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THE CHALLENGES OF CHOOSING THE RIGHT POLYMERIC MATERIAL FOR TODAY'S MEDICAL DEVICES

机译:为今天的医疗器械选择合适的聚合物材料的挑战

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Although the process of selecting the right polymer for new medical devices has not changed very much in the last 10 to 15 years, the degree of complication seems to have grown exponentially. The variety of specially designed materials, the number of suppliers, some under the same name or others with a new corporate moniker, and the availability of reference databases puts a glut of information into the hands of the design engineers. But how does one successfully navigate through this information and decide on the one material that is best for their particular application. It is much more difficult to find live technical support from either suppliers or from database providers. With staff reductions and department consolidations, many companies have also lost experts from their library of specialists that in the past have led the selection of the optimum polymer for new applications. No longer do companies have the historical databank of material expertise or on-staff resources for guiding new project efforts. The level of experience in many companies is down while the breadth of knowledge is much more focused. This coupled with the evolution of far more complicated devices that often combine advances in multiple new technologies such as conductive polymers, shape memory materials, drug eluting devices and polymers that dissolve in the body all complicate the process of selecting the right polymer for the application. Medical devices designers and engineers are tasked with selecting just the right polymer for their devices; and this requires keeping in mind all the various requirements that must be satisfied including functional requirements, chemical and biological requirements and manufacturing, assembly and sterilization. Collectively, results of the evaluation of the materials used in the construction of medical device and the function of the devices together contribute to what many refer to as the biocompatibility of the device.
机译:尽管在过去的10到15年中选择了用于新医疗器械的右侧聚合物的过程并没有变化,但并发症的复杂程度似乎已呈指数增长。各种专门设计的材料,供应商的数量,一些与新的企业绰号的名字或其他人,以及参考数据库的可用性将信息纳入设计工程师的手中。但是如何通过这些信息成功导航并决定最适合其特定应用的材料。从供应商或数据库提供商中找到实时技术支持是更困难的。凭借员工减少和部门整合,许多公司也丢失了他们的专家图书馆的专家,过去已导致新应用的最佳聚合物选择。公司不再有资料专业知识或工作人员资源的历史数据库,以指导新的项目努力。许多公司的经验水平落后,而知识的广度更为集中。这加上了更复杂的装置的演变,这些装置经常与多种新技术的进步相结合,例如导电聚合物,形状记忆材料,药物洗脱装置和溶解在体内的药物洗脱装置和聚合物中,所有这些都将其复杂化为应用施用右聚合物的过程复杂化。医疗器械设计师和工程师是任务的,选择只为其器件选择合适的聚合物;这需要牢记必须满足的所有要求,包括功能要求,化学和生物要求以及制造,组装和灭菌。统称,用于建造医疗装置的材料的评估结果以及器件的功能在一起有助于许多人认为是设备的生物相容性。

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