Manufacturing
We manufacture and assemble medical devices, components, and liquid media as an ISO 13485-certified, FDA-registered contract manufacturer. Since 1979, everything we manufacture has been made in America.
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Overview
Manufacturing is where your device is produced reliably, at cost, and in compliance with quality and regulatory requirements. We help biomedical innovators produce everything from novel, low-volume assemblies to high-volume automated products, along with the kits, packaging, and liquid media that go with them. We develop custom manufacturing solutions matched to each device and adjust them as volumes grow. The result is consistent quality and on-time delivery from initial builds through long-term production.
What manufacturing covers
Manufacturing turns a validated process into finished product. Our capabilities cover automated and manual production, liquid media, and the kitting and packaging that complete each device.
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Automated Manufacturing
Automated and semi-automated bonding, laminating, welding, die cutting, and assembly for single-use assemblies, diagnostics, stick-to-skin devices, and surgical, laboratory, and medical equipment.
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Liquid Media
Formulation, mixing, and filling of gels, creams, lotions, emulsions, and process chemicals, from low viscosity up to 200,000 centipoise and batches up to 1,500 gallons.
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Device Assembly
Specialized assembly for novel, complex, or low-volume devices not suited to automated equipment.
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Kitting
Custom kits in trays, blister packs, pouches, and header bags, combining devices, components, and accessories.
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Packaging
Primary, secondary, and tertiary packaging, labeling, and instructions for use, with packaging validation and sterilization support.
Where manufacturing shows up
Manufacturing should begin with initial production builds and lead once your device enters commercial production, scaling as demand grows.
PHASE 0
Process Development
Supports manufacturability input during process design.
PHASE 1
Pilot Production
Leads initial production builds that demonstrate process capability.
PHASE 2
Manufacturing Transfer
Supports production setup in the commercial manufacturing environment.
PHASE 3
Commercial Launch
Leads reliable, on-time production for market entry.
PHASE 4
Scale-Up
Leads increases in production volume and campaign frequency.
PHASE 4
Optimization
Supports efficiency and cost improvements in ongoing production.
The ROI on better manufacturing
Production disruptions carry direct commercial consequences, from delayed market entry to adverse regulatory events. A reliable manufacturing partner protects your quality, margin, and momentum.
Higher Quality
Consistent production under an ISO 13485 quality management system.
Lower Costs
Custom manufacturing solutions that improve efficiency and cost of goods.
Faster Time to Market
On-time production that supports your launch schedule.
Scalable Production
Capacity that grows from low-volume builds to high-volume production.
Explore our disciplines
Every program draws on a different combination of our core disciplines that together provide the manufacturing reliability your program requires.
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Quality & Regulatory
Meet quality and regulatory requirements with inspection, testing, documentation, and supplier management.
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Engineering
Design, validate, and maintain reliable, repeatable manufacturing processes.
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Material Sourcing
Source and manage suppliers of equipment, tooling, materials, components, and services.
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Manufacturing
Manufacture and assemble medical devices, components, and liquid media.