Week 1 Assignment

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Open Access Full Text Article

http://dx.doi.org/10.2147/TCRM.S88574

The potential of medical device industry in technological and economical context

Petra Maresova1

Marek Penhaker1,2

Ali Selamat1,3

Kamil Kuca1,4

1Faculty of informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic; 2Department of Cybernetics and Biomedical engineering, Faculty of electrical engineering and Computer Science, Technical University of Ostrava, Poruba, Czech Republic; 3Faculty of Computing, Universiti Teknologi Malaysia, Johor Bahru, Johor, Malaysia; 4Center for Biomedical Research, University Hospital Hradec Králové, Hradec Králové, Czech Republic

Abstract: The high quality of public health improves not only healthy life expectancy, but

also the productivity of labor. The most important part of the health care sector is the medical

technology industry. The aim of this study is to analyze the current situation in the medical device

industry in Europe, its potential strengths and weaknesses in the context of topical economic

and demographic development. The contribution specifies an analysis of the economic state of

the medical device industry in the context of demographic development of European Union’s

macroeconomic indicators and views of experts in the field of medical device development,

concerning the opportunities for entities involved in the medical device market. There is fierce

competition on the European market. The innovative activity is stable and well regulated by

responsible authorities. Worldwide, the medical device market is expected to grow.

Keywords: technology context, medical device, Europe, expenditure, review

Introduction With respect to the demographic trend in Europe, health care and the development

of health devices are hot issues. Several studies evaluate the prospects of medical

interventions,1,2 economic effectiveness of innovative technologies in health care,3 or

Health technology assessment in chosen European countries. In order to implement

innovative technologies in practice, it is becoming extremely important to be cost con-

scious and effective as well as to know and follow new guidelines in health care.4

Many studies have proved that there is a relation between health and the economic

development of countries.5–9 Improved public health leads to healthy life expectancy,

which is then reflected in increased quality and productivity of labor. It is therefore

vital to invest in the health of working people in order to prolong their active life

and achieve better health. This investment may also decrease future costs of treating

patients suffering from preventable diseases. The healthier the individual people are,

the more and longer they are able to be at the labor market. Approximately one in four

currently employed people (23.5%) suffers from a chronic condition, which limits them

in doing their daily activities. It is the more so in latter stages of their lives when their

participation in the labor market is markedly lower.10 Moreover, there is an increased

incidence of multiple diseases (comorbidity) at higher age. As a result, the pressure

on health systems and social care structures in terms of demand for care increases.

In the context of this development, the problem of investments in the medical

device industry as a part of health care becomes more significant. Medical devices are

irreplaceable in diagnostics, prevention, monitoring, and medical treatment of diseases

and in increasing the quality of life of persons with a health problem.11 Variability and

innovativeness of this industry significantly contribute to an increase in the quality

and efficiency of health care. The aim of this contribution is to analyze and specify the

Correspondence: Kamil Kuca Center for Biomedical Research, University Hospital Hradec Králové, Sokolská 581, Hradec Králové 50005, Czech Republic Tel +420 603 289 166 Fax +420 495 835 200 email [email protected]

Journal name: Therapeutics and Clinical Risk Management Article Designation: Review Year: 2015 Volume: 11 Running head verso: Maresova et al Running head recto: Potential of medical device industry DOI: http://dx.doi.org/10.2147/TCRM.S88574

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current situation in the medical device industry, its potential

strengths and weaknesses in the context of topical economic

and demographic development.

Research methods The following methods are used in the issue: retrospective

analysis (of demographic data, data related to the growth of

medical device market), structured interviews with experts,

and analysis of external environment. External analysis

focuses on the surrounding environment, aims at the oppor-

tunities, threats, as well as other factors that will influence the

future strategy of this industry. This analysis specifies politi-

cal, economic, social, and technological factors (therefore,

it is also called PEST analysis). The individual factors are

arranged according to their importance as for the expected

future state of the industry. The analysis of political factors

monitors laws, restrictions, and conditions significant for

the future development of the industry, including legisla-

tion, political stability, tax policy, and integration policy.

Among the most important economic factors are gross

domestic product (GDP), interest rate, or inflation. These

factors specify the performance of the industry. Social fac-

tors are important, in particular, for companies involved in

selling products to the end consumer. In this area, it is vital

to understand demographic stratification, lifestyle, income,

and religious issues. Technological changes may suddenly

and dramatically influence the whole industry. Among

the monitored factors are government support to research

and development (R&D), general technological level, new

discoveries, and inventions. The analyses of the external

environment served as the basis for forming the so-called

SWOT matrix (strengths, weaknesses, opportunities, and

threats). The SWOT analysis was devised by Albert Humpley

in the 1960s. The SWOT analysis process is usually divided

into three basic stages:

• Identification and assessment of strengths and weak-

nesses, which are internal to the organization.

• Identification and assessment of opportunities and threats,

which are external to the organization.

• Creating the SWOT matrix.

Strengths are internal resources of the company, its

positive attributes, or assets. Weaknesses are aspects of the

organization that need improvement and cause competitive

disadvantage. Opportunities are external attractive factors

that the organization can benefit from as they increase

demand or can better satisfy the customer. Threats include

external factors and trends beyond control that could decrease

demand or cause future losses.12,13 In the table are summarized

SWOT of the given segment. The aim was to achieve the

greatest possible objectification of the assessment, the

SWOT analysis was created by a multi-disciplinary and

international team consisting of a specialist in the develop-

ment of medical devices (two specialists), development of

pharmaceuticals (one specialist), economy (one specialist),

and modern technology (three specialists). The role of each

team member was to describe partial strengths, weaknesses,

the potential opportunities, and threats in their area of work,

which corresponded to the individual parts of the analysis of

external environment. The team members then carried out

quantified evaluation of each item of the European Union

(EU) Medical Device Industry according to their significance.

Factors were assessed on the scale from 1 to 5, where 5 stood

for the highest significance in relation to the EU countries.

Each factor was then assigned with significance, that is, the

numeric representation of the significance of its impact on

the development in the medical device industry. The sum of

significance in each category must be equal to 1.

The analysis of external environment in the medical device industry The economic situation of the medical device industry In economic terms, the current world witnesses a slow growth

and in the near future the situation probably will not change

much. A little increase in economic activities is expected

and the number of unemployed people will decrease only

little, if at all. There are still short-term risks represented

by problems in the Eurozone, the USA have not overcome

fiscal adjustments, and developing countries’ economies are

slowing down, even though the situation is getting better.

Concerning medium-term risks, several developed econo-

mies adopted unconventional and risky monetary measures

aimed at improving global financial stability.14

In relation to the medical device industry, it may be

observed that there are unprecedented opportunities loom-

ing for the medical device industry in countries such as the

People’s Republic of China, India, Latin America, the Middle

East, and other emerging markets with rising GDP and expand-

ing middle class. The rise in both population and disposable

income should lead to a much higher demand for medical

devices and medical services. The expansion of medical device

companies into developing countries will increase their manu-

facturing efficiency and decrease the price of their products.

They will also be able to better serve local markets.

The medical technology industry, with its established

centers in the USA and Western Europe, is becoming a

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Potential of medical device industry

flagship of the whole health care sector. Among other

things, it manufactures devices facilitating not only pre-

vention, but also diagnosis and the follow-up treatment.

Nevertheless, the focus of the medical technology industry

is becoming to move eastward to Asia, particularly to the

People’s Republic of China, which will probably become

prominent in the near future.15 The medical device indus-

try comprises thousands of firms, predominantly small

enterprises with up to 50 employees. The main drivers

of innovation in this area are start-ups that are usually

financed by venture capital.4

The USA is currently both the largest producer and the

consumer of medical devices, with approximately 50% of

the world market. It is followed by Japan, the EU, Canada,

and Australia, which boast of large and stable markets with

medical devices.10 Generally speaking, all developed countries

witness a significant increase in both production and consump-

tion of medical devices.16 The global market is on the rise not

only due to higher life expectancy in the developed countries,

but also because of new markets in developing countries.

Figure 1 shows an increased interest of survey participants in

the BRIC (Brazilian, Russian, Indian, and Chinese) markets.

Another attractive market is the Mexican one due to a new and

much more efficient regulatory system.17 Brazil is the leading

country with 20% of small companies, 21% of medium ones,

and 17% of large companies. It is followed by the People’s

Republic of China, which is second for both medium and

large enterprises, India, on the other hand, boasts of a higher

number of small enterprises than the People’s Republic of

China, which means an easier way to the Indian market for

those with lower resources. Some 18% of American firms

and approximately 19% of EMEA (European, Middle East,

and African) companies strive to enter the Brazilian market

this year. Concerning Asia–Pacific companies, 29% of them

plan to expand into the Chinese market.

The economic situation of the medical device industry in europe Europe boasts of some 25,000 medical technology com-

panies. Most of them have their headquarters in Germany,

the UK, Italy, Switzerland, Spain, and France. 95% of the

medical technology industry comprises small and medium-

sized enterprises. Most of them have less than 50 employees.

Small and micro-sized firms employ some 575,000 people.

The largest share of medical technology industry employees

in total employment is in Germany, while the highest number

of employees in this industry per capita is in Switzerland

and Ireland. Such high numbers of employees prove that the

medical technology industry is a significant player in Europe

and in its economy. Whereas, in the USA the medical technol-

ogy industry provides jobs to approximately 520,000 people,

the European pharmaceutical industry employs some 675,000

people. In 2012, there were more than 10,000 registered pat-

ent applications in this field. The annual investment in R&D

equals approximately 4 billion €19.19. The medical device

industry belongs to one of the most innovative sectors with

an average life cycle of only 18 months before an improved

product becomes available.11

European countries spent on average 10.4% of their

GDP on health care.1 Approximately 7.5% of it is spent on

medical technologies. Nevertheless, expenditures on medical

technologies vary significantly across Europe. They usually

Figure 1 interest in the emerging markets. Note: Data from emergo Group.18

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range between 5% and 10% of total expenditures on health

care. European per capita expenditure on medical technolo-

gies equals €1,957 (weighted average), whereas in the USA it

is €380. The average annual growth of the European market

over the last 6 years is 4%. Figure 2 shows the development

in individual years. The value of the European medical tech-

nology market is estimated at some €100 billion. Medical

technologies help solve problems in many areas. Globally,

the largest segment is in vitro diagnostics, cardiology comes

second, and diagnostic imaging third.

Technological environment of the medical device industry The technological factors affecting the economic level

include government support for R&D, the overall level

status of the use of technologies, as well as, for example,

new discoveries.19 These three areas will also be focused

on in connection with the situation in the EU and with

the medical devices sector. The economic significance

of innovation activities has been growing. Planned state

budget R&D expenditures in the years of 2013, 2014, and

2015 have been approved for €1.036 million per year.20

Up until 2015, the percentage of financial resources for

R&D provided as a special-purpose support should be

rising. These expenditures should correspond to the real

demand in the application sphere. Institutional support will

constitute a significant part of public resources for R&D.

The supported areas will be particularly the transfer of

knowledge into practice, patenting, or establishing spin-

off companies.

Another key factor of R&D development is risk capital

investment, which is private investment in companies deal-

ing with the development of new products and technologies,

usually in the initial phase (start-up and seed) or in the

expansion phase. The highest level of these investments is in

Bulgaria, Romania, and Greece. The Czech Republic belongs

to the category of countries with the lowest risk capital

investment. Luxemburg disburses by far the most risk capital

investment, followed by Denmark and Hungary. In the context

of patent activity, European countries demonstrate re-active

constant activity. The maximum value was reached in 2008,

followed by a decline. This development may be affected by

the economic crisis and a lack of funding in R&D.

The medical technology industry is known for the high

quality of R&D as well as for its cooperation with end

users, which leads to continuous innovation. An improved

version of almost any product is available within 2 years of

launching the previous model. In 2012, the European Patent

Office counted more than 10,000-plus patent applications

in the field of medical technology, which was 7% of all

patent applications. No other technical field achieved such

a high figure. European countries filed 38% of all patent

applications in this field. In order to provide a comparison,

there were approximately 5,400 patent applications in the

pharmaceutical industry and 5,300 applications in the area

of biotechnology. Within the last 10 years, the number of

European Patent Office medical technology patent applica-

tions has doubled, whereas the number of applications in the

field of biotechnology and pharmaceutics remained more or

less stable.21

Political–legal environment Significance of the political and legal environment for

entrepreneurship is indisputable. As an indispensable part

of institutional quality, it directly affects realization and

efficiency of entrepreneurial activities and total economic

efficiency. Factors related to power distribution and legislative

environment are significant in this sector. Government’s and

other state institutions’ activities may significantly influence

entrepreneurship on various types of market. This section

Figure 2 european medical technology market growth rates, based upon the manufacturer process, 2008–2013. Note: Data from Medtech europe.1

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describes legislation related to a medical device. Regulations

in the global market as in the People’s Republic of China,

Europe, Canada and follow US FDA’s model. Medical

devices are classified into Classes I, II, and III. Regulatory

control increases from Class I to Class III. The device clas-

sification regulation defines the regulatory requirements for

a general device type.

Medical device regulation in the eU Medical device regulation in the EU is governed by three EU

council directives and their subsequent amendments:22

• 90/385/EEC on Active Implantable Medical Devices,

• 93/42/EEC on Medical Devices,

• 98/79/EC on In Vitro Diagnostic Medical Devices.

The Directives are supported by guidelines, which,

according to the European Commission, are aimed at the

promotion of a:

Common approach by manufacturers and Notified Bodies

involved in the conformity assessment procedures according

to the relevant annexes of the Directives, and by the Compe-

tent Authorities charged with safeguarding Public Health.

All medical devices placed on the market in the EU must

comply with the relevant Directive. The medical device direc-

tive covers a wide range of medical devices, from first-aid

bandages and walking frames to implantable devices and

computed tomography scanners. The level of medical device

assessment therefore varies, according to the perceived risk

of the device. For medium and high-risk devices, companies

are required to have their quality systems and technical

documentation reviewed by a notified body before their

products can be placed on the market. The notified body has

a responsibility for ensuring that the relevant requirements

are met prior to the issue of certification. Manufacturers are

then able to place the European Conformity (CE) marking

on their products to demonstrate regulatory compliance. The

CE marking is recognized throughout the EU, the European

Economic Area and Switzerland, which allows these prod-

ucts to be sold over this geographically wide area. Nonethe-

less, individual states may request registration of medical

devices, and may have additional requirements relating to

the language of the device information. For manufacturers

of Class I or IVD medical devices, it is a legal requirement

to provide certain information to a competent authority in

an EU member state where they have a registered place of

business, prior to marketing their device in the EU. If the

company does not have a registered place of business in the

EU, they must designate someone who is established in the

EU to act on their behalf.22 Potential sources of financing

health care and the development of medical devices lie in

the following funds:23

• the European Regional Development Funds, which

strengthens cohesion, namely economic, social, and

territorial one, by redressing the balance among various

regions,

• the European Social Funds, which is the main instrument

of the EU for investing in its citizens,

• Horizon 2020.

These programs are relevant and provide investment

opportunities to complement those financed through Struc-

tural Funds. Furthermore, the Commission strongly promotes

Public–Private Partnerships as a means of improving the

levels of investment and innovation in a wide range of public

services including health care.24

In order to ensure the smooth functioning of a support

system, it is necessary to have a clear and efficient legisla-

tion, which must be implemented across the whole of the

EU in a consistent way and which enables quick access to

the latest technologies.

Social environment The social and cultural environment is based on demographic

situation, employment rate, the population’s education and

income, etc. It is important to monitor the basic values and

attitudes of the population and specific needs of various target

groups. The forecast percentage growth in over-65 and over-80

inhabitants in the EU countries is illustrated in Figure 3.

In developed economies, aging population will drive

the growth of medical device companies. More than 80%

of people aged 65 years or above have at least one chronic

disease. People aged 60 years or above will increase signifi-

cantly 2012 onward when the first wave of those born during

the baby boom generation begins to turn 65 years, presenting

great opportunities for medical devices companies that bring

innovative technologies to address the chronic disease.26 Table

1 shows figures of university educated citizens with degrees in

the 30–34 years age group. EU strategy target is to achieve 40%

by 2020. The demographic trend in EU acts strongly against

this objective. The Governments of chosen EU countries

determined the maximum number of accepted students.

Currently, the real income drops, which results in lower

consumer expenditures and the creation of savings. These

facts hinder economic growth. Its largest part of income is

wages. They differ significantly according to economic activ-

ity. The highest income is in finance and insurance, followed

by the information and communication sectors.

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Figure 3 Aging population. Note: Data from eurostat.25

Table 1 Total number of people in tertiary education in the eU (%)

Year 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

eU average 22.4 22.8 23.5 25.0 26.9 28.0 28.9 30.0 31.0 32.2 33.5 34.6 35.8

Note: Data from eurostat.25

Abbreviation: eU, european Union.

Social environment in the medical device industry Employment and incomes within the medical device indus-

try is quite complicated to describe. Since the production

of medical devices is part of the manufacturing industry

category, it is not monitored separately at an international

level (Eurostat databases, OECD). According to Eurostat

and OECD, 15,400 industry professionals are in the

medical device industry. The median salary grew by 5%,

to $105,000 between 2012 and 2013. The rising demand

for employees in the areas of quality and regulatory affairs

is also reflected in earnings. Salaries for quality assurance

and quality control professionals increased more than 3%

in 2013.

The situation of medical device industry – SwOT analysis The aforementioned analysis of external environment (eco-

nomic, legislative, social, and technological) described the

most significant impacts on the medical device industry.

Table 2 specifies SWOT in this industry. In the Criterion

column, the experts assessed the significance of each item

on the scale from 1 to 5 as it is described in the “Research

methods” section. On the scale 0–1, the significance was

given to each item in four categories (strengths, weakness,

opportunities, and threats) of the SWOT analysis (the sum

must equal to 1). The Total Impact column was created as

the product of “Criteria*Significance” (Table 2).

With respect to the aforementioned trends in the medi-

cal device industry, it can be maintained that it is a very

prospective field. Nevertheless, investments in it may have

their advantages as well as drawbacks and provide companies

with many opportunities.

Among the most significant strengths of the medical

device industry in the EU are, in comparison with other sec-

tors, relatively high expenditures on health care (0.75) and

medical technologies, an increasing growth in science and

research expenditures, quality research centers, and qualified

workforce (0.8).

All factors related to the scattered and dissonant EU

administration and legislation (0.4) as well as insufficient

interconnection between scientific research institutions

and practice (0.72) create obstacles to the growth of this

industry’s efficiency. In addition, a very crucial weakness

is a significant threat to the future when it will be necessary

to work on improving the cooperation among universities,

scientific research institutes, and institutions, support-

ing innovative entrepreneurship capacities of science and

technology parks. In this industry, it is also essential to pay

attention to the long-run development goals. The continuing

stagnation of the EU economy (0.1) and underrated R&D

cooperation in clusters (0.85) were marked as a threat with

relatively smaller significance.

Future opportunities in the medical device industry is

aging population (1) and clear vision (0.4) in developed

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Table 2 SwOT analysis of the eU medical device industry

Criterion Significance Total impact

Strengths High expenditures on health care, particularly on medical technologies 5 0.15 0.75 well-developed industry with a strong manufacturing base 3 0.08 0.24 Macroeconomic and price stability of the sector 2 0.05 0.1 Quality research centers 4 0.15 0.6 increasing annual growth of science and research expenditures 4 0.12 0.48 Existing qualified workforce 4 0.2 0.8 existing strategic development goals 4 0.1 0.4 existing and new business incubators and science and technology research parks 3 0.1 0.3 Growth of the medical device industry 4 0.05 0.2 Total 1 Weaknesses Disunited legislative environment in eU countries 4 0.1 0.4 Administratively demanding system of public support 4 0.08 0.32 Fragmented consultancy in the fields of public support subsidies and legislation 3 0.1 0.3 A lack of strong linkages between industries and academia 4 0.18 0.72 Insufficient coordination and standardization of the medical device industry development 3 0.12 0.36 Uncooperative research centers 3 0.17 0.51 Legislative difficulties of transferring scientific results in company practice 4 0.1 0.4 Low utilization of risk capital to financing 2 0.1 0.2 Total 1 Opportunities Favorable demographics, namely an aging population in the developed world and a higher number of active elderly people will lead to an increase in demand for medical devices and medical services

5 0.2 1

Medical device industry is expected to grow in countries like the People’s Republic of China with their expanding middle class in emerging markets

4 0.1 0.4

Significant export potential to the developing as well as developed countries 5 0.05 0.25 existence of clear visions, objectives and strategies for the future 5 0.08 0.4 Development of existing and new clusters in the field of the medical device industry 2 0.07 0.14 Increased accessibility of risk capital sources for financing companies’ developmental activities 2 0.1 0.2 Purpose-oriented financing of science and research 4 0.1 0.4 Coordination of scientific research institutes 4 0.15 0.6 Coordination and unification of law related to the medical device industry 4 0.15 0.6 Total 1 Threats Continuing stagnation of the eU economy 3 0.1 0.3 Financial and time difficulties involved in the development of innovative medical devices 3 0.08 0.24 Underestimated significance of marketing for entering foreign markets 4 0.1 0.4 Underrated R&D cooperation in clusters 3 0.1 0.3 A lack of workplaces with efficient systems for transferring science and research results 3 0.18 0.54 Preference given to short-term development goals 5 0.15 0.75 Little use of cooperation and connections among universities, scientific research institutes and institutions supporting innovative entrepreneurship capacities

5 0.17 0.85

Total 1

Notes: Criterion of each item on the scale from 1 to 5. The total impact column was created as the product of “Criteria*Significance”. Abbreviations: eU, european Union; R&D, research and development.

countries. objectives and strategies. Last but not least, also

the unification and clarification of legislative requirements.

Discussion The results from the aforementioned SWOT analysis can

be compared with similar studies7,15,27,28 carried out in this

sector in advanced and emerging economies as well as in

the European and non-European countries (Table 3). The

studies of the chosen economics such as the USA, the UK,

or Israel describe current situation of the medical device

industry in the developed countries. The opportunities and

threats are completely different in comparison with studies

of the emerging countries such as Mexico, Turkey, or the

People’s Republic of China.

Table 3 summarizes SWOT analysis items for both

developed and developing countries. The third column

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contains information from the authors’ SWOT analysis of

the European medical device industry. This analysis corre-

sponds to the results of studies in the developed countries.

At the same time, it determines other significant items that

are mentioned in the third column. The results of the authors’

study that correspond to the results of the SWOT analyses for

developed countries are not listed in the third column.

There is a clear consensus if the results of the current analy-

sis of the European medical device industry are compared with

the analyses of the developed countries. The opportunities such

as aging global population, new health care system reform,

international demand, and penetration into new markets. The

threats of the medical device market in the developed countries,

including the European countries, are global financial crisis,

strong competition, customer bargaining power, and regula-

tory environment. The strengths perceived in the present day

in advanced economies are powerful brands, strong R&D

capability, large numbers of patents, and licensed production.

The weaknesses common to advanced economies, which

can be found in the aforementioned studies, as well as in the

results of this study, are the quality management deficiency,

large scale of investment, and fixed poor financial managing

ability. In comparison with the developing economies, the lack

of human capital is found in advanced economies and the lack

of aggregate supply and demand.

The individual items of SWOT analysis were evaluated

and assessed according to the importance by a team of profes-

sionals engaged in this area. Consequently, not only aspects

of SWOT analysis that are associated with the develop-

ment of basic economic indicators were described, but also

cooperative aspects of universities, scientific research insti-

tutes, and institutions supporting innovative entrepreneurship

capacities were discussed. Unfortunately, the main findings

show that there is little cooperation between scientific orga-

nizations and private sector, undervalued R&D cooperation

in clusters, and preference given to short-term development

goals. Other differences are listed in Table 3.

Conclusion The medical device industry directly as well as indirectly,

by ensuring better health of the population, influences the

economic situations in each country.29,30 Moreover, despite

the fact that the economic recession still continues in many

countries, this industry is characterized by a slight growth. As

far as its future development is concerned, the medical device

industry may look for new opportunities for its development

in the developed economies, and the expanding middle class

in emerging nations, in aging population and more active T ab

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Potential of medical device industry

Figure 4 Financing among individual entities.

seniors. The medical device industry will move with the

general market and will grow moderately. On the other hand,

there are several threats that should not be underrated as they

may badly influence the medical device industry and worsen

its competitiveness. For instance, global competition in

world markets, low coordination of research activities within

the EU, or complicated administrative procedures.

Experts are in wide agreement that advances in medical

technology will fundamentally transform health care and deliv-

ery systems over the next decade by providing new solutions

that will challenge existing paradigms and revolutionize the

way treatments are administered. Critical elements in decision-

making about investments in developing new medical devices

are the knowledge of market needs, awareness of benefits

to society, and last but not least benefits for the health care

system by decreasing expenditures on a given type of disease

or condition. Figure 4 illustrates possible costs between the

various entities. The primary payer for many types of medical

device is the insurance company, not the patient.

In the future, the system for solving the investment assess-

ing in medical device development will be important in the

future in the developed countries. Reasons are as follows:

• limited financial resources of governments in the developed

countries and an effort to spend effectively on R&D,

• investments in the development and production of medi-

cal devices in relation to the growth of this market seems

to be prospective in the private sector,

• a growing number of patients who live longer thanks to

the high-quality health care.

Acknowledgments This work was supported by a project at the University of

Hradec Kralove titled Excellence FIM UHK 2015. It was also

supported by the long-term development plan FNHK.

Disclosure The authors report no conflicts of interest in this work.

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