(Source: Medical Device Innovation Network)

“Everyone who knows me well knows that I like to be called Dr. Zhong.”

Right at the beginning of the interview, Zhong Xinghua corrected how we addressed him.

From hepatobiliary surgeon and business vice president of a tertiary hospital, to pharmaceutical company executive and industry investor, and then to medical device entrepreneur, his career path spans clinical practice, management, capital and industry. Yet in his view, all these identities revolve around the same original aspiration: identifying clinical problems, finding the best solutions, and relieving patients’ suffering.

Since 2020, Dr. Zhong Xinghua has devoted all his energy to medical device entrepreneurship. The Hangzhou winonco Medical Technology Co., Ltd. he founded focuses on minimally invasive tumor treatment, while Hangzhou Chaobo Medical Technology Co., Ltd. focuses on surgical instruments. The two companies have different technology paths, yet their product judgments both stem from an understanding of real clinical needs.

In this interview, he talked about his career transition, the R&D paths of two core products, and the market and payment challenges that innovative devices still have to face after obtaining certification.

From the operating table to hospital management, he has never left the identity of “doctor”

Hospital management, industry investment and corporate operation are, in Dr. Zhong Xinghua’s view, different ways of solving medical problems. Doing hospital management is about improving healthcare efficiency; doing industry investment is about promoting the translation of new technologies; and entering a company is an attempt to solve clinical problems with engineering means.

When he studied hospital management at the University of Poitiers in France in his early years, he focused on medical security systems and value-based healthcare, and what that experience left him with was a set of methods for evaluating the value of medical practices, drugs and technologies. Afterwards, he took part in the project demonstration of the Shanghai Proton and Heavy Ion Radiotherapy Center, and also in the Sirtex acquisition and the domestic introduction of yttrium-90 therapy technology. These projects showed him that for a technology to be implemented, it must not only pass validation and approval, but also withstand the tests of time, cost and clinical operability. Imported technologies can bring new treatment options, but their relatively high cost limits accessibility. This reality prompted him to shift his focus toward developing and producing products with China’s own fully independent intellectual property and to domestic technologies that have the opportunity to lower the threshold of use.

A bout of illness his mother suffered changed his view of minimally invasive treatment

Dr. Zhong Xinghua’s attention to minimally invasive tumor treatment is also related to a family experience. As he recalls, his mother had her thyroid nodules followed up for many years; initially, because she did not meet the criteria for surgical resection, no surgery was performed, and later, when she did meet the surgical indication, she was diagnosed with anaplastic thyroid cancer after surgery and passed away in less than nine months.

As a physician, he was once caught up in intense self-blame and reflection. For thyroid nodules that sit between surgery and non-surgery, could a third option exist? Making a hasty decision to operate constitutes over-treatment, while waiting until the problem becomes serious means missing the best opportunity. This situation has now finally found a new solution, namely careful staging management of thyroid nodules and the widely adopted ablation surgery for thyroid nodules.

The first lesson of entrepreneurship: the technology is feasible, but doctors may not be willing to adopt it

winonco got its start with the technology of Professor Yao Chenguo of Chongqing University. Professor Yao Chenguo is the inventor of global tumor electroporation technology, and Dr. Zhong Xinghua initially participated in winonco as an investor. As the project advanced, he found that the technical team could solve engineering problems, but the product direction still needed to be judged by someone familiar with clinical scenarios. So he turned into a business operator and summed up his role as “product manager”: connecting doctors’ needs at one end and engineers’ solutions at the other.

winonco and Hangzhou Chaobo are run by relatively independent teams; the former is positioned around minimally invasive tumor treatment, while the latter develops intelligent surgical instruments. There is not much direct synergy between the two companies; what they have in common is that the starting point of R&D is a specific clinical problem rather than having a technology first and then looking for an application——this is also why we placed the two companies in the same article.

The entrepreneurial experience also revised his judgment of what constitutes a “good product”. The team once explored the use of electroporation technology to treat benign prostatic hyperplasia; early clinical observations showed good results, but patient enrollment was slow. After further communication, they found that many urologists were not familiar with the use of ultrasound, and the actual operational threshold was relatively high. The team promptly stopped advancing it and instead developed a prostate ablation surgical robot combined with a puncture robot, making treatment simpler and easier to perform.

This experience made Dr. Zhong Xinghua realize that the real need for a medical device comprises at least three layers: whether the treatment is safe and effective, whether doctors can easily master it, and whether hospitals and patients can afford it. If any layer is missing, it is hard for the technology to become a genuine clinical need.

Wknife: turning “multiple needles + general anesthesia” into “single needle + local anesthesia”

This Wknife product is, in the final analysis, about grappling with “whether doctors are willing to use it”.

Irreversible electroporation (IRE, commonly known as “NanoKnife”) uses a high-voltage pulsed electric field to act on cell membranes, causing irreversible damage; it is a form of non-thermal ablation. Compared with radiofrequency and microwave, it is not affected by the “heat-sink effect”, and at anatomically complex sites such as the liver and the pancreas it may reduce damage to adjacent blood vessels, bile ducts and nerves.

The price is operational complexity.

The traditional approach usually has to be performed under general anesthesia plus muscle relaxant, and also requires multiple needles arranged in parallel along with ECG synchronization. “Mandatory general anesthesia and muscle relaxation” and “multi-needle array arrangement” have long been the two bottlenecks in the promotion of this technology.

What winonco aims to do is remove these two prerequisites. The product adopts a bipolar single needle design and broad-spectrum synergistic pulse technology, with the goal of completing ablation under local anesthesia or sedation and reducing the anesthesia requirements caused by strong muscle contractions. For doctors, the single-needle approach is closer to the percutaneous ablation procedures they are familiar with, with a shorter learning curve; NanoKnife has gone from a technology that only a few master-level ablation physicians in China could perform to a treatment modality that primary-level doctors can also perform. For patients with intermediate and advanced tumors who can hardly tolerate general anesthesia, it adds yet another treatment option.

Dr. Zhong Xinghua stated that the team is advancing registered clinical trials in the pulmonary tumor field, and clinical studies on the ablation of solid tumors such as those of the prostate, thyroid and breast as well as glioma are also already underway.

Starlong Knife: the certificate is in hand, but the billing code is still unresolved

Unlike tumor ablation, what Hangzhou Chaobo enters is the most basic part of surgery——cutting and hemostasis. This field has long been dominated by the ultrasonic scalpel, and more than 80% of the domestic market share in large vessel sealing is held by foreign companies.

The Starlong Knife takes a different path: it uses the principle of thermal fusion to accomplish tissue cutting, hemostasis and large vessel sealing, does not rely on ultrasonic vibration, and its working current does not pass through human tissue. It therefore has no tumor cell spattering caused by ultrasonic atomization, no risk of blade breakage due to vibration, and also avoids the contraindications of current passing through the human body in patients with cardiac pacemakers and in surgery in electrically sensitive areas.

Dr. Zhong Xinghua said that the single-use cost of the Starlong Knife is far lower than that of a traditional ultrasonic scalpel, which can obviously save a great deal of cost for clinical practice and reduce the medical burden on patients. However, because the Chaobo knife is a product of an innovative category, it lacks a directly corresponding dedicated medical insurance classification code for medical consumables, making it difficult to establish a clear billing and reimbursement pathway in some regions, and hospital access has consequently been affected.

The team is currently communicating with the relevant departments about the classification coding issue, and the good news is that, with the country’s support policies for innovative medical devices, this problem will soon be resolved.

Dr. Zhong Xinghua said confidently that we believe the concept of value-based healthcare will definitely be accepted and recognized by society.

The next five years: let clinical data speak

In the next five years, winonco hopes to continue expanding its minimally invasive tumor ablation products and their scope of application, and to advance into overseas markets. Dr. Zhong Xinghua is particularly focused on combining local ablation of intermediate and advanced tumors with systemic therapies such as chemotherapy and immunotherapy, hoping to explore a new paradigm of comprehensive treatment for unresectable intermediate and advanced tumors. This direction still needs to be addressed through well-regulated clinical research in order to answer key questions such as patient selection, treatment sequence, efficacy and long-term survival.

Hangzhou Chaobo, for its part, continues to build its portfolio around intelligent and affordable surgical instruments. In addition to the Starlong Knife, the company is jointly developing an open, simple and collaborative laparoscopic surgical robot with Professor Zhou Chunlin of Zhejiang University and the team of Academician Dong Jiahong of Tsinghua University; a principle prototype has already been completed and is moving into the clinical research and industrialization stage. Steerable surgical instruments compatible with the surgical robot are also a subsequent focus. Compared with master-slave surgical robots, this kind of simple collaborative surgical robot is cheaper, simpler and easier to master, and is expected to become the preferred tool for primary-level surgeons.

From clinician to corporate product manager, Dr. Zhong Xinghua’s career changes ultimately come down to three specific questions: whether patients can truly benefit, whether doctors can operate it conveniently, and whether it has a genuinely usable value-based healthcare advantage. Both the Wknife and the Starlong Knife still need longer-term accumulation of clinical data and market validation, but “starting from real clinical needs” has already become the common criterion by which the two companies screen technologies and product directions.