Used in diverse real-world settings, medical devices often undergo rapid iterations – encountering varying levels of operator skill within changeable health infrastructure. Whilst clinical investigations such as randomised controlled trials (RCTs) remain the methodological gold standard for gathering clinical evidence, they cannot fully replicate the nuanced interaction within a real-world environment.
Against this backdrop, real-world data (RWD) and real-world evidence (RWE) have attracted growing attention as valuable complements to clinical trial data. Swissmedic and the FDA are actively exploring how to incorporate RWE into decision making for devices, balancing the promise of greater efficiency and external validity with the need for robust, reliable, and transparent evidence.
In our topical article below, our Head of Clinical Dr. Sarah Bosshard shares how real-world evidence can bolster your clinical strategy in the context of the current Swiss and US regulatory perspectives.
Defining real-world data (RWD) and real-world evidence (RWE)
Let’s begin by clarifying what constitutes RWD and RWE.
The FDA defines RWD as health-related information collected outside of traditional randomised trials – including electronic health records, claims databases, registries, mobile health technologies, and patient-generated information.
RWE is the clinical evidence derived from analysis of these data sources. For medical devices, this distinction is particularly relevant: device performance is highly context-dependent, influenced by factors such as surgical technique, patient anatomy, hospital environment, and user experience. RWE thus offers a unique opportunity to capture device behaviour in authentic healthcare settings, extending beyond the controlled conditions of a trial.
Real-world evidence in medical device regulation | The US
The FDA has been at the forefront of developing a regulatory framework for RWE in the medical device field. Its 2017 guidance, Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices, provided the first systematic articulation of how RWD could be assessed for regulatory purposes. The document emphasised two key principles: the relevance of the data to the regulatory question at hand and the reliability of the data in terms of accuracy, completeness, and transparency.
In December 2023, the FDA released a draft revision of this guidance, reflecting the agency’s accumulated experience and the growing body of RWE applications. The updated draft not only reaffirms the relevance-and-reliability framework but also expands recommendations on study design, bias mitigation, and analytic methods.
It explicitly acknowledges that RWE can play a role across the entire device life cycle: from premarket submissions and label expansions to post-market surveillance and safety signal evaluation. Importantly, the updated draft guidance also contains real examples of device approvals and modifications where RWE formed a substantial part of the evidentiary package, underscoring that this is more than a theoretical possibility – it’s a practical regulatory pathway.
Real-world evidence in medical device regulation | Switzerland
Swissmedic’s position paper on the use of RWE – most recently expanded in April this year, recognises the growing importance of RWE internationally and the potential benefits it can bring to regulatory assessments.
However, Swiss law currently requires that marketing authorisation for therapeutic products, including devices, be based on clinical investigations conducted according to Good Clinical Practice standards – and so legal, scientific, and regulatory frameworks for approving new therapeutic products, including devices, or extending an indication solely on the basis of RWE are yet to be established.
Nonetheless, Swissmedic sees RWE as an important source of supportive information, with its framework designed to gradually build experience and ensure that Swiss practice keeps pace with international developments.
The current Swissmedic advice encourages a discussion of RWE plans in pre-submission meetings for new marketing authorisations and variations that broaden the therapeutic scope. As established within the FDA guidance mentioned above, RWE can also play a critical role in post-market surveillance as part of monitoring and evaluating safety and performance – which from a European standpoint is crucial for compliance with the MDR’s Post Market Clinical Follow-Up (PMCF) requirement.
How real-world evidence can strengthen your clinical strategy
Beyond regulatory submissions, integrating RWE into your company’s clinical strategy can deliver multiple benefits:
Demonstrates real-world safety & performance and provides comparative value
An RWE study allows you to demonstrate how a device performs in routine clinical practice, providing powerful evidence of real-world safety and performance as well as providing comparative value.
RWD/RWE may be of interest when clinical investigations such as RCTs are infeasible or unethical. Similarly, the use of RWE could provide insights into the use of medical devices among underrepresented and vulnerable populations. This can support discussions with regulators, payers, hospital procurement bodies, and clinicians, who increasingly request evidence that goes beyond controlled trial results.
Identifies where your device delivers most benefit
RWE can identify subpopulations or clinical contexts where a device delivers the greatest benefit, helping to refine indications, target your marketing, and shape your post-market studies. For example, registry-based evidence might reveal that a cardiovascular implant performs especially well in older patients or in specific surgical centres, guiding both product positioning and training strategies.
Shortens development cycles
From a lifecycle management perspective, a well-designed RWE study can reduce development cycles by generating evidence that supports label expansions or incremental innovations – avoiding the impracticality of relying solely on lengthy clinical investigations for every new iteration, and providing a more efficient route to demonstrating safety and effectiveness.
Captures certain outcomes of interest more efficiently
RWE is an efficient methodology to capture certain outcomes of interest – for example, long-term performance, usability, or rare adverse events.
Anticipates reimbursement & market access challenges
In Switzerland, the Federal Office of Public Health (BAG) evaluates whether a product should be reimbursed under mandatory health insurance. In the US, medical device reimbursement depends on clinical codes, payer policies, and demonstration of substantial clinical improvement.
By generating RWE that quantifies device impact on outcomes valued by payers – such as hospitalisations, real-world effectiveness, and total cost of care, manufacturers can address key questions that influence reimbursement rates and coverage decisions. Early integration of RWE within your clinical strategy can proactively generate the evidence needed to convince payers and coding authorities, and secure favourable reimbursement decisions.
Overcoming the challenges of using real-world evidence for medical devices
Whilst the case for utilising RWE as part of your medical device clinical strategy is compelling, it’s not without challenges.
Data quality and security is a persistent concern. Consent can be challenging, along with incomplete registries, inconsistent coding practices, and variable follow-up. Observational data are also subject to potential confusion and selection bias, making causal inference difficult. For medical devices, operator learning curves, institutional practices, and device iterations further complicate interpretation. And the risk of unintentional manipulation of the outcome by repeatedly analysing the same RWD is also important to consider.
Another challenge is interoperability. Linking hospital records, device registries, and insurance claims requires technical infrastructure and legal frameworks that are not yet fully mature, particularly in Switzerland. Privacy protection and compliance with data protection laws add further complexity.
To help overcome the various uncertainties associated with the use of RWD/RWE, it’s vital to predefine detailed descriptions and explanations of the methodology and statistics in your study protocol. Particular focus should also be given to ensuring transparent data provenance, carefully planning your analytics parameters, and implementing sensitivity analyses that explicitly address potential bias.
The future of real-world evidence in device regulation
While clinical investigations including RCTs remain indispensable for demonstrating core safety and performance, RWE offers a complementary lens that captures device performance in authentic, diverse healthcare environments. Medical devices, by their nature, are inseparable from the real-world contexts in which they are used, so harnessing RWE ensures that regulatory and clinical decisions reflect not only trial conditions but also the complex realities of everyday healthcare delivery.
The FDA has already demonstrated the feasibility of incorporating RWE into regulatory decision making for devices, and Swissmedic is cautiously preparing the ground for greater reliance on such evidence in the future. As such, by embedding RWE studies into your clinical strategy, you can accelerate innovation, support reimbursement, and build a compelling evidence base that resonates with regulators, payers, clinicians, and patients alike.
Should you have a clinical strategy challenge, our team is ready and happy to help. Simply get in touch to start the conversation.