Navigating the regulatory road to a robot
With wristed instrumentation and 3D visualization, the Hugo™ robotic-assisted surgical (RAS) system is a constellation of individual technologies, and each has its own set of complex regulatory requirements.
To bring the new soft-tissue surgical robot to market, Medtronic must prove to regulators all over the world that the technology meets or exceeds those requirements. That important responsibility belongs to a team led by Beth Stephen, vice president of regulatory affairs, surgical.
It’s no small task — the submission Medtronic filed with European regulators in 2021 was over 17,000 pages long. And Stephen’s team filed that submission within three days of a making another lengthy submission to the U.S. Food and Drug Administration to begin clinical investigations in the United States.
“What we’re really trying to do with all of our regulatory submissions is to tell a cohesive story,” Stephen said. “It has to make sense to the reviewers and demonstrate how we’ve exceeded all the requirements and the product is safe and effective and ready to be brought to market.”
More people behind our pipeline:
Today, the Hugo RAS system has obtained CE Mark in Europe for multiple indications along with approvals in a growing list of countries around the world. And with start of the first clinical study in the U.S., the system is one step closer to FDA approval for use in urological procedures.
“We celebrate any time a product is approved,” Stephen said. “But just because we’ve received approval, it doesn’t mean our work is over. It’s not over until that product is safely helping patients all over the world.”
The Hugo™ RAS system is commercially available in certain geographies. Regulatory requirements and status in individual countries and regions will determine market availability of the Hugo™ RAS system and approved indications. In the U.S., the Hugo™ RAS system is an investigational device not for sale
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