NAVIGATOR medical devices
To find and to pursue the best way through the jungle of regulations and obstacles to achieve sufficient reimbursement pricing of a new product and listing of the product in the relevant directories.
This Navigator was launched for the first time in 2012 by EPC HealthCare. The Navigator is an interactive decision support tool and displays the proven Navigator logic. Information, data, facts and background information about the market, the market access hurdles and the roads to achieve reimbursement are integrated in the Navigator. The Navigator market access supports medical devices as well as diagnostic kits and covers the entire German market. In 2017 the Navigator will be extended with incorporated modules towards market access in Austria and/or Switzerland. The most relevant Navigator modules are:
- Relevant EU regulations and laws
- Definition of product risk classes
- All necessary application processes and forms to achieve reimbursement in the SHI and PHI sector
- The smart way for the ambulatory sector
- The smart way for the hospital sector
- Exemption in accordance with § 4b, Absatz 3, Satz 1 AMG
- Innovative contract models and market entry agreements (MEA)
- In-depth explanation of all relevant applications
- Case studies
- All relevant institutions for market access
- Road Map towards market access in Germany for medical devices
The market access Navigator for medical devices enables the manufacturer of an innovation to appraise his chances and risks as well as pros and cons for the market access of his medical device in different healthcare segments, outpatient and inpatient and with the different payers, SHI, PHI, rehabilitation or nursing care insurance. As a result, the manufacturer is able to choose the ideal market access for his product.
In the jungle of regulations, application procedures and entry barriers for a successful and sustainable market access for medical devices, the guiding thread, respectively a reliable navigation, to achieve the goal of a sustainable market access with a reimbursement in the SHI for an appropriate price and within a reasonable period of time is missing. The Navigator guides you towards the right way and ensures that you don’t deviate.