America First – Europe Second? Defining Global Market Access Strategies for Start-ups and New Devices

Description: Start-up companies face many financial challenges, they cannot afford to make costly mistakes and go in circles when developing a device. Selecting the right regulatory strategy to partner the commercial strategy is therefore essential. This session will look at current best practice and key considerations to develop a regulatory strategy.

Traditionally, many manufacturers chose European countries as the initial market for new products due to the lower regulatory hurdles and faster market access under the EU IVD Directive (IVDD, Directive 98/79/EC). The recent transition to the new EU IVD Regulation (IVDR, Regulation (EU) 2017/746) has significantly changed the European regulatory landscape and caused manufacturers to target the United States (US) or other geographies as initial markets for new IVD products. However, next to regulatory requirements and timelines for regulatory approval, strategies for market access also have to consider company and product specific aspects during product development (think of conduct of clinical studies and/or access to patient samples from specific geographies) and for product launch and sales & marketing (think of reimbursement requirements, building-up a sales force and required product support).

This session will discuss the requirements for market access and the evolving regulatory landscape in different geographies, namely the EU, US, United Kingdom (UK) and Switzerland. In addition, best practices for defining efficient strategies for market access in parallel with IVD product development will be shared, including the generation of performance data and clinical evidence for multiple geographies. Speakers will include regulatory experts and start-up company representatives. While the focus will be on the challenges and considerations for market access for start-ups and small companies, the content will also be applicable for the development of new IVD devices in larger companies.