Precision is something that most injection molders strive for, no matter the project or industry. But when it comes to manufacturing parts for medical devices, precision becomes non-negotiable. Injection-molded components for the medical industry — like housings, connectors, and intricate micro-molded parts — require meticulous attention to details and quality to meet the unyielding demands of the medical industry. That’s where injection molding metrology comes in.

Metrology (the science of measurement) enables manufacturers to validate every dimension and feature of a part to help ensure that medical devices perform as intended and safeguard patient health.

Let’s take a closer look at how injection molding metrology enhances quality control in injection molding for medical devices.

What is Injection Molding Metrology?

In injection molding, metrology specifically refers to the process of measuring and validating the physical properties, dimensions, and tolerances of molded parts. In this context, metrology is invaluable to ensuring that the plastic components meet the precise specifications provided by the medical device client. At its core, it usually involves detailed measurements of features like a finished part’s geometry, surface finish, and material properties.

Through the integration of metrology, manufacturers can reduce defects, ensure compliance with industry standards (such as ISO 13485), and ultimately deliver medical components that are safe, reliable, and capable of performing their intended functions.

Key Metrology Tools and Techniques Used in Injection Molding

Injection molding metrology relies on a number of highly advanced and specialized tools and techniques such as: 

  • Coordinate Measuring Machines (CMMs) — Critical tools in injection molding metrology, CMMs use probes to make precise measurements of the physical characteristics of a part, providing highly accurate 3D data. These machines are ideal for inspecting parts with intricate shapes, complex geometries, or tight tolerances — all common in medical devices.
  • Optical and Laser Scanning — These non-contact methods are designed to enhance precision, especially for delicate or intricate parts that may be prone to damage during traditional contact-based measuring tools. Optical systems use light to capture the part’s surface, creating high-resolution 3D images that reveal deviations. Similarly, laser scanning uses laser beams to capture detailed surface measurements without touching the part.
  • In-House CT Scanning — In-house CT scanning offers a unique advantage in injection molding by enabling manufacturers to verify internal structures of molded parts without causing any damage. With 3D images of a part’s internal geometry, manufacturers can thoroughly inspect for voids, internal stresses, and structural integrity. This is crucial for medical devices that require high degrees of internal accuracy like implants or diagnostic tools.
  • Automated Data Collection Systems — With automated data collection and real-time process monitoring, manufacturers can continuously track critical process parameters — such as temperature, pressure, and material flow — to ensure that any deviations from optimal process conditions are detected and addressed before they lead to defects. This also gives injection molders the ability to analyze trends over time to identify potential issues and optimize production. 

Importance of Injection Molding Metrology for Medical Device Quality Control

Ensuring Patient Safety

Patient safety is understandably the number one priority in medical device manufacturing. Injection molding metrology helps prevent defects that could compromise the functionality or integrity of medical devices. By validating the dimensions and tolerances of molded components, manufacturers can minimize or even eliminate issues such as misalignment, stress fractures, and improper fits.

For example, drug delivery systems rely heavily on accurate dimensions to ensure proper dosing and reliable performance. A dimensional flaw can result in incorrect dosages, posing serious risks to patient health.

Meeting Regulatory Standards

Stringent regulations govern the medical device industry, including FDA guidelines and ISO 13485 standards. These regulations require precise measurements and consistent quality control. Injection molding metrology provides accurate measurement data that can be used to validate processes during audits or certification renewals, helping medical device manufacturers avoid delays and penalties.

Supporting Biocompatibility

And finally, biocompatibly is one of the biggest concerns in medical device manufacturing. In order to ensure parts and devices do not cause adverse reactions when in contact with the human body, a number of factors (such as material selection) must be considered. Injection molding metrology supports this by putting materials through rigorous testing to verify their performance.

In implantable devices, for instance, metrology ensures that the materials’ thickness and surface finish meet biocompatibility standards.

Octex Ensures Superior Quality Through Metrology

At Octex, we employ advanced metrology tools, including in-house CT scanning, CMMs, and optical measurement systems, to verify even the most intricate details of your injection-molded components. Our capabilities in real-time data collection, scientific molding, and automated quality checks provide an unparalleled level of accuracy and consistency.

With these resources, we help you ensure compliance with strict medical regulations, safeguard patient safety, and deliver superior-quality devices. Whether you’re developing cutting-edge implantable devices or critical diagnostic tools, our expertise in metrology supports your success at every stage.

Ready to elevate your medical device manufacturing? Contact us today to learn how our advanced metrology and injection molding services can help you achieve unmatched quality and precision.