Manufacturing

We manufacture and assemble medical devices, components, and liquid media

 

We develop custom manufacturing solutions that optimize efficiency, enable innovation, and deliver long-term success and stability. We manufacture and assemble medical devices, components, and liquid media. We are an ISO 13485-certified and FDA-registered medical device contract manufacturer. Since 1979, everything we manufacture is Made in America.

Automated Manufacturing

We’re experts at automated manufacturing and specialized converting solutions for finished biomedical devices and custom components. We manufacture and assemble various types of single-use assemblies, diagnostics, stick-to-skin devices, surgical and laboratory equipment, and medical equipment. Our automated and semi-automated manufacturing capabilities include bonding, laminating, welding, die cutting, and various assembly processes.  

Device Assembly

We provide specialized assembly solutions tailored for biomedical devices. Assembled devices are typically novel, complex, and/or low-volume, and therefore not well-suited to automated manufacturing equipment. We leverage our process engineering know-how, skilled production operators, and quality management system to create efficient and reliable production processes no matter how challenging the task.

Liquid Media

We formulate, mix, and fill various types of liquid media used in cosmetic and aesthetic, dental, dermatology, and bioprocessing applications, including gels, creams, lotions, emulsions, and process chemicals. We work with a variety of non-drug liquid media ranging from low viscosity up to 200,000 centipoise. Our blending capabilities can mix volumes up to 1,500 gallons. Our liquid media solutions are filled into a range of containers including carboys, single-use bags, bottles, tubes, and syringes with a minimum fill size of 1 ml. Our blending and filling operations are supported by a reverse osmosis treatment and deionized water distribution system which provides USP purified water. We operate a wet lab with analytical capabilities for surface tension, density, FTIR, viscosity, pH, and other standardized testing.

What's the ROI on Better Manufacturing?

 

Better manufacturing drives measurable outcomes. Organizations that accomplish improved manufacturing enhance quality through better product reliability, achieve lower costs and a more competitive cost of goods sold, and accelerate time to market for product launches and future product iterations.

Kitting

We assemble custom kits for biomedical devices and components, including trays, blister packs, pouches, and header bags. Kits include various combinations of fully assembled devices, standard components, configured components, and accessories such as surgical tools, disposable components and instructions for use. Kitting operations range in size, configuration, and packaging design based on the specific requirements of each program.

Packaging

We support packaging design, sourcing, packaging validation, and sterilization, and incorporate a wide range of primary, secondary, and tertiary packaging into our manufacturing, assembly, and kitting processes. This includes labeling and instructions for use according to quality and regulatory requirements. 


Our Approach

We provide the manufacturing expertise and capabilities biomedical innovators need

 

We provide the expertise and capabilities necessary to manufacture with reliable product quality, competitive costs, and efficient time to market. We bring deep expertise working with biomedical devices, components, and liquid media across clinical applications.

Discovery

 

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings.

APPROXIMATE TIMING: 1-2 DAYS

 

Assessment

 

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.

 

Approximate Timing: 1 week

 

Statement of Work

 

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, cost, and key milestones.

 

Approximate Timing: 1-2 weeks

 

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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.