Production Requirements of Polymeric Medical Devices

The medical devices industry has a healthy growing trend nowadays and a promised future. However, a broad range of materials for selection and several specific requirements which concern both the functionality and safety of products are regarded as difficulties by manufacturers who want to set foot in this area. The goal of this thesis is to illustrate a clear pathway from raw material to final products for the manufacturers with production experience of polymeric material based devices. This thesis is divided into two parts. The first half of this study is a synopsis of a valid production of medical devices. At each processing stage, the requirements and corresponded solutions are generally discussed based on scientific publication, industrial experience and/or related standards and regulation. To emphasis on product validation, the discussion of regulatory issues is infiltrated along the whole medical devices processing procedure. The becoming manufacture can follow this synopsis to evaluate the relevant requirements and solutions. The Second half of this thesis is focusing on polymeric materials in a material-application manner. As a well-established material category which used in medical devices industry, polymeric materials are preferred candidates due to their processing flexibility, low cost and function diversity. Silicone rubber, thermoplastics and thermoplastic elastomers are three grouped objects with thorough discussion. Subsequently, the possible applications are introduced and categorised by contacting condition with human body. In this part, the commercialized materials and available applications are summarized to provide a direct impression of selection for manufacturers. As the end of comprehensive discussion, two case studies are given to illustrate the practice in reality. In this part, the manufacturer can choose the interested material and move forward to possible application as a fast start-up