Voices of Impact with Dr E(TM) Season 2 Episode 2

Podcast Summary: Navigating U.S. Market Entry — A Conversation with Haewon Park

In this episode, we sat down with Haewon Park, a seasoned Regulatory Affairs Consultant with expertise in guiding international organizations—particularly from South Korea—through complex U.S. market entry challenges for medical devices and cosmetics. Drawing on her background in regulatory strategy and U.S. Food and Drug Administration (FDA) compliance, Haewon provided nuanced insights into both industry-specific trends and practical considerations for successful commercialization.

We began our conversation with a macro view of the medical device industry, where Haewon outlined the evolving landscape of regulatory frameworks in the United States. She emphasized the importance of understanding 510(k), De Novo, and premarket approval pathways and discussed how medical device sponsors must balance innovation with rigorous compliance. According to Haewon, developing a robust regulatory strategy early in the product lifecycle is critical to avoiding costly delays and positioning devices successfully for market clearance or approval.

Transitioning to the cosmetics industry, Haewon highlighted how regulatory oversight is increasing, especially with new provisions like the U.S. Modernization of Cosmetics Regulation Act (MoCRA). She explained the distinctions between cosmetics and medical devices, noting that while both categories require attention to safety and labeling, medical devices face a far more structured approval landscape. For cosmetics, Haewon stressed that clear claims substantiation, ingredient compliance, and quality systems are essential foundations for brand credibility and legal compliance in the U.S. market.

A major theme of our discussion centered on Haewon’s work supporting South Korean organizations aiming to enter the U.S. market. She shared tangible examples of how Korean companies in both medical technology and beauty sectors navigate cross-border regulatory requirements, cultural nuances, and operational barriers. Haewon explained that her consultancy leverages regulatory intelligence, market analysis, and bilingual communication to bridge gaps between Korean innovators and U.S. regulatory expectations. This support often includes premarket planning, compliance audits, submission strategy, and post-market maintenance for ongoing conformity.

Throughout the episode, Haewon emphasized the value of strategic preparation, regulatory literacy, and partnership when launching products internationally. She also offered actionable advice for startups and established enterprises alike, focusing on building cross-functional teams that understand both regulatory constraints and competitive market dynamics.

For professionals expanding into the U.S., Haewon’s insights shed light on not only the regulatory landscape itself but also the broader ecosystem in which global health and beauty products must compete and thrive.

Haewon Park LinkedIn: https://www.linkedin.com/in/haewonpark/