Company insight
Harnessing real-world data: An advantage for medical device manufacturers
Crispin Bennet, Heidi Chapman and Laura C Collada Ali of Trilogy Writing & Consulting explore how it’s time for medical device manufacturers to harness the full potential of real-world data to strengthen regulatory submissions and post-market strategies.
he integration of real-world data (RWD) into healthcare decision- making is reshaping how medical devices are developed, assessed and monitored. With RWD becoming increasingly accessible, manufacturers, regulators and clinicians are recognising its value in enhancing the relevance of research findings, improving patient outcomes and supporting regulatory decisions. Medical devices – from in vitro diagnostics to therapeutic technologies – undergo rigorous clinical evaluation before market entry. However, traditional clinical investigations may not fully reflect real-world usage or long-term outcomes, especially for lower-risk devices. In Europe, the Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostics Regulation (IVDR 2017/746) mandate continuous Post- Market Clinical Follow-up (PMCF), requiring manufacturers to collect and assess data throughout the device’s life cycle. Similarly, in the US, regulations such as 21 Code of Federal Regulation Parts 814 and 822 and Section 522 of the Federal Food, Drug and Cosmetic Act establish post-market study and surveillance requirements. Recent initiatives and publications have focused on leveraging RWD to complement clinical trials and provide deeper insights into device performance, safety and effectiveness across diverse
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patient populations. For manufacturers, this means better tools to fill evidence gaps, strengthen post-market surveillance, and guide product development with a more patient-centric approach. This article reviews three key publications and one collaborative initiative that highlight how RWD is being used in the medical device sector. These resources offer practical insights into regulatory frameworks, data integration methodologies and real- world applications that manufacturers should be aware of to optimise their regulatory strategies and product life- cycle management.
RWD reflects routine clinical practice and typically includes larger, more diverse patient populations than traditional trials. This makes RWE particularly valuable for supplementing pre- and post-market clinical investigations, supporting benefit/risk assessments, and reducing the financial burden of conducting new studies. Legacy devices – those already on the market but lacking comprehensive clinical data – can benefit significantly from RWE. Regulatory frameworks now offer pathways for manufacturers to use RWD to strengthen clinical evidence, especially under the EU MDR. This
“Manufacturers should explore diverse sources of RWD, including hospital records, electronic health records, registries and even social media listening.”
Leveraging RWE for legacy devices As regulatory expectations evolve, RWE is becoming a powerful tool for medical device manufacturers, especially those managing legacy devices. A recent review (McDermott & Kearney. 2024; Expert Rev Med Devices) highlights how RWE can help bridge gaps in clinical evidence, offering a more accurate and cost- effective way to demonstrate device safety and performance.
What are real-world data (RWD) and real-world evidence (RWE)?
■RWD refers to observational data collected outside traditional clinical trials – such as electronic health records, insurance claims and patient-generated data – used to understand patient health and care delivery.
■RWE is clinical evidence about the use, benefits, or risks of a medical product, derived from the analysis of RWD.
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approach aligns with initiatives like the Food and Drug Administration’s National Evaluation System for Health Technology, which promotes the use of RWE in regulatory decision-making.
Manufacturers should explore diverse sources of RWD, including hospital records, electronic health records, registries and even social media listening. These sources can provide insights into device performance across varied clinical settings, helping to build a robust evidence base.
Defining clinical endpoints using RWD
A novel methodology has emerged that uses RWE to define meaningful endpoints
www.medicaldevice-developments.com
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