Biomedica Corporation, which has actively expanded into international markets in recent years, has achieved notable success in Thailand. During the “New Southbound Healthcare Market Expansion Experience Sharing Session,” Biomedica’s Founder and Chief Marketing Officer, Ming-Hsiang Lin, shared how the company successfully obtained TFDA (Thai Food and Drug Administration) certification in just eight months. He also revealed for the first time the company’s three core strategies for entering the Thai market—offering valuable insights for medical startups targeting Southeast Asia.

Building Market Trust Through Clinical Validation and KOL Engagement

“The challenge with AI is not the technology—it’s who’s willing to pay for it,” Lin said candidly. He pointed out that the greatest hurdle for AI-powered medical tools in global markets is the lack of clinical trust. In Thailand in particular, the medical community remains cautious about the accuracy of AI interpretation, making clinical adoption difficult.

To overcome this barrier, Biomedica adopted a dual strategy combining key opinion leader (KOL) engagement and local clinical validation. The team proactively approached orthopedic and radiology associations, and in 2024, launched clinical trials with the Thai Osteoporosis Foundation. To date, more than 50 medical institutions in Thailand have used Biomedica’s system, effectively bridging the trust gap. Lin emphasized, “Before insurance coverage is extended to AI tools, local clinical data is the key to earning government and physician recognition.”

Choosing the Right Distributor—Depth of Collaboration Is Crucial

In early 2023, Biomedica participated in the Bangkok Healthcare Forum as part of a delegation led by the Changhua Christian Hospital International Medical Center. During the event, the company was approached by a local Thai firm. After six months of discussions, a formal distribution agreement was signed in February 2024.

Lin noted that when evaluating overseas distributors, the team focuses on two core criteria: whether the distributor has strong ties to orthopedic or radiology medical systems, and whether they possess experience and long-term commitment to smart healthcare implementation. “Startups don’t generate large revenue from the start, so a distributor’s attitude toward innovation directly impacts the success of the partnership,” he said.

Leveraging International Certification Recognition Mechanisms to Accelerate Approvals

To tackle the regulatory complexities of medical devices in the Asia-Pacific region, Biomedica has developed a comprehensive strategy. Lin explained that the team leverages its cross-border regulatory expertise to optimize application timelines and approval efficiency through carefully planned market entry sequencing and certification strategies.

“This year, we successfully completed regulatory applications for key regional markets, significantly outperforming the industry average and laying a strong foundation for future expansion into other countries,” he said. He added that obtaining high-profile international certifications helps reduce uncertainty and accelerate entry into regional markets.

Market Strategy: Targeting Out-of-Pocket Consumers First in the Osteoporosis Segment

Before entering Thailand, Biomedica conducted extensive market research, analyzing equipment penetration rates, test pricing, insurance subsidies, and consumers’ willingness to pay out of pocket. Although many large Thai hospitals are equipped with DXA bone densitometers, actual usage rates remain low due to complex procedures and limited public awareness about osteoporosis.

As a result, Biomedica adopted a dual-track strategy: prioritizing the self-pay market in the short term, with government insurance coverage as a medium- to long-term goal. In the initial phase, the company focused on partnering with private medical institutions to gradually accumulate clinical data and user experience—paving the way for future integration into the public healthcare system.

Caption: The Biomedica team visits the R&D department of True Corporation in Thailand to present and discuss their AI-based bone health analysis system with key personnel in AI, telecommunications, and medical applications.

Resource: 柏瑞醫 8 個月快速取得泰國醫療認證　三大關鍵策略首度公開