Medical equipment is still in the blue ocean, but don't think of it as a pure smart wearable device.
Digital mobile medical equipment is one of the current hot items, and it is also the first choice for many people in the medical and health field. Compared with medical services and medicines, medical equipment is actually a good choice for starting a business. Medical services still need to go through a tough game with public hospitals. The license for drug sales is still a good tool for entrepreneurs. Medical equipment is the entrepreneur's blue ocean First, the development and approval cycle for medical devices has been much shorter than for drugs. It usually takes about 10 years for a new drug to go from research and development to launch. The development time of generic drugs is short, but approval is not easy. There are three types of equipment that are the most difficult, but they can still be much faster than drugs. The time for different types of medical equipment to go to the registration certificate varies greatly, generally speaking, about 3-5 years. If it belongs to innovative equipment, the approval speed will be faster. Second, the rate of failure in the development of medical devices relative to drugs is much lower. At present, the news of research and development failures in medicines continues, and many large multinational pharmaceutical companies have begun joint development to reduce the impact of R&D failures. Because drugs mainly play a role through chemical, biological, immune or metabolic methods, and a series of reactions triggered by drugs entering the human body are still unknown and uncontrollable, these factors will affect the final product development results. Medical equipment mostly works by physical means. Although equipment + drugs, equipment + biological products are also popular projects for research and development, they are relatively small compared to the overall medical equipment. The equipment is generally controllable and continues to improve the product design until the clinical validation phase, so the overall R&D failure rate is much lower than the drug. Finally, medical equipment is a very broad field, from diagnostic reagents to large imaging equipment, to implantable equipment, optics, dentistry, monitoring, rehabilitation, etc. Covered. According to the “2013 Blue Book on the Development of China's Medical Device Industry â€, from 2001 to 2012, the sales volume of China's medical device market increased from RMB17.9 billion to RMB170 billion, excluding the impact of price factors, which increased by nearly 9.4 times in 12 years. In the global market, the proportion of equipment and medicine consumption is about 1:1, while China's medical equipment consumption only accounts for about 14% of medicines, indicating that there is still huge room for the development of medical equipment, far from reaching the ceiling. At the same time, China's medical equipment is still in a stage of full competition. At present, there is no company with an absolute dominant position, that is, the monopoly has not yet appeared, which also gives the entrepreneurial company a space for development. With the rapid development of information technology, various new products are emerging one after another. Among them, the outbreak of smart wearable devices and health tracking devices has also raised a question. How do we distinguish medical equipment? At present, most of the common digital mobile medical products are based on management and communication. There are apps that help chronic disease records and management, intelligent software for information processing such as diagnosis, treatment and medication, hospital electronic medical records, online consultation/question The diagnosis system, the patient mutual help communication community, the smart wearable device and the digital processing platform, etc., are aimed at doctors and patients, but are also increasingly tending to the mass users who have a need for health management. Definition of medical equipment Are these products classified as medical devices defined in China? According to the Medical Device Supervision and Administration Regulations (Order No. 650 of the State Council), which came into effect on June 1, 2014, medical equipment refers to instruments, equipment, instruments, in vitro diagnostic reagents, calibrators, materials and materials used directly or indirectly in the human body. Other similar or related items, including the required computer software; their utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although they are involved but only play a supporting role; Yes: · Diagnosis, prevention, monitoring, treatment or relief of the disease; · Diagnosis, monitoring, treatment, mitigation or functional compensation of injuries; · Testing, substitution, adjustment or support of physiological structures or physiological processes; · Support or maintenance of life; ·Pregnant control; • Provide information for medical or diagnostic purposes by examining samples from the human body. Comparing the Regulations on the Supervision and Administration of Medical Devices, which came into effect on April 1, 2000 (State Council Order No. 276), it can be found that the scope of medical devices has expanded beyond traditional prevention, diagnosis and treatment, but has expanded to Medically intended to directly or indirectly affect various items of the human body. According to the definition of medical devices, if the aforementioned digital medical products directly or indirectly contact the human body, the examination of the human body samples will be attributed to the medical devices. For example, in wearable products, there are indicators for collecting blood pressure, heart rate, blood sugar, etc., which are medical devices; if you only calculate the amount of exercise, call, and play MP3, it is not a medical device. APP and software for assisted disease management, if only storing and processing the input data (not directly obtained from human or human samples), is not a medical device; but if the processed data is directly from the human or human sample, it is a medical device. . Eas Detector,Eas Anti Theft System,Electronic Article Surveillance,Sensormatic Anti Theft System WENZHOU BOSHINE ELECTRONIC SECURITY CO.,LTD , https://www.boshine.com