stress points, to withstand mechanical stress during use.

Joining Techniques

Twin-sheet thermoforming involves joining two molded sheets. Consider the joining method (heat sealing, adhesive bonding) and its impact on the device's overall strength and integrity.

Ergonomics

Design medical devices with user comfort and ergonomics in mind. Consider how the device will be held, manipulated, or used by healthcare professionals or patients.

Labeling and Identification

Incorporate space for labels, markings, or identification features required for regulatory compliance, including product traceability and user instructions.

Patient Safety

Prioritize patient safety by designing devices with features that prevent misuse or accidental harm. This may include child-resistant closures or tamper-evident designs.

Regulatory Standards

Familiarize yourself with the regulatory standards and guidelines applicable to FDA requirements for medical devices. Ensure that your design complies with these standards.

Applications of Twin-Sheet Thermoforming in Medical Devices

Twin-sheet thermoforming has revolutionized the way various healthcare products are designed and manufactured. Our thermoforming company is exploring the diverse range of medical devices produced using twin-sheet thermoforming by taking a closer look at its common applications.

Patient Bed Frames and Support Surfaces

Twin-sheet thermoforming is utilized to create ergonomic bed frames and support surfaces that ensure patient comfort and pressure relief, reducing the risk of bedsores.

Medical Imaging Components

The housings and covers for medical imaging equipment, such as X-ray machines and MRI scanners, are often manufactured using twin-sheet thermoforming due to the method's ability to create large, complex shapes with precision.

Diagnostic Equipment Enclosures

Medical devices like ultrasound machines, blood analyzers, and ECG monitors benefit from the durability and customization capabilities offered by twin-sheet thermoforming for their enclosures and covers.

Laboratory Equipment

Twin-sheet thermoforming is employed to create casings and housings for various laboratory equipment, including centrifuges, incubators, and diagnostic testing devices.

Medical Carts and Trolleys

Medical carts and trolleys used for transporting equipment and supplies within healthcare facilities often feature twin-sheet thermoformed components that provide structural strength and durability.

Respiratory Devices

Some respiratory devices, such as nebulizers and CPAP machines, incorporate components made through twin-sheet thermoforming for their durability and resistance to cleaning agents.

Pharmaceutical Packaging

Twin-sheet thermoforming is used to create packaging solutions for pharmaceutical products, ensuring product safety, tamper-evidence, and user-friendliness.

Contact Our Medical Device Thermoforming Manufacturers Today

Are you ready to bring your innovative medical device concept to life or enhance your existing medical product line? Contact our experienced and dedicated team of medical device thermoforming manufacturers today to kickstart your project.

At Advanced Plastiform, Inc. we invest in state-of-the-art thermoforming and injection molding equipment and technologies to ensure precision, quality, and efficiency in the production of your medical devices. Whether it's a complex implant or a simple diagnostic enclosure, we specialize in tailoring our thermoforming solutions to meet your unique project requirements. Serving clients throughout North Carolina, South Carolina, Pennsylvania, Maryland, Tennessee, Georgia, and Virginia, Contact us today by calling us at  919-404-2080 or filling out the contact form to get started.