Dream Biosensor

How to Create and Implement?

A. A. Balyakin

, G. E. Kunina

1,2

and S. B. Taranenko

1,2

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

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

Keywords: Biosensors, e-Health, Health System, High-tech Medicine, New Technology, Telemedicine.

Abstract: The idea to create a universal implantable medical device, cheap and effective (so called Dream biosensor)

is proposed. We show that it should be a universal passive wireless device made of biodegradable polymers

that have no direct impact on the body. It should be implanted during a simple outpatient procedure, and

monitors the vital signs of a person’s health. Main requirements for such a device are discussed, some

existing technical solutions are performed. The perspectives of dream biosensor implementation in Russia

are considered.

1 INTRODUCTION

High-tech implementation in medicine can be

regarded now as a world-wide trend: for developed

countries it is the way to sustain high life quality

standards, for developing countries it is seen as a

tool of modernization. Russia also strives to develop

telemedicine and to implement high-tech

achievements into practice. These efforts are likely

to intensify especially due to sanctions and decrease

in financing.

The need for telemedicine development is due to

several reasons: first, improved monitoring and

diagnostics lead to earlier detection and efficient

treatment. Second, frequently the target

measurement is most accurately obtained through

internal detection. Third, gathered statistics allows

the doctor to analyze the patient’s data, and to

determine if any lifestyle factors (such as diet) are

affecting their condition. Forth, telemedicine helps

the specialists to develop individualized treatment.

Fifth, dealing with remote areas problems and

exploration of northern poorly populated territories

(especially future probable Arctic exploration should

be mentioned).

Medical biosensors are supposed to be the most

powerful tool for that purpose. Special attention is

paid to the treatment and diagnosis of social

diseases.

Previously we reported about the 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 study we formed a list of

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

Russian market. By 01 August 2014 we have

considered more than 200 companies, and found

more than 80 devices worth to consider.

We also made a comparative analysis of health

care financing in the United States, Russia and other

countries, making the estimates of future biosensor

market development. 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. The 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). Under certain conditions distant market

medicine in Russia in 2020 could amount to 2 billion

euros.

We also conducted risks and challenges analysis

associated with biosensors implementation,

particularly: technological issues, ethical problems,

standardization issues, etc. We argue that main

obstacle (at least in Russian Federation) to

implement telemedicine into realty is connected with

institutional aspects (managerial solutions).

132

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

Dream Biosensor - How to Create and Implement?.

DOI: 10.5220/0005269501320137

In Proceedings of the International Conference on Biomedical Electronics and Devices (BIODEVICES-2015), pages 132-137

ISBN: 978-989-758-071-0

 2015 SCITEPRESS (Science and Technology Publications, Lda.)

2 DREAM BIOSENSOR

CONCEPT

However, the main question has not found its answer

yet: what kind of biosensor exactly should be

developed? If the country should implement a whole

list of different devices (each for their own purpose),

or there should be a universal one?

Within the framework of RFBR project we

strove to find the answer for this question. We

conducted the thorough study of available devices,

organized an experts’ survey, several scientific

meetings, etc. This work was done in accordance

with traditional foresight methods since the expected

result should provide authorities with necessary

measures to develop high-tech medicine.

As an outcome we formulate the idea of so called

“dream biosensor” – an ideal implantable medical

device aiming at cure of social diseases. Hereafter

we discuss main traits of proposed device, and some

arising problems.

The proposed idea is very close to the

telemedicine development based on smartphones

use. Since modern devices unite a variety of gadgets

onto a smartphone one could almost get a complete

physical treatment without visiting a doctor. This

issue from technological viewpoint has been

thoroughly studied in both Russia and abroad. All

leading Russian mobile operators have tested the

special software used for telemedicine.

The University of California, San Francisco,

hopes to enrol a staggering 1 million people in its

Health eHeart Study to see whether using mobile

technology, including smartphone tracking of

people's heart rate and blood pressure, could help

treat and prevent cardiovascular disease. The FDA

cites industry estimates that 500 million smartphone

users worldwide will use some type of health app by

2015.

We stress however that telemedicine is more

likely to focus on a smartphone as a

transmitter/receiver and to operate only with a stable

connection to the server. This on the other hand can

be seen as a universal monitoring tool, not for an

individual but for the whole society. The massive

data could be used for better medical treatment or

governmental policy.

The Dream biosensor in our viewpoint should

work regardless of the mobile network coverage,

and be reliable in remote areas. These devices would

have an important role in developing countries,

where full-size medical equipment is in short supply

but smartphones are becoming common.

2.1 Dream Biosensor.

Main Requirements

Implantable medical devices are likely to be

personalized oriented, with both active and passive

exposure to the symptoms of patient chronic

diseases. Hence, a priori, they are not supposed to be

produced in large series. Contrarily, mass production

enables to greatly reduce prices and make the

biosensor available for a large number of people.

Since solving social issues is the main priority for

both developing and highly industrialized countries,

we could draw the first requirement: “dream

biosensor” should be rather cheap and produced in a

large numbers (mass production).

Second requirements – safety. Mostly this issue

concerns biocompatibility.

Since it is assumed that the implantable device is

to monitor during limited time (the goal is to collect

and analyze information, to prevent), then at the end

it must be safely removed from the patient's body.

The best option is to create a biosensor of

biodegradable polymers. These materials possess a

number of exceptional chemical and mechanical

properties: can be completely resorbed

(bioresorbable), unlike traditional materials such as

metals, ceramics, and composites; have the

opportunity to actively use in the device for 1-6

months; their usage significantly reduces the cost of

medical care of the patient (for example, do not need

special surgical procedures to remove the devices

from the body); there is no risk of infection; they are

non-toxic; all degradation products can be

completely metabolized. Biodegradable polymers

are synthesized from various monomers, including

lactide, glycolide, dioxanone, trimethylene carbonate

and caprolactone. The polymer properties and the

degradation rate can be tailored to meet the most

stringent requirements, due to changes in the

composition of the polymer and its molecular

weight. To date there has been accumulated

considerable experience in the use of biodegradable

polymers as integral part of many commercial

medical devices and pharmaceutical products.

Additional characteristics of biosensor include

technical properties: size, weight, radiation. As a

result of available papers analysis, the device should

be rather small (approximately 10 mm), not heavy

(less than 10 gr.). System must not exceed

recommended electromagnetic radiation or tissue

heating levels, thus electromagnetic radiation should

be less that 10 mW/cm. It also should not produce

tissue heating more than 1°C increase in tissue

temperature.

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Also before mass production the device should

undergo testing for cytotoxicity, sensitization,

irritation, system toxicity, subacute and subchronic

toxicity, genotoxicity, implantation,

hemocompatibility, chronic toxicity, and

carcinogenicity.

Third Requirement is easy to use, easy to

implant. It should be injected in patient’s body by

simple outpatient, minimally invasive procedures

(eg, by special syringe). While operating, it should

be easy to navigate, to control, and/or to halt it if

necessary. This issue is often neglected, but friendly

interface greatly increase the effectiveness of such a

device and allows its vast usage. The last one is

especially important, since those are elderly people

(not ready to learn difficult rules) who are the aim of

the device.

Fourth Requirement is the maximally full list

of monitored parameters; it should not be too long,

but enough to make clear statement and prediction

about patient’s health. We asked specialists, what

should be included, and form the following list:

body temperature; blood pressure; blood analysis;

glucose level; oxygen, proteins and enzymes; ECG.

Also many producers (e.g., Biotronik with their

heart failure monitoring system) propose to combine

in one device collecting some “additional” data, not

directly referring to studied conditions, previously to

be neglected. Those parameters may include body

positioning, body temperature, speed of the

movement, etc. They provide doctors with additional

information, and could improve the diagnosis.

Fifth Requirement deals with data transmitting

and analyzing. Monitoring and data transfer should

go all day and night, in the dynamics of ordinary

routine of life. Information about physiological

condition of an organism should be transmitted from

the mobile device to a personal computer of the

treating physician in real time and with a

predetermined periodicity.

Note we do not take into account such issues as

data protection or preciseness of models used to

make the forecast.

The Sixth and most important requirement is

battery issue. Because at the moment this problem

(re-charging the device) has not been resolved, it

seems the best solution would be to apply a

biosensor as a passive device that is independent of

external charging. This, in turn, imposes a limit on

the lifetime of the device (average 1 month, and up

to 6 months).

Thus, in our view, the massive demand could

benefit from a universal passive wireless device

made of biodegradable polymers which has no direct

impact on the patient body. It should be implanted as

a result of a simple outpatient procedure, and after

monitor the vital personal characteristics. Collected

information about physiological condition is

transferred to a remote server for further analysis.

The list of requirements could be widened by

geo-positioning. This implies especially in case of

remote and poorly populated areas.

2.2 Existing Technical Solutions

To date we have identified following implantable

devices ready to produce: body temperature - smart

pill by Ohio State University, USA; arterial pressure

- EndoSure® Wireless AAA by CardioMEMS Inc,

USA; glucose level - GlucoChip™ by PositiveID

Corporation Headquarters, USA; blood analysis

(enzymes and ferments) - Chip EPFL by EPFL,

Switzerland; oxygen level in blood - B-Care5 Blood

temperature and SpO2 monitor by SORIN GROUP,

Italy; EKG - Reveal™ and Reveal Plus™ by

Medtronic, Inc, USA.

Necessary materials and parts of the device:

biodegradable polymers - RESOMER® by Evonik

Industries AG, Germany; battery charging Nyxoah

system by Nyxoah, Belgium (used adhesive patch).

We conclude that right now there is a number of

devices that can gather and transform information

about patient’s health, but they all deal mostly with

1 or 2 important characteristics, not taking into

account others. Proposed project (“dream

biosensor”) can combine them all together, using all

advantages in one device.

From the list above mostly the universality can

be attributed to following devices: 'smart' pill by

Ohio State University, USA and Chip EPFL by

EPFL, Switzerland.

The first one ('smart' pill) monitors drugs

reception: time, dose, heart rhythm, body

temperature. It is constructed as a microscopic chip

the size of a matchstick recording all the details of

the program of medication through a patch receiver,

attached to the arm or shoulder of the patient. It

transmits medical information to patient’s or

doctor’s smartphone/computer. It has been on sale in

Great Britain since September 2012 (£ 50).

Chip EPFL is an implantable device for blood

analyzing (proteins and enzymes) equipped with

wireless transmission system. It is designed to

monitor the treatment effectiveness (such as

chemotherapy, also applicable in anesthesia). It

possesses the option to simultaneously monitor

several diseases, and can detect up to 5 organic acids

and proteins at a time. The apparatus can be also

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used to monitor the overall health status (e.g. for

sportsmen). It is small and light (Length-14 mm;

weight-7g). These studies were the part of the Swiss

Nano-Tera program, some preliminary results were

first presented at 13/03/13 Europe's largest

electronics conference.

Another promising trend is connected with

creating smart devices playing several functions. In

this case the monitoring is regarded as an additional

property of the device. Mostly it is a stent that also

collects data and servers as an emitter (so called,

smart stent). Or it can be an additional attached

device only for short post-operational period.

Geopositioning could be another important issue.

For instance, chip (RFID) of Xega - a chip the size

of a rice grain inserted in the adipose tissue arm

between the shoulder and the elbow by a syringe is

widely used in Mexico to determine the location of

people online.

Another pressing issue concerns battery

charging/recharging. The original solution was

proposed in implantable devices Nyxoah system by

Nyxoah, Belgium. They apply an adhesive patch to

patient’s body. The device is intended for the

treatment of obstructive sleep apnea and snoring. It

includes the actual implantable device, a portable

battery and a charger. Implantable device is mounted

close to the nerves of the tongue muscles as a result

of a small incision. The implant is powered and

controlled via external disposable batteries, which

are fastened under the chin with adhesive pad (like a

patch). Every evening, the patient uses new

disposable sheet, which was powered previously by

a battery charger. Pad size is of 55 x 90 mm, and is

attached to the skin under the chin. It has enough

energy to activate the wireless implantable device

for full session during the calculated average

duration of a night sleep.

There is a new trend in medical biosensor

development connected with 3-D bio-printing. As a

substrate the living cells (often belonging to the

patient) are used. Previously those devices were

motionless or dependant on blood flow, but now

they are equipped with a strip of skeletal muscle

cells that can be triggered by an electric pulse thus

serving as a pusher. The size of such bio-bot is now

about 1 sm. with prospects to decrease. Experts

estimate these devices to be in use in about 3-5

years.

We note that there is no such Russian device that

could correspond to all requirements listed above.

They all lack in quality and/or performance. This

inevitably raises the demand to attract foreign

investors and/or developers to Russian market, or

require buying corresponding licenses by the

government.

2.3 Perspectives of Dream Biosensor

Implementation

In our previous work we studied risks and

challenges of biosensor implementation using

Russian Federation as an example of a country with

strong governmental support for health care system.

We listed technological issues, data handling

problems, ethical aspects of biosensor

implementation, and institutional problems. We

stressed that for the biosensor market (that has not

formed yet) the last ones are the most crucial.

However for dream biosensor to implement we

consider social obstacles to play main role, since a

person will be the ultimate consumer of innovative

services/products, his/her opinion will determine if

the device is successful or not.

Social risks of accepting the device could be

divided into 2 large groups: cognitive and behaviour

stereotypes.

Among the most significant risks one should

mention cognitive ones. The main reason for them

derives from the low level of awareness and

understanding of high-tech medicine among people,

rating it as something inaccessible and "distant". The

attitude towards innovation as a whole has similar

nature. Based on diffusion theory from sociology

one can estimate a group of high degree of

innovations loyalty (attracted to high-tech) in the

amount of 15% of the general population. In

countries such as Russia this number is also

narrowed by great difference between large cities

(Moscow and St. Petersburg) and other country.

Thus the main task for the promotion of dream

biosensor would be to inform people about the

innovation.

Behavior risks are also important. They were

formed by consumers’ stereotypes. Concerning

medicine in Russia, only 6% of the population is

ready to use the services of private medical

institutions, the vast majority (55%) prefer to go in

for free municipal/state medical institutions. This

means that people treat as unacceptable the practice

to pay for the medical treatment regardless of its

pros and cons, what is worse one third of population

is devoted to self-cure, and monitoring and

prevention seem to be useless (only 18% regularly

check their health).

These factors greatly threaten the perspectives of

biosensors implementation. There is no desire to pay

for better living, or the readiness to monitor one’s

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health. There is a contradiction: they who need the

device do not know about it or do not will to

implement it. We stress that this situation is typical

for developing countries with strong paternal ideas.

This makes the role of the government and the

experts’ community very important.

To identify the most effective way of biosensors

introduction two-component model of population

was proposed, assuming different dynamics within

two social groups conventionally called a “city”

(services) and “village” (production). The most

important term is the flow between the 2 phases.

Practically, we are talking about the so-called

“binary structures”, stratifying socio-economic

space.

A numerical simulation of the system was

carried out, characteristic regimes were studied. It is

shown that in some cases there can be observed

unstable solutions. Special attention was paid to the

opportunity to control system dynamics by changing

governing parameters (corresponding to some

managerial solutions).

Two most important results should be

mentioned: first, innovation within the conditional

“city” is not only economically feasible, but also has

a positive effect on the whole system. Given the

strong connection between “city” and “village”, the

increase of living standards in the first region

(biosensors are implemented in a big city where

infrastructure is available and costs are low)

inevitably leads to improvements in the second area.

In our simulations a 2-percent increase in the

“city” accounts for 1 percent growth in the “village”.

The second important finding was the conclusion

that changes in lifestyle (whether to use biosensor in

a habitual life or not) can be compensated by

appropriate outer management (regulation of the

flow of the population between the city and village),

and their depth can be relatively small (2-3 times

less than desired changes in lifestyle).

These results show that telemedicine

implementation should not be conducted in the

whole country or for the whole population, its

impact is transferred from one group to another, and

the purpose of the authorities is to correctly

determine the target group that is not necessarily the

very unhealthy or poor people.

3 CONCLUSIONS

Biosensors to our viewpoint have an important

peculiarity: their usage aims at preventing rather

than curing. Thus we note that the proposed device

(dream biosensor) is not long-lived and only

involves assisting a patient under special conditions

or monitoring his health. In case of serious problems

the use of more expensive and specialized devices

would be necessary. The last ones despite their

importance are niche product in contrary to “Dream

biosensor” that should involve mass production. In

this regard “Dream biosensor” can be an effective

tool for high-tech distant personalized medicine.

We have also examined the economic aspects of

the “Dream biosensor” implementation: we

conducted market analysis and evaluation of the

factors influencing the pricing of medical

implantable devices. The most challenge in

biosensor market is its small-scale production. The

expected price (affordable for the majority of

population in Russia) is approximately $3000 a year

for the whole cycle (biosensor itself, operation, post-

operation treatment).

The project to create “Dream biosensor” may

require significant investment. Therefore, the

implementation of such a project is possible only in

the form of the federal program.

In our opinion the need to implement “Dream

biosensor” is vital. We stress that on the one hand,

there is a direct interest from the main customer –

from the state (in particular, the work of the

Technology Platform "Medicine of the Future") and

on the other hand – there are already existing both

technical solutions that could be implemented and

scientific research creating the background for future

development. It will not solve all problems though,

but can greatly improve quality of living.

In upcoming future the telemedicine biosensors

are supposed to become smaller in size, and greater

in numbers, all connected together. Thus, there

could be established a smart grid. First, it would be a

“nervous system” at the level of the organism

(within next 10 years according to forecasts). The

National Nanotechnology Initiative has organized in

2013 a special roundtable dispute about probable

application of nanobots for medical purposes; some

first standards, methods and approaches were

discussed. Next discussions are to come soon.

In future medical sensors will become the part of

the Internet of things, and would play crucial role in

organizing comfortable life. The construction of

world-wide distributed systems of biosensors is

expected to occur by 2050.

ACKNOWLEDGEMENTS

Authors thank Zhulego V.G., Malyshev A.S., and

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Blokhina E.V. for useful discussions.

This work was supported by RFBR grant 13-02-

12111.

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