Company insight
for device evaluation (Wang et al. 2021; Stat Med). This approach applies entropy balancing, a statistical technique that adjusts for differences between real- world and study populations. By aligning treatment and control groups more accurately, manufacturers can reduce bias and improve the reliability of conclusions drawn from RWD. This method is particularly useful when designing clinical investigations or updating performance and safety parameters. It helps manufacturers overcome challenges related to limited or inconsistent data, ensuring that endpoints are relevant and reflective of actual clinical use.
Market access and regulatory submissions RWE is increasingly recognised by regulators as a valid component of market access strategies. A recent review of the FDA’s framework outlines how RWE can support regulatory approvals, highlighting key legislative milestones and future directions (Shi et al. 2024; Cost Eff Resour Alloc).
For manufacturers, this means that integrating RWE into submission dossiers can enhance the credibility of clinical evidence and potentially accelerate approval timelines. Understanding how to align RWD collection with regulatory expectations is essential for successful submissions.
Collaborative initiatives: the open hand approach The Open Hand Initiative (Baumfeld Andre et al. 2025; Clin Pharmacol Ther), a collaboration between the FDA, manufacturers and the Medical Device Innovation Consortium, exemplifies how industry and regulators can work together to improve the quality and transparency of RWE. This initiative encourages manufacturers to share insights from regulatory interactions, fostering a more consistent and effective use of RWD in submissions. Participating in such initiatives can help manufacturers stay ahead of regulatory trends, improve data quality and ensure that their devices meet evolving standards.
As the medical device industry continues to shift towards evidence- based regulation, RWD offers
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Key messages of the analysed publications Publication
McDermott & Kearney (2024)
Expert Rev Med Devices
Take-home messages for manufacturers
• RWD can support PMCF and clinical evaluation under EU MDR. • Helps fill evidence gaps and reduce study costs. • Suggests EU initiative similar to FDA’s NESTcc.
Wang et al. (2021) Stat Med
• Introduces a method to use unstructured data (e.g., text/images) in performance goal setting. • Reduces bias and improves reliability of statistical models.
• Useful for enhancing endpoint selection and study design.
• FDA increasingly accepts RWE for approvals and surveillance.
Shi et al. (2024) Cost Eff Resour Alloc
• Key challenges: data quality, interoperability, and regulatory clarity.
• Future focus: AI-driven analysis, cost- effectiveness and patient outcomes. • Reimbursement disparities may affect access to innovative devices.
Baumfeld Andre et al. (2025)
Clin Pharmacol Ther
• Open Hand Initiative promotes collaboration to improve RWE use in In Vitro Diagnostic approvals.
• Highlights need for better data access, standardisation and alignment with FDA expectations.
• Model could extend to broader device categories for more robust submissions.
Note: these four publications were identified as most relevant for medical device manufacturers involved in writing regulatory documents for medical devices upon the following search string on PubMed on 24 February 2025: (“real-world data”[Title] OR “real-world evidence”[Title]) AND (“medical device”[Title] OR “in-vitro diagnostic”[Title])) AND (2020:2025[pdat])
“Manufacturers should actively engage with emerging methodologies, regulatory frameworks and collaborative initiatives to ensure their devices are backed by robust, relevant data.”
manufacturers a strategic advantage. Whether supporting legacy devices, defining clinical endpoints, or facilitating market access, RWE provides a cost- effective and reliable way to strengthen clinical evidence.
Conclusion
Manufacturers should actively engage with emerging methodologies, regulatory frameworks and collaborative initiatives to ensure their devices are backed by robust, relevant data. By doing so, they can enhance patient outcomes, streamline regulatory processes and contribute to the future of healthcare technology.
References available on request.
The content of this article was first published in the European Medical Writers Association Medical Writing Journal in September 2025.
https://trilogywriting.com
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Medical writers are uniquely positioned to support medical device manufacturers in navigating these evolving challenges and opportunities, thanks to their deep understanding of regulatory landscapes, clinical evidence generation and strategic communication. ●
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