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Unlocking the U.S. Market: How South Korean Medical Device Companies Can Succeed with STAMPED Program

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/ Korea Health Industry Development Institute
/ Korea Health Industry Development Institute

The Korea Health Industry Development Institute (KHIDI) has partnered with the Texas Medical Center (TMC) to launch a program aimed at helping South Korean health industry companies break into the U.S. market.

KHIDI announced on Monday that it will conduct 11 sessions of the practical program STAMPED in collaboration with TMC, starting from October 29 and running through March of next year.

This initiative is designed to address the hurdles that Korean medical device companies face after the U.S. Food and Drug Administration (FDA) approval, including navigating insurance coverage, hospital procurement, and local distribution channels.

The program will feature key speakers from major local healthcare institutions, including MD Anderson Cancer Center and Texas Children’s Hospital. These experts from innovation teams and purchasing departments will share insights on hospital technology needs, medical device adoption procedures, and purchasing decision criteria.

The inaugural session, titled, Cleared. Now What? Life After Regulatory Clearance, is scheduled for October 29. Jeon Young-hyeop, Chief Executive Officer (CEO) of Wellysis, will share his company’s journey into the U.S. market following FDA 510(k) clearance for their wearable electrocardiogram patch.

Since July, KHIDI has been operating a support hub at TMC in Houston, focusing on hospital and clinical connections. Currently, 12 Korean companies are utilizing this space, benefiting from one-on-one consultations and clinical advice from local experts.

KHIDI has also established a foothold in Boston to support Korean health industry firms in securing investments and facilitating technology transfers.

This program marks KHIDI’s first direct initiative to connect Korean companies with TMC’s extensive hospital network, aiming to expand collaboration opportunities with U.S. medical institutions.

The sessions will be held as in-person events in Houston, with simultaneous online live streaming. Korean companies can select their preferred sessions through a pre-registration website.

Hwang Seong-eun, director of KHIDI’s Medical Device and Cosmetics Industry Division, emphasized that FDA approval is just the starting line. Success in the U.S. market ultimately depends on performance in real medical settings. It’s committed to expanding the support to help Korean companies understand local hospital demands and navigate the medical device adoption process as they prepare for market entry.

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