How Clinically Validated Innovative Medical Devices Achieve Market Breakthrough: Insights from Four Key Segments

How to Evaluate the Value of a Medical Device?

In my opinion, a medical device must not only demonstrate excellent clinical efficacy but also achieve widespread clinical adoption. This is because only through large-scale application can medical devices benefit a broader patient population. Therefore, the value of a medical device derives from both its intrinsic clinical value and its commercial viability.

Nowadays, many innovative medical devices have been approved in China, gaining clinical recognition and industry favor. As announced by the National Medical Products Administration on June 15, 2022, more than 383 products have entered the green channel for innovative medical devices, and 155 products with strong innovation, high technological content, and significant clinical value have been launched on the market.

However, as an observer of the healthcare industry, VCBeat has noted that the penetration rate of certain innovative medical devices with significant clinical value remains relatively low, given China’s vast geography and large patient population.

The efficacy of these innovative products has gained recognition from both the clinical community and the industry, yet why does their market penetration remain low? What factors are influencing the pace of their market adoption? How have those blockbuster products achieved their remarkable sales success?

To explore how innovative medical devices can achieve both critical acclaim and commercial success, VCBeat interviewed the heads of multiple innovative medical device companies as well as founders of mid-to-high-end medical clinics.

In the medical device industry, there is an abundance of outstanding products. In this article, we have selected only four types of medical devices: wearable ECG monitoring devices primarily for out-of-hospital use, rehabilitation robots applied in rehabilitation centers, elderly care facilities, and healthcare institutions, medical AI as a new billable item in healthcare institutions, and the flagship product, capsule endoscopy.

Wearable ECG monitoring devices are becoming increasingly compact and convenient, with higher precision and intelligence. Taking single-lead wearable ECG monitoring devices as an example, they are mainly used to monitor users' heart rhythms for screening and diagnosing arrhythmias, assessing cardiac health (preventing sudden cardiac death), assisting in the long-term management of heart diseases, and monitoring post-operative and rehabilitation treatments for patients with arrhythmias.

Public data show that there are approximately 330 million patients with cardiovascular diseases in China, including about 20 million patients with arrhythmia. Sudden cardiac death caused by factors such as malignant arrhythmias affects more than 540,000 people annually.

For arrhythmias, wearable ECG monitoring devices enable 24/7 continuous monitoring of users' heart rhythms, facilitating the screening of paroxysmal and elusive arrhythmias, asymptomatic atrial fibrillation, and other conditions, while prompting patients to seek timely medical attention and enabling physicians to intervene promptly.

Regarding sudden cardiac death, studies have shown that 72% of patients experience significant discomfort before cardiac arrest occurs, with 70% of these patients having warning symptoms lasting more than 15 minutes. Wearable ECG monitoring devices can promptly detect cardiac abnormalities and quickly contact emergency services (120) and the patient's family members to initiate first aid immediately.

Overall, wearable ECG monitoring devices can better prevent acute cardiovascular events and control cardiovascular diseases.

Unlike wearable ECG monitoring products, which primarily target the out-of-hospital market, medical AI systems are mainly directed at the in-hospital market, with most medical AI projects representing new service offerings (and new billable items) for hospitals.

Regarding the value of medical AI systems, Qin Lan, Chairman of Union Strong, believes that their primary benefits lie in addressing diseases or clinical pain points, significantly improving physicians’ efficiency and diagnostic and treatment precision, reducing risks, complications, and sequelae associated with diagnosis and treatment, enhancing the capabilities of junior physicians, increasing the supply of medical resources, and elevating the quality of care at primary healthcare institutions.

For example, Union Strong has launched a medical AI product: Intracranial Aneurysm Surgical Planning Software, which assists physicians in analyzing the three-dimensional morphology of intracranial aneurysms and performing automated surgical planning. With this product, clinicians can not only visualize 3D cerebrovascular images but also conduct automated measurement and analysis of the aneurysm’s 3D morphology, and shape microcatheters based on the optimal solutions provided by the software. Furthermore, the software can recommend shaping needle protocols according to the recoil characteristics of microcatheters from different manufacturers.

Data indicates that the primary challenges in neurointerventional procedures for treating intracranial aneurysms lie in microcatheter shaping and the selection of consumable device specifications. For patients, surgical planning software for intracranial aneurysm procedures addresses these two major challenges, resulting in more precise and effective surgical treatment, fewer complications and sequelae, and shorter operative and hospitalization times.

For physicians, this product simplifies neurointerventional procedures, significantly reducing the learning curve and operational barriers. With software assistance, junior physicians and those in primary care hospitals can also perform neurointerventional procedures effectively. From a societal perspective, the widespread adoption of this product will increase the penetration rate of neurointerventional surgeries and the cure rate for stroke in China, thereby supporting national stroke prevention and control efforts.

Qin Lan stated, “Previously, some medical AI products were targeted at physicians, primarily addressing their pain points, such as improving image interpretation efficiency, which resulted in a limited sense of benefit for patients. Now, an increasing number of medical AI companies are shifting toward a ‘patient- and disease-centric’ approach in product research, development, and design, focusing mainly on resolving pain points in the diagnosis and treatment process.”

While medical AI is addressing pain points in the diagnosis and treatment process, it is also expanding into areas such as postoperative follow-up, chronic disease management, and rehabilitation. In the field of rehabilitation, emerging products such as rehabilitation robots are appearing alongside medical AI.

A clinical study has shown that rehabilitation therapy enables 90% of stroke patients to regain the ability to walk and perform activities of daily living, and allows 30% of patients to return to light-duty work; whereas without rehabilitation therapy, only 6% regain the ability to walk and perform activities of daily living, and merely 5% return to light-duty work.

“China Stroke Report 2019 (English Edition)” shows that there are approximately 13 million stroke patients in China, among whom 75% have varying degrees of disability and urgently need rehabilitation treatment.

In addition to individuals with disabilities, patients with disease-related impairments, postoperative patients, those with chronic diseases, and postpartum women also require rehabilitation therapy. However, China faces a shortage of rehabilitation medical resources, with rehabilitation therapists having relatively low average educational qualifications and varying levels of professional competence, while traditional rehabilitation equipment lacks quantitative evaluation metrics.

The emergence of rehabilitation robots, such as exoskeleton rehabilitation robots and intelligent muscle exosuits, has resolved or alleviated the aforementioned issues. Ding Ye, CEO of YuanYe Technology, stated, “The intelligent muscle exosuit launched by our company provides real-time, precise muscular assistance, enabling users to perform physical movements more stably, effortlessly, and accurately. During training, patients gradually enhance their muscle control and strength, thereby improving rehabilitation outcomes and shortening recovery time.”

Compared with traditional rehabilitation therapy, intelligent muscle exoskeletons can better perform simple and repetitive rehabilitation tasks, ensuring the intensity and precision of rehabilitation training, and allowing therapists to focus solely on developing rehabilitation treatment plans and improving outcomes.

Meanwhile, with rehabilitation robots such as intelligent exoskeletons, a single therapist can serve multiple patients, which not only improves rehabilitation efficiency but also effectively enhances the utilization of rehabilitation medical resources.

Furthermore, rehabilitation robots such as intelligent muscle exoskeletons are equipped with sensors, digitalization, and information technologies that enable the monitoring and recording of patients' physiological and kinematic data during rehabilitation training.

It is worth noting that, unlike earlier rehabilitation robots that relied on traction to guide patients through movements, modern rehabilitation robots place greater emphasis on the patient’s active intent to train, rather than passively completing rehabilitation exercises through methods such as “traction.”

Similar to the rehabilitation market, early screening and diagnosis of gastrointestinal diseases also represent a blue ocean market.

Data released by the National Cancer Center indicates that in 2020, there were 480,000 new cases of gastric cancer and 370,000 deaths from gastric cancer in China.

For gastric cancer, a clinical consensus has been established that early detection, diagnosis, and treatment are effective measures to reduce mortality. A clinical study demonstrated that the 5-year survival rate for early-stage gastric cancer after treatment exceeds 90%, whereas the 5-year survival rate for advanced-stage gastric cancer remains below 30%.

Dr. Feng, founder of Beijing Fupeng Clinic, stated: “Capsule endoscopy is an innovative medical device shaped like a ‘capsule’ that patients can swallow to screen for and diagnose gastrointestinal diseases such as gastric cancer. Unlike traditional electronic gastroscopy, capsule endoscopy requires no anesthesia, is simple to operate, carries no risk of cross-infection or serious complications, offers high comfort and patient acceptance, and delivers high accuracy, thus holding significant value in the screening of gastrointestinal diseases.”

A multicenter clinical study demonstrated that the consistency of gastric examinations performed by Jinshan Science & Technology’s fully automated capsule robot RC100 with conventional gastroscopy exceeded 97%.

Guided by the clinical consensus on early detection, diagnosis, and treatment, we observe that capsule endoscopy-based screening for early-stage gastric cancer holds the promise of significantly reducing gastric cancer mortality in China.

In addition, capsule endoscopy has evolved to incorporate AI-assisted diagnostic systems, helping physicians improve diagnostic efficiency and accuracy while saving time. Its applications are expanding from screening to diagnosis: one study showed that capsule endoscopy has high sensitivity in identifying upper gastrointestinal bleeding in emergency settings and is well tolerated.

As can be seen, innovative medical devices such as wearable ECG monitoring devices, medical AI systems, rehabilitation robots, and capsule endoscopes all possess significant clinical and social value. However, these niche sectors are still in the early stages of development, with product market penetration remaining at a relatively low level.

Zhong Jing of Pulse Geek Medical believes that for wearable ECG monitoring devices primarily targeting consumers, the low penetration rate is partly due to insufficient societal and public awareness of the importance of electrocardiogram (ECG) examinations, necessitating ongoing consumer education; additionally, the professional barrier associated with ECG interpretation means that many patients and institutions in need may still be unfamiliar with devices equipped with intelligent analysis and remote diagnostic capabilities.

Unlike wearable ECG monitoring devices, the purchasers of medical AI systems are primarily healthcare institutions, and such systems represent a newly emerged, additional service offering for hospitals. Qin Lan from Union Strong attributes the low penetration rate of these products to the short development history of this niche sector and the unique characteristics of the healthcare industry.

In terms of industry development timeline, China’s first Class III medical AI product was approved in 2020, and it has been less than two years to date. The healthcare industry has its unique characteristics; compared with other industriesLengthy Review Process, for instance, bringing a product to market requires preliminary animal studies, clinical trials, and regulatory approval; the clinical application of innovative technological products necessitates validation of clinical efficacy, price approval for newly added medical service items by the National Healthcare Security Administration, and tendering and procurement processes at provincial, municipal, and hospital levels, among other requirements.

In the hospital procurement process, medical companies need to educate doctors as well as leaders responsible for procurement, budgeting, and decision-making, which involves an extremely lengthy process. Additionally, if a product is to be applied to patients, patient education is also required to ensure they understand and accept the product, and are willing to pay out-of-pocket in cases where the product is not covered by medical insurance.

However, China's medical AI industry is growing at an extremely rapid pace. For instance, since the approval of the first Class III medical AI product, Airdoc Technology saw its 2021 revenue increase by 142% year-on-year; Infervision reported a 357% year-on-year revenue growth in the first quarter of 2021; and Shukun Technology’s revenue in the first half of 2021 surged nearly sevenfold compared to the same period.

Public hospitals are the primary purchasers of medical AI products, and their criteria for product adoption and approval cycles may be more stringent than those of rehabilitation institutions. However, selling products to rehabilitation institutions is also no easy task.

Ding Ye from YuanYe Technology believes that China’s rehabilitation medical resources are unevenly distributed, patients’ awareness of rehabilitation has previously been low, payment capacity is limited, and the rate of rehabilitation consultations is relatively low. This has resulted in tight budgets for rehabilitation institutions and caution in purchasing new products. Meanwhile, rehabilitation robots currently available on the market are relatively expensive, encountering some resistance to large-scale adoption.

Furthermore, the low penetration rate of rehabilitation robots is also attributable to the fact that domestic companies have previously conducted few large-scale clinical trials to validate the clinical value of their products, and have rarely published academic papers demonstrating the value of rehabilitation robots.

In contrast, capsule endoscopy has made substantial efforts in academic promotion, with many doctors in China aware of and recognizing its value. However, its penetration rate remains low. Dr. Feng, founder of Beijing Fupeng Clinic, attributes this to cost and awareness issues.

In terms of cost, capsule endoscopy is expensive, with a single examination ranging from 3,000 to 8,000 yuan. As it is not covered by medical insurance, patients must bear the full out-of-pocket expense. Regarding awareness, many people are unfamiliar with capsule endoscopy and only know about traditional gastrointestinal endoscopy. However, after clinicians at clinics introduced capsule endoscopy products, many patients opted for capsule endoscopy screening.

In summary, public health awareness, product awareness and understanding, ease of product use, hospital procurement review processes, physician education, patient education, education for leadership (those responsible for procurement, budgeting, and decision-making), inclusion in medical insurance coverage, and validation of clinical value are all factors influencing the pace of market promotion.。

As previously mentioned, wearable ECG monitoring devices, medical AI, rehabilitation robots, and capsule endoscopes are all products with significant clinical value but low market penetration. So, how can these innovative medical devices achieve both critical acclaim and commercial success?

Regarding wearable ECG monitoring devices, Zhong Jing from Pulse Geek Medical believes that relevant companies can draw experience from the sales and promotion of similar products such as blood pressure monitors. A report released by the New Thinking Industry Research Center shows that from 2011 to 2020, the compound annual growth rate (CAGR) of China's home blood pressure monitor market was 25.8%, with the market size reaching RMB 14.2 billion in 2020.

First, the reason why sales of devices such as blood pressure monitors have exceeded ten billion units is that users can assess their physical condition based on the displayed data. Therefore, companies specializing in home ECG monitoring should develop AI-powered image interpretation systems to enable users to understand their health status through the generated reports.

Secondly, the blood pressure monitor market has grown into a multi-billion-dollar industry only after long-term public science education. Therefore, ECG monitoring companies should join forces to strengthen public education for users and increase marketing efforts targeted at patients, so that more people understand the necessity and value of ECG monitoring, thereby promoting their products.

Finally, Zhong Jing from Pulse Geek Medical Technology (Beijing) Co., Ltd. believes that relevant enterprises can further expand their channels. For instance, Pulse Geek has deployed its wearable ECG monitoring devices in nearly 1,000 primary healthcare institutions, enabling them to provide ECG monitoring services. Statistical data show that among individuals screened at the primary care level for cardiac discomfort symptoms, 72.7% required medication for prevention and control, while 23.5% were diagnosed with relatively severe arrhythmias, necessitating prompt follow-up examinations, treatment, or even surgical intervention.

This channel-expansion strategy not only facilitates the promotion of wearable ECG monitoring products but also enables the decentralization of high-quality medical resources to more remote and underserved areas.

Unlike wearable ECG monitoring products targeted at end consumers or even primary healthcare institutions, medical AI systems must first gain entry into tertiary hospitals. As a new billable item in hospitals, Qin Lan from Union Strong believes that, given the unchangeable process for medical device adoption in hospitals, companies should conduct large-scale clinical trials to validate product value and strive to have their medical AI systems included in relevant expert consensus statements and clinical practice guidelines.

Meanwhile, as medical AI systems are incorporated into consensus statements and clinical guidelines, companies should strengthen physician education and intensify academic promotion to enhance awareness among clinicians of the value and role of medical AI. Additionally, companies should strive to obtain pricing approvals from provincial and municipal authorities as quickly as possible to facilitate rapid hospital adoption. For teams initially dominated by technical personnel, companies must also bolster their marketing teams to address existing weaknesses.

Like medical AI systems, rehabilitation robots also require validation of their clinical value. Ding Ye of Yuanye Technology stated that in the rehabilitation robotics industry, companies shouldEstablish model hospitals to serve as demonstrations, andEducate the market to help hospitals, physicians, and patients recognize the value of the product; conduct extensive academic promotion to increase awareness among more physicians and hospitals regarding the existence and value of rehabilitation robots; publish numerous scholarly articles to demonstrate the clinical efficacy of the product. These are precisely the initiatives currently being undertaken by Yuanye Technology.

In the promotion of rehabilitation robots, YuanYe Tech has set some industry benchmarks, while in the promotion of capsule endoscopy, Beijing Fupeng Clinic has provided a case study for the industry.

For example, Beijing Fupeng Clinic is a mid-to-high-end general practice clinic that integrates disease prevention, treatment, and rehabilitation. Building upon basic disease diagnosis and treatment, it incorporates functional medicine testing and interventions to varying degrees, thereby enhancing its medical services for “chronic disease health management.”

Dr. Feng, founder of Beijing Fupeng Clinic, stated, “As a mid-to-high-end general practice clinic, our customer base aligns closely with users of capsule endoscopy. Therefore, we use capsule endoscopy as a patient acquisition channel to attract more clients. Subsequently, we generate revenue by providing medical services to patients diagnosed with gastrointestinal disorders through screening. Unlike health checkup institutions, our value proposition lies in medical care rather than the examination itself. We believe that this model will gain broader recognition amid the growing trend of paying for medical services.”

Overall, the market promotion of innovative medical devices requires three key strategies: first, expanding market channels and strengthening the capabilities of the marketing team; second, validating the clinical value of the product to convince physicians and patients of its benefits and efficacy; and third, conducting extensive promotional campaigns to raise awareness, foster understanding, and ultimately drive product adoption among the target audience.