New report reveals how start-ups can access Germany’s €498bn healthcare market

We are proud to launch an essential new resource that empowers start-ups to navigate the complexities of the German healthcare market. The first in a series of new Market Intelligence reports, “MedTech and Digital Health: A Comprehensive Guide to Market Access in Germany”, draws on EIT Health’s extensive expertise in supporting start-ups to achieve market access, and features insights from prominent German healthcare experts from our network. This must-read report provides actionable guidance for European healthcare start-ups aiming to introduce MedTech and digital health solutions in Germany.

Why Germany? A healthcare market of immense potential

Germany, with its €498 billion healthcare expenditure, is the largest healthcare market in Europe. [1] Its well-established infrastructure and focus on innovation present unparalleled opportunities for MedTech and digital health start-ups, particularly those developing solutions to address the unmet health needs of ageing population and support the management of chronic diseases. However, market access in Germany is notoriously challenging due to its intricate regulatory frameworks, diverse reimbursement pathways and numerous stakeholders.

Practical advice to accelerate market access

The guide offers detailed insights into overcoming these barriers. It covers:

• Navigating regulatory frameworks, such as the Medical Device Regulation (MDR).
• Obtaining CE certification, an essential milestone for entering the EU market.
• Exploring reimbursement mechanisms, including Statutory Health Insurance (SHI), covering most of Germany’s population with standardised benefits, and Private Health Insurance (PHI), offering flexible and supplementary options. Also discover Digital Health Applications (DiGA), a fast-track process for digital health solutions, and the Medical Aids Directory, listing reimbursable medical devices in Germany.
• Market access dos and don’ts, focusing on distribution, marketing, and communication strategies, as well as effective engagement with practitioners and hospitals at a local level. These tips are derived from EIT Health’s extensive experience supporting numerous start-ups, complemented by feedback and suggestions from experts in the field.
• Aligning solutions with emerging trends such as mental health technology, assistive devices, and nanomedicine.

This comprehensive approach enables start-ups to develop tailored market strategies that align with Germany’s emphasis on digital transformation and patient-centric care.

“Germany’s healthcare market offers immense potential but also presents significant complexities. This report aims to demystify the market and help start-ups devise effective go-to-market strategies,” said Jean-Marc Bourez, CEO of EIT Health. “Supporting European healthcare start-ups in launching their MedTech and digital health solutions is just one of the many ways we contribute to driving the digital transformation of healthcare, which is one of our flagship priorities.”

The importance of collaboration and localisation

The report highlights the vital role of strategic partnerships and cultural considerations in effectively entering the German market. Collaborating with local patient advocacy groups, development agencies and insurer initiative, like the Healthy Hub, can help start-ups connect with stakeholders ready to pilot innovative solutions. In addition, adapting marketing and communication strategies to the German market, such as providing materials in German and addressing cultural nuances, can significantly enhance engagement and trust.

The role of cross-sector collaboration

Beyond being a tool for start-ups, the report serves as a resource for EIT Health’s extensive network of partners, policymakers and healthcare leaders. It underscores the need for cross-sector collaboration to foster innovation, improve patient care, and address systemic challenges in Germany’s unique healthcare landscape.

Get the report

“MedTech and Digital Health: A Comprehensive Guide to Market Access in Germany” is now available to download. Gain the insights you need to navigate Germany’s healthcare market and position your start-up for success.

DOWLOAD THE REPORT NOW

Need more support? Discover our Market Access Service

Our Market Access Service (MAS) is designed for start-ups and SMEs in MedTech, BioTech, and Digital Health looking to expand into European markets, including DACH, BENELUX, UK, France, Italy, Portugal, and Spain.

We recognise the complexities of navigating regulatory requirements, identifying the right reimbursement pathways, and forging the right partnerships for market entry. That’s why our MAS goes beyond generic consultation by offering tailored, step-by-step guidance in market discovery, regulatory and reimbursement navigation, and strategic commercialisation to accelerate your market entry.

Our service starts with a needs assessment that provides a foundation for understanding your company’s specific challenges and opportunities. Then, depending on your needs, we offer in-depth validation of your product-market fit, regulatory requirements, and reimbursement models in your target countries, ensuring that your product is positioned for success.

MAS is ideally suited for start-ups and SMEs in the MedTech, BioTech, and Digital Health industries who:

• Have developed a marketable product and are exploring market expansion.
• Are near the launch stage in their home market and want to set up conditions for imminent international commercialisation.
• Have already launched in their home market and are ready for expansion into new EU regions.

Learn more about our Market Access Service. You can also reach out directly to Sabine Runge.

[1] vdek – Verband der Ersatzkassen e. V. (2024) Daten zum Gesundheitswesen: Versorgung. Available at: https://www.vdek.com/presse/daten/d_ausgaben.html (Accessed: 20 November 2024).