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TIRI & E-Da Hospital Give Boost to Taiwan-Made Medical Products

Smart medicine and precision health are major strengths for Taiwan in the field of biomedical technology, and are also areas that the National Science and Technology Council (NSTC) is committed to promoting. NARLabs' Taiwan Instrument Research Institute (TIRI), under NSTC, has implemented NSTC policy by assisting and guiding several of Taiwan's advanced medical product manufacturers who are conducting independent research and development to obtain certification and enter the market. In addition, TIRI has been working with hospitals to adopt domestic medical products and conduct evidence-based validation of those products, as favorable validation results will help local manufacturers branch into the international market.

So far, TIRI's work has achieved fruitful results. The products1 of four companies, United Orthopedic Corporation, Wiltrom Medical, INTAI Technology, and Remex Medical, have not only been successfully certified to be sold after assistance and guidance from TIRI, but have also been adopted clinically at E-Da Hospital. These products have so far been used in osteoarthritis surgery, vertebral body reconstruction, and bone spur and bone fracture surgery. The patients of these surgeries have experienced good recovery, and their ailments have greatly improved.

Excellent Independent R&D Technology + Assistance from TIRI Accelerates Product Certification

As Taiwan's society ages, the importance of medical devices has increased dramatically. According to Business Monitor International, the global medical device market was worth US$454.3 billion in 2021 and is expected to reach US$535.2 billion in 2024, making it one of the main forces of future economic development.

Before a medical device enters the market, it must pass multiple levels of testing. In addition to complying with government standards and relevant laws and regulations, it must also undergo rigorous requirements for animal testing and human testing so as to ensure safety and effectiveness during use. Without the assistance of a team familiar with the process, the time and cost involved can be significant, and the value of the product, or even the opportunity to enter the market, can be lost.

In the past, high-level medical devices in Taiwan were mainly imported from overseas, but with the advancement of local technology and superior innovation ability, cooperation among industrial, academic, and research sectors has led to the development of high-level medical devices that are 100% developed and manufactured in Taiwan, which not only reduces their cost, but also ensures quality. With assistance and guidance from TIRI, companies can quickly pass the pre-marketing hurdles for medical devices, such as prototype trial, testing and simulation site construction, medical imaging algorithm development, biomedical imaging analysis, and efficacy testing and verification so that product risk can be greatly reduced and certification can be obtained faster. Finally, and most importantly, E-Da Hospital is willing to give domestic manufacturers the opportunity to have their products introduced clinically and thereby demonstrate the innovation and quality of Taiwan-made medical devices. This not only benefits more even patients, but also opens the door for domestic medical product manufacturers to enter the international market.

Industry, Research, and Medicine Collaborate to Create Safe and Useful Medical Devices

E-Da Hospital President Dr. Yuan-Kun Tu explained that for patients in the process of receiving various surgical treatments, the attending physician will conduct a rigorous and meticulous assessment before the operation, taking the ailment as the main consideration, to draw up the best treatment plan for the patient. If appropriate, the physician will choose design and safety-ensured domestic devices to help carry out the surgery. Dr. Tu remarked that Taiwan's medical industry is tried and true, and that he and other physicians will do what is best for patients; as long as domestic medical products are of good quality, there is no reason not to use them. He also emphasized that E-Da Hospital purchases about 256 domestic medical devices every year, amounting to more than NT$300 million - the most in the country - making E-Da a domestic medical device accelerator. In the future, E-Da hopes to continue working with TIRI to support more high-quality and certified domestic medical products and strive together for Taiwan's development of medical products.

NARLabs President Faa-Jeng Lin stated that NARLabs has built a comprehensive biomedical R&D technology service platform to systematically link startups with industry, accelerate commercialization, and bring Taiwan brands to the world stage. TIRI Director-General Cheng-Tang Pan stated that since the signing of the memorandum of cooperation between NARLabs, I-Shou University, E-Da Hospital in 2017, TIRI has taken the initiative with its Medical Material Accelerator platform to provide comprehensive biomedical core facilities and capabilities to domestic high-level medical device manufacturers. This will accelerate medical device innovation and is expected to foster more cooperation between manufacturers and medical institutions in the future.

United Strength of R&D Clusters Raises Output Value

NSTC's Southern Taiwan Science Park Director-General, Chen-Kang Su, indicated that Southern Taiwan Science Park has always aimed to promote Taiwan's precision health industry chain across parks, and United Orthopedic Corporation, whose product was adopted by E-Da Hospital, is a leading manufacturer of orthopedic equipment at the Southern Taiwan Science Park's Kaohsiung Campus. In 2019, through the Park's "Southern Smart Biomedical Industry Cluster Promotion Program" subsidy, close cooperation among United Orthopedic Corporation, TIRI, and E-Da Hospital was achieved, expanding the value-added application of innovative services and creating greater output value for Taiwan's biomedical industry. Their collaboration is an indicative success story. Other manufacturers have come from all over Taiwan, showing that the government is proactively linking clusters from north to south to form a biomedical corridor, combining Taiwan's strengths in precision manufacturing, commercializing R&D achievements, accelerating startups, and ascending to the international level.

Kaohsiung City Government Economic Development Bureau Director-General Tai-Hsiang Liao stated that in recent years, due to the pandemic and coupled with changes in industrial structure, biotechnology and medical industry development regulations have extended benefits for another 10 years to allow these industries to build a greater niche. Industrial transformation and upgrades are key to urban development. The Kaohsiung City Government has long supported the development of the local medical device industry and proactively encouraged the use of domestic medical products in E-Da Hospital. E-Da's general teaching hospital in Kaohsiung has also been upgraded to a regional hospital for the benefit of Kaohsiung citizens. It is expected that the upgrading of the biomedical industry, jointly promoted by NARLabs, E-Da Hospital, manufacturers, and the Kaohsiung City Government, will create a cluster effect, expand economic benefits, and drive the prosperous development of Kaohsiung, stated Liao.