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If you are already selling your product in China but manufacturing it in Europe, there are good reasons why you should now consider having it manufactured safely in China too. And what better way to do this than to use an established UK manufacturing company that has carefully developed its own contract manufacturing capabilities in China’s main business center – Shanghai.
Without a doubt, the Chinese home market represents a huge chunk of potential business for European manufacturers of medical devices and in-vitro diagnostic (IVD) instruments – whether they are intended for the end-user market, the distributor market, or both. However, there are several considerations associated with getting EU manufactured products into China.
Shipping manufactured products from Europe to China, for example, is never going to be cheap, and it’s never going to enable the quickest route to market – necessarily raising the ‘sales price’ of the products, and thereby reducing their market attraction.
Similarly, the cost of purchasing quality components and materials is invariably going to be less in China, as would be the cost of skilled or semi-skilled labor. There are other price differentiators too, but these just further strengthen the case for manufacturing in China. However, quality control and assurances are also key concerns in any production engineering and manufacturing process, and these are strong considerations.
There are many issues that seem to favor producing your products in China; on the one hand, Europe has higher shipping costs and would take longer to get product-to-market while on the other hand, China has much lower shipping costs, lower Bill of Materials (BoM) costs, lower labor costs and would be quicker-to-market – a ‘no-brainer’ as some would say, but what about quality control and other less obvious issues such as qualifications, certifications, and experience?
In 2008, we experienced a similar situation. We viewed Chinese manufacturers as competitors, but after closer analysis of our business, we decided to take decisive action to help overcome key issues and to improve our pricing and product time-to-market in China. As part of our planned response and to further build our global business capability, we established a new manufacturing facility in Shanghai, which mirrored our successful facilities in the UK.
Our highly successful operation in Ashford, Kent, was born in 1977 to work alongside companies as a design and manufacturing partner. ‘Bringing instruments to life’ was and still is our slogan, and that’s exactly what we do. ITL Group (a G&H company) provides a fully-comprehensive service to enable the commercial realization of medical, diagnostics, analytical, and precision electro-mechanical or laboratory instrument projects.
ITL’s services can include concept generation, feasibility studies, design and engineering, prototyping, regulatory consultancy, and manufacturing – all to customer specification and all under the same set of tried and proven procedures – one specification, one solution, one company – any part of the process.
Our Shanghai-based manufacturing facility, Integrated Electronic Systems, is audited and accredited to ISO 9001: 2015 and ISO 13485:2016. Transfer into manufacturing and all production orders remain under the UK’s control to ensure high-quality standards are set and maintained. ITL’s customers may further benefit from the Chinese cost-base by appropriate materials procurement. Like ITL UK, this facility operates a lean cellular manufacturing system with component procurement from an approved vendor list (AVL) and state-of-the-art inventory management software.
The facility offers assembly, automated surface-mount, and conventional through-hole PCB production with automated test and inspection as well as cleanroom production areas. We specialize in FDA-compliant manufacturing with high quality, traceability, and precision.
ITL’s mirrored assembly and test facilities in the UK and on mainland China for contract manufacturing operations include complete turn-key electro-mechanical assembly and test within a quality accredited environment. In addition to design for manufacture and standard manufacturing services, ITL offers an aftermarket service and repair operation, warehousing, and logistics management, and obsolescence mitigation strategies, including alternative sourcing, life-time buy, and re-design. ITL’s reputation as a medical and diagnostics manufacturer has enabled expansion into patient-connected markets and non-medical precision engineering, food safety and hygiene testing sectors.
What makes us different is quite simply that we can complete both design and manufacturing functions. This means we have a symbiotic relationship between the two areas. With over 40 years of experience, we can be sure that design and development are undertaken with a view to manufacturing and that production benefits from problem-solving and next-generation product development with in-house design and development.
Greg Smith, Business Development Director, ITL, commented, “We are one of the very few companies where you won’t have to transfer your product from design with one company to manufacturing in another as we all share the same techniques and procedures. We do the lot, and we’ve earned a great reputation for doing so.”
So, if you are designing and developing a medical device or IVD instrument with China as your target region, you should now strongly consider the advantages of working with ITL’s Shanghai production engineering and manufacturing facilities.