| ObjectiveIn this paper, we describe the status of the medical device manufacturing enterprise in Guangzhou, figure out the differences of the current conditions among the different class enterprises, study the main factors influencing the regulatory behavior, and find out the problems existing in the present situation of enterprise and policy requirements from the basic situation of enterprises, the condition of quality-technology of enterprises, the condition of production and business of enterprise, the condition of regulatory behavior of government and the demand of policy. In this way, we can provide foundations for the further research on Guangzhou medical device industry development and the perfection of regulatory work in relevant departments. MethodsThe investigation objects were medical device manufacturing enterprise with activities of production and business in Guangzhou before December 31, 2012,which were classified asⅠ-class enterprise、Ⅱ-class enterprise、Ⅲ-class enterprise. Selected the object by using the stratified random sampling method.The total sampling rate was 75% and through sampling into three layers, the sampling rate of each layer were respectively the percentage of each class enterprises accounted for the total enterprises.A self-made questionnaires about the status of development was used to survey the medical device manufacturing enterprises in Guangzhou.The quantitative data was described statistically by mean and standard deviation while the categorical data was described statistically by frequence and percentage. Analyzed data with the statistical methods of chi-square test, variance analysis, and logistic regression analysis. ResultsThis study surveyed 316 companies containing 33Ⅰ-class enterprises, 212 Ⅱ-class enterprises, 71 Ⅲ-class enterprises, which had produced a total of 1742 kinds of products and 252 kinds of new registered products in 2012.In the basic status, 77.9% enterprises were enterprise of small-miniature asset;54.1% products were Ⅱ-class product;The rate of new registered products of Ⅱ-class product was the highest, which was 18.3%;85.0% enterprises were renting house;An average area covered by housing construction was(5909.6±41286.4) m2; In the company, 61.0% managers, 55.2% head of department of quality and 40.2% head of department of production had a degree which was bachelor degree or above. The average number of personnel gaining high school diploma was 32±95, while technical worker under junior title 25±87,which were the highest. In the important positions, the average number of sale was 10±24, which was followed by the average number of researchers 8±17、internal auditors of quality 4±4、full-time inspectors 4±4. In the type of talented person lacked, 56.3% enterprise lacked professional and technical people, followed by 55.7% enterprises lacking market-sale, 30.7% enterprises lacking professional manager,15.7%enterprises lacking after-sale.In the condition of quality technology of enterprise, 96.1% enterprises had established the quality-inspection institution, 94.3% enterprise had established quality system and 78.4% enterprise had established research institutions. In the condition of production and business, the products of highest value of output and sale were both the equipment of extracorporeal circulation and blood, whose value were respectively 10526.2±14678.6 ten-thousand-yuan and 10377.9±145431 ten-thousand-yuan. The products of 10 top highest value of output were mainly Ⅱ-class product, Ⅲ-class product, while the products of 10 top highest value of sale were mainly mainly Ⅰ-class product.In the condition of regulatory behavior of government, 87.4% enterprises satisfied with the regulation behavior of government.Ⅰ-class enterprise(OR = 0.2, P < 0.05) and professional and technical personnel(OR = 0.4, P < 0.05) were the dangerous factor of regulation behavior of government.In the condition of demand of policy for enterprise, among 15 demands of policies and measures for enterprise,there were four policies and measures whose rate of demand were more 80% which was the the highest rate.And the policies were inclined to promote the competitiveness of the enterprise.Compared with other two classes of enterprise:The rate of the legal representative whose degree were bachelor degree or above inⅠ-class enterprise was the highest;The rates of enterprise of small-miniature asset、quality system’s establishment inⅡ-class were the highest; In Ⅲ-class enterprise:the rate of enterprise of medium-sized asset,the rate of personnel whose degree were master or bachelor degree, the rates of managers and head of department of technology and production whose degree were bachelor degree or above were all the highest;the number of researchers was the most;it lacked professional and technical personnel mostly. The average areas covered by enterprise’s office and checkout room in Ⅲ-class enterprise were larger than that of Ⅰ-class enterprise.The differences above were statistically significant(P < 0.05). ConclusionGuangzhou medical device manufacturing enterprise has an unreasonable industrial structure and mainly operates low-grade products. The enterprise can promote industrial transformation by the means of using merger & acquisition, increasing finite supports or improving market access conditions.Housing construction composition isn’t adjust to the High-quality market. It’s necessary to strengthening the governmental supervision and perfect relevant punishment mechanism.The staffs in enterprise show many deficiencies in their educational backgrounds, management level and professional technology, so it needs to change by the way of strengthening job training, bringing the professional and technical people and improving in the management. It’s lack of funds to input into R&D, and also need to manage scientific research resources reasonably. However, its quality system is imperfect, and it’s lack of supervision. In other words, should strengthen the supervision personnel team ability construction, improve the supervision and management mechanism.The high-end products always have a high output and the low-end products are always sold quickly,so the low-end enterprise must speed up industry’s transformation of the low-end product to improve competitiveness of market. |
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