Applications | Production Automation | Medical Device Automation
Production automation for complex medical devices
Ascential engineers, builds, and integrates custom production automation for medical device manufacturers across a broad range of markets — catheters, consumable cartridges, in-vitro diagnostics, implantable devices, combination devices, cardiovascular applications, and more.
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Solutions
End-to-end medical device automation services
Get support for your full program lifecycle — from design for manufacturing, proof-of-concept to system build and qualification to long-term sustaining engineering. Our multidisciplinary team integrates mechanical, electrical, and software systems to deliver automation solutions that meet your production and scalability goals.
Custom Automation Design & Build
Get automated assembly, test, handling, and inspection systems designed around your device specs, workflows, and production requirements. We review the full station-based sequence to ensure system functionality, performance, and serviceability, not just speed.
Build-to-Print & Build-to-Print Plus
Execute existing automation with Ascential's manufacturing expertise. BTP-Plus extends standard Build-to-Print with engineering enhancements that improve performance, reduce integration risk, or strengthen regulatory documentation — without redesigning the system.
Line Transfer & Reshoring
Relocate and re-qualify existing production lines from contract manufacturers or overseas facilities. Ascential manages the full line transfer process, from line documentation and disassembly through recommissioning at the new site.
Modular Automation Systems
Deploy scalable system architectures that grow with your production volumes and budget. Modular architectures allow manufacturers to automate the highest-priority process steps first and expand capacity incrementally.
Control & Data Integration
Develop custom controls with PLC programming, HMI design, SCADA, vision, analytics and process data integration for medical device production lines. We can build in intelligent data capture and traceability to support 21 CFR Part 11 compliance.
Sustaining Engineering & Aftermarket Support
Keep production lines running with preventative maintenance programs, spare parts management, controls updates, and technical support. We are available post-delivery to support continuous improvement.
Capabilities
Multimodal automation for regulated market success
Consumable Cartridges
Automate the assembly, filling, sealing, and inspection of diagnostic and consumable cartridges. Sub-millimeter alignment, repeatable fluid volumes, and hermetic seal integrity are production-critical requirements.
Lateral Flow Tests
Automate the full lateral flow test production workflow — reagent dispensing onto nitrocellulose membrane, lamination of membrane layers, precision strip cutting, and cassette assembly.
Implantable Devices
Engineer automated systems for the assembly and handling of implantable devices. We understand the critical value of material traceability, process consistency, and contamination control requirements in this market.
Combination Medical Devices
Automate the assembly of combination products like drug-device combinations, biologic-device systems, and multi-component products. With modular systems, we can accommodate both device manufacturing and drug/biologic handling requirements.
Point of Care & Medical Diagnostics
Deploy production automation for point-of-care test devices and medical diagnostic instruments — integrating precision dispensing, optical inspection, and high-throughput assembly into systems designed for the speed and repeatability that diagnostic manufacturing demands.
Cardiovascular, Structural Heart, Catheter & Electrophysiology Devices
Leverage precision automation for cardiovascular, structural heart, and electrophysiology device manufacturing. We understand how component precision, assembly repeatability, and in-line inspection are directly linked to patient safety outcomes.
Why Choose Ascential?
Application-Specific Expertise
Ascential's teams hold deep knowledge across consumables, diagnostics, implantables, cardiovascular devices, and combination products. For our customers, this means faster program starts, fewer integration surprises, and automation systems that are designed around the real demands of each manufacturing workflow.
Integrated Engineering & IQ/OQ Documentation
We scope IQ/OQ documentation as a program deliverable, build process data capture and traceability into control architectures, and structure design history documentation to support 21 CFR Part 820 requirements throughout the program.
Global Delivery & Volume Manufacturing
With a global network of ISO-certified facilities in the U.S., South America, Europe, and Southeast Asia, we can build automated systems anywhere. Using consistent engineering standards, we offer cross-site program management and qualified delivery models regardless of geography.
Full Lifecycle Program Support
Our sustaining engineering and aftermarket teams provide preventative maintenance, spare parts, controls updates, and production improvement support throughout your program’s operational life, keeping your line running and your program on target.
Frequently Asked Questions
Get answers to common questions about our medical device automation capabilities.
Ascential has designed and implemented automated systems across programs, including, but not limited to, consumable cartridges, lateral flow tests, implantable devices, combination medical devices, point-of-care test devices, medical diagnostic products, cardiovascular devices, structural heart devices and catheter and electrophysiology devices.
Contact us to discuss how our automation experience applies to your specific device and production requirements.
Earlier is consistently better. Engaging Ascential during product design allows our automation engineers to provide automation input that reduces downstream integration complexity, lowers total capital investment, and accelerates your path to qualified production and expansion. That said, Ascential supports programs at all stages. We can evaluate and automate existing manual workflows, initiate line transfers, and develop build-to-print programs against existing designs.
Yes. Ascential regularly designs semi-automated solutions that target the highest-variability or highest-risk manual process steps while preserving existing line investments. Full-line automation isn’t always the right first step, and we won’t hesitate to tell you if that’s true for your program.
Ascential scopes IQ/OQ documentation as a standard program deliverable. We develop qualification protocols, build process parameter controls and data capture into system architecture, and structure design history documentation in alignment with FDA 21 CFR Part 820 and ISO 13485 requirements. Customer teams retain ownership of PQ execution.
Concept-to-commercialization support — from process development through full system delivery and aftermarket. Depending on where you are in your product lifecycle, Ascential offers Design for Manufacturing, Proof-of-Concept, Design & Build (DTB), Line Transfer, and Build-to-Print (BTP) models, as well as BTP-Plus solutions for those evolving existing models.
Yes. Ascential operates facilities across the U.S., South America, Europe, and Southeast Asia, with proven cross-site delivery models for global device programs. We design and deploy automated production lines wherever your manufacturing strategy requires them, with consistent quality standards across every location.
Yes. Ascential’s sustaining engineering and aftermarket support services cover preventative maintenance programs, spare parts management, controls and software updates, and production improvement projects for automation systems — including systems not originally built by Ascential.
Contact us to discuss support options for your line.
Related Resources
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