In the fast-paced world of medical device manufacturing, precision, speed, and regulatory compliance are non-negotiable. As devices become smaller, more intricate, and increasingly governed by global standards, the tools used to inspect and validate these products are evolving. While Coordinate Measuring Machines (CMMs) have long been the gold standard for dimensional analysis and First Article Inspections (FAIs), new technologies—particularly Computed Tomography (CT)—are reshaping the landscape.
The Legacy of CMMs and the Rise of CT
For decades, CMMs have offered unmatched reliability in measuring rigid components, particularly metals. Their tactile, probe-based systems excel in traditional metrology tasks, making them indispensable in many quality labs. However, as medical devices have become more complex—especially with the rise of plastic materials and miniaturized components—CT has emerged as a powerful, non-destructive alternative.
The 2015 introduction of the ISO 80369 standard marked a turning point. Designed to ensure the safety and compatibility of small-bore connectors, the standard introduced dimensional requirements that aligned well with CT’s strengths. Specifically, CT can scan both internal and external geometries with high resolution, creating full 3D representations of parts—without destroying them.
Why CT Is Becoming a New Standard
What sets CT apart is its versatility. It allows for rapid, comprehensive analysis of parts, whether they’re metal, plastic, or a mix of both. CT doesn’t rely on mechanical probes, which means there’s no risk of damaging delicate components during inspection. And because it captures a complete volumetric dataset, CT enables a deeper level of insight—supporting everything from dimensional validation to defect analysis and mold qualification.
Today’s CT systems can:
- Generate full 3D scans for internal and external features
- Enable fast comparison to CAD models using advanced heat mapping
- Validate features invisible to traditional inspection methods
- Analyze both surface and volumetric defects without sacrificing parts
Modern software has also played a major role in CT’s rise. User-friendly platforms now make it easier than ever to manipulate scan data, visualize deviations, and produce reports that support regulatory requirements. These improvements have made CT accessible not only to experts but to broader quality and engineering teams.
Not a Replacement—Yet
While CT offers many advantages, CMMs still have their place—particularly for large parts or those requiring surface-based probing. But the momentum behind CT is undeniable. Many medical device manufacturers (MDMs) are finding that a single CT system can handle the majority of their inspection needs, significantly reducing lead times and boosting process efficiency.
One of the biggest benefits? Speed. CT enables faster feedback loops, which means faster product iterations and quicker time-to-market—a crucial advantage in an industry where every day counts.
The Road Ahead: AI, Automation, and Smarter Inspection
Looking forward, CT’s role will only expand. As medical OEMs embrace fully CAD-based validation and tighter tolerances, CT’s ability to deliver precision data will be increasingly indispensable. The integration of artificial intelligence (AI) into CT and vision systems is still in its early stages, but the potential is massive—from intelligent defect detection to automated decision-making and beyond.
What was once a niche or emerging technology is now becoming a standard part of the quality control toolkit. For many MDMs, the question is no longer if they’ll adopt CT—but when.
Conclusion
Medical device manufacturing demands the highest levels of accuracy and reliability. As technology evolves, so must the tools we use to measure and validate our products. CT is no longer just a promising innovation—it’s a transformative force. With faster workflows, broader capabilities, and game-changing precision, it’s helping manufacturers bring safer, more effective medical devices to market—faster than ever before.
