“The domestic substitution of imported medical devices is an irresistible trend. As a national enterprise, Pulse Medical deeply feels its arduous mission and will further accelerate breakthroughs in key core technologies to contribute to the country’s early realization of import substitution,” said Ruan Chengmin, Chairman of Guangdong Pulse Medical Technology Co., Ltd.
Interview with Ruan Chengmin by Haiwainet
Accelerating Medical Device Localization to Support the Healthy China Initiative
With the continuous deepening of the Healthy China Initiative, China’s medical device industry has maintained steady growth. Ruan Chengmin noted that over the past decade, Pulse Medical has stayed committed to independent R&D and continuously launched original products to narrow the gap with foreign brands, speed up the localization of cardiovascular medical devices, and support the building of a Healthy China.
Ruan Chengmin explained that the physiological structure of East Asians differs from that of Europeans and Americans. In the field of structural heart disease interventional medical devices, products certified based on clinical trials conducted on Western populations pose significant risks to East Asians. Puls Medical focuses on developing structural heart disease interventional devices tailored to the physiological characteristics of East Asians. Ruan Chengmin cited an example: Puls Medical's dual-disc occluder for left atrial appendage closure comes in 16 specifications and models, while its accompanying delivery sheath has a cross-sectional area only 51% that of imported products. This design significantly reduces vascular damage to Chinese patients.
Currently, several products developed independently by Pulse Medical, such as the left atrial appendage occluder, feature globally pioneering structural designs. Ruan Chengmin stated that the left atrial appendage occluder system has been applied to hundreds of patients and received widespread acclaim from both doctors and patients. Key clinical performance metrics, including adverse event incidence rates and one-time device implantation success rates, have demonstrated outstanding results. Ruan Chengmin believes that the localization of medical devices and the acceleration of "import substitution" are inevitable trends. "China's 'import substitution' for high-end medical devices should not merely involve simple imitation but rather optimization and surpassing. Pulse Medical has consistently adhered to this philosophy."
Developing Products Needed by Chinese Patients, Adhering to the "Integration of Medicine and Engineering" Approach
In order to design products that better meet the operational needs of Chinese patients and clinical doctors, the deep "medical engineering integration" research and development model has become a product development model successfully explored by Pulse Medical. Ruan Chengmin introduced that Pulse Medical has obtained optimization and improvement ideas for existing medical device products through in-depth communication with experienced clinical doctors.
The main product of Pulse Medical, the left atrial appendage occluder system, is the result of a deep "medical engineering integration" model, "said Ruan Chengmin. Pulse Medical has established a cooperative relationship with relevant hospitals and set up a" industry university research cooperation base ". Through the deep" medical engineering integration "model, the product quickly completed 200 clinical trials within 11 months. The deep integration of medical and engineering models injects powerful innovation into product development work and will continue to provide strong support for future product development work
As an innovative and entrepreneurial enterprise in the Bay Area, Pulse Medical is growing rapidly. The business environment in the Guangdong Hong Kong Macao Greater Bay Area provides us with a good development soil for innovative enterprises, including comprehensive support such as policy support, market opportunities, legal protection, and talent resources. "Ruan Chengmin said that Pulse Medical will continue to follow the path of" deep medical engineering integration "in research and development innovation on this basis, truly achieving a" seamless connection "between scientific and technological achievements and application markets.
积极拓展全球市场 把握核心竞争力
近年来，越来越多的医疗器械制造商正积极在海外寻求发展，脉搏医疗也是其中之一。阮成民介绍，脉搏医疗已在美国加利福尼亚州成立研发中心，通过与全球顶尖心血管医疗企业和科研机构开展合作，引入先进技术并进行本土化创新，推动新型医疗设备的开发工作。
技术的发展离不开人才队伍建设。脉搏医疗广泛吸纳海外人才，通过加强与高校和科研机构合作、提供有吸引力的薪酬福利、积极参与国际科技合作和交流等方式，建设国际化的科研团队。“随着全球商业版图不断变化以及中国国家实力增强，中国企业对于海外人才的吸引力也随之增强。”阮成民说，中国企业吸引海外人才，需把握自身的核心竞争力，深入挖掘并提升软性实力，让目标人才有更强的认同感。
“目前，脉搏医疗已启动左心耳封堵器在欧洲市场的认证，未来还将和美国本土知名医药企业合作，开展此款产品的FDA认证，积极布局美国市场。”阮成民说，这些努力，提升了脉搏医疗整体研发能力和全球市场竞争力，为其在全球市场的扩展奠定坚实基础。