'Medical Device Certification' Wearable Robots to Increase... Popularization 'Accelerates'

Major Domestic Startups Pursue Certifications
Hurotics Prepares for Certification Process in September
Developing "Rehabilitation Robot Suits"
Wirobotics: "Increasing Patient Use,
Launching Medical-Specialized Products in the Second Half"
Seeking Global Expansion with Certification as a Stepping Stone
Large Corporations Like Hyundai Motor Also Show Interest

The number of wearable robots that can be used as medical devices in South Korea is expected to increase significantly in the second half of this year. Wearable robots are devices worn on the human body to compensate for physical limitations, and once officially certified as medical devices, they can be widely used for therapeutic purposes in hospitals or homes. This means they are becoming even closer to everyday life. Among the detailed fields of the robotics industry, wearable robots are considered the most likely to become popular quickly.

According to the industry on the 18th, major domestic wearable robot startups are preparing for medical device certification one after another. Hurotics, which develops rehabilitation robot suits, plans to begin the certification process in September. Wirobotics, which makes walking assistance robots, is also considering applying for certification, taking into account the increasing use by patients with Parkinson's disease and stroke. A Wirobotics official stated, "We expect to launch medical-specialized products as early as the second half of this year."

Medical device certification for wearable robots began in August 2018 when Cosmorobotics (then ExoAthlete) received the first approval from the Ministry of Food and Drug Safety for 'EAM.' Later, in December 2022, Angel Robotics' 'M20' was the first to receive a Class 3 certification, and in the same month, Cosmorobotics' children's robot 'Bambini Teens' also obtained the same grade. Hurotics and Wirobotics, currently preparing for certification, are aiming for a higher Class 2. The Ministry of Food and Drug Safety classifies medical devices into Classes 1 to 4 based on potential risk.

Once certified as medical devices, the supply channels for robots will expand significantly. Before certification, usage was limited to individuals purchasing for home use outside of hospitals, but after certification, hospital supply becomes possible and accessibility for general consumers increases. In fact, Angel Robotics' M20 has been supplied to about 70 medical institutions, including Sinchon Severance Hospital, and is being used for patient rehabilitation after certification.

Wearable robots are divided into 'therapeutic' and 'industrial' types depending on their use, and recently, demand for therapeutic use has been rapidly increasing due to aging. In particular, there is high interest among the elderly who have difficulty walking. As of December 23 last year, the population aged 65 and over exceeded 20% of the total, marking South Korea's entry into a super-aged society. Wirobotics stated that about 80% of its product buyers last year were elderly.

Domestic companies are also seeking to enter global markets such as the United States, China, and Australia, using medical device certification as a stepping stone. Large corporations are also paying attention to this field. Hyundai Motor plans to introduce the 'Xble Shoulder' robot, which is used to raise the arm during work in industrial sites, within this year. LG Electronics has continued research and development since unveiling the 'CLOi SuitBot,' which assists lower body strength, at the 2018 Berlin International Consumer Electronics Show (IFA).

Market research firm Mordor Intelligence forecasted in a report released in January that the global wearable robot market, valued at $3.37 billion (about 4 trillion KRW) this year, will grow to $13.52 billion (about 19 trillion KRW) by 2030.