NURSING INNOVATIONS IN CARDIOVASCULAR THERAPIES BY QUALITY AND PROJECT MANAGEMENT STRUCTURES AT A UNIVERSITY LEVEL

Aim: Development of novel devices and treatment concepts at a university research level is essential in advancing therapeutic cardiovascular technologies. Bridging the gap between early university level device developments and clinical application is often complicated by incomplete documentation, disregard of regulatory requirements and poor organization. The loss of time and knowledge during the transfer to an industry standard is costly and detrimental to innovation. Methods: Quality and project management (QM and PM) were implemented in university research. A main focus was placed on technical documentation, including design changes and setbacks to adhere to industrial standards. To prove the feasibility of the concept, QM and PM processes were incorporated into the everyday workflow of specific projects with the aim of clinical application. Results: Implementation of QM and PM was well tolerated once the benefits like shortened processing times, ensured compliance with regulatory requirements, and improved sustainability in knowledge were noticeable. Defined organizational structures provided more transparency for complex and creativity-driven projects. Conclusions: Our experience shows that integration of QM and PM standards at a university level is possible. It constitutes a solid basis for the transfer to clinical application. Since every research project needs and withstands different degrees of QM and PM, an adapted and scalable QM system for university research projects is under development based on our findings and experience.