From prototype to market – this is how the medical technology ecosystem of Zsámbéki Park is being built

The Zsámbék Future Industry Science and Innovation Park treats medical technology (medtech) as a priority development direction: the goal is for the park to become the leading, university-based medtech R&D and validation center in the Central and Eastern European region. To this end, the park will not only provide physical infrastructure, but also build a comprehensive ecosystem for medical technology developers, supported by regulatory advice and academic expertise.

The medical technology sector is one of the highest added value and most innovative areas of the economy, but it also poses two serious challenges for developers: the availability of strictly regulated infrastructure – clean rooms, validation labs – and the complexity of European compliance procedures (MDR, IVDR). Zsámbéki Park will offer an answer to these challenges, building an environment that will accompany developments from prototype to market.

Regulated infrastructure in one place

The development and testing of a medical technology device requires a special, regulated environment that would require significant investment to create independently. The park plans to make this background – cleanroom and laboratory capacity, as well as the associated team of professionals – jointly available to the companies developing it, so that testing and validation can be carried out locally without building their own infrastructure.

Regulatory support from design to market entry

Compliance with the EU MDR and IVDR regulations is essential for all medical technology developers, but it also requires serious professional preparation. The park will act as an active partner in this area: it will support developers in preparing for certification processes, including CE marking, and in establishing regulatory compliance, so that an innovation can reach the market faster and more safely.

University background and strategic partnerships

The park's medtech position is also based on a strong academic and industrial background. In February 2024, Óbuda University, Zsámbéki Park, MediKlaszter, representing the Hungarian medical technology industry, and Medicor Zrt. signed a strategic cooperation agreement on the establishment of a Central European Center of Excellence for Medical Technology Innovation, which serves to expand the connections and joint development of Hungarian and Central and Eastern European medtech organizations. The focus areas of the planned center of excellence include strengthening the domestic medical technology and defense industry, emergency device development, and the further development of the unique Hungarian mass ventilation system, the MASSVENTIL project. This background guarantees that the companies developing in the park will have access not only to infrastructure, but also to cutting-edge professional knowledge and an international network of contacts.

A complete ecosystem, not just a property

The three elements – regulated infrastructure, regulatory advice and academic background – together will enable Zsámbéki Park to truly offer an accelerated path for medical technology innovations from concept to market. The park will also strengthen this position in the coming period with targeted online content, an active media presence and professional events.