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Smart prefilled syringes
On Dec 3, Chinese broadcaster Oriental Finance Pudong featured a story about the partnership between Flex and global medical technology company Smith+Nephew.
Here’s a transcript of the feature broadcast, edited for brevity.
Advancing Innovative development, science, and technology. Welcome to this edition of Pioneers of Science and Technology Innovation.
The MAH policy as applied to medical devices has been successfully implemented for the first time in Shanghai Waigaoqiao Free Trade Zone. The device is an endoscopic camera system developed by Smith+Nephew and manufactured by Flex. Let’s take a look.
In October, Flex and Smith+Nephew successfully held a launch ceremony to mark the mass production of the medical device cooperation project. It is a bold attempt to pilot the MAH policy of the State Food and Drug Administration and the first successful case of the MAH policy in the Waigaoqiao Free Trade Zone.
Interview with Felix Yu, Director of operations, Flex Shanghai Waigaoqiao
Q：Hello Mr. Yu, are we in the first medical device production line of Flex?
A：Yes, that’s right. This is our first medical device production line invested by Flex in Waigaoqiao.
Q：Would you please tell us what kind of production line it is? What is its current capacity?
A： This production line is specially customized to the requirements of Smith+Nephew. The lens 4K endoscopic camera system is mainly used in orthopedic endoscopic surgery. It can zoom in on the surgical area through video and help doctors accurately perform minimally invasive surgery.
Due to the special properties of medical device products, there are extremely strict requirements for translating design to manufacturing. Flex, with its proven track record in medical production, made for a perfect match in meeting the needs of Smith+Nephew.
For Smith+Nephew’s products, we designed three assembly processes, plus two testing processes. Because of the high standards on quality, even if we only have five production processes, we would have added three inspection procedures to ensure the high quality of our products and timely delivery. The entire Flex business transformation in Shanghai is a transformation from metal parts to system integration, and then to such high-end medical products. All of this has been developed in stages.
Flex and Smith+Nephew are both important members of Waigaoqiao’s healthcare industry ecosystem. The 4K endoscope camera system developed and registered by Smith+Nephew is the region’s first localization strategy project for the Chinese market. Due to the lack of local factories, if the product is registered for import of medical devices, the import registration process may take three years or more. With the help of the Waigaoqiao Administration bureau, Flex was identified as the manufacturing partner for Smith+Nephew, which shortened the product launch time from three years to a few months.
Comments from David Lai, SVP of Flex China Government Affairs
We submitted the product for approval on July 28, 2021 under the MAH policy applied to medical devices. The audit of our production system only took 45 days to complete. It usually took three and a half years before, and it took us nearly seven months to complete the entire registration and production license approval. In fact, in our production audit process, the supervisory department completed the entire audit in only 10 working days. As such, we can improve the quality and efficiency by using the (medical device) MAH policy.
We understand that Smith+Nephew submitted an application for registration in February this year and was formally approved in July. Flex subsequently submitted its first production license application, and the entire process from submission of the application to the issuance of the license required only 45 days. While refreshing the speed of Pudong and promoting a win-win situation for many parties, it further realizes the model of rapid realization of the localization needs of multinational enterprises in the region.
Flex is among the 15 companies globally that have strong advantages in medical device manufacturing. Then, as we combine the benefits of the MAH policy and the policies of the leading district (Pudong New Development District, where Waigaoqiao Free Trade Zone is located), we are leveraging this opportunity to enable our transformation.
Thanks to the opening-up of the Free Trade Zone and the policy advantages of the Zone, Waigaoqiao is providing a new fulcrum for Pudong to accelerate its integration into a world-class industrial cluster.
That’s all for this edition of Pioneers of Science and Technology Innovation. Thanks for watching, and we’ll see you next time.
