Boosting Interregional Innovation Investment and cooperation among Health Innovation Ecosystems

Open Call Objectives

The aim of the Second Business Casses Open Call will be to select at least 15 business cases to be supported by the I3HIES project. Supported projects will be on a first-come, first-served basis, with individual cut-off dates.

Regional Impact

The I3HIES project supports solutions for Less developed regions in the European Union.

All the Business Cases must be implemented by Actor(s) or in cooperation with Actor(s) from Less Developed Regions and they should: 

• Generate Benefits for Less Developed Regions
• Be Implemented in Less Developed Regions

All the Business Cases must be implemented by Actor(s) or in cooperation with Actor(s) from Less Developed Regions and they should: 

Less Developed Regions are European Union regions (NUTS 2) which have a GDP per inhabitant that is less than 75% of the EU average.

This focus ensures that the outcomes of the process contribute to the growth and support of less developed areas, fostering broader regional development and impact. The predefined criteria can be described as follows:

Be Implemented by Actor(s) or in cooperation with Actor(s) from Less Developed Regions:

This criterion specifies that the business case must be driven by organizations, companies, or institutions that are based in or originate from less developed regions. It ensures that the leadership, decision-making, and primary stakeholders of the business case are rooted in less developed regions. This approach promotes local entrepreneurship and empowers regional actors, ensuring they play a key role in the development and implementation of the business case.

Generate Benefits for Less Developed Regions:

This criterion requires that the business case must demonstrably contribute to the economic, social, or environmental development of less developed regions. The benefits could include job creation, infrastructure development, knowledge transfer, improved public services, or other forms of positive impact that directly enhance the well-being and economic prospects of these regions. The focus is on ensuring that the outcomes of the business case provide tangible advantages to communities within less developed regions, even if the business case itself is developed and/or implemented elsewhere.

Be Implemented in Less Developed Regions:

For a business case to meet this criterion, the core activities, operations, or investments of the business case must take place within one or more less developed regions. This means that the project’s primary implementation site – whether it involves the construction of facilities, delivery of services, or deployment of new technologies – must be located in a region identified as less developed. The aim here is to directly boost the economic and social infrastructure of these regions by making them the central hub of the project’s operations.

See map of less developed regions

Thematic Areas

All applications should address one of the thematic areas, as well as have a regional impact, as presented in the next sections of this document.

The I3HIES project places special emphasis on certain thematic areas, ensuring that the supported innovations address critical needs and regulatory requirements:

• Medical Devices: Innovations related to health technologies that can significantly impact patient care and medical practices are given priority.
• Emergency Equipment: This includes tools and devices designed for use in critical situations, aiming to enhance response capabilities and safety.
• MDR Compliance: Business ideas and cases focusing on compliance with Medical Device Regulation (MDR) standards are also prioritized, ensuring that innovations meet necessary regulatory requirements.

 WHY should you apply? (benefits)

I3HIES goal is to empower SMEs and startups capacity to deliver new solutions into the e-health and digital health sectors in order to build resilience and facilitate green and digital transition. The project does not provide any direct financial support but offers a number of benefits to selected beneficiaries.

To assist beneficiaries throughout the innovation lifecycle, the project provides a range of supportive services:

• Business Case Validation: The business cases are subjected to a thorough validation process involving focus groups and a Validation Board of business development experts. This step confirms the viability, market potential, and maturity of the business cases, ensuring they are robust and ready for investment or further development.
• Improvement Guidance: For business cases that are not yet suitable for validation, participants receive targeted guidance to enhance their investment readiness. This support focuses on refining and adjusting ideas, addressing issues related to feasibility, market maturity, and bankability, thereby preparing them for successful validation in future stages.
• Pitch Preparation: Participants who want to improve their presentation, receive support in preparing and delivering pitches. This service is crucial for effectively communicating the value of their business cases to stakeholders and potential investors.
• Pitching opportunities: Selected business cases will have the possibility to participate in pitching sessions in our regions. Different types of actors will be present in the session, including inverstors.
• Investment Planning: The process also aids in the development of comprehensive investment plans tailored to each business cases. This includes identifying suitable funding mixes and mentoring the evaluation of these plans, with a focus on leveraging opportunities from European Union projects and other funding sources. Partner search services are provided to connect participants with relevant stakeholders across Europe, particularly from less developed regions.
• Interregional Investment Capacity Building: To further support participants, the process includes activities aimed at increasing their capacity to engage in interregional innovation investment projects. This involves webinars, consultations on accessing EU, national, and regional funds, and promoting funding program events. An exchange mechanism is also established to foster knowledge sharing between newcomers and experienced Community actors, enhancing the overall innovation ecosystem.
• Collaborative Project Development: Throughout the process, participants are encouraged to engage in collaborative project development. This involves bringing together various partners, including those from more developed regions, to jointly advance business cases and foster innovation through cooperative efforts.

Benefits for selected applicants!

 Who can apply?

The following eligibility criteria must be met in order to get through to the validation process:

1. The Second Open Call is open to individual SMEs / startups or consortia composed of a maximum of two SMEs / startups

2. Applicants must come from and/or collaborate with Actor(s) from less developed regions of the European Union. The list of less developed regions is attached as Annex 3 to this document.

3. In cases of equal scoring, applications addressing Hungary, Lithuania, Poland, Romania, Slovakia and Slovenia will be prioritised.

 Application process: HOW & WHERE & WHEN

• Application Submission

The Business Cases Second Open Call will remain open from 03.03.2025 until the 15.04.2025 at 17:00 CET. (CET – Central European Time).

The I3HIES project consortium reserves the right to extend the closing date if necessary. All Applicants interested in participation in the I3HIES Open Call shall send a completed application (Annex 1) to the email address: opencall@mediklaszter.eu . The application must be sent by 15.04.2025 at 17:00 CET.

•  Eligibility criteria

1. Proposals must address an innovative product, process or service addressing the Open Call thematic areas and regional impact.
2. Business cases should be at TRL ≥ 5 (TRL-Technology readiness levels).
3. Applicants can submit more than one project application (for different project cases).
4. All elements of the application must be submitted in English.
5. The application proposal must be completed by containing all requested elements specified in this document. The uncomplete proposals will not be taken into consideration.

The main steps to apply:

1. Make sure to comply with the eligibility criteria for participating in the I3HIES Open Call provided in this document.
2. Address one of the Open Call thematic areas and have the regional impact for Less Developed Regions.
3. Fill in the application form in English.
4. Complete your proposal and send it via e-mail to opencall@mediklaszter.eu .
5. Once your proposal is submitted, a confirmation email will be sent to acknowledge the application submission.

Applications will consist of the following:

1. Application form. It should explain the overall concept and development plan. The proposal should include the technology, tools expected to be used and the expected impact.

2. Declaration of honour. The applicants must certify that all information provided is correct. They have to be fully committed to participate in the project that they are submitting and comply with the eligibility criteria.

3. A 10 slides Pitch Deck. The document must contain the name and logo of the applicant(s) plus information on the project. The pitch deck template proposal is attached to the document, but you can also use your own template.

 See Technology Readiness levels.

  EVALUATION

The I3HIES validation will be transparent, fair, and equal to all our participants.  The Business Cases Second Open Call validation is structured as follows:

Eligibility check by I3HIES Consortium. The Eligibility Check will be performed by the Validation Committee, which is composed of I3HIES Team Members. They will review the submitted documents for compliance with I3HIES requirements. The Applicants might be requested to provide additional explanations clarifying, in particular, their legal and registration status, but no changes to the Application documentation are allowed once the Application is submitted.

Validation by I3HIES experts. At least 2 experts included in the individual validation committees and designated by the I3HIES consortium members will review each proposal. I3HIES Consortium Partners will validate the applications based on a scoring system, and provide a qualitative feedback to each applicant. They will make sure there is no conflict of interest. If there are ethical considerations, the proposal will be carefully studied. The validation feedback will include the score, the narrative expert opinion of the validation committee highlighting key strengths and/or improvement potentials, and recommendation for further support within the I3HIES project.

Selection of business cases. The Validation Committee will develop a ranking list according to the results and will communicate the results to all applicants via E-mail.

  Data protection

I3HIES partners are committed to protect and respect applicants’ privacy. The personal data collected in the context of the I3HIES Second Open Call will be processed in accordance with The General Data Protection Regulation (GDPR). Applicants’ files will be retained in I3HIES archives until the end of the project activities (durability period) for which the applicants submitted a proposal. It is possible to exercise your rights to access, rectify, cancel or oppose through the private profile of the entity (delete profile) or by contacting the I3HIES data controller by sending an email to: opencall@mediklaszter.eu

 Other Considerations

Questions?

Please check out the FAQ section on the I3HIES web page: https://i3hies.eu/open-call/

Contact us with any questions or feedback: opencall@mediklaszter.eu

  Business Cases Open Call Important Documents

• Business Cases Second Open Call Guide for Applicants (PDF file)
• Annex 1 – I3HIES Business Cases Second Open Call proposal template TRL 5-9 (PDF file, DOCX/WORD file – save link as… to download)
• Annex 2 – I3HIES_Business Cases Second Open Call – Declaration of Honour (PDF file, DOCX/WORD file – save link as… to download)
• Annex 3 – Less Developed Regions of the EU (PDF file)
• Annex 4 – A 10 slides Pitch Deck (template, PPTX file – save link as… to download), Note: you can also use your own template, addressing the same topics as a template,
• Business Cases Second Open Call Summary (PDF file)
  

 BUSINESS CASES OPEN CALL GLOSSARY

Business Case – a business case is a documented argument or proposal that outlines the justification for undertaking a project or initiative. It typically includes a detailed analysis of the potential benefits, costs, risks, and opportunities associated with the proposed business idea. A business case provides a comprehensive rationale for why the idea should be pursued and how it will be implemented.

I3HIES thematic areas – The I3HIES project places special emphasis on certain thematic areas, ensuring that the supported innovations address critical needs and regulatory requirements: Medical Devices, Emergency Equipment, MDR Compliance.

I3HIES services – tailored support services for selected beneficiaries offered by the I3HIES project consortium.

I3HIES experts – natural persons selected from the I3HIES consortium who have expressed interest in evaluating the applications submitted in the Open Call. All experts sign a Declaration of Impartiality, Confidentiality and Absence of conflict of interest.

Interregional Innovation Investments Instrument (I3) Programme – the Interregional innovation investments instrument as part of the European Regional and Development Fund (ERDF) aims at supporting interregional innovation projects in their commercialisation and scale-up phases giving them the tools to overcome regulatory and other barriers and bring their project to investment level. [link to I3]

Less Developed Regions – European Union regions (NUTS 2) which have a GDP per inhabitant that is less than 75% of the EU average.[link to list of Less Developed Regions]

Project mentor – each project is assigned a I3HIES project mentor who will support the applicants in the project implementation process and carefully monitors the project progress.

SME – Small and medium-sized enterprises (SMEs) are defined in the EU recommendation 2003/361. Company requirements: < 250 staff headcount and ≤ 50 million € turnover or ≤ 43 million € balance sheet total per year. [link to SME definition]

SME eligibility – the company must be legally registered in one of the EU27 Member States or countries participating in the Single Market Programme and acceding countries, candidate countries and potential candidates.

TRL levels – technology readiness levels are a method for estimating the maturity of technologies during the acquisition phase of a program. TRLs enable consistent and uniform discussions of technical maturity across different types of technology. [link to TRL levels]

Disclaimer

This website was funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council and SMEs Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.