ISO 13485:2003 and ISO 9001:2008

Utitec, Inc
169 Callender Road
PO Box 370
Watertown, CT 06795
Phone: (860) 945-0601
Email: sales@utitec.com


ISO 13485:2003 and ISO 9001:2008
FDA Registration Number: 3014032451

Utitec, Medical SA
Zona Franca Coyol
Building B-15
El Coyol de Alajuela
Costa Rica - Central America
P (506) 2429-2000 F (506) 2429-2016
Email: sales@utitec.com


Support for Miniature, High-Precision Components

Support for Miniature, High-Precision Components
Design to Manufacturing: Complete Support for Miniature, High-Precision Components

Utitec, Inc., a world leader in small, high-precision deep draw and flat-stamped components for medical devices and other applications, supports the complete design-to-manufacturing process.

The medical device, aerospace, and automotive industries are fast-moving, complex, and highly competitive. They demand suppliers who are willing and able to meet even the most rigorous production requirements, quality standards, and timetables.

Utitec, Inc., headquartered in Watertown, CT, is the industry leader in the design and manufacturing of small, formed precision components for these markets, offering expert engineering and state-of-the-art design, fabrication, inspection, and secondary technologies.

Utitec partners with customers around the world to meet their needs for highly engineered stamped and deep-drawn parts, with a particular focus on medical devices and disposable medical products. A full-service manufacturing resource certified to ISO 13485:2003 – the global quality standard for medical devices – and to the overall ISO 9001:2008 quality standard for manufacturing, the company offers a full portfolio of advanced design, fabrication, and secondary capabilities, supported by a top-down commitment to total customer satisfaction.


Significant Investments Broaden In-House Capabilities

Utitec now offers expanded in-house secondary services, as a result of significant investments made in people, facilities, and state-of-the-art equipment.

These secondary operations, which were previously outsourced, include heat treating, metal passivation using citric acid, vapor degreasing, and the ability to process and package components for medical and electronic products in a new, world-class cleanroom.

The new capabilities complement existing in-house secondary offerings such as aqueous systems, solvent vapor vacuum degreasing systems, and tumblers.

This wide range of in-house, world-class capabilities offers customers a “one-stop shop” with all critical functions under one roof, overseen by the same team, and with a convenient, always-available, single point of contact.

A World-Class Partner

More than a manufacturing resource, Utitec offers complete engineering and product design support to maximize the full potential of customers’ design concepts. When customers use the Utitec design team early in product development, innovative and cost-effective designs can emerge that may have previously been overlooked.

Whether it’s eliminating multi-piece subassemblies, replacing costly screw-machined components with more cost-effective stamped parts, adding strength to weak molded plastic parts, creating snap-fit assemblies, miniaturizing a part, or adding additional features, Utitec develops and implements creative ways to achieve the customer’s goal.

Utitec can meet virtually any small-parts challenge, from the custom fabrication of precision eyelets and stamped parts, to the high-volume production of deep-drawn tubing, including refractory metals, which until now has been considered impossible.

Moreover, unlike competitors, Utitec produces prototype parts for initial testing and qualification before production tooling is designed, saving customers time and money. Parts can be produced with diameters ranging from .010” to 1.5”, overall lengths from .020” to 2.875”, wall thicknesses from .0008” to .032”, and length-to-diameter ratios as great as 50:1.

Utitec can recommend and work with whatever metals a customer application may require. Some of the most common metals include aluminum, copper and copper alloys, brass, bronze, nickel alloys, stainless steel, and titanium.

In-House Heat Treating

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Ipsen Heat Treating (1 of 2)
Thanks to a new IPSEN H2 heat treating furnace, Utitec can now significantly reduce the lead-times for delivery of finished parts, while passing on cost savings to customers. The highly efficient furnace enables the company to perform operations such as annealing and tempering, among others, without having to interrupt production by sending parts to outside vendors.

The in-house heat treating process has been added to the scope of both of Utitec’s quality system certifications: ISO 13485:2003 and ISO 9001:2008.

In-House Citric Acid Passivation

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Similarly, Utitec now performs metal passivation in-house. Citric acid passivation technology offers better performance, lower overall costs, and fewer potential problems versus more commonly used nitric acid technology.

As a passivating agent, citric acid reacts with stainless steel much more effectively than nitric acid, and is simpler to use. Overall, it is a less harmful chemical that raises fewer environmental disposal, health, safety, liability, and regulatory issues. Derived from oranges and used in food and beverages, in some cases citric acid can go right to drain after passivation, depending on the contaminants it contains.

In-House Vapor Degreasing

Utitec’s new Pero vapor degreaser meets the specific needs of a given degreasing application easily and at high levels of productivity, which translates to faster production runs.

It is suitable for use with all typical cleaning agents including hydrocarbons, chlorinated hydrocarbons, and modified alcohols. Ultra-short cycle times, outstanding throughput, and superior surface cleaning performance help meet time commitments much better than an outside service provider would allow.

World-Class Cleanroom

Utitec’s new cleanroom is a world-class enclosed space for the processing and packaging of components for environmentally sensitive medical and electronics products.

It provides an isolated environment convenient to the production floor in which the air contains extremely low levels of dust, airborne microbes, aerosol particles, and chemical vapors. The levels of these particulates in the air are tightly controlled to a specified number of particles of a given size per cubic meter of air.

A Leader in Precision Medical Components

Medical device and medical product customers are provided with components for surgical stapling, arthroscopic cutters, endoscopic knives, catheters, syringes, and other uses. Precision deep-drawn tubing meets the needs of customers for critical applications in other industries.

The quality management system is certified to ISO 13485:2003, the global standard for medical devices. Utitec has achieved and maintained “Approved Supplier” status with some of the world’s most demanding and well-respected manufacturers of medical devices, as well as their counterparts in the aerospace and automotive industries.

For the medical industry, parts such as bands, bowls, catheter wedges, channels, cutters and knife blades, housings, needle guides, and pins can be made with features such as beads, dimples, flanges, multiple diameters, side window cutouts, and tabs.

For other industries, Utitec produces parts such as adapters, barrels, connectors, temperature gauges and probes, and receptacles.

Inspection Technologies and Equipment

In order to provide customer-specific, high-precision parts, Utitec uses technologies and industry best practices such machine vision-based inspection capabilities, coordinate measurement machines (CMM) with scanning and touch-probe capabilities, metallurgical facilities, laser micrometry, surface finish measurement capabilities, Rockwell hardness tester, Clark micro-hardness tester, and Smartscope® benchtop video measuring system for difficult metrology challenges, enabling high-resolution, high-accuracy measurements.

Critical-to-quality features can be controlled to 1.33 Cpk or higher. Standard inspection practices cover the first article produced after all set-ups and material lot changes, in-process inspections performed by operators and inspectors, final inspection, and five full-time, Six Sigma-trained inspectors available.

Decades of Experience

With customers worldwide, Utitec has more than 30 years of experience supporting the critical needs of medical, aerospace, automotive, and commercial customers, ranging from some of the world’s leading corporations to smaller specialized companies.

Utitec has more than 75 employees working two shifts in 65,000 square feet of manufacturing space, with a 20,000-square-foot expansion in the works. Engineers, toolmakers, and craftspeople are experts in small parts design and production, with years of combined experience working with small precision parts in a wide array of shapes, sizes, and materials.