According to a 2016 EY report, it’s not a question of the new European Union (EU) Medical Device Regulations (MDRs) disrupting the medtech industry, it’s how much disruption they will cause. As the deadlines quickly approach, MDRs are creating a backlog among notified bodies, lengthening time to market in the EU and creating concern in the C-Suite.
The EU used to be the best place to launch innovations, and we used to recommend our clients begin marketing their products in Europe because it was typically quicker to get into the market and gain stakeholder feedback (patients, clinicians, payors, etc.). If a client picked the right country, listening to initial customers could sharpen its messaging for the rest of the world.
In contrast, medtech executives often complained of the regulatory black hole in the U.S. Food and Drug Administration (FDA). The U.S. regulatory process could be complicated at best and unresponsive at worst. However, the FDA has dramatically improved its regulatory performance.
So, is it now good advice to recommend “America First” when considering the best place to launch a global product?
While “America First” may be a controversial political topic globally, we believe it’s a legitimate discussion in the medtech industry for multi- national companies. Specifically, if you’re a regulatory professional, we welcome your feedback.
The best policy for regional companies is home country first; however, for many international companies (see chart), it’s worthwhile to consider the U.S. as a launching point because:Faster time to market:
Starting under the Obama Administration, improvements to the FDA have helped decrease product time to marketFeedback:
The FDA can help with clinical study input to create a more impactful (clinical) trial designMarket size:
If a product/company finds success in the U.S., it can succeed (most) anywhereRegulatory harmonization:
FDA’s work with other countries is helping with regulatory harmonization
Exit strategy: Investors’ checklist items for merger & acquisition (M&A) activities typically look at either FDA clearance or an established FDA regulatory pathway for market clearance
As you consider our comments, know that one author is from the EU and the other from the U.S. Historically, we both highly recommended “Europe First” for launches, but today’s regulatory environment makes it less clear what region is best for launch. We encourage the internal debate and discussion before deciding. Consider all the available options, and consult a regulatory specialist before making a final decision.