Analysis of Current Situation and Future Trends of Medical Electronics Market

The main trends driving the advancement of the medical electronics market are the aging of the global population, the increasing cost of healthcare, and the need to implement medical diagnosis and treatment in remote and emerging regions or homes. In the next few years, different world economies will continue to promote development trends in these and other areas. Therefore, some of the major problems faced by current medical electronic device manufacturers include: portability and miniaturization, connectivity, security, data security and quality, and reliability.

Power Management

In the next decade, an important development trend is the large number of portable medical electronic devices. Making power management decisions early in the design process will help with system-level trade-offs, which may be necessary to meet portability and runtime goals. While small portable medical products may use disposable batteries, large systems will take advantage of various rechargeable battery chemistry and battery pack sizes. Features such as Dynamic Power Path Management (DPPM) allow the system to draw energy independently from the battery charging path. In this way, when a device equipped with a fully discharged battery is inserted, it can immediately function without waiting for the battery to be fully charged. This can have a life-saving effect in emergency situations.

Since the battery voltage does not drop in a linear manner, the true life of the battery cannot be known only with voltage tracking. In particular, there is a case where the voltage at one-third of the middle of the voltage range meter requires 60 to 70% of the discharge cycle time. Coulomb counting does not compensate for battery aging, so it "assumes" the battery state over time. However, impedance tracking technology allows the medical device to calculate the remaining operating time over the entire battery life, with an error of less than 1%. This is usually accomplished by integrating voltage conversion to extract the single cell voltage and charge/discharge current. Other protection features in portable power solutions include battery overvoltage, undervoltage, overcurrent, and short circuit protection.

In the medical electronics field, system reliability is critical, so battery certification is a key requirement. In some battery management products, a single-wire, two-way communication system can be used to link 96-bit device IDs, 16-bit seeds unique to each device, and 16-bit cyclic redundancy check (CRC) codes that vary from device to device to provide security. performance. This is an effective way to verify that the current battery used meets OEM requirements. Using unsuitable battery packs will not only affect system running time, but also damage the system and even cause personal injury. Appropriate power management methods not only make the product portable, but also make it economical by increasing battery life and safety.

Miniaturization and integration

Ultrasound is a market segment for medical imaging and has experienced high levels of innovation in the field of portable devices. Today's manufacturers of advanced portable or handheld ultrasound systems require highly integrated, scalable solutions that allow medical professionals to break through laboratory or office constraints and connect to customers in remote locations or in emergencies around the world.

Integration will continue to promote portable and cost-saving trends, ultrasound imaging is a good example. While maximizing memory usage and power savings, embedded processors play a crucial role in balancing the computational power, flexibility, battery life, and system size of medical imaging devices. For example, the current high-performance DSP horsepower is strong enough to perform background digital processing within the ultrasound system. At the same time, the programmability of the DSP enables it to implement the latest software algorithms without changing the system hardware. Thanks to the high degree of system integration of the DSP SoC, the OEM's development team can not only improve system performance, but also shorten time-to-market. By combining DSP processing, general control, dedicated peripherals, and optimal image and video compression, these SoCs offer cost-effective, low-power, single-package solutions. This allows developers to save board space and design time, and encourage them to focus more on developing feature products.

In addition to the continuous integration of embedded processing technologies that enable ultrasonic portability, the integration of analog signal chains is also critical. At the analog receive end of the signal chain, a single integrated analog front end (AFE) can replace discrete multi-channel LNAs, VCAs, PGAs, low-pass filters, and high-speed ADCs to provide LVDS data output. By reducing the number of devices in the system, the integrated AFE can reduce power consumption by up to 20%, reduce noise figure by 40%, and save 40% of board space. As a result, system costs are greatly reduced. The integrated AFE can achieve different levels of image performance and is suitable for all sizes of ultrasound systems from handheld devices to high-end devices.

Connectivity and remote patient monitoring

For most patient monitoring systems, data integrity, system flexibility, and activity are all critical factors. Through interfaces such as Ethernet and wireless, hospitals can connect all devices throughout the organization and even connect to the patient's home. The currently used interface allows caregivers to remotely connect with the patient through the wireless body sensor network worn by the patient. This can make full use of the hospital's intranet, or connect to the patient's home security system or mobile phone. The system is connected to an Ethernet or call center, allowing continuous monitoring without disturbing the patient. It is said that the Continua Health Alliance may adopt Bluetooth technology. Other wireless interfaces such as ZigBee are also expected to be used in consumer medical devices and portable patient monitoring devices.

When choosing a wireless interface, power consumption, data rate, and data range are three key factors that need to be considered (see Figure 2). Taking ZigBee as an example, the protocol can be used worldwide; data rates and duty cycles are moderate; wireless mesh networks are supported, allowing multiple sensors in the same system. The Bluetooth and Bluetooth Low Energy (BLE) protocols offer limited range but higher data rates. BLE has lower power consumption on the sensor side, allowing the use of a smaller battery than traditional Bluetooth.

Finally, the solution selection must fit within the system power budget range and meet data transfer requirements.

Data security

Medical data security is also another major requirement and focus of attention. The United States Health Insurance Portability and Accountability Act of 1996 (HIPAA) defined federal standards and is supported by various technical security measures. These standards contain specific privacy and security guidelines. Such guidelines prohibit the transmission of data on open networks and the download of data on public computers, and also require data encryption and access control. These security measures are applicable globally, so it is expected that sooner and later more and more versatile hardware and software tools will emerge to support the security of medical data currently in the next decade.

For example, several IEEE 802.15.4-compliant RF transceivers designed for low-power, low-voltage portable applications provide hardware MAC security operations for data encryption and authentication. Some of them also provide various encryption/decryption modes such as counter mode (CTR) and CMC-MAC authentication and encryption. Of course, in order to take advantage of these security operations, it is necessary to determine the key and set it up, usually leaving such work to the highest level of the communication protocol. For example, the CC2530 is compatible with multiple network protocols, including IEEE 802.15.4, Zigbee, Zigbee RF4CE, Smart Energy, and IP protocols. The CC2530 also provides a government-standard Advanced Encryption Standard (AES) 128-bit encryption/decryption core. This core supports the AES operations required by the IEEE 802.15.4 MAC security, ZigBee network layer, and application layer to ensure greater security.

Given the federal standards on the transmission of patient data and on how to protect this data, it is expected that more and more versatile hardware and software tools will soon be available.

For example, several IEEE 802.15.4-compliant RF transceivers designed for low-power, low-voltage portable applications provide hardware MAC security operations for data encryption and authentication. Some of them also provide various encryption/decryption modes such as counter mode (CTR) and CMC-MAC authentication and encryption. Of course, in order to take advantage of these security operations, it is necessary to determine the key and set it up, usually leaving such work to the highest level of the communication protocol. For example, the CC2530 is compatible with multiple network protocols, including IEEE 802.15.4, Zigbee, Zigbee RF4CE, Smart Energy, and IP protocols. The CC2530 also provides a government-standard Advanced Encryption Standard (AES) 128-bit encryption/decryption core. This core supports the AES operations required by the IEEE 802.15.4 MAC security, ZigBee network layer, and application layer to ensure greater security.

Given the federal standards on the transmission of patient data and on how to protect this data, it is expected that more and more versatile hardware and software tools will soon be available.

Quality and reliability

As the regulations and governmental quality requirements of organizations and the current legal environment in the world are increasingly stringent, the focus of medical device companies is constantly changing. Today, when designing semiconductor products for medical OEMs, quality and reliability considerations are very important, and both are well-known industry barriers. By incorporating enhanced product (EP) flows into the catalog process, not only the product's useful life is extended, but also the change control process is clearly defined and improved. In order to meet the demand for dedicated and controlled production lines in the medical market, changes in facilities should be effectively eliminated, and qualification practices should be expanded. At the same time, product traceability should be improved or the stringency of production testing for consumer electronics products should be strengthened. By providing an alternative to screening (upscreening), Enhanced Product Streaming can also save costs for manufacturers and shorten time-to-market, which is commonplace in high-reliability markets. Another way to solve the above problem is to use part of ISO 13485. When applied to the semiconductor industry, the quality management standard applies to all medical devices.