Product development is the vanguard of the production and operation of the whole enterprise and the most important infrastructure. The core competitiveness of science and technology enterprises is product research and development ability. At the same time, the products developed are in compliance with laws and regulations, clinical practicability, safety and effectiveness, stable quality, reasonable cost and price, and meet market requirements, so as to stand out in the fierce competition.
Development usually includes two stages: product development and technology development. Technological development is a new variety, and new technology comes from innovative ideas. Developers can develop new technologies and methods to better meet the potential needs through certain technical routes and appropriate methods.
Product development is the process of transforming technology into products. Mainly divided into original and improved development.
According to ISO 13485 quality management system, product design and development includes a series of processes such as planning, input, output, review, verification and confirmation, and design change control. According to the degree of product risk from low to high, in vitro diagnostic products are divided into three categories: category I, category II and category III. According to the source of technology, it is divided into original products, improved products and technology imported products.
The resource allocation conditions in the process of product development mainly include funds, personnel, equipment, factory facilities and so on. Project investment in the R&D process includes various expenses required in the R&D process, such as salary, bonus, allowance, subsidy, social security accumulation fund, etc. Labor costs of R&D personnel and external personnel; Fixed assets such as equipment, molds and tooling in R&D process; Raw materials and consumables used in research and development; Testing fees, registration fees and clinical fees incurred in the R&D process; Intellectual property costs, such as patent application fees, article publishing fees and other intangible assets; Contract expenses arising from outsourcing, cooperation and entrustment; Rent, water, electricity and property fees for house leasing; Travel expenses, training fees, maintenance fees, etc.