See the ABCD four-level medical device to find the biggest value-added point of electronic technology

The contribution of electronic technology to medicine is obvious to all. Who can imagine what the current doctors do without medical electronic devices? The use of electronic technology to extend or save human life has greatly increased the mission of electronic engineers. At the same time, it is also the manufacturer's concern to be able to use the medical industry to inject more added value into increasingly weak electronic products.

Due to the direct or indirect impact on human safety, countries have classified medical device products. The global standard developed by the Global Coordination Working Group divides medical devices into the following A, B, C, and D levels:

Class A refers to products that have a low risk to the human body when a malfunction occurs, such as X-ray films, scalpels, tweezers and other small stainless steel appliances, surgical non-woven gauze, medical absorbent cotton, operating tables, surgical lighting equipment, Special instruments for stomatology, surgical microscopes, first-aid bandages for home use, etc.;

Class B refers to products with lower hazards, such as blood analyzers, X-ray diagnostic equipment, medical CT machines, ultrasonic diagnostic equipment, magnetic resonance imaging equipment (MRI), electronic thermometers, electronic sphygmomanometers, electronic stethoscopes, electromagnetic blood flow meters. , heart rate monitor, electrocardiograph, EEG machine, electromyography machine, spirometer, electronic spirometer, oximeter, endoscope, capsule endoscope, blood cell counter, oxygen generator, infrared therapeutic apparatus, low frequency medical Equipment, microwave therapy device, ultrasonic therapy device, home electronic massager, hearing aid, etc.;

C is a risky product, such as continuous blood glucose meter, dialyzer, artificial heart and lung blood pump, artificial respirator, implantable hearing aid, cardiac defibrillator, external cardiac pacemaker, infusion pump, self-testing blood glucose Instrument and so on.

D refers to high-risk products such as implantable cardiac pacemakers, implantable defibrillators, implantable syringes, and implantable assisted artificial heart systems.

In these four levels, the B, C, and D levels all need to involve electronic technology, and it is obvious that the higher the risk level of the product, the higher the requirements for electronic technology, and the corresponding, constantly updated electronic technology has driven these several Application innovation in the field.

Medical imaging with higher precision and smaller size

Biomedical optoelectronics combined with optical, electronic, and biomedical technologies are widely used in Class B medical grade equipment, covering optical therapy, medical imaging, and biosensing. The main applications include early diagnostic monitoring of clinical medical lesions. Or treatment of diseases related to light guidance and stimulation. It is estimated that the sales of related products in 2010 is expected to reach 59.8 billion US dollars, accounting for 22% of global medical equipment.

From specific products, from X-ray, nuclear magnetic resonance (MRI), positron tomography (PET), CT, ultrasound, radiotherapy, photodynamic therapy, physiological signal monitoring, in vitro diagnostics and even biochips, are included in biomedical optoelectronics. In the category. The first few types of imaging technologies for these applications are the largest in the overall medical technology market. The development is also relatively mature and fiercely competitive. Because of the large market demand gap, not only well-known international and local manufacturers compete fiercely. Many vendors are still trying to enter the field.

Increasing resolution and shrinking device size are two major trends in medical imaging. New system-level requirements mean that analog semiconductor manufacturers must develop breakthrough basic ICs, and active semiconductor manufacturers continue to introduce their own Products such as TI's AFE58XX analog front end for ultrasound imaging applications, ADI's ADAS1128 for CT applications, Xilinx and Altera for high-resolution image processing and high-performance data analysis, Austrian Microelectronics for DR and CT applications High precision amplifiers and sensors.

In addition to optoelectronic imaging technology, the innovative swallowable endoscope (also known as capsule endoscope) breaks through the inherent shortcomings of traditional endoscopes and effectively transmits images from the human body to the outside. The latest capsule endoscope technology places the sensor and circuit in the middle of the capsule. When the patient swallows, the capsule will rotate 360° in the body. The circuit contains LEDs for illumination, which can effectively transmit the image back to the body. External device. However, the technology is still in its infancy, and future adoption will require both cost and performance improvements.

Science fiction-like implant technology

Consumer electronics are making MEMS applications hot, but medical electronics and diagnostics provide a larger arena for MEMS applications. More and more application ideas combine MEMS technology with medicine to benefit humanity. For example, STMicroelectronics designed a contact lens for embedded wireless MEMS sensors designed by Sensimed AG of Switzerland, using an embedded micro strain gage to continuously monitor the curvature of the eye over a period of time (usually 24 hours), in addition to the contact lens An embedded antenna, a miniature dedicated processing circuit, and a radio frequency transmitter that transmits measurement data to the receiver.

In the application of biochemical medicine, MEMS has also been actually increased. In clinical medicine, sensors and intelligent control technologies are used to treat tuberculosis and heart disease, and the heart is stimulated and dredged. Innovative applications include Proteus Biomedical's revolutionary application, the implantable electrode, which stimulates different chamber locations within the heart to synchronize or resynchronize the heartbeat. Its core technology is to use chip-scale packaging technology to place millimeter-sized MEMS sensors and processor packaging systems inside the human body, and can be maintained for many years, avoiding the need to use more insertion catheters to stimulate A solution for different locations of the heart.

Implant technology is as legendary as science fiction, and it belongs to high-risk C and D equipment. Most of the current implant product categories are for heart disease treatment, and the future will focus on the brain, such as the use of electronic nerve stimulation equipment to treat diseases ranging from drug addiction to epilepsy, Parkinson's disease and depression. In fact, about one-third of the world's health problems are related to the neurological field at this stage. Medtronic, a large heart rate regulator company, has developed equipment for the treatment of mild diseases such as Parkinson and is developing a range of neuroimplant products.

Relying on the advancement of electronic technology, there are many innovative examples in the field of medical electronics. In the future, medicine and electronics will be more closely combined to create more powerful and innovative medical equipment.

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