Hightech "made in China" - Contract manufacturer Flexan has been operating a branch since 2004 and reports from practical experience

Highly precise silicone components for medical devices: How beneficial is it for Western OEMs to manufacture in the Middle Kingdom?

The use of Chinese manufacturing facilities is becoming increasingly attractive for many Western OEMs in the medical technology sector. It is worthwhile for specialized manufacturers with a relatively high product mix, even in medium batch sizes, for which full automation in the USA or Europe is not…

The increasing demand for plastic or silicone products manufactured using microextrusion or micromoulding processes can, among other reasons, be attributed to the excellent properties of the material. (In the picture: micro-silicone mold parts in front of a U.S. one-cent coin.) (Source: Flexan)

Above all, the biocompatibility of the material enables trouble-free use in the manufacture of medical devices. Furthermore, the chemical and thermal stability of the silicones, as well as their bacterial resistance, support the use of the material in the medical sector. In the picture: extrusion hoses next to a match head. (Source: Flexan)

While the low viscosity of the material provides an advantage in the production of thin-walled products and also allows for complex geometries, the various consistencies of silicones available on the market require extremely precise tooling to prevent leaks and flash formation. (In the image: micro-silicone mold parts compared to a matchstick head.) (Source: Flexan)

Multilumen or multi-lumen catheters are required with increasingly smaller diameters and thinner walls. The multilumen catheter in the picture easily passes through a needle eye. (Source: Flexan)

23.10.2018

Flexan Group presents full-service concept for silicone- and thermoplastic-based medical devices

All in one piece

With the acquisition of IntroMED LLC in April of this year, the Flexan Group has successfully continued to expand and broaden its own portfolio. The contract manufacturer of patented insertion sets for catheter placement significantly contributes to the fact that the globally operating contract manu…

FMI supplies OEMs with complex silicone parts.
Source: Flexan

The advantage of process FMEA is that potential sources of errors can be identified before the actual production, allowing measures to be taken as early as possible in the process chain. This helps prevent the delivery of a defective product.
Source: Flexan

The company has already conducted a gap analysis and identified the areas where changes need to be made to achieve compliance with ISO 13485:2016.
Source: Flexan

To meet the increasing quality demands, FMI has, for example, optimized its risk management for product realization as well as its CAPA program.
Source: Flexan

28.11.2017

New requirements for quality management in medical devices

Deadline in March 2019: No access to the European market without compliance with EN ISO 13485:2016

How OEMs can recognize in time whether their suppliers will achieve certification within the set deadline

Medical device manufacturers are responsible for ensuring that even components not produced in-house comply with all relevant ISO guidelines. To this end, they must verify and ensure that their…

To meet the increasing demand for components of the highest cleanliness standards, FMI, a Chicago-based specialist for complex silicone parts, has established a 1,900 m² cleanroom production facility of class 7 and has acquired additional premises. (Source: Flexan) / To meet the challenges of the market and to increase its own production capacity, FMI has decided to use additional facilities for clean-room production. The company moved into new 6,500 m² headquarters close to the former production site in Chicago and constructed an ISO Class 7 clean room with a surface area of approx. 1,900 m² there. (Source: Flexan)

FMI now produces four times the components for medical devices of classes 2 and 3. (Source: Flexan)

The Class 7 clean room is equipped with state-of-the-art production technology. (Source: Flexan)

At the new production site, among other things, hoses for catheter products are to be manufactured.
(Source: Flexan) / Initially, the focus at the new production site is on various catheter products as well as other medical devices combined with a tube.

A current look into the new cleanroom production. (Source: Flexan)

19.07.2017

Manufacture of medical devices

New company headquarters: medical silicone component manufacturer constructs 1,900 m² clean room and adds extrusion processes to the company portfolio

Thanks to its biocompatibility, silicone rubber is more and more frequently used in medical implants, such as defibrillators, heart pumps or components for reconstructive surgery. As these implants must not contain any contaminations which could endanger the health of patients, some extremely string…

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