NorTrials Medical Devices – Professional Advice and National Network

Inquiries to NorTrials concerning testing of medical devices often differ from requests for clinical trials on pharmaceutical products. The pharmaceutical industry has special expertise in clinical trials, and the development of medicines usually follows a similar course. The pharmaceutical industry contacts the hospitals when they have a product that is ready to be tested and a plan for how to do it.

For medical devices, the situation is quite different. Although there are large international companies that develop and manufacture medical devices, there are also many small start-up companies and individuals who have a product under development, or just a good idea, that need help to find out whether there is a market for their product and how to get the necessary approvals.

Medical devices comprise very different products and can include everything from plasters and prostheses to advanced surgical equipment, or mobile apps where patients record health data and communicate with healthcare personnel. The requirements for approval depend upon the type of product. Medical devices are classified in four risk classes and it is the intended purpose - and possible risk associated with using the device - that determines the risk class. The requirements for documentation therefore depends on which medical claims the manufacturer wishes to document and this will in turn determine how the device can later be used.

When NorTrials Medical Devices receives requests from companies and researchers, they always start with a physical meeting where a thorough survey is made of how far the company is in the product development process, what use they are seeking approval for and what they specifically need help with. Many are not aware of the relatively complicated regulations for the approval of medical devices, so informing about this is an important part of the survey.

Inquiries are submitted via the NorTrials feasibility portal, but it is important that the companies do not attach documents describing the product before the necessary patents, copyrights, etc. are in place.

After the mapping has been done and it is clear what the company needs from the hospitals, NorTrials Medical Devices contacts relevant collaborators.

NorTrials Medical Devices collaborates with many health technology clusters, such as Norway Health Tech, Smart Care Cluster, Health2B and Oslo Cancer Cluster. This ensures an overview of the possibilities for trial and testing of medical devices, i.e. which test bed possibilities exist for different types of medical technology in Norway. It is also worth mentioning that, for example, Sunnaas Hospital has a well-established system for receiving inquiries from industry. NorTrials Medical Devices and Sunnaas work together to coordinate inquiries and ensure the best possible testing of medical devices for the industry. 

For testing in less specialised environments, hospitals can be contacted via NorTrials coordinating unit and their network of contact persons in all Norwegian hospitals.

An inquiry to NorTrials Medical Devices can therefore provide access to professionals and testing environments throughout the country.

The most important, however, is to get a thorough review of the project and a better understanding of what it takes to succeed.