Call for regulatory body

Of the 300 biotech firms at Hong Kong Science Park, 10 are focusing on AI surgical robots.

However, Benny Lo Ping-lai, of the Hong Kong MedTech Association, says that the lack of a local regulatory body for medical-innovation validation hinders medical technology startups' development.

Without such a regulator, devices must seek approvals from external authorities, such as the United States Food and Drug Administration and the National Medical Products Administration on the mainland, before registering in Hong Kong — a difficult process that would involve trials in those regions. The FDA's approval often needs Caucasian trial data, while the NMPA requires data from mainland hospitals.

The Hong Kong Special Administrative Region government recognizes the need for its own medical registration regulatory body. Chief Executive John Lee Ka-chiu's 2023 Policy Address proposed establishing the Hong Kong Centre for Medical Products Regulation to provide evaluations for local medtech innovations.

"Securing the first approval is always the hardest," Lo says. "But once this is achieved, subsequent market access becomes easier as startups can use this evaluation to knock on other markets for approval."

The proposed CMPR would be part of the SAR's broader medtech hub ambitions. As an interim measure, the "1+" mechanism, introduced in November 2023, streamlined drug and device registration, allowing approval with just one external authority's endorsement plus local clinical data for life-threatening conditions.

Fred Tung, a member of Hong Kong Health Bureau's Advisory Committee on Health and Medical Innovation Development, says the CMPR would help local startups and mainland companies expand globally, provided they get approvals from both the CMPR and NMPA.

Yet, unlike other markets that prioritize local innovations, Hong Kong's Hospital Authority — the largest medical device buyer in the city — dose not show an apparent preference for homegrown products. "It's like pitting a child against an adult," says Lo, noting multinationals' resource advantage in securing HA contracts. With hospital procurement cycles spanning a decade, many startups can't survive long enough to compete.

Braillic — a Hong Kong-based startup that provides augmented-reality neurosurgery navigation — is seeking more funding for validation of its product after having secured HK$1 million in angel funding. "First, we'll target approval from the NMPA on the mainland, then acquire Europe's CE marking and, finally, the FDA's backing," says Camroo Ahmed, Braillic's CEO.

Ahmed, who founded Braillic after graduating from the City University of Hong Kong, says the city's global ties, talent pool and proximity to the vast mainland market are key reasons for the company to stay.

Braillic plans to expand to Shenzhen, but will keep Hong Kong as its hub, leveraging the city's world-class neurosurgeons.

Liu believes the true value of technology such as AI is augmenting human capabilities — overcoming physical and cognitive limits.

Liu envisions an operation room where surgeons command AI-assisted devices like MicroNeuro, enabling junior doctors to perform like experts. AI surgery planning, he says, will soon be as simple as planning a trip.

While being bullish on AI's potential to reduce costs and expand scope in neurosurgery, Liu stresses that doctors must have the final say in decision-making.

AI advances, but surgeons grow along with the technology, he says.

The future forward for MicroNeuro's R&D team

1. Develop a multiarm flexible surgical robot.
2. Scale down the footprint of the robotic arm.
3. Upgrade CARES Copilot as an AI-powered surgical assistant.
4. Incubate a portable hand-held flexible endoscope.

Contact the writer at stushadow@chinadailyhk.com