'Korean health AI innovators face challenges in US due to limited engagement with key opinion leaders'

The U.S. is actively seeking AI collaborations, eyeing technologically advanced countries like Korea as potential partners. Yet, Korean innovators with cutting-edge AI solutions, riding a wave of optimism, may be in for a rude awakening.

For Korean innovators, particularly those introducing groundbreaking products, success in the U.S. market demands a “radically different approach from what has worked in Korea,” according to Suzy Im, managing partner at Boston-based BDMT Global. 

During a webinar hosted by BDMT Global on Oct. 24, Im emphasized that disruptive innovations like AI cannot rely on a one-size-fits-all strategy. So what holds these medical innovators back in a landscape ripe with opportunity?

“Korean innovators possess the technical prowess to meet U.S. market demands,” Im said. “But they must ultimately form relationships with key opinion leaders (KOLs) to accelerate their growth.”

Despite the success of six of Korea’s top 10 AI healthcare startups, as ranked by Tracxn Technology last year, their ambitions to penetrate the U.S. market remain nascent. 

Im pointed to a critical misstep: as Korean companies venture into the U.S., they often limit their engagement with KOLs to narrowly defined roles—focusing primarily on clinical collaborations or pre-FDA approval discussions—missing the broader opportunities for lasting impact.

“Companies have the wrong idea when it comes to making full use of KOL management,” she said. “Many mistakenly confine KOL involvement to a few specific activities.” Im argued that innovators should integrate KOLs throughout the entire product lifecycle— from research and development to marketing—and particularly during experimental execution.

Companies often invest years in clinical trials and data-building in Korea, banking on a smooth transition to the U.S. But with all that groundwork, the question of whether the U.S. market will recognize the value of this home-grown data remains. 

A key strategy, Im said, is ensuring that clinical studies and databases are truly applicable to the U.S. landscape. “Companies using AI need to assess if their software stacks up in the U.S., where competition can be fierce, and users may already have benchmarks for comparison,” she said. “This kind of fine-tuned analysis can turn tentative feedback into decisive competitive edge.”

Im highlighted another common mistake among innovators, which is the assumption that Korean market positioning will resonate in the U.S. “After 20 years in this field, if there’s one hard truth, it’s that adaptation is the ‘game changer,’” she said. She noted that many companies blur the lines between business development and marketing, a gap that widens upon entering the U.S. market. For those with FDA approval, delays in marketing can sap momentum, leaving firms unprepared to capitalize on initial success.

In the competitive U.S. market, single-strategy approaches often fall short, especially for technologies like electrical stimulation devices, which demand broad acceptance. “For U.S. traction,” Im said, “companies need a climate of acceptance,” meaning layered channels, varied partnerships, and backup entry routes.

“Successful companies don’t just blitz the FDA and wait,” she added, noting that they take years to lay the groundwork—networking with stakeholders, crafting content, building a community—so that when the green light comes, they’re ready to ignite the market. “Market readiness is everything,” Im said. "It's not just about clearance; it’s about positioning and quality assurance paired with a primed audience."

Many innovators miss the mark on targeting the right audience, assuming their device fits one field only to find through KOL feedback that it’s primed for a different niche. This pivot, guided by KOL insights, cuts costs and refines market entry, avoiding costly trial and error. “Getting stakeholders on board before FDA approval sets companies up to hit the ground running once clearance arrives, moving them closer to that IPO finish line,” Im said.

Meanwhile, BDMT Global specializes in helping companies navigate the complexities of entering the U.S. market, a task that is becoming increasingly important as technologies like medical AI gain mainstream acceptance.