To keep their competitiveness due to price pressure, more and more medical device manufacturers of disposable devices from the US and Europe are coming to Asia to outsource the manufacturing of their products. They all have one big issue, how and where to locate the most suitable outsourcing partner?
In general, these manufacturers need the contract manufacturer to do manufacturing services like the product prototype, production mold, plastic injection molding, liquid silicone injection molding (LIM), silicone compression molding, ultrasonic, heat and high frequency welding, assembly and packaging in a control environment cleanroom and other auxiliary services like metal machining. In addition, the contract manufacturer needs to have a quality system for medical devices, e.g. ISO 13485 for EU and the QSR for US FDA, and possess regulatory knowledge. Sounds basic, but all mentioned are crucial to achieve price reduction on the product without sacrificing the product quality.
Other than that, there are a number of commercial concerns which are more important the manufacturers need to consider in choosing the right partner:
– Protection of proprietary information of the medical device manufacturer;
– Logistic arrangement of the final products;
– Financial status of the contract manufacturer;
– Communication ability of the staff of the contract manufacturer.
Although the manufacturing capabilities and quality system are important to make a quality medical device, these commercial concerns are critical for the manufacturers to have a success in the long run.
– To protect its proprietary information, the manufacturer needs the contract manufacturer to sign documents like non-disclose agreement and respect the legal responsibility which is similar to that of the medical device manufacturer.
– The location of the manufacturing facility of the contract manufacturer should be closed to seaports and/or airports to facilitate the delivery of the finished products back to the country of the medical device manufacturer. Besides, these ports should be viable for the contract manufacturer to provide value added service to arrange direct shipments to its distributors in other countries to save both time and money.
– Since the product life cycle of a medical device is very long in comparison with other commercial products and the regulatory issues related to changes in manufacturing facility, a stable and sound financial status of the contract manufacturer is important.
– To assure a smooth transfer of the production from the manufacturer to the contract manufacturer, a good communication between both parties at different functions in different stages is critical. Communication barrier due to language and culture differences will cause unnecessary misunderstanding and disaster in the whole project.
To meet all the above criteria, a Hong Kong medical device contract manufacturer with its manufacturing facility in Shenzhen, China is the best option.
– Hong Kong has a well established legal system which is closed to the UK one due to historical reason and the Hong Kong companies have the practice of protecting their customers’ proprietary information.
– Hong Kong has well known international airport and seaport, and Shenzhen has also developed well equipped seaports in recent years, so both optimize the logistic arrangements to worldwide destinations in a quick turnaround time.
– Since the financial information is sensitive, it is suggested to gather it from the management and/or marketing people of the contract manufacturer in face to face meeting during personal visit.
– English speaking is common in Hong Kong and its Eastern and Western fusion culture will enhance the communication during the project operation.
– Easy to get raw materials and auxiliary services in the Pearl River Delta area.
In conclusion, to find the most suitable manufacturing partner, the medical device manufacturer needs to do a thorough assessment and site visit before making the final decision to appoint its China medical device contract manufacturer.