For early-stage MedTech ventures, the path from idea to market is often slowed by too many supplier handovers, capital-heavy infrastructure and gaps in regulatory expertise.
At OxDevice, part of the Kaleidex Group, we provide a single, integrated pathway, offering ISO 13485 facilities, specialist engineering capabilities and regulatory support that reduce both cost and complexity.
By removing barriers that typically stall progress at prototype or pilot stage, we help young companies progress confidently towards regulatory readiness and investor milestones.
What this means for spin-outs and universities:
- End-to-End Capability: From design through to compliant EN ISO 14644 Class 7 cleanrooms
- De-Risked Development: Embedded quality and regulatory systems.
- Scale Without CapEx: Flexible access to infrastructure and expertise.
- Specialist Expertise: Nitinol, fibre-optic sensors and neurovascular devices.
- Faster Scale-Up: Smooth path to pilot builds and trials.
Instead of burning scarce capital on facilities or managing multiple external suppliers, founders can focus on innovation while leveraging compliant infrastructure only when required.
The result is faster milestones, improved investor confidence and a smoother journey from spin-out to market-ready enterprise. Explore how we can help bridge your prototype to compliant build. Book a short call with our team here.
