What is happening in the development initiative: Support measures for clinical studies on medical devices

Karin Skoglund has been project manager for the development initiative Support measures for clinical studies on medical devices. Among other things, the work has resulted in suggestions on how information on kliniskastudier.se can be developed to meet the needs of all those involved in clinical studies with medical devices. Read more about this and what will happen next in the interview below.

karin skoglund projektledare

Why did we invest in an initiative on support measures for clinical studies on medical devices?

In connection with support services in the regions and nodes, we have encountered various types of challenges linked to conducting clinical studies on medical devices. The reason for challenges in this area is probably because the regulations for medical device studies are not as well known as the regulatory framework for clinical trials on medicines. In addition, collaboration between the academy, health care and industry looks very different for medical devices. We wanted to investigate special needs related to medical devices and to evaluate whether we can make a targeted effort to help ensure that more safe, high-quality studies are carried out.

What was the result of the development initiative?

In a pilot study, we have identified the needs of academia, industry and healthcare when conducting clinical studies on medical devices. We have also analyzed which support functions and other resources that are already available. We have developed a number of proposals for actions that could meet several of the identified needs. A relatively comprehensive pilot study has given the opportunity to develop well-founded proposals for initiatives that hopefully will make a difference for those seeking support for medical device studies in our national infrastructure in the future.

What happens next?

Currently, the Committee for Clinical Studies discusses the prioritization and funding of the proposals presented in the pilot study. We have just been notified that we will be able to start up the first implementation project in the beginning of 2018. This work will be about developing the information on the kliniskastudier.se website to make it a neutral and quality assured source of information for all stages of a clinical study on medical device. Later in 2018 we are awaiting a decision on an education initiative in the medical device field, aimed primarily at academia and healthcare. Similarly, we hope for a decision to establish a national group with representatives from the regional nodes that can act as an "expert function" and point of contact in the field of medical device.