What is happening in the initiative? Support measures for clinical studies in medical technology
At the same time as new EU directives for medical technology come into force, the development initiative “Support interventions for clinical studies involving medical technology” has concluded its needs analysis. Karin Skoglund is the project manager at Forum Southeast, and in the interview below you can read more about the project and what will happen next.
Why do we have a project on medical technology within the framework for Clinical Studies Sweden?
Clinical studies using medical devices often encounter entirely different problems and obstacles in their implementation compared to other types of clinical studies. Within the framework for our national infrastructure for clinical studies, Clinical Studies Sweden, we should therefore investigate in which way we can support clinical studies using medical devices specifically. Our development project has been aimed to do just this – investigate what the needs are from the viewpoint of academia, companies and healthcare, and on the basis of these see how we can contribute to enabling more studies using medical devices to be carried out in Sweden.
What has happened since the project started?
I think we have managed to get a relatively good picture of what the needs are, in particular for academia and healthcare personnel. We have carried out interviews with 29 persons within these categories throughout the country, and also partaken of a large amount of information on the challenges encountered by companies. Thereafter we have worked hard at analysing how we can address the needs we have found. It looks like we will need to implement measures such as using each other’s skills better within the nodes, developing our joint website and coordinating our actions at local and regional level with the innovation-supporting operations that are in place.
Another positive effect of the development initiative has been that so many parties from various directions have shown interest in the project, and I can see several opportunities for collaboration in the future. We who work in the nodes have also become better acquainted with each other as a result of the project, both as persons and as organisations, and it feels like we have good prerequisites for conducting any continuation projects together.
What will be happening in the project in the near future?
Now, all the wise things said by various parties during the project will be put into writing and presented to all stakeholders, including the Committee for Clinical Studies. I think we would be wise to equip ourselves well in the nodes, in order to best support clinical studies using medical devices. The new EU directive will probably mean that considerably more clinical studies using medical devices will be carried out in the future, and here our support functions have an important job to do to contribute to as many studies as possible are carried out – with high quality as well, of course.