【新春走基层】刘淑琴的新年愿望

Core Viewpoint - The article highlights the successful development and approval of a domestically produced ECMO (Extracorporeal Membrane Oxygenation) device by Shandong Hengxin Medical Equipment Co., showcasing the company's commitment to innovation and the support from regulatory authorities in China [2][4]. Company Overview - Shandong Hengxin Medical Equipment Co. is led by Liu Shuqin, a retired professor and expert in magnetic levitation, who aims to accelerate the development of portable and intelligent ECMO devices to fill domestic market gaps [2][3]. - The company has successfully obtained the third-class medical device registration certificate for its ECMO, marking it as the sixth approved ECMO product in China and the first in Shandong [2][3]. Research and Development - The R&D team at Hengxin Medical comprises experts from various fields, including mechanical, electrical, magnetic, control, and materials engineering, as well as medical professionals from critical care and emergency medicine [3]. - The ECMO device's blood flow control precision is achieved at 20 ml/min, with a temperature difference of 0.1 degrees Celsius, surpassing the regulatory requirements and reaching international standards [3]. Regulatory Support - The Shandong Provincial Drug Administration has provided significant support to Hengxin Medical, guiding the company through product testing, clinical trials, and quality management system establishment [4]. - The recent inclusion of ECMO in the National Medical Products Administration's priority approval list for high-end medical devices is seen as a major advantage for Hengxin Medical [4].