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Navigator of supportive measures
For ad manufacturers
Support fund deafblind

Social sphere:
new technologies
and equal
opportunities

About Initiative

In May 2015, at the meeting of the Supervisory Board of the Agency for Strategic Initiatives, the President of Russia V.V. Putin approved the strategic initiative “The New Quality of Life for People with Disabilities”, as well as have a personal instruction of the RF Government, with participation of the ASI, to ensure, under the PPP conditions, the launching of pilot projects to organize the modern production of rehabilitation equipment. Taking into account its experience and the competences in the area of preparing and launching PPP projects, the main partner of the ASI in the implementation of this new initiative was appointed the Center for Development of the Public and Private Partnership.

Purpose of the Initiative

Creation of a modern system for disabled people socialization due to provision of 100 pct access to high-tech and high-quality RE.

State

Users

Producers

Development and implementation of a new model to organize the disable people?s access
to RE

Introducing and individual approach to the development, selection and maintenance of RE

Import substitution and support for domestic manufacturers of RE

95pct

share of imported RE
in the public procurement

30bln

regional costs for provision
of disabled people
with RE

60bln

potential
of the market of RE
for people with disabilities

Navigator of supportive measures for physically challenged people

Collection of model solutions for ensuring accessibility of social infrastructure facilities for disabled persons.

Collection of model solutions

Russian-manufactured active wheelchairs

Preodoley-ka

Observer Electric Wheelchairs

Integrated approach to solving the problems of hearing impaired persons.

Istok-Audio hearing aids

Orthopedic footwear can be functional and also stylish!

Orthomoda orthopedic footwear

UNA WHEEL is a unique electric drive for wheelchairs. Now, every wheelchair can become electric and each mobility impaired person can obtain freedom that was previously accessible by few!

Electrical attachment for wheelchairs UNA WHEEL

All useful information for physically challenged people at one website.

New Quality of Life Portal

Motorica develops and produces modern functional upper limb prostheses – Cybi active body-powered hand and forearm prostheses and Stradivary bionic forearm prostheses

Active Arm Prostheses from Motorica

Rehabilitation with the use of a medical exoskeleton in patients with locomotor lower limbs disorders resulting from injuries, surgeries, as well as musculoskeletal or nervous diseases

Exoskeleton rehabilitation

Structure of the Market of Medical Products for People with Disabilities

Means to facilitate the mobility

Support and tactile canes, crutches, supports, railings

Wheelchairs hand-operated (room, stroll, active types), with electric drive, small-sized

Prostheses, including endoprostheses, and ortheses

Orthopedic shoes

Means for care, medical furniture and equipment

Antibedsore mattresses and pillows

Appliances for dressing, undressing for gripping objects

Special cloths

Specials means in case of excretion dysfunctions (urine and feces receptacles)

Absorbent underwear, diapers

Armchairs with sanitary equipment

Means to improve vision and for reading

Special devices for reading “talking books”, for optical correction of low vision

Guide dogs with a set of equipment

Guide dogs with a set of equipmentì

Light and vibration sound signalers

Means to improve hearing

Hearing aids, including custom-made earmolds

TV sets with teletext to receive programs with closed captions

Telephone devices with text output

Voice-producing devices

RESOURCE CENTERS FOR PHYSICALLY CHALLENGED PERSONS

The work of resource centers for persons with health limitations (HL) is organized on a one-stop basis.

Providing services to disabled persons through one access point ensures route reduction when solving disability-related problems. At a single location, persons with HL can receive all necessary information on social support measures, as well as assistance at all stages of applying for disability benefits and obtaining assistive devices (AD).

A resource center can be organized at any platform that shall act as an interdepartmental interaction operator. Such centers are a point of contact between Medical and Social Assessment Board, Social Insurance Fund, Pension Fund of the Russian Federation, prosthetic and orthopaedic enterprises, social protection authorities, and medical organizations.

Resource center services

Medical and social assessment
Filing applications for AD provision, compensation for AD purchased at the person's own expense, and disability pension payment
Consultative support on pension, employment, social insurance, social support measures
AD hiring
Assistance in AD selection and training AD use in case necessary

Resource center model

Resource centers for
persons with HL

AD rentals and
AD selection assistance

Medical and social
assessment

Social insurance
fund

Social welfare
bodies

Employment
center

Pension Fund of
the Russian Federation

Informational
support

Resource centers for people with disabilities work in the regions:

Altai region
Kaliningrad region
Kamchatka Krai
Leningrad region
Republic of Dagestan

Republic of Tatarstan
Samara region
Sakhalin region
Sverdlovsk region
Tyumen region'

For medical device and ad manufacturers

From idea to export: business process flowchart for medical device and assistive device manufacturers with supportive measures.

Idea

Order for
product development

R&D

Research
and development

Prototype

Intellectual property
protection

prototype improvement;
business concept development;
development of a manufacturing project and a treatment method project;
assessment of social and economic efficiency

Assistive devices

Medical devices

Declaration of
Conformity

The declaration is performed according to one of the schemes provided in Article 24 Clause 1 of Law No. 184-FZ.

Based on the manufacturer's own evidence obtained with the participation of a certification body or an accredited testing laboratory. The required documents are:

Technical documentation for assistive devices
Results of in-house studies and measurements
Study and measurement protocols of accredited testing laboratories
Quality system certificate of the testing laboratory

Based on the manufacturer's own evidence. The required documents are:

Technical documentation for assistive devices
Results of in-house studies and measurements
Confirmation of product conformity to technical regulations requirements

Declaration registration in the
unified register of the
Federal Service for accreditation

Series
Production

Use of the
medical device
and treatment method

Use of the
AD in rehabilitation
practice

Evidence-Based
medical
practice

Interaction with a
Medical Organization

Development of a reference sample of the medical device, preparation of a treatment method project Initiation of the procedure for obtaining a marketing authorization for the medical device Clinical studies of the reference sample of the medical device:

Identification of usability and appropriateness
Technical testing of the medical device in an accredited testing organization
Toxicological studies of medical devices in an accredited testing organization
Medical device testing in an accredited testing organization for the approval of the type of measuring tools
Clinical trials are conducted in a medical organization authorized by the Federal Service for Surveillance in Healthcare (Roszdravnadzor); the conduction of trials requires a conclusion on the ethical reasonableness of clinical trials from the Ethics Board of the Ministry of Health of the Russian Federation

Submission to Roszdravnadzor of study and trial conclusions

Expert examination
of the
medical device

Class I
medical device

Class IIa/IIb/III
medical device

Stage I of the expert examination of the medical
device quality, efficiency, and safety

Clinical trials

Stage II of the expert examination of the medical device quality, efficiency, and safety

Obtaining of a
Marketing Authorization

Obtaining of a marketing authorization for the medical device from Roszdravnadzor.
According to Resolution No. 1416 of the Government of the Russian Federation 'On Approval of the Rules for State Registration of Medical Devices' dated December 27, 2012

Серийное производство

Применение
медицинского изделия
и метода лечения

Доказательная
медицинская
практика

Initiation of clinical testing of prevention, treatment, diagnostic, rehabilitation, and care methods According to Order No. 433-n of the Ministry of Health of the Russian Federation dated July 10, 2015 Application for clinical testing protocol review submission to the Ministry of Health of the Russian Federation by the developer until March 1 Review of the clinical testing protocol by the Ethics Committee of the Ministry of Health of the Russian Federation Submission of the approved clinical testing protocol to the Expert Council of the Ministry of Health of the Russian Federation by the Ethics Committee. Number of patients, testing period, and financial costs to be determined Publication of the testing protocol on the official website of the Ministry of Health of the Russian Federation Acceptance and review of applications from federal medical organizations for the clinical testing of the protocol Identification of a list of organizations involved in medical care as part of clinical testing by the Expert Council and submission to the Ministry of Health of the Russian Federation Clinical testing Submission of a clinical testing report to the Expert Council of the Ministry of Health of the Russian Federation Recognition by the Expert Council of the Ministry of Health of the Russian Federation of the efficiency of the prevention, treatment, diagnostic, rehabilitation, and care method Recommendation by the Ministry of Health of the Russian Federation to professional non-commercial organizations (medical expert communities) to include the method in the clinical guidelines (treatment protocols)

Inclusion of the tested
treatment method in the
clinical guidelines (treatment protocols)

Use of the
medical device/treatment
method in clinical practice

Production Expansion

Supportive measures

DEVELOPMENT PROJECTS PROGRAM (Industrial Development Fund (IDF)): support of projects aimed at import substitution and the manufacture of competitive civilian products; loans at the rate of 5% per annum for up to five years in the amount of 50 to 300 mln rubles (not more than 50 % of project needs) for implementation of projects aimed at introducing advanced technologies, creating new products, or organizing import-substituting productions
) JOINT LOANS PROGRAM (IDF): support of projects aimed at import substitution and the manufacture of competitive civilian products jointly with the federal and regional fund; borrowings at the rate of 5% per annum for up to five years in the amount of 20 to 100 mln rubles (not more than 50 % of project needs) for implementation of projects aimed at introducing advanced technologies, creating new products, or organizing import-substituting productions

COMMERCIALIZATION PROGRAM (INNOVATION ASSISTANCE FUND): support of companies with a track record of selling science-intensive products that have completed the R&D stage and are planning to create or expand the manufacture of innovative products – 15 mln rubles and more for creation/expansion of in-house manufacture of science-intensive products; growth of sales of innovative products created as a result of the project implementation; creation and/or modernization of high-performance jobs
INTERNATIONALIZATION PROGRAM (INNOVATION ASSISTANCE FUND): support of projects with the participation of foreign partners and support of companies developing the products intended for sales in foreign markets – 15 mln rubles and more for IP protection during the R&D process, creation of in-house manufacture of science-intensive products, as well as creation and/or modernization of high-performance jobs by companies with a track record of R&D and sales of proprietary science-intensive products

Export

*Custom-made medical devices with special medical prescription requirements intended for the sole purpose of the personal use by a specific patient are not subject to state registration. The list of goods subject to mandatory declaration is approved by Resolution No. 982 of the Government of the Russian Federation 'On Approval of the Unified List of Products Subject To Mandatory Certification and the Unified List of Products for Which the Confirmation of Conformity Is Made in the Form of a Declaration of Conformity' dated December 1, 2009.

Pavel Seleznev

Leader of the Initiative, Chairman
of the Managing Board of the Center
for Development of the PPP

“An important step towards the implementation of the initiative shall be the building of an information system, which will allow – taking into account the needs of disabled people – for developing an individual approach to the production of the RE, providing the ability to choose products and, what is important, ensuring further social support to people using these goods”.

Gulnaz Kadyrova

Deputy Minister of the Industry
and Trade of the Russian Federation

“Surely, the issues of communication are becoming increasingly important with the development of the society. And we must pay attention to this problem, especially to people with reduced mobility, some health restrictions… Actually, this market is formed by the Bureau of Medical and Social Expertise; they prescribe specific products from the list they are notified of. Given that we are developing, this list of RE shall be updated from time to time”.

Roman Aranin

General Director of Observer, LLC

“Speaking about the problems, that an end user has to face, it worth noting that actually state procurements cover at least 85 pct of the market, and only the remaining 15 pct account for direct purchases (individually or via sponsors)”.

Dmitry Yanin

Chairman of the Managing Board of the International Confederation of Consumer Societies

Chairman of the Managing Board of the International Confederation of Consumer Societies Dmitry Yanin proposed to structure the tasks aimed at the development of industry into separate segments and to prepare a draft of the corresponding “roadmap”. “There is a problem of accounting, a problem of classification, a problem of interaction of social protection bodies, the Ministry of Industry and Trade – in term of support for the production. If such support is required, in which form it shall be carried out: loans, grants, etc.? Taking into account the user’s opinion, accordingly, we are getting to the scenario of public councils with the customers. This has really a weight of a “road map”, because, having heard everything discussed here, I realize that the market is small, with a high pressure of the public procurement and all the accompanying drawbacks. As it was noted, 9 bln rubles is the whole market; if 85 pct is the public procurement, so live money from the population amounts to 1.5–2 bln rubles. And surely, counting upon these 1.5–2 bln rubles, it is difficult to create services such as Yandex market, where only declarations of manufacturer are published, but there is no audit of such declaration, we haven’t even such a level of information in this area”.

Early assistance to families raising children with disabilities

Early Care is an interdepartmental interaction model including a package of medical, social, psychology, and pedagogical services for families with children having health limitations. Comprehensive support is aimed at the early identification of children with HL and the promotion of their development, physical and mental health, as well as integration in society and peer environment. The model also includes tools for assistance and support of families with children having HL and measures to improve parents' competence.

DEAFBLIND SUPPORT FOUNDATION

German Gref

Chairman of the Boards of Trustee of the Deafblind Support Foundation

The initiative to create the Foundation was announced on April 8, 2014 at the meeting of the Supervisory Board of the Agency for Strategic Initiatives and was supported by its Chairman – Vladimir Putin. This a correct and actual product.

The tradition of care for the deafblind in Russia has a 105-year history. It is interesting that it was in Petersburg, in mid-May 1909, virtually on the same days, the Charter was approved of the first such society, consisting of private benefactors, enthusiasts, devotees who drew attention to this group of disabled people, particularly vulnerable at all times. Then and now, one of the main tasks was creating conditions for development of the deafblind and drawing attention to their problem. It is important not to lose this tradition in our modern Russia.

A few years ago, my colleagues and I visited for the first time the Orphanage for the Deafblind in the town of Sergiev Posad. It was not some kind of noisy action, we just came on a weekend to help build a playground and to spend time with children. I still remember and wonder: how these children, whom nature has doomed to live in total darkness, fight for their future, learn and show the same talents as they “healthy” peers. After talking with them you understand: there are no difficulties that cannot be overcome. We just need to give a push, to create appropriate conditions, to bring modern technologies, and these kids are sure to overcome the disease and become full members of society.

The Deafblind Support Foundation is similar in its aims. An important role in achieving these goals belongs to us – the Supervisory Board. At the same time, we are talking not only about material support – by finances and organizational resources.

It is important for the members of the Supervisory Board to be involved in the Foundation’s activity, to help it in relying upon your knowledge and experience. And most importantly: being public persons, we have to try by joint efforts to change the attitude of our society to deafblind, to awaken in people a sense of understanding and charity. We all must become guides for deafblind in the world of sighted and hearing.

Go to Con-nection website