For MedTech SMEs, scaling from prototype to pilot manufacture can be slowed by fragmented suppliers, infrastructure barriers and regulatory complexity.
At OxDevice, part of the Kaleidex Group, we provide a single, integrated pathway; combining design, pilot manufacturing, coatings, cleanroom assembly and regulatory support under one roof.
Our ISO 13485-certified facilities and Class 7 cleanrooms provide a compliant, flexible environment to help growth-stage companies move efficiently from pilot build to clinical readiness.
What this means for SMEs:
- End-to-End Capability: Design through to compliant cleanrooms.
- De-Risked Development: Embedded quality and regulatory systems.
- Flexible Capacity: Scale pilot runs without heavy CapEx.
- Specialist Expertise: Nitinol, fibre-optic sensors, coatings and neurovascular devices.
- Faster Route to Market: Integrated support reduces supplier handovers and delays.
By keeping design, coatings, assembly and packaging in one place, we help reduce cost, avoid duplication and accelerate timelines, giving SMEs a smoother path to trials, regulatory approval and scale-up.
Let’s talk about how we can support your next project. Schedule a scoping call to discuss here
