The medical device sector is one of Europe’s key innovative strengths, filing more patents than any other industrial sector, and delivering a positive trade balance for Europe of over €15 billion. In recent years, more than 10,000 medical device patent applications are filed annually with the European Patent Office (EPO) in the field of medical technology – 7% of the total number of applications. Unusually for such an impactful sector, this innovation is primarily driven by indigenous SMEs, as opposed to larger Multinational Corporations (MNCs). In recent years, emerging medical devices SMEs are facing significant challenges due to an increased regulatory burden, more complex reimbursement landscapes internationally, an ever-increasing cost of clinical trials, and difficulties securing international financing. This complex environment has resulted in a growing failure rate in EU medical device SMEs. To maintain and support the sector, and to address these challenges within the Atlantic Area, the work programme will comprise of four major blocks, focused on targeted supports for medtech SMEs:
Develop and implement novel pre-acceleration supports to identify and support medical device SMEs with high growth potential;
Support transnational funding access for high potential SMEs, allowing for greater visibility of international finance opportunities and the ability to negotiate better terms with funders;
Providing regulatory, clinical evidence and reimbursement guidance toSMEs.