摘要: | 由於文明進步所帶來的全球經濟成長與高齡化,糖尿病患者逐年成長。根據國際糖尿病聯合會(International Diabetes Federation, IDF)的統計,2010年到2030年全球糖尿病人口將由4.3億成長到5.6億人,盛行率也將由6.4%成長至7.7%。因此血糖儀產業未來發展空間很大。目前全球約有96%血糖儀產品市場為國際大廠所寡佔,競爭非常激烈。台灣廠商除了有效整合關鍵核心技術、優秀研發能力和低成本優勢之外,致勝關鍵就是如何藉由完善有效率的「品質驗證」方法,順利取得醫療器材認證,加速產品上市的時程,如此方能早一步搶得市場的商機。 本研究將利用整數線性規劃來分析D公司從2013年1月1 日至2015年12月31 日,三年間各型號血糖儀產品的軟體驗證異常資料去找出符合限制條件的目標測試組合。經實驗證明,本論文建立的方法,不但可以大幅減少測試項目來提升軟體測試的效率,更可以確保一定程度的測試涵蓋率。未來將此方法導入自動化後,更可以提供給相關研發和品保單位測試標準化之參考依據及建議。 ;Due to the progress of civilization brought about by the global economic growth and aging, the diabetes grow up yearly. According to Statistics by International Diabetes Federation, IDF, the worldwide population of diabetes will grow from 430 million to 560 million people from 2010 to 2030, and the prevalence will grow from 6.4% to 7.7%. So, the industry of blood glucose monitoring meter will develop in the future. The oligopoly about 96 %blood glucose monitoring meter market by international companies, the competition is fierce. In addition to the effective integration of the key core technology, outstanding R&D capability, and cost advantage for Taiwan manufacturer, the key to success is how to improve efficiency by a "quality certification " approach , successfully to achieve certification of medical equipment , and to accelerate time to market process in order to garb market opportunities. In this study, we use integer linear programming to analyze D Company of validation exception information of each model glucose meter software product for the period of three years from January 1, 2013 to December 31, 2015 to find out the conditions of the target test combinations.Experiments indicate that, by the method we establish, not only reducing test project to improve the efficiency of software test , but also ensuring a certain level of test coverage .In the future, introducing this method into automation can be provided to the relevant research and development and quality assurance unit of reference for standardized tests and recommendations. |