The development of medical devices is a complex process, involving many stakeholders. Often, the point of view of future users (i.e. physicians and hospital staff) is neglected or is taken into account only at a relatively late stage of development, leading to an inefficient, and sometimes even ineffective, development process. The overall goal of KIZMO is therefore the development of a prototypical clinical platform for promoting user integration in the development and testing of innovative medical technologies. The Clinical Innovation Center for Medical Technology Oldenburg (KIZMO) was initially established for a limited range of fields (audiology, phoniatrics, otorinolaryngology, and neurosurgery) at the Lutheran Hospital in Oldenburg. Following successful assessment, the concept is to be made available to other fields of medical technology on a permanent basis. The focus is on tools for diagnosis and treatment used by physicians and clinical staff.
KIZMO continually involves all relevant stakeholders in the development process for medical devices. The platform is implemented as a central contact and coordination office (hub), thus ensuring a holistic and efficient approach to development, which, if required, accompanies every new medical device from conception to post-market surveillance.
KIZMO's range of services is targeted at manufacturers of medical devices who wish to innovate in clinical settings and thereby rely on cooperation with a competent service partner.
Industry-in-clinic platforms (“Aufbau von Industrie-in-Klinik-Plattformen zur Entwicklung innovativer Medizinprodukte“, Federal Ministry of Education and Research, BMBF)
• Lutheran Hospital Oldenburg (leading)
• University Hospitals for ENT Medicine and for Neurosurgery at the Lutheran Hospital Oldenburg
• Hörzentrum Oldenburg GmbH
• HörTech gGmbH
• EFNW GmbH
• Carl von Ossietzky University of Oldenburg, Department of Medical Physics
September 1, 2015 to February 29, 2016 (6 months)