Healthcare: Deep dive into Reimbursement and Regulatory Strategy

EIT Health

Germany

Service ID:

EP30S2
Service description
For healthcare companies, it is key to respond to country-specific reimbursement and regulatory system requirements. EIT Health has a track record of working with reimbursement and regulatory consultants with expertise in 25+ European systems and provides consultation with local experts to establish optimal reimbursement strategies and to ensure market compliance. This service relies on consultation with validated and experienced local reimbursement and regulatory experts and will help EIC Beneficiaries/Seal of Excellence holders establish the pertinent roadmap. In this process, it is possible to take advantage of the specific knowledge concerning comparable medical products and benchmark routes, already successfully taken. The service offers diverse components such as: a) Screening of the reimbursement system in the target market, to define the most optimised reimbursement pathway; b) Screening of the regulatory system in the target market, with a special focus on device, technology, or service; c) Up to two digital workshops each on country-specific regulatory and country-specific reimbursement systems (highlighting differences between public and private) for medical devices and digital healthcare solutions; d) Based on needs the service might contain arranging a meeting with a national insurance company to learn deeply about their culture and to share new opportunities among insurance companies network; e) Facilitating contacts with relevant institutional stakeholders. By outlining project context, scope, objectives, key success factors, and timelines, this comprehensive service offering enables companies to navigate reimbursement and regulatory requirements effectively, ensuring seamless market entry and compliance. The service will be conducted online, but a hybrid format is also possible if needed.
Sector
Biotech
Digital Health
Medtech
Technology Readiness Level
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Disclaimer related to service

A.This service is recommended as a follow up of Market Exploration and Validation (see Service EP30S1: Healthcare Market Exploration and Validation). B. Target: Digital Health, Biotech and MedTech ventures, who: have a developed and marketable product/ services but need to identify the appropriate market; are close to launching their product in home market and are already setting up conditions for imminent international expansion and commercialisation; have already launched their product at home market and are ready for international expansion and commercialisation. C. Selection: Please note all EIC beneficiaries and Seal of Excellence holders may apply but are subject to a brief selection process to determine the service fit. D. This service is carried out in collaboration between EIT Health and specific market-specialised partner entities, who offer soft-landing services within a local market of your interest. The market offer is currently limited to markets within the European Union (including Switzerland and Uk/Ireland). E. The EIC Beneficiary and Seal of Excellence holders will need to sign a service agreement with EIT Health, setting the legal and operational framework of the collaboration to benefit from the service. F. More information can be requested through: sabine.runge@eithealth.eu. Don’t hesitate to reach out if you have any doubts regarding the service offer and the service fit to your needs.

Financial requirements

Hourly rate varies from €60 to €500 depending on the innovation, healthcare sector and targeted market area(s). The full price will be adapted to the tailor-made service offer.