The highly anticipated Congenital and Structural Interventions (CSI) conference, focusing on interventional treatment for congenital, structural, and valvular heart disease, was held in Frankfurt, Germany from June 28th to July 1st, 2023. CSI Frankfurt 2023 covered a wide range of topics, including medical device development and innovation, mitral valve repair, tricuspid valve interventions, transcatheter aortic valve implantation (TAVI), left atrial appendage (LAA) closure, structural electrophysiology, and heart failure management.
Ⅰ. Innovation Development with LINKS
LINKS, as a CRO (Clinical Research Organization) representative specializing in innovative and high-risk interventions of medical devices in clinical trials, is the only CRO from China. Dr. Martin Chen the founder of LINKS, was invited to participate in the Workshop of Device Development. and gathered with top medical experts, company founders, CEOs, and investors from all over the world to discuss the topic of "Device Challenges: Financing and Maintaining Founders' Equity in a Changing World." Other panellists included Dr. Helen Yang, Chief Investment Officer of Fosun Medical Device Division, Mr. Stefan, Chief Marketing Officer of Abiomed, and representatives of some early-stage startup founders.
"Deglobalization," post-pandemic era, and EU MDR regulations were keywords of the conference. The increasingly stringent global regulations on medical devices have raised the development costs for companies and made it almost difficult to achieve early-stage financing for product innovation, technological advancement, and effective solutions to clinical needs driven by clinical value.
Additionally, adequate financial support is another key factor. Many innovative devices and startups failed due to funding shortages or poor cost control. As the world's second-largest medical device market, the Chinese medical device market has gained significant attention. Early-stage companies from Israel and the European Union have already set their sights on the Chinese market for their First-in-Human (FIH) trials. LINKS，which has been deeply rooted in the industry for many years, can facilitate these innovative pioneers in expanding into new territories and will definitely become their ideal partner for comprehensive planning throughout the entire innovation cycle. By leveraging efficient clinical support, from innovation to clinical translation, LINKS will connect the dots and facilitate commercialization in China's positive business cycle.
Ms. Kate Marshall, the founder of MAXIS, a strategic partner of LINKS, served as the chairof this Workshop. She emphasized that CRO companies provide comprehensive support to innovative medical device enterprises. As excellent partners in the field of innovative medical devices, MAXIS and LINKS can help shorten the product development and market entry cycle, reduce the risk of failure and R&D costs, mitigate funding risks and challenges, and assist medical device companies in achieving rapid commercialization of innovative devices in the right markets.
Ⅰ.Meet again in CSI，Focusing on China's Innovative Medical Devices Going Abroad
Professor Horst Sievert, the chairman of the conference, is a renowned expert in the field of Structural Heart Disease (SHD) and was the first to propose the concept of SHD. In the early years, Professor Sievert helped Dr. Martin Chen in leading CE-Mark studies of innovative medical devices which came from China and successfully obtained EU CE-Mark. After the pandemic, Professor Sievert and Dr. Martin Chen met again at the CSI conference to discuss the breakthrough progress made in SHD interventional therapy in the past few years Martin shared the rapid development of LINKS and the changing world regarding structure heart device in China. Prof. Sievert expressed the willing to help genuine original Chinese medical devices enter the global stage like CSI and promote the successful commercialization of original Chinese medical devices and novel technique entry into the European and other developed areas. Likewise, Prof. Sievert is also happy to continuously facilitate world-leading innovative devices to China like what he did for TAVR in China.
With the recovery of the international medical device market, medical device companies that have weathered the cold winter will finally see their efforts bear fruit and usher in a new era of rapid development in the innovative medical device industry. During CSI Frankfurt 2023, LINKS had fruitful exchanges and discussions with top global experts, aiming to explore opportunities for win-win cooperation. LINKS will continue to focus on innovation, high risk implantation(intervention) medical device, focus on innovation, stay truewhy we started，and contribute to the development of the medical device industry.
LINKS CRO
As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.
Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.
