Five to 10 years ago, many medium- and high-risk medical devices were expected to be commercialized first in Europe, with U.S. approvals lagging years behind. Industry leaders often criticized the FDA for inconsistently enforcing sometimes unclear regulations, and lamented that the lengthy and unpredictable U.S. approval timelines were driving innovation overseas.
There are always exceptions, but on the whole, this EU-first dynamic is becoming less prevalent. In some categories, early stage trials in the U.S. are now outpacing those in Europe. While the FDA is actively looking to create new and innovative pathways to market, European notified bodies are tightening their controls with stricter pre-market requirements for high-risk devices, reinforced clinical evaluation rules, and new data sharing requirements. Cumulatively these changes are causing a regulatory convergence between the two markets.
It’s not just theoretical, either: In 2011, the United States was the 42nd country to gain commercial access to a first-generation transcatheter aortic valve replacement device (Edwards Lifesciences’s Sapien THV), but earlier this year the FDA was the first regulatory agency in the world to approve the latest iteration of the Sapien 3 for a valve-in-valve indication in patients with worn-out surgical valves. This approval was sped along by the agency’s use of data from the Transcatheter Valve Therapy Registry, a practice that’s likely to become more commonplace following the FDA’s publication of final guidance on the use of real-world evidence last August. Additional innovative pathways, such as the Early Feasibility Study designation, will shorten time to market and encourage companies to think twice when they broach the topic of where to launch first.
In the absence of significant differences in the regulatory timelines, launch planning discussions focus more on the underlying market dynamics. Launching in the United States provides access to half of the world’s medical device market with a single approval. To boot, the homogenous nature of the market is logistically easier than navigating the complexities of Europe’s country-by-country requirements, nuances and reimbursement regimes. While the U.S. market is highly attractive, a U.S.-first launch today will face a different dynamic than the U.S. “fast-follow” launches of the past. Here are five factors for medical device companies to consider when preparing for a U.S.-first launch:
- Consider market development needs: In a “fast-follow” launch, earlier European commercialization of the device likely supplied ‘real-world’ experience that provided U.S. providers, payers and patients with a certain degree of confidence s in the device’s safety and efficacy. In the absence of this, companies may need to invest in additional market development. A more concerted effort may be needed to reach physicians who are used to having years of European or South American data available on “new” devices.
- Pressure test strategies and messaging pre-launch: In lieu of leveraging their own overseas experiences, teams need to find ways to validate their thinking. Companies can conduct pre-launch tests to hone untried product messaging and incorporate the findings into the sales team product training. For products in new categories, conducting buying process research can save valuable time and inform the go-to-market model.
- Build flexible and frequent checks into the training approach: Teams will need to build in nimble feedback loops to incorporate and share changes to employee and end user training programs in real-time.
- Plan for iteration: Less data may be available to support reimbursement decisions at launch, requiring companies to rely more heavily on clinical trial data and potentially plan for launches with less than optimal and evolving coverage. Similarly, companies may opt to launch with narrower indications, and expand as additional data becomes available from both pre- and post-market sources.
- Evaluate the required capabilities: For companies looking to leverage real-world data to speed along label expansions or line extensions, it’s best to consider pre-launch how existing capabilities will need to be modified to gather data in a way that meets the criteria for RWE, and can be used to support the evaluation of the device across the total product life cycle.
While plenty of devices will continue to be commercialized in Europe first, medical device companies should no longer assume that this has to be the case. If the choice is made to pursue a U.S.-first strategy, proper launch planning can ensure that it runs as smoothly as the ‘fast-follow’ launches of the past.v