Medical devices are a blue ocean for entrepreneurs

Absrtact: The digital mobile medical service is one of the hot spots, and it is also the first choice for many people in the Medical medicine health field. Compared to medical care and medicine, medical devices are a good choice for starting a business. Medical services now need to be repeated

with public hospitals

The digital mobile medical service is one of the hot spots, and it is also the first choice for many people in the medical drug health field. Compared to medical care and medicine, medical devices are a good choice for starting a business. Medical services are still in need of a hard-fought game with public hospitals, and drug sales licences are still a sword in the head of entrepreneurs.

Medical devices are entrepreneurs blue sea

First, the development and approval cycle for medical devices is much shorter than for pharmaceuticals. Now usually a new drug from research and development to the IPO takes about 10 years. Generic drug development time is short, but the approval is not easy. Three kinds of devices are the hardest, but they can still be much faster than drugs. Different kinds of medical equipment to get the registration certificate time difference is very large, generally speaking, 3-5 years or so. If it belongs to innovative devices, the speed of approval will be faster.

Second, the failure rate of medical devices in relation to drug development is much lower. As news of the current failure in drug development continues, many large multinational pharmaceutical companies have begun joint development and hold a group of heating to reduce the impact of research and development failures. Because the drug mainly through chemical, biological, immune or metabolic methods to play a role, and drugs into the body after the triggering of a series of reactions are still unknown and uncontrollable, these factors will affect the final product development results. Medical devices are mostly through the physical way to play a role, although the current equipment + drugs, devices + biological products are also research and development hotspots, but compared to the overall medical equipment, these small proportion. Devices are generally controllable and continue to improve product design until the clinical validation phase, so the overall failure rate is much lower than the drug.

Finally, medical devices are a very broad field, from diagnostic reagents to large imaging equipment, to implantable devices, optics, dental, guardianship, rehabilitation ... field of wide, is our current medical equipment is far from covered. According to the Blue Book of the development status of China medical device Industry 2013, from 2001 to 2012, China's medical Device market sales volume from 17.9 billion yuan to 170 billion yuan, excluding the impact of price factors, 12 years increased by nearly 9.4 times times. In the global market, the proportion of equipment and drugs consumption is about 1:1, and China's medical device consumption accounted for only about 14% of the drug, indicating the development of medical devices there is a huge space, far from reaching the ceiling.

At the same time, China's medical equipment is still in full competition stage, currently has not occupied the absolute dominant position of the company, that is, the monopoly has not appeared, which also gave the development of entrepreneurial companies space.

With the rapid development of information technology, a variety of new products are emerging, including intelligent wearable equipment and health tracking equipment concentrated outbreak, but also brought a grounding of the question, how can we distinguish medical devices?

The current common digital mobile medical products are mostly based on management and communication as the starting point, app for the record and management of chronic diseases, intelligent software for information processing such as diagnosis, treatment and medication, electronic medical record of hospital, online counseling/interrogation system, mutual communication community, intelligent wearable equipment and data processing platform, etc. , the goal is to focus on doctors and patients, but it is also becoming more and more popular with people who have a need for health management.

Definition of medical devices

Do these products belong to medical devices? Under the regulations on the administration of medical devices (order No. 650), which came into force on June 1, 2014, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrations, materials and other similar or related items, including required computer software, that are directly or indirectly used in the human body. , whose utility is obtained mainly through physical means, not by pharmacological, immunological or metabolic means, or by means of such participation but only as a supplementary function;

Diagnosis, prevention, care, treatment or remission of

diseases, diagnosis, monitoring, treatment, remission or functional compensation of the lesion, examination, substitution, adjustment or support of physiological structure or physiological processes; support or maintenance of life; pregnancy control; By examining samples from the human body, Provide information for medical or diagnostic purposes.

In contrast to the medical Devices Supervision regulations (No. 276), which came into effect on April 1, 2000, the scope of medical devices can be found to extend beyond the traditional prevention, diagnosis and treatment, but rather to extend to medical purposes the direct or indirect use of various objects for the human body.

According to the definition of medical device, if the digital medical products mentioned above directly or indirectly contact with the human body, the examination of human body samples, will be classified as medical equipment.

For example wearable products, there is a collection of human blood pressure, heart rate, blood sugar and other indicators, is medical equipment; If only to help you calculate the amount of exercise, call, play MP3, it does not belong to medical equipment. For applications and software that assist in disease management, it is not a medical device to store and process the input data (not directly from the human body or the human body), but if the data processed is directly from a human or human sample, it is a medical device. For some indirectly collected data, participation in the diagnostic process is also considered a medical device, such as a company's CT/PET data-processing workstation, but it is not counted if it is simply a storage backup transmission.

The state classifies medical devices according to the degree of risk: the first category refers to the low risk, the implementation of conventional management can guarantee its safety, effective medical devices; The second category refers to the medical devices that have moderate risk and need to be strictly managed to ensure their safety and effectiveness. The third category refers to the higher risk, Special measures need to be taken to strictly control the management in order to ensure its safe and effective medical devices.

Under the entry into force of October 1, 2014, "Medical device Registration Management measures" (State administration of Food and Drug Administration order 4th), the first category of medical devices to implement the record management, the second category, the third type of medical devices to implement the registration management. In general, the third category of medical devices, because of high risk, often require clinical trial data to support registration; The first category is simpler, the record can be; the second type of medical device, according to the "Medical device clinical evaluation of technical Guidelines (draft)", the need to collect relevant data to demonstrate the product. If the existing data can clearly demonstrate the validity and safety of the product, it is not necessary to do clinical trials, whereas the data of clinical trials are required to support the effectiveness and safety of the product.

Assess the potential of overseas markets

For the evaluation of the risk degree of medical devices, the main factors such as the intended purpose, structural features and use methods of medical devices are considered. FDA adopts similar risk assessment and management methods as shown below:

If you really don't know what kind of product you belong to, you can submit your application on the FDA's website, and the FDA will help you determine the category of the product, which, of course, is charged. CFDA can also classify the products of unknown classification to define, is currently free, is the time is relatively long, about half a year.

If you choose to start a business, understanding some of the regulatory requirements for medical devices will help entrepreneurs:

Understanding regulatory access rules can more accurately plan the product lifecycle, market positioning and target groups. If the product is a medical device, in the early business plan, can be based on the product declaration and registration time, calculate the approximate date of the registration certificate, according to the timeline, the product life cycle can be estimated to determine the follow-up plan. Because of the rapid development of digital mobile products, a few months early or later a few months to get the registration certificate, it is possible that the market positioning and target customers will be very different.

Follow prevailing product standards, avoid potential risks, and reserve enough space for future development. The registration, labelling, production and management of medical devices have mandatory requirements for regulations. Once found to be inconsistent with regulatory requirements, the penalties will be very severe. Therefore, understanding these provisions helps to avoid risks. In addition, the medical device industry has a variety of industry standards. Mobile medical products, are basically active products, the world has a lot of industry standards can be referenced. The advantage of meeting these standards is that once they are promoted outside the future, products can adapt to various systems and testing.

Expand the scale when providing new ideas and outlets. Regulations are particularly important when products are ready for export. The regulation of medical devices is not the same, and in contrast, getting a listing permit (CE) in the EU is easier than in the US (PMA) and probably easier than China. China is at the stage of full competition, with a large number of small companies similar and identical products competing in the domestic market. In this case, for some of the more special medical devices, transfer to overseas markets, may be another way of thinking and outlet.

Due to the digital process is too fast, the digital medical regulations and regulation is too late to update, there is not too many constraints, but to give innovators more space to play. Internet technology into the medical field, perhaps the beginning of innovation.

The above simple introduction of the digital mobile medical products related to some regulations, hoping to give entrepreneurs a little inspiration or provide a little thought, but also welcome to explore and correct.