DISCIPLINES

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.

  • 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.

  • 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.

  • Device Assembly

    Specialized assembly for novel, complex, or low-volume devices not suited to automated equipment.

  • Kitting

    Custom kits in trays, blister packs, pouches, and header bags, combining devices, components, and accessories.

  • 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.

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Your innovation Just Might change the world. But is your manufacturing up to the task? We help you turn Just Might into Just Mighty.