National Cheng Kung University Department of Biomedical Engineering & Institute of Medical Device Innovation

(1) Institute of Biomedical Engineering

The Institute of Biomedical Engineering was founded in 1988, boasting a history of over thirty years. In its early stages, it integrated university resources across biomechanics, medical electronics, biomaterials, medical informatics, and rehabilitation technology. The Ph.D. program was established in 1993, and the undergraduate program was introduced in 2011, at which point the institution was officially renamed the "Department of Biomedical Engineering," dedicated to advancing interdisciplinary research and education combining medicine and engineering.

NCKU's College of Engineering has a long history and comprises eighteen departments and institutes, making it the largest in the nation. In 1984, the establishment of National Cheng Kung University Hospital and College of Medicine was initiated as one of the government's 14 Major Construction Projects, with biomedical engineering identified as a key development focus. Both colleges reached a strong consensus to actively collaborate on research in medical engineering and related technologies, with our department tasked with leading this critical interdisciplinary development.

(2) International Institute of Medical Device Innovation (MDI)

To respond to global industry trends and internationalization demands, the department established the "International Institute of Medical Device Innovation (MDI)" in 2017 under the active planning of Distinguished Professor Fong-Chin Su.

Medical devices offer high added value alongside strict regulatory requirements, serving as a key focus for Taiwan's industrial upgrade and transformation. Centered on "demand-driven innovation," MDI spans engineering, medicine, regulations, and market strategy. By integrating the entire training process from R&D, manufacturing, and clinical service to commercialization, MDI is committed to cultivating interdisciplinary innovators with global vision and business development capability.

(1) Institute of Biomedical Engineering

We are committed to integrating biomechanics, medical electronics, biomaterials, biomedical diagnostics, medical informatics, and rehabilitation technology to cultivate biomedical engineering professionals equipped with solid theoretical foundations, innovative practical skills, humanistic literacy, and an international perspective.

Leveraging the abundant faculty and clinical resources of the College of Engineering and the College of Medicine (including the teaching hospital), the department focuses on educating cross-disciplinary talent capable of advancing healthcare technology R&D. Simultaneously, we assist clinicians in mastering modern engineering techniques, fostering cross-field integration across medical treatment, diagnosis, and research to maximize technological impact.

(2) International Institute of Medical Device Innovation (MDI)

• Deepening International Collaboration and Local Engagement: Moving beyond short-term exchanges to build long-term, deep international academic and research collaboration mechanisms. We bring top global R&D energy to Taiwan and guide traditional industries in upgrading into the medical device sector.
• Connecting Engineering Expertise with Clinical Needs: Combining NCKU's engineering strengths with the clinical resources of the College of Medicine to encourage clinical experts and engineers to collaborate, precisely addressing unmet clinical needs.
• Building a Cross-Disciplinary MedTech Innovation Ecosystem: Cultivating versatile talents skilled in technology R&D, international regulations, and global marketing strategies to accelerate research translation and commercialization, completing Taiwan's medical device innovation ecosystem.
• Core Competency Training – Need-Based Innovative Design: Drawing on the Stanford Biodesign program model, students are trained to start from clinical needs. By observing medical workflows and consulting with clinicians, students identify problems, propose solutions, and execute the complete medical device R&D lifecycle.
• Practical R&D Training: Offering phased courses covering ergonomic design, R&D technologies, clinical trials, patent regulations, business management, and negotiation skills. Backed by NCKU Medical Center, we provide excellent clinical trial environments and hands-on industry exposure.
• Cross-Disciplinary Exchange Platform: Inviting domestic and international academics, entrepreneurs, executives from medtech firms, and venture capitalists to share real-world insights into startup development, market operations, and commercialization strategies.
• International Regulatory and Certified Lab Training: Utilizing the resources of the Medical Device Innovation Center (MDIC) and certified testing laboratories, students gain hands-on experience with international standards such as ISO 13485, cGMP, and PIC/S GMP, covering facility planning, documentation, analytical method validation, certification application, and laboratory management.
• Regulatory Frameworks for Testing, Registration, and Market Clearance: Guiding students to master medical device regulatory systems across Taiwan (TFDA), the United States (FDA), and the European Union (CE), including device classification, substantial equivalence, database searching, product registration, and marketing clearance documentation.
• Intellectual Property and Patent Competencies: In response to patent challenges faced by the medtech industry in global markets, patent concepts are integrated into the curriculum to build students' capabilities in safeguarding innovative research outcomes.

A. Interdisciplinary Integration

Biomedical Engineering is inherently a practical, cross-disciplinary field. In addition to offering courses in biomechanics, medical electronics, biomaterials, medical informatics, and basic medicine, the department breaks traditional inter-college barriers through the Interdisciplinary Program in Medical Devices and Systems. Students across faculties interested in medtech development participate in problem-based courses that spark innovative concepts. Our students work directly with clinical doctors to explore unmet needs, tackle real-world challenges set by biotech firms in science parks, and culminate in BioDesign capstone courses that interface with entrepreneurs. We offer end-to-end training covering clinical needs identification, core prototype development, patents, regulations, business models, and startup incubation.

B. Rich Educational Resources

Our faculty spans diverse engineering disciplines, clinical medical specialists, and distinguished industry mentors. Built upon the solid foundation, equipment, and faculty of the College of Engineering, alongside the clinical resources of the College of Medicine and NCKU Hospital, we train students in engineering sciences, biomedicine, and device commercialization. Concurrently, we introduce modern engineering techniques into clinical specialty training, helping clinicians address unmet medical needs and bringing diagnosis and research up to top international standards.

C. Equal Focus on Academics and Industry

The medical device industry is a key emerging sector in Taiwan, prioritized by national policy within the biotechnology strategy. Regional medtech clusters across Taiwan are growing rapidly, driving significant increases in output value. Our faculty actively engages at the industry frontlines, leading numerous industry-academic research projects with extensive cases of technology transfer and patents applied in the field. Beyond hiring faculty with clinical and industrial expertise, we regularly host keynote lectures and workshops led by successful professionals. The NCKU BioDesign curriculum and the MDI program further bring together industry experts, healthcare practitioners, and interdisciplinary students to practice innovative design, integrate commercialization resources, and incubate medtech startups.

D. Encouraging International Exchange

The department actively encourages and funds students to participate in overseas summer exchange programs, international biomedical engineering conferences, and global biotech exhibitions. We maintain active research collaborations with institutions in the US, Japan, France, Russia, New Zealand, Israel, and Singapore, creating numerous international exchange opportunities. To align academic learning with practical application, faculty and student teams are encouraged to join domestic and international competitions, consistently achieving outstanding results. Furthermore, we warmly welcome international degree-seeking students. English-taught courses foster an internationalized environment where local and international students interact and learn from one another.

Benefiting from favorable geographical and academic conditions, graduate students can complement departmental coursework in biomechanics, electronics, biomaterials, informatics, and basic medicine by taking elective courses across the Colleges of Science, Engineering, and Medicine according to their career goals. Our teaching philosophy balances theory with practical application. Research endeavors involve close collaboration with professors and clinicians across NCKU's departments of mechanical, electrical, chemical, materials, aerospace, computer science, and system engineering, as well as clinical departments at NCKU Hospital.

(1) A Cradle for Cultivating Interdisciplinary Professionals

Biomedical engineering encompasses nearly every engineering domain and applies across all medical and biological fields. As an application-driven discipline, its advances are vital to life sciences, basic medicine, and biotechnology. By developing underlying theories, technologies, and equipment, biomedical engineering allows us to probe the nature of life, contributing directly to better patient care and improved quality of life for healthy individuals.

(2) Alignment with Global Standards through English-Medium Education

Since 2021, NCKU has been selected as one of Taiwan's four key benchmark universities for bilingual education. The department has long promoted English-Medium Instruction (EMI); master's and doctoral programs are currently fully taught in English. With a large international student body, an international village environment has flourished. We actively encourage faculty and graduate students to collaborate with global academic and industrial bodies on high-value R&D projects and student exchanges with world-class universities.

(3) Promoting Legislation and Certification for Biomedical Engineers

Biomedical Engineers apply professional expertise to provide quality control, risk management, installation, maintenance, training, clinical trials, and safety surveillance for medical devices. By supporting physicians with advanced medical technology, they elevate healthcare quality. Promoting the Biomedical Engineer Act and a national licensing examination system will legally safeguard professional services, enabling biomedical engineers to fulfill independent, vital roles for optimal patient outcomes.

(4) Transformation and Development of Taiwan's Healthcare Industry

Taiwan possesses strong foundations in ICT and electronics. The medical device sector—spanning precision diagnostic devices, surgical equipment, and telehealth—has attracted major technology conglomerates, making medical electronics a rising star in Taiwan's biotech landscape. Combining Taiwan's healthcare infrastructure with world-leading ICT creates immense growth potential, particularly for AI-driven precision medicine. As medtech clusters mature across Taiwan, our MDI program will continue driving device commercialization, startup incubation, and innovative design to elevate overall healthcare quality.