Shorter time to market: US contract manufacturer produces high precision silicon components for in-vitro fertilisation in China.
To manufacture a medical device specialising in in-vitro fertilisation, a European OEM required a special injection moulding component made of silicon. Not only did this need to be high quality but should also have very precise dimensions, and special surface characteristics. As the component also had to be manufactured within a short timeframe and on a low budget - a volume of 400,000 units - the supplier Polyfluor Plastics decided to appoint the Chinese branch of the US contract manufacturer Flexan due to its expertise and ability to reduce the time to market. The project with Flexan Suzhou progressed swiftly – the plant produced the injection moulding tools within five weeks and provided the first samples just five days later.
“We were appointed by an OEM, to manufacture components for a product for in-vitro fertilisation,” explained Eric Wetzels, managing director of Polyfluor Plastics, a Dutch supplier of polymer products. This also includes a special silicon injection moulded part, which is not very complex in itself, but whose manufacture in a cleanroom according to the strict specifications of the customer, posed a challenge.
“On the one hand, there were very small tolerances for the dimensions, but on the other hand it is required that its surface feels pleasant and smooth. This requires extensive knowledge, as for example the original material must be injected into the tools and cooled correctly.”
Polyfluor’s customer initially needed this component in a volume of 400,000 units, but subsequently an increase to up to 3 million would be possible.
“We asked several manufacturers. With the requirements for the components and the specified time and cost restraints. The quote from Flexan for production in Suzhou offered the best conditions, for example in terms of tool costs and delivery time,” continued Wetzels.
The advantage of the Chinese branch with regards to time to market can be attributed to an industry-wide development. Western production sites are currently so stretched, that there are long waiting times for tools and products.
“With other manufacturers, it would have taken four to six months until the injection moulding tool had been built,” confirmed Wetzels.
In contrast, Flexan was able to agree a time of two months. “In Europe and the USA, for example in our factory in Chicago, express tool manufacture is of course still possible – but with additional costs,” explained Werner Karau, European commercial leader at Flexan, who is responsible for the project with Polyfluor.
“Here, the client has to think carefully, particularly if the same quality can be provided in China.”
Injection moulds finished in five weeks
However, the particularly short delivery time in Suzhou can also be attributed to the fact that the factory has many different injection moulding tools, and therefore has fixed capacity commitments with a large number of qualified tool manufacturers.
“These reserves generally allow us quick tool manufacture,” said Karau. At the same time, the Chinese branch can also rely on the knowledge of high precision medical silicon components, which has been accumulated since 1946. Due to these various factors, the injection moulding tools were able to be completed within five weeks, and the first samples were sent to Polyfluor around five days later.
“Due to our collaboration with Flexan Suzhou, we received our components very quickly, in the correct quality, in a high volume and at a competitive price,” said Wetzels.
As a wholly owned subsidiary of Flexan, LLC, the plant in Suzhou combines the cost and capacity advantages of the Chinese site with US company standards.
“Western structures prevail in the management, all procedures are identical throughout the whole group, as far as possible,” confirmed Karau. Production and development management and quality management for example are internationally integrated. As with all other Flexan factories, Suzhou also adheres to the quality standards in accordance with ISO9001/13485 and undergoes the audits that inspect this conformity.
“The only difference between the American sites and China is that Suzhou is more set up to manufacture many different tools and parts in high quantities, while the US factories specialise in the manufacture of even more complex parts, and services for the end product such as assembly and secondary operations,” added Karau.
