Internationalisation Services for EIC Beneficiaries in the Healthcare Sector

EIC Internationalisation Services by inXso

Internationalisation services for EIC beneficiaries in the healthcare sector are provided by inXso in the framework of the EIC Ecosystem Partnerships and Co-Investment Support programme.

Due to the extensive network of experts operating in this area, the internationalisation services are focused profoundly on internationalisation in the US, the United Arab Emirates (UAE) and Asia, in particular Japan, South Korea, Malesia and Taiwan.

Tailored to meet the needs of EIC beneficiaries from the Health and medical care, Biotechnology and Health Tech, and Pharmaceuticals sectors, specifically such as:

• Medical Devices
• Implantable devices
• Digital Health
• Biopharmaceuticals, Biosimilars
• Cell & Gene Therapeutics
• Tissue Engineered Medicines
• Cell-based Medicines
• Combined ATMPs
• Integrated Drug Delivery Devices
• AI Integrated solutions

The service is directed to EIC pathfinder, EIC transition and EIC accelerator innovators in all TRL levels, henceforth beneficial to EIC beneficiaries in the research stage, spinout/startup, and scale-up.

The Significance of Internationalisation Services

Companies in the healthcare sector are facing a solid push towards internationalisation in order to recover their investment and increase turnover as they operate in a particular niche market sector with a very limited domestic market.

At the same time, the companies are faced with forces constraining operations, as the industry involving implementation of medical research to improve health care and quality of life distinguishes itself from other high-technology sectors in that it has precise requirements when it comes to standardisation, quality management and regulatory compliance.

Emerging, breakthrough, and deep health technologies have a competitive edge much needed in accessing the health market, yet they may need more design aspects for overseas adaptation.

Concurrently, healthcare is inherently local with culture and nation-specific requirements to meet the safety design of the technology. Moreover, the purchasing decisions involve the need to understand how reimbursement works within the healthcare ecosystem.

inXso’s internationalisation services for EIC beneficiaries are tailored to address these barriers and accelerate market access from the HealthTech, MedTech, BioMedTech and Biotech & Pharma sectors.

Assessment of the Asian, the US and the UAE Markets for the Healthcare Sector

Build capacity for agile internationalisation through co-creation and co-design via individual training and coaching tailored to the needs of biomedical technology, medical technology, biotech and pharma industry.

The assessment will map the development process, considering its current TRL level and the value chain, including customers, competitors, public authorities, and other stakeholders relevant to the innovation’s development, approval, adaptation, and implementation.

Key features:

• Market-specific trends and business opportunities.
• Assessment of technological, market, financial, and clinical feasibility aspects.
• Market-specific requirements for the development and market access stage.

Benefits for EIC beneficiaries in i) research stage, ii) spinout/startup, iii) scale-up:

• Accelerate the R&D process by ensuring that the product meets multinational customers’ needs, processes and environment.
• Gain an understanding of how to adapt the product for multinational markets and implement the adaptation agilely in healthcare units, biomedical facilities or clinical environments.
• Gain an understanding of where the innovation may have the most need, its safety, efficacy, and cost-effectiveness in its user environment that, in turn, will give a competitive edge and marketing advantage.

The aim is to accelerate the innovation development process from its current TRL to market, create an agile approach and provide expertise to build a value chain that fits the ecosystem.

The service is directed to EIC pathfinder, EIC transition and EIC accelerator innovators by dedicated in-house or external experts depending on the target market via online, offline or hybrid models.

International Business Design Focused on Asia, the US, and the UAE

Build capacity for agile market entry and expansion through co-creation and co-design via individual training and coaching tailored to the needs of biomedical technology, medical technology, biotech, and pharma industry.

Considering its current TRL level and value chain, the guidance will navigate through innovative business models, commercialisation, Go2Market, and reimbursement strategies.

Key features:

• Business model optimisation with review & analysis.
• Business strategy optimisation with review & analysis.
• Commercialisation strategy optimisation with review & analysis.
• Regulatory gap analysis and reimbursement strategy.
• Market entry strategy analysis.
• Growth hacking.
• Distribution channels with cost estimation analysis.
• Strategic partnerships & agreement negotiation.

Benefits for EIC beneficiaries in i) research stage, ii) spinout/startup, iii) scale-up:

• Ensure your local market fit: Align policies with the local legislation and business practices.
• Secure revenues and stay ahead of competitors: Incorporate a feasible reimbursement strategy according to the local legislation.
• Accelerate market entry: Understand how the local health ecosystem works and align the go2market strategies accordingly.
• Clinical evaluations: Prepare in advance in case they are required for market accession. Also, use them in assessing the pricing model.
• Product success: Ensure reimbursement strategies optimally meet the target market regulatory requirement.

The service is directed to EIC pathfinder, EIC transition, and EIC accelerator innovators by dedicated in-house or external experts depending on the target market via online, offline, or hybrid models.

R&D Support for International Commercialisation for Healthcare Sector

Build capacity for inherent safe-by-design, standardisation, quality, and regulatory assurance through co-creation and co-design via individual training and coaching tailored to the needs of biomedical technology, medical technology, biotech, and the pharma industry.

The guidance will navigate the framework for complex health and medical care technologies, especially borderline cases, customised and personalised solutions that are challenging due to regulatory barriers, considering its current TRL level and the value chain.

Key features:

• Design of Experiments (DoE) and Human Factors Engineering (HFE)
• Proof of Concept (PoC) and prototyping.
• Safe-by-Design, and cross-cultural and cross-national design.
• Standardisation, Risk Management and QARA.
• Verification and Validation.
• Clinical design.

Benefits for EIC beneficiaries in i) research stage, ii) spinout/startup, iii) scale-up:

• Demonstrate the viability by early end-user feedback and check the manufacturability, cost, acceptability, accessibility, and market relevance of the final design.
• Incorporate requirements of the intended or potential market areas in the research and development phase, avoid costly redesign phases, and increase user safety of the innovation by considering multicultural design features.
• Incorporate target market-specific design features and carry out clinical evaluations to ensure regulatory compliance.

The aim is to accelerate innovations for health and medical care with high quality that are ready for the regulatory approval process and user-safe.

The service is directed to EIC pathfinder, EIC transition, and EIC accelerator innovators by dedicated in-house or external experts depending on the target market via online, offline, or hybrid models.

What is the EIC Ecosystem Partnerships and Co-Investment Support Programme?

The EIC Partners are selected under the EIC Ecosystem Partnerships and Co-Investment Support programme.

Launched in 2021, this programme has the goal of expanding the EIC Business Acceleration Services by addressing two of the greatest challenges for its innovators: access to specialised sector-focused services and attracting private investors.

The EIC Partners address the first need by providing:

• Standalone services such as workshops, training and matchmaking on topics that aren’t covered by BAS.
• Highly specific, niche services, such as the usage of specific laboratory equipment or technological due-diligence, and even relocation services and IPO coaching.
• Integration into partner’s accelerations, incubation, or venture building programmes, according to the technology stage and specificities of the innovators’ project.

On the co-investment front, beneficiaries are supported and trained to make the most of their interactions with investors and matched with the most relevant ones, both through events and direct introductions.
For more information, please refer to the EIC Ecosystem Partnerships and CoInvestment Support programme webpage.

About European Innovation Council

The European Innovation Council (EIC) has been established under Horizon Europe, with a budget of over €10 billion (2021-2027) to support game-changing innovations throughout their lifecycle, from early-stage research to market.

The EIC provides funding opportunities for companies in different stages of technological maturity through its instruments: EIC Pathfinder, EIC Transition and EIC Accelerator. These projects are selected through highly rigorous and competitive processes.

EIC Accelerator projects can receive up to €2.5M in grant funding, and are further eligible for up to €15M in direct equity investments from the EIC Fund. EIC innovators are also given access to the EIC Business Acceleration Services (BAS), which include coaching, mentoring and opportunities with corporates, procurers and investors.