The Intervention Centre has developed a Testbed for medical devices that serves as a platform where new early stage and pre-market diagnostic and therapeutic equipment and devices can be evaluated. The Testbed has capabilities to perform testing in various phases of development of new devices or equipment. The services include performing both pre-clinical and clinical testing.
The purpose of the Testbed is three-fold:
The Testbed uses resources within the Regional Technological Core-Facility of the Intervention Centre to perform necessary tasks using capacity not utilized by researchers using the facilities. The Core Facility has to its disposition three highly advanced and hybrid operating theaters as well as multi-disciplinary staff including health personnel and technologists. The focus areas of The Intervention Centre are image-guided intervention and radiology, robotics and simulators, biosensors and telecommunication and diagnostic physics.
The Testbed can also serve as a gateway to Oslo University Hospital (OUS) or other South-Eastern Regional Health Facilities and identify clinicians who may be interested in testing new equipment or devices.
The Testbed personnel will initially perform a brief evaluation of projects submitted. If necessary, appropriate experts from other departments in Oslo University Hospital will be consulted.
After initial evaluation a written report will be provided to the requesting company and initial recommendation given. The recommendation may give advice about the possibilities for testing and whether The Intervention Centre or other departments may conduct the necessary studies.
If the testing may be performed at the Intervention Centre, the Testbed staff may participate in developing protocols, submit appropriate applications to authorities, organize the studies, statistical analysis etc. Such services will be billed at market prices.
The TTO organization Inven2 serves the commercial functions of the test-bed and will negotiate individual prices for each project depending on project type and hospital resources necessary.
Schematic process description of potential TestBed deliveries to early phase Start-Up companies (click figure for large view):
The Testbed cooperates with external partners, usually companies wishing to test their products, which may be in various phases of development. The form of cooperation will vary depending on the development stage of the product and may include experiments performed ex vitro or in research animals, in volunteers or in-patients. All experiments are performed in strict compliance with laws regarding Ethical Standards (REK), humane treatment of animals (FOTS) and all patients or volunteers must give full informed consent.
The organization of the work will be variable depending on the project phase and type. In certain cases, it may be typical contract research where the manufacturer covers expenses; in others, the product evaluation may be included in PhD programs and the manufacturer may be a cooperating partner.
Visit the web page of the MedTech Test Facility at Oslo University Hospital. The Test Facility is a professional gateway for companies with new high tech equipment in need for early phase clinical trials.
English is the main language in this web portal. Some information is also available in Norwegian
The Interventional Centre receives donations to medical research. Questions related to donations can be sent to head of department professor Erik Fosse.
Author: Erik Fosse
Publisher: Det Medisinske Selskap 2007
Price: 180 kr
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