5 Ways to Find MedTech Global Market Efficiencies Now

Pursuing market approval for medical devices that will be used in both the EU and the U.S. is more complex than ever due to the transition from the Medical Device Directive (MDD) to the more stringent demands of the Medical Device Regulation (MDR) in Europe. In addition, data and documentation demands can differ greatly depending upon the region in which one is operating. Yet significant opportunities exist to identify overlaps in clinical data across multiple geographies and capitalize on them, resulting in pre- and post-market efficiencies that can accelerate timelines, trim budgets, and optimize the chances of a streamlined path to market approval.  

Here are five ways to find such efficiencies between MedTech EU/U.S. data overlaps. 

1. Create a comprehensive plan early on 

• Integrate your clinical development plan with the complexities of multiple geographies from the start  
• Design highly efficient clinical studies to capture the right data; collecting reimbursement data and documentation from the onset of your clinical program can provide potential applicable data sets for countries around the world 

View marketing claims and reimbursement strategies as equally important to regulatory issues. Too often in the course of medical device development across multiple geographies, regulatory approval is seen as the overarching goal. Delaying consideration of marketing claims and reimbursement strategies risks a costly and prolonged time to market. Learn more about U.S./EU medical device reimbursement strategies.  

2. Align data to identify efficiencies  

Design clinical strategies that align the data you are capturing now with data necessary to satisfy requirements in both the U.S. and the EU. To do so, ask the following questions: 

• Product life cycle: Where is my product in its development life cycle by geography? 
• Regulatory and reimbursement requirements by region: What are each country’s regulatory and reimbursement requirements? The Centers for Medicare and Medicaid (CMS) in the U.S., for example, require that study results be published in key medical journals prior to reimbursement approval. Target specific journals early on and ensure you are collecting the right data for them.  
• Endpoint identification: What are the endpoints I need to support regulatory approval, optimal reimbursement, and marketing claims?  
• Marketing claims: What marketing claims will help spur user adoption in a specific geography? Will the claims be the same in all geographies or will they have to be adapted for each region? 
• Project timelines and budgets: What are my timelines, goals, and budgets for each geography? Have a strategic plan for how you will cover them simultaneously. Identify where there is medical device pre- and post-market overlap and which regions have unique demands. 

3. Use data poolability to leverage clinical data sets  

Data poolability can help leverage the clinical data sets you’ve collected across the U.S. and EU to take advantage of overlaps. Doing this allows you to run smaller clinical trials simultaneously across multiple geographies. The comprehensive MedTech data pool can then be used in support of regulatory approval, marketing tactics, and reimbursement strategies. 

You must ensure your trial’s data poolability across each region, however. This requires understanding not only the similarities and differences between patient populations in each geographic area, but also the potential different clinical outcomes between the populations, medical practice patterns, and a host of other factors.  

For a more in-depth analysis of how to find medical device data overlap and medical device data efficiencies between the EU and the U.S., as well as actionable steps your organization can take, consult our white paper or watch our webinar. 

4. Consider risk classification, indication, and equivalency 

Understanding the risk classification for your device in each region will impact your clinical strategies. Ask whether each device has similar classifications in multiple regions and whether the requirements of clinical data are similar. For example, Class III devices need post-marketing data when they are on the market and Class II devices have different requirements for clinical data in the U.S. versus the EU. 

Data requirements for each device are also impacted by indication. Learn the key differences in indications between the EU and the U.S. or hire an expert to guide you through them.  

Equivalency is the final and perhaps most important manifestation of clinical data overlap. As with indication, there are significant differences between what is required to establish equivalency on the EU’s MDR and equivalency as defined by the FDA. This difference will impact what clinical data related to the equivalent device you can and cannot use as clinical evidence for your own medical device. 

5. Seek expert guidance  

Since extracting efficiencies from clinical data overlap across the EU and the U.S. is so complex, guidance from experts can be essential. Avania’s experts have extensive knowledge of medical device submissions across multiple geographies and can help you take advantage of MedTech data overlap opportunities to capitalize on the resulting efficiencies.  

Among other things, our experts can: 

• Offer insight into the areas of significant overlap between the guidelines set forth by the EU’s MDR and the standards outlined by HIPAA and the U.S. FDA 
• Develop your clinical protocol to collect the data needed for pre-approval activities (such as preparing for the PMA pathway for class III devices) and post-approval activities (for example, how your regulatory pathway may affect future market entries) 
• Advise on device classification; for Class II devices, for example, you might pursue 510(k) clearance in the U.S. first as this can streamline the collection of patient data in the U.S., which can then be used to obtain regulatory approval in the EU 
• Share insights on equivalence, including whether it is necessary and possible to claim equivalence, and if so, provide support with demonstration of equivalence  
• Offer counsel on data consent issues, which differ from the EU to the U.S. 
• Ensure compliance with GCP standards for the EU and U.S. companies that comply with both in the process of designing their clinical studies having a huge advantage compared to those that don’t 

When you need to capitalize on clinical data overlap when developing MedTech for multiple geographies, It Takes Avania.  

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