Real-World Evidence: The need for continued dialogue across device stakeholders.

The Real World Evidence panel at The MedTech Conference will feature representation from the FDA, NEST and other industry representatives. Below, moderator Seth Goldenberg (vice president of medical devices and diagnostics at Veeva) and panelist Manish Bharara (senior manager of global clinical affairs at Siemens Healthineers) discuss why this topic continues to be front of mind for many in the medical device industry. 

Seth Goldenberg (SG): Real-world evidence (RWE) has been in discussion for the last several years, especially since the FDA put out its RWE Guidance. Why do you think this continues to be a hot topic? 

Manish Bharara (MB): When a product is developed, safety and effectiveness concerns are taken into consideration. But as the product gets used in the public domain new risks might emerge and with it, new sources of information. Unfortunately, none of this information is fed back to the manufacturer in a standard format. Having some standardization on how these disparate data sources are fed back into the product development process is going to enhance manufacturers’ ability to produce safer and effective devices that continuously evolve through real-world use.

SG: Is the burden on industry to figure out how to get all these different data sources and bring it together? What do you think is the biggest challenge in doing so? 

MB: I think interoperability and data privacy are two major hurdles that have to be addressed. This should be a shared responsibility across industry policymakers and regulators to come together and really think about how some of these challenges can be addressed.

SG: Do you think if interoperability and data privacy are handled in the right way, this data has the potential to feed innovation, not just improve safety? 

MB: Absolutely. If we surveyed manufacturers today and ask them what regulatory and clinical affairs mean to them, the answer is unanimously going to be “a cost center.” We have to shift from that cost center approach. Clinical and regulatory have the opportunity to be considered a value-offering business that can enhance innovation. RWE can strengthen that belief and enable monetization from that perspective.

SG: What are you most looking forward to by participating in this panel?

MB: Bringing together people within the manufacturing community, regulators and policymakers who share a common interest in tackling the problem together. It’s important to start talking about KPIs and a quality framework because data collection is definitely important. But, the quality of data collection and the quality of data analytics is the next step and is critical to the success of this initiative. That can only happen when all the entities come together.

SB: What do you hope will result in the long term from gathering these like-minded individuals? 

MB: I hope that we will be able to define some sort of framework and KPIs to guide manufacturers and regulators on how to assess the benefits coming out from this and fine-tune these as we go. Especially in light of the technologies that exist today and the technologies that are coming, it becomes really important to evolve with the technology landscape. This continuous evolution is what will make it sustainable, which is very important.

To hear more from Manish and the other panelists and learn more, join us for this panel session and visit Veeva booth at The MedTech Conference.


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