Biosensors as Emerging Market: Obstacles to Implement

Russian Case

A. A. Balyakin

, E. V. Blokhina

, G. E. Kunina

1,3

and S. B. Taranenko

1,3

National Research Center Kurchatov Institute, 1, ac. Kurchatov sq., Moscow, Russia

Univeresity College Dublin, Belfield, Dublin 4, Co. Dublin, Ireland

NGO “ANEK”, 16 Maximova str., Moscow, Russia

Keywords: Biosensors, Emerging Market, Distant Medicine, Health System, Prognosis.

Abstract: We discuss the modern trend in high tech medicine connected with biosensors implementation. Though this

technology being mature with a number of interesting technological and/or scientific solutions, the

corresponding market has not been formed yet. In our work we try to summarize the obstacles for

biosensors implementation using Russian Federation as an example of a country with strong governmental

support for health care system. We argue that biosensors implementation should give rise for more proper

monitoring and data handling, providing more correct choice of treatment, but should not be regarded as

medical solutions.

1 INTRODUCTION

The modern pace of high technology development

inevitably raises the question of its practical

application, and medicine is one of the most

promising areas. In particular, the general trend of

devices miniaturization and progress in data

handling have led to the possibility of developing

biosensor systems used for the treatment and

diagnosis of social diseases. Currently, the

increasing worldwide attention is given to the

prospects of usage of implantable sensors that

In Russian Federation, the implementation of

high-tech medicine service into reality is listed as

government priorities, with special attention paid to

the development of distant medicine. The need for

such development is due to several reasons: first, an

aging population and the associated rapid growth of

health care costs, second - the growing shortage of

qualified medical staff, third - the technical

readiness for such devices production, and fourth -

the defence needs.

We conducted a study of probable biosensors

that could be implemented in Russia. The focus of

our work was given to devices and approaches

aimed at reducing mortality in the following areas:

diseases of the cardiovascular system, control blood

sugar levels, the disease of the gastrointestinal tract,

and timely medication to the patient (drug delivery).

As a result of our work we formed a list of

ready-to-produce devices that are in demand on the

Russian market. This work is still under progress,

and we are searching for new devices that could be

implemented. Hereafter we present the results of our

work as of 1 September 2013.

Totally about 150 companies were considered. It

was found that following companies are the leading

manufacturers and suppliers of implantable cardiac

pacemakers and defibrillators: Medtronic, Boston

Scientific, Biotronik and St. Jude Medical. Leading

manufacturers and suppliers of implantable

neurostimulators are Medtronic, and St. Jude

Medical. These four companies account for 56

selected technical solutions while all other

companies produce only 28 items.

Russian companies provide original solutions

exclusively to the diagnosis and treatment of

diseases of the cardiovascular system. Three main

companies were identified - The Bakulev Center for

Cardiovascular Surgery (Bakulev CCVS) of the

Russian Academy of Medical Sciences (RAMS),

Federal State Unitary Enterprise "IMZ" and

"Kardioelektronika" Ltd. We also found several

commercialized solutions for gastrointestinal tract

diseases (particularly endocapsule "Lily of the

Valley", developed by specialists of the Moscow

102

A. Balyakin A., V. Blokhina E., E. Kunina G. and B. Taranenko S..

Biosensors as Emerging Market: Obstacles to Implement - Russian Case.

DOI: 10.5220/0004748301020106

In Proceedings of the International Conference on Biomedical Electronics and Devices (BIODEVICES-2014), pages 102-106

ISBN: 978-989-758-013-0

 2014 SCITEPRESS (Science and Technology Publications, Lda.)

Engineering Physics Institute). Though many

Russian companies are said to operate in the field of

high-tech medicine, we found that actually only 14

companies should be taken into account.

Major domestic results are still in the category of

research, not many of them are ready for practical

implementation. Thus, the analysis of 250 Russian

projects under the Federal Target Program

"Research and development on priority directions of

scientific-technological complex of Russia for 2007-

2013" revealed just 39 projects related to biosensors,

and only 3 of them were proved to be ready for

practical implementation.

Our short list of practical solutions contains 51

devices dealing with cardiovascular disease (market

leaders - pacemakers, 43 items), 8 devices dealing

with gastro-intestinal tract problems, 4 devices for

blood sugar levels control, 10 neurostimulators (5 of

them - at the stage of clinical trials, awaiting

approve from FDA), and 11 other devices (typically

- a targeted drug delivery system).

Comparative analysis of health care financing in

the United States, Russia and other countries shows

that the level of funding in Russia is about 20 times

lower than in the U.S. The Russian market of mobile

biosensors by 2015 will be about 1.5-2% of the

world (with the prospect of up to 3%), i.e. will be

largely a niche market with no significant export

prospects (unless special measures are taken, such as

production localization, building a cooperation

research-production-implementation via

governmental demand).

The expected growth in the Russian biosensors

market is expected to be rather high, (about 10% in

2014-2017), with gradual decreasing (down to 5%

after 2017). In this case, based on the market size of

$ 300 million to date, by 2015 the expected volume

will be 585 million, in 2020 - 845 million (18 and 26

billion roubles, respectively). Under certain

conditions (first of all - managerial) distant market

medicine in Russia in 2020 could amount to 70

billion roubles.

2 OBSTACLES TO IMPLEMENT

This forecast is however rather uncertain. Most

analysts suppose the very problem is technological,

and do not take into account obstacles that would

arise after the device is ready for fabrication. During

our study we encounter a number of obstacles that

prevent biosensors to become the large-scale market

in nearest future. This does not mean the

impossibility to produce such devices, but rather

refers to their usage and/or consequences that we

suppose would be very different from ones expected

now.

2.1 Technological Issues

First, let us consider problems derived from

technological aspects. At present, modern advances

in technology allow the design and implementation

of very complex integrated microscale systems,

including MEMS and labs-on-a-chip for biological

applications. By a complex system we should

understand a system that includes components from

different physical domains and their behaviour is not

obvious from the behaviour of their components.

BioMEMS are true complex systems in this sense.

They perform multiple functions and they combine

elements from different physical domain. Therefore,

there will be a number of difficulties in the

fabrication and applications of BioMEMS that arise

from their complexity and are typical for other

MEMS devices. On the other hand, there will be

specific issues related to the presence of biological

agents and biological functions performed by

BioMEMS.

Among the general difficulties from the first

group, we should mention the following:

 The lack of tools for the complete modelling

and design of BioMEMS. In addition, we still

need to develop the understanding of their

behaviour on the system level. This will

become an issue in the next years since the

modern technology allows the fabrication and

integration of extremely complex and multi-

function systems;

 Issues related to the reliability, lifetime and

long-term stability of used materials and the

dependence of their properties on the

environment;

 The reliability and lifetime issues can be

expanded specifically to BioMEMS.

BioMEMS are particularly sensitive to short-

term and long-term material stability issues.

The materials used for BioMEMS as reacting

agents must be biocompatible and highly

selective. (i.e. the material must accurately

quantify a selected bio-agent in the

environment where many other bio-agents can

also be found). The materials used for

BioMEMS structure and wafers must also be

biologically stable and compatible and

resistant to oxidation;

 The lifetime of material/devices is also a very

sensitive point. Particularly for implanted

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bioMEMS when there is no possibility to

replace the device too often;

 Since we mentioned implanted BioMEMS

(which are impossible to access too often to

replace batteries), effective power supply is

another problem;

 It is widely argued if the device could operate

independently or if it should be controlled by

an operator. At any case this issue requires a

stable connection and/or synchronization with

PC.

It is important to understand that due to the

complexity of such systems, designers have to

address numerous issues: packaging, material

selection, energy efficiency, signals acquiring and

processing, biocompatibility and etc. There are

many researchers that tackle these issues at different

levels. For instance, material reliability/selection is

solved by introducing new materials. Lifetime and

power consumption is solved on the engineering side

by introducing low-power efficient control circuitry

and energy harvesting from human/environment

motion. Signal processing – by improving the

algorithms that allows to analyse sparse or distorted

signals. Finally modelling and design is a multi-

disciplinary area addressed by researches in the area

of physics, engineering biology and mathematics.

2.2 Data Handling

Most biosensors work with numerous data obtained

from human body and handling it is a great

challenge.

First, by now most biosensors work as devices

individually adjusted in any chosen case. That

means the necessity of individual data handling.

Second, it is still not clear what data is sufficient.

How much information should be collected? And if

we gather all possible information, is it possible to

transmit and analyse it? What part of data could be

lost without serious consequences? Third, if a

biosensor is supposed not to only monitor, but also

to act as a therapeutic tool, the question is what

algorithms should be used to take the decision? And

to what extent could we transfer this option from a

man to the computer?

All these issues are not new, and most of them

have been successfully solved in other areas

(decision making, data processing, etc.), but in case

of biosensors one should take into account that most

information is private or can be supposed to be

private, that restricts its usage.

2.3 Ethical Aspects of Biosensor

Implementation

In our opinion, in Russia in the near future two

problems with moral and ethical aspects of the use

of biosensors will manifest: on the one hand -

populist and unexamined, but vibrant domestic

"threats", and on the other - articulated long-term

questions from abroad (where this problem has been

studied for a much longer time). The first will be as

permanent bursts, in which interest will be warmed

up by certain quarters for their own purposes

(political or financial), the second - will be the

limiting factor in a number of research, development

and implementation for the Russian market.

Let us list a number of basic problems of moral

and ethical plan, relevant in Russia:

First, it is a threat to establish total control over

the person from the state or medical services. In the

Russian emphasis it is the suppression of the

individual, while in the West the problem is

considered from the point of view of the loss of

human autonomy and the loss of personality.

Secondly, the problem “end justifies the means”.

This problem is always neglected in Russia, but is a

key issue for Western professionals: what is to

improve a man? Where man ends and a machine

starts, if any? It continues to the general concept of

life and death in the concept of modified human. Is it

ethical to interfere in the future?

Third, issues related to information security (that

is very closely connected with data handling

problems). What information collected by

biosensors, is ethical? What information can and

should be collected? Should we limit the collection

of information? There is no doubt that the

widespread adoption and use of biosensors will lead

to a correction of the relevant laws.

Fourth, the issue of equality and accessibility of

services in the field of bio-sensing technology. Who

could use biosensor technology and why? What are

the limits? Price? Religious beliefs? We note a great

concern of probable inequality that could derive

from biosensor implementation in nearest future.

Fifth, what would be the overall effect of high

tech implementation in medicine on the society? On

the socio-political structure, the economics, etc.? We

have not found any detailed study yet. Let us just

mention a survey on high-tech medicine conducted

in Russia in 2012 that reveals the following. Just

16% are familiar with this issue, 68% see no need of

high-tech implementation, the average amount of

subsidy from the government was about 4000 USD,

83% got the information from their physician, the

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main drawback mentioned by people were quotas for

high–tech medicine implementation. Thus we see

that people just do not understand what biosenors

mean and if they can be used in their everyday life.

2.4 Institutional Aspects of Biosensor

Market Formation in Russia

The formation of the market of high-technology

medical care in Russian Federation today is hindered

by a number of institutional factors that need to be

addressed.

First of all, it is the lack of institutionalization of

the actors of the market - the economic and

technological agents that form stable types of

behaviour in the market, both in the short and in the

long term. Institutionally, the market of high-

technology medical care in Russia, as in many other

countries, is not a classic, i.e. the consumer of health

services, as it was not veiled insurance mechanisms,

not the taxpayer, which determines the range of the

market. That is the government, and precisely – the

main actor is the Ministry of Health of Russia that

forms the demand in high-tech care in Russian

Federation, as well as put the standards for them.

That is easily understood in term of price and money

needed: the only source for a large-scale financing is

governmental budget.

However, Russian Ministry of Health constitutes

its viewpoint based on medical issues, i.e. is inclined

to current medical practice, not assuming innovative

proposals that the market could offer today and/or in

the future. The only actors, able to properly move

the aspects in the formation of the nomenclature of

the market towards the introduction of the

achievements of biosensor technologies are experts’

community. One of them is the technological

platform "Medicine of the Future", that brings

together specialists from different fields and

organizations in solving the general problem of the

development of new high-tech face of the Russian

medicine - the task set and maintained by the state.

Biosensors are distinguished as a special trend

within the Technology Platform. Among the

organizations that might have a major influence on

the direction of development of high-tech medicine,

it is necessary to highlight the National Research

Centre "Kurchatov Institute" - a fundamentally

interdisciplinary leading research and technology

centre in the country with the functions of the

organization and promotion of technologies in

various sectors of the Russian Federation.

Thus we conclude that nowadays the position of

experts’ community is crucial: they can attract more

attention to biosensors, influencing the authorities to

bring innovative ideas into practice.

Another important issue is financing the

biosensor technology implementation. By now it is

supposed to be financed via the Fund of obligatory

medical insurance. However expensive medical

treatment (or rather long one) could not be afforded

and the idea is to develop a voluntary medical

insurances company. Scientific research is funded

through highly specialized grants systems (Russian

Foundation for Basic Research, Bortnik Fund, etc.).

Commercialization is supposed to be supported by

Vnesheconombank program (public-private

partnership for the development of distant medical

services). There are some signs of big mobile

operators’ interest to this issue. In 2012 Beeline (one

of three largest mobile companies in Russia)

conducted a test of mobile medicine usage in

Moscow region that has rather promising results.

Thirdly, the very important issue is the question

of standards. Data collecting (what exactly, with

which preciseness, etc.), parameters of the devices

(size, weight, electrical circuits inside, etc.),

parameters of the resulted information (what is

“out”?). If those standards refer to medicine?

Technical devices? Information processing? This

question has not been solved yet, and biosensors can

be considered differently: there is no precise rule.

Practically, he, who establishes the standards, will

control the market. Russian Federation strives to

strictly protect its independence, and do not adopt

foreign standards. European Union, as can be

concluded from plans of Horizon 2020, will not

supervise it, and European standards are supposed to

follow ones proposed by the US. This means that for

Europe the United States will form the biosensors

market, and demand will be defined by US needs

and preferences.

3 CONCLUSIONS

The problems of biosensors implementation are not

limited to the obstacles listed above, and for sure

there are a lot of other issues that would arise while

developing the biosensor market. Our work is still

continuing, and we are currently updating the lists of

technical solutions appropriate for Russian market,

as well as lists of challenges.

We stress, however, the hope that biosensor

could solve all medical problems and distant

medicine would substitute the old one is useless.

So what could be “Dream Biosensor”? To

answer this question we conduct a short survey of

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specialists in the field of medicine and

biotechnology. By the end of 2013 we received more

than 100 filled questionnaires. Experts stress that the

device should be small (light weight), should deal

preferably with cardiovascular decease, and should

have some new (re)charging mechanisms. The last

peculiarity seems to be the most important.

An ideal “Dream Biosensor” could be described

as passive universal implantable medical device that

measures and transmits to mobile devices and/or

personal computers a number of selected indicators

(such as temperature, pulse, blood pressure, the

content sugar in the blood). The collected data are

used for 2 purposes: first, the government has the

precise statistics about national health, and can

modify its politics in accordance with real situation;

and second it can be used for better medical

treatment. This should be performed either by the

patient himself advised by a physician (likely after

the case of alert), or by specialist who interprets the

data distantly. The decision making procedure could

never be fully automatized, and human control

proves to be necessary.

One can hope that in this case the biosensor

would not be too “individual” with high price, and

could be produced in a large numbers in different

areas of the country.

Thus, to our viewpoint biosensors should be

considered as a tool to optimize the decision

concerning health issues. And those decisions could

be both medical and managerial: what treatment

would be better? What politics should be followed?

As the government is the main customer of high-

tech medicine in Russia, its position will be decisive.

At the same time, as of today the market in Russia

has not formed yet, the purpose of all stakeholders

(both Russian organizations and foreign

manufacturers) is to form the market, to identify key

trends and to offer a wide range of devices for

different price range which could be introduced in

Russia.

Thus, we see three essential steps for biosensor

market development in Russia. First, to form the

consolidated viewpoint of experts’ community.

Second, to influence the government, to convince

the authorities to support distant medicine

implementation. And third, to arrange the production

of the devices. We note that similar model attracting

the most promising and profitable solutions for their

implementation under the governmental control,

could then be replicated in other countries with

strong state influence on the health system.

ACKNOWLEDGEMENTS

This work was supported by RFBR grant 13-02-

12111.

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