Medical devices for health and sustainablility

Purpose and goal

The purpose of part two of the project, Medical Devices for Health and Sustainability - Increased knowledge through collaboration, was to raise questions about reasonable and necessary requirements for the introduction of innovative medical devices. Increased demands on evidence lead to more clinical trials, which in turn leads to higher costs for both companies and healthcare. The project raised this and other issues, such as the evidence grading system and how to include the patient perspective in evidence generation.

Expected results and effects

At a roundtable discussion, 19 stakeholders with different backgrounds, expert areas and assignments gathered to discuss how to develop and improve evidence-based decision-making for healthcare, and specifically the view of sufficient and necessary evidence of medical devices. The discussion about how the patient perspective should be incorporated into evidence as well as how and when the patient should be included is an intricate issue and this work will continue. Reports from the discussion can be downloaded from Swedish Medtech´s website.

Planned approach and implementation

The project dealt with a complex subject, with many stakeholders involved. However, the question of evidence is crucial for the introduction of, and access to, innovative medical devices. Therefore, the project gathered stakeholders for a roundtable discussion, which took place on 3/10 2017 in Gothenburg, in collaboration with Sahlgrenska Science Park. The conversation had four different perspectives: patient, care, authorities and companies, and all were represented. A progress report was compiled prior to the meeting in order to create a shared view of the present situation.

External links

Länk till Swedish Medtech för beskrivning av projekt kopplade till HTA och evidens. Rapporter för nedladdning.