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Innovative medical device research and development brave “no man's land”

Jan. 14, 2019

On January 4, the official website of the Medical Device Technology Evaluation Center of the State Drug Administration (hereinafter referred to as the Appraisal Center) issued an announcement to initiate a collective decision-making mechanism for the conclusion of the technical review of medical device registration, and form a rectification notice for the group review project through collective discussion. Single and initial registration, change of registration of licensing items and review of clinical trial approval projects.

This is the first new reform of the review and approval system issued by the Center for Appraisal this year. On the afternoon of the same day, the State Food and Drug Administration held a hearing at the symposium on representatives of the National People's Congress, members of the National Committee of the Chinese People's Political Consultative Conference, experts, scholars and industry associations to discuss the drug regulatory plan. "Since the establishment of the State Food and Drug Administration, we have vigorously promoted drug medical care. The reform of the equipment review and approval system, a batch of clinically urgently needed and independent innovation drugs were approved for listing, and became the high-frequency statement used by the participants.

In 2018, China's innovative medical devices attracted much attention. In the "Innovative Medical Devices Catalogue (2018)" released by the Ministry of Science and Technology in December 2018, "international originality" and "domestic initiative" became the main vocabulary to describe the type of product innovation.

Not afraid of challenges, continuous release of reform dividends

In November of the same year, the State Food and Drug Administration revised and released the "Special Examination Procedure for Innovative Medical Devices" to encourage innovation in medical device research and development and promote the high-quality development of the medical device industry.

In 2018, the national medical device review and approval department tried to make breakthroughs in system construction and communication methods, and accelerated the review and approval of innovative products. "Implementing the approval channel for medical device innovation is of great significance. Promoting innovation requires the joint efforts of enterprises and drug regulatory and review departments. Under the situation that the system and concept of the State Food and Drug Administration is becoming more and more open, it is recommended that companies boldly take innovative products. Participate in the review and application. Jiang Feng, executive vice president of China Medical Device Industry Association, said.

"Our communication with the inspection center is very smooth. If there is a problem in the review process, the inspection center has a special person to contact us and finally reach a consensus and properly handle it." When encountering problems, come to the enterprise and the inspection center It is said that they are all challenges. The two sides unanimously hope that through various effective exchange methods, they will take less detours and speed up the examination and approval.

"The review of innovative products demonstrates the recognition of innovative medical devices by the State Food and Drug Administration and the Appraisal Center. Next, it is recommended to continue to support the innovation of domestic enterprises and give enterprises more confidence and patience."

According to the data, as of the end of December 2018, the inspection center received a total of 1081 applications for innovative products, and a total of 197 products entered the special approval channel for innovative medical devices, of which 54 innovative medical device products were approved for listing. The Medical Device Priority Approval Process was implemented on January 1, 2017. Up to now, 20 products have been included in the priority approval list, and 5 of them have been approved.

China's "intelligence" power reserves to benefit patients as soon as possible

In September 2018, the world's top authoritative medical journal "The Lancet" published the results of a large-scale clinical trial conducted in China by the Firehawk (Raw Eagle) coronary rapamycin targeted eluting stent system developed in China. It shows that it has the efficacy of common drug stents and maintains the long-term safety of bare metal stents. This is the first time that the "Lancet" has been published in China for nearly 200 years.

In November of the same year, the third-generation orthopedic surgery robot "Tianzhu" made its debut at the first China International Import Expo. In the category of "International Originality" in the Catalogue of Innovative Medical Devices (2018), "Scorpio" is listed. As a new generation of orthopedic surgery robots, "Scorpio" not only has the same or even better performance indicators as foreign products, but also more creatively expands the applicable field of surgical robots to total orthopedic surgery.

The transcatheter artificial aortic valve replacement system VenusA-Valve, which was developed in response to the characteristics of Chinese patients with aortic valve stenosis, became the first Chinese-made transcatheter heart valve system to be approved prior to its similar imported products.

LAmbre left atrial appendage occluder has completely controllable recovery, multiple fixation mechanisms and other design features, becoming the only product in China that can sell left atrial appendage occlusion products to Europe in 2017.

Approved is not the ultimate goal of innovative medical device applicants and approvers. How to make patients benefit patients is the original intention of drug regulatory departments and developers.

"From the current study, the time to take dual antiplatelet drugs after the installation of the Fire Eagle stent is expected to be shortened from long-term treatment to 3 months, and each person can save nearly 10,000 yuan per year."

"In Zhejiang Province, the relevant regulations, patients with VenusA can subsidize 30,000 yuan in equipment costs and surgery costs." In 2018, VenusA entered 101 hospitals and implanted more than 850 cases.

So far, 117 hospitals in 24 provinces and cities have carried out LAmbre implantation surgery, successfully treating more than 1200 patients, and the product market share in the country in 2018 is close to 1/3.

It is reported that as of the end of November 2018, more than 40 hospitals in more than 20 provinces (autonomous regions and municipalities) have been equipped with "Scorpio", and nearly 5,000 robot-assisted operations have been carried out with a success rate of 100%. With "Scorpio" assisted surgery, time can be reduced by 20%, intraoperative radiation is reduced by 70%, and surgery costs are reduced by an average of 15%.

This is just a microcosm after the launch of innovative medical devices. In addition to the above products, high-definition image radiotherapy equipment such as OMX6i, positron emission tomography and magnetic resonance imaging systems are also providing international standard treatment solutions for Chinese patients.

Accelerate catching up and depict the "global alternative" picture

At present, the market share of domestic products such as cardiac stents, cardiac occlusion devices, and vena cava filters for preventing pulmonary embolism has exceeded that of imported products, and import substitution has been achieved to some extent; in high-end fields such as magnetic resonance equipment and 64-row CT, domestically produced The brand has gradually begun to penetrate into the high-end imaging market.

Global substitution should be the ultimate goal of the enterprise market layout, which is the proper meaning of China's innovative brand in the world. "Innovative medical devices are of great significance for the realization of import substitution. However, from a global perspective, the proportion of domestic enterprises' products in the global market is still low. In addition to accelerating the realization of domestic substitution, the level of innovation should be continuously improved. The global market should be taken into consideration. However, this is not a matter for companies to go it alone. The listing and application of innovative medical devices requires a multi-disciplinary effort to create an environment.

In September 2018, the first China Medical Device Innovation and Entrepreneurship Competition and Medical Device Innovation Week organized by the Medical Device Industry Technology Innovation Strategic Alliance and China Medical Device Industry Association was held in Suzhou. Intellectual property became one of the hot words of the event. "Intellectual property protection is very important for innovation. We want to encourage local companies to form real self-owned intellectual property and develop medical device products for the world."

"Innovative devices must have mechanisms to identify infringing products when intellectual property rights are questioned.", "I hope that the government will create conditions to enable innovative products to be quickly used in clinical practice for the benefit of patients; increase the proportion of medical insurance reimbursement after the launch of innovative products. Many patients can afford innovative equipment; optimize the registration of innovative product registration and standardize the approval of innovation, so that more truly innovative device products can get innovation approval faster."