Wearable devices are an important area of ​​domestic Internet medical care . A wearable device is an electronic or intelligent computing device that is worn or implanted on the surface or inside of the human body and belongs to the Internet of Things. At present, domestic health wearable devices are mainly used in the fields of chronic diseases, old-age care, women and children, smart sportswear, etc., and are divided into sports health and medical wearable devices. Domestic wearable device manufacturers generally adopt two business strategies, one is self-developed hardware and application App, which leads sales, promotion and post-data mining; the other is self-developed hardware, which is promoted by WeChat, Apple Health Kit and other health data platforms. , get late income.
As the core application form of the Internet of Things, domestic wearable devices belong to the blue ocean of the market, but the Chinese manufacturers are facing two major problems on the road ahead. Only when these two major problems are properly handled can spring be ushered in.
From the consumer level to the medical level is the only way for the industry
At present, there are many manufacturers of medical wearable devices. Due to the integration of software and hardware, the R&D cycle is long, the capital investment is large, and the product homogeneity is serious. Only diabetes products and applications are in the dozens. Even the medical writer Liu Qian has recently established. “Unicorn Studio†is an independent independent investigation and evaluation of related applications. Medical wearable devices have the substitution of medical devices or drugs, but lack access and regulation in the medical industry .
First, the reliability of technical indicators is doubtful. Domestic medical devices and drugs have strict approval procedures and comparative evaluation of effects. They need to use raw materials, side effects and double-blind control tests, thus establishing a barrier to entry, effectively curbing unlimited market competition and reducing patient safety hazards. The domestic R&D equipment research and development, there is still no supervision, patients often choose independently, and bear the cost, can not identify the product quality. The lack of government industry regulation restricts the development of the industry. The consistency evaluation of domestic generic drugs is still in the stage of strong push, and it will take time for the regulatory authorities to cover medical wearable devices.
Second, the equipment lacks maintenance and debugging. Medical devices used in hospitals require regular maintenance checks, commissioning and maintenance to ensure reliability and availability. Many medical wearable devices, after being sold as products to patients, focus on consumables revenue, or accumulate patient data, lack the ability to provide similar services, and patients lack the willingness to pay for purchases. Most medical wearable devices are only of the quality of consumer electronics and do not meet industrial control and medical standards. Domestic consumers are generally accustomed to paying for physical products, lacking the habit of paying for services directly, restricting the multiple benefits of wearable device manufacturers.
The third is the unavoidable legal and moral hazard. Based on the above two problems, if the patient simply trusts the wearable device that does not have medical quality, and guides the medication and life according to the data indicators it displays, serious health risks and damages will occur. For example, if a patient chronically trusts a meter with an inaccurate reading, it can lead to irreparable complications. Of course, wearable device manufacturers can use the terms of the format contract to avoid risks, but it is a major obstacle to the development of enterprises and industries.
The US FDA has incorporated medical wearable devices and apps into medical device management, and it needs to pass the technology and effectiveness test before it can be listed. The threshold is to curb the disorderly competition in the market; the second is to protect the safety and health of patients; It is a confirmation of the efficacy and provides a basis for the medical insurance department to reimburse it. Therefore, the path of medical wearable devices in the United States gives us a lot of inspiration, points out the development path, and requires the competent authorities of our government to assume corresponding responsibilities.
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