Real-World Data: The fuel behind modern clinical evidence, and why Post Market Surveys are a smart way to capture it
By Ellie Baker, Commercial Director
Real-world insights have guided MedTech decision-making for decades, long before "Real-World Data" (RWD) and “Real-World Evidence” (RWE) became formalised terms. Today, as regulators worldwide including the FDA and EU Notified Bodies place greater emphasis on RWD, the industry faces a familiar but intensified challenge: how to generate high-quality, device-specific evidence efficiently, reliably, and without escalating costs.
That’s where Post Market Surveys come in. Once seen mainly in the context of supporting regulatory needs under frameworks such as EU MDR, they have evolved into one of the most strategic, scalable mechanisms for capturing structured RWD across device types and markets. Working with manufacturers globally, Purdie Pascoe helps ensure these surveys are structured, targeted, and capable of generating high-quality RWD. When executed well, they produce meaningful evidence on safety, performance, usability, and real-world clinical practice, providing evidence that stands up to both regulatory scrutiny and internal decision-making.
What do we mean by RWD and RWE?
RWD is health and device-related information captured outside traditional clinical trials, reflecting real patients, real settings, and real use. It includes:
• Electronic health records (EHRs)
• Registries
• Insurance/claims databases
• Device usage logs
• Patient-generated data
• Surveys and questionnaires
When analysed with rigorous methodology it becomes RWE insight into how your device performs in actual use, how patients experience it, and what risks or benefits emerge in real-world use.
Why RWE is now a global priority
1. Traditional studies don’t reflect real patient populations
Randomised controlled trials often exclude older adults, patients with comorbidities, or those with complex care pathways. In contrast, real-world data captures the full spectrum of users and clinical scenarios.
2. Regulators increasingly accept RWE as meaningful evidence
The FDA has already approved devices and label expansions based primarily on RWE.
Under the EU MDR, Article 61 and Annex XIV allow manufacturers to leverage diverse data sources — if quality and traceability are proven.
Notified Bodies now routinely ask for real-world performance data during clinical evaluations.
3. Evidence is no longer a one-off exercise
Under EU-MDR, PMCF requirements make it clear that evidence can no longer be a one-off exercise. Globally, regulators and manufacturers are aligned: evaluating safety and performance must continue throughout the entire product lifecycle. RWD is the foundation that enables this ongoing, real-world understanding of device performance across markets.
4. Faster insights = faster innovation
Manufacturers using RWE can identify risks and opportunities far earlier, enabling faster and more informed iteration.
The challenge: Getting high-quality RWD isn’t easy
Manufacturers consistently tell us the same things:
“Our registries don’t include the device-specific detail we need.”
“Extracting meaningful data from EHRs is slow and inconsistent.”
“Our retrospective reviews are patchy and incomplete.”
“We know we need continuous clinical evidence, but the cost and workload is overwhelming.”
High-quality RWD must be:
✔ representative
✔ traceable
✔ device-specific
✔ complete
✔ aligned with defined endpoints
✔ analysable and defensible
Few data sources tick all these boxes. Post-Market Surveys do.
Post Market Surveys: The Most Scalable Way to Capture High-Quality RWD
Well-designed Post Market Surveys (whether clinician-reported, patient-reported, or both) offer a uniquely efficient way to gather targeted RWD that meets regulatory expectations.
1. They generate device-specific insights regulators value
Unlike registries or EHRs, survey questions can be built precisely around:
Your device’s performance
Known or emerging risks
Evidence gaps
Claims you want to make
2. They reach the right users, at global scale
You can rapidly target:
Your device’s performance Defined user segments
High-risk cohorts
Innovators and early adopters
Broad, multinational user population
3. They provide structured, analysable data
Clear endpoints + validated questions = data suitable for statistical analysis and regulatory submissions.
4. They’re cost-effective
Compared to prospective clinical studies, surveys deliver robust evidence in a fraction of the time and budget.
5. They support the entire clinical evidence lifecycle
Survey data directly feeds into:
Clinical Evaluation Reports (CERs)
SSCP updates
Risk management files
PMS and PMCF plans and reports
Label expansions
Why some surveys fail, and why ours don’t
Manufacturers often come to us saying they’ve tried surveys before and been disappointed. When we dig deeper, we usually uncover one of the following problems:
❌ Endpoints weren’t aligned with clinical claims
❌ Questions didn’t map to the device’s risk profile
❌ Respondents weren’t the right population
❌ Data lacked statistical robustness
❌ Surveys were treated as “tick-box” exercises rather than evidence-generating tools
A poor survey wastes time, budget, and credibility. A well-designed one is transformative.
Why Purdie Pascoe?
With 500+ surveys delivered since 2019, we know what it takes to produce evidence that passes regulatory scrutiny without unnecessary complexity.
Working with Purdie Pascoe ensures:
The survey design aligns precisely with your device’s risk profile and evidence needs
Questions are mapped to clear, measurable clinical endpoints
Surveys are integrated into your long-term clinical evidence strategy, not treated as stand-alone activities
All data collected is robust, traceable, and defensible for regulatory review
The Bottom Line
Post-Market Surveys are one of the most scalable, targeted, and cost-effective ways to generate real-world data, and convert it into real-world evidence that supports compliance, innovation, and patient safety.
Manufacturers who embrace this approach don’t just meet regulatory expectations, they accelerate innovation, strengthen clinician confidence, and improve patient outcomes worldwide.