The NEST Mark initiative which is being developed by the National Evaluation System for health Technology (NEST) has succeeded in empowering yet another efficient and streamlined path to FDA clearance for Intuitive labeling modification for its previously cleared robotic-assisted surgical devices (RASD) da Vinci Xi and X Surgical Systems.

Recognizing the immense potential of real-world evidence (RWE), Intuitive sought to identify and leverage fit-for-purpose data through the NEST Mark process in their pursuit of the labeling modification. This achievement is the latest success story powered by NEST Mark, a collaborative program focused on partnering with industry to maximize the impact of the use of RWE in the premarket stage of product development.

“Working 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, Intuitive’s senior vice president and senior medical officer. “The NEST Mark process demonstrated for us the utility of this type of collaboration, which is a significant advancement in regulatory science,” said Wong.

RESULTS THAT ARE FIT-FOR-PURPOSE

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

Working across an extensively verified network of research partners and commercial services partners, NEST Mark facilitates efficiency through the assessment of data sources and the identification of best-positioned collaborators to pursue RWE based submissions. The NEST Mark process allows a company to perform a quick evaluation of the likelihood of success with the real-world data (RWD) and proceed to a study with greater confidence.

“We are excited to have served as a force multiplier for Intuitive Surgical on their journey to clearance on this label expansion. Building the momentum of the NEST Mark process through another success is encouraging and we are hopeful more companies come to the table and discover the cost savings, efficiencies, and accelerations to be found by partnering through NEST Mark. As our research network deepens, we look forward to empowering more and more companies by leveraging RWE that is truly fit-for-purpose and tailored to individual premarket needs.”

—Simon Mason, President, NEST

About NEST (National Evaluation System for health Technology)

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

About MDIC (Medical Device Innovation Consortium)

At MDIC, we unite in a shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads the way in advancing the scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science, MDIC develops new approaches and tools for addressing shared challenges among medical device manufacturers, researchers, regulators, payers, patients, and health care providers. We deliver high impact work in the core 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 of robotic-assisted surgery. At Intuitive, our mission statement is we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures, and markets the da Vinci surgical system and the Ion endoluminal system.

Funding for NEST was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

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