Medical devices that integrate materials, machinery, electronics, and biomedicine are an indispensable part of the biomedical industry. Since the 1940s, Taiwan’s textile industry has been the primary manufacturer of Class I medical devices such as gauze, bandages, and other surgical dressings. In the 1970s, the industry mostly manufactured infection control products, such as masks and surgical gowns. However, because medical devices affect human safety, their technologies are more complex than those of the material and machinery industries, and strict regulations are in place. As a result, not many SMEs could produce medical devices in Taiwan at the time.

To enable Taiwan’s medical device industry to master related core technologies and transform from medical material OEMs to medical device manufacturers, ITRI conducted a feasibility study on the medical device industry in 1988. In 1990, ITRI performed preliminary research on monitors, ultrasound, and rehabilitation equipment, and in 1992, ITRI joined the development of biomedical devices. In 1998, ITRI became an accredited 510(k) medical supply review institution, becoming one of thirteen 510(k) medical device review institutions recognized by the U.S. FDA. As the only such institution in Asia, ITRI plays an important role in the cooperation between Taiwan and the US in managing medical devices.

After 1999, ITRI helped industries develop new biomedical materials, such as non-sterile orthopedic biomedical products, transdermal patches, and electronic noses, using high-value medical materials to develop niche markets. In 2009, ITRI built Taiwan’s first medical device rapid trial production service center. In 2011, ITRI helped LITE-ON Spin-in its medical business department with the Micro Blood Analyzer Technology. In 2012, ITRI developed the Hyaluronic Acid (HA) Joint Injection Liquid, and transferred this technology to Yungshin Pharm Ind., the largest pharmaceutical company in Taiwan, and pushed the company to invest in high-end medical materials. In 2022, ITRI released the Dual-Phase Hydrogel, a novel implantable cross-linking agent with no additives.

To promote medical device industrialization, ITRI facilitated the establishment of several startup companies, such as Andros Pharmaceuticals Co., Ltd. in 2008, Wiltrom Medical in 2010 (co-established with INTAI Technology), and spun-off Taiwan Biomedical Company in 2013. These efforts added new vitality to Taiwan’s medical device industry, promoted the industry to export its manufactured devices, and accelerated Taiwan’s economic growth.