Medical Devices

On average, approximately 4,500 drugs and medical devices are withdrawn from U.S. shelves each year, despite having obtained FDA approval. These products, entrusted with the well-being of countless individuals, are often ingested, injected, or implanted before the need for recall becomes evident.Engineers working on the next generation of life-saving medical devices need the best tools at their disposal to ensure that only safe and effective technologies reach patients. From connector and seal failures to assembly misalignments and anomaly detection, the challenges facing medical device manufacturers carry distinct risks and costs. Industrial CT scanning emerges as a powerful ally in this quest for quality, offering non-destructive, high-resolution imaging to pinpoint defects with unparalleled precision.

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Industrial CT provides a dimensional record of the interior of medical instruments with the device still assembled, so those features can be measured in the state a surgeon holds them.

Lumafield's affordable and accessible Neptune industrial X-ray CT scanner is complemented by Lumafield’s AI-driven Voyager analysis software, a cloud-based inspection platform that operates right in your web browser. Voyager gives you the power to visualize, analyze, and share your CT data directly from your computer, regardless of your location.

With Voyager's dimensioning tools, engineers can take precise measurements and detect deviations swiftly. Porosity analysis helps uncover hidden voids within materials, a crucial capability to address issues of material integrity. CAD Comparison and Scan to Scan Comparison enable engineers to compare components with CAD models and other parts to quantify deviations, providing insights to combat misaligned assemblies and ensure seamless fits.

I was able to have a meeting with our customer, log into Lumafield's software, and show evidence that prompted a design modification.

Ryan Kircher

Senior Additive Manufacturing Engineer

EpiPen

Within the EpiPen, Voyager allows for inspection of the complex assemblies, including the needle, spring alignment, plastic support structures, and the plunge mechanism.

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Medical clamp

Atlas, the AI co-pilot that guides users through Voyager and offers engineering expertise, can automate workflows such as comparing a manufactured part to the original CAD file. Here, there are clear dimensional deviations on this medical connector.

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Cannula

Verify dimensional conformance across single-use disposable medical devices and build a traceable inspection record in Voyager before nonconforming units leave the facility.

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Applications include:

Download

The Engineer’s Guide to Medical Device Defects

Medical Devices

Ryan Kircher

EpiPen

Medical clamp

Cannula

Applications include:

The Engineer’s Guide to Medical Device Defects

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