Fabrication and Commercialization Pathway for an Intravenous Catheter Used in Low-Temperature Plasma Treatment
Low-temperature plasma medical treatment has emerged as a promising new method in medicine. One of the application methods for LTP in medical treatments is to use a catheter to reach and treat a target internal to the body. Inspired by recent advances in optical fiber manufacturing, we have designed an extrusion nozzle for including electrodes and dielectric material in catheters during their manufacture, enabling the generation of localized, non-equilibrium plasma in body fluids. As we consider bringing the catheter to market, this thesis focuses on the information and steps required to bring a medical device to market and considers what work needs to be achieved to meet the requirements.
The thesis provides background on IV catheters and low-temperature plasma treatment. Then it describes the manufacturing process of the designed catheter for administering plasma treatment within the body. With this background information, we discuss the requirements to obtain FDA approval, as that is critical when commercializing any medical device and for ensuring the safety and effectiveness of a medical device. This process requires defining the intended use of the catheter, choosing the correct commercialization pathway, conducting the required clinical test(s), and submitting the application for FDA approval. By analyzing the requirements listed by the FDA and researching similar approved products in the FDA database, we then discuss what information needs to be prepared and what else is needed to meet the FDA’s requirements. The information from the FDA helps us determine the outline for commercializing a medical device and helps us think about what is required for the catheter at its current stage of development.
