At present, various countries and regions around the world pay more attention to the development of the medical device industry, and the strong regulatory efforts have become increasingly strengthened. Under the normalization of the prevention and control of the new crown pneumonia, the in -depth integration of digital technology and medical services has promoted the continuous upgrading of the medical device industry, and product innovation iterative iterations. Speed up; at the same time, with the enhancement of people's health and environmental awareness, the medical device industry is expected to usher in new changes ... There are eight major trends in the global medical device industry worthy of attention.

Regulatory environment is stricter, enterprises are facing challenges

In 2022, the EU's new version of the medical device regulations MDR (EU2017/745) entered the first year of implementation, and the in vitro diagnostic medical device regulations (I VDR) also officially implemented this month. After the new EU's new version of in vitro diagnostic medical device classification standards are promulgated, more in vitro diagnostic products will need to pass the compulsory qualified assessment of the specified institution. Although the number of designated certification institutions in the field in the second half of 2022 will increase, medical device manufacturers will still face huge challenges from clinical efficacy assessment.

In addition, from July 1, 2023, medical devices planned to be put on the British market need to meet the requirements of the UKCA logo, including medical devices that have obtained the EU CE certification.

Digital -driven sales and service model changes

Affected by the epidemic of new crown pneumonia, the medical device market sales, training, and services are accelerating the expansion of online channels. This 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 models, and believe that they can effectively maintain data coherence, thereby improving user satisfaction.

It is not difficult to see that the virtual interaction model will put pressure on the medical device manufacturers who have not developed digital innovation business models, and will promote it to establish a customer -centric digital marketing system to meet customer sales, training, services, inventory, inventory Management such as a series of needs.

Remote medical diagnosis tool innovation accelerate

At present, remote medical levels are mainly limited to insufficient remote diagnosis. Remote diagnosis still has limitations in many fields, such as eye, ear, throat visual diagnosis, lung auscultation, body temperature measurement, sweating assessment, rash examination, etc.

Affected by the epidemic home, home medical monitoring technology is expected to usher in further upgrades. Innovative home testing tools will be widely used, providing patients with more accurate remote diagnosis and treatment services.

Digital therapy products are still difficult to include medical insurance

In recent years, more and more digital therapy (DTX) products have been approved by authoritative institutions such as FDA, and often include related components for treatment, such as the antibody and slow pulmonary treatment related products produced by Propeller Health, and Livongo Health Company Diabetes related products produced. However, there are very few DTX products incorporated into the medical insurance.

The reason, first of all, such DTX products are too novel, and its services cannot be effectively integrated into the current medical insurance system; second, new therapy and products usually do not replace existing products, so it is difficult to prove to the payment party that it is sufficient to be sufficient Cost and benefits; Finally, it is difficult for the payment party to pay for the treatment cost or results for a long time for the innovative concept of digital tools. In view of the above -mentioned restrictions and lack of strong evidence -based medical basis, DTX products will still be difficult to include medical insurance.

Surgery robot track competition is unprecedentedly fierce

As a representative of surgery robots, the Da Vinci Surgery Robot of the U.S. intuitional surgeon still occupies most of the market share at this stage. However, as the patent -related patents of Da Vinci surgery have been invalidated since 2016, more and more surgical surgery robots have gradually launched fierce market competition in this field, and they have more advantages in product prices, size, and tactile feedback. Essence

For example, in addition to the EU CE certification and passing the EU CE certification and passed the medical device registration of the HEALTH Canada in Canada, in 2021, it has also obtained the US Food and Drug Administration (FDA) research instrument exemption approval in 2021. In 2021, CMR Surgical, a British surgery robot company, received $ 600 million in financing, and its research and development of the surgical surgical robot system Versius global industrialization process is accelerating; in addition, Johnson \\u0026 Johnson launched the OTTAVA surgery robot system in 2020 and plans to pair in the second half of 2022. It conducts clinical trials.

Medical data security will face strict supervision

At present, with the increasing value of medical data, the ability to collect, merge and analyze patients in the medical device industry has continuously improved, including the rapid development of artificial intelligence technology, including machine learning capabilities, and digital medical software has gradually become the products of many medical device products Important components. However, because medical data is highly sensitive and many medical device manufacturers provide patients with data collection, storage and analysis services, the above services must fully guarantee data security compliance.

Therefore, medical data and technical security are bound to become one of the regulatory priorities of relevant departments. For example, the FDA has set up Digital Health Excellence Center (DHCE) and launched a digital medical software pre -certification plan to enhance the supervision of related innovative technologies.

Real global evidence acceptance and utilization rate increase

At present, the real world evidence (RWE) with high quality reliability and correlation is gradually widely adopted by regulators globally, such as in medical device clinical trial research for product safety and effectiveness monitoring, etc., to support Related regulatory decisions. In addition, regulators also actively use RWE to focus on the innovative research and design of specific test methods for medical devices to solve relevant regulatory research issues.

At the same time, more and more medical device manufacturers are studying how to better use RWE to formulate product research plans to optimize test design and patients into groups to ensure the safety and clinical efficacy of the product.

Medical waste treatment needs to be upgraded

At present, the medical device industry has produced and used the use of disposable plastic packaging materials and products, although it has many advantages such as sterile, low cost, and easy to manufacture, it has also produced a large number of medical waste. In the past, discussions on medical waste usually revolved around the potential risks of their disease transmission; today, the environmental pollution problem brought by a large number of plastic waste (such as infusion packaging bags) has attracted increasing attention and attention.

Although the medical device industry has made certain improvements in improving product recycling, many recyclables are still ultimately abandoned due to the low resource utilization rate. At present, the progress of work in this area is still insufficient. Therefore, related enterprises can consider using biodegradable materials during the production process to reduce the production of packaging materials waste; in addition, it can also innovate material sterilization technology to increase the duplicate utilization rate of packaging materials.