Non-Destructive Testing and Its Importance For Medical Devices

The importance of traditional dimensional metrology equipment cannot be overemphasized; however, they have their limitations. With traditional metrology equipment, you may be unable to analyze the interior of a product and fail to notice cracks or other problems. It is also almost impossible to measure the clearance between the mating components of a product (using traditional metrology equipment) after it is assembled.

Computed tomography is an effective non-destructive testing technique for producing dimensionally accurate 2-D and 3-D cross-sectional images of objects using X-ray images. It allows engineers to study the details of a part’s interior. Advanced CT software can generate important data that can be utilized to identify defects early.

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CT Scanning Benefits  

CT scanning is a well-understood, reliable, and effective technology. It can help analyze the internal structure of a workpiece much faster than destructive cross-sectioning testing. In many cases, the scanning process can be completed in a few minutes. The result? Reduced inspection costs and higher throughput.  

Detecting Defects

Unlike vision machines that generate only dimensional data, computed tomography can help carry out an in-depth analysis that involves studying the internal structure of a workpiece, its material properties, and potential failure points. Analysis software in industrial CT scanning processes X-ray images to reconstruct three-dimensional models of scanned objects, enabling detailed examination of internal features and identification of defects through advanced algorithms and image analysis techniques.

In addition to helping detect defects, the function can assist manufacturers in evaluating porosity or the size and shape of pores relative to their position in the wall of a workpiece, for instance. Computed tomography facilitates normal-to-actual comparisons and digital imaging of internal features and surfaces of parts – something that’s impossible with traditional dimensional metrology equipment.  

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Here’s Why Medical Device Manufacturers Use Computed Tomography to Non-Destructively Test Their Medical Devices  

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Medical devices are some of the most regulated items. Non-compliant medical devices can leave manufacturers vulnerable to lawsuits, penalties, or government audits. NDT carried out using computed tomography can help manufacturers ensure their medical devices are safe, reliable, and compliant.  

Here are some reasons why every medical device manufacturer should use computed tomography for non-destructive testing to check the quality of their devices.  

• Assures Safety: Defective medical devices can cause injuries or even death. Computed tomography can help medical device manufacturers identify defects such as cracks in their products and design flaws early. The sooner a product design problem is detected, the easier it is to address it.‍
• Helps Ensure Regulatory Compliance: Medical devices should meet all quality and other standards set by regulatory bodies such as the FDA and MDR. CT is a powerful non-destructive evaluation technique that can help manufacturers ensure product compliance, protecting them from legal liability.  ‍
• Improves Quality Control: Non-destructive testing carried out using computed tomography can assist manufacturers in ensuring their products meet all standards and specifications. Effective quality control can help maintain consistent quality, so that medical devices are fit for their intended use. ‍
• ‍Reduces Costs: By helping medical device manufacturers identify flaws in their products early, computed tomography allows them to cut costs associated with product recalls and reworks and improve production efficiency. ‍
• Helps With Material Characterization: CT can help manufacturers assess the density, porosity, and composition of their products that come into direct contact with the human body to ensure they’re biocompatible and perform as expected.  ‍
• Fosters Innovation: Inspections performed using computed tomography allow manufacturers to test and validate novel medical devices and components.

In a traditional manufacturing environment, the manufacturer has to wait until the pre-production run to receive inputs (after the inspection) and must make changes to the mold cavity based on their skill level and experience. By clearly identifying any deviations, CT software can help medical device manufacturers accurately measure the geometry of parts.

Many CT software are capable of evaluating stress distribution under extreme loading. Some tools work directly on scanned surfaces and internal voxels, eliminating the need to pre-process mesh conversions. As a result, it becomes easier to run simulations against data.  

Nel PreTech offers a range of NDT services. No matter how complex your product is, we can conduct an in-depth inspection to detect hidden defects. To schedule an appointment, call 708-429-4887.