Professor Wang Jie of Jiangsu Provincial Institute of Clinical Medicine Highlights Critical 'Starting Points' and 'Milestones' for Medical Innovators in IPO Prospectus

Recently, at the event “CNIT Innovation Week Talk Season 1: Bridging the First Mile of Medical Innovation Translation,” hosted by the China Neurointerventional Innovation and Translation Alliance (hereinafter referred to as CNIT),Professor at Jiangsu Provincial Institute of Clinical Medicine / Jiangsu Province People's Hospital, Serial Entrepreneur, and Venture Partner Wang Jieas for“The ‘Starting Points’ and ‘Key Nodes’ for Healthcare Innovators to Watch”In-depth insights were shared on this topic.

The following is a transcript of Professor Wang Jie’s speech, edited for reader convenience.VCBeat Orange BureauThe text has been edited without altering its original meaning.

To begin with, let us borrow a quote from Albert Einstein: “Science cannot grow merely on the basis of experience; in establishing science, we are inevitably compelled to freely create concepts, whose applicability can be tested through empirical methods. Therefore, in clinical practice, there is no room for chance; even the most accidental occurrences appear to follow an underlying inevitability.”

There are two key points in this statement: first, “concepts must be validated through empirical methods,” and second, “innovation leaves no room for luck.”

Therefore, as clinicians, if we aspire to pursue innovation, we must have a solid scientific foundation and profound professional expertise. At the same time, we need specific training that covers how to conduct innovation, how to navigate regulatory registration and applications, how to engage with the market, and how to achieve a successful transition in our professional identity, among other aspects.

This series of actions is, of course, fraught with risk, as you are constantly engaging in endeavors that are both unfamiliar and outside your area of expertise. Therefore, whenever innovation is mentioned, it naturally evokes associations with the risks it entails.

First and foremost are the scientific and conceptual risks. The innovations we are currently pursuing, such as catheters, stents, and valves, no longer carry significant scientific risk, as others have already paved the way. We often speak of “overtaking on a bend,” but in reality, the bend itself has already been established. Therefore, for true innovation, the greatest risk lies in blazing a new trail.

Next is the risk of patent infringement. You need to engage a professional platform or expert to verify whether the technology you are researching and the patent you are applying for infringe upon the patent rights of other research teams.

Next are the risks associated with engineering and manufacturing. Most physicians in China do not have an engineering background, so they severely lack the understanding and application of engineering knowledge. Therefore, when you have a good idea, whether you have the capability to realize it constitutes an inherent limitation for physicians in China.

Next are the risks associated with regulations and clinical validation. Clinical validation is a highly time-consuming and challenging aspect of innovation, where many innovative projects fail. Therefore, you need a highly professional clinical research team, which is not easy to assemble due to the severe shortage of such talent in China.

Furthermore, there are risks associated with team management. If you are fortunate enough to overcome all the aforementioned risks and assemble such a team, can you effectively oversee and control your team’s activities? Can you maximize their potential to ensure efficient operations, thereby providing robust support for your innovation to continue evolving in a positive direction?

Finally, there are risks associated with market operations. When your product successfully transitions from the laboratory to the marketplace, determining whether sufficient market space exists—and, if so, how to capture your own market share—presents significant challenges.

At this point, there are actually two interpretations: one concerns the purpose of innovation, and the other concerns the innovator’s purpose; these two are fundamentally distinct.

First, let’s address the purpose of innovation. This is straightforward to answer, especially in the healthcare sector: the aim of innovation is simply to better serve patients. In contrast, the motivations of inventors vary widely—some seek bonuses, others career advancement, and still others are driven by a personal desire for innovation, among other reasons.

Such misalignment of objectives can lead to discrepancies or conflicts during the innovation process, ultimately resulting in divergence. Therefore, it is essential to clarify our objectives before embarking on innovation: Are we truly aiming to generate new knowledge? Is wealth creation a necessity? Is the primary goal to serve patients, or are there other underlying motives?

At least for us physicians, the purpose of innovation must be to address clinical problems and ultimately better serve patients. In the past, we often described innovation as “turning money into papers,” meaning that substantial funds were spent on research, resulting merely in a published paper or a research report.

We now propose the concept of “turning paper into money,” which means ultimately applying our research findings in clinical practice, fully aligning R&D products with the market, and generating substantial social benefits. This constitutes sustainable innovation.

However, innovation cannot be achieved by individuals alone; it requires institutional frameworks to cultivate the necessary environment, which is tantamount to establishing a culture of innovation. What, then, underpins the development of such a culture? It relies on policies and systems that are aligned with key milestones in the innovation process.

Taking intellectual property (IP) as an example, this is actually a critical component in the innovation process. A major reason for the low rate of innovation commercialization in China at the current stage is the unclear delineation of IP rights. This issue is not unique to China; the United States previously faced similar challenges.

Prior to 1978, the commercialization rate of biotechnology-based research outcomes in the United States stood at merely 5%. By the early 1990s, however, this rate had surged to 80%, marking a rapid transition from “novice” to “elite” within just a decade.

All of this is attributable to the Bayh-Dole Act enacted in 1978, which has been hailed as “the most inspiring legislation passed in the United States over the past half-century.” The Bayh-Dole Act effectively resolved the issue of intellectual property rights allocation through four fundamental principles: first, universities retain default ownership of inventions arising from government-funded research; second, universities hold exclusive patent licensing rights, with revenues from technology transfer reinvested into teaching and research; third, inventors are entitled to share in the income generated from patent licensing; and fourth, the government retains “march-in rights,” allowing the federal government to intervene and manage the invention under special circumstances.

The impact of the Bayh-Dole Act was immediate. Since its enactment, the Act has driven a $1.7 trillion increase in U.S. economic output, supported 5.9 million jobs, and helped spawn more than 14,000 healthcare-related startups.

From the outset, we primarily emphasize a “starting point”: before embarking on innovation, have you considered whether your surrounding environment and your current capabilities can truly support your innovative efforts?

Therefore, a crucial factor here is “class consciousness,” which encompasses both “clinical awareness” and “scientific awareness.” “Clinical awareness” refers to a physician’s ability to identify novel insights and pinpoint genuine pain points in daily clinical practice. “Scientific awareness” denotes the capacity to conduct further research into clinical issues and translate them into practical solutions.

What comes next is translation, but there is a huge gap between research and translation, so you need to clarify the key "nodes" in the translation process and do your best to cross these "nodes".

First is the generation of innovative ideas. This primarily refers to whether the proposed concept originates from clinical practice and whether it represents a “first-in-class” innovation within the entire research field.

Second is the validation of innovative ideas. Once an innovative idea is proposed, do you have the corresponding resources and capabilities to validate this concept?

Third is intellectual property protection. On one hand, does your medical institution have corresponding policies to help you better facilitate commercialization? On the other hand, have you established a robust patent system that can prevent plagiarism?

Fourth is prototype fabrication. This primarily tests your engineering capabilities—specifically, whether you can build the functional prototype yourself or secure an engineering team to assist you in developing it.

5. Animal testing. Once you have a prototype, can you validate your innovative concept through animal experiments?

Sixth is clinical trials. After animal studies, can you find a professional clinical research team to assist you in conducting clinical trials and obtain reliable clinical data?

Seventh, license transfer or company formation. Once you have a prototype and clinical data, what is your next step? Will you assign the patent, or dive in to establish your own company?

Eighth, assemble a diversified operational team. If you are starting a company, do you intend to hire professional managers to help you manage it? Or do you plan to build your own team? If you choose the latter, do you possess the necessary talent resources and the multidisciplinary capabilities required to form such a team?

9. Securing Early-Stage Innovation Incubation Funding. For early-stage innovation projects, reliance on external funding is inevitable. Therefore, can you access these early-stage capital resources at this phase? If so, how do you select the early-stage funding that best suits your needs, and do you possess the ability to communicate efficiently with investment institutions?

10. Innovating Role Selection. As the enterprise begins to operate on a stable track, will you choose to continue forward as an entrepreneur, or step back into your original role as a clinician? If you intend to undergo this identity transition, do you possess the entrepreneurial vision and the managerial and operational capabilities required of an entrepreneur?

11. Product Approval for Market Launch. For startups, it is essential to continuously develop new products and secure regulatory approval for their market launch in full compliance with applicable laws and regulations. Therefore, do you have a thorough understanding of the entire product approval process, and do you have a specialized team to support you in achieving these objectives?

12. Product Commercialization. This is the final stage, yet a critical one. It also represents a capability that physicians often lack: the ability to commercialize products. Success in this area depends not only on the market potential of the product itself but also on the commercial competencies of your team, which largely determine the survival or failure of a startup.

Therefore, physicians must carefully manage the “starting points” and “nodes” of innovation, which are intrinsically interlinked. If you fail to properly define your own innovation “starting point,” or lack the requisite capabilities or resources to traverse these innovation “nodes,” the more efforts you expend, the greater the troubles you will encounter, the higher the likelihood of failure, and the greater the costs incurred.