Latest Sales Success Intuitive Powered by NEST Mark

ARLINGTON, Virginia, August 5, 2024–(BUSINESS WIRE)–The National Institutes of Health Technology Assessment (NEST) Mark Initiative has succeeded, providing another efficient and streamlined path to FDA approval for an intuitive labeling modification for previously approved da Vinci Xi and X Surgical Systems robotic-assisted surgical devices (RASDs).

Recognizing the enormous potential of real-world evidence (RWE), Intuitive sought to identify and leverage fit-for-purpose data through the NEST Mark process in its pursuit of labeling change. This achievement is the latest success story driven by NEST Mark, a collaborative program focused on partnering with industry to maximize the impact of RWE use in the pre-market phase.

“Collaborating with the National Evaluation System for health Technology helped us find and synthesize real-world data into real-world evidence that could support our labeling revision,” said Jaime Wong, senior vice president and senior medical officer at Intuitive. “The NEST Mark process has shown us the utility of this type of collaboration, which is a significant advance in regulatory science,” said Wong.

RESULTS THAT ARE FIT FOR PURPOSE

The NEST Mark process is created by NEST to help catalyze the use of real-world data and evidence to support the development and use of new health technologies. In collaboration with all NEST stakeholders, the NEST team leads the design and execution of studies to deliver results that are fit for purpose and consistent with the highest standards for RWE applications.

Working within a broadly vetted network of research partners and commercial service partners, NEST Mark facilitates efficiency by assessing data sources and identifying the best-prepared contributors to execute RWE-based submissions. The NEST Mark process allows the company to quickly assess the likelihood of success with real-world data (RWD) and move into research with greater confidence.

“We are thrilled to have been a driving force for Intuitive Surgical on their journey to gain approval to expand this label. Building on the momentum of the NEST Mark process with another success is encouraging, and we hope that more companies will come to the table and discover the cost savings, efficiencies, and acceleration that can be found through partnerships through the NEST Mark. As our research network deepens, we look forward to empowering more and more companies with RWE that is truly fit for purpose and tailored to their individual needs before launch.”

—Simon Mason, CEO of NEST

About NEST (National Health Technology Assessment System)

In 2016, the U.S. Food and Drug Administration (FDA) awarded Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for Health Technology Coordinating Center (NEST). NEST promotes the use of real-world evidence (RWE) in medical devices to inform regulatory decisions and is committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines the RWE infrastructure with the unmatched expertise of network collaborators to accelerate patient access to safe and effective health technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About MDIC (Medical Device Innovation Consortium)

At MDIC, we are united in our shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads in advancing the scientific and technical foundations for medical device design, manufacturing, regulation, reimbursement, and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to advance regulatory science, MDIC develops new approaches and tools to address the shared challenges of medical device manufacturers, researchers, regulators, payers, patients, and healthcare providers. We deliver high-impact work in the critical areas of quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement. To learn more and join us in our mission, visit MDIC.org.

ABOUT INTUITIVE

Intuitive, headquartered in Sunnyvale, California, is a global technology leader in minimally invasive care and a pioneer in robotic surgery. At Intuitive, our mission is to believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we empower physicians to heal without limits. Intuitive brings more than two decades of experience in robotic surgical technologies and solutions to its offering, and develops, manufactures and markets the da Vinci Surgical System and the Ion Endoluminal System.

Funding for the NEST program was made possible in part by a grant from the Food and Drug Administration (U01FD006292). The views expressed in written materials or publications and by speakers and moderators do not necessarily represent the official policy of the Department of Health and Human Services; nor does any mention of trade names, trade practices, or organizations imply endorsement by the U.S. Government.

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