Historically, the pace of research and development in China for medical devices has been slowed by segregation in the health care sector and a lack of communication between the different players in the field. Medical device companies and physicians worked in separate silos. Physicians focused only on the use of medical devices and did not communicate with engineers about the problems they identified. Medical device companies concentrated on research, development, and sales. Universities were keen on basic research in life sciences, but they paid little attention to utilizing their discoveries to create new therapies or medical devices. Neither universities nor the government encouraged physicians to participate in device development.
However, in Hangzhou — capital of Zhejiang Province in East China, emerging technological innovation hub, and headquarters of Alibaba, the world’s fifth-largest Internet company — a four-way collaboration among government, a university, a company, and a hospital has broken down the traditional silos. The collaboration began in 2010, and today clinicians are working closely with university researchers and engineers on the creation of new clinical technologies.
The synergy created by this new model of integrated, multidisciplinary development is driving the research and development of new procedures such as the cutting-edge Transcatheter Aortic Valve Replacement (TAVR). TAVR is a procedure to treat patients with aortic stenosis, a degenerative valve disease common in developed countries. Thanks to its minimally invasive nature, it is well suited to patients who are considered to be at increased surgical risk. In the United States, TAVR is well developed and already has a large market. In China, it is a newer procedure with a much smaller market currently since its introduction in 2010. However, with an aging population, the number of Chinese patients with aortic stenosis is increasing, and TAVR in China will eventually represent a larger market than in the United States.
What Is Behind the Transformation?
First and foremost, this transformation is driven by the Chinese government’s emphasis on innovation. The government is mobilizing universities, enterprises, hospitals, and other stakeholders to engage in medical device innovation through favorable policy and incentives.
On the other side, both medical organizations and individual researchers and clinicians are eager to make contributions to human health. Medical device innovation can help universities increase their scientific output, attract world-class talent, and raise their global competitiveness; help enterprises expand profits; help hospitals improve patient outcomes and efficiency; and help individuals achieve rapid promotion, increase their income, and enhance their influence.
The Chinese government has introduced preferential policies, as well as land, capital, and tax support, designed to encourage innovation and support medical device companies at the national and provincial levels. For example, the China Food and Drug Administration (CFDA) has introduced a “green channel” to shorten the approval time for medical devices. The manufacturer of the TAVR device, Hangzhou Venus Med Tech Company, has received a total of RMB ¥17.73 million (approximately USD $2.64 million) in research funding from the central government.
Zhejiang Provincial Government has granted Hangzhou Venus Med Tech Co. 3 years of rent exemption and special funding of RMB ¥20.3 million (USD $2.9 million). The provincial government also founded the Interventional Valve Research Institute in 2016, a key corporate-based research organization located inside Hangzhou Venus Med Tech Co. The provincial government provided RMB ¥10 million (USD $1.5 million) as research funding and has appointed Professor Jian’an Wang, a cardiologist (and co-author of this paper), as Dean of the Interventional Valve Research Institute. He is also Director of the Heart Valve Innovation Center established by Zhejiang University, thereby acting as a bridge between government, university, corporation, and clinicians. The work of each organization complements the other: the innovation center does basic research in all areas related to heart valves, and the research institute applies that work to the development and refinement of devices.
Zhejiang University has begun promoting interdisciplinary cooperation and innovation. The university established the Heart Valve Innovation Center in 2016 to foster an educational model by nurturing a multidisciplinary team with cardiovascular physicians as the core and other professionals in engineering, material science, informatics, chemistry, and life sciences. The center occupies 2,000 square meters at the university’s affiliated hospital.
Meanwhile, a dual-tutor system, where each PhD student is cross-trained by a physician and a professional from one of the other disciplines, has been funded at RMB ¥10 million (USD $1.5 million) annually for 5 consecutive years and will train at least students annually. Most will enter the program having already earned a lower degree related to medicine.
To incentivize R&D personnel, the center has allocated 70% of revenue from patents transfer and patents investment to the individuals responsible for the invention, an increase from the 60% that was the previous university policy.
An Expanded Role for the Hospital
The Second Affiliated Hospital of the Zhejiang University School of Medicine (SAHZU), one of seven associated with the university, is an essential part of the collaboration. To promote the application of basic research, as well as clinical and translational research, the hospital is building a research area of 25,000 square meters, out of which 20,000 is a shared facility including an integral basic research laboratory, a small animal experimental center and a large animal research base, and 2000 m2 is for the Heart Valve Innovation Center.
The hospital also provides matching grants of an additional 30 to 100% to any project that receives government funding and has founded an Innovation Club, which holds annual innovation competitions to reward outstanding projects and promote research. The competition attracts 20 to 30 projects, of which 10 will receive awards ranging from RMB ¥10,000 to ¥50,000 (USD $1,500 to $7,500).
Collaboration with Industry
A cross-disciplinary heart valve team, comprising doctors and experts in cardiology, cardiac surgery, echocardiography and electrocardiography, anesthesiology, radiology, and experts in material science, and 3-D printing and basic research, is set up to be actively involved in the development of the devices.
R&D engineers are on site at the hospital observing every valve procedure and receiving real-time feedback on the pros and cons of the product. The clinical and corporate engineering teams meet every 2 weeks to discuss clinical issues. This process significantly expedites development of new and improved devices. During the first 5 years of the collaboration, between 2010 and 2015, the team was granted nine patents relating to heart-valve development. In the past 2 years alone, from 2016 to 2018, seven patents have been granted and four are in process. Moreover, this team developed an innovative technique called the Hangzhou Solution to select the correct device size for bicuspid aortic stenosis patients undergoing the TAVR procedure. This technique has been widely accepted and applied in many other centers all over the world.
Speeding Heart-Valve Development
It took a decade for Venus A, Venus Med Tech’s first generation of domestically produced transcatheter valves, to receive CFDA approval for sale in 2017. Since its approval, the company has sold 1,010 units in China, representing total revenue of RMB ¥240,000,000 (USD $36 million). As the first and only approved transfemoral heart valve in China, it currently enjoys 100% market share. Professor Wang’s team has taught TAVR with this valve in person at meetings in India, Argentina, and Greece and presented it virtually at several international conferences.
VenusA Plus, a second-generation valve that improves on the original model because it can be retrieved and repositioned when necessary, experienced a much quicker development cycle due to the collaboration described above. The design phase began in 2016 and human clinical trials began in November 2017, less than a year later. CFDA approval for the VenusA Plus is expected in the fourth quarter of 2019. Research and development on the third generation, the VenusA Plus II, began in December 2017.
This partnership of government, business, research, and hospital has produced significant achievements in Hangzhou, and we are optimistic that our model will be adopted for other types of medical device innovation elsewhere in China.
We believe the following points are essential for medical organizations wishing to pursue a similar collaboration model:
Policy and funding support are essential in every medical innovation. Enlist cooperation and support from policymakers in your region.
Leading clinicians should act as the bridge between various organizations and facilitate their communication.
Each organization should integrate advantages of the other organizations, making sure everyone is doing the most suitable thing.
Efficient workflow should be established during collaboration. For example, our collaboration included include regular weekly meetings and having engineers attend procedures to observe issues with devices firsthand.
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