Introduction

The Department of Biomedical Engineering was founded in 1988, initially offering a master’s program. The doctoral program was established in 1993, followed by the undergraduate program in 2011. In 2017, in response to emerging global trends and the need for internationalization, the International Institute of Medical Device Innovation was established under the leadership and active planning of Distinguished Professor Fong-Chin Su.

The program originally admitted 5 local students, which has since increased to 6, along with 10 international students, with the actual number of international admissions subject to university-wide allocation.

The International Institute of Medical Device Innovation focuses on the medical technology innovation industry. It integrates innovation, design, manufacturing, service, and marketing to promote interdisciplinary research and development. With a needs-driven approach to innovation, the program aims to cultivate outstanding professionals in medical device innovation.

Background

Medical devices have high added value and are governed by unique regulatory requirements, making them a suitable target for upgrading Taiwan’s traditional industries. As a result, the medical device industry has become one of the key sectors promoted by the government in recent years.

Although NCKU’s Department of Biomedical Engineering and the Medical Device Innovation Center have established collaborations with leading international biomedical engineering and medical device research institutions, many of these collaborations have remained short- to medium-term. Further in-depth exchange and learning are therefore necessary to help root the outcomes of international collaboration in Taiwan.

The development of market-oriented medical devices begins with clinical needs. Research outcomes must be translated into innovative medical device products through design, evaluation, testing, manufacturing, and marketing. This process involves engineering, medicine, regulatory affairs, marketing, and even insurance, making it a highly interdisciplinary undertaking.

NCKU has long maintained close collaboration with industry and has achieved strong results in technology transfer. However, cultivating biomedical engineering talent requires more than research and development capacity or startup creation. It also requires long-term planning in international marketing and global business development.

Therefore, the mission of this master’s program is not only to integrate mechanical, electrical, and materials engineering, but also to connect these fields with medicine. By bringing together international biomedical engineering talent, the program aims to guide domestic researchers in biomedical engineering and medical device development to better understand the importance and process of integrated medical device innovation.

The program also seeks to encourage clinical medical experts in Taiwan to participate in medical device research and development. Through this integration, clinical needs can be more accurately addressed, and a complete medical device innovation ecosystem can be established.

Purpose

The purpose of this program is to cultivate international professionals in biomedical engineering and medical device innovation. These professionals will not only enhance Taiwan’s advanced research and development capacity in medical devices, but also help guide traditional industries in upgrading toward the medical device sector through academic research and innovation.

The program also supports the current policy goals of promoting the international medical industry.

The key development goals of the program are:

1. To recruit and cultivate innovative and entrepreneurial talent from around the world.
2. To develop new business models and business practices.
3. To support and propose forward-looking government policies in medical care.
4. To build a complete medical device innovation ecosystem.

Student Training Focus

Core Skills Training

The program strengthens students’ knowledge and training in medical devices, with innovative medical device design as the core objective of the curriculum.

Drawing on the experience of Stanford University’s Biodesign program, the curriculum emphasizes the process from clinical needs to product concepts. Students learn and practice the full medical device research and development process, supported by discussions with clinicians and observations of medical treatment processes.

Through this approach, students are encouraged to identify problems encountered in clinical practice, propose solutions, and design innovative medical devices.

Additional Skills Training

Practical R&D Training

The program offers staged courses in areas such as human factors design, research and development technologies, clinical trials, patent regulations, business management, and negotiation skills.

With the advantage of NCKU’s affiliated medical center, the program provides students with access to a strong clinical trial environment and opportunities to engage with the front line of the medical device industry.

Cross-Disciplinary Medical Device R&D Exchange Platform

The program invites speakers with entrepreneurial experience from academia and industry, both domestically and internationally, to share their insights with students.

These exchanges help students gain knowledge beyond technical expertise, especially in startup development and industry practices. In addition, executives from medical device companies and professionals from venture capital firms are invited to share practical experience, including market operations and commercialization strategies.

Learning and Management of International Regulations and Accredited Laboratories

The advanced biotechnology and medical device industries must comply with standards such as ISO 13485. These standards govern product manufacturing, quality assurance, and quality control testing to ensure product quality.

To equip students with knowledge of international regulations and practical experience, the program makes use of NCKU’s Medical Device Innovation Center and other accredited laboratories. Students are given opportunities for hands-on learning in areas such as international regulatory principles, cGMP and PIC/S GMP facility planning and requirements, ISO documentation, validation requirements for analytical methods, certification applications, and laboratory management.

This training prepares students to meet industry demand for R&D professionals with expertise in international regulations.

Regulations Related to Product Inspection, Registration, and Market Approval

Students are guided to become familiar with medical device regulations in Taiwan, the United States, and the European Union, including those of the Taiwan Food and Drug Administration (TFDA), the U.S. Food and Drug Administration (FDA), and CE marking requirements in the European Union.

Training includes medical device classification, product equivalence, database searches, product inspection and registration, documentation required for market approval, and relevant international regulations.

Patent-Related Competencies

As medical device companies enter the international market, they often face patent challenges from major global corporations. In addition to academic research, industry-academia collaboration, and regulatory training, this program incorporates patent concepts into the curriculum.

This training helps students develop soft skills beyond technical expertise and learn how to use patents to protect their innovations and research outcomes.

Admission Information

Strong candidates should hold a B.S. degree or above in engineering, biotechnology, medical science, or other interdisciplinary fields.

Students with backgrounds in business, management, law, industrial design, information technology, healthcare, or related fields who have a strong interest in medical device innovation, entrepreneurship, and career development are also encouraged to apply.

For further information, please refer to the attachment.