Who will inhabit the land of cyborgs? On the future status of the island of Russian told the director of development of the company "Motorika"

Developers of bio-medical technologies and rehabilitation devices will receive resources, support, and the opportunity to go through a simplified registration procedure. Such prospects are prompted to the industry by a new priority development zone, which is planned to be created on Russky Island, two kilometers from Vladivostok. A proposal for the relevant bill will be made in early March, after a four-day project session in the “Boiling Point” - Vladivostok.

The basic look of the future bill will be created by scientists and direct market participants, who will gather in the Far Eastern Federal University (FEFU) on March 1-4 at a special session of legal design and engineering, convened at the suggestion of the Agency for Strategic Initiatives and the Motorika Company.

The main topics for discussion will be ethical and legal issues of cyborgization of people, simplified modes of introducing new technologies in medicine, as well as ways to attract foreign companies and apply their developments in Russia.

What are the prospects for developers of medical devices? What problems will help solve the special status of the island of Russian? What will be the main provisions of the law? And what is the result of the cybermedicine market?

These and other questions are answered by one of the initiators of the draft law - the Director for Development of the Motorika Company, Vasily Khlebnikov.

- Vasily, hello! If it's not a secret, tell me why you decided to address the issue of registration of medical devices?

- Hello! Today, the situation is such that young developers, in order to get the opportunity to conduct clinical trials, need to be engaged in preclinical research for quite a long time, to pass various commissions. In most cases, the requirements are for them impracticable.

Currently, there are large players on the world market creating various invasive devices (medical implants, neurostimulators, implanted under the human skin through a puncture, incision or operation). But many of these solutions remain inaccessible for the Russian market, because it is relatively small, and the costs for registering new developments, on the contrary, are high.

We came to the conclusion that producers and developers need an advanced development zone, within which licensing procedures will take place much faster. Responsibility for them will fall on the shoulders of specific people. According to preliminary plans, literally several commissions and involved development institutions will be responsible for the development in the priority development zone. They will be able to solve some of the issues arising from projects: technical, legal, medical and financial.

- And what exactly will be the responsibility of these commissions?

- Their basic goal is to quickly analyze the requests of the teams and give permission for tests and studies. Today, if young developers do not understand some moments and submit incorrectly executed documents - no one explains them - what is the mistake and what needs to be corrected. They are simply denied.

And we want to create a structure in which all participants can quickly reach the results in their research, quickly test their effectiveness and get an economic effect, bypassing the years of permissive red tape.

Our current goal is to build work with the Russian Technopark, the medical center of the Far Eastern Federal University and create an environment in which information will be obtained not only through commercial consulting.

- What does the agreement between Motorika and the Far Eastern Federal University include?

- Together with FEFU, we are creating a “Project Center”, this is a separate organization for work, in which a certain list of experts is now being assembled. We have decided on the basic organizational structure of the “Project Center” and are now starting to develop services for developers. Now we need to create a roadmap for future residents: how developers get to clinical trials, how to register their research, etc.

Together with FEFU, we are preparing amendments to the law “On the Free Port of Vladivostok”, which describes the procedure for medical care. We want to supplement this law so that there is an opportunity to conduct clinical trials of technical means of rehabilitation. Now, first of all, we will work on simplifying the system of registration and approbation of medical devices, bringing invasive devices to clinical trials.

- When the new bill will be adopted and come into force, and your system will work - what stages will the developers have to go through in order to enter the market?

- First, of course, conducting research and development, preclinical testing. For some projects, in particular, for all invasive devices, additional research is being conducted with laboratory animals. If everything goes well, then the developers get an expert opinion confirming the safety of the procedure, its positive effect and can already submit a request for clinical trials.

We plan that initial testing with specific people who need these technologies will be conducted on the basis of the FEFU medical center, and then on the basis of medical institutions in other regions. And after it you can talk about the widespread introduction and withdrawal of rehabilitation facilities on the Federal market.

- Why was the Far East chosen to create a special zone?

- We chose the island of Russian, because we are interested in Vladivostok and the Asia-Pacific region as a whole. From there, just a few hours of flight to Seoul, Beijing or Tokyo. On the territory of Vladivostok, the “Free Port” zone is already operating, enjoying the right of duty-free import and export of goods (the sea’s equivalent of the customs zone at the airport is “duty free”). And foreigners can stay there for eight days without a visa.

Thus, we see the development of Vladivostok as a center of competence in the field of medical technology. “Cyborg Island” will become a place where cyborgization technologies will be developed for all those who need it for medical reasons ... And for those who want to change the properties of their body.

Today, many people are looking for opportunities to become carriers of non-medical invasive devices. As a rule, we are talking about chips from bank cards or health monitoring systems. For such people, all formal licensing procedures should be as simple as possible.

- Tell us, what other support tools do you offer to developers?

- Based on the FEFU Medical Center, developers will receive resources for clinical trials. And within the framework of the Technopark "Russian" technical support for the projects will be carried out. We can talk about production facilities, technical specialists and project acceleration.

In addition, developers will receive legal support. Further, we will develop financial support tools, attract venture funds, and public and private investment in projects.

Of course, we are also considering existing support tools, for example, grants from the Skolkovo Foundation or the Innovation Promotion Foundation. The Agency for Strategic Initiatives is also showing interest in a territory development project. In general, our task is to create a point of attraction for people who are engaged in technology and medicine.

- In addition to novice developers, who are you ready to invite?

- We are aimed, among other things, at attracting any major players who want to enter the Russian market and quickly bring some kind of technological initiative to approbation. In the future, it may be large pharmaceutical companies.

Now we are interested in recruiting a team of people who are interested in it - developers and medical workers who are to some extent the customers of the services of the “Project Center”. In addition, an important aspect for us is legal work - lawmaking. Therefore, we will also be happy lawyers.

- Under what conditions can developers and enterprises join you?

- We will establish a cooperation procedure - conditionally residency - in one format or another. So far, legally, all these conditions have not yet been registered, but we already have some understanding. There will be several options. For start-up projects, the condition for entry will be the passage of the acceleration procedure, for large companies - just residency.

We need major players and advanced technologies to come to the region, so that professionals come.

- What should enterprises and development teams who want to start cooperation with you be ready for?

- Obtaining a residency and opening a legal entity in a new territory should not take a lot of time. But it is likely that the most active development teams will want to move here and work in Vladivostok.

From the point of view of the development of the territory, it is especially important for us - to gather developers in one place. We are ready and we will consider various options for remote interaction. Most of the procedures will try to digitize, so that the direct presence of the developers was optional. But all medical interventions, implantation operations will have to be carried out only on the territory legally possessing special status.

- Who can be contacted on cooperation?

- In the company “Motorika” you can contact me (our office is located in Moscow), if you are in Vladivostok, then you should contact the FEFU Technopark directly. Our partner in the FEFU Medical Center is Arthur Biktimirov, a neurosurgeon and one of the main ideologists of the project. We will be glad to see developers of rehabilitation devices and invite everyone to cooperate. You can contact us via email: info@motorica.org.

- Thank you for the interesting conversation, Vasily. We wish you success and your initiative!

Slides for the material provided by the company "Motorika".

The session of legal design and engineering for the development of a draft law on the creation of a special medical status on Russky Island will be held March 1-4 at the Far Eastern Federal University (Vladivostok).

Apply for registration here.

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