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Full-service concept for silicone and thermoplastic medical devices

Flexan Group continues to expand and develop its portfolio following the acquisition of IntroMED LLC in April 2018. IntroMED, a contract manufacturer of patented introducers for catheter placement, plays a key role in enabling multinational contract manufacturer Flexan to go on increasing the depth of its own production and value added in medical technology. In conjunction with the acquisition of Medron Inc. in 2016, a specialist in the in-house manufacture and assembly of catheter end products, plus investments in the new headquarters of medical technology division FMI, the US company has strengthened its market position as a full-service provider in the industry. The firm's focus is on development services and products in micro lumen extrusion of thermoplastic and silicone medical devices.

Primarily the biocompatibility of silicones makes them easy to use in the production of medical devices.

"Demand for medical devices made of plastic and silicone as well the capability to combine and assemble them has been increasing steadily over the last few years, as have the quality requirements that these products have to meet," says Werner Karau, European commercial leader at Flexan. According to a survey by US market research firm Global View Research, this upward trend is set to continue. By 2025, global sales of silicone medical devices will reach approximately USD 597 million, with an average annual growth rate of 6.6 per cent. In light of this, in order to be able to focus on their own core processes, OEMs are increasingly turning to highly specialised contract manufacturers to produce individual components. "As a full-service provider in medical component manufacture, Flexan supports the entire value chain, from product development, prototyping and toolmaking all the way to mass production with comprehensive quality assurance and logistics," says Karau.

Buyers want multi-lumen or multi-chamber hoses with smaller and smaller diameters and thinner walls

The increasing demand for plastic and silicone products produced in microextrusion processes is partly attributable to the excellent characteristics of the materials – primarily their biocompatibility, which makes them easy to use in the production of medical devices. Other reasons for the popularity of silicones in the medical sector are their chemical and thermal stability and bacterial resistance. However, processing liquid silicone (LSR) is extremely challenging. While its low viscosity is an advantage in the manufacture of thin-walled products and also allows for complex geometries, the varying consistencies of the silicones on the market require extremely precise tooling to prevent leaks and burrs. "We've been working closely with certified tool and mould makers for many years now, which means we can make the necessary adjustments and modifications quickly and cost-effectively during prototyping. So it takes us very little time to produce a custom tool for every job," says Karau. This flexibility is key, because customer requirements in extrusion are essentially increasing with every new product. Buyers want multi-lumen or multi-chamber hoses with smaller and smaller diameters and thinner walls. "Our task is to develop the right process time and time again, and to identify the right material for these products," explains Karau.

About the company

Flexan is a global contract manufacturer and assembler of custom, high-precision silicone, rubber, and thermoplastic components and devices. Founded in 1946 by the Lilleberg brothers, the company offers contract manufacturing services for a broad array of products including: medical devices, hearing technology devices, miniature pneumatics, industrial controls, aerospace and defense industries. Manufacturing footprint consists of 4 locations: Lincolnshire, IL, Chicago IL, Salt Lake City UT and Suzhou China.

» Publication Date: 23/01/2019

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This project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° [605658].

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