US medical device maker Cranial Technologies is making its China debut at the China International Import Expo, aiming to tap into the country's growing demand for advanced infant care solutions and make the country one of its most important international markets.

Cranial Technologies has treated over 400,000 babies worldwide with its FDA-cleared DOC Band, the first cranial orthotic of its kind designed to gently correct plagiocephaly, or flat head syndrome, as babies grow. The product was granted clearance from the National Medical Products Administration and will be available soon in the Chinese market.

"We are truly honored to participate in CIIE for the first time. It's one of the world's most influential platforms for global trade and innovation," said Debbie James, CEO of Cranial Technologies.

"CIIE provides a valuable platform for us to connect with potential partnerships that can help bring our world-class infant care solutions to more Chinese families. Our mission is closely aligned with the vision of Healthy China 2030, making this the ideal time to deepen a dialogue with this vital market."

James said China's open and high-standard business environment offers "tremendous opportunities "for international healthcare innovators like Cranial Technologies. "We plan to develop the local market into one of our most important international markets," she added.

The company's expansion comes amid renewed growth in China's newborn population. According to official data, 9.54 million babies were born in China in 2024, up 520,000 from the previous year.

"Research shows that a significant proportion of newborns need treatment for plagiocephaly in the US. Studies indicate a similar ratio in the Chinese market. Bringing the most advanced technology to these babies was a primary driver for us to launch in China," James said.

The DOC Band is a custom-made orthotic helmet created using the company's proprietary 3D imaging system and AI-driven design software. "Each band is designed to address each baby's unique needs — as like snowflakes, no two are the same," James said.

Cranial Technologies began laying the groundwork for its entry into China in 2023, with its first clinic located close to Beijing Children's Hospital. The company has developed strong partners in Shanghai and Wuhan, Hubei province, as well.

The company's expansion has been bolstered by support from Eurazeo, a leading European private equity firm, and China Investment Corp (CIC), the country's sovereign wealth fund. James said the partnership significantly accelerated the company's China launch.

Cranial Technologies' China strategy emphasizes localized clinical training and service quality. James said that the key lies not only in their market-leading device but also in the intensive clinical service protocol surrounding it. To ensure consistent outcomes, the company has developed a customized e-learning platform for Chinese clinicians, supported by the local China team and backed by the US-based team that has been training clinicians for more than 30 years.

One of the key challenges ahead, James said, will be raising awareness among both physicians and parents, as early detection is critical, given the limited window for treatment.

"Parents often notice their baby's head tilting or flattening before a pediatrician does," she said. To address this, the company plans to launch social media campaigns and educational initiatives, positioning parents as advocates for early intervention.

"We're entering China not just to offer a solution, but to share decades of clinical expertise and help more families give their babies a 'well-rounded' start," James said.