这只是新的市场研究中的一个发现“超越医疗器械制造业的权衡：平衡创新，质量和合规性，同时提高利润，”2012年7月由Cambashi（www.cambashi.com）发布，这是一个领先的研究和咨询公司生产行业。两者都被定义为“进展”的公司更有可能加速他们的创新步伐加上，这是对关键质量指标进行重大改进的可能性是审计结果，投诉，不良事件和供应商质量等的两倍。
By focusing on product quality at the source rather than just quality inspections, Advancers have lowered their cost of quality and compliance. In fact, the majority of survey respondents, including quality professionals, executives and others (except regulatory affairs staff) believe their company does more quality checks than are actually required by the regulations. Even 40 percent of the regulatory professionals are in agreement. Clearly, unnecessary checks, balances, and error-proofing add cost and time to the process, which may be hurting profitability and business performance.
While logic says it’s easier to grow dramatically as a small company, the Advancers are somewhat more likely to be large. Advancers are far more likely to use software of all kinds. Still, when faced with a need to grow, companies of any size can create the discipline and implement systems that work. About an equal portion of advancers are small (under $25M annual sales), medium (between $26M and $1B annual sales) and large (over $1B annual sales).
“Respondents say that the top two challenges to high quality are changes in regulations and changes in products. Changes in regulatory requirements are simply a fact of life, and the data shows that the pace of innovation is likely to increase. Clearly, companies must find better ways to address these changes and keep quality high. Spreadsheets, homegrown software, and paper-based processes will be unable to keep up with this pace of change. Fortunately, applications do exist to serve nearly any functional need for companies of all sizes in the medical device industry,” according to lead researcher Julie Fraser.
The study is based on over 120 responses from individuals in medical device manufacturers or their direct materials suppliers. The study focused on the challenges Medical Device manufacturers face in seeking to not only grow but also to increase quality and financial performance in the face of complex and changing regulatory requirements.
这款在线调查涉及受访者的现状，挑战和改进以及绩效改善成就。问题还询问了通过全球供应链和产品生命周期支持可靠，安全和高质量的医疗设备制造的流程，供应商，软件技术，信息流和战略行动。除了在线调查外，还通过电话采访了一些教授，他们的见解是在综合报告中引用的。
这项研究是由可能的支持下the UBM Canon Medical Device Media Group, plus the financial backing of premium sponsors Apriso Corporation (www.apriso.com) and Dassault Systèmes (www.3ds.com), and supporting sponsor Epicor Software Corporation (www.epicor.com). These companies seek to serve the MedTech industry by offering software and deep expertise on how to best ensure quality, growth and profits in this highly regulated operating environment.
Report Indicates Many Medical Device Manufacturers Overdoing Compliance Checks
Most companies in the medical device industry are growing, but only a quarter have managed to both grow and make major improvements in business performance.
2012年7月23日
