How Teleflex Leverages Real-World Evidence to Help Strengthen Regulatory Strategy

Key Takeaways:

• Teleflex partnered with Premier Applied Sciences, the research division of Premier, to generate a robust real-world evidence (RWE) package for a high-risk implantable device, navigating challenges concerning device visibility, traceability and long-term tracking.
• Leveraging the Premier Healthcare Database (PHD), Teleflex built well-substantiated evidence designed to align with regulatory expectations and reflect real-world device performance.
• The work reflects a broader strategic shift: embedding RWE expertise within internal teams to align evidence generation with business needs, regulatory requirements and, ultimately, patient-centered outcomes.

When it comes to medical devices, having the right data can make or break a regulatory strategy. But for forward-thinking companies such as Teleflex, a global provider of medical technologies, collecting data is only the starting point.

Real-world data (RWD) has become central to regulatory strategy in the medical device and life sciences industries. However, the true value lies in transforming that data into structured, validated insights that meet the standards of global regulators, accelerate market access and keep patient safety front and center.

Working with Premier, Teleflex created an evidence set for a high-risk implantable device that is precise, traceable, clinically meaningful and fit for real-world decision-making.

Real-World Evidence Grounded in Strategy, Not Just Support

Regulatory complexity has moved beyond checklists. Today’s submissions must demonstrate not only safety and efficacy but also a real understanding of how devices perform over time and across populations. One of the largest and most comprehensive healthcare data repositories, the Premier Healthcare Database’s (PHD’s) de-identified data* includes:

• Chargemaster data.
• Electronic health records (EHR) data.
• Closed claims data.
• Purchasing data.
• Administrative billing records.

“The chargemaster descriptions, in particular, have given us the ability to identify the devices,” said Trevor Carden, Director of Scientific Affairs at Teleflex.

Chargemaster data provides information on a significant number of interventions used as well as cost of care, physicians, drugs, diagnoses, department detail and demographics. This data provides the detailed, itemized information needed to generate high-quality RWE for regulatory submissions and to demonstrate a device’s value and effectiveness.

Regulatory Expectations are Global — But Not Uniform

As RWE becomes more central to regulatory decision-making, the complexity of compliance grows, particularly across international markets.

European regulators, for example, require robust evidence of long-term device performance, especially for implantables. That means demonstrating the ability to track a device well beyond the point of procedure and accounting for downstream outcomes across varied populations.

“In order to demonstrate, particularly in Europe, that you understand the lifetime of your device and can speak to success rates and complication rates over a long period of time, you have to be able to identify your device and track it over the implantable life of that device,” Carden said. “An exciting use case with Premier is using procedure codes to identify the procedure that's being done with our device.

“From there, we can determine which anatomy the device is being used on. Then, by tracking diagnosis codes, we can monitor any complications or damage related to the structures our device interacts with and continue tracking these over the duration of the patient’s time in the database.”

Making Real-World Evidence Operational

Success with RWE isn't just about access to the right data — it's about knowing how to use it.

For Teleflex, that meant building internal fluency: starting with clear research questions, defining protocols upfront and identifying data sources based on those needs.

It's a shift from opportunistic exploration to intentional evidence-building. It also speaks to a broader trend across the industry: companies investing in RWE not as an ad hoc function but as a core capability alongside traditional clinical research.

“It’s been an excellent use case for us in terms of getting our foot into the real-world evidence realm and showing Teleflex (internal stakeholders) the value of RWE,” Carden said.

That internal capability isn't just nice to have: It's becoming essential. As RWE's ability to influence regulatory decisions grows, organizations that know how to work with it and not just around it will be the ones positioned to lead.

The Path Forward

The next wave of regulatory submissions is already being shaped by RWE. But the differentiator won’t be data access — it will be data strategy.

Regulatory-grade evidence isn’t the result of scale alone. It’s the outcome of clear intent, structured collection, rigorous validation, and the ability to tell a credible, clinical story from real-world patterns.

The companies that lead this space will be those that don’t just collect data but build evidence with purpose, precision and foresight.

For more:

• Teleflex's success is just one example of what’s possible when real-world evidence is done well. Learn more about how Premier Applied Sciences can help your business unlock the power of RWE as part of a sound regulatory strategy.

Interested in ongoing updates from Premier Applied Sciences? Subscribe to Premier Perspectives to get timely updates in your inbox.

*Information in the PHD, a retrospective database, is de-identified and HIPAA-compliant in accordance with the HIPAA Privacy Rule.