The development of mobile medical will be increasingly vigorous. In order to explore new blue ocean business opportunities, manufacturers of traditional medical electrical equipment and information and communication (ICT) products are all actively moving towards the mobile medical market, such as investing in the development of wearable medical devices and portable ultrasound equipment, not only to make the mobile medical ecosystem more complete, It also drives the demand for microcontrollers (MCU) and various wireless communication semiconductor components.
Mobile medical business opportunities continue to emerge in various markets. Especially in advanced countries such as Europe, America and Japan, due to the serious population aging problem, the relevant governments and health management agencies have spared no effort to promote mobile medical services, in order to reduce huge medical expenditures to reduce the national financial burden.
For the card-bit mobile medical market, many medical product or service providers have launched acquisition and offensives in the first half of this year to enhance the development capabilities of mobile medical devices or applications, including the cloud electronic medical record service and software developer Athenahealth. US $ 293 million acquired Epocrate, a developer of mobile medical applications; and wearable health product supplier Jawbone has acquired Massive Health, Visere, and BodyMedia in a larger way, comprehensively enhancing the lineup of physiological information monitoring technology and application products.
In addition, ICT players are also eager to test mobile healthcare. For example, Microsoft, Intel, Samsung, and Qualcomm have joined the ConTInua Alliance to actively promote common industry standards, and recently launched new Product development strategy. For example, Qualcomm Life (Qualcomm Life) has bought HealthyCircles in May to improve its software-as-a-service (SaaS) mode of operation on its 2net platform. Microsoft plans to deploy mobile medical information management services on the Bing platform. As for Intel and Samsung, they have also continuously increased their investment. , And expand cooperation with medical electrical equipment factories, in the development of mobile medical industry is injecting strong momentum.
However, with the acceleration of mobile medical development, the US Food and Drug Administration (FDA) also plans to finalize the mobile medical application (MMA) specification in the fourth quarter of this year to guide mobile medical to cause the boundary between medical and health care behaviors to gradually evolve. The chaotic image.
FDA's new regulations will be launched
The US FDA proposed the draft MMA guidelines as early as 2011, and included more definitions and regulations in 2012, and revealed that the final specifications will be announced before the end of 2013. At the same time, pre-market certification operations will be launched to ensure the safety and functionality of mobile medical software and hardware , Has driven supply chain players to fully prepare for war.
Figure 1 Huang Yubin, an analyst at IEK ’s IEK medical equipment and health care research department, said that Taiwan ’s ICT industry must pay close attention to the regulatory trends of the US FDA in order to enter the mobile medical industry.
Huang Yubin (Figure 1), an analyst at IEK's medical equipment and health care research department, said that the FDA's latest draft MMA guidelines clearly specify three definitions of MMA, and any mobile application that meets the definition of medical equipment in section 201h of the Federal Food, Drug and Cosmetic Act Programs, or attachments for regulated medical devices, and the conversion of a mobile platform to regulated medical device programs will be considered as medical products, and must be approved by the FDA in the future to be approved for marketing.
Lin Yuting (Figure 2), technical engineering manager of the life and medical science business of UL Greater China, added that the mobile medical application is built into mobile devices and is not subject to strict medical device regulations. Although many companies use health care as a product request However, in fact, it has more or less involved medical behaviors, which has led to the increasingly blurred application boundary between the two, and affects the user's perception and safety of use, forcing FDA to take control.
Lin Yuting pointed out that the FDA has revealed the new draft mobile medical specifications in the middle of this year, including the relevant information security, functional effective certification, and risk management recommendations before the market. At the same time, it also plans to enter the final review stage from September to October this year. The complete mobile medical MMA certification regulations will be announced. In the future, all mobile medical software and hardware that will be applied for listing in the United States will be included in the FDA's 510 (k) medical device certification specifications, and must be compared with the same type of products already listed. It is bound to raise the entry threshold for the mobile medical industry.
Figure 2 UL Yulin Lin Yuting, technical engineering manager of life and medical sciences in Greater China, mentioned that FDA has established strict PMA pre-market approval specifications for mobile medical products for special applications.
It is reported that the 510 (k) licensing listing certification lists at least eighteen test requirements for the safety, reliability and functional integrity of medical devices, and must undergo at least a 90-110 day verification process. Technology and capital investment is undoubtedly a big test. In this regard, Huang Yubin believes that in the future, the cooperation between medical power providers and ICT solution providers will be closer, and the two parties are expected to focus on technology and capital investment in a strategic alliance to expand their mobile medical industry.
In fact, mobile medicine refers to an application mode in which healthcare equipment connects to mobile devices through applications and provides physiological information measurement and analysis functions. Therefore, various semiconductor components must be equipped to drive a new wave of market opportunities. Among them, the microcontroller (MCU) and wireless communication module are indispensable solutions, which have inspired relevant companies to step up the card position.
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