Partner feature: The use of real-world data and real-world evidence in medical device evaluation

Medical device companies sit at the forefront of innovation, developing cutting-edge products and technologies that have the potential to transform patient care. Yet moving from concept to commercialism is a complex journey. Robust real-world data (RWD) and real-world evidence (RWE) are indispensable for demonstrating safety, efficacy and real-world impact.

In this article, Premier Applied Sciences’ Ariann Stone, Vice President, Business Development and Strategic Relationships, and Myla Maloney, Chief Growth Officer, discuss how large, fit-for-purpose healthcare data sets can help medical device manufacturers solve tough challenges and open new doors. They also share perspectives on what the industry needs to enable broader and more consistent adoption of RWE.

Advantages of using RWD and RWE across the product lifecycle

RWD and RWE play an important role in demonstrating the safety, efficacy and value of healthcare interventions in everyday practice. In medical devices, while randomized controlled trials (RCTs) remain a strong tool for assessing efficacy and safety, RWD provides important insights on a treatment’s impact in routine clinical practice that can complement findings from RCTs.

Rich healthcare data is also enabling more innovative, efficient study designs. For example, synthetic control arms (SCAs) can help lower trial costs, accelerate development and ease patient burden by using de-identified patient data from existing datasets. SCAs become especially valuable for conditions that are serious or life-threatening or affect a small percentage of the population, because they eliminate the need for a placebo group and reduce patient recruitment demands.

“Randomized clinical trials are important, explains Maloney. “However, they have limitations from a patient population perspective. From assessing therapeutic interventions not studied in RCTs to streamlining regulatory submissions, RWD and RWE can help bridge gaps. This delivers many benefits, from giving providers better guidance, to making a treatment accessible to more patients, to encouraging payer coverage.”

The role of RWD and RWE in regulatory decision-making

Medical device companies must continue to lean into RWD and RWE as payers, regulatory bodies, hospitals and health systems increasingly demand proof that a medical solution delivers real value by doing what it’s intended to do. When combined with clinical trial data, RWE can shorten the regulatory approval process and increase the chances of Food & Drug Administration (FDA) and European Union Medical Device Regulation approvals.

One way to generate that practice-based evidence at scale is through large, fit-for-purpose healthcare datasets. The Premier Healthcare Database (PHD) is a HIPAA-compliant, retrospective database and one of the most comprehensive electronic healthcare data repositories, representing 1.5 billion outpatient visits and about 25% of US inpatient admissions. The PHD also includes chargemaster data. When paired with claims data, this data set – the largest of its kind in the country – identifies every device and drug used, delivering essential context to inform the decision-making process.

With de-identified data, representing about 1,400 hospitals and health systems, insights from PHD can play a pivotal role in these decision-making processes.

“It’s geographically and demographically representative of the nation, capturing about one in every four patients, Stone says. “It includes administrative data, such as facility and patient demographics; service-level data, such as CPT codes, ICD codes and HIX codes; and even financial and billing data. The database is a rich resource supporting evidence generation for regulatory purposes.

“One of the PHD’s key differentiators is the inclusion of specific product names. For a medical device company, the ability to see a specific device in the dataset and the clinical information surrounding the use of that device is extremely valuable.”

Choosing the right data is not a one-size-fits-all approach. Companies must consider several key factors to ensure the data meets study needs and stringent regulatory requirements. “When you're selecting a real-world data source for your particular real-world evidence generation project, it's important to think about the regulatory use and the clinical context,” Stone advises. “This includes ensuring that the data you're using and your study methods align with your purpose.

“Consider these questions: Is the data set relevant to the study population? Does it have the right variables and covariates to support your endpoints? Does it provide appropriate data provenance? The answers will become critical as you evaluate your data and work toward submission.”

Strategic partnerships are also helpful in advancing medical device innovation. In 2025, Premier announced a collaboration with the National Evaluation System for health Technology (NEST), an initiative within the Medical Device Innovation Consortium (MDIC), to do just that.

“What's important about this collaboration is that both organizations are aligned to advance the use of RWD in medical device evaluation and for evidence generation purposes,” Stone says. “Premier’s data has been assessed using the NEST Mark approach, designed to de-risk the use of RWD for supporting regulatory filings. This effort aims to not just improve the industry’s confidence in RWE but also support predictability in medical device evaluation.

“We’re proud to be on the leading edge of RWD and RWE for regulatory decision-making, and we’re excited to see how the industry broadens usage.”

RWD and RWE in action

RWD and RWE have proven invaluable for not only shepherding treatments and devices through the regulatory process but also for supporting improved patient outcomes. RWD and RWE can also accelerate speed to market for products that may have otherwise taken much longer to reach patients.

“One company working with us hypothesized that a device could deliver benefits beyond current indications,” Maloney recalls. “Could they achieve appropriate efficacy and safety for those patients? They used our data to determine efficacy and safety for more patients, and their FDA submission was successful. Furthermore, they estimate that they saved $3 million and more than 18 months by doing it in this way. “This is obviously great for the company, but it's also a huge win for patients who would have to wait for a RCT but instead were able to get access more quickly.”

In another instance, Teleflex, a global provider of medical device technologies, partnered with Premier to generate a robust RWE package for a high-risk implantable device. By leveraging the PHD, the company built well-substantiated evidence designed to align with regulatory expectations and reflect real-world device performance.

“We've been saying RWE instead of an RCT, but sometimes, RWE is instead of nothing", Maloney notes. “And what a loss that is, from both an innovation and patient benefit standpoint, if you can't do that. So few companies are willing to share their data because it's proprietary. While this makes sense, it also makes it hard for companies to learn from each other. In a difficult and highly competitive industry, leveraging RWD for RWE generation is a literal game changer.”

Looking ahead

Momentum around RWD and RWE continues to accelerate, with 90% of global life science leaders saying it will influence company decision-making – and regulators are following suit: A growing share of FDA approvals now incorporate RWE, and recent milestones, such as the first label expansion granted entirely on RWE derived from electronic health records, signal increasing confidence in its role.

Together, RWD and RWE are helping companies meet rising demands to demonstrate safety and effectiveness, inform device development, differentiate products in a crowded market and streamline regulatory pathways.  

“I’m hopeful that the use of RWD to generate evidence for regulatory submissions becomes the standard moving forward,” Stone says. “But to get there, companies need the type of guidance that has been coming out from regulators and from other organizations, such as NEST, so that they can become more comfortable. Expanding RWD and RWE usage in medical device innovation is a win for everyone.”

Ready to harness the power of RWD and RWE for medical device evaluation? Learn more about how Premier Applied Sciences can help you solidify your position as a leader.

Published as part of the Evidence Insights, "Real-world evidence in medical device regulation: From data to decision-ready evidence", sponsored by Premier Applied Sciences.