Purpose Medical technology manufacturers and innovators have raised the need for more transparency on health technology assessment (HTA) and evidence requirements. The aim of this project was to develop and evaluate an evidence generation tool, a process map to support evidence generation in the context of Swedish HTA. This was facilitated by mapping the Swedish HTA system and processes.

Methods The project undertook a mixed methods approach. Data collection and analysis was carried out to inform mapping of the HTA system and its processes, and evidence generation. A series of discussions were carried out with experts to refine the material. An expert workshop was organised to gather wider input on the current state of evidence generation for medical devices in Sweden. A proof-of-concept usability study was carried out to evaluate the evidence generation tool. The material was developed into a website.

Results Here we present an analysis of the Swedish HTA system and processes, and hurdles for medical device evidence generation. A tool was developed, evaluated, and presented on a dedicated website to support evidence generation for medical devices in the context of Swedish HTA.

Conclusions Evidence evaluation needs to be adapted for medical devices through wider and more informed collaboration between industry, assessors, patient representatives, and other stakeholder groups. This may increase the likelihood of more conclusive HTA. Further, improving the knowledge among companies and researchers on the HTA process may lead to more efficient clinical evidence generation. Further dissemination of the evidence generation tool may facilitate this.