Interview

1May, 96016th, American physicist Maiman made the first laser: ruby laser. Turn a new page for the application of light. Since then, the role of light is no longer limited to lighting, but has begun to enter many fields such as communication, medical care, environmental protection, energy and so on, pushing human development onto the "high-speed train".

In order to commemorate the first ruby laser made by Maiman, UNESCO designated May 16 as the "International light day" every year, aiming at demonstrating the great influence of optics and photonics.

Similarly, optical technology is constantly empowering the field of medical devices, and its application is gradually maturing and its scope is gradually expanding, showing a huge market prospect. Focusing on the application status and market of optical technology in the field of medical devices, as well as the opportunities and challenges of local optical technology in the field of medical devices, Perceptual Core Vision conducted an exclusive interview with Dr. He, an associate researcher at the National High Performance Medical Device Innovation Center.

Editor's Perceptual Core Vision

| People interview

He Yejia, Associate Research Fellow, National High Performance Medical Device Innovation Center.

He, Ph.D., Associate Research Fellow of National High Performance Medical Device Innovation Center. 20 13 graduated from the Department of Mathematics, Cambridge University, UK. He holds master's degrees from Cambridge University and Warwick University, and is a doctor and postdoctoral fellow at Max Planck Institute in Germany. He has been engaged in bio-optical microscopic research at UW- Madison and Moggridge Institute. Jan Huisken, a doctoral tutor, is the founder of optical microscope, and Ralf Jungmann, a postdoctoral tutor, is the founder of DNA-PAINT super-resolution technology. During his doctorate, he completed the world's first optical imaging of various model organisms.

He joined the National High Performance Medical Device Innovation Center in 20021to carry out technical research on new pathological optical imaging detection instruments. In just two years, its team has completed nearly 10 core patents and principle prototypes, and plans to carry out clinical verification within one year to realize the localization and industrial transformation of international cutting-edge optical detection technology.

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Without clinical application scenarios, simple technological innovation is not enough.

Optics is everywhere, including solar energy utilization, laser welding and cutting, chip manufacturing, film projection, optical fiber communication, photosynthesis, X-ray application and microscope application. Optical technology plays an irreplaceable role in the medical field.

As an important tool of modern medical treatment, medical devices play an extremely important role in the prevention, diagnosis and treatment of diseases, and their strategic position is highly valued by all countries in the world. Optical technology is one of the core technologies of high-performance medical devices, which makes the medical device industry flourish.

The National High Performance Medical Device Innovation Center (hereinafter referred to as the "National Innovation Center") aimed at the multiple applications of optical technology in medical devices at the beginning of its birth, aiming at breaking through technical barriers and filling technical gaps in domestic industries.

In April, 2020, Mindray Medical, Shenzhen High Court of Chinese Academy of Sciences, UIH Medical, Xianjian Technology and Harbin Institute of Technology took the lead in establishing the National High Performance Medical Device Innovation Center, focusing on high-end medical imaging, in vitro diagnosis, biomaterials and implanted devices, robots and advanced treatment and rehabilitation information. The National Innovation Center has built a research and development platform of nearly 20,000 square meters.

According to He, in the National Innovation Center, the research on medical devices with optical technology as the core is divided into three directions: first, the research on optical imaging instruments in vivo, such as endoscopes, ophthalmic instruments, dermoscopy, etc. Second, in the field of in vitro diagnosis, ultra-sensitive single molecule detection is studied by using optical technology; Third, the research of medical image detection instrument can make pathological imaging of some isolated tissues and make auxiliary diagnosis.

When it comes to self-developed optical medical devices, what He Yejia said most was "the transformation of scientific and technological achievements". From the perspective of technological revolution, the transformation of scientific and technological achievements is indeed imminent. Because at present, a new round of scientific and technological revolution and industrial revolution is sweeping the world, it is urgent to bring China's cutting-edge technology from the laboratory into industrial application.

According to He, at present, these three research directions of optical technology have basically completed the verification of engineering prototypes, and will be connected with clinical applications as soon as possible, which is expected to be transformed into industrial applications within one year.

However, it is not easy for scientific research results to go out of the laboratory and embrace industrial applications. He believes that the current research and development of optical medical devices mainly faces three challenges:

First, scientific research and technological innovation are not equal to clinical needs. All the high-value patents and technologies of scientific research institutes cannot be transformed and applied to industry. The industrial demanders don't know all the core technologies of the research institute. So the dilemma now is that "one side has technology and the other needs technology, but they can't connect accurately."

Secondly, different doctors have different specific needs for medical devices, which requires researchers to "delegate power" from the upstream of the industrial chain to medical institutions as students, discuss the direction of technology research and development with doctors in depth, sort out the most * * * clinical needs in the shortest time, and focus on the pain points to propose targeted solutions.

Finally, on the premise of domestic substitution, on the one hand, some domestic original products can not meet the requirements of competitive indicators. On the other hand, foreign product parts and components can't be transported to China because of limited epidemic logistics, which leads to the delay of research and development. R&D personnel need to spend a lot of energy to try which domestic products meet the demand. He Yejia said frankly, "This is a long process of seeking domestic substitution, but it is of great significance."

In response to the above challenges, the National Innovation Center is also constantly playing a connecting role, aiming to drive the upstream and downstream of the industrial chain to "move".

Specifically, on the one hand, the National Innovation Center actively sorts out industrial needs and undertakes corresponding tasks. If it exceeds the capacity, it will take advantage of the platform to help scientific research institutes, industrial demanders and other technical parties to accurately connect.

On the other hand, at every stage of the project establishment and progress, self-developed medical devices have established an interactive mechanism with clinicians, and set up "laboratories" in hospitals and bedside to ensure that the research and development of medical devices is based on clinical needs and truly solve the pain points of clinical application scenarios.

He Jiayu further emphasized that "the clinical application scenario is patient-oriented, and researchers need to consider the comprehensive factors such as practicality, stability and cost of medical devices developed by technology, and it is not feasible to find clinical outlets simply based on technological innovation".

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Optical technology has been widely used, and local brands have risen rapidly.

In recent years, the application of optical technology in the field of medical devices has shown powerful functions. According to He, the specific products of optical medical devices are mainly divided into two categories.

One is a medical instrument with optical technology as its core. Optical imaging instruments include surgical microscope, in vitro tissue imaging microscope, endoscope, near infrared brain imager, etc. Optical detection instruments mainly use optical technology to read molecular signals, such as nucleic acid instrument fluorescence PCR, sequencing instrument and some single molecule detection instruments.

The other is medical equipment assisted by optical technology, such as thermal surgery robot. The most important module is to use binocular vision in optical technology to help doctors accurately locate the position and direction of the lesion area and improve the surgical accuracy. In addition, there are optical related products such as sensors and wearable monitoring instruments.

With the continuous development of China's economy and the continuous improvement of living standards, people's awareness of medical care is gradually enhanced, so the demand for medical device products is also rising, making the domestic medical device market stand out.

By 2020, the market size of medical devices in China will be about 734 1 100 million yuan, up by 18.3% year-on-year, which is close to four times the growth rate of global medical devices and keeps a high growth level. It is estimated that the average annual compound growth rate of the equipment market will be about 14% in the next five years, and it will exceed one trillion by 2023.

While the market demand is strong, the government is constantly introducing policies to promote the development of the medical device industry. Since 20 16, the progress of the policy has been obviously accelerated, further standardizing the market and encouraging investment and technological innovation. This will undoubtedly inject a shot in the arm for the accelerated growth of local enterprises.

At present, a number of outstanding enterprises have emerged in the industry, and domestic medical device enterprises represented by UIH, Mindray Medical, Lepu Medical and Neusoft Medical are increasingly participating in global competition.

There are also many excellent optical medical devices in the subdivision, such as Zhongke Microlight, which pioneered the domestic high-speed 3D endoscope optical coherence tomography system, Haitai Guangxin, which sells endoscope components in overseas markets, Mo Ting, a leading ophthalmic medical device in China, and local excellent companies with high-end microscope production capacity, such as Yongxin Optics, Mike Audi and Yu Shun Optics.

He commented on this, "These local optical medical device enterprises, which mainly invest in R&D, have a certain market scale and great potential. The technical level has reached a very high level, and the R&D level is also in the forefront of the world. "

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The innovation level "keeps pace" and the industrial strength "falls behind" remain to be solved.

Optical medical equipment is a typical high-tech industry, and its most remarkable characteristics are intensive technology application and wide interdisciplinary. After years of cultivation, China's optical medical device industry and innovative enterprises have entered the fast lane of development, but there are still some challenges to be solved.

According to public data, European and American imported brands account for 80% of the high-end medical device market in China. Foreign products such as ventilator, high-end X-ray CT, magnetic vibration diagnostic instrument, fiber endoscope, surgical robot, extracorporeal membrane oxygenation (extracorporeal membrane oxygenation) and other high-end medical devices occupy the main market of domestic tertiary hospitals. Even the core components of some high-end medical devices cannot be produced in China and need to be imported.

The local industrial level of R&D keeps pace with the international first-class. Why can't industrial development keep up with the pace? He believes that high-end medical devices in China face multiple constraints, mainly in three aspects:

First of all, the differences in technology and industrial chain at home and abroad lead to unequal R&D costs. For example, he said, "If an endoscope front-end optical probe is developed, foreign manufacturers may only need a few teams to complete it in a short time, while teams of dozens of people in China need to dig deep into key technologies for one to two years before it is possible to mass-produce this widget."

Second, the market share of local manufacturers is small. Under the constraint of economic conditions, the willingness to innovate is faced with multiple-choice questions: whether to invest more money to break through a certain subdivision technology, just to broaden the product line, or just to make some optical medical devices with lower technical threshold, just to form large-scale products and put them on the market as soon as possible?

"If it is in a mature industrial chain and technology system, I believe that local manufacturers will also be willing to lay out some new tracks and carry out new technology research in some sub-sectors, because these R&D costs are acceptable." He Jiawei further analyzed.

Third, the challenges faced by the local optical medical device industry are not only whether domestic substitution can be realized, but more importantly, whether comprehensive indicators such as product cost, high-level performance and user experience can be guaranteed after domestic substitution.

As an important strategic industry related to the national economy and people's livelihood, the situation that the high-end market of medical devices is monopolized by multinational enterprises and the key core technologies are controlled by people needs to be broken urgently. In recent years, national and local policies have provided a lot of support for domestic substitution of medical devices.

In 20021year, the Ministry of Finance and the Ministry of Industry and Information Technology jointly issued the "Guidelines for the Examination and Approval of Government Procurement of Imported Products" (20021version), which clearly stipulated the proportion requirements for government agencies (institutions) to purchase domestic medical devices, of which 137 types of medical devices all required 100%.

Since the beginning of this year, several provinces have issued documents to further tighten the "gap" in government procurement of imported products and promote the rapid development of domestic medical devices including optical medical devices.

He is also full of confidence in the growth of local optical medical devices. "On the one hand, under the guidance of strong policies, domestic medical devices will continue to go deep into medical institutions and accelerate technological innovation and upgrading through more and more user experiences. On the other hand, high-end optical imaging detectors, optical detection chips, optical fibers, laser light sources, etc. have achieved certain independent innovation results, and it is just around the corner to gradually break through the passive situation that core components rely on imports. "

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Good winds are caught up by strength at the right time! The market demand continues to be strong, national measures continue to release policy dividends, and cutting-edge innovative technologies emerge one after another ... The domestic substitution of medical devices represented by optics is surging. With the deepening of domestic substitution, local innovative enterprises will undoubtedly usher in a golden period of development.