Applications | Production Automation | Structural Heart
Structural heart device manufacturing that never cuts corners
Structural heart devices demand the highest standards in assembly precision, in-process inspection, and manufacturing traceability. Ascential engineers production automation systems for the full workflow — from valve crimping and nitinol component fabrication through in-line inspection and end-of-line testing. Our experience includes:
- Valve Crimping and Delivery System Loading
- Nitinol Frame and Catheter Tip Fabrication
- Balloon Catheter Build and Coating
- In-Line Vision Inspection and Dimensional Verification
- Electronic Traceability and Data Capture for Regulatory Compliance
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Solutions
Comprehensive support for structural heart programs
Valve Crimping & Delivery System Loading
Accelerate precision crimping and loading for transcatheter valve and delivery system assembly. We collaborate with your team to engineer to the dimensional tolerances and force profiles your device requires, with per-unit traceability built in.
Nitinol Frame Prep & Catheter Tip Fabrication
Streamline nitinol component processing with automated integrations, including laser cutting, welding, edge finishing, and in-line inspection for frames, tips, and other precision metallic structural heart components.
Precision Balloon Catheter Assembly & Coating
Ensure accuracy in delicate production steps such as balloon forming, tip bonding, and catheter assembly with process-controlled coating (dip coat, spray coat, or hydrophilic) and functional tests integrated from the first build.
In-Line Vision & Dimensional Inspection
Catch defects in real time without slowing throughput with vision-based inspection integrated at every critical station. Verify dimensional conformance, surface integrity, and assembly completeness per unit.
Custom Fixturing & Tooling
Get fixtures and tooling for handling, aligning, and assembling complex structural heart components — engineered for your specific device geometry, production environment, and operational realities.
IQ/OQ Documentation & Support
Scope and budget qualification documentation as a program deliverable from kickoff. While you own PQ, Ascential ensures the system is built and documented thoroughly so it’s simple to achieve compliance.
Capabilities
Capabilities matched to structural heart device complexity
Precision Assembly at Scale
Eliminate operator variability with automated systems engineered for high-precision structural heart assembly. Our team helps you achieve repeatable, reliable results at production speed.
Regulatory-Ready Traceability
Ensure every unit that leaves the line carries a complete, auditable record. We enable per-serial-number data capture and individual unit traceability using auto-ID technologies to support your regulatory compliance requirements.
100% In-Line Inspection
Integrate vision-based inspection at every station to streamline quality control and assurance without compromising production throughput. That means no escapes, and no rework surprises downstream.
End-to-End Program Partnership
From early-stage process development through scaled manufacturing, Ascential supports the full product lifecycle — reducing handoff risk, compressing time to market, and staying engaged across line transfers, scale-up, and sustaining engineering.
Why Choose Ascential?
Structural Heart Process Expertise
We manufacture synthesizer platforms and production automation equipment for leading life science companies. Our team works with you to solve precision and integration challenges and optimize processes against reagent waste per cycle and maintenance realities, not just flow specs.
Class III Program Experience
Our team has delivered automation programs for the world's leading cardiovascular OEMs, with full GAMP documentation. We can help your team fulfill 21 CFR Part 820 requirements and provide access to ISO 13485-certified facilities as needed.
Full Product Lifecycle Support
Traditional engineering firms deliver a machine; Ascential stays engaged for the life of your product: through process development, IQ/OQ support, scale-up, line transfers, and aftermarket support. And wherever you manufacture, our global footprint means you can scale without starting over.
Frequently Asked Questions
Get answers to common questions about our structural heart device manufacturing capabilities.
Concept-to-commercialization support — from process development (PoP) through full system delivery and aftermarket. Depending on where you are in your product lifecycle, Ascential offers Design & Build (DTB), Line Transfer, and Build-to-Print (BTP) models, as well as BTP-Plus solutions for those evolving existing models.
Yes. BTP and BTP-Plus options are available. Ascential handles procurement, fabrication, assembly, and FAT from customer-supplied print packages, with your process and control architecture preserved.
Our team regularly delivers medical device manufacturing equipment that complies with Class 10K and Class 100K cleanroom standards across diverse customer specs and patient care needs.
Yes, we have facilities in the U.S., South America, Europe, and Southeast Asia. We design and execute where your manufacturing makes the most sense, using proven cross-site delivery models.
We scope and budget for IQ/OQ support documentation as a program deliverable and build GAMP packages where required. We build data capture into your systems to support 21 CFR Part 11 requirements, while you own and execute PQ.
Related Resources
Release every structural heart device with confidence
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