WANG Guangzhi of Tsinghua University School of Medicine: Promoting Intelligent Medical Device Innovation through Engineering-Clinical Integration

From medical imaging technologies such as CT and MRI, to surgical robots, and further to brain-computer interfaces, the integration of medicine and engineering has played a significant role in driving innovation and development in clinical diagnosis and treatment, thereby advancing medicine, particularly clinical medicine. Currently, the concept of integrating medicine and engineering has gained widespread recognition in China. Many universities and large hospitals are actively engaged in related initiatives, with numerous institutions establishing dedicated departments for medical-engineering integration and technology transfer. Relevant government agencies, as well as the industrial and investment sectors in China, have also paid close attention to and participated in these efforts.

To align with this trend, VBEF, in collaboration with the Chinese Association of Medical Biotechnology and Tsinghua University’s School of Clinical Medicine, hosted the China Conference on Medical-Engineering Integration at the 8th Future Healthcare Ecosystem Expo. The event established an academic exchange and industry promotion platform to empower the advancement of medical-engineering integration.

At the meeting,Wang Guangzhi, Executive Dean of the School of Biomedical Engineering at Tsinghua University and Tenured Professor at Tsinghua University, shared his insights in “Integration of Medicine and Engineering to Promote the Development of Intelligent Medical Devices”Below is a summary of the speech.

The integration and interdisciplinary convergence of medicine and engineering have become increasingly significant themes in recent years, serving as a crucial foundation for innovation in diagnostic and therapeutic methods. Since the 1950s, biomedical breakthroughs marking each “decade milestone” have stemmed from the high-level interdisciplinary integration and deep convergence of medicine and engineering, with innovative medical devices emerging as a key driver advancing the development of medical technology.

In China, progress in this area has been particularly rapid over the past decade. Last July, the State Council Information Office’s “Authoritative Departments Speak on the Opening Phase” series highlighted the development of innovative medical devices. Since 2014, China has implemented a special approval pathway for innovative medical devices, establishing a “fast-track” channel for device evaluation and review, which has significantly facilitated and advanced the evaluation and registration of innovative medical devices.

As the National Medical Products Administration (NMPA) continues to deepen reforms in the review and approval system for drugs and medical devices, policy incentives encouraging innovation are being continuously unleashed. China’s innovative medical device sector is experiencing rapid development, with innovative achievements entering a period of explosive growth. As of April 30, 2024, a total of 265 innovative medical devices had obtained Class III registration certificates from the NMPA, with both application and registration volumes rising year by year.

After nearly a decade of development, China’s medical device industry has made significant progress in domestic substitution for mid-to-high-end products. However, it still lacks original innovation in terms of concepts and mechanisms, necessitating the promotion of greater innovation through the integration of medicine and engineering.

The development of innovative medical devices begins with clinical needs and physicians’ insights. Physicians identify problems, which scientists and engineers address by applying a range of scientific and engineering principles, necessitating interdisciplinary collaboration. Through such cross-disciplinary cooperation, engineers develop proof-of-concept prototypes based on these needs, and conduct clinical research and validation with the assistance of physicians.

Having a working principle/mechanism that is a first-of-its-kind in China, holding a Chinese invention patent granted within the past five years, having a basically finalized product design, and demonstrating significant clinical value are necessary conditions for passing through the Special Review Channel for Innovative Medical Devices. This process can by no means be accomplished independently by any single role, such as a physician or an engineer; it inevitably bears the hallmark of medical-engineering collaboration. If the degree of innovation in the working principle or mechanism is insufficient, or if the clinical value is difficult to demonstrate, the product will fail to gain registration approval through the “Green Channel.”

From the perspective of the innovation chain for medical device research, development, and application, product registration represents only one part of the iterative cycle integrating medicine and engineering. To benefit society, registered products must be translated into practical innovative diagnostic and therapeutic methods. Furthermore, widespread adoption depends on multiple factors, including reliability and applicability. Ultimately, the goal of innovation is to validate its value through large-scale implementation, while generating new tools and methodologies in the process.

The chain of medical device innovation is extensive, requiring deep interdisciplinary integration and collaborative division of labor between clinicians and engineers at every critical node, thereby underscoring its significant value.

In the past, I had frequent interactions with physicians in the field of biomedical engineering. They raised clinical questions, and we worked to provide solutions, fostering a positive and productive collaboration. Next, I will discuss our research and exploration into intelligent neurosurgical devices through the integration of medicine and engineering.

Through our collaboration with orthopedic and neurology specialists, we have identified numerous pain points in traditional neurosurgical procedures. For instance, in the localization and treatment of epileptogenic foci in drug-resistant epilepsy, challenges such as poor visualization, inaccurate targeting, difficulty in precise resection, and significant surgical trauma are prevalent. Consequently, there is a strong demand among physicians for minimally invasive surgical approaches. In response, we began exploring how technology can be leveraged to reduce surgical trauma.

Based on the stereotactic concepts proposed by neurosurgical pioneers in the 1970s, we collaborated with physicians to establish a stereotactic framework for the diagnosis and treatment of focal epilepsy. This framework encompasses a comprehensive clinical and surgical workflow, ranging from multimodal image acquisition and processing, surgical planning, and minimally invasive procedures, to high-frequency EEG signal extraction and analysis, localization of epileptogenic zones and functional brain areas, and finally, lesion management.

We first addressed the issue of limited visibility for surgeons by leveraging 3D multi-modal magnetic resonance imaging (MRI) technology to provide three-dimensional surgical maps, which serve as the foundation for surgical planning. Meanwhile, we further developed intelligent image processing and modeling technologies to facilitate more efficient surgical planning for physicians.

Next, we recognized the challenge physicians face in translating computer-based surgical plans into physical-space operations. To address this need, we developed robotic technology that enables robots to automatically locate the patient and perform precise surgical procedures.

Finally, we employed mechanical modeling to enable surgeons to perform procedures with the assistance of robotic arms, thereby addressing the challenge of precise electrode placement and exploring therapeutic approaches via minimally invasive surgery.

Our technology has been adopted both domestically and internationally, receiving registration certification from China’s National Medical Products Administration (NMPA) in 2018 and U.S. FDA clearance in 2023.

Through practice, we have deeply realized that the integration of medicine and engineering not only drives innovation in medical devices but also provides physicians with new diagnostic and therapeutic approaches, ultimately benefiting patients. However, the value of interdisciplinary convergence between medicine and engineering extends far beyond this. Minimally invasive surgery is not our ultimate goal; we must also locate and treat cerebral lesions using electrodes.

For instance, each electrode in stereoelectroencephalography (SEEG) features more than ten contacts. We need to analyze EEG signals to localize the epileptogenic zone and functional areas, thereby achieving safer and more effective treatment. Therefore, we collaborate with laboratories specializing in EEG analysis to convert EEG signals into maps, identify areas of abnormal discharge, and determine the functional regions corresponding to each electrode. This interdisciplinary collaboration not only resolves issues related to data fusion and analysis but also promotes the development of brain-computer interface technology, bringing new possibilities for treatment.

Our research did not stop at EEG detection. Physicians raised a new question: Can minimally invasive treatment be achieved?

We collaborated with department directors at Tiantan Hospital and Xuanwu Hospital to adopt a technical approach similar to stereotactic electrode implantation, inserting optical fibers into deep brain structures to deliver energy at their tips for precise ablation of localized tissue. Using magnetic resonance imaging (MRI), we accurately monitored temperature and predicted the ablation zone through computational modeling, thereby ensuring precise execution. This technology was developed in 2020 and approved via the “green channel” expedited review pathway. After three years of effort, we obtained the medical device registration certificate in April 2023 and have since conducted minimally invasive treatments for small intracranial lesions, particularly deep-seated lesions, at Xuanwu Hospital and Tiantan Hospital.

The integration of medicine and engineering, along with interdisciplinary collaboration between science and engineering, has brought us tremendous opportunities and momentum for development. We need not only the convergence of medicine and engineering but also cross-disciplinary efforts in science and engineering to address challenges in areas such as materials.

How to More Effectively Promote the Development of Innovative Medical Devices and Drive Valuable Iterations: We Believe It Is Necessary to Establish Cross-Disciplinary Branches, Build an Ecosystem, and Cultivate Talent.

Finally, I wish to emphasize that all innovations and improvements should ultimately return to clinical practice. We require the assistance of physicians to continuously validate and refine these advancements, thereby establishing a virtuous cycle.