He is a medical device and pharmaceutical industry expert with an MPharm and an MBA, and the Founder and Managing Partner of Hedgehog Consulting. His firm supports market entry strategies, market and competitive landscape analysis, market access and reimbursement, and overall commercialization for companies targeting the European and U.S. markets. He has extensive global business experience in the medical device and pharmaceutical sectors and is also an active investor in numerous startups and ventures.

Although CE marking under the EU MDR is a critical requirement for entering the European market, the actual processes of purchasing and adoption vary significantly by country. This presentation will examine country specific market needs, adoption barriers in clinical settings, reimbursement pathways, payers, purchasing and decision making stakeholders, and end users.

Drawing on real world cases, the session will also outline how to select target countries and develop tailored market entry and commercialization strategies. These strategies will consider customer needs, value propositions, pricing, positioning, and distribution approaches for each market.

He is the Co‑Founder and CEO of Global Certification Body, an EU Notified Body for medical devices. Over the past 16 years, he has served as CEO of the CRO Pure Clinical, a Notified Body expert, and a technical specialist, auditor, and certification decision-maker for the European Commission and various governmental authorities. He is also active in academia as a lecturer and has authored multiple publications related to the medical device industry.

This presentation explores the actual market entry process for medical devices in Poland following MDR compliance and CE marking. It will cover the role of the Polish regulatory authority URPL, local requirements such as language obligations, market entry pathways, hospital public procurement procedures, and the two reimbursement routes. The session will also explain the roles of key institutions including AOTMiT, NFZ, URPL, and the Ministry of Health.

In addition, the presentation will compare Poland’s system with those of Germany, Italy, France, and Spain, and highlight common challenges and key considerations that foreign manufacturers frequently encounter when entering the Polish market, supported by practical real world examples.