Welcome to the Access & Acceleration Roadmap!

The Roadmap is a tool for small and medium-sized enterprises (SMEs) and other companies who wish to enter the Danish or German healthcare market with their innovative product(s). It is notoriously difficult to access the Danish and German markets for healthcare products with new technological solutions and it is especially hard for SMEs that do not possess the necessary knowledge and market insight to enter the healthcare industry.

The content of the Roadmap is centered on the three most common barriers to entering these markets as identified in a stakeholder analysis from 2019.

The Roadmap addresses each of these barriers and gives helpful information about the Danish and German markets as well as tips to succeed in entering these markets. Use the links in the interactive Roadmap to navigate directly to a specific topic or scroll down to start reading.

Access - Roadmap to market Do you have any trouble with the MDR or with European regulations? Do you know the differences between the Danish and the German healthcare sector? Do you need funding for your product to be a success? Are you looking for information regarding the Danish or the German healthcare market?
Access - Roadmap (developed by CIMT, MMMI and UKSH)

1. How to comply with the European legislation?

In the section below the new medical device regulation is shortly described and we will provide you with information and tools that will help your company to solve the challenges:

  • Understand and get an overview of the MDR/IVDR
  • Share and get knowledge
  • Get contacts for clinical investigation/collaboration
  • Getting access to a notified body

The Medical device regulation (MDR/IVDR) replace the Medical device directive (MDD) originates from start/middle 90. The MDR is a result of scandals and incidents with medical devices. The MDR covers all medical devices including active medical devices and is significantly more comprehensive and detailed compared to the MDD.

The key changes in the MDR is classification according to risk, contact duration and invasiveness, further expansion of the product scope. The requirement for documentation, clinical evaluation, postmarket clinical follow-up and traceability is significantly increased for all risk classes.

The European Database on Medical Devices (EUDAMED) provide an information exchange system between the European commission and the competent authorities. The Unique Device Identification (UDI) and EUDAMED shall improve the traceability. EUDAMED will now also store information regarding the postmarket surveillance activities.

All European notified bodies for medical devices will lose their designation as of the date of application of the MDR and IVDR due to the change in the legal framework and must therefore be redesignated under the MDR. All notified bodies are published on the NANDO database.

European Commission - MDR Timelines
European Commission - MDR Timelines, Source
  • Exchange experience with companies from your own network
  • Register in cluster organisations
  • Participate in a knowledge exchange through networking
  • Organise workshops for knowledge exchange
  • Appoint an adviser
  • Found a special department
  • Find and hire a specialist for the company
  • Hire an external service provider
  • Obtain an overview of MDR, notified bodies and Eudamed
  • Participate in webinars

2. Understand the structure of the healthcare systems in Denmark and Germany

In the section below the structures of the healthcare systems in Denmark and Germany are shortly described and we will provide you with information and tools that will help your company to solve the challenges:

  • Understand the reimbursement process
  • Get an overview of the tender process
  • Share and get knowledge
  • Improve your development through collaboration
  • Get access to the catalog of assistive devices
  • Purchasing managers/departments for the medical equipment
The Commonwealth Fund - Healthcare system Denmark
The Commonwealth Fund - Healthcare system Denmark, Source

Healthcare in Denmark is provided by the local governments of the five regions, with coordination and regulation by central government, while nursing homes, home care, and school health services are the responsibility of the 98 municipalities.

Danish government healthcare expenditures amount to approximately 10.4% of the GDP, of which around 84% is funded from regional and municipal taxation redistributed by the central government. Because basic healthcare is taxpayer-funded, personal expenses are minimal and usually associated with co-payments for certain services. Those expenses are for the most part covered by private health insurance.

Use of electronic health records is universal, and efforts are underway to integrate these at the regional level. For every 1,000 people in Denmark, there are about 3.4 doctors and 2.5 hospital beds. Spending on hospital facilities, at 43% of total healthcare spending, is above the average for OECD countries, even though the number of beds has decreased considerably in the last decade.

In Germany, the principle of self-administration applies: Although the Federal state sets the legal framework and tasks, the insured and contributors as well as the service providers organise themselves in associations that are responsible for providing medical care to the population.

The Federal state holds most university hospitals, while municipalities play a role in public health activities and hold about half of all hospital beds. Patients health insurance covers costs that are directly associated with the treatment in the hospital. The State in which the hospital is located finances so-called ‘investment costs’ such as diagnostic machinery, ambulance vehicles, and building maintenance. Source: "Report: Comparison of the Danish and German healthcare system"

The German health care system is supported and self-managed by many institutions and actors. The core area, also known as the first healthcare market, comprises the area of "classic" health care, which is largely financed by statutory health insurance (SHI) and private health insurance (PHI) including nursing care insurance. All privately financed products and services related to health are referred to as the second healthcare market. Source: "Bundesgesundheitsministerium - Gesundheitswirtschaft im Überblick"

The Commonwealth Fund - Healthcare system Germany
The Commonwealth Fund - Healthcare system Germany, Source
  • Gain knowledge about the structure of the healthcare system
  • Contact potential customers (doctors, pharmacies...) at fairs, events
  • Obtain knowledge about the reimbursement process
  • Obtain knowledge about the tender process
  • Take part in the tender process
  • Find and hire an expert of/for the tender process
  • Register at international cooperation exchanges for partner search
  • Find a partner for the distribution of your product
  • Gain knowledge about the structure of the healthcare system
  • Contact potential customers (doctors, pharmacies...) at fairs, events
  • Obtain information about the catalog of assistive devices (Hilfsmittelverzeichnis)
  • Get access to the catalog of assistive devices (Hilfsmittelverzeichnis)
  • Aquire knowledge about the reimbursement process
  • Take part in the tender process
  • Find and hire an expert of/for the tender process
  • Register at international cooperation exchanges for partner search
  • Find a partner for the distribution of your product

3. Funding opportunities to support your company

In the section below the different funding programs, networkgroups that can support you and help matchmaking. The challenges we will adress are:

  • Overview of funding programs
  • Ideas for network groups
  • Investment possibilities for companies
  • Get contacts for funding/collaboration

To have the right product idea is not always enough. The product will often need adjustments to fit the content. There are different funding programs that support public and private innovation both nationally but also internationally. To navigate in the different funds, search for relevant network etc. is difficult for SMEs, this section will provide you with an overview of relevant funding programs, relevant networks, and where get the support for cross boarder collaborations.

The European Union (EU) supports companies and research institutions with a variety of funding programs and financing instruments. In addition to research and development projects, the EU also funds projects in the area of opening up new markets. Horizon Europe is the research and innovation framework programme running from 2021-2027.

EIT Health is one of the largest healthcare initiatives worldwide. Its goal is to sustainably advance the fundamentals of healthcare and thus promote suitable future conditions for healthy living of people across Europe.

European Commission - Horizon Europe
European Commission - Horizon Europe, Source

Brief introduction to target markets Denmark and Germany - Facts & Figures

Access - Country profile Denmark - The healthcare system in numbers
Country profile Denmark
Access - Country profile Germany - The healthcare system in numbers
Country profile Germany
  • The German and the Danish healthcare systems are notably different in many characteristics:
  • The sharing of decision-making powers between states, the federal government and self-regulated organisations of payers and providers.
  • The separation of Public/Statutory Health Insurance (SHI) (including the social LTCI) and Private Health Insurance (PHI)(including the private LTCI).
  • German hospitals can be compared to a profit centre, whereas in Denmark it is more a social institution.
  • Germany has over 200 health insurances compared to only one in Denmark.

About 250 companies in Denmark work in the various branches of the medical industry. But in total, just over 1,000 companies are to a greater or lesser degree active in the medical field as one of several customer bases. The 20 largest companies account for approx. 75% of revenue. 2/3 of the companies in the industry have less than 50 employees.

The Danish market for medical devices accounts for 0.5% of the global market. Expenditure on medical equipment amounts to approx. 5% of the total public expenditure on the Danish healthcare system. Source: "Espicom".

The public health service via the five Danish regions is the largest buyer of the industry's products. Other customers are municipalities (e.g. in connection with care and rehabilitation), private hospitals or private citizens.

In 2014, the USA was Denmark's largest export market for medical equipment with 25% of exports. This was followed by Germany (15%), Sweden (6%), Japan (4%) and China (4%). Source: "Espicom". Over 95% of Danish production of healthcare technology is exported.

Health expenditure in Germany amounted to 390.6 billion euros, or 4,712 euros per inhabitant, in 2018. The Federal Statistical Office (Destatis) also reports that this was a 4.0% increase on 2017. By far the largest share (57%) of this amount is accounted for by spending on statutory health insurance. The next largest item, 13.3% (Euro 52 billion), is for private households and private non-profit organisations. The third position in the list of expenditures is for statutory long-term care insurance with 10.1% (Euro 39 billion). Source: "Destatis - Health Expenditure"

Compared with the economy as a whole, the German healthcare industry is showing above-average growth rates with a 4.1% annual increase over the past ten years. The German healthcare industry employs 7.6 million people and generates almost 370 billion euros. This corresponds to a share of 12.1% of gross domestic product. The industry makes a significant contribution to achieving key economic policy objectives and influences them in terms of adequate and steady economic growth and high employment levels.

The medtech sector in Germany is dominated by medium-sized companies. 93 percent of medtech companies employ fewer than 250 people. There are 13,000 micro-enterprises alone with around 60,000 employees. Only 90 medtech companies in Germany have more than 250 employees. The medtech industry is innovative and has very short product cycles. Source: "BVMed - Branchenbericht Medizintechnologien 2020"

For questions about the roadmap, please contact Camilla Stryhn, Projectmanager, Centre for Innovative Medical Technology, University Hospital Odense