Principles for Medical Device Innovation to Ride the Healthcare Industry's Innovation Wave

Innovation is undoubtedly the main theme in the current healthcare sector.

First, in terms of policy. In 2021,China Has Issued 49 Policies Related to Medical Innovation and Translation, further strengthening social guidance and support for scientific research.

Secondly, in terms of technological breakthroughs. According to incomplete statistics, there have been a total of in China's healthcare sector this year31 Frontier TechnologiesAchieved historic breakthroughs, mainly concentrated inCOVID-19, Cancer, Rehabilitation, Reproductionand other sectors with high-intensity demand.

Finally, in venture capital investment. According to statistics from VCBeat, a total of in China's healthcare sector in 202159 Early-Stage Investment and Financing Events, with total financing reaching a record high ofRMB 2.5 billion, capital’s enthusiasm for early-stage healthcare projects has reached an unprecedented high.

However, the issues remain glaringly obvious, particularly in the highly scrutinized field of medical devices.Significant Challenges in Medical-Engineering Integration, Insufficient Original Innovation, and Low Translation RateThese, among others, are persistent bottlenecks that remain difficult to overcome in the current pathway for the innovation and commercial translation of medical devices.

Therefore, in the new issue of "CNIT Innovation Weekly,"Dr. Pan Wenzhi, Chief Physician of the Department of Cardiology at Zhongshan Hospital, Fudan University, and the principal inventor of two world-first medical devicesShared in-depth insights on the topic of “Several Basic Principles for Medical Device Innovation.”

The following isDr. Pan WenzhiVerbatim Transcript, for the convenience of readers,VCBeat Orange BureauThe text has been edited without altering its original meaning.

Medical devices are applied to patients and used by doctors; therefore,Clinical NeedsandPhysician User Experienceis crucial.

First is the clinical need, which is the source of vitality for medical devices. The conditions it must meet are: first,The audience must be sufficiently large., namely, there must be a certain patient volume, and the disease prevalence should be relatively high. Conditions with high prevalence, such as hypertension, atrial fibrillation, valvular heart disease, and heart failure, are more favored by capital and the market compared to diseases with low prevalence; secondly, there must beHard Requirements, i.e., truly needed by the market and without substitutes.

The second point isPhysician User Experience. Why is this particularly emphasized? Because in the technological innovation of medical devices, clinicians often play an extremely important role, such as reliably grasping clinical needs; understanding the advantages and disadvantages of existing devices; and providing active feedback on product performance after market launch, among others.

In practice, most medical devices are used by physicians, while some are intended for patient self-use. Therefore, as with other industrial products, user experience is of paramount importance; it is essential to carefully heed user feedback and avoid developing products in isolation without external input.

In summary,Innovation is ultimately driven by clinical needs.One approach is to first identify clinical needs, then seek out suitable materials, processes, and structural designs, followed by product development to meet those clinical needs. The other approach is based on breakthroughs in materials and processes, where a new physical, chemical, or medical principle is discovered, and then its potential application in addressing clinical needs is explored.

The Tao Te Ching states: “"The Origin of All Things: The Great Way Is Utterly Simple, Yet Evolves Into Ultimate Complexity"”. The origin of all things is the simplest existence.

Therefore, new developments should be kept as simple as possible; both structural design and surgical procedures must be extremely straightforward in all aspects.

Why Keep It Simple?In fact, the simpler something is，the broader its scope of application, just like the theory of Yin and Yang, which, despite involving only two variables, can explain many phenomena in the natural world. If a model is made overly complex, it will have numerous independent variables and influencing factors, thereby narrowing its scope of application and imposing many constraints.

Medical devices may appear highly sophisticated and cutting-edge, but they place greater emphasis onMinimalist, The so-called simple design of medical devices is not only for ease of use, but more importantly, to reduce the failure rate and improve the stability of the devices. Of course, this will also expand their scope of application.

Medical devices differ from other industrial products in that the individual patients and clinical environments in which they are used exhibit substantial variability, making it impossible to conduct large-scale, challenging, or even destructive testing prior to market launch, as is done for automobiles or mobile phones.

In contrast, clinical trials for medical devices typically select classic, straightforward cases. Therefore, problems must be addressed using concise and clear methods that remain effective across varying scenarios, thereby preventing the occurrence of extreme adverse events when the product is widely used after market launch.

“The Principle of Simplicity” in the Application of Implantable Medical Devices Includes Two Aspects:First, fewer implants—reducing side effects associated with foreign bodies; second, precise targeting—minimizing impact on other areas.

In summary, the quest for the most concise solution—striking at the vital point with pinpoint accuracy—is the core proposition of medical innovation.

Medical principles form the foundation of medical devices and dictate the strategic direction of their innovation. If the underlying medical principles are flawed or imperfect, the overall development trajectory will be misguided, rendering all subsequent efforts futile.

For a medical device product, if its primary function is medical diagnosis or treatment, it must be grounded in reliable medical principles. In the process of medical device innovation, a prudent approach entails leveraging previously validated and established medical principles, or even modifying existing, mature medical devices.

Certainly, new medical principles or novel device designs may be proposed or modified; however, re-validation would entail a protracted and arduous process. Therefore, prior to pursuing innovation, careful consideration must be given to conducting thorough validation and demonstrating the scientific rigor of the underlying medical principles.

After validating the medical principles, the next step is to consider engineering technology.. Engineering and industrial technology form the foundational basis for innovation in medical devices; medical principles require the support of engineering technologies, and without reliable engineering support, medical concepts remain merely fanciful ideas.

Creative engineers design novel medical devices by applying established medical principles alongside their expertise in mechanical and industrial engineering. In this process, engineers are responsible for optimizing product performance, enhancing system stability, and facilitating scaled manufacturing. Moreover, the involvement of medical professionals is essential, primarily to provide feedback on clinical usage.

In general,Medical device innovation is the product of medicine-engineering integration and a process of seeking the common ground between medicine and engineering.. Physicians and engineers share a relationship that is both contradictory and unified. Physicians often desire products with extensive functionalities, high performance, and complex composite structures, which are frequently difficult to achieve in practice. Engineers’ designs may not always be user-friendly, as they may fail to account for the impact of the complex human physiological environment on medical devices. Their approach can be overly mechanistic, thereby overlooking the surgeon’s subjective role in calibrating device operation.

A review of the history of medical technology development reveals an evolution from major invasive procedures to minimally invasive ones, and further to non-invasive approaches. The pursuit of minimally invasive and non-invasive techniques remains an enduring theme in the advancement of medical technology.

Special emphasis is placed on minimally invasive procedures.The Essence of Minimally Invasive Therapy: Multiple Interventions to Enhance Therapeutic Efficacy。

Minimally invasive surgery differs from traditional open surgery in terms of efficacy, as open surgery allows for direct visualization of the lesion through an open field and provides ample local space to perform a wide range of maneuvers.

Minimally invasive surgery is typically performed in confined spaces, under indirect image guidance, and with limited instruments, which may preclude the execution of complex surgical maneuvers and lesion intervention. Consequently, its efficacy may be inferior to that of traditional open surgery in certain technical scenarios and patient cases, potentially leading to postoperative recurrence. In such instances, the feasibility of re-intervention becomes critical, thereby necessitating the use of interventional therapeutic devices.

Essential Criteria for an Excellent Interventional Medical Device:Adheres to fundamental medical principles; facilitates easy catheterization and operation; requires minimal implants; offers precise targeting; allows for multiple interventions.

An ideal medical device is invariably a perfect fusion of science and art,It possesses both scientific value and artistic appeal.。

In fact, a careful examination of every medical device implanted in the human body reveals that its design is invariably streamlined and aesthetically pleasing, standing in stark contrast to the angular designs characteristic of many industrial products.

This is because the removal of sharp edges and the adoption of a streamlined design can minimize damage to surrounding human tissues during surgery and after implantation. Furthermore, the streamlined design ensures uniform stress distribution, preventing fracture due to localized stress concentration after implantation, thereby enhancing fatigue durability.

Furthermore, the streamlined design of the delivery system and other in vitro operating systems conforms to ergonomic standards, thereby enhancing user experience. Additionally, aesthetic and artistic design elements can improve the product's visual appeal and foster greater user affinity.

In fact, during the process of research and development innovation in medical devices, we are often surprised to discover that,When a device’s performance reaches its peak, its form also achieves its utmost aesthetic appeal.

In fact, human organs represent a perfect fusion of science and art. The human body comprises scientific elements while also embodying artistic aesthetics; therefore, devices implanted in or used on the human body must adhere to this principle to achieve biocompatibility.

Currently, our medical device R&D has entered a new phase, with innovation gradually becoming the main theme.

While this presents new market opportunities, it also imposes new requirements on industry professionals to shift their mindset, master the underlying principles and fundamental rules governing medical device R&D, and place greater emphasis on the role of medical experts in driving medical device innovation.

In the past, most medical devices were developed by engineers through reverse engineering of foreign products. However, in the future, we must emphasize pure innovation that originates from clinical integration.

But most importantly, whether it is R&D or innovation, one must adhere to a golden rule, which isAchieve 100% execution efficiency, without execution, everything is merely empty talk.