Hong Kong opto-mechatronics industry has been one of the fastest growing industry sectors in the past. However, as the competition in the opto-mechatronics industry has become extremely vigorous in recent years (contributing from the shortening of product-life as well as keen competition in the Asian region), local opto-mechatronics SMEs are facing great challenges to sustain their business. Competition with our regional counterparts, for instance, South Korea, Taiwan, Singapore and our mainland counterparts are substantially increased. Hong Kong opto-mechatronics SMEs are gradually losing their competitive edge, and urgently needed to transform their business in order to survive. It is crucial for our local opto-mechatronics SMEs in expanding their business into the high value-added market, by leveraging our strong industry foundation and know-how in opto-mechatronics design, manufacturing and assembly. It is common to find opto-mechatronics components being the critical components of many medical and healthcare devices. For instance, the endoscopic devices which are widely employed in minimally invasive surgery are composed of precision optics, mini-motors/actuators, illumination source, micro-gears, etc., which are supplied by opto-mechatronics manufacturers, who have the know-how on high-precision manufacturing, optics design and opto-mechatronics system assembly. Since the entry-barrier for migration from the traditional opto-mechatronics industry into medical and healthcare industry is relatively high, a lot of local opto-mechatronics SMEs are facing great challenges to overcome such barrier, which includes the medical device risk management, regulatory requirement (e.g. pre-market approval, US FDA clearance requirement, MHRA requirement, EU medical device directive 93/42/EEC, etc.), medical device quality management system (e.g. ISO13485, QSR, cGMP, etc.), post-market surveillance requirement, etc. Local opto-mechatronics SMEs are in need of support to overcome the mentioned barrier, in order to open up the medical and healthcare device market.

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This project aims at enabling the local opto-mechatronics SMEs in further expanding their business into the medical and healthcare device market, through a) hands-holding pilot scheme to develop and demonstrate the know-how on upgrading from opto-mechatronics manufacturing operations into medical device complied manufacturing operations and quality management systems; b) a series of systematic and opto-mechatronics industry-specific training to the local SMEs, to equip them with the essential knowledge on medical device regulatory affairs, safety and compliance requirement in order to upgrade their business into "medical-grade ready".