To stay competitive due to price pressure, more and more US and European disposable medical device manufacturers are coming to Asia to outsource the manufacturing of their products. Everyone has a big problem: how and where to locate the most suitable outsourcing partner?
Generally, these manufacturers need the contract manufacturer to perform manufacturing services such as product prototype, production mold, plastic injection molding, liquid silicone injection molding (LIM), silicone compression molding , ultrasonic, thermal and high frequency welding, assembly and packaging in a clean room control environment and other ancillary services such as metal machining. In addition, the contract manufacturer must have a quality system for medical devices, eg, ISO 13485 for the EU and QSR for the US FDA, and possess regulatory knowledge. It sounds basic, but all of the above is crucial to achieve product price reduction without sacrificing product quality.
Apart from that, there are a number of more important business concerns manufacturers need to consider when choosing the right partner:
– Protection of proprietary information of the manufacturer of the medical device;
– Logistic arrangement of final products;
– Financial statement of the contract manufacturer;
– Communication capacity of contract manufacturer personnel.
Although manufacturing capabilities and the quality system are important to manufacturing a quality medical device, these business concerns are critical for manufacturers to be successful in the long term.
– To protect its proprietary information, the manufacturer needs the contract manufacturer to sign documents such as a confidentiality agreement and abide by the legal liability that is similar to that of the medical device manufacturer.
– The location of the contract manufacturer’s manufacturing facilities should be close to seaports and/or airports to facilitate delivery of finished products to the country of the medical device manufacturer. Also, these ports should be viable for the contract manufacturer to provide a value-added service to arrange drop shipments to their distributors in other countries to save time and money.
– Given the very long product life cycle of a medical device compared to other commercial products and regulatory issues related to changes in manufacturing facilities, a stable and strong financial status of the contract manufacturer is important.
– To ensure a smooth transfer of production from manufacturer to contract manufacturer, good communication between both parties in different roles at different stages is critical. The communication barrier due to language and culture differences will cause unnecessary misunderstanding and disaster in the whole project.
To meet all of the above criteria, the best option is a Hong Kong medical device contract manufacturer with its manufacturing facility in Shenzhen, China.
– Hong Kong has a well-established legal system which is closed to the UK for historical reasons and Hong Kong companies have a practice of protecting their customers’ private information.
– Hong Kong has a well-known international airport and seaport, and Shenzhen has also developed well-equipped seaports in recent years, so both of them optimize logistics arrangements to worldwide destinations with fast response time.
– Since financial information is confidential, it is suggested to obtain it from the contract manufacturer’s management and/or marketing persons in a face-to-face meeting during a personal visit.
– Speaking English is common in Hong Kong and its eastern-western fusion culture will enhance communication during the project operation.
– Easy obtaining of raw materials and auxiliary services in the Pearl River Delta area.
In conclusion, in order to find the most suitable manufacturing partner, a medical device manufacturer must conduct a thorough assessment and site visit before making the final decision to appoint their medical device contract manufacturer in China.
