Value-Based Strategy for Medical Devices

Value-Driven Health Care

There is a growing recognition of value demonstration and HTA for procurement and reimbursement of medical devices in hospitals and health systems alike. In contrast to a solely price-based strategy, value-based payment strategies incorporate measures such as outcomes (including health, socioeconomic, etc.) and life-cycle costs into decision-making practices. An advantage of value-based strategies is that overall costs are considered, which is useful for long-term strategic decisions. Hospitals (public and private) use of this strategy for adopting a medical device is a solution-driven approach, offering options such as risk sharing schemes (RSS) for greater responsibility to the product provider. Medical device companies make use of HTA for reimbursement to access health system markets, where public payers often operate on tight budgets and where prevention is key. Value-based strategies allow greater consideration for preventative methods by considering outcomes, which in turn can translate to cost-savings for the hospital/health system, better care for patients and improved products in the medical device industry with the patient in mind.

Medical Device Legislation in Central & Eastern Europe

With the increased recognition of value-driven health care, hospitals and health systems of all economies are looking for solutions to rising costs, including in Central and Eastern Europe (CEE). As was noted in a previous post for hospital-based procurement of medical devices in Poland, there is an increased awareness of the importance of HTA in hospitals for medical devices. Furthermore, a draft amendment to the law on reimbursement in Poland is stalled under consultations, which includes a part for medical devices distinct from pharmaceuticals. Other countries in CEE are also shaping their policies for medical devices. For example, the Ministry of Health in the Czech Republic is working on new legislation for pricing and reimbursement of medical devices and the Ministry of Health of Montenegro announced a call for inclusion in preparing a draft law for medical devices to align it more closely with EU law. You can stay up-to-date on the latest changes to medical device regulations in the CEE region and beyond by signing up to our free Market Access Sentinel (MAS) newsletter for 30 days.

Make use of value-based strategy for your product, our consultants will be happy to speak with you! We offer a full strategic services for medical devices for value and HTA to gain market access and reimbursement in desired markets in the CEE region.

How We Can Assist You

Our wide range of services for Medical Devices includes:
  • HTA Value Dossier
    • A universal tool for every stage of applying for reimbursement
  • Simplified analysis of the decision problem
    • Gathers data on the clinical context and key information on the use of a medical device in a target population of patients, ready to be used during negotiations
  • Systematic literature reviews
    • Collection of scientific evidence is a necessary step to obtain financing from public funds, and a great source of scientific evidence used during negotiations
  • Manager Calculator
    • Forecasts sales and reimbursement costs in a given limit group, analyzes the relationship between selected price level and forecasted sales.
  • Simplified budget impact analysis
    • Identifies financial consequences of introducing or changing financing conditions for a product within a given health system
  • Proposals for Risk Sharing Agreements (RSS)
    • Proposal of a risk sharing instrument and its ensuing acceptance by the decision-maker increases chances of obtaining a positive reimbursement decision
  • Analysis of reimbursement potential
  • Support in negotiations with payer for reimbursement
  • Feasibility studies (e.g. limit group creation, HTA report)
  • HTA for hospitals
  • E-platform for Real World Data collection and RWE studies


If you have any questions about our services or would like to schedule a meeting, please e-mail us at or call +48 669 322 632
Value-Based Strategy for Medical Devices