Report Summary
Mobile medical devices refer to devices and/or software that use non-invasive mobile computing terminals to achieve one or more medical purposes. Among them, mobile computing terminals refer to mobile computing technology product terminals for personal use, including general-purpose (commercial ready-made) terminals and specialized (self-made medical) terminals. The forms of use can be divided into handheld (such as tablets, laptops, smartphones, etc.), wearable (such as smart glasses, smartwatches, etc.), and hybrid (combining handheld and wearable).
Driven by technology and terminal demand, the market size of the mobile medical device industry has steadily increased. According to sales statistics, the market size of China's mobile medical device industry increased from 21.39 billion yuan to 48.46 billion yuan from 2015 to 2019, with a compound annual growth rate of 22.7%. The market size of China's mobile medical device industry will continue to grow at a compound annual growth rate of 27.3% from 2019 to 2024, and it is expected that the market size will reach 162.2 billion yuan by 2024. The market size of China's mobile medical device industry continues to expand, mainly driven by three factors: gradual maturity of software technology, continuous upgrading of hardware products, and high terminal demand.
The joint progress of software technology and hardware products promotes the performance improvement of mobile medical devices
Software technologies such as cloud computing and network security are gradually maturing. Among them, cloud computing has advantages such as reducing information costs, reducing duplicate construction, improving resource utilization, increasing business flexibility, and enhancing service professionalism. Combining it with mobile medical devices can reduce digital costs and improve intelligence levels; Mobile medical devices usually have network connection function for Electronic data interchange or remote control, which has network security risk. The progress of cloud computing and network security technology is of great significance for improving the intelligence level and security of mobile medical devices. Important accessories such as displays and batteries are developing rapidly, and the deepening of applications such as flexible displays and lithium batteries is beneficial for improving the performance indicators of mobile medical device products.
The demand for both internal and external markets remains high, and the development space for mobile medical devices is vast
Mobile medical devices are small in size, mobile, contain medical device software, or are inherently independent software, thus having a wider range of applications and broader development space compared to traditional medical devices. On the one hand, mobile medical devices have a wider range of application departments and are more applicable in hospital settings. On the other hand, mobile medical devices are suitable for both grassroots healthcare and out of hospital healthcare, which are driven by national policies and are showing a positive development trend, driving the continuous expansion of the mobile medical device industry.
Outstanding advantages of mobile medical devices, promoting the deepening of medical big data applications
Mobile medical devices have three major advantages in data collection, management and application: standardized data collection, centralized data management, and data networking applications. Medical big data is the basis for realizing "Internet plus medical". Therefore, mobile medical device manufacturers can make profits by relying on a large number of high-quality data obtained in the use of products, and will also promote the deepening of medical big data applications.
Part 1: Market Overview of China's Mobile Medical Device Industry
1. Definition, Types, and Judgment Principles
There is no clear boundary between mobile medical devices and mobile health electronic products. Mobile computing devices or software that meet the definition of medical devices belong to mobile medical devices.
Definition: According to the Guiding Principles for Technical Review of Mobile Medical Device Registration issued by CFDA in December 2017, mobile medical devices refer to devices and/or software that use non-invasive mobile computing terminals to achieve one or more medical purposes. Among them, mobile computing terminals refer to mobile computing technology product terminals for personal use, including general-purpose (commercial ready-made) terminals and specialized (self-made medical) terminals. The forms of use can be divided into handheld (such as tablets, laptops, smartphones, etc.), wearable (such as smart glasses, smartwatches, etc.), and hybrid (combining handheld and wearable). Mobile medical devices that contain medical device software or are independent software themselves are not considered mobile medical devices. Mobile and wearable medical devices that do not include medical device software are not considered mobile medical devices.
Type: Mobile medical devices can be divided into three categories: mobile medical devices, mobile independent software, and mobile medical accessories.
Judgment principle: There is no clear boundary between mobile medical devices and mobile health electronic products. Mobile computing devices or software that meet the definition of medical devices belong to mobile medical devices.
(1) Mobile computing devices or software intended for health management, targeting healthy individuals, and recording and statistical health information do not have medical purposes and are not considered mobile medical devices;
(2) Mobile computing devices or software intended for disease management, targeting healthcare professionals and patients, controlling and driving medical devices, and processing, analyzing, and monitoring medical data/images have medical purposes and belong to the category of mobile medical devices.
2. Product technical requirements
Mobile medical devices not only need to meet the performance indicators equivalent to traditional medical devices, but also have strict technical requirements in terms of network security capabilities, display screen performance, environmental light anti-interference capabilities, battery performance, cloud computing service capabilities, and other aspects.
Mobile medical devices not only need to meet the technical level of conventional medical devices in terms of performance indicators, but also need to meet certain technical requirements in terms of network security capability, display screen performance, environmental light anti-interference ability, battery performance, cloud computing service ability, etc. before they can be applied in clinical settings.
Technical requirements for mobile medical devices
3. Representative Product Introduction
Mobile medical devices involve a wide range of fields and products, with different representative manufacturers of various products. There is currently no leading enterprise in the industry that covers all fields.
Mobile medical devices cover a wide range of products. At present, typical mobile medical device products in the market include: smart cloud blood pressure monitoring system, smart cloud blood glucose monitoring system, smart cloud electrocardiogram monitoring system, mobile DR, smart temperature monitoring, chronic disease management platform, and remote medical platform. All types of products have different main participating manufacturers, and there are currently no leading enterprises covering the entire field.
4. Analysis of representative product advantages
The patient mobile medical device has functions such as long-term continuous recording of data, access to complete historical data, and remote monitoring; Mobile medical devices on the doctor's end have broken the limitations of departments and medical institutions, making patients a medical service center.
Mobile medical device (patient side): Taking the smart cloud blood pressure monitoring system as an example, a wireless Bluetooth data transmission function has been added to the traditional blood pressure monitor, which can synchronously transmit monitoring data to the mobile phone and visually display blood pressure changes in the form of charts. For patients, the smart cloud blood pressure monitoring system can continuously record blood pressure data for a long time and provide timely warnings based on blood pressure changes, which helps with disease recovery and prevention; For doctors, the ability to access complete blood pressure data from patients in the past during diagnosis can effectively improve the disease diagnosis rate; For patients' families, remote monitoring of their blood pressure can be achieved, enabling remote care beyond space.
Mobile medical equipment (doctor side): Taking mobile DR as an example, it is smaller in size and movable compared to traditional DR. On the one hand, mobile DR breaks the limitations of departments and can be moved between multiple departments such as radiology, ICU, obstetrics and gynecology, orthopedics, and emergency department to meet the needs of patients; On the other hand, mobile DR breaks the limitations of medical institutions and can provide diagnostic services for patients in multiple different scenarios such as ambulances, wilderness, and homes. Mobile DR enables patients to truly become the center of medical services, and patients (especially critically ill patients) do not need to move back and forth to accommodate medical equipment. Mobile DR can switch usage locations according to patient needs, and is an important product for improving the quality of medical services.
The patient mobile independent software can achieve full coverage before, during, and after diagnosis, helping to improve the patient's medical experience; Mobile independent software on the doctor's end can assist doctors in improving their medical skills.
Mobile independent software (patient side): Chronic disease management refers to the organization of chronic disease professionals, pharmacists, and nursing staff, through the three links of pre diagnosis, diagnosis, and post diagnosis, to build an integrated chronic disease course intervention and management mechanism, providing comprehensive, continuous, and proactive management for chronic disease patients, in order to promote health, delay the process of chronic disease, reduce complications, reduce disability rates, and extend life A scientific management model that improves the quality of life and reduces medical expenses. The chronic disease management platform can achieve full coverage in the three stages of pre diagnosis, diagnosis, and post diagnosis, and improve patient compliance through continuous tracking, effectively improving the efficiency of chronic disease management.
Mobile independent software (doctor side): Taking remote medical platforms (doctor side) as an example, they are mostly in the form of software or apps. On the one hand, they provide a platform for doctors to communicate with patients and other doctors, which can remotely manage patients and assist patients in accelerating recovery. At the same time, they strengthen academic exchanges among excellent doctors and help doctors improve their professional level. On the other hand, remote medical platforms can become auxiliary medical tools, helping doctors achieve automated analysis, and providing doctors with cutting-edge and comprehensive knowledge bases and databases. Doctors can freely access them according to their diagnosis and treatment needs, thereby better serving patients.
5. Industrial chain analysis
The mobile medical device industry in China has not yet formed a mature industry chain, with main participants including medical device manufacturers, software manufacturers, and accessory manufacturers.
The industry chain of China's mobile medical device industry is divided into three links. The upstream participants in the industry chain are raw material suppliers, including hardware suppliers such as core components and accessories, and software suppliers; The participating entities in the middle reaches of the industrial chain are mobile medical device manufacturers, including device manufacturers and software manufacturers; The downstream of the industrial chain includes sales channels and application terminals.
6. Upstream analysis of the industrial chain
The high price and highest cost proportion of core components, as well as the low prices of accessories and software, are the key factors affecting the performance of mobile medical devices and achieving their "movable" attributes.
Except for mobile independent software, among the raw materials of other mobile medical devices, core components still account for the largest proportion of cost, such as the cost of core components such as mobile DR's X-ray tube and flat panel detector, which can reach 55% or more. The prices of other accessories are relatively low, with the overall cost accounting for about 30% -35%, but it has a significant impact on the final performance of mobile medical devices. The software price is also relatively low, accounting for less than 10% of the overall cost, but it is the key to achieving the "movable" attribute of medical devices.
Core components: The performance of core components determines the technological level of mobile medical devices. At present, most medical device manufacturers in China do not have the ability to independently develop and produce core components, and need to purchase from other manufacturers before assembling the entire machine. Manufacturers with core component supply capabilities have strong bargaining power.
Other accessories: The manufacturers of accessories are concentrated in the Yangtze River Delta, Pearl River Delta, and other places, without obvious leading enterprises, with numerous market participants and weak bargaining power.
Software: Software manufacturers are concentrated in Guangdong, Fujian, Zhejiang, Beijing Tianjin Hebei and other regions. Currently, mature industries have formed, with numerous market participants and no obvious leading enterprises, and limited bargaining power.
7. Midstream analysis of the industrial chain
The mid stream market participants in the industrial chain include hardware manufacturers and software manufacturers, both of which currently have no significant leading companies. In the future, with the addition of technology giants, software giants will gradually emerge.
Mobile medical device manufacturers include hardware manufacturers and software manufacturers, both of which independently conduct research and sales of mobile medical device products and cooperate in the development of new products and business models.
(1) Hardware manufacturers: The products provided by hardware manufacturers are mainly mobile medical devices, with representative products including smart cloud blood pressure monitoring system, smart cloud blood glucose monitoring system, smart cloud electrocardiogram monitoring system, mobile DR, etc. There are significant differences among different products, and the main participating manufacturers also have significant differences. There has not yet been a leading enterprise that can cover multiple fields at the same time. Compared with traditional medical devices with similar functions, the market price of mobile medical device products can be higher by more than 50%. For example, a DR device with a retail price of about 500000 yuan can have a retail price of over 800000 yuan if the "movable" attribute is added. However, compared to traditional DR, mobile DR has a cost increase of less than 10%. From this, it can be seen that mobile medical device manufacturers have a higher profit level, attracting more participants to enter the field.
(2) Software manufacturers: The products provided by software manufacturers are mainly mobile independent software, with representative products including chronic disease management platforms, conventional health management platforms, remote medical platforms, etc. Different products also have significant differences, and participating manufacturers also have significant differences. Currently, the industry is unable to cover top enterprises in multiple fields at the same time. However, technology giants such as Alibaba and Huawei are actively expanding into the field of mobile medical devices. In the future, this type of technology giant enterprise is expected to become a leading enterprise in the field of mobile independent software with strong financial strength.