Since its birth in the 1970s, laser medicine has opened up a new way to study the occurrence and development of human science with its high accuracy, good and reliable characteristics, and also provided a new means for clinical diagnosis and treatment of diseases, which is used in almost all clinical departments and can treat hundreds of species, becoming an important branch of modern medicine and promoting the progress and innovation of medical technology. The history of "light to the disease" has become a reality, and the history of human beings completely relying on it is gone, and laser medicine is profoundly changing human life.

On June 17, 2009, the Laser Medical Device Innovation Sub-Alliance of China Medical Device Industry Technology Innovation Strategy Alliance was officially established. In this background, it is necessary to stand in the global industry height, to sort out the industry industrial technology situation, to refine, to argue and to plan the future development direction, and to drive China's laser medical device industry to achieve sustainable development through the innovation mechanism of the alliance combining industry, academia, research and application.

I. Overview of the development of laser medical device industry

1、The development status of global laser medical device industry

In 1960, the birth of ruby laser created an important material basis for optical medicine to cross over to laser medicine, and medicine also became the first batch of ruby laser applications, in 1961, the world's first laser medical treatment machine - ruby retinal coagulation machine was introduced in the United States, the United States, the former Soviet Union and other countries kicked off the laser medicine By the end of the 1960s, there were hundreds of laser medicine papers and more than ten monographs published, and laser biomedical symposiums were held in Florida, London, England and the former Soviet Union, etc. During the period, Beijing Tongren Hospital also started the animal experiments of ruby laser retinal coagulation in 1965. In the 1970s, laser medicine began to enter the stage of clinical application, with an average of about 70 laser clinical application papers per year worldwide, and the average annual sales of laser medical devices reached tens of millions of dollars, and the worldwide laser medical fever began to rise. In the 1980s, laser medicine had developed into a new fringe discipline, various academic conferences were globalized, specialized and regular, new laser technology had been more maturely used for research and diagnosis, more than 40 kinds of commercialized medical laser devices had been sold, and the global laser medical device industry had initially formed.

Today, due to the accuracy, efficacy and safety exceeding traditional treatment methods, a wide variety of laser devices have been widely used in various clinical departments such as general surgery, urology, dermatology, otorhinolaryngology, stomatology, gynecology, orthopedics, cardiovascular surgery, neurosurgery and oncology, which can treat hundreds of diseases, using gas, solid-state, semiconductor, excimer, tunable lasers, covering almost all wavelengths from ultraviolet to far infrared. In developed countries, an average of 10-15% of surgical procedures use laser surgical instruments, and 2/3 of outpatient institutions in the United States have laser medical equipment. A number of laser medical industry giants have emerged, represented by the U.S. company LUMENES, and the global laser medical device industry has entered a phase of rapid development, showing the following characteristics and trends.

(1) Active M&A. On February 26, 2001, Israel ESC and Coherent Medical Group merged to form Lumenis; on July 1, 2002, Italy E1.En Group acquired the American Sanosu Medical Laser Company; on January 13, 2009, Abbott announced the acquisition of AMO. the above companies through the integration and allocation of external resources to achieve complementary technology and market The above companies achieve complementary technologies and markets through the integration and allocation of external resources, divide or expand their business scope, and enhance their competitive advantages, etc.

(2) R&D has become a key driver of future market growth. Famous foreign laser medical device manufacturers are increasing their investment in R&D, which is regarded as an important marker for the growth of the laser medical industry. New laser medical devices based on advanced lasers such as medium and high power thulium, erbium, holmium, 308nm excimer, semiconductor, and all-solid-state red/green/yellow multi-wavelength lasers are emerging and showing strong development momentum.

(3) Digital and other high-tech widely penetrated. Modern electronic technology, computer technology, information and information processing technology, biotechnology, etc. are widely penetrated into the field of laser medical devices, laser medical devices digital minimally invasive treatment features more obvious.

(4) laser medical is expected to become the fastest growing medical technology in this century. 2005, the U.S. MDDI journal of medical laser as one of the top ten major medical instrument technology, proposed that it is affecting patient care, clinical practice, product development and medical device industry.

2, China's laser medical industry development status

In 1971, Shanghai Sixth People's Hospital published a report on the clinical application of ruby laser coagulation of the retina, which is a report on the clinical application of laser in China; in 1973, the Ear, Nose and Throat Hospital of Shanghai Medical University used a homemade carbon dioxide laser scalpel to perform successful surgical operations, which is a pioneering work in the clinical application of laser outside of ophthalmology; in the same year, Guangdong In the same year, Zhongshan Medical University used homemade carbon dioxide laser treatment machine to carry out laser treatment in the fields of surgery, dermatology, ophthalmology, gynecology, physical therapy, acupuncture and oncology, etc., and achieved satisfactory results; at the same time, some medical units in Shanghai Second Medical University, Wuhan Tongji Medical University and other provinces and cities have carried out the application of laser in almost all clinical departments; by June 1977, by the By June 1977, a national academic exchange meeting on laser medicine was held in Wuhan under the auspices of the Institute of Scientific and Technological Information, at which more than 80 papers were read. To the late seventies statistics, in our country has used helium-neon laser, carbon dioxide laser, ruby laser, aluminum garnet laser and its frequency doubling laser, nitrogen molecular laser, argon ion laser, krypton ion laser, helium-cadmium laser and dye laser and other ten kinds of commonly used medical laser treatment throughout all clinical departments of more than 250 kinds of diseases, nearly a million patients received millions of times of laser treatment, in the treatment of disease and In terms of the types of diseases treated and the number of cases, foreign countries combined during the same period are far from our country's more. However, due to the domestic economic environment at that time, China's laser medical device industry did not really form, and the annual sales revenue of domestic laser medical devices was only a few million yuan, until after the 1980s, under the impetus of the reform and opening-up policy, laser applications in the medical industry have attracted widespread attention, and basically formed a large-scale production centered on three series of CO2, Nd:YAG and He-Ne lasers. Especially since the end of the last century, under the vigorous promotion of the Ministry of Science and Technology and the Ministry of Health, China's laser medical device industry has gained rapid development, the Ministry of Science and Technology, Department of Basic Research High Technology statistics in 2005 showed that sales reached 74.91 million yuan in 1995, and in 2004, it exceeded 1 billion yuan, domestic laser medical devices rose to the third place in the sales of domestic lasers, and in 2007 reached 16.2 billion yuan. The development overview is as follows.

(1) Industrial layout: 134 enterprises registered with SFDA, mainly concentrated in Hubei (29), Beijing (18), Shanghai (12), Guangdong (11), Jilin (11). Five laser technology research centers and more than 10 research institutions have been formed.

(2) Organizational structure: small and medium-sized private enterprises are the mainstay, and foreign laser medical companies, such as TechMed People and Allen (Decker), have registered enterprises in China to seize the Chinese market.

(3) Product structure: Medical devices based on CO2, He-Ne and Nd:YAG lasers are the main products, which have reached a suitable cost performance ratio and have been applied in a large number of hospitals at all levels in China.

(4) Industrial cluster: Wuhan, Beijing, Shanghai and other industrial clusters have been formed, including Wuhan laser medical production group represented by Chutian Qizhi Company and Lingyun Photoelectric Company, which has developed rapidly in medical lasers, software control, system integration and clinical application research, and its market share has been expanding, becoming one of the most important bases for the development and production of laser medical devices in China.

Second, the global laser medical device product technology and clinical application status

Since 1962, when the ruby laser was applied to ophthalmology and opened up a new field of laser therapy, laser therapy technology and laser therapy equipment industry have been developed significantly. Laser therapy makes full use of the advantages of monochromaticity, high directionality, high coherence and high energy density of laser, and cooperates with fiber optic conduction and endoscopy and other related technologies to coagulate, cut and vaporize the diseased tissue for surgical or interventional treatment, thus achieving clinical treatment.

Due to its accuracy, efficacy and safety over traditional treatment methods, various laser treatment devices have been introduced into various clinical departments such as general surgery, urology, dermatology, otorhinolaryngology, stomatology, gynecology, orthopedics, cardiovascular surgery, neurosurgery and oncology, etc. Hundreds of diseases can be treated, such as: laser treatment of benign prostatic hyperplasia, laser lithotripsy, laser fiber endoscopy, laser therapy for cancer, laser therapy for cancer, laser therapy for cancer, laser therapy for cancer, laser therapy for cancer, laser therapy for cancer, laser therapy for cancer. Laser endoscopic surgery, photodynamic therapy for cancer treatment, laser treatment of cardiovascular diseases, excimer laser keratoplasty, laser thoracic and laparoscopic surgery, laser arthroscopic surgery, laser surgery, etc. For many diseases such as psoriasis, leukodystrophy, diabetic fundus, stones (intracavitary lithotripsy) and benign prostatic hyperplasia, laser therapy is an irreplaceable and unique treatment method, opening up a new field outside the two major treatment measures of surgery and drugs, and becoming an important branch of modern medicine.

Neurosurgery: Intracerebral tumors (substantial astrocytoma, ventricular meningioma, pituitary tumor, craniopharyngeal tumor, auditory neuroma, cystic tumor, angiodysplastic tumor, glioblastoma), cerebral artery malformation, aneurysm, vascular anastomosis and neural welding, hydrocephalus fistula, ventricular septal resection, etc;

Ophthalmology: retinoblastoma, glaucoma peripheral iridectomy, cataract capsulotomy, fundus disease photocoagulation (retinal fissure, peripheral retinal degeneration, diabetic retinopathy, macular lesions), corneal scarring opacities, pupillary membrane closure and atresia, pre-crystalline pigment, iris cyst, intraocular vascular hemorrhagic disease, iris bulge, congenital pupillary residual membrane, vitreous mechanization strip release keratoplasty, keratoconus surgery, corneal scar removal, retinal fixation, vision correction, etc;

Otolaryngology: vocal cord mammary adenoma and tumor, oral tumor, hemangioma, tonsillectomy, DCR surgery, turbinate hypertrophy, nasal polyps, tracheal stenosis, allergic rhinitis, oral inflammation, chronic pharyngitis, etc;

Respiratory: photodynamic therapy for lung cancer, airway tumors, airway obstruction (caused by cancer, inflammatory granuloma, tuberculosis granuloma, etc.), bronchial tuberculosis, amyloidosis, granuloma, scar stenosis, pediatric laryngeal papilloma, etc;

Gastroenterology: malignant tumors of the gastrointestinal tract (colon cancer, rectal cancer, etc.), anastomotic stenosis after resection of esophageal cancer and cardia cancer, gastrointestinal polyps, etc;

Hepatobiliary surgery: hepatocellular carcinoma resection, vaporization, hepatobiliary stones, etc;

Cardiovascular surgery: coronary heart disease, peripheral vascular disease, heart valve disease, ischemic heart disease, congenital heart disease, hypertrophic cardiomyopathy, angina pectoris, hypertension, angioplasty, vascular anastomosis, etc;

Urology: bladder tumor, kidney tumor, ureteral tumor, urethral tumor, benign prostatic hyperplasia, urinary stones, urethral stricture, ureteral polyps, penile tumor, penile circumcision, acromegaly, etc;

Oncology: benign/malignant tumor resection, vaporization, photodynamic cancer treatment, etc;

Orthopedics: herniated disc, bone and joint surgery, etc;

Gynecology: cervical erosion, vaginitis, venereal disease, removal of peritoneal adhesions, tubal reconstruction, tubal ostomy for congenital pregnancy, myomectomy, endometrial inflammation, pelvic inflammatory disease, ovariectomy, etc;

Dermatology: vitiligo, psoriasis, skin exfoliation, vaporization, ortho-N dermatitis, seborrheic keratosis, solar keratosis, warts, macular tumors, sweat duct tumors, acne scars, keloid scars, hypertrophic scar, varicose veins, etc;

General surgery: surgical scalpel;

General: physical therapy.

Lasers are the core devices of laser therapy devices, and the photobiological effects between lasers of different wavelengths and biological tissues are the cornerstone of various laser therapies. At present, domestic and foreign laser therapy devices that have entered the clinical application stage are mainly based on gas lasers, solid-state lasers, semiconductor lasers, excimer lasers, tunable lasers and other medical lasers, covering almost all wavelengths from ultraviolet to far infrared.

Gas laser medical equipment: including atomic lasers (He-Ne laser), molecular lasers (carbon dioxide laser, nitrogen molecular laser), ion lasers (argon ion laser, krypton ion laser, helium cadmium laser) and other medical equipment, with a wide range of coverage of the spectrum, continuous laser output, directional, monochromatic better, easy to manufacture, low cost, reliability and other advantages, so gas Laser treatment equipment is most widely used.

① He-Ne laser output wavelength of 632.8nm visible red light, mainly used for local or acupuncture point irradiation, can adjust the physiological function of the body, diastolic blood vessels, improve local blood circulation and nutritional status to stimulate the activity of enzymes in the body, accelerate and improve the permeability of local tissues, promote the absorption of secretory fluid, increase blood phagocytosis, stimulation, anti-inflammatory, analgesic, vasodilatation, enhance immunity and acupuncture, etc.;

② Carbon dioxide laser output power, high energy conversion rate, clinical use of its thermal pressure effect, melting tissue, penetration and destruction and can accurately control the "burn" site range size and depth and other characteristics, so that tissue water volatilization, removal or oxidation of diseased tissue, closed and coagulated arteriovenous vessels, to achieve tissue coagulation, carbonization, rapid cutting and other effects. Rapidly produce cutting and other effects, clinically commonly used in soft tissue diseases, especially in the surgical treatment of dermatological diseases;

③ Argon ion excitation spectral line distribution in the blue-green area, with 514.5nm and 488nm as the strongest, mainly used in surgery, ophthalmic coagulation and comprehensive medical treatment.

Solid-state laser healing equipment: laser working material to doped ion-based insulating crystals and glass. So far, only the ions of rare earth group, transition metals and actinides can be used as the activation particles of the laser working material. Among them, the trivalent rare earth group ions occupy a very important position in the solid laser working substance, such as neodymium ion (Nd3+) is the most widely used, almost in 80 kinds of crystals and glass matrix observed laser oscillation, to its activation particle Nd:YAG laser medical equipment application amount; holmium ion (Ho3+), erbium ion (Er3+), thulium ion (Tm3+) application has also been remarkable, while the transition The trivalent chromium ions (Cr3+) in metals have also long been known for the creation of ruby lasers.

① Nd:YAG laser has deep penetration to skin mucosa, good absorption effect to red, blue and black, poor cutting ability, but good hemostatic effect, mainly used for hemostasis of bleeding diseases (such as upper gastrointestinal bleeding), vascular lesions, etc., and combined with endoscopy to treat tumors in the bladder, lung, gastrointestinal tract or vocal cord lesions, nasal polyps, etc.;

② Chromium-doped ruby laser was first used in ophthalmology, later replaced by argon laser, dye laser, etc., and is now mainly used to remove tattoo spots;

Thulium, holmium and erbium lasers are new rare earth doped mid-infrared solid state lasers developed rapidly in recent years, thulium and holmium laser wavelengths are around 2.0 μm, with shallow penetration depth to biological tissues and good vaporization and coagulation effects, the former can be used for benign prostatic hyperplasia surgery and soft tissue fine cutting such as ureter/urethral stricture incision, the latter has excellent performance in the field of intracavitary lithotripsy, which is a light source with current lithotripsy efficiency . The erbium laser with a wavelength of 2.94 μm has unique advantages in the field of skin peeling and vaporization, and is considered the most ideal light source to replace carbon dioxide laser in the field of dermatology.

Semiconductor laser medical treatment equipment: semiconductor laser working substance are potassium arsenide (gaas), indium arsenide (inas), indium antimonide (insn), gallium aluminide (gaalas), etc., the output wavelength is mostly in the visible light between the long wave to near infrared, the shortest medical 650nm (commonly used as targeting light), common wavelengths are 810nm, 980nm, etc., different types of semiconductor Laser output power varies widely: double heterojunction bar laser continuous output power of hundreds of milliwatts, pulse output can reach tens of watts; laser array devices continuous output power of up to 100 watts, pulse output up to kilowatt level; tunable laser continuous output power of a few milliwatts, pulse peak power can reach tens of watts. Although the semiconductor laser spectral structure is also more complex, poor monochromatic, output power is also less than YAG, CO2 laser 1%, but easy to operate, low price, with high electro-optical conversion efficiency (30%), compact structure, small size, light weight, long life and other advantages, has a good prospect for development.

① 810nm semiconductor laser medical equipment power of 0.5~25~60w, vaporization effect is three times faster than 1064nm laser, while both good hemostatic effect, in addition with a variety of internal diameter fiber can be easily matched with any kind of endoscope, in open surgery can also be applied flexibly.

② Semiconductor laser medical equipment used in dentistry center wavelength of 790 ~ 800nm, only 5v DC voltage power supply, can output power of hundreds of thousands of milliwatts of laser, generally used for physical therapy and acupuncture.

The red semiconductor laser with a wavelength of 635 nm has also shown good efficacy in the field of photodynamic therapy.

Excimer laser medical equipment: Excimer laser is a kind of pulsed laser developed in the 1970s, with short wavelength and high power, its working substance is rare gas halide and rare gas oxide, output wavelength from vacuum ultraviolet to visible light region. At present, the most mature technology development and the most widely used is the rare gas halide excimer laser. Excimer is a molecule composed of two atoms, this molecule is not a stable molecule, only in the excited state is stable, and the excited state has a very short life span, has the ability to precisely cut a variety of different tissues, and does not mix with thermal changes during the cutting process. In recent years, the application of excimer laser in medicine has attracted widespread attention, and it is mainly used clinically for laser angioplasty, refractive keratoplasty and central nervous system lesion removal. It is important to note that the excimer laser at 308 nm is considered to be the wavelength of ultraviolet light for the treatment of vitiligo and psoriasis, which induces T-cell apoptosis and promotes pigment synthesis better than conventional therapies.

Tunable laser healing devices: The wavelength of the general laser output is fixed single, at most a few wavelengths, which has some limitations in the application. In some applications, there must be tunable radiation to meet the needs. There are a variety of tunable lasers, such as dye lasers, semiconductor lasers, optical parametric oscillators, laterally excited CO2 lasers, etc.. The reason is that the central wavelength of the dye laser varies with the cavity length, dye concentration and cavity mirror reflectivity, which makes it easy to change and control the central wavelength of the output laser of the dye laser using various methods to obtain a continuously tunable laser wavelength. Dye lasers for ophthalmology are simpler, smaller and easier to use than other lasers. Because of its continuously adjustable wavelength, it is possible to adjust the laser output wavelength to fit the ophthalmic treatment range. In addition, the dye laser is now widely used as an effective light source in photodynamic therapy (PDT) for clinical treatment of deep malignant tumors.

Multi-wavelength laser treatment devices: Since the beginning of this century, multi-wavelength laser combined medical devices have started to appear, showing good prospects for development. The working process is that the green laser first forms a plasma zone on the surface of the stone, and then the infrared light is absorbed by the stone, so that the laser energy is converted into shock waves in a short time to break the stone. The representative model is the U100 dual wavelength laser lithotripter launched by German WOM in 2000, and the dual wavelength laser lithotripter developed by Wuhan Qizhi Laser Technology Co. It is used for treatment of fundus disease, for different fundus diseases, different fundus sites, different refractive interstitial conditions, choose different wavelength laser treatment, broaden the scope of treatment of fundus disease, to achieve the treatment effect. The world's first solid-state multi-wavelength fundus laser was launched in 2004, with the output laser wavelengths of green 532nm/yellow 561nm/red 659nm. In addition, Nidek Japan launched a multi-wavelength laser fundus treatment device in 2005, including the combination of 532nm-561nm-659nm, 532nm-593nm-671nm and 532nm-593nm-671nm. 671nm three-wavelength combination; ③ Dermatology laser super platform. In recent years, the U.S. company Sciton introduced to the market Profile dermatology super platform, consisting of six functional modules, namely, erbium laser microablation module (MLP), erbium laser advanced fractional module (ProFractional), 1064nm Nd:YAG laser module (ClearScan), 1319nm Nd:YAG laser module ( ThermaScan), six-wavelength color light treatment module (BBL) and infrared wave skin tightening module (SkinTyte), hair removal, wrinkle removal, skin tightening, skin rejuvenation, acne scars, hyperpigmentation, photoaging, vascular lesions and other common skin diseases can be treated.

Third, the development of advanced laser medical devices at home and abroad in recent years

With the accelerated combination of laser technology and medical clinical technology, the global medical laser output power is getting higher and higher to meet the demand of shortening the operation time and improving the treatment effect. In addition, new lasers such as femtosecond lasers and multi-wavelength lasers have started to be used in clinical practice, which has promoted the development of medical laser technology. See the following table for details.

Foreign advanced laser medical devices and application department overview table

No. Light source Product Application department Typical enterprise

1 Nd:YAG laser Q-switched Nd:YAG laser ophthalmic treatment system (YAG light blast mode) Ophthalmology Lumenis

Dual Frequency Dual Wavelength Lithotripter Urology WOM

2 Thulium Laser 120W Thulium Laser Medical System Surgical/Urological Lisa

3 Green laser 120W green laser medical system Urology (prostate enlargement) AMS

Q-switched YAG frequency doubling green laser ophthalmology system (SLT mode) Ophthalmology Lumenis

Semiconductor-pumped green laser ophthalmology system (photocoagulation mode) Ophthalmology Lumenis

4 Holmium laser 100W Holmium laser medical system Urology (prostate enlargement) Lumenis

Holmium laser lithotripter 60W Urological (lithotripsy) Lumenis

5 Erbium laser 40W Erbium laser medical system Dermatology Sction

6 CO2 laser Multifaceted hand ultra-pulse CO2 laser treatment machine Surgical Asclepion

40W CO2 laser treatment machine Otolaryngology Asclepion

7 Semiconductor laser 800nm semiconductor laser hair removal system Cosmetic Lumenis

980nm Laser Urology/Orthopedics CeramOptec

1470nm semiconductor laser treatment system Dermatology/Dentistry Lumics

8 Excimer XTRAC Excimer Laser Dermatology System Dermatology (psoriasis/vitiligo) PhotoMedex/Wavelight

Excimer laser ophthalmology system Ophthalmology (refractive correction) VISX

9 Ruby Ruby laser treatment system Dermatology Asclepion

10 Multi-wavelength PROFILE Super Platform Dermatology Sciton

Multi-wavelength fundoplication (red/green/yellow light) Ophthalmology Lumenis /Nidek

11 Femtosecond laser Femtosecond laser treatment system Ophthalmology (LASIK surgery) Intralase

At present, among various types of laser treatment equipment, due to the maturity of domestic gas lasers, Nd:YAG lasers and other technologies, a series of gas laser treatment equipment and Nd:YAG laser treatment equipment has been localized to achieve a suitable price/performance ratio, and a large number of affordable and stable performance of domestic medical equipment are deployed in hospitals at all levels in China. In addition, with the development of domestic semiconductor lasers, green lasers, holmium-doped solid earth elements such as laser technology, medical laser technology, the corresponding low power sets of laser medical equipment also began to market, showing good prospects for development. The domestic laser medical equipment products that have been listed in bulk are shown in the table below.

Domestic laser medical devices and application departments overview table (registered and valid)

No. Light source Product Application department Typical enterprise

1 Intense light Photorejuvenation instrument Skin beauty Chizhi laser

2 Nd:YAG laser Nd:YAG laser treatment machine Comprehensive (surgery, stomatology, otorhinolaryngology, urology, dermatology, gynecology, anal ulcer, neurosurgery, venereal disease, etc.)

Neurosurgery, Venereal Disease, etc.) Chizhi Laser / YAG Photoelectric

Q-modulated Nd:YAG laser treatment machine (dual wavelength) Skin treatment

YAG ophthalmology laser treatment machine Ophthalmology Wuhan Lailkang/Wuhan Jingliel/Wuhan Tiandu/Wuhan Huada/Wuhan Bodakang/Baoding Lanqiu

3 CO2 laser Ultra-pulse CO2 laser treatment machine Surgical Chizhi laser / Laser Technology

4 He-Ne laser He-Ne laser physiotherapy instrument physical therapy Chizhi Laser / Yageo / Laser Technology

5 Green Laser 80W Green Laser Prostate Treatment Machine Urology Chizhi Laser/Wuhan Guangfu

6 Holmium laser 30W holmium laser lithotripter extra-urinary Beijing Aiko Kainan / Hefei Coreida / Wuhan Guangfu

7 Erbium laser Erbium laser blood collection machine Testing Wuhan Lightfoot/

8 Semiconductor laser Semiconductor laser treatment machine comprehensive Lingyun photoelectricity / Boji Century

Photodynamic therapy instrument tumor Lingyun photoelectric / Yag photoelectric

Semiconductor laser physiotherapy instrument Physiotherapy Wuhan Lightfoot

Fourth, the opportunities and challenges facing China's laser medical device industry

Compared with the United States, Europe and Japan and other developed countries, there are still certain gaps in the development of China's laser medical device industry, as shown in.

1, industrial concentration is not high, not formed the flagship square: the existing more than 100 enterprises to small and medium-sized enterprises as the main body, the scale is generally small, there is not a listed enterprise, scattered, small problems, low concentration of production, globalization competitive advantage is not obvious;

2, the industrial structure is unreasonable: domestic products are mainly concentrated in low-end products, high technology content, high value-added products, product homogenization and scale is not economic phenomenon is serious, a large number of enterprises stay in the mutual imitation stage, the lack of independent innovation capacity;

3, the combination of industry, university and research has not become a system: industrial resources are not fully integrated with strong intellectual resources, clinical resources, the main position of enterprises in the combination of industry, university and research is missing, resulting in a disconnect between research and the market, so that intellectual and clinical resources are not reflected in the industry.

Driven by the domestic market demand and related industrial policies, the long-term trend of China's laser medical device industry development is positive, showing the following characteristics.

1, the overall market capacity continues to expand: China has 1/5 of the world's population, has become the world's third largest laser medical consumer market after the United States and Japan, the demand is huge; benefit from the medical reform policy being launched, the domestic major hospitals to update and upgrade the amount of medical equipment, as well as new purchases in primary hospitals will be long-term positive;

2, the backbone of the gradual growth of enterprises: With the development of China's laser medical device industry, a number of national enterprises are growing up from weak to strong, from small to large. Such as Chutian Qizhi company in the skin, urinary line products, Lingyun photoelectric company in the field of semiconductor laser medical products has the initial ability to compete with foreign enterprises;

3, independent intellectual property products began to appear: a number of products with independent intellectual property rights have been put into the market, and occupy a certain market share, the formation of a certain brand, and show a virtuous cycle of continuous innovation and development. Chutian Qizhi has declared 55 patents in the field of laser medical devices, authorized 24 patents, and obtained provincial famous brand products and famous trademark certificates.

In recent years, in order to compete for the Chinese market pie, the globalized multinational groups, represented by KMD, Allen (Decker), etc., have seized the Chinese market, and even registered enterprises in China directly, and the domestic high-end market is almost completely occupied by foreign industrial giants, and is becoming a key area of their global industrial layout, bringing a huge impact on local enterprises. And China's laser medical device industry from the overall point of view of the existing products to low-end products, profit margins are small, enterprise independent innovation and business development at a lower level, resistance to market risks and globalization competition is weak, how to quickly enhance the core competitiveness, and actively respond to global competition, is the challenge we face! At the same time, the following opportunities should be grasped.

1、Market opportunity. The stabilization of economic growth, the start of medical reform policy, the change of medical model, will bring a huge increase in medical demand, China's laser medical industry will usher in a sustained prosperity of the market spring;

2, industrial policy and regional development opportunities. At present, many domestic provinces and municipalities have taken the medical device industry as a new economic growth point in the cultivation, such as the Pearl River Delta region has proposed to support it as a new pillar industry, Shanghai and other places of the medical device industry has also begun to rise, Wuhan has also put forward the development plan of the Optics Valley Biopolis, which includes the medical device industry;

3, the opportunity brought by the change of industrial technology innovation model. The formation of China Medical Device Technology Innovation Strategic Alliance Medical Laser Sub-Alliance is a major initiative in response to No. 770 and an inevitable choice for each sponsor unit to enhance its independent innovation capability, which will become an important innovation platform for the technological progress of China's laser medical industry and has great strategic significance for the laser medical device industry to achieve sustainable development.

In the face of opportunities and challenges, our response is to

1、Adjust the industrial structure, support the development of backbone enterprises, form their own flagship squad, encourage bilateral and multilateral deep cooperation among alliance members, so as to drive the whole industrial team to take the development path of "special, precise, special and new" (precision, specific market, novel and new technology).

2, increase the government's scientific and technological guidance funds and enterprise R & D investment, industrial technology alliances as an innovation platform to promote the rational allocation of science and technology, talent, information, market, management and other resources, cultivate enterprise innovation capacity, promote the enterprise to become the main body of innovation, especially to break through a number of key common technology bottlenecks that can support the future development of the industry, the formation of a number of new generation of laser medical equipment products with global level, to enhance the global market competitiveness of enterprises. Enhance the global market competitiveness of enterprises.

3, increase government procurement efforts, giving priority to the purchase of domestic laser medical equipment products. Formulate tax and credit preferential policies, gradually regulate the market, create an environment conducive to the development of enterprises, and support the development of the laser medical device industry.

4, strengthen the cultivation of famous brands, publicity, improve the visibility of enterprises and products, rapidly expand the product market, to achieve rapid growth of enterprises. Support backbone enterprises to enter the domestic capital market through capital operation and achieve the goal of going public.

5、Strengthen the guidance and service function construction of industry associations and industrial alliances, assist the government in formulating industry development plans, carry out domestic and international economic and technical exchange activities, and create opportunities and platforms for enterprises to cooperate.

V. Future development direction of China's laser medical device industry

In the future, China's laser medical device industry should take a path that combines with national conditions, take the general trend of medical transformation and photonic biomedical development as the guide, take the medical laser technology innovation strategy sub-alliance as the platform, give full play to the advantages of existing resources of all parties, take cultivating and strengthening the innovation ability of enterprises as the starting point, and transform the resources of science and technology, talents, clinical, information, management and market into the source of industrial development, so as to To realize the sustainable and benign development of China's laser medical device industry.

Development goal: The future laser medical devices will develop in the direction of high power, miniaturization and intelligence, aiming at the global advanced laser medical products with wide application and high demand, and through the joint research and joint application of alliance related parties, break through the key common technology bottlenecks in 4-6 fields within three years to leap to the global level, realize the industrial scale application within five years, form a new generation of laser medical devices, and drive The whole industry to achieve leapfrog development.

In order to achieve the above goals, it is recommended that around the key areas identified in the "medium and long-term scientific and technological development plan (2006-2020)", combined with the new development trend of the global laser medical industry technology, the current situation of domestic industrial technology development and the urgency of the demand for disease treatment and other factors, should focus on research based on a new generation of advanced lasers for difficult diseases, common disease treatment, with a broad range of popular applications The prospect of laser medical treatment equipment. Including.

1, infrared wavelength series of solid-state laser medical equipment (thulium / erbium / holmium / dual wavelength) ;

2, 308nm excimer laser medical equipment;

3, a series of semiconductor laser medical equipment;

4, all-solid-state multi-wavelength (red/green/yellow light) fundus disease laser medical equipment.

The reasons are: 1, the above areas involve four types of difficult diseases and eight types of public diseases, the source of large, high incidence, and increasing year by year, some patients lost their ability to work due to disease, due to the disease caused by poverty, the urgent need to get medical treatment

2, industry, academia and research parties have the corresponding technical basis and industrial conditions, conducive to the realization of all devices localization; 3, lasers and other core technologies cover the global frontier areas of laser medicine, is conducive to drive China

The development of the optical medical device industry group; 4, the urgent need to change the domestic medical departments related to the more backward medical treatment technology; 5, the need to replace imports and reduce social medical costs.

The above involves four types of difficult diseases: 1, white epilepsy, more than 13 million people in China, the incidence rate is increasing year by year; 2, psoriasis, China has about 20 million patients suffering from this disease; 3, diabetic fundus disease, China has been diagnosed with diabetes mellitus patients amounted to 40 million, of which nearly 20 million suffer from diabetic retinopathy; 4, superficial tumors, superficial bladder tumor incidence The incidence of superficial bladder tumors ranks 4th among all tumors in men and 9th among tumors in women.

Involved in eight types of public diseases: 1, benign prostatic hyperplasia, China's patients more than 40 million people, 8 million patients need surgery; 2, stones, China's patients more than 200 million people; 3, common skin diseases, almost everyone in the lifetime of the skin disease; 4, herniated discs, common diseases, the incidence of herniated discs second only to the cold; 5, warts and other sexually transmitted diseases; 6, varicose veins; 7 The incidence of angiosarcoma, the incidence of up to 1%, the number of incidence of 12 million people or more; 8, oral diseases, the incidence of oral diseases in China accounted for 74% of the Chinese population.