Reimbursement & Market Access Expert

Reimbursement & Market Access Expert – Methodological advisory and quality assurance of reimbursement analyses for digital health startups across six EU markets (SE, DK, DE, NL, FR, BE) Background DigiH4A is an Interreg Noth Sea Region EU Project that aims to enhance the innovation capacity and uptake of digital health solutions, accelerating the digital transformation of NS healthcare systems for the benefit of citizens, society, and caregivers. This is achieved by integrating these solutions into NS-wide reimbursement schemes and by providing a set of cost-benefit evaluation tools. The project is composed by a consortium of 11 partners where Innovation Skåne is lead. Partners: Biotech Sante Bretagne, Region Midtjylland, Eurasanté, Karlstads universitet, National eHealth Living Lab, VITO, Høgskolen I Innlandet, HAWK, Sozialbehörde Hamburg, Sahlgrenska Science Park. These actors represent 9 different countries within the North Sea Region. This is a 42 month long project which started 1st of October 2024. Context Within DigiH4A, Innovation Skåne has developed a set of reimbursement intelligence tools that help digital health and medtech startups understand how their solution can be financed, reimbursed and procured in a given health system. The analyses are produced with the support of generative AI (a large language model) and are based primarily on the DigiH4A project reports A1.1 and WP2.1 (Digital Health Market Access), the sources cited in them, and open clinical and care pathway data. The tools include: Step-by-Step Reimbursement Guide – a 7-step market entry pathway (typically 18–24 months) with four intelligence layers (unwritten rules, opportunities, watch-outs and timelines), stakeholder mapping per step and alternative route maps (e.g. regional-first vs. national-first). Patient Journey Based Reimbursement Analysis – up to 15 analytical layers across 7 patient journey phases, covering the health system funding architecture, reimbursement mechanisms, a service blueprint of the patient journey, stakeholder incentives, procurement pathways and business-driven recommendations. The model has been piloted on heart failure remote monitoring in Sweden; models for further countries are under development. Supporting instruments – a startup intake questionnaire, a reusable analysis template and a supplement on municipal-level reimbursement. In the next phase the tools will be applied to a cohort of [6] healthtech startups from Sweden, Denmark, Germany, the Netherlands, France and Belgium. Each startup will be analysed against the funding and reimbursement structures of all six markets. To ensure a reliable, high-quality product, Innovation Skåne is looking for an external expert to carry out the following two parts. Part 1 – Methodological advisory Assess whether each analytical element (tools, analytical layers, intelligence layers, templates) adds value to startups’ market access decisions in each of the six markets, and recommend what to keep, adapt, merge or remove. Identify gaps in the current structure, e.g. country-specific reimbursement pathways, evidence or HTA requirements, or payer perspectives that are not covered. Advise on how to compare the six markets consistently, including a source hierarchy and a verification protocol for future analyses. Part 2 – Validation and quality assurance Verify the factual accuracy of each startup analysis per market: payers and funding flows, reimbursement mechanisms and pathways, eligibility criteria, codes and tariffs, responsible actors and timelines. Check that every claim is traceable to reliable primary sources, and flag outdated, unsupported or AI-generated (fabricated) specifics. Classify findings by severity and propose corrections with references to the primary source used. Confirm when an analysis can be considered validated. Deliverables D1: Methodology assessment report with recommendations (Part 1). D2: QA review log for each startup analysis (Part 2). D3: Final validation summary with cross-market observations and a recommended QA protocol for future DigiH4A analyses. The working language is English. The work is mainly carried out remotely, with digital meetings with Innovation Skåne and, where relevant, DigiH4A partners. Must have requirements: - At least 5 years of professional experience in market access, reimbursement and/or health economics for medical devices or digital health in Europe (lead consultant). - Documented hands-on reimbursement or market access experience in at least three of the six markets (SE, DK, DE, NL, FR, BE). The tender as a whole (individual or team) must cover all six markets. - In-depth knowledge of the funding architecture, payer structures and reimbursement pathways of the six markets, including national, regional and municipal levels where relevant - Documented experience of reviewing or quality-assuring market access analyses, reimbursement dossiers or HTA submissions against primary sources. - Fluent professional English, written and spoken. - No conflict of interest with the startups included in the analysis. Nice to have requirements: - Experience of digital health-specific reimbursement routes, e.g. DiGA (Germany), PECAN (France) or the mHealthBelgium validation pyramid. - Experience of remote patient monitoring or chronic care models (e.g. heart failure). - Knowledge of how regions and municipalities finance and procure care in the Nordic countries. - Ability to read primary sources in one or more of Swedish, Danish, German, Dutch or French. - Experience of advising startups/SMEs on market entry. - Experience of evaluating AI-generated or AI-assisted analyses. - Experience of EU-funded projects, preferably Interreg. - Relevant academic degree, e.g. health economics, public health or health policy. Scope Part-time. Estimated total effort: [17] hours. Part 1 is concentrated at the start of the assignment. The initial assignment will consist in delivering Part 1. Part 2 of the assignment w