Zhongguancun Development Group builds full-chain service platform for medical devices

Recently, Zhongguancun Development Group has invested in building an optimized service platform to provide medical device companies with services in "medical device engineering design + certification & inspection & registration + clinical (contract research organization) CRO + vertical circulation + funds".

Operated by Beijing Zhongguancun Shuimu Medical Technology Corporation, the platform provides full-chain medical device industrial services including contract research organization (CRO) and contract sales organization (CSO).

It is expected to improve the functionality, reliability, compliance, usability, batch size, and competitiveness of domestic medical devices.

We are integrating registration, inspection, clinical trials and regulation into new product R&D, said the founder of Beijing Zhongguancun Shuimu Medical Technology Corporation.

He added that the company will guide other companies at the very beginning of new medical device product R&D in engineering design, inspection, certification, registration, and clinical trial research, reminding them of what to verify and how to compile a clinical plan.

Through that process, it will help client companies reduce the cost and timelines of research and development.

Meanwhile, Beijing Zhongguancun Shuimu Medical Technology will improve the reliability of medical devices before registration, inspection and technical review, so that they can quickly pass registration, inspection and clinical trials and be ready for market.

For instance, the knee joint surgery robot product developed by Hehuaruibo completed R&D, passed registration and inspection and entered the clinical stage within half a year, more than a year faster than most medical device products.

"The medical device inspection business is now mainly operated by designated inspection agencies, but in the future, more and more third-party inspection agencies will be engaged in the business," said the founder of Beijing Zhongguancun Shuimu Medical Technology.

His company has invested over 50 million yuan in a third-party inspection agency which covers more than 3,600 square meters and includes an electrical safety laboratory, an electromagnetic compatibility laboratory, a reliability laboratory, IVD reference material and a quality control R&D laboratory and other facilities including an environment & packaging laboratory. The agency can inspect 90% of active medical devices.

In the next three years, Beijing Zhongguancun Shuimu Medical Technology will invest a further 110 million yuan in establishing professional medical device R & D and testing laboratories.

It has already completed a medical robot laboratory, and will cooperate with more than 1/3 of the domestic medical robot R & D companies in compliance, reliability, formulation of standards, and research on testing methods.

With a clinical CRO + vertical circulation + funds platform, it has been included in the Zhongguancun high-grade, precision and advanced industry collaborative innovation platform and the Ministry of Science and Technology's list of technology-based SMEs.