Ingeniería Técnica

Engineering
Insights

Engineering deep-dives for CDMO partners — from balloon pressure engineering and multi-layer shaft extrusion to FANS-UAS suction architecture.

ISO 13485 Certified Manufacturing
Balloon & Sheath Extrusion Capability
Hydrophilic Coating & Validation

2

Engineering deep-dive guides

20 ATM

Max balloon rated burst pressure

FANS

Suction-assisted UAS technology

CDMO

Custom design & manufacture capability

Proving Manufacturing Capability Through Engineering Depth

When a potential distribution partner or hospital procurement team evaluates a medical device manufacturer, they look beyond the product brochure. These technical guides open the engineering hood — demonstrating the materials knowledge, manufacturing precision, and design expertise behind every Envaste device. For CDMO enquiries, they serve as a capability reference that replaces the factory visit.

Manufacturing Capabilities Documented in These Guides

Multi-layer extrusion Pebax® processing PTFE liner co-extrusion SS + Nitinol braid reinforcement Balloon blow moulding PVP hydrophilic coating Radiopaque marker integration Burst pressure validation Kink-resistance testing Active suction valve assembly EO sterilization (ISO 11135) IQ / OQ / PQ validation

All Engineering Guides

2 articles

See the Engineering in Action

Every principle documented in these guides is realised in the Envaste Manawa and Tahina product ranges.

Explore the Full Knowledge Center

Clinical evidence and regulatory compliance resources to complete the picture

Partner with Envaste as Your CDMO

Looking for a urology device contract development and manufacturing partner? Our engineering team is ready to discuss your project — from concept through CE marking.