[K-Healthcare Goes Global] Peruvian employee at Lunit aims to bring Korean medical AI to Latin America

2024-07-23     Kim Ji-hye

During his internship at Daewoong Pharmaceutical, a Korean drugmaker, in 2018, Bryan Rossi received an urgent message from his boss. A doctor from Argentina had reached out with a desperate plea: His father, suffering from diabetes, needed Easyef (EGF), a diabetic foot ulcer treatment that only Daewoong Pharmaceutical produced. The situation was dire, and the medication was needed immediately. 

However, regulatory barriers made it impossible to send the medication from Korea to Argentina.

The regulatory process involved numerous clearances and extensive documentation, typically requiring months to complete through channels like Emergo by UL, a global regulatory compliance consulting firm for medical products. People in Argentina had high regard for Korean medicines, often preferring them over local options. The trust in Korean pharmaceuticals was a driving force behind the urgent plea.

The medicine couldn't just be sent across borders without the proper clearances, even for emergencies; Rossi knew the rules. 

But this was a life on the line. Rossi couldn’t ignore the desperate plea.

“I’m going to figure out how we can export this product to Argentina,” Rossi had told his boss.  Rossi discovered that he could send the product if he obtained a doctor’s certification and took full responsibility.

His determination was evident, and Daewoong Pharmaceutical, recognizing his good intentions, supported his efforts. Just as Rossi was about to send the medication, he received another message: “I appreciate your efforts, but my father passed away.”

The news hit Rossi like a physical blow. “All I could think was if we had acted just a little sooner, we could have saved one life,” he said in an interview with Korea Biomedical Review last Thursday.

Rossi realized that medical AI solutions – machine learning models that help process medical data – weren’t like commodities that could be traded freely across borders. 

“It’s not like coffee where you can just buy it,” he said. The complexity of global healthcare systems became painfully clear to him. “I knew how globalized Korea already was, but from that point on, I knew I had to do something to help the Latin American market get closer to accessing the Korean healthcare market.”

Bryan Rossi, senior business development manager overseeing the Latin America and APEC (LATAM) market at Lunit, a medical software company specializing in AI solutions, met with Korea Biomedical Review for an interview last Thursday at Lunit's headquarters in Gangnam, Seoul. (Credit: Lunit)

Rossi, 32, is from Peru. He first arrived in Korea in 2003 where he attended middle school in Bucheon. Since he was 12, his mother has always encouraged him to enter the business sector or pursue a financial career. 

Determined to secure a better future, Rossi moved to Korea in 2014.

Rossi majored in business management at Korea University and planned to secure a stable, lucrative position in the business sector after graduation, just as his mother had envisioned. However, life had a way of shifting even the most carefully laid-out plans.

Rossi’s life took a sharp turn during college due to a series of family health crises. At 20, he learned his grandmother had been diagnosed with diabetes. On a visit to Peru, he had hoped to see her healthier but instead found her in the hospital.

The sight of her, frail and pallid, was a shock, but then, a second blow struck: his cousin’s cancer diagnosis. First ovarian, then breast cancer – it eventually claimed her life. 

Initially focused on business management, his family members' harrowing experiences sparked a flame within him that grew into a vision: a desire to do something more. He began to explore the Korean healthcare system, determined to connect its advancements with the needs of the South American market.

In his final year at university, Rossi applied for the Daewoong's  "Woongtoring School" scholarship recently opened to international students. The competition was fierce – attracting 800 applicants from around the world. According to a Daewoong spokesperson, the school aimed to “identify candidates with the potential to be globally outstanding talents.”

With odds of 10 to 1, only 80 were selected from the pool, and Rossi emerged as one of the elite few.

The scholarship opened doors. Rossi spent a year as a scholar focusing on his studies, followed by an internship and a one-year contract, and eventually transitioned to a permanent position at Daewoong Pharmaceutical.

“I like the healthcare system here,” he said. “And even though I wasn’t in charge of promoting or selling the products, I was conducting crucial market research.” 

 

Rossi oversees Latin American biz at Lunit 

After four years at Daewoong, Rossi decided it was time for a change. He jumped at the opportunity to join Lunit, a medical software company specializing in AI solutions for diagnostics and treatment support, particularly in the fight against cancer.

In his role at Lunit, Rossi  primarily oversees the Latin American business, which spans South America, Mexico, and Central America. 

“Ever since the passing of my relatives and the life I could have saved at Daewoong Pharmaceutical, I’ve wanted to bridge the gap between Korea and Latin America,” Rossi said. 

His impact at Lunit had been significant. Rossi secured a tender to provide AI solutions and modalities to 62 hospitals in Panama’s public sector, where low-income patients would soon gain access to advanced diagnostic tools. He is currently in negotiations with key institutions in Mexico and Brazil. 

A landmark achievement was Lunit's software license agreement with Hospital Israelita Albert Einstein in Brazil, Latin America’s top medical institution recognized for its high-quality care.

"It’s not easy to get in there," Rossi said, emphasizing the rigorous approval process. “We were the first to install AI solution in that hospital.” Under the agreement, Lunit will supply the hospital with its AI solution for chest X-ray imaging analysis, Lunit INSIGHT CXR, for three years until 2025. 

The hospital’s adoption of Lunit’s AI solutions has opened doors to other regional prestigious institutions.

“If you say you worked for Hospital Israelita Albert Einstein, it’s easier to get in anywhere,” Rossi said. “That’s why we were targeting that big fish.”

The achievment was a milestone, but it was just the beginning.

 

Regulatory hurdles: battle to expand Lunit’s reach in Latin America

As senior business development manager, Rossi's mission was clear: generate revenue in the Latin American market. But he soon discovered that success was anything but straightforward.

"The greatest challenge in the Latin American market is the lack of clear regulatory guidelines," Rossi said. "Some regions allow direct sales, while others require going through distributors."

Lunit’s team, heavily reliant on the third-party consultant Emergo, faced a new setback a year ago. Emergo had reported that Mexico’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) had imposed new requirements for medical device registration, potentially stalling Lunit’s market entry.

However, after gathering intel from every possible source—distributors, regulatory experts—Lunit believed they were in the clear. AI medical devices, they had been told, didn’t need registration for Mexico and Panama.

When Lunit told their regulatory team that they didn’t need registration, the team pushed back hard. “Emergo says we need registration for Mexico,” they insisted. Rossi was stunned.

Just as Lunit was celebrating a major victory eight months ago—securing a tender to install its AI solutions in 62 hospitals across Panama—news broke that Freyr Solutions, its international contract research organization (CRO) and regulatory partner, had also announced a new registration process for AI medical devices in Panama. 

“We were stunned again,” Rossi said. Lunit’s local distributors in Panama—Maxia Latam— who were in close contact with the COFEPRIS, were equally caught off guard.

The lack of clear communication between COFEPRIS, Ministry of Health of Panama, Emergo, Freyr, and Lunit created a maze of confusion. Rossi’s team was trapped in limbo for nearly a year, unable to confirm if they could sell their product. Emergo’s response was always the same: “We’re still checking.”

Rossi began to suspect foul play. He believed Emergo wanted to keep Lunit dangling, making it harder for distributors to navigate the process. 

“It felt like they wanted to force distributors into preemptive applications to profit from the delay,” Rossi asserted. “COFEPRIS made changes, and we were told to wait longer. It seemed like a tactic to keep us entangled.”

Rossi’s frustration was compounded by personal stakes. The regulatory chaos reminded him of the tragic incident six years earlier when the lack of clear guidelines had led to the death of the Argentinian doctor’s father. Rossi was determined not to jeopardize more lives, so he fought back. 

“The local distributors understand their own regulations best,” he said. Maxia Latam had reassured him, “There is no new process. If there were, we’d know. We’ll even put it in writing and take full responsibility.”

Armed with this assurance, Rossi confronted Lunit’s regulatory team. “We’ve got the green light from Maxia Latam,” he said, urging them to seek confirmation directly from COFEPRIS, bypassing Emergo and Freyr’s middleman tactics. 

The response came swiftly: No registration was required. Lunit could now offer its medical AI solutions in Mexico, Panama, Chile, Colombia, Peru, Argentina, and Brazil.

“Even though we’re now free to deploy our medical AI solutions, the bureaucratic hurdles and regulatory ambiguity continue to pose significant challenges,” Rossi said. “Doctors are eager to use our technology to save lives, but the licensing delays are still holding us back.”

Rossi’s quest to integrate AI in Latin America’s healthcare system

Two years ago, the rise of AI in healthcare was a double-edged sword. The prospect of AI replacing radiologists in Latin America loomed large, casting a shadow of uncertainty over the field. 

Algorithms promising unparalleled accuracy and speed led many to fear that these advanced technologies might not only replace doctors but also question if they would merely ease their workload. 

“There was a genuine fear that AI would replace them,” Rossi said. “The early statistics showed AI outperforming experienced radiology specialists in accuracy, which was alarming.”

However, the narrative around AI has shifted significantly.  Doctors have gradually come to see AI not as a rival but as a powerful tool that enhances their capabilities.

Today, the urgency is clear: doctors who resist AI risk falling behind their peers who embrace it. Lunit’s mission is to bridge this gap by integrating AI solutions into the public sector.

“Our goal is to make advanced AI solutions accessible to all, regardless of income,” Rossi said. “We want to ensure that early cancer detection is available not just to those who can afford it, but to everyone.”

Despite this progress, a new obstacle has emerged. Doctors are now reluctant to introduce AI to their patients, primarily due to the “time-consuming process of explaining the technology and addressing numerous patient questions,” according to Rossi. This reluctance creates a significant barrier to widespread adoption.

Rossi explained, “There’s a lack of awareness among patients about what AI can do. Many have never heard of these solutions that could potentially save their lives.” He noted that despite the effectiveness of Lunit’s AI in catching what human eyes might miss, many doctors hesitate to share this technology with their patients.

Rossi recounted a story of a doctor who, despite having access to AI, initially missed a cancer diagnosis because he didn’t use it. It was only when the patient’s condition weighed heavily on him that he used AI for a second check—confirming the cancer that had initially gone unnoticed. 

Yet, convincing doctors to embrace and advocate for AI remains a challenge. “Doctors are hesitant to spend extra time explaining AI to patients,” Rossi said. “They’d rather avoid the questions and complications that come with it.”

Lunit is actively working to overcome this hurdle by increasing patient awareness and pushing for broader adoption of its AI solutions. With over 100 published studies attesting to its efficacy, Lunit’s AI technology is proven to detect cancers earlier than traditional methods. “Our AI’s performance is superior to that of its competitors in the global market,” Rossi said.

Lunit’s vision is ambitious: to make AI a standard in cancer care and significantly improve survival rates. “Once AI is widely adopted and integrated into everyday practice,” Rossi said, “the potential for saving lives will increase exponentially.”

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