Technical Engineering

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.