| Along with China's economic development and the trend of population aging and gradual improvement of People's health consciousness,the growing market of medical device industry,currently is the one of the most glooming industries[1].Medical device manufacturer in China at the beginning of the reform is approx.100 and it has been increased to 1.42Million at the end of 2016.However,China medical device market scale only has 1/5 scale of its pharmaceutical market,its far behind of the level 1:1 in developed countries.In addition to that,local medical device manufacturer,which volume and market capitalization are relative small.The top 100 ranking that issued by Medtech Insight in 2016,in which,no Chinese company is listed,and in the global revenue ranking list,the biggest player is Medtronic,which avenue in 2016 is 28.83 billion USD while the biggest local player Xinhua Medical,which revenue is only 8.36 Billion CNY.There is the difference nearly 25 times.Medical device industry as an urban construction,which has broad development prospect in china.However,most of local medical device manufacturers,which scale is small,product aims to middle and lower market,product development capability is weak;Development process management capability is shortage,all those elements that constrains local medical device manufacturer's further development.Moreover,this gets local company difficulty to gain advantage in fierce market competition.Medical devices are characterized by diversity,complexity,high investment in technological innovation,long product development cycle and high requirement of safety and effectiveness,the development of medical devices involves multiple disciplines and regulatory compliance as well.A complete medical device development process that includes project approval,design planning,design development,design input,design output,design transformation,design verification,design confirmation,design change and design confirmation etc.steps.Inadequate management of medical device development may not only lead to product quality issue and safety risk,but also will generate regulatory compliance issue;therefore;it is of great significant to improve the management of medical device development for both manufacturers and society.AG Pharma business unit is a subsidiary of K group,an American listed company.in China.As a leader in China's packaging industry,AG's business covers three areas:Beauty,Food and Beverage and Medical,Over the past 20 years,AG's business in China has been growing at an annual rate of 20%.in order further expand their business,AG pharma business unit started to develop their first generation of dry powder inhalation device.During the device development process,due to risk management is insufficient,device safety evaluation process is missing,Equipment validation is inadequate,change control cannot be well implemented,document control does not cover each critical aspect,this results in a big scrap during validation process and that further results in AG pharma business unit eventually cannot achieve ISO13485 audit.This article investigated the issues that occurred during the development of the first generation medical device at AG pharma business unit.According to the investigation and integrate the requirement of ISO13485.2016,ISO14971.2016 and Medical device GMP,Considering AG pharma business unit actual condition,this article well addressed improvement action for risk assessment,product safety,equipment validation,change control,documentation control etc.5 parts.Moreover,the effectiveness of those actions have been demonstrated in the second Dry powder inhalation device development process.The study achievements of this article is instructive and meaningful to the product development process control of Medical device manufacturer. |
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