From Sci-Fi to Reality: How Close Are Vascular Interventional Surgical Robots to Widespread Adoption?

Today, China-produced vascular interventional surgical robots have entered the top tier globally, becoming one of the few industries in China that lead worldwide.

As of now, the vascular interventional surgical robots from global device giants have gradually moved towards clinical use. For instance, Siemens' CorPath GRX vascular interventional surgical robot has entered the NMPA Innovative Medical Device Special Approval Channel; Robocath's R-One vascular interventional surgical robot has also entered China and has begun clinical trials.

In China, domestically produced vascular interventional surgical robots have also advanced to the stages of animal experiments and clinical trials in recent years. For instance, vascular interventional surgical robots developed by companies such as WeMed and Aopeng Medical have entered registered clinical trials; those from Shenzhen Aibo Medical Robot Co., Ltd., RaysightMed, Suzhou Rainmed Medical Technology Co., Ltd., Shenzhen Lancet Robot Co., Ltd., and MicroMedical have completed animal experiments.

How Far Are We from the Large-Scale Application of Vascular Interventional Surgery Robots in Clinical Trials?

An innovative medical device, from its inception to maturity, requires the joint efforts of engineers, scientists, doctors, patients, and others. Only through step-by-step optimization and iteration, addressing clinical pain points, will an initially innovative medical device gradually evolve into a mature and user-friendly medical device.

For vascular interventional surgical robots, the same holds true. Currently, some vascular interventional surgical robots face issues such as needing improvement in smoothness, not covering all procedural movements, and being limited to specific indications. However, Chinese manufacturers of vascular interventional surgical robots have not lost their courage to explore due to potential risks, nor have they given up in the face of numerous challenges. Instead, they have risen to the occasion, investing more funds, deepening exchanges with clinical experts, gradually addressing the pain points of robot use in clinical operations, and steadily enhancing the performance and functionality of vascular interventional surgical robots.

We also believe that, with the efforts of related companies, China-produced vascular interventional surgical robots will gradually move towards clinical application.

To get back to the point, multiple respondents indicated that there are three steps before vascular interventional surgical robots become accessible to ordinary patients: clinical trials and product registration, product adoption by hospitals, and large-scale application. Once these three steps are achieved, vascular interventional surgical robots will be utilized in the treatment surgeries of the vast majority of patients.

We know that every step forward in medical devices comes with significant risks. So, what difficulties will the "three-step" development of vascular interventional surgical robots face? Are companies prepared for these challenges?

Medical devices must obtain registration approval before they can be marketed for sale. Moreover, the vast majority of medical devices must undergo clinical trials in order to gain this registration approval.

It is reported that the main difficulties in clinical trials of medical devices lie in product reliability, design of clinical trial protocols, and screening of subjects.

In terms of product reliabilityIf the vascular interventional surgical robot used in clinical trials is not stable enough, it may lead to surgical failure, ultimately causing the entire clinical trial to fail.

In response to this, the vascular interventional surgery robot developed by Shenzhen Aibo Medical Robot Co., Ltd. has been optimized and iterated to the third generation; the digital and intelligent vascular interventional surgery robot developed by RaysightMed has undergone three generations of optimization iterations based on clinical needs and completed more than ten animal experiments… It can be seen that companies related to vascular interventional surgery robots have fully verified the reliability of their products before clinical trials to ensure the smooth progress of clinical trials.

WeMed founder Yang He stated: "In the field of medical devices, any company that dares to conduct clinical trials must have made thorough preparations in terms of preliminary safety analysis, safety experiments, and finalization."

In terms of clinical trial protocolsThe design of clinical trial protocols for medical devices is relatively simpler compared to those for pharmaceuticals, with a shorter observation period and stronger controllability. Therefore, as long as the Principal Investigator (PI) has a deep understanding of the protocol during the clinical trial, selects patients who meet the protocol requirements, and completes the surgery according to the required procedures, the clinical trial can generally be completed successfully.

It should be noted that the clinical trials of vascular interventional surgical robots are very different from those of traditional devices, and also differ significantly from drug clinical trials. For example, in the clinical trials of vascular interventional surgical robots, CRCs are required to follow the procedures and record data parameters during the surgery. This requires CRCs to be highly familiar with the workflow and protocols of clinical trials, which is not something that general CRO companies can achieve.

It is worth mentioning that companies such as RaysightMed and WeMed have rich experience in clinical trials, and each company has multiple products approved for marketing previously. This experience in clinical trials and clinical resources provides significant support for vascular interventional surgical robots.

At the same time, well-known medical institutions such as 301 Hospital and Anzhen Hospital, as units conducting clinical trials, also have clinical experts with rich experience in clinical trials.

With rich experience from enterprises, hospitals, and PIs, combined with the product's reliability, it is believed that the clinical trials of the vascular interventional surgical robot will be successfully completed.

In the screening of subjectsRaysightMed stated, "The environment in China is different from that abroad. For instance, people in the United States tend to be more proactive in their mindset, while domestic participants lean towards being conservative. To convince patients in China who meet the clinical trial criteria to participate, we will engage in deeper communication with them. We will explain the process and advantages of robotic-assisted vascular interventional surgery, such as the ability to place stents more accurately and achieve better postoperative outcomes."

When clinical trials are successfully completed, the vascular interventional surgical robots of various companies will be one step closer to registration and approval. It is believed that positive clinical trial data will facilitate the smooth approval of vascular interventional surgical robots.

The medical device registration certificate is the ticket for product sales, and the next challenge is how to get the product into hospitals. The entry of medical devices into hospitals involves various factors such as the hospital's budget, the needs of department doctors, the recognition of clinical experts, and the benefits to patients.

Currently, as an innovative medical device, there are no approved vascular interventional surgical robot products in the Chinese market. This also means that Chinese-produced vascular interventional surgical robot companies cannot replace imported products with the cost-performance advantage of their products like Chinese heart stent companies did. Instead, they can only choose to independently educate the market and cultivate doctors' habits to open up the vascular interventional surgical robot market.

In the face of this entirely new situation, domestically produced vascular interventional surgical robot companies need to intensify market education before their products enter hospitals. Only when hospitals, doctors, and patients understand and recognize the value and advantages of vascular interventional surgical robots will there be a greater chance for these robots to be adopted by hospitals. Otherwise, vascular interventional surgical robots may forever remain confined to PowerPoint presentations or warehouses.

RaysightMed believes: "The key to the adoption of vascular interventional surgical robots in hospitals lies in the product. When vascular interventional surgical robots deliver value to hospitals, patients, and doctors through reliable quality, and when doctors recognize the clinical effectiveness of the product and patients experience higher clinical benefits, vascular interventional surgical robots with unique functions and advantages will have a greater chance of being successfully adopted by hospitals. The RaysightMed team has gone through the certification, hospital access, and usage cycle of the entirely new product CTFFR, and such capabilities and experience are crucial for advancing the progress of surgical robots."

Shenzhen Aibo Medical Robot Co., Ltd. stated: "The users of vascular interventional surgical robots are highly professional doctors. If they can genuinely meet the needs of doctors, ensure patient safety, and improve the service quality of hospitals, then they can quickly enter hospitals with excellent user experience, good reputation, solid technical accumulation, safe and reliable product performance, and extensive sales channels."

Some industry experts also suggested that, in order to better educate the market, companies should strengthen clinical training for vascular interventional surgical robots. In terms of operation, relevant enterprises can build their own training centers, and at the same time, collaborate with well-known tertiary hospitals to establish training centers, allowing the training centers to reach more doctors. This way, an increasing number of doctors can learn to use vascular interventional surgical robots and gradually understand and recognize the value and clinical advantages of the robots during the learning process.

It can be seen that the construction of the training center will not only cultivate the habit of a large number of doctors using a certain brand of vascular interventional surgical robot, but also create another different way of surgical operation for doctors. At the same time, the training center will also enable more doctors to learn how to use vascular interventional surgical robots to carry out vascular interventional surgery, steadily increasing the penetration rate.

In addition, market promotion measures such as academic conferences, product exhibitions, and academic article publications have also been arranged by various companies.

However, currently, surgical robot products represented by the Da Vinci surgical robot are extremely expensive.。

WeMed founder Yang He believes: "The surgical robot market can be divided into several different development stages, such as the introduction phase, growth phase, maturity phase, and decline phase. In the introduction phase, there are fewer competitors in the surgical robot market, the price is expensive, and related companies need to invest heavily in market development and promotion. In the maturity phase, the number of surgical robot competitors increases. To enhance product competitiveness, companies will reduce product prices, and market development and education efforts will be jointly undertaken by multiple enterprises."

Products like the da Vinci surgical robot, when sold in China, are priced much higher than in the North American market. While this generates excessive profits, it is not conducive to market promotion.

Unlike laparoscopic surgical robots, the vascular interventional surgical robot industry, although still in its infancy, exhibits some characteristics of a mature industry. For instance, the vascular interventional surgical robot market is currently untapped, but multiple companies are at a similar stage of progress. It is expected that several companies will simultaneously engage in market education, reducing individual market education costs for each company. To enhance product competitiveness, companies will focus on improving product performance while setting more reasonable prices.

In terms of setting product prices, WeMed views vascular interventional surgical robots as a production tool and sets reasonable prices accordingly.

Yang He stated: "As with other industries, the automation and intelligence of production tools are inevitable trends. For example, new energy vehicles are advancing automated driving, while the vascular interventional surgical robot industry is helping doctors perform surgeries more efficiently. In the past, doctors relied on their own skills to complete surgeries. However, 'skills' have drawbacks such as being non-standardized, unable to be quantitatively analyzed, uncontrollable surgical quality, and high learning difficulty. As a production tool, vascular interventional surgical robots will help doctors shorten operation time, lower the threshold for surgical procedures, standardize operations, and ultimately greatly improve the efficiency of doctors' surgeries."

As a production tool, vascular interventional surgical robots can only maximize their value when they become widely adopted. Otherwise, they are merely a luminous pearl on the crown—beautiful but impractical. To promote the widespread adoption of vascular interventional surgical robots and effectively unleash productivity, WeMed decided at the outset of its research and development to set a reasonable price, ensuring that more doctors can afford to use this production tool.

Shenzhen Aibo Medical Robot Co., Ltd. also stated: "The core technologies of the company's vascular interventional surgical robot are all independently developed, and several technologies are at a globally leading level. After years of research accumulation, we have a clear understanding of the advantages and disadvantages of technical routes during the R&D process, while also possessing significant cost advantages. Additionally, the vascular interventional surgical robot adopts a natural interaction design concept, which allows it to inherit the doctor’s original operating skills, shortening the learning curve for doctors and offering distinct clinical advantages. When communicating with well-known PI in the industry, they highly recognize our vascular interventional surgical robot and are confident in the future application of our product in hospitals and the clinical value it will bring."

Driven by various factors such as market education, doctor training, academic promotion, standard guidelines, and reasonable pricing, the integration of vascular interventional surgical robots into hospitals will be a natural progression.

As the core medical institutions serving surrounding areas, tertiary hospitals have sufficient funding and are able to train doctors from grassroots hospitals in these regions. Perhaps precisely because of this characteristic, domestic vascular interventional surgical robotics companies all plan to first enter the market through tertiary hospitals, leveraging them to drive other markets.

However, unlike tertiary hospitals, most grassroots medical institutions do not have sufficient funds and may not be able to bear the financial pressure of purchasing vascular interventional surgical robots. If grassroots medical institutions do not purchase vascular interventional surgical robots, it will be difficult for the product to truly achieve large-scale application.

In response, some companies choose to develop market strategies that align with China's national conditions. For instance, RaysightMed, WeMed, and Shenzhen Aibo Medical Robot Co., Ltd. will leverage local cost advantages to set prices that most hospitals can accept, securing reasonable profits.

RaysightMed stated: "Apart from the selling price, we believe it is more important for companies in the industry to help the government clarify the health economic value brought by vascular interventional robots, assist hospitals and doctors in enhancing their diagnostic capabilities, treatment levels, and research abilities, and at the same time help patients improve clinical benefits and postoperative value. For example, with products such as Raysight Score, coronary artery intelligent post-processing systems, surgical planning systems, and surgical robots, vascular interventional surgeries will improve precision, reduce complications and sequelae, shorten hospital stays, and lower overall treatment costs."

"At the same time, the value of health economics, the improvement of hospital diagnosis and treatment levels, and the clinical benefits to patients are more important and long-term than the procurement costs of vascular interventional surgical robots. Equipment procurement is just a one-time transaction, but the health economics value and clinical benefits it brings will continue to be released as the number of surgeries increases."

Shenzhen Aibo Medical Robot Co., Ltd. also provided its own answer: "The company's modular product design concept can not only meet the requirements of doctors for multiple surgical procedures but also allow hospitals to make modular choices based on actual needs and budget. Modular products cater to the needs of hospitals at different levels, facilitating large-scale application."

In addition, WeMed has proposed different solutions: launching high-end application products for large medical institutions such as tertiary hospitals, and practical products for grassroots medical institutions.

WeMed stated: "The difference between the two lies in their functions. This is because, in grassroots hospitals, doctors mainly address common conditions; whereas in tertiary hospitals, doctors need to solve not only common conditions but also complex and difficult cases."

Regarding the financial difficulties faced by grassroots medical institutions, VCBeat believes: First, the national finance is continuously supporting the development of grassroots medical institutions. For instance, the "Outline of the 14th Five-Year Plan for National Economic and Social Development and the Long-Range Objectives Through 2035" proposes to "strive to have 500 additional county-level hospitals (including TCM) meet the facility conditions and service capabilities of tertiary hospitals." The National Health Commission has also released the "Thousand Counties Project" list, aiming to ensure that "through five years of effort, at least 1,000 county hospitals across China reach the medical service capability level of tertiary hospitals."

Second, high-quality enterprises can provide a portion of funds to grassroots hospitals through medical financial financing solutions.

Third, vascular interventional surgery robots are not equipment that every grassroots medical institution needs to purchase; they can benefit grassroots patients through resource sharing. For example, mobile vehicles can be equipped with vascular interventional surgery robots, allowing them to move around at the grassroots level. Meanwhile, vascular interventional surgery robots generally have a master-slave structure, and the mobile vehicle only needs to carry the slave end of the robot, enabling clinical experts to perform surgeries on distant patients.

It can be seen that each company has its own unique approach to the large-scale application of vascular interventional surgical robots.

From clinical trials to product approval, from product entry into hospitals to large-scale application, China-produced vascular interventional surgical robotics companies still have a long way to go, and they will undoubtedly encounter various difficulties and challenges along the way. However, in the process of overcoming these challenges, they will certainly gain valuable experience.

We believe that with the joint efforts of various enterprises, vascular interventional surgical robots will be getting closer to us.