Global Quality and Regulatory Compliance
Considerations for “First to Launch”
As companies seek to launch their medical devices in multiple regions globally, it’s important to understand the differing guidelines and regulations across geographies. But staying current on rules and regulations across areas can be challenging – especially when a company is considering its “first to launch” region.
Many companies place intense focus on how their global regulatory strategy will be affected by their selection of a “first to launch” region. But – without an understanding of regulatory compliance issues across locations – it may be difficult for a company to deploy across regions in a timely and systematic manner.
Because business implications across the globe can impact outcomes, companies must simultaneously consider the many aspects that can impact the choice for success in both a “first to launch” location and subsequent launch locations. Among others, these include:
Product design and performance requirements
Differing requirements for clinical performance data submission
Countries or regions with a “faster” timeline to market if a United States Food and Drug Administration clearance or Conformité Européenne (CE) mark is obtained prior to submission to launch in those locations
If these considerations are made only with the “first to launch” location in mind, subsequent launches may not be able to be deployed as efficiently as hoped.
Beyond the aspects just mentioned, there also has been a shift in behavior with the application of the European Medical Device Regulation (EU MDR) that must be considered. These regulations expanded clinical data requirements for new product applications. Prior to the EU MDR application, one strategy that was commonly exercised was to launch in the EU prior to the United States as a means to observe outcomes and gather evidence to support a submission in the United States. Now that the clinical evidence requirements between these leading markets are more similar, other factors such as access to key customers or approval timelines play a larger role in the decision to designate a “first to market” region.
Emerging markets, such as China, Brazil, and India are also increasingly being considered as “first to launch” geographies. However, these areas may refuse to accept global clinical trials and require the local equivalent or bridging, which can significantly impact the anticipated launch timeline. Other regions streamline their own regulatory approvals by requiring a product to be pre-approved in a major “reference market,” such as the U.S. or EU.
Further, there are cross-regional trade-offs whenever considering a “first to launch” market. Data harmonization, for instance, is intended to ensure that clinical trials are designed to meet multiple regional regulatory thresholds. Further, Intellectual Property considerations can alter launch dates, regardless of regulatory approval. And, aside from aforementioned factors, product type and target patient population are critical factors in mapping an optimal global submission sequence. All in all, there are a number of strategic factors to evaluate whenever a company is considering the “most advantageous” location as its first to launch.