Ortho · RWE · Registries
Real-world evidence, the engine behind orthopedic innovation.
Orthopedics generates real-world data at a scale few specialties can match. Used well, it accelerates development, strengthens PMCF and opens market access. Here is how.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Ortho RWE, led by an ortho reviewer.
Turning registry data into evidence is a specialty. Ours is led by a former Notified Body reviewer for Class III implants.
Dr Nikhil Khadabadi
Former Notified Body assessor for Class III implants; PMCF and CER methodology, ortho and high-risk devices.
in LinkedIn
Sébastien Meier
Endpoints, statistics and RWE; architect of the MILO EDC, 21 CFR Part 11 and real-time dashboards.
Awards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The opportunity
Why orthopedics leads on real-world evidence.
Mature national implant registries make orthopedics one of the few fields where large-scale, long-term real-world data is genuinely available, and that changes how innovation is evidenced.
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The registry advantage
Registries such as the NJR, EPRD and Swespine track implant survivorship and revision across hundreds of thousands of procedures over many years. That gives orthopedic teams a real-world evidence base for benchmarking, safety signal detection and long-term performance that most specialties simply do not have.
02
Where RWE drives innovation
Real-world evidence is not only a post-market obligation; it shapes development.
RWE across the lifecycle
- Design decisions informed by real-world revision patterns
- Benchmarking a new implant against registry survivorship
- Efficient PMCF built on registry data (EU MDR)
- Market-access and reimbursement dossiers grounded in real outcomes
03
Where registries stop
Registries excel at survivorship and revision but rarely capture function, patient-reported outcomes or imaging detail, and cannot answer every comparative question. That is where a lean prospective study or PRO survey complements the registry, filling the specific gaps a claim depends on.
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Putting it together
The strongest orthopedic evidence strategy blends registry RWE for scale with targeted primary data for the endpoints registries miss. We design that blend so each source answers what it is best at, and the whole package holds up in the Clinical Evaluation Report (CER) and PMCF.
Ortho RWE
Scale plus specificity.
Talk to a specialist
How could real-world evidence strengthen your orthopedic device?
Book a free scoping call with a former Notified Body ortho reviewer. We design a registry-plus-study RWE strategy matched to your device and claims.
Book a free scoping callIn orthopedics, real-world evidence is a head start, not an afterthought.
An expert read shows where registry data and targeted studies together can accelerate development, strengthen PMCF and support market access for your device.
Book a free scoping callQuestions we hear first