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MRI Medical, Flexible solutions

Manufacturing in Action, Source : The Manufacturer US
Published : August 2006

MRI Medical has used its high-tech expertise to refine an ancient medical instrument. WH Parson reports

Catheters have been used by doctors since 4000 BC. Onion stalks were used to empty bladders in ancient China. Ouch! Ancient Greeks, Romans, and Egyptians employed tubes made from wood, reeds, and precious metals. In the Greco-Roman era and in the Middle Ages in Europe, S-shaped bronze catheters were common. By the beginning of the 11th century, straight or one-curve catheters made of gold, silver, copper, lead, or salve of white lead were the standard instruments. All these were rigid—and therefore uncomfortable—and it wasn’t until Benjamin Franklin designed a silver coil device for use by his brother that the flexible catheter was born.

The invention of vulcanized rubber in the middle of the 19th century allowed much more flexible catheters to be made, and the first rubber catheter was made by Nelaton. The technology was refined in 1935 by the Minneapolis urologist Frederick Foley, who invented the rubber balloon catheter that is held in place without the use of bandages or tape.

The first person to use liquid silicone in the fabrication of ballooned catheters was Robert Kelliher, who founded the company that is now Manufacturing and Research, Inc. (MRI Medical) in 1986. The first line of MRI products included Foley catheters, gastrostomy tubes, and temperature-sensing Foley catheters. Today, MRI Medical’s 250 employees produce medical products on an OEM basis for major medical companies, and develop solutions for start-up and emerging medical technology companies to help bring new technologies to market.

Twice recognized in Inc. magazine’s “Inc. 500” as one of the fastest-growing privately held companies in the US, MRI is recognized as a world leader in the manufacturing and development of silicone catheters. The company now makes products for urology, cardiology, hemodialysis, anesthesiology, radiology, pediatrics, oncology, and more. These are used worldwide to treat benign prostatic hyperplasia, cardiac arrhythmias, and kidney ailments and are also employed in open-heart surgery and ICU.

MRI Medical produces more silicone catheters with bio-sensing capabilities than all other sources combined. It offers a standard range of temperature-monitoring Foleys starting with the world-exclusive 6FR (2.0-mm diameter). A comprehensive inventory of component tooling keeps new product development quick and economical. MRI Medical has extensive experience in urology products, including standard Foley catheters and innovative tissue ablation catheters for BPH treatment, and produces a significant portion of the silicone urology catheters sold worldwide. Specializing in the technically challenging balloon replacement tube, MRI Medical produces two standard versions as well as a wide variety of custom configurations of enteral feeding tubes.

Small-diameter catheters are an MRI Medical specialty. Conformable balloons beginning at 2FR (0.67-mm) suit a variety of vascular and pediatric applications. Wire-reinforced shafts provide the softness and biocompatibility of silicone rubber with superior column strength and stretch resistance—improving the clinician’s ability to manipulate the catheter within tiny vessels.

MRI Medical’s 47,000-square-foot facility in Tucson, AZ, is climate-controlled, has a cleanroom, and is ISO 13485:2003 and FDA registered. Capabilities include molding, extrusion, packaging, and assembly, but what differentiates MRI Medical is its pursuit of innovative design solutions after products reach production. The company works collaboratively to take costs out of the supply chain and to identify cost saving opportunities at every stage.

MRI Medical has a comprehensive service offering from concept, design, and assembly to engineering and supply chain services. The company has partnered with medical companies many times to be the first to launch innovative products to the market. Its engineers have over a century of collective experience working with silicone and other materials. Its comprehensive range of capabilities enables it to custom-design the fabrication solution best suited for clients.

These include liquid injection molding, dip molding, transfer and compression molding, and extrusion. Highly skilled and tenured teams specialize in the assembly of multi-component, complex products. The design and engineering team works to enhance client concepts to develop truly innovative products through partnership. Painstaking attention to detail, well-developed quality systems, and an experienced, well-trained professional staff have won MRI Medical an outstanding compliance track record demon-strated through customer and regulatory audits.

MRI Medical can deliver a packaged sterile product directly to clients’ warehouses, and its supply chain programs dramatically reduce lead times and inventory. The company also operates in-production shared savings programs designed to drive value through improved efficiencies. It has a formal continuous improvement program in place and is committed to lean manufacturing.

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