The development trend of the global medical device industry in 2022- Zhengda Medical Co., Ltd.

At present, countries and regions around the world are paying more and more attention to the development of the medical device industry, and the supervision is increasingly strengthened; under the normalization trend of the prevention and control of the new crown pneumonia epidemic, the deep integration of digital technology and medical services promotes the continuous upgrading of the medical device industry and product innovation iterations At the same time, with the enhancement of people's awareness of health and environmental protection, the medical device industry is expected to usher in new changes... The following trends in the global medical device industry are worthy of attention.

The regulatory environment is becoming stricter, and enterprises are facing challenges

In 2022, the new EU Medical Device Regulation MDR (EU2017/745) will enter the first full-year implementation phase, and the In Vitro Diagnostic Medical Device Regulation (IVDR) will also be officially implemented this month. After the promulgation of the new EU classification standards for in vitro diagnostic medical devices, more in vitro diagnostic products will need to pass the mandatory conformity assessment of designated agencies. Although the number of designated certification bodies in this field will increase in the second half of 2022, medical device manufacturers will still face great challenges from clinical efficacy evaluation.

In addition, from July 1, 2023, all medical devices that are planned to be put on the UK market need to comply with UKCA marking requirements, including medical devices that have obtained EU CE certification.

Digitalization Drives Sales and Service Model Changes

Affected by the new crown pneumonia epidemic, medical device marketing, training, service and other businesses are accelerating the expansion of online channels, which not only provides more choices and convenience for medical institutions and clinicians, but also effectively improves the work of medical device manufacturers. efficiency. Studies have shown that many clinicians and sales representatives prefer virtual interaction mode, which is believed to be effective in maintaining data continuity and thus improving user satisfaction.

The innovation of telemedicine diagnostic tools accelerates

At present, the level of telemedicine is mainly limited by the lack of remote diagnosis capabilities. Remote diagnosis still has limitations in many areas, such as eye, ear, and throat inspection, lung auscultation, temperature measurement, sweating evaluation, rash inspection, etc. Affected by the epidemic at home, home medical monitoring technology is expected to usher in further upgrades, and innovative home testing tools will be widely used to provide patients with more accurate remote diagnosis and treatment services.

Medical data security will face strict supervision

At present, with the increasing value of medical data, the medical device industry's ability to collect, merge and analyze patient data continues to improve, and artificial intelligence technology, including machine learning capabilities, is developing rapidly. Digital medical software has gradually become the core of many medical device products. important component. However, due to the high sensitivity of medical data, and many medical device manufacturers provide services such as patient data collection, storage and analysis, the above services must fully guarantee data security and compliance. Therefore, medical data and technology security is bound to become one of the regulatory priorities of relevant departments. For example, the FDA has established a Digital Health Center of Excellence (DHCE) and launched a digital medical software pre-certification program to strengthen the supervision of related innovative technologies.

At the same time, more and more medical device manufacturers are studying how to make better use of RWE to formulate product research plans to optimize trial design, patient enrollment, etc., so as to ensure product safety and clinical efficacy
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