Currently, countries and regions around the world are paying increasing attention to the development of the medical device industry, and regulatory efforts are strengthening; Under the trend of normalization of prevention and control of COVID-19, digital technology and medical services have promoted the continuous upgrading of the medical device industry and accelerated product innovation iteration; Meanwhile, with the increasing awareness of health and environmental protection among people, the medical device industry is expected to usher in new changes... There are eight major trends worth paying attention to in the global medical device industry.
Enterprises face challenges as regulatory environment tightens
In 2022, the new version of the EU Medical Device Regulation MDR (EU2017/745) entered the full year implementation stage, and the In Vitro Diagnostic Medical Device Regulation (IVDR) has also been officially implemented since this month.
Affected by the COVID-19, medical device marketing, training, services 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 working efficiency of medical device manufacturers. Studies have shown that many clinical doctors and sales representatives prefer virtual interaction modes, believing that they can effectively maintain data coherence and improve user satisfaction.
It is not difficult to see that the virtual interaction mode will bring pressure to medical device manufacturers who originally did not develop digital innovation business models, and will promote them to establish a customer-oriented digital marketing system to meet a series of needs such as customer sales, training, service, inventory management, etc.
Innovation of remote medical diagnostic tools accelerates
At present, the level of telemedicine is mainly limited by insufficient remote diagnostic capabilities. Remote diagnosis still has limitations in many fields, such as eye, ear, throat visual examination, lung auscultation, temperature measurement, sweating assessment, rash examination, etc.
It is still difficult for digital therapy products to be included in medical insurance
In recent years, more and more digital therapy (DTx) products have been approved by FDA and other authorities, and often contain relevant components for treatment, such as asthma and chronic obstructive pulmonary disease treatment related products produced by Propeller Health, and diabetes treatment related products produced by Livongo Health. However, currently, there are very few DTx products included in medical insurance.
The competition in the field of surgical robots is unprecedentedly fierce
As a representative of surgical robots, the Da Vinci surgical robot from American Intuitive Surgical Company still holds the vast majority of market share at present. However, with the expiration of Da Vinci surgical robot related patents since 2016, more and more surgical robots have gradually engaged in fierce market competition in this field, and have advantages in product price, size, and tactile feedback.
The Ottava surgical robot system was launched in 2020 and clinical trials are planned for the second half of 2022.
Medical data security will face strict supervision
Currently, with the increasing value of medical data, the medical device industry's ability to collect, merge, and analyze patient data is constantly improving. Artificial intelligence technologies, including machine learning capabilities, are rapidly developing, and digital medical software is gradually becoming an important component of many medical device products.
Improved acceptance and utilization of real-world evidence
Currently, real-world evidence (RWE) with high quality reliability and relevance is gradually being widely adopted by regulatory agencies worldwide, such as for monitoring product safety and effectiveness in clinical trials of medical devices, to support relevant regulatory decisions.
Medical waste disposal needs to be upgraded
Currently, the medical device industry produces and uses a large amount of disposable plastic packaging materials and products. Although they have many advantages such as sterility, low cost, and ease of manufacturing, they also generate a large amount of medical waste as a result. In the past, discussions about medical waste often revolved around its potential risk of disease transmission; Nowadays, the environmental pollution caused by a large amount of plastic waste, such as infusion packaging bags, has increasingly attracted social attention and importance.
Although the medical device industry has made some progress in improving product recyclability, progress in this area is still insufficient due to low resource utilization rates, and many recyclables often remain as waste. Therefore, relevant enterprises can consider using biodegradable materials in the production process to reduce the generation of packaging waste; In addition, innovation in material sterilization technology can be carried out to improve the reuse rate of packaging materials.
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