For thousands of years, humanity’s struggle against diseases and exploration of itself have never stopped. With the development of medical technology, the application of various medical devices has greatly improved human ability to combat diseases, and the improvement of diagnostic technology has also enabled more diseases to be detected and dealt with as soon as possible. Among them, IVD (In Vitro Diagnostic) technology has attracted widespread attention, including in vitro diagnostic reagents and instruments, belonging to the medical device industry. In vitro diagnosis is known as the “doctor’s eye” in the medical field, and its clinical application runs through the entire process of disease prevention, preliminary diagnosis, treatment plan selection, efficacy evaluation, and other disease treatments. It can provide doctors with a large amount of useful clinical diagnostic information and is increasingly becoming an important component of human disease diagnosis and treatment.
According to statistics, by 2035, the population aged 65 and above in China will exceed 20%. As China enters a deeply aging society, the demand for healthcare products and services will continue to rise. From the “14th Five Year Plan” for the development of the bioeconomy and the “Action Plan for High Quality Development of the Pharmaceutical Industry (2023-2025)” to the “Action Plan for High Quality Development of the Medical Equipment Industry (2023-2025)”, the country has successively introduced multiple policies to encourage the development and innovation of the in vitro diagnostic industry. In the past three years, while the in vitro diagnostic industry has made significant contributions, it has also welcomed opportunities for development. According to the calculation of the Medical Equipment Research Institute, it is expected that by 2030, the size of China’s in vitro diagnostic market will grow to RMB 288.15 billion, accounting for 33.2% of the global market and becoming the largest consumer of in vitro diagnostic products.
Behind these growth figures is the increasingly fierce competition in the industry: after the wind blows, the explosive growth of the in vitro diagnostic industry will return to rationality, the industry value will focus more on products and technology itself, and the intensity and precision of regulation will be increasingly strengthened. What enterprises need to improve is not only their investment in research and innovation, but also their ability to quickly put new safety and compliance products into the market. At the same time, how to achieve cost reduction and efficiency improvement for existing highly homogeneous products is also a must answer question for enterprises in the in vitro diagnosis industry.
In vitro diagnostic industry: facing the five challenges of digital transformation
From the perspective of production process, in vitro diagnostic reagents and instruments belong to mixed and discrete industries respectively, and exhibit different characteristics: diagnostic reagents include liquid preparation production and reagent assembly, which have the attributes of both process industry and discrete industry, and have the characteristics of multiple varieties and small batches. They pay attention to process compliance and data integrity, and have high environmental requirements; And instruments are generally used as supporting production for reagents, with a high demand for lean production. Overall, the in vitro diagnostic industry must address the following five challenges in exploring digital transformation:
From manual solution preparation to automated production: Taking diagnostic reagents as an example, due to the wide variety of products, traditional production mainly relies on manual solution preparation. The transformation from manual solution preparation to automation and digitization is difficult. How to achieve process compliance and consistency through automated systems and achieve flexible switching of different types of products through batch production is the primary issue that needs to be considered;
Production process safety compliance: With quality and safety compliance as the main driving factors, it is a significant feature of the life science industry. Recently, the State Food and Drug Administration issued the “Drug Standards Management Measures” to further standardize and strengthen the management of drug standards, ensure drug safety, effectiveness, and controllable quality, and ensure high-quality and safe production of drugs. In addition, with the implementation of the new healthcare reform policy, GMP (Good Manufacturing Practice) certification has become a normalized regulation, and drug consistency evaluation has become a mandatory requirement in the industry. It is imperative for enterprises to strengthen safety and compliance development;
Market response speed needs to be accelerated: The technological characteristics of medical devices and diagnostic reagents determine the complexity of their facilities and systems, and their construction and validation often take weeks or even years. Every upgrade and adjustment of the production line, even if there are minor changes, may require lengthy debugging and verification of the entire system, which is time-consuming and labor-intensive, delaying the production progress and product delivery time of the production line, and unable to respond quickly to the market;
Response to cost pressure: With the comprehensive implementation of centralized procurement in the pharmaceutical industry, the cost pressure on enterprises has increased. In addition, there are a wide variety of medical devices and diagnostic reagents, and the production batch of single products is small. The same enterprise often needs to quickly adjust its production line to produce multiple products in a short period of time to meet its needs. At the same time, the procurement prices of key raw materials for many products are converging, so the ability to finely manage the production process, improve efficiency, reduce waste, and become the source of improving the core competitiveness of enterprises in the market;
Sustainable development goal: Medical device products represented by biological reagents have strict requirements for the production environment and need to maintain the stability of the production environment. The energy control ability of enterprises over buildings and production lines will directly affect product quality; In addition, the excessive consumption of electricity and water resources poses challenges to the sustainable development of enterprises. Efficient energy management not only reduces costs, but also helps enterprises fulfill social responsibility and improve reputation.
Focusing on four layers of application, assisting in vitro diagnostic enterprises in building digital factories
As an important component of life sciences and an extension of the value chain, as well as one of the direct ways for pharmaceutical research achievements to be applied to consumers, the in vitro diagnostic industry requires enterprises to have higher technological innovation capabilities, utilize their digital capabilities to deeply integrate with enterprise operations and production manufacturing, and enhance the agility and flexibility of factory building and product production. On the basis of rich technical reserves and industry practical experience, Schneider Electric assists in the digital transformation of in vitro diagnostic industry enterprises with a complete solution that runs through four layers of applications:
The production process of diagnostic reagents is a complex process, including manual mixing, liquid preparation, online cleaning, weighing instruments, laboratory calibration equipment, pure water system, filling, and other links. Enterprises need to strictly control each link to ensure product quality and safety. From the device access layer, to the production control layer, data center, production operation application layer, and management analysis layer, Schneider Electric can provide complete digital solutions to help achieve digital control throughout the entire process.
At the production control level, the FMCS factory management and control system can integrate a series of systems such as high and low voltage distribution, air compression, air conditioning, and water treatment that are integrated into the factory, improving the operational efficiency and optimizing control of factory equipment through full lifecycle management, providing support for enterprise energy management and production environment certification compliance; The SCADA system based on production lines can collect relevant data on machine operation, timely grasp production dynamics, and provide a foundation for data analysis and decision-making. The ESOP workflow management system can effectively guide employees to execute the correct processes in the correct order, while fully recording manual operations to achieve data integrity of manual operations. The building management system BMS achieves stable control of the entire pharmaceutical storage environment and pharmaceutical production environment by controlling industrial air conditioning units. The environmental monitoring system EMS monitors the key production areas and equipment environment, and real-time views the environmental temperature, humidity, and pressure difference in the drug production area, achieving data integrity of production environment records.
In the data center, through the AVEVA AIM digital delivery system and AVEVA PI System big data management platform, Schneider Electric can help achieve enterprise level information integration and management covering GMP and Non GMP, and build an enterprise level industrial data dual base.
At the production operation application layer, the MES system and warehouse management system WMS can help comprehensively standardize the production execution process and achieve lean warehouse management; The laboratory management system LIMS can uniformly store experimental data and literature, helping the laboratory achieve digital management; There are also equipment management systems such as EAM, AVEVA UOC integrated operation center, EMS+energy efficiency management and control system, which enable the visualization of factory equipment, energy consumption and other information and break away from the “black box” state.
At the management analysis level, a series of enterprise management system software such as supplier management system, business process management software, and quality management system are utilized to improve the efficiency of business management and achieve unified management from decentralization to centralization.(https://www.weikunfadacai1.com/)
Merier Bio is a leader in the in vitro diagnostic industry. In the construction of its Suzhou base, Schneider Electric has adopted a complete set of power distribution, automation, and information technology solutions, including EMS environmental monitoring system, PO power monitoring system, EBO building operation system, and production process automation system PAS based on AVEVA system platform. With more advanced management and control technology and more efficient energy efficiency strategies, Promote the construction of automated production lines and improve user management of the environment and production data, reduce costs, improve efficiency, and help them achieve sustainable development goals, creating a benchmark for the biopharmaceutical industry.
The changes in social environment and policies have brought many opportunities and challenges to the medical device industry. How to improve efficiency through comprehensive digitization of production and management work has become an industry consensus. Schneider Electric has been deeply involved in the life science industry for a long time, combining its own technical expertise and industry experience to provide digital solutions covering the entire lifecycle for medical device and diagnostic reagent enterprises, assisting in production and operation safety compliance, ensuring strict quality control, accelerating digital transformation, and thus maintaining a leading position in the new round of market competition.
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