--Strong R&D capability and sufficient technical reserve
The company has strong independent R&D and innovation capability, and has been recognized as "High and New Technology Enterprise" by Beijing Municipal Science and Technology Commission, and has been awarded as one of the first batch of "Independent Innovative Product Enterprises" in Beijing. In 2009, the company was evaluated as the unit of integration of production, learning and research in Changping District of Beijing, and was evaluated as the third batch of 100 innovative pilot enterprises in Zhongguancun National Innovation Demonstration Zone by Beijing Municipal Government, the Ministry of Science and Technology, and the Chinese Academy of Sciences, and was evaluated as the New Third Board Company with the most investment value and the advanced unit in Zhongguancun Science and Technology Park in 2011.
The company has developed the "special multi-channel atomic absorption spectrometer + special detection reagents" to measure the human trace elements of the overall program, the use of "composite light source", "light path angle", "light path", "light path", "light path", "light path", "light path", "light path", "light path", "light path" and "light path". "Compound light source", "optical path angle", "beam alternating grouping" and other combination of technologies, combined with "high-temperature oxygenation technology", "special self-absorption buckle background technology" and "tungsten boat atomization technology" and "tungsten boat atomization technology". Combined with "high-temperature oxygenation technology", "special self-absorption buckle background technology" and "tungsten boat atomizer de-carbonization technology", the goal of simultaneous measurement of multiple elements has been achieved. Combined with the measurement technology of the instrument, the sample pre-treatment technology and method are integrated into the random special reagent box, replacing the sample pre-treatment process that needs to be carried out on the client side in the past, which successfully solves the difficulty of atomic absorption spectrometry in the field of clinical testing. Successfully solve the atomic absorption spectrometry in the field of clinical testing is difficult to break through the technical limitations of the instrument and must be operated by professional researchers, to achieve the atomic absorption detector in the hospital clinical trace element detection, thus promoting the human trace element testing in China to carry out large-scale.
The human trace element testing system developed by the company consists of testing instruments, testing software, testing reagents, calibration products, quality control products and national secondary standard substances, and is a systematic integration of technologies in multiple fields of optics, mechanics, electronics, computers and clinical chemical analysis. In the field of clinical testing, analytical system integration is conducive to ensuring the stability of measurement results, traceability and quality control in the process, and is the trend of the development of international clinical laboratory medicine. Due to the many technical categories involved in analytical system integration and the high technical requirements, there are very few domestic manufacturers who can truly realize system integration.
The company's development of "whole blood lead, cadmium analysis of standard substances", "copper, zinc, calcium, magnesium, iron, potassium, sodium composition analysis of standard substances" and "bovine serum, bovine blood composition analysis of standard substances "solved the problems of traceability, calibration and quality control of instruments and measurement systems in the process of production and use, and obtained the certificate of national secondary standard substances issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. The successful development of the standard substance marks the company's transformation from a single supplier of instruments and reagents to a complete testing system integration supply service provider.
Based on the consolidation of human trace element testing business, the company continues to research and develop new technologies in order to maintain its technological leadership in the field of clinical testing. The company has successfully developed a series of technologies such as special fluorescein coupling technology, microspot excitation light path technology, special narrow-band receiving spectroscopy technology, etc. The company has pioneered the combination of immunofluorescence detection technology and immunochromatography technology to form a platform of immunofluorescence chromatography detection technology, which can effectively improve the detection sensitivity of the measured substance, solve the problems of dry chemical chromatography, such as low sensitivity and easy to produce human misreading, and shorten detection time and simplify operation procedures. It also shortens the detection time, simplifies the operation procedure, and ensures the accuracy of the test results. At present, the company has applied this technology platform in the field of intestinal multivirus detection, successfully developed immunofluorescence chromatography intestinal multivirus joint detection system (instrument and supporting reagent kits), and realized commercial production.
Relying on the company's excellent technical R&D capability, the company has developed into the largest testing system integration supplier in the human micro-assay market in China, which not only provides customers with testing instruments, but also testing reagents. The company has developed into the largest integrated supplier of testing systems in the human trace testing market, providing customers with not only testing instruments, but also testing reagents, standardized substances, calibrators and so on. Due to the technical requirements of the company's products in the process of use, the company has formed a business model of "instrument + supporting special reagents" in the field of testing. Similar to the business model of "razor blade holder + razor blade" and "printer body + ink cartridges" in the field of personal consumption, in order to ensure the accuracy of the test results, the user continues to purchase the company's supporting reagent products based on the purchase and use of the company's instruments. This business model enables the company's products to realize multiple sales development on the basis of ensuring that the original customer does not lose, forming a continuous accumulation effect.
In the future, with the diversification of the company's products, the expansion of the scope of coverage of the testing population and the increase in demand for clinical testing, the company will take advantage of the business model to continue to consolidate and strengthen the market position it has achieved. --Perfect marketing service network, large customer base
In the process of cultivating market demand and promoting product application over the years, the company has implemented the principle of "occupying the market with instrument sales to build up a customer network, and then driving the sales of reagents through continuous technical services to consolidate and improve the company's market position and sustained profitability". The company has implemented the sales strategy of "dominating the market with instrument sales to build up customer network, and driving reagent sales through continuous technical service to consolidate and improve market position and enhance the company's sustainable profitability", and has formed a wide-coverage sales network, accumulated rich and stable customer resources, and constructed the company's competitive barriers through the provision of good and systematic after-sales technical services. The products developed by the company in the future can realize rapid sales through the formed sales network, with obvious scale effect and first mover effect.
By the end of 2011, the company's products have covered 31 provincial-level administrative regions, covering 476 counties and county-level cities, and 519 cities above the county level. The company has realized effective management of its sales network through regional division and hierarchical management, and has established cooperative relationships with about 1,000 dealers around the country.
As of the end of 2011, the company's products are used by more than 1,400 municipal hospitals and more than 1,000 county hospitals; the customer structure covers maternal and child health care institutions (hospitals), children's hospitals, general hospitals, community service centers, independent laboratories and other testing institutions. (1) The company's products have a high degree of intelligence, by curing the standard measurement conditions, simplifying the measurement operation; testing instruments equipped with software and hospital information management system automatic docking, easy to apply the product, the ordinary medical examiners can be operated, do not need to be equipped with a special laboratory or scientific research personnel, for the human body trace element testing in the clinical and medical institutions, to create conditions for the extensive use of the clinical and medical institutions.
(2) The company's products have rich application fields and are highly applicable.
The company's human trace element products have a wide selection of samples, widely used in whole blood, serum, milk, urine and other samples, which greatly facilitates the user's application, and also expands the tested population from children to pregnant women, chronic disease patients and other types of adults. At the same time, the company's human trace element products can measure a wide range of elements, covering copper, zinc, calcium, magnesium, iron, potassium, sodium, lead, cadmium and other beneficial and harmful multi-elements, for medical diagnosis to provide a scientific basis for human body testing.
With the promotion and listing of the company's new products, immunofluorescence analyzer and rotavirus, enteric adenovirus test kit, the company's product structure will be further enriched, and the field of application will be more expanded.
(3) The company's production system has passed ISO9001-2008 quality system certification and ISO13485-2003 medical device quality management system certification. The company's reagent production workshop has passed the acceptance of the Beijing Municipal Drug Administration's Class II and the State Drug Administration's Class III (mainly including enterovirus kits) in-vitro diagnostic reagent production environment standards, and the standardized production makes the company's reagent products of guaranteed quality.
(4) The company's products BH5300, BH2100S instruments and reagents have passed the European Union standard inspection and obtained CE product certification, which creates conditions for the company's products to enter the international market. The management standard of product development and industrialization of BH Innovation is based on ISO9001-2008, which is through market and technical research project, design task plan, design and development input, design and development evaluation (including R&D plan evaluation, principle development evaluation, test prototype evaluation, commercialization prototype evaluation, process research and design evaluation, small batch trial production evaluation, pilot and batch trial finalization evaluation), design and development verification, product clinical validation, project acceptance, and product testing. validation, product clinical confirmation, project acceptance and other multi-process control. At the same time, the national drug regulatory authority has a strict regulatory process and complex assessment of the research and development and industrialization of medical devices and medical testing instruments and reagents. In order to realize the industrialization of a medical device product and to be approved for marketing, it is necessary to go through the review and filing of product standards by the drug regulatory authority, testing of prototype samples, validation of the product's clinical trials, as well as including the industrialization of the production of environmental equipment, facilities and environmental control, research and development, purchasing, production process control, inspection and acceptance of projects, and other multi-process control, Procurement, production process control, inspection and quality control, sales and service, organization, document control and other ten aspects of the 156 on-site assessment and the final product registration certificate, at present, BHI has already obtained the product registration certificate of the drug administration department for 13 instruments, *** 19 varieties, 13 reagents, *** 13 varieties, which indicates that BHI has accumulated a lot of rich industrialization experience and has a solid foundation for the industrialization. This shows that BHI has accumulated a lot of experience in industrialization and has a solid foundation and strength in industrialization.
In order to better implement the effective industrialization of the products, BHI is currently carrying out the construction of R&D and pilot plant in Zhongguancun Life Science Park, with a total construction area of about 30,000 square meters, including 5,000 square meters of instrument R&D and pilot plant, and 8,000 square meters of reagent and microchip R&D. It is expected that BHI will have a total of 8,000 square meters in 2012-2013, and will be able to develop its products in the coming years. 8000 square meters, is expected to be completed and put into use in 2012 ~ 2013, in order to ensure that the R & D pilot base of industrialization to carry out reliably, but also intends to carry out GMP licensing certification, such as obtaining medical instruments, testing reagents R & D pilot production license.
In the construction of engineering, industrialization of the environment and facilities based on process planning and process equipment, the company currently has a high and low temperature chambers, vibration table, terminal embossing machine, 3D optical image measuring instrument, ultrasonic welding machine, laminating and bonding machine, high-speed machining centers, freeze-drying machine and a large number of process equipment, for the microfluidic control project, but also the acquisition of high-speed bonding machine, precision injection molding machine, medium-sized For the microfluidic control project, we will also purchase high-speed bonding machine, precision injection molding machine, medium-sized high and low temperature equipments, laser laminating machine for air circuit boards, precision film dotting machine, chip pressure tester, precision laser microporous cutter, and at the same time, we will also develop the related process equipments, such as the extraction film cutting and assembling tooling, hybridization film cutting and assembling tooling, bonding tooling, testing tooling for air circuit boards, testing tooling for three-dimensional motion components, isolation film cutting and assembling tooling, chip cover assembly tooling and hybridization film cover assembly tooling. The company will build three production lines. Bohui intends to build three production lines: microfluidic molecular detector production line, with an annual output capacity of about 300 units; microfluidic chip production line, with an annual output capacity of about 2 million copies; and nucleic acid molecular detection reagent production line, with an annual output capacity of about 2 million copies.