Natalie Schibell, MPHMar 17, 20253 min read

Real-World Evidence in Action: Supporting Regulatory Advancements in Robotic-Assisted Surgery

The National Evaluation System for Health Technology (NEST) Coordinating Center was created through a U01 Cooperative Agreement with the FDA and is helping establish clear scientific and methodological approaches for using Real-World Evidence (RWE) in medical device evaluation. Through its Medical Device RWE Marketplace, NEST provides medical device manufacturers with access to high-quality, real-world data (RWD) sources and facilitates connections with research partners. This effort increases confidence among manufacturers and regulators that RWE studies are generated and applied in a way that meets regulatory and scientific expectations.

As part of NEST’s Medical Device RWE Marketplace, Aetion collaborates with NEST and medical device manufacturers to ensure that their RWE studies meet the highest scientific and regulatory standards. A mid-2024 FDA clearance for revised labeling of the da Vinci X and Xi surgical systems demonstrates the role of RWE in regulatory decision-making. Using RWD spanning 2007 to 2014, this evaluation, led by Aetion scientists Liz Garry, PhD and Liza Gibbs, PhD(c) provided long-term survival insights into robotic-assisted radical prostatectomy compared to traditional open surgery. The analysis confirmed that five- to 10-year survival rates for robotic-assisted prostatectomy were comparable to those of open surgery, supporting an update to the device labeling.

This strategic partnership between NEST, Intuitive, the FDA, and Aetion applied the NEST Mark process to assess data reliability and ensure alignment with regulatory-grade standards. The outcome demonstrates how methodologically rigorous RWE can be incorporated into regulatory submissions to support critical decision-making, labeling modifications, labeling updates, and long-term clinical understanding of medical device performance.

A Data-Driven Approach to Regulatory Science

Regulatory agencies increasingly incorporate RWE into medical device evaluation, recognizing its ability to complement traditional clinical trial data. While randomized controlled trials (RCTs) remain essential for establishing efficacy and safety, they often do not capture long-term outcomes, real-world utilization patterns, or comparative effectiveness across diverse patient populations.

The Use of RWD in Regulatory Submissions

Key Objective	Description
Conduct longitudinal analyses	Provides a more complete picture of device performance by assessing treatment outcomes over time
Leverage retrospective cohort studies	Uses structured healthcare claims data for large-scale evaluations of device effectiveness and safety
Ensure collaborative regulatory approaches	Aligns RWD with regulatory standards to support decision-making

For this study, healthcare claims data from Optum’s de-identified Clinformatics® Data Mart (with linked mortality data) enabled researchers to assess a cohort of nearly 25,000 patients who underwent radical prostatectomy. The study design accounted for confounding factors, ensuring a robust and reliable evaluation of long-term survival.

Strengthening Evidence Generation with RWD

This FDA clearance demonstrates how rigorous, well-designed RWE studies support regulatory labeling modifications and long-term clinical insights. As regulatory expectations evolve, medical device manufacturers must generate high-quality, fit-for-purpose evidence to inform decision-making across pre-market and post-market strategies.

A Structured Approach to RWE for Manufacturers

Key Objective	Description
Produce credible evidence	Supports regulatory labeling updates with scientifically valid RWE
Address long-term safety and effectiveness	Utilizes larger, more diverse patient populations to assess real-world outcomes over time
Improve post-market surveillance	Tracks real-world utilization and outcomes to ensure continued safety and effectiveness
Ensure regulatory-grade RWE	Requires scientific rigor, validated methodologies, and transparent study designs to generate reproducible, reliable findings that withstand regulatory scrutiny

Aetion’s Expertise in Regulatory-Grade RWE

Aetion’s role in this collaboration underscores its expertise in RWD analytics and regulatory science. As a leader in RWE generation, Aetion applies validated methodologies to help medical device manufacturers:

Key Objective	Description
Assess regulatory feasibility	Evaluates RWD sources to determine their suitability for regulatory decision-making
Design fit-for-purpose studies	Aligns study designs with FDA, EMA, and global regulatory expectations to generate scientifically valid evidence
Ensure transparency and reproducibility	Applies validated methodologies to strengthen regulatory submissions and support confident decision-making

This work, led by NEST in collaboration with Aetion, Intuitive, and the FDA, demonstrates how well-structured RWE supports regulatory decision-making, from initial approvals to post-market evaluations. As regulatory agencies continue to refine RWE standards and expectations, the ability to produce high-quality, decision-grade evidence will be essential for medical device manufacturers navigating an increasingly data-driven regulatory landscape.

Drive Regulatory Confidence with RWE

Explore how Aetion helps medical device manufacturers generate regulatory-grade evidence. Schedule a consultation today.