Research On Improvement Of Product R ＆ D Quality Management Of TP Company

With the improvement of global residents’ living standards and the strong demand for residents’ medical services and medical devices,medical devices have become one of the most concerned industries.In 2020,the market scale of the global medical device industry was US$477.4 billion,with a year-on-year increase of 5.63%.It is expected that the scale of the global medical device industry will reach nearly US $600 billion by 2024,with a compound growth rate of 5.6% from 2017 to 2024.The industry is expected to maintain stable growth.At present,the market scale of China’s medical device industry ranks second in the world,and ranks first in the world in the scale of medium and low-end medical device industry.In terms of segments,medical equipment is the largest segment market.The domestic ownership rate of China’s medical equipment market is low,the high-end market is still dominated by imported products,and the domestic alternative market is broad.The product research and development of medical devices,especially high-end medical devices,involves multiple disciplines,which should not only meet the needs of the market and customers,but also meet the regulatory requirements and industry standards;We should not only break through technical barriers,but also reach the level of industrialization ability.The insufficient quality management level of medical device R ＆ D will lead to product quality problems,which will collapse the brand image of the enterprise and eventually lead to the exit of the enterprise.Therefore,improving the R ＆ D quality management of medical devices is an urgent need for many small and medium-sized medical device start-ups in China.TP company is a medical technology start-up company established in 2017.Relying on the transformation of technical achievements of domestic top universities,the company is committed to creating a new situation of domestic high-end ophthalmic medical equipment.In the past five years,TP company’s product R ＆ D has achieved a leading position in global technology in the product categories of subdivided industries.With the rapid development of the company,the company has expanded new product lines and doubled the number of personnel.However,due to the problems of inappropriate R ＆ D organization structure,imperfect personnel composition,imperfect product development process,insufficient design and development verification test,unreasonable design change control process and so on,the company received frequent feedback from customers on quality problems after the products developed by the first generation were put on the market,which caused a great blow to the company’s brand image.Therefore,the management of TP company proposes to improve the product R ＆ D quality management of the company.In the research on the improvement of product R ＆ D quality management of TP company,this paper combs the current situation of product R ＆ D quality management of TP company and analyzes its existing problems from the aspects of R ＆ D organization structure,personnel composition,product development process The corresponding improvement schemes are put forward in five aspects: design development and verification test and design change control,and the improvement effect of R ＆ D quality management is verified through the new product R ＆ D project ZW of TP company.The research results of this paper have a certain reference significance for the product R ＆ D quality management of small and medium-sized start-up companies in China’s medical device industry.