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Gerresheimer s factory in China to expand the ability of medical molding
German medical injection molder Gerresheimer Regensburg GmbH company in the next 18 months, factories in China will quadruple production capacity expansion, and is actively planning to build a second plant in China.
Gerresheim Plastic Products (Dongguan) Co., Ltd., general manager Stephane Pianigiani said the Dongguan factory expansion is mainly to meet the multinational medical device manufacturer customers, they want to reduce product costs, but now more and more accustomed to China, sensitive health care products.
The company, based in Regensburg, Germany, the end of 2012 the company plans to existing factory in Dongguan 8 to 30 sets of injection molding machines, the number of employees expanded from 100 to 350 people, he was on September 7-8 in Shanghai at the China International Medical Equipment Design and Technology Exhibition (Medtec China) said in an interview on the news.
Pianigiani said: \"The [medical device industry over the past customers] always want to come to China for production, but now they have changed the concept.\"
Gerresheimer\\ s Dongguan plant is the first step in expansion plans in China, the company is a manufacturer of large-scale drug delivery systems, including inhalers and other products.
Pianigiani said that while the company is also actively preparing to build a first in China to build or buy an existing plant for the medical industry, injection molding factory.
He said: \"Although the long view, only by virtue of a factory in Dongguan that we can not become the market leader in China, but to January 2013, we will have a new plant into operation.\"
If all goes well, Pianigiani said the company will \"soon acquire\" a new plant, but he said the fact that to find a suitable acquisition target is not easy.
Currently, the company\\ s worldwide total of 15 injection molding plant, of which eight specialized production of medical equipment products. Its customer base includes most of the well-known manufacturer of medical products and pharmaceutical companies, such as Zogenix company, Becton Dickinson Medical, Novartis Pharmaceuticals and Merck KGaA.
The annual global production of about inhalers 100 million, 50% of its plastics division more than clean room capacity for the production of drug delivery systems, such as powder and capsule inhalers and aerosols. The company\\ s other products include disposable dialysis medical supplies, insulin pen, surgical instruments and medical clinics for laboratory test equipment.
He said the Dongguan factory was built five years ago, over the years to strengthen customer relations efforts have begun to show results. \"We are a [footprints all over the world] a full-service provider customers tell us their ideas from our design and production work, including all of the molds and tools.\"
He said that while factories in Dongguan, more than 95% of the products are exported to North America and Europe, but the company chosen to participate in the development of this Medtec China, hoping to expand the business in the local market.
He said: \"We see a huge population, China has a tremendous untapped market opportunity, we believe that a considerable number of Chinese people can afford our products.\"
Medical device suppliers how to deal with the weight of FDA regulated
U.S. FDA issued to medical device and equipment suppliers are increasing year by year the warning letter, the health care market in the taut nerves at the same time, how to improve the efficiency of the market control it?
In the past five years, the world\\ s many contaminated products led to patient injury and death and end-users. In 2007, the toothpaste containing diethylene glycol and millions of lead-containing toys were recalled. In 2008, the U.S. FDA recall of contaminated heparin (a widely used in kidney dialysis patients after surgery and blood thinners to prevent blood clots), and milk containing melamine has led to thousands of serious incidents and more than infant mortality. In 2009, due to flavor foods containing peanuts contaminated peanut butter led to a lot of people sick. In these adverse events led to investigate the cause found, except for some other reasons, the supplier\\ s control is inadequate or not in place one of the reasons. U.S. FDA issued to medical device manufacturers observations and warning letters to 19 from 2006 to 2007 25 and 2008 35.
These events have caused the United States and European regulatory agencies to strengthen the medical device and pharmaceutical industries suppliers control. In December 2008, the global coordination group (GHTF) issued a guidance document, lists the manufacturers of medical equipment suppliers in the control process must include steps.
November 2009 issued a second document (in draft form) describes the inspection of medical device manufacturers suppliers control techniques. In 2009, AdvaMed Conference, from the U.S. FDA AdvaMed, said, \"Compared to 2007, the supplier management and control issues is a growing problem, although there are issues of toothpaste and peanut products and equipment sector is not directly related However, these events are still greatly influenced the thinking and the U.S. FDA\\ s control. control of the supplier and the relationship between risk management will continue to increase the attention. \"
The level and extent of control should be based on the importance of product or service and risks that may affect the final product safety, efficacy, and the importance of quality and risk. The final product or device manufacturer has the responsibility and their suppliers to identify and communicate these requirements. Good supplier management and control can be converted into an effective quality management systems and risk management processes, high quality and consistent products, productivity improvements and waste, adverse events, complaints and recalls reduced.
For medical device manufacturers and healthcare industries components, parts and raw materials suppliers must be prepared to meet its customers from more stringent controls. Suppliers control the level and extent will depend not only on the suppliers of the importance and risks of the product, including the supplier in the supply chain in the position. Compared to level 2 and 3 suppliers, supplier of level 1 management and control more (see Figure 1). Both material suppliers in the value chain in what position, they still must ensure that its products meet all the performance and application-specific regulatory requirements.
The medical industry supply chain, many companies do not fully understand the risks for their products and changes come from. In some cases, they believe that the risk of medical equipment and pharmaceutical market high and low profits. A small number of vendors have developed a class of special programs for the needle in this market with its products and services. LyondellBasell, Clariant and every aspect of their supply chain to work closely not only to reduce their own risk and its direct customers, and ultimately reduce drug and medical device company\\ s risk. LyondellBasell is a PE (polyolefin) resin suppliers, its customers include a variety of industries, including health care industry. The two companies have services for the healthcare industry for decades, and has passed a similar approach to ensure that their business processes and health care products are ready to respond to a tightening of control challenges.
Medical device and pharmaceutical industries continue to use the high performance characteristics of the plastic, and use the number is increasing. These materials must meet specific characteristics, such as can be disinfected, resistant to chemicals and lipids, biological compatibility. Impurities, the extract or leachate at a slight difference on the final formulation may affect the biocompatibility and toxicity of the product. United States Pharmacopeia (USP) and European Pharmacopoeia (Eur.Ph) requirements (supplier) to provide the material composition and formula, production technology and the physical and mechanical properties, chemical properties, biocompatibility and toxicity testing of a large number of test data. These results must be placed in a specific file, or material must meet the standards set forth in the property requirements. Advantage of this system is that product manufacturers can design and products in their use of these materials and is confident that its products meet regulatory and application requirements. However, the shortcomings of this system is that the document or record is submitted when the second application, and the use of materials and formulations are very specific. As time goes on to make any material changes or formula is not an easy task, and from the commercial and regulatory point of view have become a difficult task.
In order to meet the health care industry and its customers\\ changing requirements and needs, Clariant and LyondellBasell have implemented a strategic business processes, which relate to their customers (health care products developer and manufacturer of the product, brokers and processors, the industry associations, etc.) and suppliers (resin, masterbatch, additives, catalysts and other suppliers) common management, control and reduce the supply of its products to the healthcare industry risk.
Clariant is a professional manufacturer of specialty chemical products listed international company headquartered in Switzerland. The company has multiple business units (BU) to the medical device and pharmaceutical industries intermediates, excipients and masterbatch products. In the masterbatch for the plastics processing industry and additives, and mixtures, BU Masterbatch is a famous brand. Plastics processing industry ranging from consumer electronics, toys, food, personal care packages, textiles and automotive parts. The company\\ s focus on the health care industry to implement the strategy include a risk-based program designed to be controllable, stable and compliant products. Business unit focused on the distribution of the three global center of expertise for analysis, so that it can provide a complete medical materials for the production line isolation. These centers have the production of goods based on the current practice of quality management system, and the implementation of ISO 13485 standards for medical equipment. The three technology center has two external authentication is complete, the rest of this home in 2010 after an external certification. Process for medical products and production processes including the production of batches of fully traceable, an \"open to review\" policy (the policy to encourage direct customer and brand owner for review) and strict change control process. Eventually launched two products for medical and pharmaceutical applications of the new internal classification: MedCat 1 and MedCat 2, also released a product for traditional products and services and to distinguish the new brand. Notice of material changes to the company, process control, risk management, quality management system and document the level of control compared to the standard mixture and masterbatch production plants are different from the conventional process.
LyondellBasell, the world\\ s largest suppliers of the PE material. Purell is a development of materials for the medical industry, PP and PE material brands. Purell is the value of the product formulation and stability of supply, purchased separately, backup facility and meet the pharmacopoeia requirements. LyondellBasell Company introduced a series of specialized products for medical applications, and have a special internal quality systems and procedures, which the pharmaceutical and medical device practice the essence of production of goods. Control the risk management process is the integral part of the process.
Clariant and LyondellBasell\\ s work together to train medical and pharmaceutical suppliers. The supplier of the polymer, a mixture of masterbatch and implement change control, they are establishing the importance of change control and the significance of understanding. The use of risk management products used to control the medical industry, is also part of their strategy. The two companies agreed that the risk with the complexity of the supply chain increases, and has developed strategies to mitigate these risks and management of raw materials change, consistency and quality. Clariant has been collaboration with its suppliers to provide quality and purity and stability of masterbatch and additives. These chemicals change the less, the more confident you will not change the different batches of masterbatch products, bio-compatibility and toxicity. Clariant\\ s global markets division of consumer products and medical head Stephen Duckworth said, \"After an independent study to seek medical equipment and pharmaceutical industry demand, we made in 2008, a reserved and sober investment in this area decision on a change of raw materials and suppliers are common industry requires very aware of the market, including the risk of change come from and we now need the environment in which the culture of these three technology centers, technology and standards and training for our team to change the world we know we do not need to spread around the world throughout our 50 masterbatch production point, we realized that the market (health care market) is different now have customers tell us Our program for the achievement of new levels of security to make a contribution, however, we clearly recognize that if the vision of the entire supply chain, including our suppliers, we still have more work to do. \"
Macroscopic properties of polymers and resins, such as viscosity, flow rate, physical and mechanical properties have been well understood by manufacturers and can be controlled and measured. These physical properties are client applications for health care evaluation and selection of materials. Certificate of Analysis (CoA) and quality standards certificates are also based on these macroscopic properties. LyondellBasell\\ s that for specific medical applications and critical properties such as dissolution and extracts, biocompatibility and toxicity is highly dependent on the microscopic properties of the resin, such as impurities, molecular weight distribution and low molecular weight oligomers . \"Since 2002, LyondellBasell has been developing and marketing for the medical industry customers use the products, we enhance our quality standards, and on how to effectively meet the health care industry need to form a better understanding of the information in our medical policy is to be provided — a concentrated and used to control product consistency, quality and production policies.
This policy is a dynamic concept; it is to be modified regularly to meet growing customer demand, industry standards and the requirements of GMP. This policy is reflected in our Purell brand and products, so our customers to meet their regulatory and application requirements, LyondellBasell\\ s closed system of medical applications and closed head Jochen Schneider said. \"This fall, we work together with our customers, through the application of risk assessment to understand how our resin products for health care applications based on these data, we can provide on whether the resin product for these applications to make comprehensive information about The decision risk assessment based on the EMEA and the Medical Device Directive (MDD) of the risk classification. LyondellBasell such partnerships benefit both companies and their customers, regardless of the supply chain to reduce the risk of end-users or end-to reduce the risk. \"
Supplier management and control is becoming a health care industry product manufacturers quality system in a very important aspect. Regulatory inspections will further emphasize the importance of procurement controls to ensure that these manufacturers based on product risk and the importance of its suppliers to the appropriate extent and level of control. Clariant and LyondellBasell has taken a proactive program for the establishment of its customers reduce risk, reduce the changes and maintain its health care industry products, compliance and the importance of consistency. By taking this action, Clariant and LyondellBasell\\ s ready for those who need to understand the health care industry suppliers and deploy risk-based quality system to provide services to customers.
Create new business opportunities in the medical industry, a strong international venture “get involved”
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Global medical technology industry Jixun new growth, venture capital caught on to. According to Ernst & Young consulting services medical technology industry, recently released 2010 annual report, despite U.S. and European medical technology industry in 2009 made a net profit growth of nearly 11%, but new challenges to traditional business models constitute greater pressure.
Ernst & Young Global Life Sciences Centre, managing partner Glen Giovannetti, told reporters: "The global medical technology industry revenues were flat last year in the case is still to achieve profit growth, but the future will face more severe challenges. As income levels stabilized, especially in the mature markets, related companies need to find a new growth point. "
In this context, venture capital investments in the medical technology industry will continue strong. Glen Giovannetti, told reporters in 2009, U.S. venture capital investments in medical technology amounted to $ 2.7 billion; the same period in the European medical technology industry is a $ 701 million in venture capital, tied in 2008. The first six months of this year, venture capital in the U.S. and European medical technology investments totaled $ 2.4 billion.
Portable Medical: Integrated MCU into a trend
With the increasing aging population, public health awareness and the new medical reform policy, the portable / home medical electronics sudden emergence in recent years, growth is very impressive, it also led to the MCU and other chips.
Present in the home medical equipment, the main chip MCU, some of the interface chip and A / D conversion, and now there are some vendors in A / D and so integrated into the MCU. Home medical electronic equipment due to the complexity of the test equipment used on the hospital compared to a relatively simple, in some low-end products such as blood pressure, blood glucose meter, etc., the 8-bit MCU that is enough. But with the development of the market, there are several trends worth noting:
First, large storage capacity and processing power. In order to store more data, such as patient test data storage for more than a month, and now the global market also requires some relatively complex equipment, such as the United States and other family demands with ECG monitoring equipment, medical equipment, which requires higher performance, the need for graphical display capabilities, storage capacity, wireless connectivity, which requires greater processing power MCU, higher parallel processing capabilities, as well as highly integrated, fast accurate computing power, 8-bit MCU will be 16, 32 bit MCU replacement. Before MCU and discrete graphics chip is the GPU, but with the size of home medical equipment requires more compact design, integration is also a future trend.
Second, low power consumption. Of home medical equipment, power consumption is very high. Such as nurses with medical equipment to home visits, may one day need to visit a lot of home users, which requires medical equipment to maintain the battery at least one day of battery life with this high demand, but also need power management chip is designed with ultra-low power design.
The third is security. To prevent hackers access to patient data, need to implant chips in encryption technology, making the chip with authentication, this high-security chip market demand. Program providers for medical electronics, medical electronics industry to understand and grasp the relevant standards and norms and certification throughout the program design and management, increase the product\\ s features more than competitive and strategic significance.
Fourth, long-range chip management. Remote update via the Internet and remote delete patient information, which requires stronger security MCU communications.
Fifth, many running in parallel and inter-MCU communication capabilities. With the equipment of the complex and multi-functional devices usually have a number of MCU, effective communication between them will be very important. The MCU should establish standard communication protocols.
Sixth, to support medical data exchange standards, in particular, HL7V3 standard, so that the device can be directly linked into the public health information network.
In addition, medical electronics, in addition to the basic home medical equipment, there is an aging population, nursing facilities, chronic disease management devices also have great needs. Care equipment in addition to the aging population to care for the body, but also for body care, such as the elderly can not fall, if fall it may lead to stroke, which also need to place monitoring. Chronic disease management requires long-term measurement, monitoring equipment, such as hypertension, diabetes, and some data to store 10 or even 20 years, and the equipment to the smaller development. These are made on the MCU higher requirements. Future integration, networking, digital, intelligent development of portable medical electronics will become a catalyst for rapid growth, future MCU integration will be higher, this will reduce power consumption, the cost will be significantly reduced.
In addition to MCU, the sensor also need to have greater development of its accuracy, reliability requirements are higher, even more than military. There are pH sensors, optical sensors, electronic sensors, these sensors to combine with the MCU, medical equipment manufacturers will be the real test.
Two major challenges facing the development of medical electronics: portable and low power consumption
Aging global population, people\\ s living standards improve and the demand for medical services in remote areas and other factors are contributing to the change in the way of traditional medicine, mobility and portability of medical electronics industry has gradually become a key influence. On the other hand, promote the development of semiconductor technology the pace of medical innovation to move forward at an unprecedented rate, calculated in the fast processing, high-precision analog-digital conversion and wireless networks, driven by technological advances, medical electronics and miniaturization of portable products to become a reality .
Medical electronics market is a stable market, it is not like consumer electronics products as easy and quickly burst the bubble, although the industry\\ s longer-term return on investment, but it may provide participants with more stable than other commercial areas and more lasting in return. According to market research firm Espicom expected, the global medical equipment market in 2010 will exceed $ 200 billion, of which medical electronics will account for 45 percent to $ 90 billion in size. Huge market potential and stable returns attracted many investment companies, from semiconductor manufacturers to the EMS, OEM\\ s, they expect from the medical electronics market to dig out gold.
Portable medical electronics market, the hot application
SteveKennelly: portable medical electronics products for the chip requirements of the program is to have a more powerful computing capabilities at the same time with low power consumption.
The emergence of portable medical electronics trend of the origin of the rise of home health care and consumer concern about their own health increase. \"More and more people began to take the initiative to care for their health status, which leads to personal and consumer health care needs of a simple diagnostic products.\" Microchip\\ s medical products Division senior strategy and product marketing manager SteveKennelly example, such as blood glucose meter, oxygen meter, disease control and diagnostic monitoring systems and other equipment began to portable, this is the response to the present, these products began to enter the family trend.
TI\\ s MSP430 Bao Zhen, senior market development engineer said that the current in the field of portable medical electronics applications more heat is mainly with LCD thermometer (thermometer), blood glucose meter, oxygen meter, biochemical analyzer, insulin injection and defibrillation instrument and other products, \"in which blood pressure is the most widely used portable medical devices in a market.\" Bao Zhen is mainly responsible for MSP43016-bit ultra-low power MCU in China, the promotion of the health care market.
Bao Zhen pointed out, portable medical equipment into the home and the people\\ s living standards are closely related, \"At present in Europe and America, such as blood pressure and blood glucose testing products has become a household essential medical equipment, while China is still forming so environment is expected as the coastal cities and the mainland cities gradually began to consume these products, the market will slowly up, which is the degree of affluence. \"He added that the current portable medical electronics market in China, more heat is applied hand-held thermometers, \"This is the S RS rise to the demand after the market very large amount.\"
In addition to the basic test of medical devices, the \"health products\" is a home portable medical devices is another major development. \"As more and more health groups, many domestic medical device manufacturers are taking health products line, such as some manufacturers do with our MCU frequency therapy device, the pulse signal by generating a number of relevant points for relaxation and health present market, consumers are interested in these products, future market prospects are good. \"
Undoubtedly, the home health care market is to promote portability of medical electronic devices is one of the main driving force. At the same time, changes in the way of medical care in remote areas and increased demand for health services driven by other factors, hospitals with a large professional medical equipment have begun to move toward portability. \"The most obvious is the monitor and the ultrasound equipment, before these two types of devices to desktop-based, not power, but now you can see on the market similar to the appearance of portable ultrasound equipment, laptop and monitor.\" TI\\ s HPA business Ma adds that the development engineers, specialized medical equipment for hospitals began to respond to two types of portable primary needs: First, for patients who can not move, portable medical devices can bring the convenience of care and treatment; the second is for the remote rural areas, doctors can carry professional equipment for home treatment, increased the level of medical care in remote areas.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., a senior product manager, said portable medical electronics product development is a major trend, not only to achieve a mobile health care and treatment, but also make it possible to move the surgery. \"For example, in the military applications, portable medical devices allow doctors to quickly build up in the field of professional operating room, timely treatment of the wounded.\" He also pointed out that the trend for portable electronic devices, connectivity will become a medical Standby function, \"health care system is the emergence of a new trend, portable medical products to get the data sent by networking the way to the hospital\\ s electronic medical record systems, timely access to medical diagnosis and advice.\"
New program aimed at the medical electronics market
The trend towards portable medical electronics product design of a low-power, compact and easy to use and other requirements. Response to these requirements, the leading semiconductor manufacturers have introduced a highly integrated chip solutions to help medical electronic equipment manufacturers to quickly launch products.
TI MSP430 series is designed for the medical market of ultra-low power MCU program, consists of three product lines: FG43X, FG461X and FG42X0. According to Bao Zhen introduced, the FG439 is the first launch world\\ s first electronic market for medical single-chip solution, \"This product was specifically designed for foreign markets blood glucose meter, has been applied to many new areas, such as biochemical analyzer . \"he said, the chip integrates front-end op-amp, 12-bit dual channel high-precision ADC, DAC and DMA and built-in reference sources. \"This is a highly integrated solution, using the chip we did blood pressure and blood glucose meter, without using any external components, the volume is very small, low power consumption.\"
Bao Zhen said, MCU used in the special needs of medical electronics mainly in three aspects: First, high level of integration; second, ultra-low power consumption; third is easy to use. \"This is the three major characteristics of our products.\" He said, following the FG439 series, TI has launched an upgraded version of the FG461X series, further reducing the power consumption of the product, but also includes up to 120KB Flash memory and 8KBRAM, because it on a single chip to provide highly integrated intelligent peripherals and larger memory options to meet the pulse oximetry test meter and wireless electrocardiograms and other portable medical equipment. On this basis, TI also introduced the FG42X0 series, will improve the accuracy of the ADC to 16 bits.
In addition, TI also plans to launch next year a new generation of MSP products, according to the current demand for portable medical electronics, built-in USB interface and RF wireless transmission function. \"This is a trend in the future, more and more portable medical products will be asked to transfer the collected data to the computer.\" Bao Zhen said, \"for the medical market, TI\\ s products will continue to consider the future development of the market demand, On the one hand a huge repository of TI, the device will be more integrated into the overall program, to further improve product integration, low power consumption while meeting the requirements of the product, the other would consider taking the bus extensions, increase the number of interfaces to improve product design flexibility. \"
Microchip is another active part in the medical electronics market, semiconductor companies. It was set up last year, the Department of medical products, medical electronic equipment specifically to meet the specific needs of the market. With the establishment of the department, the company also offers a Web-based medical design center. \"Portable medical electronics product development trend is small, intelligent and better connectivity requirements of the program for the chip is the availability of more powerful computing capabilities, low power consumption. To respond to this demand, we launched 8-bit and 16-bit MCU with integrated low-power high-precision analog and serial EEPROM, in addition to ultra-low quiescent current in addition, it can help designers achieve high performance with low power control, which require high battery life portable products is very important. \"Kennelly said that this year will be for the medical market, Microchip introduced a new 8-bit and 16-bit products, integrated high-precision analog amplifiers, data converters and power management chip.
Kennelly further added that the medical electronics product development began in the chemical, biological and sensor technology, electronics design engineer experience in the design of relatively small, this, Microchip introduced the easy to use development tools, compatible with all of Microchip\\ s 8-bit and 16-bit MCU products to help design engineers reduce development effort and risk.
For medical electronic devices, high-precision analog device is also very important. Focus on analog semiconductor companies are also actively respond to portable medical devices for low power consumption and high integration requirements, such as ADI\\ s recently launched a complete single-chip 8-channel analog front end AD9271, a single chip integrates a complete 8-channel ultrasonic receiver, the main aim of portable ultrasound equipment. As with previous multi-chip solutions, system size and power consumption decreased by 50% and 25%, while noise levels are achieved and other performance requirements of emergency critical care.
Respond to the needs of mobility, ADI also announced late last year to use its latest precision PulSAR ADC AD7980, the product of the small package size and low power consumption make it suitable for wearable ECG (EKG), blood pressure monitoring , oxygen sensors, and other portable medical products, wireless patient information can be transmitted to a data center or the nurse\\ s office. This mobility allows the patient walking in the hospital only when wearing the same size as the PDA monitor without adding a large volume of medical equipment, thereby increasing patient comfort.
In the analog side, TI has a high precision ADC, operational amplifiers and sensors integrated into the SoC program. In addition, for high-end professional-grade large-scale medical equipment applications, TI offers analog special program, such as 24 6-channel or 8-channel ADC and precision amplifiers. \"The body\\ s signal is very weak, usually produces a lot of mixed-mode interference, therefore, for analog devices, the high-precision analog signal acquisition and noise immunity is very important.\" Ma said, \"With the move toward portable medical products, Analog signal acquisition part of the increasingly high demand for integration, before the 3-channel, 8 channels are now, and also the need for portable charging, it also increases the power management part of the requirements. \"
Pay attention to the program choose
With the increasing attention of medical electronics, semiconductor solutions available on the market more and more. For medical device manufacturers, how to make a reasonable choice? Mindray manager of that company\\ s products, medical products designed to bring portability to the biggest challenge is the power consumption problem, \"With the development of medical standards, the product of this industry have become increasingly demanding of computing power, while at the same time , also requested portable power products, the lower the better. how powerful computing capabilities of the product with the premise of maintaining low power consumption is a critical issue. \"
In addition, he pointed out that the leakage current is also important to consider product design problems. He explained that the medical electronics products in the export market to meet the needs of the local government on regulatory rules and regulations, health requirements, accept a variety of certification. \"In these certification, product safety is first, such as the U.S. FDA approval, taking into account the safety of the human body, their leakage current detection of the product is very strict, even lower than this value directly with your fingers holding the 5 batteries positive and negative conduction current. \"He said that in the portable medical electronics products, the leakage current problem mainly in the power management section, so the power management options, important to consider the different environments in the device leakage current the problem.
Response to many medical products isolation voltage requirements, TI introduced a capacitive digital isolators, \"the traditional design is the use of opto-coupler or inductive method, integrated on-chip capacitor isolation can achieve faster data transmission and higher signal integrity , its anti-magnetic interference to six times more than inductive devices, high performance optical coupler power reduced by 60%. \"He said the current TI released a 2-channel, then there will be 3 channel and 4 channel product release.
For the medical electronics field, the product quality and reliability is a top priority. In the U.S. FDA certification, and even requests for medical device manufacturers, component suppliers the certification process, while ensuring the traceability of the product, to prevent gray market components mixed with medical electronic products. Therefore, the choice of the program, the equipment manufacturer to the supplier\\ s quality assurance system of particular concern. Microchip\\ s Kennelly said: \"We have passed the ISO/TS16949 certification to meet the medical field to the strict quality requirements of customers.\"
In addition, the continued supply of mass production stage is device selection requires careful consideration. \"Medical electronics design cycle is usually very long, in the selection of the device to carefully consider the product life cycle issues and potential suppliers of historical availability, product design in order to avoid having to complete mass production of components cut the risk.\" Kennelly said.
Mindray\\ s product manager also pointed out that the bit in the product design stage selection factors into account the supply chain for medical electronic equipment is especially important, \"the production of medical devices are mostly small-volume purchases, it is difficult to component suppliers for your special custom development, as consumer purchasing power and strong communications equipment manufacturers, and medical electronic product life cycle is very long, the design of components to be especially careful stop the problem. \"He suggested that manufacturers In the component selection is best based on two principles: First, mainstream programs; the second is easy to replace, \"the mainstream programs and suppliers continue to supply more secure, as far as possible in the design of standard devices, which experience for the future supply of cut-off and other problems can quickly find alternatives to provide a guarantee. \"
Medical visualization software will be a substantial increase in revenue
Research shows that many doctors can make medical consultation for patients with visualization software, virtual reality technology in the health care market, one of the key growth areas.
The \"virtual reality (VR) in the U.S. health care industry,\" the study is expected in the next five years there will be more doctors in the increasingly common health information technology systems and networks used in the application of advanced visualization techniques This will lead to medical visualization software revenue will increase 12% annually.
Kalorama\\ s research focused on virtual reality technology, the four applications, one of which is medical data visualization, including multi-mode image fusion, advanced 2D/3D/4D image reconstruction, and surgical planning and other advanced analysis software tool.
Expected growth in this area, because medical institutions in the radiology information (such as the radiology information system RIS) and inter-departmental picture archiving and communication system (PACS) has a long-term investment. According to the medical market researcher in New York City reflects the investment in information technology, medical visualization software provides an integrated basis. The report notes that film and other media were replaced by digital copies, but can be more than one doctor through health information technology systems and web applications to access the program; advanced visualization technology allows image navigation and interaction can be achieved.
Departmental web server end medical imaging systems and advanced visualization software for the doctor\\ s personal computers and video consoles to provide a powerful rendering capabilities and virtual reality capabilities, which greatly expanded its customer base. The report notes that because the company will use the \"economic enterprise-class servers and software licensing package integrating advanced visualization software suite,\" which is department-wide software license revenue will rise.
Do not Let the width of the path of independent innovation into medical device industry, foreign meal
At present, China\\ s high-end medical equipment in more than 80% of the multinational monopolies, leading to \"your doctor, see\" the problem intractable. Multinational strong \"staking\", China\\ s own medical device industry is facing a grim situation, how local enterprises out of the woods? Whether the localization of high-end medical equipment to make the road wider and wider innovation?
Medical Device Market: Foreign gluttonous feast?
2009 announced the implementation of new medical reform program has created a huge demand for medical devices. April 14, \"made innovative medical device products demonstration project\" on-site exchange was held in Chongqing. Data show that in 2010, China\\ s medical device industry was strong, the market size exceeded 100 billion yuan, up 120 billion yuan, an increase of up to 23%. It is predicted that the next five years, China\\ s entire medical instruments and equipment market will double.
At present, China\\ s enterprises in addition to a handful of focused ultrasound technology in the international advanced level, the high-tech products, the overall level of China\\ s medical devices and foreign advanced level of about 15 years. Medical device industry is highly technology-intensive, involving a wide and comprehensive academic industry, technology threshold is high, cross-border medical device manufacturing in high-end medical equipment market has been in a monopoly position, including ECG, CT, MRI and other high-end medical Basic equipment can not see the domestic brands, the field of ultrasonic instruments share the monopoly of multinational companies even more than 90%. One, GE, Siemens, Philips and other major multinational giants basically divided up China\\ s high-end medical equipment market, GE and Philips medical equipment business in China have suffered double-digit growth, while Siemens said it aims to medical imaging equipment market in China is higher than expected sales growth of 10% annual growth.
Has been focused on high-end medical equipment companies began to focus on cross-border health care in low-end medical device product development, have the layout of the low-end products and sales. 2011 Medical Equipment Fair, GE, Philips, Canon, Carestream, etc. have demonstrated their targeted counties, townships, towns and other primary health care sector and the development of new products, as well as financial services, medical information services, including a full set of solution. In contrast, in recent years, China\\ s national medical device industry developed rapidly, in some high-end digital medical equipment, research breakthrough, but the overall level of the point of view, due to late start, small business, \"scattered\" chaos, not yet the formation of iconic products, the core competitiveness, international brand, with the developed countries there are periodic gaps. \"Most domestic industry to do the low-end assembly, non-core technology.\" Vice president of the Chinese Medical Association recently Professor Dai Jianping, \"MRI-US Summit in 2011,\" said. China\\ s own industry is facing a grim situation: medical device market, international giants have been \"swallowed\" the danger!
China Medical Device Industry Association, former vice president of Xerox, said Zheng, multinational strong \"staking\", \"The result is high prices, but also exacerbated the people \\ expensive\\ the problem.\"
Local enterprises: to rely on independent innovation to break the monopoly
\"Twelve Five\" period, China\\ s medical device industry will be how to break through? Expert analysis, the future development of China\\ s medical equipment will be divided into two levels: one is technical and product development, and the other is the industry platform to build bases. In the steady implementation of the new medical reform, the increase of medical products research and development is the focus of the industry, \"scattered, chaotic, and poor,\" the urgent need to improve the situation, to achieve healthy development.
Development of magnetic resonance equipment for example. With the 3.0T into the era of nuclear magnetic resonance, NMR future high-end products will be the focus of the hospital purchasing the product. Medical Technology Co., Ltd. in the United States when a group represented by R & D manufacturer of high-end medical equipment, adhere to independent innovation, research and development efforts with independent intellectual property rights of magnetic resonance core technology, breaking the monopoly of foreign products.
NMR imaging signal to noise ratio index increased by 100% -200%, a substantial increase in cost of hospital … … established in the United States when China Medical City medical technology company with self-developed high-temperature superconducting MRI coil technology, nuclear magnetic resonance medical equipment, technological innovation, low-cost high quality. International Society of Magnetic Resonance Medical Imaging former chairman of the U.S. Department of Radiology, University of California, San Diego, Mr. Director WilliamBradley technical standards for high-temperature superconducting coils highly praised: \"Time Medical\\ s innovative technology – the emergence of the superconducting RF coil will be on the magnetic resonance revolutionary impact, making it low-field magnetic resonance to change the view of high temperature superconducting coil SNR increase 2-5 times. \"
China\\ s 1.3 billion population, only 2,300 have MRI equipment, MRI of the price, for our more than 20,000 county-level hospitals, unbearable. When the United States the global leader in medical technology, high-temperature superconducting coils, the use of \"interchangeable lens\" approach, did not increase the field strength on the condition of the greatly improved image quality, can effectively reduce the cost of MRI diagnosis. Currently, the United States when the medical establishment of the China Medical City in an R & D and production base with an annual capacity of 180 units, which marks the completion of China\\ s major medical equipment – magnetic resonance imaging system to standardize the development and production, large-scale. It is reported that when the current U.S. health care has begun construction of its two R & D and production base.
In this regard, Professor Dai Jianping that \"the emergence of new technologies will further promote the development of magnetic resonance market, when the United States has its own core of medical technology – high-temperature superconducting coils of the magnetic resonance machine affordable, cost-effective, attention to two hospital market very suitable for this trend. \"
The future, as the country\\ s increasing investment in health care reform, the second and third line of the county, township primary health care sector will be the top priority of China\\ s medical device market. April 14, Chongqing Science and Technology and Ministry of Health jointly organized the \"China-made innovative medical device products demonstration project\" on-site exchange, further promote innovative medical devices national demonstration project implementation. Some local governments are implementing grassroots activities of domestic medical equipment delivery and medical device manufacturers benefit and patients.
Time Medical Officer Professor Ma Qiyuan appeal, the state should use the health reform of the machine, and actively support the related enterprises to strengthen the high-end medical devices R & D and investment, and guide enterprises to improve their capability of independent innovation, to build its own brand, and encourage medical institutions to give priority to purchase domestic high-end medical equipment. Meanwhile, the core technology with independent intellectual property rights of enterprises, to seize the new opportunity to support health reform policy as soon as technical superiority into market advantage, multinational medical device companies to break the monopoly of high-end products to meet the challenges of low-end products into the basic way .
U S researchers invented the fool medical emergency unit
According to reports, the University of Utah human factors / ergonomics researchers invented a device – instant support unit (referred to as JITS), can determine the patient s condition and needs, how to guide the implementation of bystander CPR. This device so that no first aid training experience cardiac arrest patients for emergency treatment possible. The researchers will be Wednesday in the human factors / ergonomics 50th Annual Meeting of the display of the product.
Used in the study JITS including dummy, baroreceptor pillows, anesthesia mask, defibrillator pads, and a display screen and microphone, used to guide the user how to operate the operating results and feedback. Operating according to the American Heart Association (AHA) protocol development. Use JITS simulated emergency Participants who finish achieved AHA standards.
Each year about 30 million U.S. cardiac arrest, and sometimes their lives on hold in the hands of bystanders, the ambulance rushed to the scene because at least six minutes, every minute in the past, the likelihood of survival decreased by 70%. Research shows that less than 1% received bystander cardiopulmonary resuscitation training, and not a few months after training, they forgot to put the things learned nothing left. If JITS can put to use, can be implemented on-site first aid will greatly increase the number of cardiac arrest patients rescued will greatly enhance the chances.
Lactic acid in tumors can predict tumor resistance to radiation
There are ideas that lactate accumulation by lactate or glycolytic metabolic intermediates, such as pyruvate scavenging of radicals lead to cancer radiation, for the detection of this hypothesis, the scientists-five cases of human head and neck squamous cell carcinoma cell line (HNSCCs) transplanted into nude mice, and 30 points with 6 weeks for radiation treatment.
50% local tumor control radiation dose required (TCD (50)) of 47.4 to 129.8Gy. Quantitative structure-related by bioluminescence imaging to assess different areas of tumor glucose, lactate and ATP concentrations as an indicator of glycolytic activity. The results can be seen, different tumor cell lines, the average lactate concentration in the 7.3-25.9mumol / g between, TCD (50) value of tumor lactate levels were positively correlated (R = 0.9824, p = 0.0028).
Therefore, these results support the tissue lactate and human solid tumor resistance to radiation-related assumptions, in addition, results also suggest that tumor lactate can also be used to predict clinical radiation resistance of malignant tumors, and the course of treatment a transient inhibition glycolysis may increase the sensitivity of tumors to radiation therapy.
Sea developed AIDS diagnostic kits and acceptance
A use of specific cell-mediated detection test kit developed by the Central Hospital of Xuhui District, Shanghai Shanghai Central Laboratory and Department of Cell Biology and Technology Co., Ltd. After four years of successful development, 6, and acceptance by experts in Shanghai, will enter the clinical application stage.
According to the Central Hospital of Xuhui District, Shanghai, Distinguished Research Fellow, Department of Cell Biology, Shanghai Science and Technology company introduced Bo Cao, CD4 cells are the body\\ s immune system regulation of the hub cells, also known as \"commander of the human immune system.\" When CD4 cells are infected with HIV, their number with the progression will continue to decrease, eventually leading to complete collapse of the immune function and death.
Thus, CD4 cell counts to monitor HIV infection and immune status of patients and clinical processes, determine the timing of medication and to determine the most important indicator of drug efficacy. Conventional CD4 cell testing, the equipment is expensive, cost of reagents, test the high cost, the impact of AIDS prevention and control work smoothly.
\"CD4 cell detection kit\" is the use of specific detection methods developed cell detection kit. It slides as a carrier, just a finger blood collection can be in ordinary optical microscope manual CD4 cell count. The U.S. CDC (Centers for Disease Control), a total of more than 1300 cases of clinical trials, the product has accurate, simple, sample processing capacity, kits can be stored at room temperature, specimens can be permanently archived, low cost, can be detected at any time or review, etc., with the original relevance of flow cytometry to 0.96; by the Chinese pharmaceutical and biological products sampling, the kit all in compliance with quality standards.