In Vitro Diagnostic (IVD) device

From the laboratory to the factory

When selecting a Contract Manufacturing Organisation (CMO), careful consideration must be given to the technical capability of the organisation to support the Medical Device OEM throughout the life cycle of the project. Sovrin as a CMO have a proven track record developing automated assembly processes for mass production.

Medical Device OEMs often possess world-class scientific expertise, proprietary IP, and visionary product designs. Frequently emerging from laboratory-based roots, these organizations often seek specialized support in Design for Manufacture (DfM), assembly automation, and process development to successfully transition their innovations into full-scale mass production.

One such collaboration involved developing a fully automated assembly process for a specialist in vitro diagnostic (IVD) device used to detect serious bacterial infections.

Theory to Reality

On the surface, the project appeared straightforward: attach a membrane to an injection-molded component, clip on a protective cover, and the assembly is complete. Since the client had already invested in a pilot production line, it initially seemed like a “copy and paste” exercise. Our remit was simply to automate the handling and part marking.

However, the reality was far more complex. The quality benchmarks were exceptionally high, and the pilot phase had exposed several inherent technical hurdles. Scaling this to a high-volume solution would require significant engineering finesse and deep technical expertise

A Partnership Built on Precision

The foundation of any successful industrialization is a transparent technical partnership between the CMO and the client. By working in lockstep to dissect every individual element, we developed a truly robust production solution. The Sovrin NPI team provided critical support across the entire lifecycle:

Risk Assessment & Pilot Process Engineering
Proof of Concept & Supplier Selection
Documentation: RFQ, URS, and Full Process Validation ( $DQ, FAT, SAT, IQ, OQ, PQ$ )
End-to-End Technical Project Management

The Outcome

While the physical system was built by a strategic technical partner, Sovrin’s engineers mastered every nuance of the process. This hands-on expertise ensured the transition from design to validation was seamless.

The final result was a sophisticated, 23-station fully automated assembly line featuring: