Medicinteknisk produktutveckling : Fixeringsteknik för talonaviculär artrodes

Sammanfattning: ABSTRACT The purpose of this study is to develop a fixation technique for talonavicular arthrodesis. A talonavicular arthrodesis is a problematic arthrodesis of the foot and is done when the patient is suffering from pain in the joint. There are two difficulties with this operation. At first, the operation is problematic in that it is difficult to reach the talus and navicular bones. The bones are positioned deep within the foot and surrounded by many other bones and tendons. This makes it difficult to fixate the bones. This problem indirectly causes the other problem. The fact that it is difficult to fixate the bones results in no direct method to perform the operation. Different surgeons have different solutions to fixate the bones which makes the operation vary in results depending on the surgeon who performs the operation. This thesis is a start-up of the project to solve the problem with a talonavicular arthrodesis. Therefore, the aim of the thesis is to investigate whether it is possible to find a standardized method of the operation and reach a final concept that could solve the problems with the operation. The method chosen for this project has been shaped by the standard EN ISO 13485:2016, which deals with quality management systems and requirements for regulatory purposes for medical devices. Behind the thesis is a case study carried out in parallel with a literature study which is the basis for this thesis The product development has been characterized by the regulatory requirements, as the medical device industry requires. The project began with a project planning which was then followed by a problem understanding phase. When the problem understanding phase was completed a concept development phase began that led to concept evaluation. The result of this project is a final concept. The concept is a staple designed with a strong focus on stress distribution in the joint surface and the limitations of accessibility to the joint. The concept is designed to standardize the fixation on talonavicular arthrodesis. The conclusion of the project is that the concept is considered interesting to go on with. However, a deeper understanding of quality assurance has been obtained during the project. The understanding has contributed to the realization that further validation and verification is required in order to realize the concept into a real product. Recommendations to proceed with the project is to do more tests and creating a quality assurance system that meets the requirements of the “Medical product agency”.