# Navigating Value in Digital Health: Factors Shaping Digital Medical Device Value Propositions for Healthcare in the EU

> Effective value propositions for EU digital health reflect shifting stakeholder, regulatory, and funding dynamics.

## Context and Challenges in EU Healthcare
Europe’s health systems are currently strained by demographic shifts, a rise in chronic conditions, and healthcare worker shortages, necessitating more efficient resource allocation (OECD & European Commission 2024). While "value-based healthcare" is a growing priority, there is no universal consensus on the definition of value, as stakeholders—including patients, physicians, providers, and manufacturers—hold differing interests (European Commission 2019). Furthermore, a disconnect between the healthcare and technology sectors often hinders the successful translation of scientific innovation into practical medical devices (Bergsland, Elle & Fosse 2014). Despite these hurdles, digital medical devices offer significant potential to improve access to care and provide added convenience for patients (Essén et al. 2022).

## The Digital Medical Device Industry in the EU
The digital medical device industry is a vital economic contributor in Europe, largely driven by small and medium-sized enterprises (SMEs) (European Commission n.d.). However, these manufacturers frequently struggle to demonstrate value to diverse stakeholders while navigating complex EU regulatory requirements. These challenges often lead startups to pivot toward consumer-facing products or alternative markets, such as the United States (Maresova et al. 2021; Mantovani et al. 2023).

## Research Overview
The master’s thesis, *“Navigating Value in Digital Health: Factors Shaping Digital Medical Device Value Propositions for Healthcare in the EU”* (2026), aimed to identify the sector-specific factors influencing value propositions for SMEs entering the EU market. The study utilized a narrative literature review and inductive content analysis of ten peer-reviewed articles published between 2024 and 2025.

## Key Findings
The research concluded that value propositions for digital medical devices in the EU are shaped by an interconnected web of stakeholder perspectives, regulatory frameworks, and funding decisions. These factors are further influenced by evolving cultural and political trends that vary across member states. To succeed, companies must:
* Understand the specific factors shaping the EU market.
* Stay updated on future regulatory and policy directions.
* Utilize structured tools, such as early-stage health technology assessment, to navigate the complex environment.

## Authors
* **Meri Mäkelä**, Student (Digital Health), Master School, Savonia UAS, Kuopio, Finland
* **Bryn Lane**, CFA, Adjunct Lecturer, Master School, Savonia UAS, Kuopio, Finland
* **Liisa Klemola**, PhD, R.N., Senior Lecturer, Master School, Savonia UAS, Kuopio, Finland

## References
* Bergsland, J., Elle, OJ. & Fosse, E. 2014. Barriers to medical device innovation. *Medical Devices: Evidence and Research* 7, 205-209. https://doi.org/10.2147/MDER.S43369. Accessed 16.9.2025.
* Essén et al. 2022. Health app policy: international comparison of nine countries’ approaches. *npj Digital Medicine* 5 (31). https://doi.org/10.1038/s41746-022-00573-1. Accessed 11.3.2026.
* European Commission 2019. Directorate-General for Health and Food Safety, Defining value in ‘value-based healthcare’. Report of the Expert Panel on Effective Ways of Investing in Health. Publications Office. https://data.europa.eu/doi/10.2875/35471. Accessed 25.11.2025.
* European Commission n.d. Public Health – Medical Devices Sector – Overview. Website of the European Union. https://health.ec.europa.eu/medical-devices-sector/overview_en/. Accessed 1.9.2025.
* Mantovani, A. Leopaldi, C. Nighswander, C. & Di Bidino, R. 2023. Access and reimbursement pathways for digital health solutions and in vitro diagnostic devices: Current scenario and challenges. *Frontiers in Medical Technology* 5, 1101476. https://doi.org/10.3389/fmedt.2023.1101476. Accessed 31.5.2025.
* Maresova, P., Rezny, L., Peter, L., Hajek, L. & Lefley F. 2021. Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic. *Frontiers in Public Health* 9, 666453. https://doi.org/10.3389/fpubh.2021.666453. Accessed 11.9.2025.
* OECD & European Commission 2024. Health at a Glance: Europe 2024: State of Health in the EU Cycle. OECD Publishing. https://doi.org/10.1787/b3704e14-en. Accessed 25.11.2025.