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