Digital health technology companies' experiences of the Finnish Digi-HTA method: An interview study

Health Technology Assessment (HTA) is becoming a core activity for digital health technology companies. Engaging with HTA at the earliest possible stage is beneficial for companies in the development of solutions and in optimizing and prioritizing their research and development work. However, companies face challenges in engaging with HTA, and knowledge about HTA from their perspective is limited. This study aimed to describe the experiences of digital health technology companies of the Finnish Digi-HTA and identify factors that motivated, enabled, and inhibited their engagement in the Digi-HTA process. Data were collected through thematic interviews with companies that had completed Digi-HTA and had a valid assessment. Seven remote interviews were conducted between August and October 2024, and the data were analyzed using inductive content analysis. Companies' experiences with Digi-HTA were mainly positive. The most negative experiences were related to the perceived low effectiveness of Digi-HTA. Nine common drivers for companies in the Digi-HTA process were identified: competition, customer requirements, preparation for future demands, solution for professional use, company strategy, external evaluation, openly available criteria, easy access to the process, and a cost-free process. Nine enablers were also identified: planning, understanding of Digi-HTA, adequate resources, organized task distribution, commitment, company culture, medical devices and certifications, available documentation and evidence, and controllable solution. In addition, companies faced four overarching barriers in the Digi-HTA process, including limited resources, incomplete documentation and evidence, uncertainty about the criteria and requirements, and lack of communication with the evaluator. The findings contribute to a better understanding of companies' perspectives on Digi-HTA and highlight the importance of improving their engagement. It is also important to promote the overall effectiveness of Digi-HTA at a national level. The research results may be useful in developing the capacity of companies to engage in HTA processes.