Evidence4MedTech
Supporting Evidence Evaluation and Generation in a Swedish Context
Clinical research for medical devices is a costly and lengthy process. We have developed a tool to support clinical evidence generation to ensure that this results in sufficient and relevant evidence in the context of Swedish health technology assessment (HTA). Here you will find a process tool for evaluating available evidence and avoiding the most common pitfalls and hurdles during evidence generation.

This website supports evidence evaluation and generation for medical devices by providing information on the Swedish health technology assessment (HTA) process, including hurdles, enablers, and supplementary resources. It is aimed at smaller MedTech companies, start-ups, and innovators in academia and healthcare.


You can read more about the the work in the companion paper, published in Health and Technology:

Darwich et al. 2025. Evidence for MedTech - The Swedish Case of Health Technology Assessment and A New Tool to Navigate It. Health and Technology 15:67-80

Download the new digital HTA guide Here.

The website contains the following pages:




Overview, 

which presents an overview of (1) the Swedish HTA System, including the actors involved in validating a medical technology and (2) the evidence generation process.

Evidence Evaluation, 

which presents the requirements according to which your evidence will be evaluated.

Evidence Generation, 


which presents a step-by-step guide to generating the evidence required to assess your medical technology.

Database, 



which presents a searchable database of an analysis we have conducted on HTA reports published between 2016 and 2024.

HTA Aspects, 



which presents a searchable list of all the aspects that were considered in the HTA reports between 2016 and 2024

This material was developed through a collaboration between KTH Royal Institute of Technology1, Danderyd Hospital2, Karolinska Institute3, and Swedish Medtech4, by Adam Darwich, José Bertil González Guve, Suzanne Palmcrantz, and Malin Hollmark. We would like to acknowledge and thank all the experts and stakeholders that have provided input and feedback throughout the development. We include here a link to the report on the expert workshop that was arranged as a part of this process: Report.pdf.



The project was funded by Medtech4Health, Vinnova’s Strategic Innovation Programme