Medical Device Research and Development, Production, and Sales


Source: Medical Device Distributors Alliance
Editor: Jin Fan
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Since 2021, when joint-related consumables were first included in the centralized procurement scope, orthopedic consumables categories such as trauma, spine, and sports medicine have successively come under pressure, with prices "halving" and profits squeezed, already becoming a true reflection of the entire orthopedic consumables market.
According to statistics, as of July this year, the centralized procurement has covered a total of 2,779 products in orthopedic consumables, accounting for 72%. Such a large-scale centralized procurement seems to have completely squeezed out the "excess" in the orthopedic consumables market.
As the saying goes, "When the nest is overturned, how can the eggs remain unbroken?"Faced with the severe situation of a sharp decline in the billion-dollar market size, how should millions of medical device companies and agents find a way to break the deadlock?Recently, Just Medical has brought a ray of hope to the industry.
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01
Farewell to Bone Cement
China-Made Innovative Knee Implant Approved!
Recently, according to the official website of the National Medical Products Administration, it has been officially approved.Just Medical (Tianjin) Co., Ltd. (hereinafter referred to as "Just Medical")Self-developedBiological Knee Joint Prosthesis SystemInnovative Product Registration Application, Successfully Launched.

It is reported that the product is composed of a femoral condyle, tibial plateau, tibial insert, positioning post, and compression rod. AsNon-cemented prosthesis for primary total knee arthroplasty, is one of the few orthopedic implant products in China that has been approved through the special review channel for innovative medical devices.
At present, the knee prostheses used clinically are mostly cemented fixed prostheses, namely bone cement, which can fix the knee prosthesis on the bone interface, butThere are always certain clinical drawbacks,Such asThe monomer of bone cement has a certain toxicity, and there are issues such as osteolysis at the contact surface between the bone cement and bone. Over time, bone cement may deform and deteriorate, leading to a reduction in its ability to withstand stress.
As a leading enterprise deeply engaged in the field of orthopedic artificial joints, Just Medical has been initiating research and development projects for biological knee joint prostheses since 2018.System, this innovative product not only eliminates the use of bone cement during surgery but also incorporates a 3D-printed zonal trabecular structure and self-compressing mechanical design.Successfully攻克了骨假体植入“即刻稳定性不足”“骨长入效率低”等临床难题,Provides a new and more advantageous treatment option for global patients undergoing total knee replacement.
EBM 3D Printing Zonal Trabecular Technology Enhances Bone Integration Efficiency
The product is manufactured as a single piece through 3D printing, enabling the precise fabrication of zonal trabecular porous structures and self-compressing mechanical stability structures.Significantly enhance bone integration and initial stability, effectively reducing the risk of prosthesis loosening.; At the same time, the trabecular structure in different zones can ensure the uniform distribution of stress at the prosthesis-bone interface, and is able toRapid Induction of Bone Ingrowth, ensuring the long-term stability after prosthesis implantation.
Self-compression Mechanical Stabilization Technology: Immediate Fixation and Long-term Stability, Dual Assurance
Self-innovated self-pressurized mechanical stabilization structure, through the axial compression effect of the penetrating claws, canIncrease the Initial Stability After Prosthesis Implantation, and effectively reduce the risk of postoperative prosthesis loosening.
Cementless Implant, Enhanced Safety and Postoperative Recovery
Compared with traditional cemented prostheses, biological knee prostheses have no risk of cement toxicity or allergic reactions and canEffectively reduce the incidence of venous thrombosis and aseptic loosening, while avoiding soft tissue thermal damage, providing patients with a more stable and reliable postoperative recovery guarantee.
In order to fully verify the clinical effectiveness of this biotype knee prosthesis system, its pre-market clinical trial was conducted byWest China Hospital of Sichuan University, Peking University Third Hospital, Qilu Hospital of Shandong University, Third Hospital of Hebei Medical University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine in Hebei, etc.Conducted jointly by multiple authoritative hospitals and clinical research centers, with a total of 124 valid cases included, providing solid and reliable data support for the evaluation of product effectiveness.
The test results showed that the excellent and good rate of HSS score after the surgery was as high as 95.3%.The excellent rate of prosthesis implantation reached 100% at 7 days post-operation; the follow-up after 5 years showed that the in-situ rate of the prosthesis was 100%.Imaging examinations all indicated good prosthesis alignment, no loosening, no osteolysis occurred, and long-term stability was significant.
It is worth mentioning that the biological knee joint prosthesis system has successfully applied for multiple global technology patents, fully demonstrating its technical leadership and uniqueness on an international scale. Moreover, due to its outstanding innovative value, the product has been awarded the Second Prize of Tianjin Science and Technology Progress Award and has been included in the R&D plan of Tianjin's major science and technology projects.
*The above product-related information is sourced from the company's official WeChat account.
Its successful listing not only signifies a major breakthrough in China's high-end joint prosthesis implant consumables field,More so, it provides medical device distributors with highly competitive and innovative product options against the backdrop of normalized centralized procurement of orthopedic consumables.`, is expected to bring new development opportunities and vitality to the orthopedic consumables market in China.`
02
Unearth Annual Revenue Exceeds 50 Billion Yuan in Blue Ocean
Revolutionizing Knee Implants, a Promising Future Ahead!
Total Knee Arthroplasty (TKA)Mainly through the complete replacement of the knee joint with artificial implants, which can relieve knee pain and restore knee function, it is suitable for patients suffering fromPatients with osteoarthritis, rheumatoid arthritis, or traumatic knee injuriesThePreferred treatment method.
Take osteoarthritis as an example. It is a degenerative disease closely related to age, and the elderly population aged 65 and above are the high-risk group for this condition. Relevant surveys show,In people over 60 years old, more than 80% show radiographic signs of osteoarthritis in the knee., 50% are troubled by pain.
At present, China is in a phase of accelerating aging. According to data from the National Bureau of Statistics, by the end of 2024, the population aged 60 years and above in China has reached 310.31 million, accounting for 22.0% of the total population. Moreover, the average life expectancy in China has reached 79.0 years, which means the population at higher age groups will continue to increase.The scale of high-risk populations for osteoarthritis-related diseases will also continue to expand, fostering a large potential patient pool for total knee arthroplasty., with unlimited market potential.
In response to such a large patient demand, the number of total knee replacement surgeries in China has shown an explosive growth trend in recent years.
According to statistics, the total number of total knee arthroplasties (excluding unicompartmental knee arthroplasties) in China exceeded 480,000 cases in 2020 alone, and during the 10-year period from 2011 to 2020,The surgical volume has achieved an astonishing 9-fold increase., fully demonstrating the strong development momentum in this field.
With a global perspective, the total knee arthroplasty market is also thriving, with extremely broad development prospects.
A research report shows that in 2023, the global knee replacement market revenue reached $10.9 billion, with the total knee arthroplasty (TKA) segment dominating the market, accounting for 73% of the total revenue share.Nearly $8 billion (equivalent to 57.5 billion RMB), the medical field is truly the "golden track".
In the field of total knee arthroplasty, non-cemented TKA technology is gradually gaining widespread recognition from clinicians and patients due to its advantages in promoting bone ingrowth and enhancing long-term stability.
According to the latest data from the American Joint Replacement Registry (AJRR) in 2023,The clinical application of this technology in the United States has exceeded 20% and is showing a continuous upward trend, rapidly becoming an important technological development direction in the field of knee replacement., Leading the industry transformation.
At present, the Just Medical biological knee joint prosthesis system, as a high-quality representative of non-cemented total knee arthroplasty prostheses in China, not only deeply aligns with the technical trends in clinical TKA treatment development, but also, combined with the enormous patient demand brought by China's aging society, leverages its advanced technology and excellent clinical outcomes to...It is expected to quickly become popular in the Chinese market, and its development prospects are promising.
03
Post-centralized Procurement Era
Innovative Products Become a New Growth Pole for Orthopedics?
The approval of Just Medical's new non-cemented total knee joint prosthesis will not only lead the technological innovation in China's bone and joint market, but also allows us to realize that, in today’s era of comprehensive expansion of centralized procurement of orthopedic consumables,Innovative medical products may become an important path for a large number of medical device companies and dealer partners to break through.
From a policy perspective, in recent years, the state has continuously increased its support for innovative medical devices, with relevant policies being introduced in quick succession.
In several medical consumables procurement projects this year, it was clearly pointed out that ""Innovative medical devices recognized by provincial-level or higher drug regulatory authorities are not included in the volume-based procurement scope."。
Moreover, at the recent press conference series on "High-Quality Completion of the '14th Five-Year Plan'" held by the State Council Information Office, it was clearly stated that the new round of centralized procurement will guide high-quality products to stand out through "clinical choice," abandon the tendency of awarding contracts based solely on the lowest price, and simultaneously promote the early inclusion of innovative technologies into the medical insurance payment system.
This series of measures shows that after many rounds of "soul-cutting bargaining,"The centralized procurement policy is shifting from "price-only" to "value-oriented"., which undoubtedly means that innovative products with "technological advantages" will have broader profit margins and development opportunities.
For medical device distributors, thisIt is not only an excellent opportunity to摆脱 "price war"困境, but also a strategic turning point for转型 to high value-added products.
And the market is also fully validating the importance of innovative products to the survival of enterprises.
In the financial reports released by major companies in the first quarter of this year, we can see that the leading Chinese orthopedic companies represented by WEGO Orthopaedic, Chunli Medical, Double Medical, and Sanyou Medical,Have gradually emerged from the "down cycle" caused by centralized procurement, with significant recovery in net profit growth rates., which behind the scenes is undoubtedly inseparable from the company's relentless pursuit of technological innovation.
Taking WEGO Orthopaedics as an example, in 2023, the companyStartIntelligent orthopedic therapy research, with a future focus on emerging fields such as artificial intelligence and surgical robots., ThroughThrough full product line layout, efficient response in the era of centralized procurement, and continuous technological innovation, Just Medical is actively building a globally competitive orthopedic brand. In January this year, the company's net profit increased by 48.37% year-on-year.
Centralized procurement is not the end of a company's survival, but a new starting point for industry upgrading and moving towards high-quality development. When traditional products are mired in a "price red ocean," struggling painfully in fierce price competition,Innovative products are opening up a "value blue ocean" with their unique technical advantages and value appeal.
For medical device distributors, the orthopedic market has always been a crucial segment in the medical device field. Actively investing in innovative orthopedic medical products such as biologic prosthetics, 3D-printed implants, and intelligent surgical robots is undoubtedly a wise move to seize the initiative and secure a leading position in the next wave of growth in the orthopedic market.


Note:The above content is for reference only and does not constitute investment advice.The interpretation of official policies in this article only represents the views of this platform, and the content is subject to official documents. If any platform reprints this article, it must take responsibility for the content itself. The Medical Device Dealers Alliance is not responsible for the impact of secondary dissemination caused by reprints. Please contact the editor via the backend for reprinting.。
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