Navigating value in digital health : factors shaping digital medical device value propositions for healthcare in the EU

Abstract

Digital health technologies have significant potential to address challenges within healthcare systems across European countries. The rapidly expanding SME-driven health technology sector plays a crucial role in this growth. However, digital medical device manufacturers face challenges demonstrating value to a diverse range of stakeholders and complying with the European Union’s regulatory requirements.

This thesis aimed to identify and describe sector-specific factors that influence the value propositions of digital medical devices targeting EU healthcare systems, considering the perspective of SMEs seeking to enter the market. A narrative literature review, combined with inductive content analysis, was conducted on ten peer-reviewed studies published between 2024 and 2025.

The results showed that value propositions for digital medical devices aimed at EU healthcare systems are influenced by multiple stakeholder perspectives, regulatory requirements, and funding decisions. These factors are interconnected, shaped by changing cultural and political contexts, and vary across EU member states. The findings suggested that SMEs developing digital medical devices can strengthen their value propositions for healthcare customer segments in the EU by considering these dynamics and staying informed about future developments. The research also introduced structured tools, including early-stage health technology assessment, to help navigate this complex environment. The insights can be leveraged not only by ventures in the digital medical device sector but also by any entity seeking to understand digital health dynamics in the EU.