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Working with Microvista was an extremely professional and straightforward experience for us. Whilst other service providers turned down our complex, in-production testing project, Microvista rose to the challenge straight away following a brief analysis. Thanks to the rapid and non-destructive CT analysis, we were able to ensure our manufacturing quality whilst saving many thousands of euros in potential costs for destructive testing. We were particularly impressed by the open communication and close collaboration with our contact person.
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– Director, Head of Area Quality –
Several service providers pulled out
A leading medical technology manufacturer produces complex assemblies for clinical use. The devices consist of mechanical components and various materials. After production, several devices are packed in a sealed box in a sterile condition.
A crucial step was missing between packaging and dispatch: a 100% inspection of every single assembly. Complete, documented, traceable. Quality management demanded it, regulatory requirements demanded it, and responsibility towards patients and users demanded it anyway.
The obstacle was the packaging itself. It was not permitted to be opened. Any opening would have compromised sterility and thus triggered re-sterilisation, re-packaging and re-approval. Given the volumes involved, this was simply not an option.
Several CT service providers rejected the project. Too complex, too many components per box, no automated solution available.
What made this project difficult
- Sterility: The products were already packaged in sterile conditions. The testing method had to be entirely contactless, capable of working through the sealed packaging.
- Quantity: This involved ongoing series production with high volumes. The inspection process had to fit into the production cycle, not the other way round.
- Complex assembly: Each device consists of several individual functional parts. All components had to be recorded and assessed simultaneously.
- Multiple devices per box: The devices were not delivered individually, but in a single box. Nevertheless, each assembly had to be individually tested, assessed and documented.
- Traceability: Each device had to be assigned to a specific location within the box. In the event of a NIO finding, it had to be immediately clear which box, which layer and which device was involved.
Anyone who tackles one of these issues has a task to complete. Those who have to tackle them all at once have a project that overwhelms most service providers.
How Microvista solved it
After a brief analysis, it became clear that it was possible. Not using standard processes, but with a solution tailored precisely to this requirement.
The scan: one cardboard box, several devices, six minutes
The entire box was placed unopened into the CT scanner. No unpacking, no repositioning, no sorting. One scan, six minutes, several devices. Thanks to the parallel reconstruction of the data, the effective inspection time was one minute per device. Sterility was fully maintained throughout the process.
The data pipeline: from scan to test result
Once the scan was complete, the entire workflow ran without any manual intervention. The volume was reconstructed, the cardboard box was automatically aligned within the dataset, and the various assemblies were automatically separated and assigned to their respective positions. A standardised inspection image was generated for each device, always aligned identically and always in the same format. The operator received a clearly structured image for each device and made the Pass/Fail assessment. No searching, no interpreting, no guessing.
Traceability: from the box to the individual device
A two-stage system was implemented to enable the customer to take immediate action in the event of an NIO finding.
Each box contained an accompanying note. For each layer position, the note indicated whether the device was OK or NOK. The logistics team knew immediately which box needed to be opened and which layer needed to be replaced. Fault-free boxes remained sealed. The printout was generated directly from the portal, thereby eliminating the risk of manual transcription errors.
At the same time, all results were transmitted live to the Microvista InspectHub portal. This portal stores the OK/NOK assessment for each device, the corresponding test image and the allocation of device, box and layer, supplemented by a live progress indicator and the complete history. A reporting module with export functions to CSV and PDF completes the portal. Even if a delivery note was lost, the allocation could still be retrieved at any time via the box number. This meant the process was fully traceable at all times, even during audits.
Validation: Radiation compatibility
Before the series went into production, one question needed to be answered: does the CT scan alter the materials used in the product? The customer had a sample batch of devices examined by its own quality assurance department following the scan. The result was clear: there were no changes whatsoever to the materials. The testing method was officially approved.
Microvista also provided a formal radiation statement. This included the specific radiation intensity per scan, proof that only a single scan was performed per box, and a list of all tested batches with dates, batch numbers and radiation exposure data. This provided transparent and regulatory-compliant evidence.
The result
The effective testing time was one minute per device. In total, more than 15,000 assemblies were tested, meaning the process is also suitable for high production volumes. Sterility was maintained throughout. No packaging was opened, re-sterilisation was not required, and there was no risk of contamination at any point.
Data processing was fully automated, from scanning to the test image. This ensured high reproducibility and a clear, uniform structure. Faulty devices could be precisely located using the layer number system, so that the logistics team knew immediately which device in which box needed replacing. Traceability remained digital throughout, accessible at any time, exportable and audit-proof.
This also significantly reduced the workload for logistics. Fault-free boxes did not need to be opened, manual sorting was eliminated, and there was no need for any searching whatsoever. Intervention was only required where it was actually necessary.
What other companies can learn from this
This case study is by no means an isolated instance in the medical technology sector. Time and again, there are products that are already packaged in sterile form yet still need to be inspected, or complex assemblies where disassembly is not an option. Added to this are high-volume production runs where manual inspection would be too slow and prone to errors, and regulatory requirements that demand comprehensive documentation and traceability.
If you are facing a similarly challenging task, please get in touch with us.
