9
ORIGINAL ARTICLE Microsystems in medicine – results of an international survey S. SCHOSTEK 1 , H. FISCHER 2 , D. KALANOVIC 1 & M. O. SCHURR 1 1 IHCI – Institute of Healthcare Industries, Steinbeis University Berlin, IHCI Office Tuebingen, Germany, and 2 Forschungzentrum Karlsruhe, Institut fu ¨r Biologische Grenzfla ¨chen (IBG-1), Eggenstein-Leopoldshafen, Germany Abstract The utilization of microsystems technology (MST) in medical applications is instrumental in opening up new market segments, in the creation of novel, more effective diagnosis and therapy options in medicine, as well as in the further development of MST. However, the players in the healthcare industry are faced with technical and non-technical difficulties. The present study analyzes this emerging field from the viewpoint of medicine, market, and MST. It identifies applications of medical devices with microsystems components and analyzes their potentials in great detail. Thus, especially the creation of new market segments is expected from a broad use of MST in medicine. Furthermore, problems and conditions during the entry of microsystems into medical products are illuminated, in particular considering the specific market features of the healthcare industry. The high expenditure necessary for establishing this technology in healthcare industry is the most significant obstacle, since this market is dominated by small and medium-sized enterprises (SMEs). But there are non-technical difficulties as well. This article presents selected results of the study, which was carried out in the scope of the EU project netMED (virtual institute on micromechatronics for biomedical industry). Key words: Microsystems technology, MST, micro-electromechanical systems, MEMS, micromechatronics, medical technology Introduction Microsystems technology (MST) is a young discipline whose importance for the present as well as its potential for the future is undisputed. The main characteristic of MST is the possibility to integrate sensing, signal processing, and actuating capabilities into a single miniaturized device of only a few millimetres or less. With these capabilities, microsystems can actively influence their environment on the basis of stand-alone decisions which are based on data acquired from their environment. Further, the spectrum of sensing and actuating components is very broad, comprising micromechanical sensors, micro-optical elements, bio- chemical depositions, micro-fluidic structures, and a great number of mechanical actuators. Due to these features, microsystems are good for use in numerous biomedical applications (1,2). Cardiac pacemakers, implantable hearing aids (3), and insulin pumps (4) are only some examples of successful medical devices whose function is based on MST. Those devices have already achieved a remarkable importance in healthcare industry, but the future potential of MST for medical applications could only be exploited to a limited extent so far. Material compatibility, electrical hazard, energy supply, heat dissipation, and device stability are current medicine-specific technical problems of MST devices to be solved (5). Future medical microsystems e.g. may enable knives to cut only selected tissues (6), surgical grippers to feel grasped objects (7), or self-propelling endoscopes to locomote through tubular organs for diagnostic and therapeutic purposes (8); implantable drug delivery devices may drastically improve the medical care by means of measuring respective parameters and delivering drugs on demand in appropriate doses (9); the possibility to simultaneously monitor multiple biomedical para- meters may lead to significant progress concerning novel treatment options due to more reliable data about physiological and pathological mechanisms of the human body. The penetration of the medical technology market with MST components is by far not as high as e.g. in Correspondence: S. Schostek, Steinbeis University Berlin, Dorfackerstr. 26, D-72074 Tuebingen, Germany. Fax: +49-(0)7071-763574. E-mail: [email protected] Minimally Invasive Therapy. 2005; 14:6; 360–368 ISSN 1364-5706 print/ISSN 1365-2931 online # 2005 Taylor & Francis DOI: 10.1080/13645700500393870 Minim Invasive Ther Allied Technol Downloaded from informahealthcare.com by University of Waterloo on 11/24/14 For personal use only.

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Page 1: Microsystems in medicine – results of an international survey

ORIGINAL ARTICLE

Microsystems in medicine – results of an international survey

S. SCHOSTEK1, H. FISCHER2, D. KALANOVIC1 & M. O. SCHURR1

1IHCI – Institute of Healthcare Industries, Steinbeis University Berlin, IHCI Office Tuebingen, Germany, and2Forschungzentrum Karlsruhe, Institut fur Biologische Grenzflachen (IBG-1), Eggenstein-Leopoldshafen, Germany

AbstractThe utilization of microsystems technology (MST) in medical applications is instrumental in opening up new marketsegments, in the creation of novel, more effective diagnosis and therapy options in medicine, as well as in the furtherdevelopment of MST. However, the players in the healthcare industry are faced with technical and non-technicaldifficulties. The present study analyzes this emerging field from the viewpoint of medicine, market, and MST. It identifiesapplications of medical devices with microsystems components and analyzes their potentials in great detail. Thus, especiallythe creation of new market segments is expected from a broad use of MST in medicine. Furthermore, problems andconditions during the entry of microsystems into medical products are illuminated, in particular considering the specificmarket features of the healthcare industry. The high expenditure necessary for establishing this technology in healthcareindustry is the most significant obstacle, since this market is dominated by small and medium-sized enterprises (SMEs). Butthere are non-technical difficulties as well. This article presents selected results of the study, which was carried out in thescope of the EU project netMED (virtual institute on micromechatronics for biomedical industry).

Key words: Microsystems technology, MST, micro-electromechanical systems, MEMS, micromechatronics, medicaltechnology

Introduction

Microsystems technology (MST) is a young discipline

whose importance for the present as well as its potential

for the future is undisputed. The main characteristic of

MST is the possibility to integrate sensing, signal

processing, and actuating capabilities into a single

miniaturized device of only a few millimetres or less.

With these capabilities, microsystems can actively

influence their environment on the basis of stand-alone

decisions which are based on data acquired from their

environment. Further, the spectrum of sensing and

actuating components is very broad, comprising

micromechanical sensors, micro-optical elements, bio-

chemical depositions, micro-fluidic structures, and a

great number of mechanical actuators. Due to these

features, microsystems are good for use in numerous

biomedical applications (1,2). Cardiac pacemakers,

implantable hearing aids (3), and insulin pumps (4) are

only some examples of successful medical devices

whose function is based on MST. Those devices have

already achieved a remarkable importance in healthcare

industry, but the future potential of MST for medical

applications could only be exploited to a limited extent

so far. Material compatibility, electrical hazard, energy

supply, heat dissipation, and device stability are

current medicine-specific technical problems of

MST devices to be solved (5). Future medical

microsystems e.g. may enable knives to cut only

selected tissues (6), surgical grippers to feel grasped

objects (7), or self-propelling endoscopes to locomote

through tubular organs for diagnostic and therapeutic

purposes (8); implantable drug delivery devices may

drastically improve the medical care by means of

measuring respective parameters and delivering drugs

on demand in appropriate doses (9); the possibility to

simultaneously monitor multiple biomedical para-

meters may lead to significant progress concerning

novel treatment options due to more reliable data

about physiological and pathological mechanisms of

the human body.

The penetration of the medical technology market

with MST components is by far not as high as e.g. in

Correspondence: S. Schostek, Steinbeis University Berlin, Dorfackerstr. 26, D-72074 Tuebingen, Germany. Fax: +49-(0)7071-763574. E-mail:

[email protected]

Minimally Invasive Therapy. 2005; 14:6; 360–368

ISSN 1364-5706 print/ISSN 1365-2931 online # 2005 Taylor & Francis

DOI: 10.1080/13645700500393870

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the transportation industry, since the entry into the

healthcare market represents a considerable chal-

lenge for many companies working in the field of

MST (10). Research and development activities

in the healthcare industry are mainly carried out in

small and medium-sized enterprises (SMEs), in

contrast to the transportation industry. Those

organizations often cannot handle the high expendi-

tures which are necessary to implement microsys-

tems technology. In addition, innovative products

are traditionally judged conservatively in medicine.

A new technology has to be fully understood and

accepted, along with the proof of the medical

effectiveness of course, in order to be broadly used.

Furthermore, medical indications often require

highly specialized medical devices; thus, high lot

numbers, which are necessary to produce micro-

systems in an acceptable price range, are often

hardly achievable.

Since these problems are commonly known, high

effort has been made to overcome them. Special

funding programmes aimed at promoting the devel-

opment of microsystems for medical devices, the

creation of specialized foundries and interdisciplin-

ary research and development centres enabled SMEs

to develop microsystems on their own, and training

centres are increasing the acceptance of innovative

products among the customers.

The Institute of Healthcare Industries (IHCI),

Steinbeis University Berlin has conducted a study

among experts in medicine, technology, and indus-

try. The goal of the study was to learn more about

the actual market situation regarding medical

devices based on MST, and to obtain information

about the importance of specific medical applica-

tions and innovation requirements in this field. In

addition, a strategic orientation of an international

R&D network was developed, which can solve

current entry problems and, at the same time, uses

the specific chances and potentials of microsystems

in the biomedical sector.

This study was carried out in the scope of the

netMED project (GIRT-CT-2002-05113), which

was funded by the European Commission in the 5th

FP, and aimed at facilitating the applications of

R&D results of MST in the biomedical sector.

Within this project, a virtual institute was set up,

which is supposed to be a one-stop shop for users

looking for innovative and marketable solutions for

their needs. A total of nine partners located in six

European countries constituted the project consor-

tium (Table I).

Material and methods

The core element of the study was a formalized

questionnaire consisting of 35 main questions with

altogether 850 variables. It was designed in co-

operation with opinion leaders in medicine, MST,

and the healthcare industry. With this survey we

equally addressed experts from science and industry

about both technical and medical aspects, in order to

obtain representative data.

Structure of the questionnaire

The questionnaire was thematically structured into

six topics (Table II). In question block A, the

participants were asked demographical data (free

response) and information about their organizations

(categorized answers), while the blocks B to F

interrogated specific questions concerning different

aspects of medicine, microsystems technology, and

the related industries.

In blocks B to F essentially two question types

were used; the dominating type were questions with

a Likert scale, i.e. a rating scale for measuring the

strength of agreement with a clear statement, from

zero for ‘‘no importance’’ to four for ‘‘high

Table I. netMED consortium.

N Scuola Superiore di Studi Universitari e di Perfezionamento Sant’Anna, Italy (Project Coordinator)

N Katholieke Universiteit Leuven, Belgium

N Institute of Healthcare Industries, Steinbeis University Berlin, Germany

N Universita di Pisa, Divisione Chirurgia Generale e Trapianti, Italy

N Swiss Federal Institute of Technology, Switzerland

N Centre National de la Recherche Scientifique (CNRS), Laboratoire de Physique et Metrologie des Oscillateurs, France

N Institut fur Medizintechnik und Biophysik, Forschungszentrum Karlsruhe, Germany

N Consejo Superior de Investigaciones Cientifica, Spain

N El.En S.p.A, Italy

Table II. Topic-related subdivisions of the questionnaire.

Block A General data

Block B Applications in medicine

Block C Medical technology and medical products

Block D Components and interfaces

Block E Co-operations

Block F (Appendix) Medical applications in detail

Microsystems in medicine 361

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Page 3: Microsystems in medicine – results of an international survey

importance’’. The second question type asked to

pick up the three most important out of various

alternative answers, which were presented in a

special cross-tabled format. An alternative answer

was composed by marking the appropriate crossing

fields of a category out of the lines and a category out

of the columns.

A further characteristic of most questions from

parts B to F was the evaluation of the questions from

two perspectives: on the one hand from the view-

point of the healthcare market in general, on the

other hand from the viewpoint of the respondent’s

organization in particular. Thus, an organization

could rate specific aspects for the business in

general, even if these aspects are currently not

important for the organization itself. The reason

for this distinction was that we wanted to be able to

obtain representative data for the industry in general,

taking into account the high specialization of

individual organizations.

Body of data

A total of 109 experts from science and industry

participated in the survey. Almost every second

responding organization (48%) was a small and

medium-sized enterprise (SME) with between 10

and 499 employees. 12% of the answers came from

very small companies (one to nine employees), the

remaining 40% of the respondents were large

organizations with more than 500 employees.

The primarily targeted groups were significantly

represented, with 55% of the respondents belonging

to medical device companies and every third (33%)

coming from the MST domain. 56% of the

responding organizations were active in the field of

research and development; 28% were hospitals /

doctor’s practices. Other participants were active in

the fields of production, service, consulting, supply,

pharmaceutics / biotechnology, distribution, public

administration, and financing. The end users were

represented with 14% of the answers.

Statistical analysis

The data of the questionnaire were analyzed with the

statistics software SPSS (SPSS Inc., Chicago, USA).

The analysis relied mainly on descriptive statistics, in

particular mean values. We also computed standard

deviations, which describe the distribution of the

answer values around the mean value. With respect

to the explorative character of this study, inference

statistical methods were used sparingly. They were

used wherever ex ante hypotheses could guide

meaningful analyses to valid prognoses.

Results

Applications in medicine

Key finding: The application of microsystems technology

in medicine is focused on several specific indications. The

market demand for technologies to improve disease

prevention is still underestimated by industry.

The cardiovascular system, followed by the sensory

and metabolic organs, was identified as the most

important field of application for microsystems in

medicine (Figure 1). The continuously high discre-

pancy between the rating of MST for the healthcare

industry in general and for the individual organiza-

tion in particular, concerning the importance of

microsystems for different applications in medicine,

indicated a high grade of specialization of the

enterprises. Many of the respondents are interested

in one or few of the mentioned topics and therefore

gave high ratings of the topic for their own

organizations, while they were still recognizing the

importance of other fields for the branch. Especially

the end users of medical products, hospitals and

Figure 1. The importance of microsystems for different medical applications (extract).

362 S. Schostek et al.

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Page 4: Microsystems in medicine – results of an international survey

medical practices, showed a high sense for the

importance of the utilization of microsystems in

medical devices from the viewpoint of the healthcare

industry in general, in particular for the cardiovas-

cular system (M53.6, SD50.5) and diseases of the

endocrine system (M53.0, SD51.2).

The analysis of the importance of MST for

specific diseases in block F confirmed the leading

role of the cardiovascular system. The importance of

all cardiovascular diseases was rated by the respon-

dents as very high (M52.9 to 3.3, SD50.7 to 0.9),

while the field of metabolic organs was dominated by

diabetes mellitus (M53.0, SD50.9) and the field of

sensory organs by the sense of hearing (M53.3,

SD50.8) and the sense of vision (M53.2, SD50.8).

Microsystems turned out to be most important for

diagnostic, therapeutic, and monitoring purposes

(Figure 2). This situation was proven for both the

medical industry in general and the individual

organization in particular. Also the different market

participants generally agreed with the high impor-

tance of diagnosis, therapy, and monitoring as fields

of application for microsystems.

Prevention and rehabilitation turned out to be less

important in this context, according to the opinion

of the responding experts. While the importance of

these phases of medical care was almost equivalent

from the viewpoint of the industry, the activities of

the individual organizations were obviously more

focused on the field of prevention.

However, a clear discrepancy showed up by

comparing the opinion of the end users with the

opinion of the medical device industry (Figure 3).

While the medical device industry interpreted the

attractiveness of prevention as field of application for

microsystems as relatively low, the end users stated

to see a potential which is comparable to that of

diagnosis, therapy, and monitoring. This may

indicate that the healthcare industry is currently

underestimating the potential of MST for use in

preventive measures.

Future potential

Key finding: The future potential of microsystems

technology in medicine is assessed differently by indivi-

dual market participants. The creation of new products

as well as the expansion of functionality and miniatur-

ization of existing products are the most important issues.

The expectations regarding a positive effect due to

the use of microsystems in medical devices were

generally higher for the future than for the pre-

sence. Especially pharmaceutical and biotechnology

Figure 2. The importance of microsystems for specific phases of medical care.

Figure 3. The importance of microsystems for prevention, rated by the end users and the medical device industry for the own organization.

Microsystems in medicine 363

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Page 5: Microsystems in medicine – results of an international survey

enterprises as well as companies of the MST domain

were optimistic. According to the responding

experts, miniaturization (importance within five

years: M53.6, SD50.6; importance for today:

M53.3, SD50.9) was the essential advantage on

the product level achieved by the use of MST.

Furthermore, positive effects for the opening up of

new market segments (importance within five years:

M53.4, SD50.8; importance for today: M52.9,

SD51.0) as well as for present markets (importance

within five years: M53.3, SD50.8; importance for

today: M52.8, SD51.0) were expected.

The main expectation beyond the product level

was a general technological progress (M53.3,

SD50.8). Since a broad utilization of microsystems

in medical devices could hardly be achieved without

a corresponding adaptation of the workers, the

creation of new, specialized jobs (M53.1, SD50.9)

was by far more expected than the maintenance of

existing jobs (M52.3, SD51.1). Also, an increasing

competition among different companies was highly

expected (M52.9, SD51.0), in particular by phar-

maceutical and biotechnology enterprises.

Components

Key finding: The medical domain is paying particular

attention to microsensors. Piezoceramic and microfluidic

structures are dominating the field apart from the sensors.

The production of components of microsystems technology

is mainly carried out in small and medium-sized

enterprises.

In this study, the components of MST were grouped

into sensors, actuators, and structures. The partici-

pants were asked to rate the future importance of

altogether 29 components. Table III shows the

three most important components of each group,

respectively.

The end users of medical devices, hospitals and

medical practices, highlighted the importance of the

measurement of mechanical parameters, in particu-

lar pressure (M53.8, SD50.4), force- and bending

sensors (M53.1, SD50.9), torsion sensors (M52.5,

SD51.2), and length sensors (M52.5, SD51.1).

The pharmaceutical and biotechnology industry was

most optimistic regarding the future importance of

piezoceramic (M53.4, SD50.5) and fluidic

(M53.1, SD51.1) actuators as well as microfluidic

structures (M53.7, SD50.5).

SMEs were the most important suppliers of MST

components in the medical industry (M52.1,

SD51.5), followed by in-house production

(M51.9, SD51.7). Companies of the pharmaceu-

tical and biotechnology industry (M53.1, SD51.6)

and of the MST domain (M53.0, SD51.2) stated

that they produce the majority of microsystems on

their own, while the customers (M50.8, SD51.3)

didn’t have these capabilities.

Market entry problems

Key finding: The main problem of the introduction of

microsystems technology in medicine is the initial

investment.

First of all the results indicated a certain self-

confidence among the market participants, since the

responding experts rated the importance of specific

hurdles higher for the medical industry in general than

for their own organization. However, the high expen-

diture which is necessary for the establishment of MST

in medicine turned out to be the most important road

block concerning the utilization of microsystems in

medical devices (Figure 4). The different players of the

healthcare industry generally agreed on this point.

Compared to the problem of high initial costs,

every single remaining barrier was rated as signifi-

cantly less important. Difficulties due to insufficient

reimbursement, scepticism of the users, and low

reliability of the systems were judged to be delicate

but solvable. It is remarkable that problems con-

cerning the reliability of microsystems were playing a

comparatively big role for the individual organiza-

tions. Social aspects like an impairment of the

patient-doctor relationship (M51.5, SD51.1) or a

low social acceptance (M51.3, SD51.0) were

generally rated as least problematic.

Among the functional barriers, the risk of product

liability in the medical domain turned out to have

high importance for the industry in general, while

Table III. The future importance of specific sensors, actuators,

and structures (extract).

Future importance for

medicine / medical products

(05no importance, 45high

importance)

Sensors

Bio sensors M53.6, SD50.7

Chemical sensors M53.4, SD50.8

Pressure sensors M53.3, SD50.8

Actuators

Piezoceramic / ultrasound

actuators

M53.1, SD50.9

Electromechanical actuators M52.7, SD51.0

Hydraulic- / liquid-operated

actuators

M52.6, SD51.0

Structures

Microfluidic structures M53.3, SD50.8

Valves M53.3, SD50.8

Electrodes M53.2, SD50.8

364 S. Schostek et al.

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difficulties in implementation of new MST compo-

nents was very significant for the individual organi-

zations in particular (Figure 5). Further important

hurdles, from the viewpoint of the industry in

general, were mainly of a non-technical nature, such

as strong competition with established conventional

products (M52.6, SD51.1) or problems in search-

ing partners in the industrial environment (M52.6,

SD51.1) or in judging the healthcare market

(M52.4, SD51.0).

Preconditions

Key finding: The access to international R&D networks

is an important precondition for a widespread use of

microsystems technology in medicine. The experiences

concerning the commercialization of R&D results focus

on the phase of research and development.

The preconditions for a broad use of MST in

medical devices were different for the healthcare

industry in general and for the individual organiza-

tions in particular. The most important precondition

for the medical industry in general was a good

availability of integrated MST solutions. Other

preconditions, which were relatively important as

well, were of a non-technical nature: Increase of

acceptance among the payers / health insurances

and special funding programmes. Most important

for the individual enterprises was an easy access to

international research and development networks,

followed by special funding programmes and the

creation of interdisciplinary development centres

(Figure 6).

Know-how in the commercialization of R&D

results was available basically for the R&D phase

(technical research, consulting, filing patents). With

increasing concretization of a product development

(foundation of a start-up company, joint ventures,

licensing), the experiences were decreasing

(Table IV).

Networking

Key finding: Co-operations are dominated by technical

issues. Medical technology enterprises are favoured as co-

operation partners due to their reliability; creativity is

assigned to universities.

Co-operations turned out to be dominated by topics

concerning technical issues during the research and

development phase, in particular technical research

Figure 4. The importance of specific hurdles for the broad utilization of microsystems in medicine (extract).

Figure 5. The importance of specific functional problems / barriers for the utilization of microsystems in medical devices (extract).

Microsystems in medicine 365

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(M52.8, SD51.3), test / assessment (M52.7,

SD51.2), and design of prototypes (M52.6,

SD51.4). They were followed by non-technical

topics during the product development, which were

consulting (M52.3, SD51.3), financing (M52.1,

SD51.6), and market research (M52.0, SD51.4).

Issues with regard to the manufacturing of products

played a subordinate role (Limited-lot production:

M51.9, SD51.5; Assembling: M51.8, SD51.4).

Topics related to the commercialization of R&D

results have lowest importance in co-operations with

external partners (Distribution / marketing: M51.7,

SD51.4; Licensing: M51.6, SD51.4).

The most important criteria for the assessment of

the work of an external co-operation partner were

professionalism, reliability, and creativity / innova-

tivity, according to the opinion of the responding

experts. Regional presence, reputation, as well as

promptness were less important in this context.

The most important quality of universities and

non-university research institutes turned out to be

their creativity. Consulting firms and medical device

companies were thought to be the most professional

and reliable organizations.

Networks

Key finding: Assistance is required both on functional

and strategic level. Small organizations as well as

research institutes will have most profit by the use of a

R&D network.

The present study paid attention to the general

conditions for the establishment of an international

R&D network by means of netMED as a virtual

institute. The netMED network was supposed to be

a ‘‘one-stop shop’’ for users looking for innovative

and marketable solutions for the conversion of R&D

results of microsystems technology into applications

in medicine.

A certain demand addressed to an international

R&D network emerged for the assistance particularly

at an early stage of a product development process.

Thus, assistance in acquiring grants (M52.9,

SD51.2) turned out to be the most important

offering of such a network, followed by technical

research (M52.8, SD51.2) and services for product

regulatory approval (M52.7, SD51.1). The market

participants showed a great willingness to provide

assistance in technical research to other netMED

partners in return (M52.6, SD51.4). The largest

discrepancy between supply and demand emerged in

Figure 6. The importance of specific preconditions for an increased utilization of microsystems in medical devices (extract).

Table IV. Specific experiences concerning the commercialization

of R&D results.

Experience (05no

experience, 45high

experience)

Contract research and development M52.7, SD51.4

Consulting / expertise M52.5, SD51.3

Filing patents M52.3, SD51.4

Foundation of a spin-off company M51.7, SD51.5

Joint venture M51.5, SD51.3

Licensing M51.5, SD51.3

366 S. Schostek et al.

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the case of assistance in market research. The high

demand (M52.6, SD51.3) faced only a reserved

offering (M51.8, SD51.4).

The preferred business connection turned out to

be membership in an industry liaison programme

(M52.5, SD51.2) in most cases. Purchase orders /

contracts (M52.1, SD51.2) were preferred by large

SMEs with 250 to 499 employees (M52.8,

SD51.5). Joint ventures (M51.8, SD51.4) and

licensing (M51.6, SD51.3) were particularly

favoured by very small (joint ventures: M52.3,

SD51.3; licensing: M51.8, SD51.2) and very large

enterprises (joint ventures: M52.1, SD51.5; licen-

sing: M52.1, SD51.4).

Discussion

Microsystems technology (MST) can improve both

the quality and safety of healthcare delivery.

Although several medical devices based on MST

have been successfully brought to the market, the

potential of MST for medical technology has not

been exploited to the full extent so far since the

different players of the healthcare industry have to

cope with certain difficulties, both of a technical and

a non-technical nature. But our study demonstrates

that the efforts in utilizing MST for medical

applications are still ongoing.

MST will have a positive effect on existing

products, due to their miniaturization capabilities

mainly. It will further facilitate the opening up of

new market segments since microsystems make

many biological systems accessible for the first time

and they combine sensing, signal processing, and

actuating capabilities on the smallest space, which

may enable future intelligent medical devices

to reach stand-alone-decisions on therapeutic

measures. Widespread health disorders like diseases

of the cardiovascular system or diabetes represent

important indications for novel medical devices

based on MST. Thus, those medical indications

seem to be attractive for the application of MST

which promise high lot numbers, involve anatomical

and/or physiological structures that are delicate to

influence, and have a significant social and economic

impact. However, this outline of the market might

not be crucial for the realization of novel medical

products, but an analysis of the field of application,

restricted to the use of the respective product, since

MST allows an adaptation of a medical device to

highly specialized fields of application.

But there are significant information deficits,

on the one hand about characteristics of related

industries, on the other hand with regard to the

phase of product concretization. Basic research and

development (R&D) is carried out mainly in

universities, due to their creativity and innovativity.

But with increasing proximity to the product phase,

non-technical competences gain importance, and

the responsibility shifts more and more to private

enterprises. Especially in the case of the transfer of

MST into medical applications, various interfaces

between different phases of product development,

like adapting basic R&D results into a customer

orientated development process, further founding a

start-up company, and launching the product

successfully and sustainably into the market, neces-

sitate certain experience and special knowledge.

Our study demonstrates that the approach to

accompany the whole development process by an

international R&D network is a promising option to

overcome the said difficulties. Further, the concept of

the netMED project to encourage the users to provide

own services to the network in return seems to be

sustainable. The only discrepancy between demand

and offering emerges in the case of market research.

We of course have to acknowledge that our study

only represents a snapshot of the fast changing

healthcare environment. Writing this, changes on

organizational and monetary issues go into effect.

However, all players of the healthcare market, in

particular university and non-university entities, care

providers, and, last but not least, insurers and

politicians, have to work together in order to create

a positive atmosphere, in which the potentials of

MST in medicine can be exploited with positive

effects for all involved.

Acknowledgements

The research for this study was funded by the

European Union in the scope of the project netMED

(virtual institute on micromechatronics for biomedical

industry, GIRT-CT-2002-05113) in the 5th FP.

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