Introduction
At one time, companies needed little more than a quality management system to obtain a CE mark and start selling devices in Europe. The rules have tightened up somewhat since then, but today Europe still offers companies the chance to bring devices to market based on limited data. Importantly, CE markings awarded to devices in Europe also serve as keys to other countries as Australia, enabling businesses to quickly start generating sales in multiple geographies.
Now, Europe is set to shed its reputation as the gateway to global medical device markets through a radical regulatory overhaul. Adam Steadman, vice president of clinical development at Syneos Health, said that while at one time European market access rules did not address "whether a device worked, whether it was safe," beginning next year, the requirements in the region will be "in many ways tighter than in the US."
The upshot is that now, more than ever, companies need to think differently. Strategies that worked well in the past will simply not work in the future. In this new environment, the concept of integrating clinical and commercial teams and putting an Asset Strategist at the center of the resulting broader group is gaining traction.
To understand the emerging landscape, Medtech Insight sat down with Steadman to discuss how market changes are driving clinical-commercial integration and how device developers can adapt to the new normal.
The EU's well-trodden route for commercializing medical devices is now permanently altered. Regulatory changes in Europe mean companies can no longer use the region as a springboard for rolling global commercialization plans, forcing them to rethink how to efficiently get devices to market. In this new, more demanding environment, for manufacturers there are big benefits to integrating their clinical and commercial teams.
Traditionally, developers of medical devices have been able to defer big investments in clinical trials until after their products are on the market and generating sales. The deferral was enabled by the path to market available in Europe.
