The U.S. medical injection molding market is a significant segment of the healthcare industry.
This market was valued at approximately $3.4 billion in 2023 and is projected to reach around
$4.8 billion by 2030, growing at a compound annual growth rate (CAGR) of 5% from 2024 to
2030. One factor driving this trend is the increased demand for medical devices such as
syringes, IV components, diagnostic equipment, and surgical instruments. Plastic injection
molding's versatility, cost-effectiveness, and use of plastics with diverse material properties
make it ideal for producing these devices.
Choosing the right material for a medical device injection-molded part is a crucial decision that
should be made during product development and design. Choosing incorrectly can seriously
impact the device's performance, safety, and reliability, as well as negatively impact the
manufacturer. Therefore, it is imperative to understand the importance of selecting the correct
material for your applications.
The Importance of Material Selection
Selecting the correct material for your medical device is essential because it directly influences
its performance, durability, and biocompatibility. Each characteristic of the chosen plastic must
align with the specific requirements of the medical application, such as resistance to chemicals,
sterilization processes, and mechanical stress.
The medical device category is massive and is defined by the Food and Drug Administration
(FDA) as a tool or equipment used to diagnose, treat, or prevent diseases in humans or
animals. It may also affect the body’s structure or function, but it doesn’t work through chemical
action or need to be metabolized. So, a medical device can range from a simple bedpan to
complex implants. It also includes surgical tools, products used in invitro diagnostics, ultrasound
and MRI machines, and so much more. Whatever the application, it is critical that its specific
needs are considered when choosing the plastic, as well as any FDA regulatory requirements.
Key Characteristics of Plastics in Medical Devices
While the FDA does not provide a specific definition for medical-grade plastic, it regulates the
materials used in medical devices through various guidelines and requirements. The FDA
categorizes medical devices into three risk classes (Class I, II, or III), with higher-risk devices
subject to more stringent material requirements. The FDA’s product classification database lists
regulated products and provides recognized consensus standards that may include materials
and other specifications. Medical products not classified as medical devices may still be subject
to regulatory or industry-specific requirements.
When choosing a plastic material for medical device parts, you should consider several key
characteristics:
- Biocompatibility— Ensures the material is safe for use in and contact with body tissues
and fluids. - Strength and Durability— The material should withstand mechanical stress and last over
time without degrading. - Chemical Resistance— Ability to resist various chemicals, including those used in
sterilization processes. - Stability— Ensures the material maintains its properties under different environmental
conditions. - Ease of Processing— The material should be easy to mold into complex shapes without
compromising its properties. - Sterilizability— The plastic should be capable of undergoing sterilization processes
without compromising its integrity. - Radiolucency (for imaging devices)—The material should permit X-rays to pass through
it partially to allow visibility.
Specific Plastics Used for Medical Injection Molding
Several plastics are commonly used for injection molding in the medical industry, each with
unique characteristics that make them suitable for specific applications.
Acetal (Polyoxymethylene)
This plastic is known for its high stiffness, excellent dimensional stability, and low friction
properties. It provides outstanding durability, precision, and resistance to wear in medical
devices, making it ideal for use in surgical instruments, drug delivery mechanisms, and valve
components.
Acrylic (Polymethyl Methacrylate)
Acrylic is valued for its exceptional clarity, lightweight nature, and resistance to environmental
conditions. In medical applications, it offers reliable biocompatibility and visibility for diagnostic
and surgical equipment, such as incubator enclosures, transparent covers, and viewing ports.
ABS (Acrylonitrile Butadiene Styrene)
This thermoplastic is recognized for its toughness, impact resistance, and machinability. Within
medical devices, ABS excels at providing durable and lightweight housings for diagnostic tools,
handheld instruments, and non-invasive medical equipment.
HIPS (High Impact Polystyrene)
Known for its ease of fabrication and cost-effectiveness, HIPS is a popular choice for disposable
products. In the medical field, it is commonly used for single-use items such as trays, sample
containers, and instrument blister packaging.
LDPE/HDPE (Low-Density Polyethylene / High-Density Polyethylene)
Polyethylene stands out for its chemical resistance, flexibility (LDPE), and rigidity (HDPE). It
supports various uses for medical applications, from flexible drug-delivery pouches and tubing
to durable, sterilizable containers for medical supplies and instruments.
Nylon (Polyamide)
Nylon is a strong, wear-resistant plastic known for its versatility. In medical devices, it is
commonly used in applications requiring durability and biocompatibility, such as catheters,
surgical sutures, and prosthetic components.
Polycarbonate (PC)
Polycarbonate is recognized for its outstanding impact strength, transparency, and heat
resistance. In the medical industry, it is highly valued for its biocompatibility and ability to
withstand sterilization, making it suitable for syringes, IV connectors, and protective instrument
housings.
Polypropylene (PP)
This lightweight and fatigue-resistant plastic offers exceptional chemical resistance and stability.
Due to its ability to endure various sterilization processes, polypropylene is frequently used in
medical applications for sterilizable containers, packaging for surgical instruments, and pill
dispensers.
PEBA (Polyether Block Amide)
PEBA excels in medical settings because it is known for its elasticity and superior performance
in low-temperature environments. It is commonly utilized in flexible components such as
catheters, tubing for infusion pumps, and elastic medical devices requiring strength and
flexibility.
TPE (Thermoplastic Elastomer)
TPE is characterized by its rubber-like elasticity, ease of molding, and recyclability. In medical
applications, it is a preferred material for ergonomic grips on surgical tools, seals for medical
devices, and flexible closures for sterile packaging, offering excellent biocompatibility and
comfort.
Why Choose Advantech Plastics for Medical Injection Molding
At Advantech Plastics, we pride ourselves on delivering high-quality injection-molded parts that
meet the stringent requirements of the medical industry. Our commitment to excellence is
reflected in our ISO 9001:2015 and ISO 13485:2016 certifications, which ensure that every
product we manufacture adheres to the highest standards of quality and safety. These
certifications demonstrate our adherence to regulatory standards and our dedication to
continuous improvement.
Choosing the right material for your medical device is a critical step in the manufacturing
process. With our expertise and dedication to innovation, you can trust Advantech Plastics to
provide the perfect solution for your injection molding needs. We understand the complexities of
the medical device industry and are equipped to handle even the most challenging projects.
Let’s work together to bring your medical device to life with precision and reliability.
Contact us to get started.