Getting the Right Data – Why registry-led collaboration is the new standard for real-world evidence

As regulatory demands on MedTech increase, the challenge is no longer whether real‑world evidence is needed, but how clinicians, registries, regulators and industry collaborate to generate data that is both credible and usable. This theme was central to NEC Health’s recent webinar, Getting the Right Data: Enhancing Collaboration Between MedTechs and Health Registries, chaired by Catherine Castillo, Real‑World Evidence Specialist, and featuring experts from BSI, Medtronic, and major health registries. What followed was a practical, honest, and collaborative conversation about how the ecosystem can bridge the gap between regulatory expectations and clinical reality.
 

Registries as sustainable, multi‑stakeholder evidence platforms 

For collaboration to work in practice, registries must be designed as long‑term platforms that balance clinical priorities with the needs of multiple stakeholders from the outset.  Dr Emin Aghayev, Senior Advisor at EUROSPINE, described registries as long‑term systems whose value grows as more stakeholders rely on them. He explained that most registries begin with a clinical focus, but longevity depends on broader relevance. “The system that benefits many stakeholders would have the best chances to be sustainable and grow, because value and responsibility are shared.” 

This evolution requires deliberate design. Dr Aghayev described how Spine Tango introduced structural changes to support MedTech, including a detailed implant catalogue. “We obviously had to introduce changes to the registry to accommodate their needs and expectations. This included the detailed catalogue for the implants, which is essential for high-quality data, and it required real collaboration from the MedTech side.”  

He stressed that quality is not static. “The usage of data makes the quality of the data higher,” he noted, underlining that registries improve when they are actively used, interrogated and relied upon across the ecosystem.
 

Trust, governance and transparency as evidence enablers 

As registries begin to serve a broader set of clinical, regulatory and commercial purposes, trust, governance and transparency become the foundations that collaboration depends on. Dr Aghayev was clear about what is at stake. “You could have a very solid database rich in data, but no trust. That would be the worst‑case scenario, because all the effort to establish such a database would be lost for nothing.” 

From the regulatory perspective, Marion Soubelet, Principal Technical and Clinical Evaluation Specialist at BSI, reinforced that trust is built through rigorous and transparent practice. “We should have full visibility of how clinical data is collected. Transparency is quite key, and clinical data must be complete, accurate, consistent and collected under predefined, validated processes.” 

For regulators, clarity and relevance are non-negotiable; definitions and endpoints must align with intended use. This level of scrutiny underscores why registries require professional oversight to function as trusted evidence sources.
 

Why MedTech turns to registries for real‑world insight 

When governance is clear and trust is established, registries become one of the most valuable sources of real‑world insight for MedTech manufacturers. Floris van de Geijn, Senior Director for Medical Affairs at Medtronic, described them as “one of the few ways we can really understand real-world safety and performance at scale over time, across different surgeons, techniques and patient types.” 

In spine care, outcomes are multifactorial, shaped by pathology, surgical approach, and technologies like robotics. Registries allow manufacturers to observe these variables in routine practice rather than controlled environments. 

He emphasised that governance and structure are what make registry partnerships valuable. “Clear governance around data, follow‑up and meaningful endpoints is critical,” he said, because it allows evidence to support safety monitoring, regulatory readiness and long‑term evaluation in parallel.
 

From regulatory complexity to operational excellence 

Rather than sitting outside day‑to‑day registry operations, regulatory expectations increasingly shape how collaborative evidence systems are designed, managed and sustained. Marion Soubelet noted that registry data is a powerful source of evidence when it meets defined quality standards: “It is a great source of clinical data to demonstrate safety and performance, particularly for legacy and implantable devices, provided transparency, provenance and relevance are maintained.” 

Floris van de Geijn acknowledged the operational demands this creates. “Standards of care across centres and countries vary tremendously,” he noted, meaning registries must handle real-world variability without compromising integrity. This complexity is not a weakness, but a reason why registries require strong methodological design and experienced stewardship to remain credible across jurisdictions.
 

Benchmarking and disciplined comparison 

At its most mature, registry‑led collaboration enables fair and disciplined benchmarking that holds all participants to the same standards.  Keith Tucker, Chairman of ODEP and Beyond Compliance noted: “What benchmarking does is make manufacturers look at their data. Before 2002, there was no obligation for anyone to check whether the implant they were using was actually doing any good.” 

By drawing on data from a wide range of hospitals, benchmarking reveals how devices perform in everyday practice, “in everybody’s hands, not just the very good ones.” Fairness is central to this process. “There’s no favouritism and no conflict of interest. Everyone submits data in exactly the same way, and that’s why the comparisons matter,” Tucker explained.
 

Complexity as the catalyst for better evidence 

Serving clinicians, regulators and industry simultaneously is inherently complex, but this shared complexity is what drives more professional, trustworthy and collaborative evidence systems. Registry‑led collaboration brings together differing priorities, regulatory expectations and operational realities, requiring deliberate design, clear governance and sustained stewardship to succeed. 

The discussion highlighted that when registries are treated as shared evidence infrastructure rather than isolated datasets, they are better able to reflect real‑world clinical practice while meeting the standards required for regulatory confidence and long‑term evaluation. This approach does not simplify the challenge, but it ensures that complexity is managed transparently and consistently across stakeholders. 

The panel concluded that the future of real‑world evidence will be shaped by those willing to invest in registries as long‑term, collaborative platforms. By embedding trust, governance and shared responsibility at their core, registries can support safer, smarter decision‑making and deliver evidence that is credible, usable and fit for purpose across the healthcare ecosystem. 

To explore these themes in greater depth, you can watch the full recording of the ‘Getting the Right Data’ webinar using the form below or download the white paper, ‘Unlocking the Power of Registry Data: How health data partnerships can drive safer, smarter patient care.