News Digest 20.12.2024 — 27.12.2024
Regulators
Recommendations for registration of medical devices in the EAEU adopted
At a meeting on December 23, the Board of the Eurasian Economic Commission adopted the Methodological Recommendations on the content and structure of documents of the registration dossier of a medical device and the examination of the safety, quality and effectiveness of a medical device for the purpose of its registration.
The recommendations were developed to replace the Methodological Recommendations adopted by the Commission in 2019 for the examination of the safety, quality and effectiveness of medical devices for the purpose of their registration within the EAEU and the Methodological Recommendations on the content and structure of documents of the registration dossier of a medical device.
Taking into account law enforcement practice, the document defines approaches to the examination of the safety, quality and effectiveness of medical devices, and also unifies approaches to the type and content of evidentiary materials (documents) of the manufacturer of a medical device submitted for examination to prove the safety and effectiveness of the medical device and the preparation of its registration dossier in accordance with the Rules for Registration and Examination of the Safety, Quality and Effectiveness of Medical Devices.
The Ministry of Education is preparing a Federal State Educational Standard for prosthetic, orthopedic and rehabilitation equipment
The Ministry of Education of the Russian Federation has published a draft of the Federal State Educational Standard (FSES) of secondary vocational education (SVE) in the specialty "prosthetic, orthopedic and rehabilitation equipment". According to the draft, such a standard is a set of mandatory requirements for the implementation of SVE programs, which should be drawn up on its basis. Among other things, the document states that upon completion of the program, students should be able to manufacture individual prosthetic, orthopedic products and technical rehabilitation equipment, as well as teach people with disabilities their safe and effective use. The term of study in the specialty "prosthetic, orthopedic and rehabilitation equipment", as stated in the draft order, will be 3 years 10 months based on nine classes and 2 years 10 months - based on eleven classes. In case of receiving education in full-time and part-time form, as well as according to an individual plan, the term of study can be extended by no more than one year. Graduates who have mastered the program will be able to work in such areas as the production of machinery and equipment, trade, technical maintenance, repair, as well as in others corresponding to the level of their competencies. The section devoted to the structure and scope of the educational program states that at least 2,052 hours must be allocated to disciplines, at least 900 hours to practice, and at least 216 hours to the state final certification. It is required that the total volume of the educational program based on nine classes be 5,940 hours, based on eleven classes - 4,464 hours. The draft educational standard specifies that the training program should include three cycles: social and humanitarian, general professional and professional. It is assumed that each cycle should be divided into mandatory and optional parts, where the first should be at least 70%. During the training, students must master such activities as carrying out work on preparation for prosthetics and providing technical rehabilitation means taking into account the purpose, manufacturing individual prosthetic and orthopedic products and technical rehabilitation means, teaching a disabled person the safe and effective use of such products. The mandatory part of the social and humanitarian cycle includes the study of such disciplines as "History of Russia", "Foreign language in professional activity", "Life safety", "Physical education", etc. The mandatory part of the general professional cycle includes "Human anatomy and physiology", "Fundamentals of psychology", "Fundamentals of engineering graphics", "Metrology and standardization", "Materials science", "Biomechanics". The professional cycle is formed directly by the educational organization itself in accordance with the Federal State Educational Standard.
Upon completion of the educational program, students should be able to choose ways to solve professional problems in various contexts, use modern means of searching, analyzing and interpreting information, work in a team, demonstrate a civic-patriotic position, contribute to the preservation of the environment, and also master other skills and competencies.
The explanatory note to the draft order states that it was prepared to achieve one of the results of the federal project "Professionalism" of the state program "Education Development".
In November 2024, the Ministry of Education proposed to adjust the Federal State Educational Standard of Secondary Vocational Education in the specialty "Installation, maintenance and repair of biotechnical and medical devices and systems". Among other things, the document regulates the terms of training and the number of academic hours allocated to disciplines, requirements for the results of mastering the educational program. The thematic document was last updated in December 2020.
Market news
Motorika acquired more than 50% of shares in a wheelchair manufacturer
Russian manufacturer of functional bionic prostheses Motorika announced the acquisition of 50.1% of shares in Special Equipment Plant LLC (ZSO), which specializes in the manufacture of wheelchairs. The parties did not disclose the amount of the transaction. The changes were reflected in the Unified State Register of Legal Entities on December 24.
The shares in ZSO were acquired by MK OOO Homo Auktus (owner of the Motorika Group of Companies). The special equipment plant is one of the largest manufacturing enterprises in Russia producing wheelchairs. The company's portfolio includes more than 30 models of wheelchairs, sanitary chairs, lifts and other related products, and the share of high-tech devices is 65%. The capacity of the ZSO plant, located in the Vladimir region on an area of 5 thousand square meters, is more than 40 thousand products per year. Motorika believes that the partnership will allow the Group to enter several segments of the Russian wheelchair market at once - for children with cerebral palsy (CP), basic mechanical and electric wheelchairs with retrofitting options for adult users with CP. According to the company's estimates, the Russian wheelchair market reached 8.8 billion rubles by the end of 2023. According to SPARK-Interfax, OOO Zavod Spetsial'nogo Oborudovaniya was registered in the Vladimir Region in 2010. In addition to Motorika, Nikolay and Pavel Kuznetsov also have shares in the company - 24.95% each. The company's revenue in 2023 amounted to 568 million rubles, net profit - 61.2 million rubles. The company Motorika through MK OOO Homo Auktus is owned by the RDIF structure PPIT-15 (share of 25%), Andrey Davidyuk (21.51%), Vasily Khlebnikov (12.80%), Ilya Chekh (8.24%), Ruslan Babintsev (8.01%), Arkady Fateev (3.23%), as well as the ZPIF Pervaya - Direct Investments (share of 10.16%). In 2023, the legal entity's revenue amounted to 1.858 billion rubles, net profit - 685.8 million rubles.
"Motorika" is a developer of products using artificial intelligence technologies. Since 2015, the company has been working in the field of creation and production of functional hand prostheses with an individual design.
In August 2019, the Russian Direct Investment Fund (RDIF) invested 200 million rubles in Motorika. Then it became known that following the results of the deal, the investor would receive at least 25% of the company's capital, and representatives of the fund would join its board of directors. It was planned that the funds would be used to create bioelectric multifunctional prostheses and stimulate exports. The company noted that by 2021 it plans to develop artificial muscles for fine motor skills of the fingers controlled by artificial intelligence technologies. In 2025, the company intended to release a robotic prosthesis with mobility identical to the motor ability of the hand. The Far Eastern High Technology Fund (FEHT) invested another 200 million rubles in Motorika in January 2021, and the Russian Direct Investment Fund (RDIF) added another 100 million rubles. The funds were intended for the development of upper limb prostheses, the Attilan telerehabilitation platform, and other solutions in the field of invasive technologies. The financing was supposed to cover the costs of scaling up production, developing a service network in Russia and other countries, as well as creating an R&D office based at the medical center of the Far Eastern Federal University in Vladivostok. In 2021-2022, Motorika increased its prosthesis sales by 4.5 times, and in the first half of 2023, it produced the same volume of products as in the entire previous year. In mid-December 2024, the company attracted 100 million rubles in investments from the Moscow Venture Fund. The funds will be used to finance an IPO, which is scheduled to take place in 2026. It is expected that the return on investment will be made within two years. The company attracted financing at a preferential rate - half as much as the current key rate, but not less than 10% per annum.
Other
Sechenov University and Neuromed have created an AI assistant for cardiologists
Scientists from Sechenov University, together with specialists from the technology startup Neuromed, have created an innovative chatbot for cardiologists. The development of a new tool based on generative AI has already been completed, and the bot is currently undergoing clinical testing at the Clinical Center of Sechenov University. The technical implementation was carried out by specialists from Neuromed, and researchers from the Institute of Personalized Cardiology validated all the data and approaches from a medical point of view, writes Cnews. The chatbot was trained on a data array of more than 37 GB, including both Russian and international clinical guidelines, scientific articles and open data sets. It performs several tasks at once: it prepares standard documents, such as appointment protocols and discharge summaries, provides access to professional information on drugs, gives recommendations on diagnostics and treatment based on current clinical guidelines, helps to assess certain risks associated with the patient's health characteristics.
Source: https://t.me/medicalksu/5426
Newly registered medical devices
We publish a list of new medical devices registered from 12/20/2024 to 12/27/2024
Link to the list: [see table in the attachment]
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