Many of the products that are developed based on health data are either medical devices or medical technologies. For procurement, subsidy and use in healthcare additional evidence may be required beyond what is necessary for meeting the regulatory requirements (e.g., CE-marking). Evidence generation for MedTech is costly and complicated with several unique challenges in terms of study design and execution. The demands on evidence from a healthcare-perspective and health technology assessment (HTA) are often unclear. This leads to four out of five products being assessed to have insufficient evidence based on HTA.
Evidence4Med.Tech is a tool to support MedTech innovators in their clinical evidence generation process by avoiding de most common pitfalls and working more systematically towards meeting the demands of the Swedish HTA organisations. This service can be delivered as an introductory workshop, workshops focused on an innovator’s specific product, and as a consultancy service.