Recently, the National Healthcare Security Administration issued the "Notice of the National Healthcare Security Administration on the 5th Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference02866number(Social Management263number)The "Proposal Reply Letter" once again sent a signal that innovative medical devices will not be included in centralized procurement.
What are the reasons why innovative medical devices still find it difficult to be procured through centralized procurement? What changes will occur in China's cloud service market? The State Healthcare Security Administration's clear stance that innovative medical devices are not currently included in centralized procurement is either negative or positive news? What impacts will it have on enterprises and the market respectively? Frost & SullivanFrost & SullivanLi Qian, Senior Consulting Director for Healthcare in Greater China at Frost & Sullivan (referred to as 'Frost & Sullivan'), was interviewed by Huaxia Times to discuss the above topics.
Huaxia Times
Innovative medical devices have temporarily become a safe zone for centralized procurement.
Recently, the National Healthcare Security Administration issued the "Notice of the National Healthcare Security Administration on the 5th Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference02866number(Social Management263number)The "Proposal Reply Letter" once again sent a signal that innovative medical devices will not be included in centralized procurement.
Previously9In the month, the National Healthcare Security Administration issued a document titled "The National Healthcare Security Administration's Response to the Fifth Session of the Thirteenth National People's Congress4955In the 'Reply to the Proposal No. [X]' document, a comprehensive explanation was provided regarding mechanisms such as online listing and pricing for innovative medical devices, as well as issues related to centralized procurement. It was clarified that innovative medical devices are not yet included in centralized procurement.
It is reported that innovative devices specifically refer to a category of high-value medical device products that possess internationally leading patent technologies and are characterized by special review procedures for innovative medical devices. With continuous issuance of documents, some industry views suggest that enterprises in the medical device industry are gradually adapting to the pace of centralized procurement, and innovative medical devices may be poised to receive 'warmth' from policies.
In response, Li Qian, Senior Consulting Director of Frost & Sullivan Greater China, told a reporter from China Times that 'centralized procurement has always been market-oriented, focusing on including products with high clinical usage and full market competition into the procurement scope. The National Healthcare Security Administration has made it clear that innovative medical devices are not included in centralized procurement at this stage, providing ample space for innovative device companies to improve technology and cultivate the market.'
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No centralized procurement for now
10month12On the same day, the National Healthcare Security Administration issued the "Opinions of the National Healthcare Security Administration on the 5th Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference02866number(Social Management263number)The 'Proposal Reply Letter' (hereinafter referred to as the 'Reply Letter') responds once again to the issue of procurement of innovative medical devices.
According to the 'Reply Letter', this proposal involves discussions3DWhether the printing of innovative spinal products is included in the scope of centralized procurement. The National Healthcare Security Administration stated that the current focus of centralized volume-based procurement will be to include some medical consumables with high clinical usage, mature clinical applications, high procurement amounts, and sufficient market competition into the procurement scope. By publicly disclosing competitive rules and ensuring transparency, prices are expected to return to a reasonable level.
The National Healthcare Security Administration pointed out that consideration3DThe printing product is still in its startup phase, with insufficient market competition. Moreover, the product features are quite complex, and some products have personalized customization capabilities. The cost and efficacy of these products are difficult to simply compare directly with those produced in large quantities. Therefore, there are no clear requirements for centralized procurement of consumables for spinal products.3DPrinters participating in spine-related products should choose whether to participate in centralized procurement on their own. At the same time, to prevent inflated prices and promote fair competition, for those that have not participated in centralized procurement3DPrinted products will have their online prices standardized in subsequent work.
The National Healthcare Security Administration has made it clear that for similar3DIn printing innovative products such as orthopedic consumables, comprehensive considerations will be given to their technical characteristics, production costs, usage conditions, clinical efficacy, and other features. An 'one product, one policy' approach will be adopted to determine appropriate procurement rules, improve the market-led price formation mechanism, promote the high-quality development of the medical device industry, and provide the public with more innovative products at reasonable prices.
a certain3DPrint machinery industry insiders told the China Business Times reporter, 'The clarification of centralized procurement policies (either purchasing or temporarily not purchasing) is conducive to the development of domestic innovative enterprises in this sector. At this stage.'3DThe printing of orthopedic consumables is still in an upward phase, and companies are conducting dual explorations in the market and technology. Users of these consumables have high requirements for systems, and product user services are not yet mature. If there is a sudden drop in profits due to centralized procurement price cuts at this time, it is very likely to affect employee motivation.
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Commercialization dilemma
In fact,3DThe policy on printing consumables only presents the tip of the iceberg of the challenges faced by innovative device development. For innovative medical device companies, the issue that urgently needs to be addressed is that they are not yet able to commercialize and profit from technology research and development. 'Innovative devices not included in centralized procurement may not have a substantial impact on the company's operations, but it is a significant positive for the company's development and product research.' A person in charge of marketing at a domestic surgical robot enterprise told the China Times.
It is reported that the concept of 'innovative devices'2014year2month7It was first made clear on the day. At that time, the China Food and Drug Administration issued the Food and Drug Administration's Medical Device Administrative Approval [2014〕13The 'Special Approval Procedure for Innovative Medical Devices (Trial)' was issued. The document specifies that innovative devices need to possess the following elements: First, a patent, which must include an invention patent with core technology; second, performance, where the main working principle or mechanism is domestically original, technologically leading internationally, and has significant clinical application value; third, finalization, meaning that preliminary research has been completed and a basic finalized product is available. Therefore, the industry generally regards products approved through the special review procedure for innovative medical devices as 'innovative medical devices'.
2018year11month5On the same day, the National Medical Products Administration revised and issued the "Special Review Procedures for Innovative Medical Devices," further refining the applicable circumstances for "innovative devices." It is pointed out that this includes the applicant having legally owned the core technology invention patent of the product in China, and the time for applying for innovative review shall not exceed the date of patent authorization.5In [year], the core technology invention patent possesses novelty and creativity; the main working principle and mechanism of the product are domestically original, with significant clinical value, etc.
The person in charge of the marketing department mentioned that, 'Innovation device companies currently have an advantage over their competitors in the domestic market, but they still need time to settle in. These companies are entering new fields with a late start and high industry technical barriers in China, where the market has long been firmly held by established foreign brands. Coupled with patent restrictions, it takes some time for domestic companies to achieve a commercial closed loop.'
Against this backdrop, the National Healthcare Security Administration has started from practical considerations and this year9The released "On the Fifth Session of the 13th National People's Congress4955In the 'Reply to the Proposal', it was clearly stated for the first time that innovative medical devices are not yet included in centralized procurement. The National Healthcare Security Administration pointed out that due to the immaturity of clinical use and the temporary difficulty in estimating usage, it is still difficult to implement volume-based methods. During the centralized volume-based procurement process, the National Healthcare Security Administration will reasonably determine the volume ratio based on factors such as clinical usage characteristics, market competition patterns, and the number of winning enterprises. A certain market space is reserved outside of centralized volume-based procurement to provide room for innovative products to develop their market.
In fact, the 'first move' in medical device centralized procurement was made with coronary stents, which is also the category of consumables with the highest penetration rate in China. According to a Frost & Sullivan report,2019In China, the number of coronary intervention surgeries reached10810,000,000, and in the same year, WHO statistics showed that the total number of coronary heart disease patients in China was approximately187ten thousand.
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Regarding this, Li Qian analyzed, 'The centralized procurement follows the development cycle and phased changes of medical devices, focusing on including products with high clinical usage and full market competition into the procurement scope. The temporary non-centralized procurement of innovative devices reflects the country's strong encouragement for technological innovation in the medical field. This will reserve a certain development space for innovative device R&D enterprises, enhance their confidence in R&D, focus on innovative technology development, optimize their product lines, strengthen market access and commercialization capabilities. At the same time, centralized procurement will also lead to an increase in market concentration and promote the market towards innovation.'
Taking the surgical robot track in innovative devices as an example, in terms of market deployment, among the top ten companies ranked by sales volume, domestic products...23688.57Ten thousand yuan, proportion14.6%;Sales volume of foreign brand products138540.06Ten thousand yuan, proportion85.5%Data from the Medical Device Data Cloud shows that from2021In terms of the market share of surgical robots in 2023, iRobot, a subsidiary of Compassion Robotics,67.52%Ranked first, its varieties cover endoscopy, neurology, and orthopedics, while Chinese enterprises are only visible in orthopedics and dentistry.
"Temporary centralized procurement has helped enterprises secure sufficient development time. Domestic companies are still in the shaping phase, so costs are relatively high in all aspects for the short term. In the future, as domestic companies continue to mature, our local advantages will gradually increase, but it takes time to accumulate," said the head of the marketing department mentioned above.
*This article is reprinted from China Times. Reporters: Guo Yilin, Yu Na Original title: Innovative medical devices are not included in centralized procurement for now. How much room is left for innovation under the 'one product, one policy'? ">
