Governmental Funding for Medical Device Manufacturers

Funding Instruments for SMEs, Institutional Investors and Early Stage Venture Capitalists at a Glance

There is a variety of governmental funding tools available that are aimed at maintaining innovation and excellence in the dynamically changing medical device environment. We put together an overview of these tools to support small and medium sized companies in the effort to promote innovation and to adapt to the changing regulatory environment under Regulation (EU) 2017/745 and the increased need for clinical data.

Moreover, the overview summarizes funding opportunities at German foundations supporting research in the field of medical sciences. Finally, private equity funds supporting the development of early stage start-ups and business expansion of SMEs are presented.

Loans to lower the acute burden of the Coronavirus crisis

KfW coronavirus aid: loans for companies

General overview.

The german KfW bank initiated different programs to support companies, self-employed persons and freelancer who encounter financial difficulties during the Coronavirus crisis.

Different application prerequisites and variable funding values apply depending on the specific program and applicant. Interested persons are encouraged to follow the link on the right to access the KfW web portal for further information.

EU-funded programs

EIC Accelerator (European Innovation Council pilot)

What is funded?

The EIC program helps to develop high-risk business ideas into a market-ready product. Funded activities include trials, prototyping, validation, demonstration and testing in real-world conditions, and market replication. There are no set topics but negative impacts on climate and the environment should be avoided. (https://ec.europa.eu/research/participants/data/ref/h2020/other/guides_for_applicants/h2020-guide-eic-smeinst-18-20_en.pdf)

 

Who can apply?

The EIC Accelerator program is intended to provide financial assistance to innovators, entrepreneurs, SMEs and scientists. The EIC Accelerator program grants funding to high-risk, high-potential and medium-sized entities and innovators to facilitate product develpment and successful market access. The program explicitly funds radically new idea / solutions that are supported by a business plan for for-profit SMEs only. From June, 5th 2019 on, only single entities can apply for grants.

 

What are crucial project and / or funding prerequisites?

If the activity concerns a primarily technological innovation, a Technology Readiness Level (TRL) of 6-8 is envisaged for projects requesting grants only.

Projects should normally take 12 to 24 months to complete, but could be longer in exceptional and well-justified cases. Financial funding amount is limited to € 0.5 to 2.5 million. From June 5th, 2019 the EIC Accelerator offers a blended finance in form of an optional investment in equity with a maximum of € 15 million.

Buisness acceleration services, coaching and mentoring programs are readily available to scale and grow your business.

 

Funding quote?

No equity quote was defined in the EIC Accelerator announcement.

 

Application deadline:

In 2020, four different application cut-off dates were defined: January, 8th 2020, March, 18th 2020, May, 19th 2020 and October, 7th, 2020.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

German Funding Tools

KMU-innovativ: Medizintechnik (BMBF)

What is funded?

The program is intended to enable high-risk R&D projects with focus on maintenance and applicability. Scientific and pre-clinical development projects as well as early clinical feasibility studies are eligible for funding. The projects are thought to spotlight medical devices and are expected to have a crucial impact on the applicant´s future success.

 

Who can apply?

SMEs according to Annex I, AGVO with an office in Germany and medium-sized companies not excceding 1.000 employees and revenues above 100 Mio Euros (among others).

 

What are crucial project and / or funding prerequisites?

Funding can be granted to individual or joint project proposals. Application rules demand that at least one commercial entitiy is involved. In the case of joint projects, a coordinating entity has to be determined. Moreover, the collaboration details must be defined among the parties involved in a legally binding contract.

The fund covers personnel costs, expenses for instruments / equipment and contract research among others. The maximum funding period is 3 years.

 

Funding quote?

The funding instrument finances up to 50% of the project-related costs. Concomitantly, the BMBF expects own co-payments of at least 50%.

 

Application deadline:

April, 15th or October, 15th. The duration of the funding program directive is initially restricted to June 30th, 2021 with the possibility of extension.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Medizintechnische Lösungen in die Patientenversorgung überführen –
Klinische Evidenz ohne Verzögerung belegen (BMBF)

What is funded?

The funding instrument supports clinical validation of medical devices and in-vitro diagnostics successfully passed the R&D phase to prove safety and performance from the clinical perspective. Enclosed are medical devices of risk classes IIa, IIb and III as well as in-vitro diagnostics of risk classes B, C and D. Moreover, the development of relevant associated processes and qualifications / knowledge is eligible for grants.

 

Who can apply?

SMEs according to Annex I, AGVO with an office in Germany.

 

What are crucial project and / or funding pre-requisites?

The program requires the availability of convincing technical and scientific data sets on the medical device. Furthermore, initial pre-clinical data must confirm the suitability of the medical device for its intended purposes before submission of a grant application.

The applicant is requested to survey the IP landscape with regard to the subject device protectability. For innovations, (application for) patent protection is advised.

Expenses covered by the fund are listed on the webpage linked on the right and accessory documents referred to.

 

Funding quote?

The funding instrument finances up to 50% of the project-related costs. Concomitantly, the BMBF expects own co-payments of at least 50%. Grants are non-refundable.

 

Application deadline:

A application deadline is not defined. The duration of the funding program directive is restricted to June 30th, 2021 with the possibility of extension until December 31st, 2022.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Förderung von klinischen Studien mit hoher Relevanz für die Patientenversorgung (BMBF)

What is funded?

To accelerate the transition of scientific advancements into the daily patient care routine, the funding program grants support for clinical investigations and / or syystematic analysis of results thereof. Investigations with high relevance for the healthcare system and studies which are intended to close evidence gaps will be funded.

 

Who can apply?

For-profit companies can not apply. However, commercial companies can act as a subcontractor for the following entities that are eligible for grant application: Universities, Community Health Care Institutions and Hospitals.

 

What are crucial project and / or funding prerequisites?

Clinical investigations, a grant is requested for, must be highly relevant for patient care in Germany and must not be supported by other German funding programs. Moreover, a immediate economic interest of the applicant must be negated.

The fund covers personnel costs, patient reimbursements, insurances for patients, registration of the study and quality assurance among others. The maximum funding period for clinical trials is 4 years with the possibility of extension.

All results independent of the clinical outcome must be published.

 

Funding quote?

The funding instrument finances up to 50% of the project-related costs. Concomitantly, the BMBF expects own co-payments of at least 50%.

 

Application deadline:

June, 14th 2019 (applications can be submitted afterwards, but consideration is not guaranteed)

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Werkstoffplattform Biomaterialien (BMBF)

What is funded?

The BMBF program focusses on R&D projects advancing biomaterials used in medical engineering. Program goals are to (1) qualify existing materials for application in medical devices, (2) improve properties of materials already used in medical devices and (3) enable innovation. Ultimately, biocompatibility according to ISO 10993 and pre-clinical requirements is expected to be established within the funding period

 

Who can apply?

SMEs and joint ventures with clear focus on medical devices (among others)

 

What are crucial project and / or funding prerequisites?

The program demands the collaboration of cross functional teams to address the research questions a funding is requested for.

Before submitting the proposal, the applicants must be certified according to e.g. ISO 9001, or ISO 13485. Manufacturer of medical devices must have a system to audit supplier up and running.

The fund covers personnel costs, consumables, devices, literature, traveling, workshops, events and contracting. The maximum funding period should not exceed 3 years.

 

Funding quote?

The funding instrument finances up to 50% of the project-related costs. Concomitantly, the BMBF expects own co-payments of at least 50%. For non-profit organizations different rules apply.

 

Application deadline:

December, 6th 2019 (applications can be submitted afterwards, but consideration is not guaranteed)

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Zentrales Innovationsprogramm Mittelstand (ZIM) (BMWi)

What is funded?

The program is intended to foster innovation and competitiveness of medium-sized companies. The funding aims at minimizing R&D-related risks, encouraging market-oriented R&D efforts, enabling co-operations, translating R&D results into market-ready products and internationalization of participating companies. R&D activities performed in Germany as well as innovative products, processes and technical services will be funded without any limitations towards technology or sector.

 

Who can apply?

SMEs according to VO (EU) 651/2014 Annex 1 with an office in Germany, medium-sized entities located in Germany when the total number of employees including those of partner companies does not exceed 500, or medium-sized companies with less than 1000 employees in case a co-operation with a company that receives a R&D funding has been initiated.

Non-profit entities located in Germany acting as a collaboration partner for a company that receives a R&D funding.

 

What are crucial project and / or funding prerequisites?

Funding can only be granted to high-risk projects residing on a prime innovation level to advance competitiveness. Moreover, R&D efforts must be intended to deliver new products, processes or technical services.

All parties involved in the joint projects must conduct innovative tasks to achieve the ultimate goal: market access. To ensure innovation for each participating entity, the distribution of man hours must be balanced out with a maximum of 70 % of the granted man hour for a single entity in bilateral projects. Different rules apply for projects including more than two companies.

 

Funding quote?

The funding quote is tiered depending on the size of the company and the proposed project (R&D single vs joint projects, innovation networks or management promotion). The quote varies between 25% and 90%. As a general rule, the funding quote for R&D projects decreases as the company size increases. For further details, follow the link on the right. Section 5.2 provides detailed information. Grants are non-refundable.

 

Application deadline:

The directive was issued on January 20th, 2020. No application deadline was defined as of yet.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

go-Inno (BMWi)

What is funded?

The program is intended for SMEs and supports consulting services to expedite innovation. No limitations towards certain technologies, products or sectors are applicable. However, projects in agriculture and fisheries are not funded.

 

Who can apply?

SMEs with less than 1000 employees and annual sales of maximum 20 Mio. Euro.

 

What are crucial project and / or funding prerequisites?

None.

 

Funding quote?

The funding is provided as vouchers. These voucher cover up to 50 % of the consulting expenses for BMWi accredited consultancies. Five vouchers per year not exceeding a total sum of 20.000 Euro can be granted. Grants are non-refundable.

 

Application deadline:

No application necessary.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

WIPANO (BMWi)

What is funded?

The program funds the economic utilization of innovation. The funding supports patent applications, advancement of innovation, diffusion of innovation by means of norms and standardization.

 

Who can apply?

SMEs, state universities and publicly-funded research facilities

 

What are crucial project and / or funding prerequisites?

The funding program is subdivided in 5 major packages including consulting towards novelty, examination towards economic exploitation, consulting towards patent application and prosecution and commercialization. Each package has a certain funding amount as specified in the directive. The funding period is 24 months.

 

Funding quote?

A maximum of 50% of the total expenses are financed. Grants are non-refundable.

 

Application deadline:

Applications should be submitted through the online system (https://foerderportal. bund.de/easyonline) in German language. No deadline defined.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Bavarian Collaborative Research Program (BayVFP) (STMWI)

What is funded?

The program aims at substantiating the R&D and innovation capacities in SMEs. Breaks in innovation process shall be released. Focus is on 4 main fields of action: information and communication technology, life sciences, materials and mobility. However, funding in other research areas is not precluded.

 

Who can apply?

SMEs, universities and extramural research facilities located in Bavaria

 

What are crucial project and / or funding prerequisites?

The R&D project funding is requested for must be accompanied with severe economic and technical risks. The project must be highly innovative shifting the limits of the current State-of-the-Art. Research activities are thought to be conducted in Bavaria mainly. Crucial knowledge to successfully run the project must be available. More prerequisites exist, please refer to the directive for more details.

 

Funding quote?

The maximum funding quote is up to 50%. Partly self-financing is expected. For universities different percentages may apply.

 

Application deadline:

Funding calls are issued regularly and are accessible under www.fips.bayern.de. Application deadlines are specified therein.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Neue Versorgungsformen und Versorgungsforschung (Gemeinsamer Bundesausschuss - Innovationsausschuss)

What is funded?

The program funds projects aiming at the advancement of patient care including digitalization and patient empowerment. Projects on the improvement of current patient care paradigms and related research projects are eligible for funding.

 

Who can apply?

No restrictions, but for the application a health insurrance should be involved. If not, a justification must be provided. The requirement on inclusion of a health insurance does not apply to research projects.

 

What are crucial project and funding prerequisites?

The overall contribution to patient care and the relevance of the proposed type of care should be described and evaluated in details including an estimation on the potential of the care and a feasability determination.

The following, non-exhaustive list summarizes same areas that are not target of the current funding program: R&D on product innovations, studies in the context of the conformity assessment of medical devices and in-vitro diagnostics, clinical trials to confirm efficacy of pharmaceuticals and medical devices among others. For a comprehensive list refer to https://innovationsfonds.g-ba.de/downloads/media/168/2019-12-12_Foerderbekanntmachung_NVF_themenoffen_2020.pdf.

Funding is expected for a maximum duration of 3 years.

 

Funding quote?

Project-related expenses can be covered by up to 100%. Grants are non-refundable.

 

Application deadline:

April, 28th 2020, 12 a.m.

March, 31st 2020, 12 a.m. (applies to research project only)

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Foundations

VolkswagenStiftung

What is funded?

The Volkswagen Foundation aims at advancing the sciences and the humanities: stimulating, interdisciplinary, and transboundary and thus runs a set of funding programs supporting different areas of research with variable funding amounts and periods. Eligible for grants are research projects, positions, seed funding, organizational events and awards. Among the research areas are research, science, engineering, natural and life sciences, chemistry and humanities / social sciences among many others.

 

Who can apply?

Eligible for grant application are scientific institutions and academics.

 

What are crucial project and / or funding prerequisites?

The VolkswagenStiftung grants a maximum funding of 2 Million Euro for up to 5 years depending on the funding program chosen. However, given the diversity regarding the framework of each individual funding program, it is suggested to refer to the VolkswagenStiftung webpage for further details. Funds can not be allocated to profit-generating projects, equipment to be used in therapy, exploitation of patents, individual scholarships, supplements to travel costs, congresses and exhibitions.

 

Application deadline:

Application deadlines have not been specified.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Dietmar Hopp Stiftung GmbH

What is funded?

The Dietmar Hopp Stiftung GmbH allocates funding to projects focussing on sports, medicine, social affairs and education. In medical research, emphasis is on projects in the fields of oncology, pediatrics or gerontology.

 

Who can apply?

Eligible for grant application are entities with approval of their non-profit character

 

What are crucial project and / or funding prerequisites?

The Dietmar Hopp Stiftung GmbH acts locally in a single geographical region in Germany and grants funding to projects executed in the Rhein-Neckar region only. The foundation gives start-up financing and pilot projects priority.

 

Application deadline:

Application deadlines have not been specified. Application must be in German language and can be submitted throughout the entire year.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Helmut Fischer Stiftung

What is funded?

The Helmut Fischer Stiftung sponsors scientific works in the MINT disciplines, especially the areas of physics, chemistry, electrical engineering and medical technology. The foundation supports professorships, grants scholarships, organizes congresses and enables cultural projects in art and literature.Thus, the range of funding opportunities is diverse and special attention is paid to scientific progress and social development. The foundation´s ultimate goal is to fortify technological innovation and to elevate commitment and curiosity towards technology.

 

Who can apply?

Individuals from academia

 

Application deadline:

Application deadlines have not been specified.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

PRO-IMPLANT Foundation

What is funded?

The PRO-IMPLANT Foundation invests in medical research, professional education and improved patient care. Grants are awarded to young medical scientists. PRO-IMPLANT Foundation is committed to support innovative research in the field of prosthetic joint infections.

 

Who can apply?

The recruitment process is not made transparent. For further details, follow the link on the right.

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

Seed and early stage venture capitalists

High-Tech Gründerfonds

What is funded?

The HTGF is a seed investor for innovative technologies and business models – from the foundation of a start-up to its exit.

 

What are crucial project and / or investment prerequisites?

The company must be headquartered in Germany (or an independent branch office in Germany if it is based in another European country). Commercial registration within the last 3 years is expected. No more than 500.000 Euros raised.

The HTGF invests up to 1 Million Euros in the seed round and is able to increase the investment up to 3 Million Euros across all financing rounds.

 

How to apply?

The HTGF provides a webpage to upload pitch decks. For further information follow the link: https://www.htgf.de/en/founders/pitchdeck-upload/

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

NRW.BANK

What is funded?

The NRW.BANK focuses on investing in projects related to biotechnology and medical technology among others. Financing is intended for SMEs, early stage and fast-growing entities in North-Rhine Westphalia. The CV program targets to strengthen R&D, market entry, access to new markets, sales setup and production capabilities.

 

What are crucial project and / or investment prerequisites?

The NRW.BANK acts as a co-investor only. Thus, involving a second investor is required to receive an investment. Due to individualized investment opportunities the NRW.BANK can invest between 0.5 and 5 Million Euros per company. The estimated investment duration is 3 to 7 years. A positive operative cash flow is expected after at least 3 years.

 

How to apply?

The NRW.BANK allows inquiries via phone and mail: beteiligungen@nrwbank.de

 

 

This section provides a brief overview, for further details on e.g. application documents and the application procedure follow the link on the right.

How we can help you!

Find the right funding for you!

Identification of suitable funding instruments fulfilling your needs.

Writing / review of your grant application to fully comply with the funding organization´s requirements throughout the application process.

Identify your Clinical Data Gaps!

Identification of risks potentially associated with an innovative medical device.

Identification of (clinical) data gaps and recommendation of funding programs to close data gaps.

Develop a strategy to close your Data Gaps!

Compilation of a clinical evaluation according to Regulation (EU) 2017 / 745 and MEDDEV 2.7/1 rev 4

Strategy development towards compliance with legal requirements on GSPRs and PMCF in relation to State-of-the-Art alternatives.

Find the right partners for you!

Connecting you with our broad network including well regonized, specialized CROs and medical device experts

We team up with you to get your products to market. Get in touch with us for further information.