The German Medical Technology Industry · 6 The high-tech industry at a glance Revenues 2017 – 2018 2017 » 63,7% 2018 Export rate 65,4% Overall revenue €30.28 billion 2018 2017

The German Medical Technology Industry SPECTARIS Yearbook 2019 / 2020

With friendly support from:

Highly innovative with strong

exports – medical technology

“Made in Germany” enjoys great

popularity across the globe and has an

excellent reputation. Many of these med-

ical technologies are cutting-edge and are

thus important economic drivers. They

make a significant contribution to Germa-

ny’s position as an industrial centre. Ger-

man medical technology companies invest

around 10% of their revenue in research

and development – more than double the

amount of the average German industrial

company. The medical technology indus-

try also plays a crucial role in helping us

to master challenges like demographic

change. More than virtually any other in-

dustry, medical technology relies on a very

diverse range of key enabling technolo-

gies: the sector makes good and proactive

use of the opportunities deriving from

Germany’s high-tech capabilities.

Innovations in medical technology are in-

creasingly the result of interdisciplinary

collaboration between different technol-

ogies and scientific disciplines. In many

forward-looking areas, such as regenera-

tive and bespoke health, as well as tele-

health and e-health, the industry’s players

are reaching out into uncharted areas of

medical technology. I therefore believe it

is crucial to use our funding instruments

to continue supporting, in a differentiated

and target-orientated manner, the inno-

vative capacities and research activities of

our companies. Our support goes not least

to start-up companies, small and medi-

um-sized enterprises and the funding of

advances in technology.

The most significant factors influencing

the medical technology industry at present

are probably digitalisation and artificial

intelligence. Digitalisation of medical sup-

ply and production processes is in full

swing; more and more operations are be-

ing carried out with the use of robot-as-

sisted systems. Micro-robots are injected

into the bloodstream to measure blood

pressure, and machine learning allows for

greater precision in analyses of imaging

data. Adaptive systems support laboratory

employees and physicians in fields where

computers outperform humans: in the

analysis of large data quantities, recogni-

tion of patterns, and the cross-referencing

of a large number of symptoms. In the

end, this results in greater security for the

physician and the patient.

We will continue to support our compa-

nies as they master challenges like these.

Germany’s Artificial Intelligence Strategy

is designed in an adaptive manner, to be

continuously and collaboratively updated

by science, business, and civil society: we

want to display courage and creative drive

as we develop artificial intelligence which

serves the interests and well-being of hu-

mankind.

On this note, I wish you and all of us con-

tinued economic success and hope that

the articles in this publication will stimulate

your thinking and discussions.

Peter AltmaierFederal Minister for Economic Affairs and Energy

Message of greeting

2

SPECTARIS Yearbook 2019/2020 | Medical Technology

Table of contents Greetings ......................................................................................................................... 1 – 4

Industry The medical technology industry in Germany .................................................................. 5 – 9

The medical technology in Europe ................................................................................... 10 – 11

The global medical technology industry ........................................................................... 12 – 15

MEDICA – World Forum for Medicine .............................................................................. 16 – 17

International markets German medical technology is in demand – even as it faces growing

challenges on world markets ............................................................................................ 18 – 20

SPECTARIS partnership project in East Africa – initial successes and prospects

for the second phase ....................................................................................................... 21

Russian market for medical technology continues to grow ................................................ 22 – 23

The Brazilian medical technology market is booming ........................................................ 24 – 25

Medical technology in China: A lucrative, but increasingly competitive market ................. 26 – 29

Regulatory affairs With the date of application only a little over six months away – what is the state

of the Medical Device Regulation? ................................................................................... 30 – 33

Successful approval of medical products in China – a road with many obstacles ............... 34 – 36

Health spending ............................................................................................................... 37

“Hazardous substances” under the Medical Device Regulation ......................................... 38 – 39

Connecting medical devices across manufacturers ............................................................ 40– 41

Research & Innovation The innovative force of German medical technology producers ....................................... 42 – 43

Public healthCooperation agreements with medical institutions and industry experts ........................... 44 – 46

Health spending ............................................................................................................... 47

Ethical aspects in nursing bed care .................................................................................. 48 – 49

DigitalisationRequirement for the digitalisation of the healthcare system: the further

development of assessment procedures .......................................................................... 50 – 51

Digitalisation and lack of skilled labour ............................................................................ 52 – 53

A strong domestic market as a driver of global success – how Germany can

defend its edge in medical technology ............................................................................ 54 – 55

ProfileMedical Technology in the German Industry Association SPECTARIS ................................ 56 – 58

German Industry Association SPECTARIS ......................................................................... 59

3

4 Greeting | Dr Martin Leonhard · Chairman Medical Technology in the German Industry Association SPECTARIS

The German medical technology

industry is growing. Drivers in the

background are the innovative force

of the sector and demographic change.

Growth is, however, slowing down signif-

icantly. In spite of all lip service paid to the

strengthening of Germany as an industri-

al centre, which is in many respects the

foundation on which our international

success story is built, a rising number of

regulatory burdens are impeding further

growth. Growth and innovation go hand

in hand with new and additional oppor-

tunities for the diagnosis and treatment

of patients, who depend on this progress.

Medical technology helps us heal. We

see it as our obligation to open up new

market opportunities for both users and

patients.

As SPECTARIS, we represent the interests

of the German medical technology indus-

try, which is still shaped by many small

and medium-size enterprises. The new

European Regulation on medical devices

will enter into full effect six months from

now. Implementing the new framework

will require great effort and equally size-

able resources. Companies are will have

to invest large percentages of their annu-

al revenues into implementing the Medi-

cal Device Regulation (MDR). A study by

the Swiss Federal Office of Public Health

and the State Secretariat for Economic

Affairs forecasts a total of 9.3% of EU

revenues each year. This negatively im-

pacts innovative projects. Niche products

will disappear from the market, together

with the companies serving these niches.

This above all affects small and medi-

um-sized enterprises (SMEs). An exempla-

ry company developing and marketing eye

implants for the visually impaired has al-

ready ceased operations together with

other market participants. Other compa-

nies move abroad or have their products

initially or solely approved for the US mar-

ket. By now, access to the US market is

easier than accessing the European home

market. This sends a fateful signal to Ger-

many’s innovative capacities.

As an association, we focus on the inter-

ests of our member companies, on the

interests of the German medical technol-

ogy industry. The regulatory environment

will continue to become more restrictive

after the MDR. On a national as well as

international scale. Before any market pro-

cesses manage to sort out the situation,

we need to design our processes in a more

efficient manner to meet mounting reg-

ulatory pressure. Let’s also take these chal-

lenges as an opportunity. We will grow

more powerful if you share your expertise

and examples from everyday business with

us.

Our contribution to the political discussion

is particularly valued so much because we,

SPECTARIS, explore and represent interests

in a well-founded manner. The trust you

as a member place in our association is

shared by our partners in politics and pub-

lic administration.

Our yearbook again explores the key issues

and topics in the MedTech industry, with

the MDR being just one of many diverse

challenges. I hope you enjoy reading

through this edition and would be delight-

ed to welcome you as a fellow campaign-

er for better framework conditions for our

medical technology industry.

I would like to thank all members, sup-

porters, and partners for their constructive

cooperation, built on trust.

Dr Martin Leonhard

Medical Technology in the German

Industry Association SPECTARIS

Dr Martin LeonhardChairman Medical Technology in the GermanIndustry Association SPECTARIS

5


Industry | The medical technology industry in Germany

The medical technology industry in GermanyThe German medical technology is a job motor; growth threatened by over-regulation

A report of the Federal Statistical Office

showed that the 1,350 German producers

of medical technology generated overall

revenues of 30.3 billion euros in 2018. This

calculation equates to a 1.2% growth over

the previous year. As a result of changes

to the calculation basis, the values of 2017

and 2018 can only be compared to a cer-

tain extent, with actual growth probably

somewhat higher. Domestic revenues

were 10.5 billion euros, with foreign rev-

enues amounting to 19.8 billion euros.

The industry is highly innovative and

shaped by SMEs: Over 93% of companies

in the industry have fewer than 250 em-

ployees. The R&D ratio, i.e. the share of

expenditures for research and develop-

ment relative to the overall revenue, is at

9%. Similarly to previous years, the num-

ber of employees increased in 2018, by

3.9% to around 143,200. The industry

above all sees itself confronted with in-

creasing over-regulation, particularly as a

result of the new ordinance on medical

devices. Many companies expect this to

jeopardise further revenue and employ-

ment growth and already today see the

first signs of this development.

The industry benefits from trends in society, but has difficulties finding skilled employees

On the other hand, there are opportunities

as a result of demographic changes, par-

ticularly in the mature economies, as well

as opportunities opened up by sizeable

health investments in many emerging

economies. The growing importance of

good health, as well as technological in- » Source: SPECTARIS, Federal Statistical Office

Employees and companies

2017 – 2018

2018 » 143.178

2018 » 1.352

2017 » 137.857

2017 » 1.310

+ 3,9%

+ 3,2%

Employees

Companies

Contact: Mike Bähren

SPECTARIS e. V.

novations and further development, are

market drivers. Digitalisation currently has

the greatest impact on the sector. The

health economy is undergoing a phase of

rapid change. Digitalisation is already now

influencing all areas of care, and the busi-

ness model of producers is changing as a

result: from the classical device technolo-

gy providers of the previous decade to

solutions providers in the current decade,

up to providers of digital and comprehen-

sive health solutions in the coming decade.

6

The high-tech industry at a glance

Revenues 2017 – 2018

2017 » 63,7%

2018

Export rate

65,4%

Overall revenue

€30.28 billion

2018

2017 » €29.93 billion

Domestic revenue

€10.49 billion

2018

2017 » €10.85 billion

Foreign revenue

€19.79 billion

2018

2017 » €19.08 billion

» Source: SPECTARIS, Federal Statistical Office

Notes:

» The figures refer to companies with 20 or more employees» Including small companies: €32.73 billion, 11,600 companies, 198,000 employees (2016)


To make sure that the full potential of this

change can be exploited, the framework

conditions of Germany as a leading mar-

ket must be optimised and the problem

of a lack of qualified personnel countered

purposefully.

Trade barriers hinder international business

With an export rate of over 65%, foreign

business is of great importance. Around

42% of German medical technology ex-

ports were to countries of the European

Union in 2018. As such, the robust devel-

opment of demand from these countries

was a key pillar of industry growth. How-

ever, Brexit is already casting its shadows

over business with the UK – exports in

2017 fell 7% short of the previous year.

In 2018, exports again decreased slightly.

With a look to the coming year, it is also

expected that revenue growth will lose

some of its traction as a result of the new

Medical Device Regulation. Demand from

North America again grew in 2018, but

growth was comparatively weak at 3%.

On the other hand, the development of

exports to China was very positive, with

a high increase of 12%. After exports to

Russia increased by almost 28% in 2017,

growth was a bit weaker in 2018, but still

positive at 4%.

The global market for medical technology continues to grow

The market drivers explained above give

producers fairly positive expectations for

the coming years; revenue is expected to

grow in 2019 and 2020 as well, even with

the possibility of growth slowing against

the backdrop of economic development

as well as the illustrated over-regulation.

Experts forecast average annual growth

of the world market for medical technol-

ogy of around 5.6% over the coming

years. The market size should reach 595

billion US dollars in 2024. German medi-

cal technology – with its high innovative

force, good positioning, and internation-

al competitiveness – will continue to

benefit from this development.

7


Overall revenue

» Companies with 20 or more employees; figures contain rounding differences


» The figures refer to companies with 20 or more employees.


Medical technology benefits from international business

Revenues 2011 – 2018 (in billion €)

SMEs shape the sector

When looking at the distribution of German medical technology

producers by size categories, it becomes apparent that the in-

dustry is shaped by SMEs. The 1,262 companies with fewer than

5

10

15

20

25

30

7,825

10

15

20

25

30

2013

24.62

15.9

1

8.72

Foreign revenueDomestic revenue

5

10

15

20

25

30

< 50 employees

50 – 99 employees

100 – 249 employees

250 and more employees

Total employees

143,178

1,352

€30.28 billion

77,282

90

€21.89 billion

22,911

151

€4.08 billion

16,254

233

€2.00 billion

26,731

878

€2.31 billion

2011

23.17

14.4

6

8.71

2012

24.10

15.5

1

8.60

2014

25,44

16,3

9

9,05

20159.

97

17.6

3

27.60

2016

10,5

8

18,6

1

29.19

2017

10.8

5

19.0

8

29,93

2018

10.4

9

19.7

9

30.28

250 employees offered almost 66,000 jobs in 2018, realising

revenues of 8.4 billion euros.

Com

pani

esRe

venu

e

8

Bavaria

6.1 billion

30,685

179

North Rhine-Westphalia

1.6 billion

13,094

227

Bremen

95 million

690

12

Hamburg

614 million

3,266

25

Schleswig- Holstein

2.3 million

10,184

64

Mecklenburg- Vorpommern

185 million

1,981

36

Berlin

623 million

4,153

68

Brandenburg

166 million

2,484

53

Lower Saxony

1.1 billion

7,218

91

Saxony

391 million

3,954

85

Saxony-Anhalt

69 million

1,131

33

Saarland

982 million

2,378

11

Rhineland-Palatinate

223 million

2,454

55

Baden- Württemberg

6.6 billion

34,839

265

Thuringia

887 million

4,837

57

Hesse

3.3 billion

13,523

88

» The figures are for the year 2018 and for companies with 20 employees or more. For reasons of confidentiality, the data of some federal states do not include Economic Class 26.6. (Production of Radiation and Electrotherapy Devices).


Federal states invest in medical technology

When looking at the regional distribution of companies active

in the production of medical technology, it becomes clear that

Baden-Württemberg holds the top spot as regards the number

of producers and revenue. The state is joined at the top by Ba-

varia, Hesse, Schleswig-Holstein, and North Rhine-Westphalia.

Most federal states already recognised the massive potential of

medical technology long ago and initiated measures to actively

promote the establishment of new companies in this sector.

> €1 billion

€500 million–€1 billion

< €500 million

Revenue

KEY:


9


International comparison of healthcare expenditure

Industry | International comparison of healthcare expenditure

In an international comparison of healthcare expenditure, relative to the national gross

domestic product, Germany and France are among the three highest spenders, with 11.2%

each. Only the USA (16.9%) and Switzerland (12.2%) spend an even higher share on healthcare.

For comparison: This value was still at 10.2% in 2005. The OECD average was 8.8% in 2018.


SPECTARIS e. V.

» Source: OECD Health Data

Health expenditure of selected countries as a % of the gross domestic product in 2018

4.2

16.9

12.2

11.2

11.2

11.0

10.9

10.7

10.5

10.4

10.3

10.2

9.9

9.8

9.3

9.3

9.1

9.1

8.9

8.9

8.8

8.3

8.1

7.9

7.8

7.5

7.5

7.0

6.8

6.7

6.6

6.4

6.3

5.9

5.5

5.4

USA

Switzerland

Germany

France

Sweden

Japan

Canada

Denmark

Belgium

Austria

Norway

Netherlands

United Kingdom

New Zealand

Australia

Portugal

Finland

Chile

Spain

Italy

Iceland

Republic of Korea

Slovenia

Greece

Israel

Czech Republic

Ireland

Lithuania

Slovakia

Hungary

Estonia

Poland

Latvia

Mexico

Luxembourg

Turkey

10 Industry | The medical technology industry in Europe

Medical technology in Europe Germany is ahead of the curve

G erman medical technology companies assume the lead-

ing position in Europe. Of all revenues realised by the

industry within the EU – around 78 billion euros in 2016

–, 40% are generated by German producers. There are a total of

68,000 European companies active in medical technology (in-

cluding small enterprises), and they employ around 530,000

people. These figures clearly illustrate how important the med-

ical technology sector is not just for Germany, but the European

economy as a whole.

1 In 2016 or the last year with figures available; including small enterprises

» Source: SPECTARIS, Eurostat

Country Revenue ¹ (in millions)

1. Germany 32,729

2. France 11,360

3. Italy 9,797

4. United Kingdom 7,189

5. Sweden 2,274

6. Denmark 2,245

7. Spain 2,094

8. Austria 1,733

9. Netherlands 1,568

10. Belgium 1,475

11. Poland 1,170

12. Hungary 1,118

13. Finland 954

14. Czech Republic 832

15. Portugal 379

16. Slovakia 265

17. Romania 194

18. Iceland 146

19. Slovenia 144

20. Other EU countries 492

Spain

€2,094 million

7


SPECTARIS e. V.

Austria

€1,733 million

8

Belgium

€1,475 million

10

11


» Note: The figures refer to the respective overall revenue of local producers in 2016 or the last year with figures available (including small enterprises)

» Source: SPECTARIS, Eurostat

France

€11,360 million

2

Italy

€9,797 million

3

Sweden

€2,274 million

5

Dänemark

2.245 Mio. €

6

The Netherlands

€1,568 million

9 1

Germany

€32,729 million

52% of German medical technology

exports are to European countries

United Kingdom

€7,189 million

4

> €5 billion

€1 billion–€5 billion

< €1 billion

Revenue

KEY:

12

NORTH AMERICA


CENTRAL AND SOUTH AMERICA

18.5%(+3.2%)

26.7%(+ 4.9%)

THE REST OF EUROPE

11.9%(-6.0%)

9.6%(+2.6%)

3.6%(+9.5%)

6.3%(+17.2%)

The importance of emerging markets continues to grow, Europe still the most important trade partner

Industry | The global medical technology industry


SPECTARIS e. V.

3.91USA

TOP 5 countries of origin for German imports

Switzerland

China

Japan

The Netherlands

2017 (billion EUR)2018 (billion EUR)

1.55 1.67

1.101.02

0.820.74

0.780,64

4.12

0 0.5 1 1.5 3 4 4.52 2.5 3.5

USA4.20

TOP 5 target countries for German exports

4.05

1.971.75

1.531.48

1.51

1.131.12

China

France

The Netherlands

Italy

2017 (billion EUR)2018 (billion EUR)

0 0.5 1 1.5 3 4 4.52 2.5 3.5

1.46

13


AFRIKA

REST OF THE WORLD

EUROPEAN UNION

ASIA

MIDDLE EAST

42.1%(+3.2%)

33.0%(+7.8%)

18.7%(+4.5 %)

19.9 %(+5.1 %)

3.7%(-5.2%)

1.0%(+7.9%)

1.9%(+3.8%)

0.1%(+12.0%)

1.8%(+2.9%)

1.2%(+21.2%)

Share of the overall German medical technology exports in 2018 (in brackets: export growth/decrease)

Share of the overall German medical technology imports in 2018 (in brackets: import growth/decrease)

Import

Export

KEY:

T he most important export region for German medical tech-

nology in 2018 was the European Union, with 42% of

exports relevant to the industry made to EU countries. Add

to this the exports to other European countries (9.6%), and

over half of exports of medical technology goods was made to

another European state. Almost 19% of exports were delivered

to both North America and Asia. European Union countries also

dominated in terms of imports, accounting for a 33% share of

all German imports, followed by North America (share: 26.7%)

and Asia (19.9%).

»» Source: SPECTARIS, Federal Statistical Office

14

www.spectaris.de

Der Weltmarkt für Medizintechnik wächst weiter

Quelle: Frost & Sullivan

» Erwartetes Wachstum Gesamt-markt 2019: +5,6 %

Orthopädie 12,2 %

Robotische Assistenzsysteme

1,9 %

Andere Bereiche

25,3 %


» Hilfsmittel, medizinische Ausrüstung und Mobiliar, Verbrauchsgüter, Sterilisation, Dekontamination

Ästhetische Medizin 1,8 %

Neurologie 2,7 %

Urologie/Gynäkologie 1,8 %

Respiratorik/Anästhesie 4,6 %

Audiologie 4,3 %

Patientenüberwachung 5,1 %

Wundversorgung 5,3 %

Ophthalmologie8,4 %

Kardiologie9,4 %

Asien und Pazifik25,9 %

Nordamerika39,2 %

Mittel- und Südamerika4,6 %

Restliche Welt3,3 %

Europa27,0 %

445,5 Mrd. USD

Der Weltmarkt 2019 für Medizintechnik nach Bereichen

Der Weltmarkt 2019 für Medizintechnik nach Regionen

445,5 Mrd. USD

Minimal-Invasive Medizin10,3%

Bildgebende Verfahren 7,1 %

Minimally invasive medicine10.3%

Industry | The global medical technology industry

The global market for medical technology continues to offer great potential

» Source: Frost & Sullivan

The global medical technology market in 2019 by segment

T he market research company EvaluateMedTech expects

the global market for medical technology and in-vitro

diagnostics (IVD) to show average annual growth of 5.6%

up to 2024, to reach a volume of 595 billion US dollars. The

consultancy company Frost & Sullivan estimates the global

market volume of medical technology (without IVD) to amount

to 422 billion US dollars and expects the market to grow by

5.6% to 446 billion US dollars.

Orthopaedics12.2%

Cardiology9.4%

Ophthalmology8.4%

Wound care5.3%

Patient monitoring5.1%

Audiology4.3%

Respiratory/Anaesthesia4.6%

445.5 billion USD

Urology/Gynaecology1.8%

Aesthetic medicine1.8%

Robotic assistance systems

1.9%

Neurology2.7%

Other segments25.3%

Imaging methods7.1%

15


» Source: Frost & Sullivan, EvaluateMedTech

www.spectaris.de

Der Weltmarkt für Medizintechnik wächst weiter


» Erwartetes Wachstum Gesamt-markt 2019: +5,6 %

Orthopädie 12,2 %

Robotische Assistenzsysteme

1,9 %

Andere Bereiche

25,3 %


» Hilfsmittel, medizinische Ausrüstung und Mobiliar, Verbrauchsgüter, Sterilisation, Dekontamination

Ästhetische Medizin 1,8 %

Neurologie 2,7 %

Urologie/Gynäkologie 1,8 %

Respiratorik/Anästhesie 4,6 %

Audiologie 4,3 %

Patientenüberwachung 5,1 %

Wundversorgung 5,3 %

Ophthalmologie8,4 %

Kardiologie9,4 %

Asien und Pazifik25,9 %

Nordamerika39,2 %

Mittel- und Südamerika4,6 %

Restliche Welt3,3 %

Europa27,0 %

445,5 Mrd. USD

Der Weltmarkt 2019 für Medizintechnik nach Bereichen

Der Weltmarkt 2019 für Medizintechnik nach Regionen

445,5 Mrd. USD

Minimal-Invasive Medizin10,3%

Bildgebende Verfahren 7,1 %

The global medical technology market in 2019 by region

445.5 billion USD

Europe 27.0%

North America 39.2%

Central and South America

4.6%

Asia and the Pacific 25.9%

The rest of the world 3.3%

» Expected overall market growth for 2019: +5.6%

16

Guest article

With friendly support | MEDICA – World Forum for Medicine

MEDICA – World Forum for Medicine Where all global players in medicine meet to discuss health market trends

M edical technology industry is facing the future, more

dynamic, digital, and connected than ever before. One

must keep up with current developments to meet the

challenges of tomorrow. Companies, opinion leaders, decision-

makers, and medical as well as business and research experts

need a shared platform for dialogue and international business.

Medica has been this platform for almost 50 years. The wold’s

largest and leading medical trade fair welcomes exhibitors,

visitors, and press representatives from across the globe to

Düsseldorf each year in November. It serves as the yardstick of

global goings-on: three-quarters of all exhibitors, regularly over

5,000 of them in the previous years, are international. The over

120,000 specialists who visit the trade fair come from more than

150 countries.

The supplier trade fair COMPAMED has shown similarly strong

growth since the first edition in 1992. It takes place simultane-

ously with the MEDICA in Düsseldorf, and has developed into

the uncontested hotspot for complex high-tech solutions. In

addition, it has become the internationally leading event in its

industry as well, with the last edition drawing 800 exhibitors and

around 20,000 visitors.

17

Contact:Messe Düsseldorf GmbH · Infoservice · Messeplatz · D-40474 Düsseldorf

Phone: +49 (0)211 4560 - 01 · Fax: +49 (0)211 4560 - 668 · EMail: [email protected] · www.messe-duesseldorf.de

Everything – in a nutshell

The key driver behind the success of the trade fair, in addition

to its unrivalled international character, is the range of topics

covered at MEDICA. It not only spans the individual subsegments

of the market in a clearly structured and focussed manner, but

also complete processes of outpatient and inpatient care. Key

areas are electromedicine and medical technology, digital health

(incl. m-Health, e-Health, IT for medical practices and clinics),

laboratory technology and diagnostics, physiotherapy and

orthopaedic technology, medical products, as well as medical

furniture.

The COMPAMED fair, which takes place at the same time,

rounds off this offer, turning the event into a permanent fixture

where all players along the entire value-added chain meet and

discuss medical technology devices, instruments, and products

each year. This creates the perfect framework conditions for

producers of medical technology, as well as their users and sup-

pliers, to enter into new partnerships and work towards the

success of shared projects.

Providing trendsetters with impulses

Those who consider themselves trendsetters in an already

particularly innovation-driven industry must be creative and

constantly reinvent themselves – just like MEDICA. New pro-

gramme elements are developed time and again, expanded into

indispensable components of the event in close collaboration

with renowned industry partners.

Digitalisation? That’s not just a hyped trending topic, but part

of everyday operations at MEDICA. Still-sceptical physicians

already attended a special exhibition on a first IT offer for

physician practices in the 1980s. This initially developed into the

MEDICA MEDIA, which then became the MEDICA HEALTH IT

FORUM dialogue platforms – with a trailblazing mix of stage

events, expert discussions, and exhibition areas.

Connectivity? That’s only now picking up steam in Germany.

With a look to global trends, MEDICA has already been provid-

ing the right orientation assistance for years – with the MEDICA


CONNECTED HEALTHCARE FORUM and the integrated MEDICA

App COMPETITION as the central pitch for the best global mobile

health solution.

Entrepreneurial spirit? As the industry’s most important

sources of ideas, digitally driven start-ups are given a permanent

stage each year at the MEDICA START-UP PARK. Other exhibitors

have by now recognised the potential of this concept, copying

it in “friendly recognition” of MEDICA, along with the MEDICA

App COMPETITION. This only proves that the global number one

is on the right track!

MEDICA is and remains the original trade fair, with many

exhibition highlights, integrated forums, and accompanying

conferences.

Information can be found online at:

https://www.medica.de

https://www.compamed.de

18 International markets | German medical technology is in demand – even as it faces growing challenges on world markets

German medical technology is in demand – even as it faces growing challenges on world markets

Medical technology from Germany is in demand across

the globe. Successes in collaborations with other

countries are substantiated by the industry figures:

With an export rate over 65%, the most important markets are

situated outside of the home market, whereby the EU countries

traditionally account for the lion’s share of export activity at over

40%. North America and Asia take up the next spots, both with

shares of almost 19%. Asian companies realised growth of

almost 5% in 2018. Furthermore, Latin American markets have

recovered a bit, once again showing growth of around 5% over

the previous year.

The trade conflict between the large US and Chinese markets

is however dampening the positive trends somewhat and result-

ing in greater compliance expenditures for companies. The USA

has withdrawn from the Joint Comprehensive Plan of Action

(JCPoA), which has resulted in US sanctions, above all against

foreign financial institutions. Business with Iran has for the most

part ground to a halt for many German producers of medical

technology, in spite of exception regulations in place. The

remaining parties to the JCPoA have not yet managed to find

an effective countermeasure. The establishment of INSTEX –

Instrument in Support of Trade Ex-

changes – is only forecast to

compensate for the major

withdrawal of foreign

financial institutions

from doing business

with Iran in the me-

dium to long term.

The current leit-

motif pursued by

the USA, “Ameri-

ca first”, is further-

more reflected in

various new legis-

lative initiatives to

intensify US sanctions

against the Russian Feder-

ation as well as to impose

potential sanctions against EU products. The volatility of US trade

and customs policy as well as “Brexit”, which was still pending

by the copy deadline, carry with them great insecurity and risks

for companies. With its comprehensive range of information and

by representing interests at the German, European, and US lev-

el, SPECTARIS attempts to exert influence on the current political

developments and to counteract punitive duties as well as further

intensification of US sanctions.

At the same time, successes have become apparent in the area

of free trade agreements, which can have a positive effect on

exports of German medical technology. The Economic Partnership

Agreement between Japan and the EU, the most comprehensive

free trade agreement ever negotiated by the EU, took effect on

1 February 2019. The agreement has achieved decisive improve-

ments to non-tariff trade barriers. For example, Japan agreed to

further liberalise access to public tenders, among other things

allowing European companies to participate in tenders for 51

universities, 25 hospitals, and 11 industry and industrial research

centres.

Consensus was reached on new free trade agreements with

Vietnam and the Mercosur states in June 2019. The free trade

agreement with the Mercosur states forms part of a more com-

prehensive association agreement between the EU and the four

Mercosur states Argentina, Brazil, Paraguay, and Uruguay. The

final version is expected soon. The agreement with Vietnam is

slated to take effect at the end of 2019 or beginning of 2020.

Free trade agreements are currently being negotiated with Aus-

tralia and New Zealand as well.

The negotiations between the EU and USA on a trade agree-

ment, as well as to solve the trade conflict, picked up steam

again after the EU member states gave their consent to the

European Commission to start formal negotiations on an agree-

ment on conformity assessment and to abolish tariffs on indus-

trial products.

Contact: Jennifer GoldenstedeAnne-Kathrin Schmalz

SPECTARIS e. V.

19


Structured support on the potential in developing and emerging markets helps German medical technology SMEs

Taking into consideration the potential offered by emerging

countries, with their progressing economic markets, investments

in future markets are even more worthwhile. The countries con-

tinue to show promising growth, with their potential in growing

demand for modern healthcare infrastructure providing good

market opportunities for German exporters in the area of hos-

pital expansion and equipment.

At a larger scale, emerging countries will continue to play a

key role for German medical technology exports, also outside

of Asia. IW Cologne has found that by now over 20% of all

German exports of medical devices and materials are delivered

to emerging countries, with an upward trend. These mar-

kets, with their rapidly expanding digital infrastructure

and great willingness to adopt e-health applications,

additionally show demand for new digital busi-

ness models, which might prove decisive in

future market shares. African countries are

increasingly assuming a more important role

here.

Therefore, the Federal Government

wants to address the economic potential

of Africa in a more targeted manner,

striving for far-reaching relationships with

the African states and doing justice to the

political and economic importance of Africa

and its potential. The relationships should at the same time

respect the considerable regional diversity and complexity of

Africa and serve German and European interests. That’s not an

easy task with an economic structure of such heterogeneity.

Various approaches should thus result in structured support in

tapping the potential of the African states – above all by working

together more intensively with the “Compact with Africa” coun-

tries. Here, SPECTARIS is involved in various activities together

with the Federal Government. To name an example, we support

the “Africa Business Guide” of Germany Trade and Invest, which

clearly summarises information on opportunities presented by

the continent, sorted by industry. In addition, the Africa Business

Network of the Federal Ministry of Economics strives to support

companies in their African activities. SPECTARIS is also closely

involved in this project and will accompany a special pilot project

in Morocco for the health sector. The topic of “Global Health”

is addressed together with the Federal Ministry of Health.

1 Emerging countries: Brazil, Russia, India, China, Chile, Colombia,

Mexico, Peru, Egypt, Qatar, South Africa, United Arab Emirates,

Indonesia, Korea, Malaysia, Philippines, Taiwan, Thailand, Turkey

» Source: IW Cologne

The overarching business topics are addressed at

SPECTARIS over the course of numerous events. Legal

matters relating to tariffs and export controls are discussed

within the working groups for tariffs, export control, and

foreign trade practice, for example. The working groups

meet in the spring and autumn. By facilitating an intensive

exchange of experiences and opinions, they offer impor-

tant assistance and a helpful network for internationally

active SPECTARIS members. Once every two years, the

established foreign trade day event takes place, the

centrepiece of political activity and networking in Berlin,

covering trending topics in medical technology, the

pharmaceutical industry, and lab technology. The event

takes place at the Foreign Office, which hosts the net-

working event together with SPECTARIS.

20 International markets | German medical technology is in demand – even as it faces growing challenges on world markets

Here, SPECTARIS supports the activities of the network with its

expertise in medical technology. The great relevance of health

topics and the engagement of medical technology companies is

recognised by the Federal Ministry for Economic Cooperation

and Development, which is why a EZ (Development Cooperation)

Scout has been active at SPECTARIS again since March 2019. The

EZ-Scout can provide targeted support to the business activities

of companies in Africa and developing and emerging countries

on other continents.

A EZ-Scout supports members in their activities in developing and emerging countries

As development in the developing and emerging countries

continues to push forward, their markets for first-class and high-

tech products also mature. These countries are thus becoming

increasingly interesting for export-oriented economies, especial-

ly also for the industries represented by SPECTARIS. In turn, these

countries are increasingly dependent on modern, state-of-the-art

technology for the further development and improvement of

their own performance. By connecting development cooperation

(EZ) with foreign trade, Germany’s partner countries offer very

interesting opportunities. This above all applies to medical as

well as analysis, bio-, and laboratory technology in the develop-

ing healthcare systems.

Since March 2019, Dr med. Franz von Roenne has been active

in the Foreign Trade department as a EZ-Scout. As a delegate

of the Gesellschaft für Internationale Zusammenarbeit (GIZ)

GmbH (Association for International Collaboration), his deploy-

ment is part of a programme by the Federal Ministry for

Economic Cooperation and Development (BMZ) for the targeted

promotion of collaboration between business and programmes

for state development cooperation. There are EZ-Scouts at 17

umbrella and industry associations, in three state associations,

at 11 chambers of industry and commerce, as well as in craft

and association institutions.

The SPECTARIS EZ-Scout connects interested members with

development cooperation programmes and networks and their

links with foreign trade funding instruments. They offer individ-

ual consulting and provide bespoke information on request, as

well as organising topical information events. They take care of

networking with the Agency for Economy and Development at

the BMZ, other EZ-Scouts, as well as similar positions at German

chambers of industry and commerce (ExperTS) and to countries

with a German Desk to link up German foreign trade (Global

Business Network). By making connections to bilateral and multi-

lateral development cooperation programmes and their networks,

they help establish specific contacts.

The EZ-Scout systematically supports the interlinking of foreign

trade and development cooperation, particularly on site and as

needed. There is an important reason for this: Healthcare, in-

cluding its design, planning, and financing, is organised by pub-

lic authorities across the globe. Effective care, however, relies to

a large extent on state-of-the-art, tailored technologies as sup-

plied by private business. Intensive cooperation is required to

optimally attune supply and demand, long before common mar-

ket mechanisms start to result in actual business. The EZ-Scout

at SPECTARIS therefore above all looks for an exchange with

interested members on the design and use of optimised business

models. During the first six months of his activity, numerous

members who are active in developing and emerging markets

have shown an interest in using, expanding, and sharing their

experiences. The EZ-Scout is available to answer any questions

related to the various topics and offers surrounding development

cooperation.

Contact:Dr med. Franz von Roenne

EZ-Scout of the Deutsche Gesellschaft für Internationale Zusam-

menarbeit (GIZ) GmbH on behalf of the Federal Ministry for

Economic Cooperation and Development (BMZ)

Phone: +49 (0)30 414 021 55

Mobile: +49 (0)170 54 14 357

Email: [email protected]

21


International markets | SPECTARIS partnership project in East Africa – initial successes and prospects for the second phase

A look back to the first phase

The first project phase, designed with a duration of three years,

focused on strengthening the local health sector, stimulating

regional integration, and establishing initial contacts to German

producers of medical technology. Our local partner is the East

African Healthcare Platform (EAHP), which was founded as the

central opinion-forming institution to support all regional health

industry stakeholders. During the project, East African companies

visited trade fairs such as the MEDICA in Düsseldorf and analyt-

ica in Munich, where they first came into contact with German

producers. The progress of the project was assessed on-site in

the early summer of 2019, with a positive report on the attain-

ment of goals and recommendation to continue the project.

A look forward to the second phase

SPECTARIS is currently assessing the continuation of the project.

In the next phase, stronger focus should things be placed on

SPECTARIS partnership project in East Africa – initial successes and prospects for the second phase Since 2016, SPECTARIS has been involved in a project funded by the Federal Ministry for Eco-

nomic Cooperation and Development (BMZ), through sequa, to develop the health industry

in East Africa. Target countries are all member states of the East African Community (EAC):

Burundi, Kenya, Rwanda, Tanzania, Uganda, and since 2018, Southern Sudan.

Contact: Krasimira

Maryanska SPECTARIS e. V.

could be created through the development of market expertise,

by sharing market analyses, as well as through the initiation of

business contacts to local users and distributors in the health

industry. German companies active in medical and laboratory

technology will have the opportunity to actively explore the mar-

ket by participating in delegation trips, study trips, and local

conferences. Furthermore, there are prospects of investing in a

pilot project in the private health industry and the opportunity

to carry out sponsored workshops and training courses on the

company’s own equipment. The partnership with the East African

Health Platform opens up the opportunity to gain deeper insight

into the East African market and gain long-term access to it.

With the EAHP, SPECTARIS has a reliable partner to safeguard

and expand future market opportunities for our member com-

panies.

concrete business and cooperation oppor-

tunities, among other things, that

offer various options for com-

panies to participate. These

Company address of

the East African Health

Platform in Arusha,

Tanzania

» Source: Elke

Carolin Demtschück,

Organisation and

Business Consulting,

Change Map

Team of the East African Healthcare Platform

» Source: Elke Carolin Demtschück, Organisation and Business

Consulting, Change Map

22 International markets | Russian market for medical technology continues to grow

As part of the national project “Healthcare”, the govern-

ment is to invest around 23.6 billion euros in national

healthcare until 2024. Focus is placed on the treatment

of cardiovascular disease and cancer. This should improve the

average life expectancy of the Russian population by 5 years by

2024.

The Ministry of Industry expects the Russian market for med-

ical technology to grow to around 4 billion euros in 2019 (295

billion roubles). In 2018, the market grew by around 10% to

approx. 3.8 billion euros (281 billion roubles, ECB annual average

exchange 2018: 1 euro = 74.04 roubles). Around 80% of pur-

chases were made by public health institutions.

Strong growth of the market for private medicine

Russia’s market for medical services has expanded by 11.6% over

the previous year in 2018, to around 41 billion euros. The largest

share is attributable to benefits under the obligatory state insur-

ance (OMS). The share of private medicine amounts to 15.8%.

The private health market is among the most promising mar-

ket segments in Russia. In 2018, the value of legally provided

private medical services increased by 10.8% to 6.5 billion euros.

The consulting firm KMPG expects the market to grow to approx.

8 billion euros by 2012. As they are subject to less stringent

regulation, private clinics can continue to procure foreign med-

ical technology without any restrictions.

The market for telehealth (e-health) continues to offer good

business opportunities. In 2018, the market volume amounted

to approx. 100 million euros. Until 2030, this market could grow

Hans-Jürgen Wittmann,

Moscow Office,

Germany Trade and Invest

Contact:www.gtai.de

to 1.2 billion euros; however, legislative obstacles and immature

regulation still impede industry development. Currently, diagno-

ses via online consultations are not yet allowed.

Government supports domestic producers

The approx. 400 Russian producers had a revenue share of the

domestic market for medical products of approx. 23%. With the

“Strategy to Develop the Medical Industry by 2030”, the Ministry

of Industry strives to increase the production volume of Russian

medical technology producers by a factor of 3.5 over the course

of 2017 (910 million US dollars), with a more than tenfold in-

crease of exports (to 1 billion US dollars). At least 100 new

medical products “Made in Russia” are to be approved each year.

The Federal Antitrust Agency has identified a lack of compat-

ibility between medical products. According to the agency, this

makes it harder for domestic producers to access the market

while keeping prices high. Standardisation catalogues should

resolve this issue. The Ministry of Healthy strives to work out

such a catalogue by the end of 2019.

Market access to become harder for foreign producers

The Ministry of Industry endeavours to reduce import depend-

ency of 111 medical products by 2020. With Directive No. 813,

enacted on 26 June 2019, the government added 14 items to

the list of foreign medical products and devices on which restric-

tions are imposed with public procurements, including otoscopes,

tonometers for the measurement of intraocular pressure,

Guest article

Russian market for medical technology continues to growGovernment intensifies import substitution of foreign medical products

Moscow (GTAI) – Russia to invest 24 billion euros in its healthcare system until 2024. Intensifica-

tion of import substitution regulations pushes foreign medical technology producers to develop

local production.

23

respirators, ultrasound scanners, and intraocular lenses. If at least

two Russian producers participate in a public procurement

tender with their products, similar foreign products are excluded.

Prime Minister Dmitry Medvedev signed a directive in June

2019 restricting the freedom of public institutions to act in pro-

curing medical technology through competition proceedings. In

these, quality criteria can be included in addition to the price;

however, for X-ray machines, optical microscopes, dental and

ophthalmological instruments, sterilisers, and other medical

products, the price is now the decisive factor.

Russia starts digital labelling of rehabilitation technology

Russia is also expanding the obligation to digitally label goods

to encompass medical technology, and particularly rehabilitation

technology. This should allow for seamless tracing of products

from the manufacturer to the end user. The start is marked by

a pilot project to label wheelchairs, running from 1 September

2019 until 1 June 2021. During a first phase, wheelchairs with

manual drive are affected, after which this will be extended to

wheelchairs with a motor or other mechanical moving devices.

The Centre for the Development of Promising Technologies (ZRPT),

which is part of the business empire of oligarch Alisher Usmanov,

in entrusted with implementing the project.

Single market requires new registration

In the wake of the establishment of a single medical technology

market in the Eurasian Economic Union (EEU), all medical de vices

are subject to new registration by the end of December 2021.

The Association of Medical Technology Producers Medizinskie

Resursy estimates that this would take at least20 years. As a

result, the industry association warns that medical technology

bottlenecks could start from 2022 onwards. The deadline might

eventually be postponed, but foreign producers should already

now carefully examine the new requirements of the EEU.

German medical technology producers expand their presence in Russia

To retain access to public orders in spite of all obstacles, German

companies are investing in the creation or expansion of local

production. The medical technology producer Sarstedt laid the

foundation for a factory to produce disposal blood collection

systems in July 2019. A total of around 31 million euros will be

invested in the project until 2022. The medical supply manufac-

turer B. Braun is investing around 40 million euros in the con-

struction of a logistics centre and the expansion of the production

plant in the Twer region until 2022. Fresenius Nephrocare is

building three dialysis centres in the Rostow area by 2020, at a

cost of around 6 million euros.

The localisation of production has already paid off for medical

technology producer Otto Bock. Along with three other provid-

ers, the Russian representative office Otto Bock Mobility was

selected to provide 39,000 wheelchairs of the “Start” model to

public health institutions.

Even with intensification of import substitution politics, Russian

imports of medical technology are on the rise. German produc-

ers’ exports to Russia grew by around 3.9% over the previous

year in 2018, amounting to around 640 million euros. Russia

accounts for 2.7% of the overall export revenue, ranking tenth

on the list of the most important purchasing countries of German

medical technology.


Customs tariff Product group 2017 2018 of which from number Germany (2018)

» 9018.11 to .20 Electrodiagnostic appliances and devices 287.2 310.4 26.4» 9022 X-ray devices, etc. 431.1 380.6 77.0» 8419.20 Sterilisation devices, etc. 33.1 34.4 5.5» 8713 Wheelchairs 29.0 33.1 6.2» 9018.41, .49 Dental instruments; not otherwise specified 136.5 140.3 37.5» 9018.31 to .39 Syringes, needles, catheters, cannulas, etc. 322.3 368.7 66.7» 9018.50 Ophthalmological instruments 91.1 109.2 26.0» 9018.90 Other instruments, appliances, and devices 900.8 930.3 251.1» 9019, 9020 Therapeutic devices, respirators, etc. 223.6 259.1 46.9» 9402 Medical furniture, etc. 55.5 71.0 14.3» 9021 Orthopaedic technology, protheses, etc. 661.1 715.7 98.1

» Source: UN Comtrade

Import of selected medical technology products to Russia (in million US$)

24

Guest article

International markets | The Brazilian medical technology market is booming

The Brazilian medical technology market is booming With over 210 million inhabitants, Brazil ranks among the ten most populous countries in the

world; with a GDP of 2.14 trillion US dollars (2018), it is the ninth-largest economy. From a

health perspective, the rapid ageing of society is relevant: With the share of over-65-year-olds

still falling short of 10% in 2019, it is set to rise to approx. 17% by 2040 and double to over

25% by 2060.1 Moreover, life expectancy is set to rise from the current age of 76.5 to 81 years

in 2060. This will pose many challenges to the country, which in turn offer opportunities to

German medical technology companies as a result of increasing demand for medical technology.

The Brazilian economy is slowly recovering, and with

approval of the pension reform in mid July 2019, growth

is expected to accelerate. The government of President

Jair Bolsonaro, who has been in office since January 2019, en-

deavours to not just ease pressure on the national federal budget,

but has also initiated various reforms to open up the market.

Moreover, anti-corruption efforts have intensified with measures

such as Operation Lava Jato.

In 2018, 528,000 formal jobs were created on the Brazilian

labour market, 18% of these in the health industry.2 With the

national health system SUS, the country currently has the

eighth-largest health market in the wold and the fourth-largest

medical population with 2.18 physicians per 1,000 inhabitants.

In 2018, health expenditures amounted to 637 billion Brazilian

real,3 around 9.3% of the Brazilian GDP. Of these expenditures,

57% were spent on private health insurance or private costs,

and public funds made up the remaining 43%.4

The MT market grew by 13.5% in 2018, amounting to 10.5

billion US dollars. In 2019, growth is expected to be five to 7%.5

Over the course of the year (2018), imports increased by 21.8%

to a total of 5.4 billion US dollars, and national production (51.5%

of the overall industry volume) grew by 5.6% to 5.7 billion US

dollars. This increase is attributable to investments in electro-

medical and electrotherapeutic as well as radiation devices and

fixtures.

Germany takes second place in the Brazilian import ranking

of medical technology, at 10.4%, topped only by the USA with

32.7% (2018). Directive RDC no. 208/2018 has simplified the

procedure for importing products subject to health monitoring.

Moreover, risk management and freight parametrisation proce-

dures were introduced, speeding up the analysis and approval

processes of imported goods and reducing processing times. This

has made German medical technology companies significantly

more competitive.6 The partnership established by the health

authority ANVISA and InMetro (duration of five years) in 2015

to protect public health is making a significant contribution to

solving complex tasks, such as improving the quality of medica-

tion, medical devices, and prostheses.

1 IBGE2 GTT Healthcare3 2018 EUR-BRL: 4.4

4 ANAHP5 O Globo6 ABRAIDI» Source: ABIMO

Ricardo Castanho,

Director, Market Entry and

Business Development

Services

Contact:[email protected]

Imports (million USD) Exports (million USD) » Medical equipment 843.25 63.82» Implants & prostheses 188.65 60.27» Laboratory equipment 981.39 47.5» Durables 1.186.01 338.71» Dental technology 147.97 87.71» Medical imaging equipment 566.4 27.73» Rehabilitation equipment 448.99 53.34» Overall 4.36 billion 679.10

25

To name an example, this resulted in a significant reduction (or

even elimination) of product registration backlogs, strengthened

the analysis capacities of laboratories, and created greater trans-

parency as well as efficiency in communication between stake-

holders. This was partially achieved through greater use of pro-

cess automation technology.

Hospitals have been restructured in a more vertical manner for

a few years, which ensures cost reductions and high-quality care.

Health insurers are investing in their own networks, and on the

other hand, hospitals are establishing their own health insuranc-

es. Related to this process, there were 107 mergers and acqui-

sitions in the Health, Hygiene, and Aesthetics segment in 2018.7

While domestic investors outpaced foreign investors, more foreign

investors are expected over the coming years. Among others,

investments are coming from the Cura Network for Diagnostic

Care, contributing 300 million Brazilian real to open new labo-

ratories, and Fleury is investing 170 million real, purchasing the

Lafe network of clinical analysis labs in Rio de Janeiro. Sabin, the

fifth-largest company in this industry, acquired six laboratories

from October 2018 to February 2019 and is planning to invest

170 million real in this expansion. Ghelfond and competitors such

as Alliar want to grow with their own services for health insurers,

with their own network of hospitals and clinics such as Notre-

Dame Intermédica and Hapvida. These operators achieve

above-average performance through better cost control.8 Hap-

vida acquired the São Francisco Group in 2019 for 5 billion Bra-

zilian real and is the health insurer with the largest number of

customers, with 5.8 million policyholders of (dental) care plans.

The group has net revenues of 6 billion Brazilian real. German

companies can benefit from opportunities in medical imaging

procedures, which require high equipment investments and spe-

cialised staff. Diagnostics companies are investing heavily in tech-

nology and the development of new examinations. Dasa, the

industry leader with 250 million examinations carried out annu-

ally, is investing 30 million Brazilian real in artificial intelligence

(AI), digitalisation, and genetic tests.

On a larger scale, the trade agreement between the EU and

Mercosur also provides new drivers through the simplification

of bilateral trade. German medical technology companies ben-

efit from the use of international standards and the alignment

of technical regulations to the needs of micro businesses and

SMEs, from the transparency provided through the free provision

of relevant information, as well as from Mercosur accepting

compliance with technical provisions. This facilitates market ac-

cess, removes (bureaucratic) obstacles, and creates new business

opportunities. Assuming quick approval of the agreement in the

relevant national parliaments, the agreement is predicted to take

effect in approximately five years.

The German-Brazilian Foreign Chamber of Commerce and In-

dustry (AHK) in São Paulo also strives to draw investments to the

7 DCI 9 GTAI8 Valor Econômico 7 10 Abimo

region, reinforce bilateral trade, and promote cooperation be-

tween the Mercosur countries and the EU as well as business of

its members. As an important business platform, the AHK opens

up the Brazilian market to interested partners, for example

through establishing a business presence (among other services

a virtual Brazilian business address, support from multilingual

AHK employees). Important business relationships are made as

part of the business partner arrangement service.

During a pre-market check, the market is probed in line with

current trends and opportunities. Individual market entry strat-

egies are additionally developed in collaboration with the com-

panies, which promises good results on the booming market for

medical technology.

Current market trends

1. Digitalisation

» Ministry of Health: introduction of electronic patient files

» Intelligent hospital beds at 9 de Julho in São Paulo

2. Telehealth

(Segment growth rate 20% p. a.; by 2022, revenue over

12.2 billion Brazilian real)10

» Synchronous telehealth at the Albert-Einstein Hospital

in São Paulo connects physicians and patients through

teleconferences

» Treating neurological emergencies, (strokes, fits, head

injuries) in hospitals of the Leforte Group in São Paulo

» The Federal State Rio Grande do Sul has reduced waiting

times for ophthalmic consulting through Teleoftalmo

3. Artificial intelligence, big data

4. Lending out MT devices

Editing: Ronja Tewes, German-Brazilian Chamber of Industry

and Commerce

An overview of opportunities

» Market growth prognoses range from 5–7%,

clearly outpacing the Brazilian economy (0.9%

GDP growth in 2019)

» Higher share of the GDP for health expenditures

(9.3% in 2018)

» One of the ten most populous countries in the

world, rapidly ageing population, ninth-largest

national economy

» Demand cannot be covered by national production:

Brazil procures around 65% of its medical

technology demand abroad 9


26 International markets | Medical technology in China: A lucrative, but increasingly competitive market

Guest article

Medical technology in China: A lucrative, but increasingly competitive market

T he global med tech industry is booming – and China rep-

resents one of the world’s largest markets for medical

technology. In 2017, it accounted for almost 19% of the

global med tech market. Although the growth of China’s med

tech industry has significantly slowed down, to a rate of 8.3% –

compared to an annual growth rate of over 20% between 2013

to 2016 –, it still expands at almost double the pace of global

growth.

From 2011 to 2017, China generated an export surplus in med-

ical devices. The three most important product categories on the

Chinese market are medical imaging (16% market share), in-vit-

ro diagnostics (14%), and medical consumables (13%). The most

important foreign suppliers of medical technology for China have

been USA, Germany, and Japan.

Anna Holzmann, Analyst, Mercator Institute

for China Studies (MERICS), Berlin

Contact:MERICS gGmbH · Klosterstrasse 64 · 10179 Berlin

Phone: +49 (0)30 3440 999-0


Size of the medical technology market (revenue)

Healthcare expenditure (total)

Population share > 65 years

Number of hospitals

An overview of China’s medical technology industry

23,9 Prozent 10,3 Prozent

8,4 Prozent

2017 * Estimate

» Source: OECD, NBS, Statista

70.0

60.0

50.0

40.0

30.0

20.0

10.0

0.0

30.0

25.0

20.0

15.0

10.0

5.0

0.0

6,000.0

5,000.0

4,000.0

3,000.0

2,000.0

1,000.0

0.0

35,000.0

30,000.0

25,000.0

20,000.0

15,000.0

10,000.0

5,000.0

0.0

8.4%113.5 million persons



2010 2017 2050*

20,918

31,056

2010 2017

19.4 billion USD

58.6 billion USD

2010 2017

1,998.0 billion CNY

2010

5,259.8 billion CNY

2017

27

By far the largest import product categories are diag-

nostics and treatment equipment as well as dental

care. The need for orthopaedics devices is par-

ticularly high in China, with products “Made

in Germany” in hot demand. In general,

China is one of the most important markets

for the German medical technology in-

dustry after the USA. In 2017, German

companies realised revenues of around

1.8 billion EUR in China, an increase in

export volume of almost 14% over the

previous year.

China’s demand for medical technology remains high

The Chinese government has been investing

efforts in improving the health insurance and

health care systems since the 1990s – and particu-

larly since 2009. With a growing middle class and great-

er health awareness, there has been a call for better quality.

This is an important driver of high demand for advanced medical

technology devices. Another key driver behind the need for

high-quality medical technology and devices is the rapidly age-

ing Chinese population, with the resulting increase of chronic

disease and age-related illnesses.

The Chinese government has taken measures to respond to

this development, among other things through budget increas-

es. Since 2010, China’s public health expenditure has almost

tripled to approximately 1,521 billion Chinese Yuan (CNY) in

2017.1 However, China still cannot meet the domestic demand

for state-of-the-art medical technology itself.

Foreign companies still dominate the premium segment of medical technology

The Chinese medical technology market can roughly be divided

into two sectors: the low and medium-price segment and the

expensive, technologically more advanced premium segment.

The latter is clearly dominated by foreign companies – above all

by Philips, Roche, and Medtronic. But other companies such as

Siemens, General Electric, and Johnson & Johnson also rank

among the foreign top companies for medical technology in

China.

Chinese suppliers, in turn, dominate the low to medium-price

segment. Over 80% of Chinese suppliers can be assigned to this

segment. Foreign imports barely play a role here anymore. More-

over, Chinese providers are increasingly pushing into the premium

segment. In 2016, no less than three Chinese producers intro-

duced high-class PET-CT devices. This breached the de-facto

import monopoly in this field. In the following year, Chinese

producers already managed to take a share of around 10% of

the upper segment of China’s market for medical technology

devices.

In parallel to the advancing modernisation and digitalisation

of the industry, the quality of medical technology products in

China is improving too – among other reasons as a result of state

financial support.2 In comparison to their foreign competitors,

Chinese companies still invest relatively little in research and

development. The performance and quality of premium medical

technology products from China is still lagging behind foreign

competition. As a result, Chinese producers primarily enter into

price competition with international providers.

1 1 CNY ≈ 0.13 EUR 2 To name an example, the national government supported 25 research and development

projects in digital diagnostics technology with 150 million CNY in 2018.


28 International markets | Medical technology in China: A lucrative, but increasingly competitive market

Guest article

China’s medical technology market is increasingly competitive

The Chinese market is highly competitive: According to the US

government, there were approximately 16,000 Chinese produc-

ers of medical technology devices in 2017. However, this num-

relative homogenous product range. With support of the Chinese

government, however, some larger companies have also formed.

Three Chinese medical technology companies already ranked

among the ten largest in China in 2017: Mindray, Shinva, and

WeGo. Mindray is already operating internationally as well. It is

seen as one of the most promising companies of the Chinese

med tech industry.

The Chinese government sees strategic merit in the development of medical technology

The medical technology industry is of great strategic importance

to China. The role of innovation in healthcare and medical tech-

nology is, amongst others, emphasised in the current Five-Year

Plan, the key policy document for the scientific and societal de-

velopment of the People’s Republic of China (PRC). A large num-

ber of plans in support of these fields were introduced in the last

four years. The “Internet+Health” initiative to accelerate the

digitalisation of China’s healthcare, and the underlying “Healthy

China 2030” strategy deserve special mention. The latter focuses

on providing better healthcare to China’s rapidly ageing society

and enhances the roles of general practitioners, local medical

care, as well as private healthcare providers. Advancements

should also be made in telemedicine and mobile healthcare.

Initial successes can already be witnessed in the digital field: In

2015, there were only six so-called “Internet Hospitals” that rely

more heavily on the use of artificial intelligence and new infor-

mation technologies. By May 2019, this number had already

increased to 158.

Medical technology also plays a major role in the comprehen-

sive innovation strategy “Made in China 2025” (MIC25).

High-performance medical devices are identified as one of ten

core industries in which China strives to assume a globally lead-

ing position by 2049. To this end, for instance, the degree of

localisation – i.e. the share of domestic solutions on the Chinese

market – should be increased.

By 2020 By 2025 » Share of county-level hospitals 50% 70% with mid- to high-end medical equipment » Domestic market share of core components 60 – 70% 85 % (e.g. for medical use of big data and 3D printing) from Chinese producers

» Source: NMSAC

ber is set to decrease significantly as the

result of many mergers on the Chinese

market. The medical technology industry

of China is primarily located along the

coast, above all in the Beijing-Tianjin-

Hebei region, and both the Yangtze and

the Pearl River Delta. Interesting hubs are,

how ever, also developing in the country’s

heartland, for instance around the cities

of Chongqing, Chengdu, and Wuhan.

Many Chinese manufacturers have their

interests represented by the China Asso-

ciation of Medical Device Industry (CAM-

DI) – the national industry association for

medical technology. These are usually

smaller companies competing within a

MIC25 sets ambitious market share goals for Chinese med tech

29

China’s domestic market is set to reach a scale of around 168

billion USD by 20253. Moreover, significant advancements are

to be made in equipment for medical imaging, implantations,

clinical tests, advanced therapeutics, as well as health monitoring.

To achieve this, China resorts to foreign know-how. At the same

time, however, the development of internationally competitive

high-quality brands is another goal set by the Chinese govern-

ment.

Preferential treatment for domestic producers is common on China’s procurement market

The growth of the Chinese medical technology market can pri-

marily be attributed to the procurement activities of hospitals.

They are key players in China’s healthcare system, with public

institutions providing the largest share of services. It is therefore

important to have a basic understanding of the public procure-

ment activities of Chinese hospitals. They are primarily governed

by two laws, the “Tender and Bidding Law (TBL)” and the

“Govern ment Procurement Law (GPL)”. Products and services

which fall under the GPL are listed in a central catalogue. In

addition, however, local governments often introduce their own

catalogues and regulations. China’s public procurement market

therefore continues to be seen as non-transparent. It is also used

to the benefit of Chinese competitors. After all, solely the (low-

er) prices of Chinese products – and not a combination of price,

quality, and performance – often seem to be the decisive crite-

rion in procurements. In addition to that, the use of domestic

products is endorsed by government authorities.4 The GPL itself

states that domestic solutions are to be preferred. Since 2014,

the National Health Commission (formerly the National Health

and Family Planning Commission) also lists “excellent” domestic

medical products. The Chinese manufacturers included in these

lists are usually preferred in tendering procedures.

Good knowledge of local conditions is crucial to foreign companies

In principle, the Chinese market for medical technology is high-

ly attractive to foreign companies, not least because of the im-

pressive growth figures and high demand for premium products.

Chinese alternatives do not yet represent a strong competition

in this segment. Beijing did, however, clearly state the objective

to strengthen domestic solutions. The increasing decentralisation

of China’s healthcare system also poses a challenge for foreign

suppliers of medical technology. Smaller companies in particular

might experience difficulties in taking root or defending their

position on the Chinese market without a local partner. Foreign

companies are thus well advised to diligently analyse the regu-

latory environment and strategic context of China’s medical

technology industry. A well-founded and comprehensive China

strategy is required to compete on the increasingly competitive

domestic market of the PRC.

3 1 USD ≈ 0.90 EUR4 Officially, a product is considered “domestic” if it has for the most part been

manufactured on Chinese territory. In practice, however, this attribute is usually

understood to refer to the manufacturer’s country of origin.


30 Regulatory Affairs | With the date of application only a little over six months away – what is the state of the Medical Device Regulation?

With the date of application only a little over six months away – what is the state of the Medical Device Regulation?Disclaimer: The editorial deadline of this yearbook was in October 2019; developments after this date could not be considered.

The new Regulation (EU) no. 2017/745 on medical products (or “MDR” – Medical Device Regula-

tion) was published in the Official Journal of the European Union on 5 May 2017 and took effect

twenty days after publication, with full application from 26 May 2020. The MDR will replace the

currently valid guidelines 93/42/EEC for medical products (MDD – Medical Device Directive) and

90/385/EEC for active implantable medical devices (AIMDD – Active Implantable Medical Device

Directive). What’s the current state of affairs, with application of the new directive in just over

six months away?

Bottleneck Notified Bodies (NB)

Many requirements to actually implement the MDR are still not

in place. Producers still have an insufficient number of NB. How-

ever, these are absolutely necessary for market approval of med-

ical products. They carry out special inspections and evaluations

depending on the risk class of the medical products; moreo-

ver, they certify that the so-called conformity assessment is

correct. Further tasks include auditing the QM systems in

accordance with EN ISO 13485:2016 as well as carrying

out audits to evaluate compliance with requirements,

such as those resulting from the MDSAP (Medical Device

Single Audit Programme).

Producers are generally free to appoint NB and con-

clude an agreement with them. However, before an

NB is allowed to carry out activities under the MDR,

they must complete a comprehensive appointment pro-

cess specified in the MDR. This process is much more

complex and protracted than expected by all participants.

The average duration of the entire process is 18 months.

Currently, a little over six months before the date of appli-

cation of the new MDR, the approximately 27,000 medical

technology companies in Europe have only 5 NB available for

market approval of their products (as of the beginning of Octo-

ber 2019: There are currently 58 notified bodies available in the

EU for the old MDD/AIMDD). Producers of medical technology

from non-EU states also need an NB to sell their products on the

EU market, further compounding this bottleneck effect. This low

Contact: Corinna Mutter SPECTARIS e. V.

31

medical products is associated with such costs that the revenues

expected to be realised with the products no longer justify the

expenditure. According to a Swiss study from 2018, commis-

sioned by the Swiss Federal Office for Health and the Swiss State

Secretariat for Economic Affairs, the overall costs for the imple-

mentation of the MDR and IVDR in Europe will amount to ap-

proximately 18.8 billion US dollars from 2017–2020, with pro-

ducers (incl. their market players along their value-added chain)

and suppliers shouldering the lion’s share of the burden (18.4

billion US dollars). The sum of annual running costs in Switzerland

is calculated to be 525 million Swiss francs, or 9.3% of the an-

nual revenue of Swiss medical technology in the EU and EFTA.

The costs for conformity assessments are expected to rise by 50

to 60% on average. Producers will start thinking about stream-

lining their portfolio and take the necessary measures. A survey

carried out by the German Chamber of Commerce and Industry

(DIHK) and SPECTARIS in the summer of 2018 shows that around

80% of medical technology companies expect serious difficulties

in bringing innovative products to market in the future. Around

half of all surveyed companies see themselves forced to slim

down their product lines, with one third planning to take prod-

ucts out of their range altogether.

Legal uncertainty

Many of the legal acts, standards, and guidelines strictly neces-

sary to implement the MDR are not yet in place. Various standards

must be aligned to and harmonised with the MDR. For a few

number of available NB is alarming, particularly because several

NB currently active under the MDD/AIMDD have communicated

that they will not seek appointment under the MDR. The finan-

cial and bureaucratic burdens are too sizeable, and many have

difficulties finding qualified professionals. The situation is further-

more exacerbated by a significant increase in the number of

products to be certified under the MDR, with the resulting

auditing efforts increasing.

In the future, a hard Brexit might reinforce the bottleneck,

because BSI Assurance UK Ltd, one of the five previous NB, would

no longer be able to carry out its activities if the UK leaves the

EU without an agreement. Moreover, 70% of all companies not

registered in the EU (above all from the US) currently use BS in

Great Britain; these companies would have to find another solu-

tion within the EU-27 area. The European Commission is cur-

rently expecting the appointment of up to 20 NB under the MDT

by the end of the year; however, even if this ends up being the

case, this will still not be sufficient to have all producers and

products re-evaluated by 26 May 2020.

Medical products unavailable

This might impact product diversity in the future, and lead to

certain medical products – above all niche products – becoming

unavailable. The in part significantly more strict regulative re-

quirements placed on products will likely result in discontinuations

of tried-and-tested medical products. This is always the case

whenever compliance with the new requirements placed on

» Source: SPECTARIS

3-year transition period

2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

26 May 2017 •The MDR takes effect

2018 (or later) •Legal act to appoint the UDI Issuing Agencies (until then, GS1, HIBCC, ICCBA can be used)

26. November 2017 •Earliest date for notified bodies to apply for reappointment under the MDR •Member states appoint competent authorities •Founding of the MDCG (made up of representatives of member states)

July 2019 •Predicted availability of the first notified bodies under the MDR

26 May 2020 •Date of application of the MDR •MDD and AIMDD no longer valid •All appointments of notified bodies under the MDD and AIMDD no longer valid

27 May 2024 •All MDD/AIMD certificates no longer valid (at the latest) •Until this date, producers can maintain MDD and MDR certificates in parallel

26 May 2025 •End of the “sell-off regulation” for products which were put on the market under the previous legislation before 26 May 2020 or with a still-valid MDD certificate after 26 May 2020

26 May 2025 •UDI marking must be included on labels of Class I products

3 May 2018 •Publication of the rules of procedure and description of tasks of the MDCG

26 March 2020 •Earliest date on which the EUDAMED can go into operation

26 May 2021 •UDI marking must be included on labels of implantable and Class III products (if reusable: 26 May 2023)

26 November 2021 •Economic operators must enter information about the product (Annex VI, Part A, Paragraph 2) in EUDAMED •Notified bodies must enter information on the product certificates in EUDAMED

26 March 2023 •UDI marking must be included on labels of Class IIa and Ib products

Implementation timeline of the EU-MDR


32 Regulatory Affairs | National implementation MDR

months now, the procedure has been stuck while points of con-

tention are worked out between the European Commission and

the competent standardisation bodies. Companies suffer from

this significant legal uncertainty. The European database for med-

ical products (Eudamed) will not be completed with all modules

at the announced date. The “MDR/IVDR Implementation Rolling

Plan” of the European Commission states the following: “It is

indicated that modules for clinical investigation and market sur-

veillance will not be available at the time of application of the

MDR due to workability issues.” Without being aware of all

necessary functional specifications, companies must already now

adapt their IT systems in order to meet the MDR requirements

in due time. Moreover, downstream European legal acts and

guidelines for implementation are still not in place, which addi-

tionally adds to the legal uncertainty companies are facing.

Even if the MDR is a European directive already effective as

law in all member states, attention should be paid to national

legislation. In the end, the MDR also allows for member states

to draft national regulations for certain issues, which must then

be observed. The Federal Ministry of Health proposed a draft bill

to update the Medical Products Act on August 2019. The draft

bill of 163 pages will, among other things, adapt the current

Medical Products Act (MPG). In addition to this legislative pro-

posal, the Federal Ministry of Health is preparing another prod-

ucts regulation to revoke, modify, and even reintroduce existing

legislation on medical products law.

Already now, larger companies are faced with the tremendous

challenge of keeping an overview of the numerous directives,

guidelines, laws, and standards at the national, European, and

international level and observing the many regulatory requirements.

For SMEs, this is virtually impossible without external assistance

and in some cases even threatens their very existence.

Conclusion

The main and important, objectives of the MDR, to improve

patient security and quality assurance, are not attained at the

current state of implementation. The future unavailability of nec-

essary medical products is not in the interest of patients. The

many, in part unclear, regulatory hurdles are posing major chal-

lenges to companies. Therefore, it is crucial to in the first place

ensure the functionality of the overall system. This functionality

of the overall system also comprises a sufficient number of no-

tified bodies for product approvals, a sufficient number of expert

committees and laboratory bodies for clinical trials, and the avail-

ability of a functional Eudamed database. Moreover, the require-

ments to be met by companies must be specified with sufficient

clarity.

The SPECTARIS “Regulatory Affairs Forum for Medical Technology” and further working groups

To support producers, above all in this special period, SPECTARIS

operates a Regulatory Affairs Forum for Medical Technology (for-

merly known as the Technical Commission for Medical Technol-

ogy) as well as further regulatory affairs working groups, par-

ticularly geared towards the field of medical technology.

Participants are given a compact overview of current regula-

tory developments and challenges at the national, European, and

international level. The activities of the Regulatory Affairs Forum

for Medical Technology (RFMT) offer valuable assistance to com-

panies to help them understand the situation, analyse it, and

carry out implementations. The RFMT and working groups open

up room for dialogue and the exchange of experiences between

The MDR brings with it countless new requirements for

producers of medical products, among others:

» The introduction of an additional “Scrutiny Procedure”

in the clinical evaluation of implantable medical prod-

ucts of Class III and active products of Class IIb which

are intended to deliver and/or remove a medicine to/

from the body

» Introduction of an electronic European vigilance and

market surveillance system with shorter reporting

deadlines

» More discerning requirements on clinical evaluation

and the creation of clinical data with more compre-

hensive equivalence inspection

» Mandatory clinical trials for implants and Class III prod-

ucts

» Significantly stricter documentation obligations, in-

cluding a monitoring plan after bringing the product

to market, regularly updated reporting on security

(from Class IIa onward), a plan and evaluation report

on clinical monitoring after bringing to market

» Introduction of a European traceability system, Unique

Device Identification (UDI), in a phased manner de-

pending on the product risk class

» New rules on classification; partially connected with

higher classifications (e.g. products with nanomateri-

als, material medical products, introduction of Class Ir

(reusable) for surgical instruments which can be reused)

» Producers require a “person responsible for regulato-

ry compliance”. This person is to observe significantly

more comprehensive tasks than the current Security

Officer of the company

33

producers. Here, focus is placed on understanding and proper-

ly implementing regulatory requirements.

In addition to direct dialogue, the Regulatory Affairs Forum as

well as the working groups impart further expert knowledge.

Experts from the field are invited as guests. Experienced working

group members are represented in national, international, and

European expert committees and share insights on current issues,

interpretations, and implementation ideas at the national as well

as European level.

The association regularly informs its members on the regula-

tory developments in the field of medical technology and gives

them the opportunity to provide input on specific legislative

measures and current issues.

34

Guest article

Regulatory Affairs | Successful approval of medical products in China – a road with many obstacles

Successful approval of medical products in China – a road with many obstacles

T he approval of medical products in China starts with their

classification following the Medical Device Classification

Catalogue, the current version of which was published

on 31 August 2017 by the China Food and Drug Administration

(CFDA). This catalogue is clearly illustrated with a large number

of examples. If a device cannot be unequivocally classified into

one of the 22 specified product categories, the Rules for Med-

ical Device Classification are to be used. In borderline cases, there

exists the option of applying for official qualification with the

National Medical Products Administration (NMPA, formerly

CFDA). Potential risks, specific characteristics, and the use of the

device must be described in the application. The producer must

submit a detailed functional description and proof of classifica-

tion of the device in the producer’s country of origin together

with the application.

It can take months to process applications. China uses the

three risk classes I, II, and III for medical technology and in-vitro

diagnostics (IVD). European classifications merely serve as an

indication for the class, with Chinese officials very frequently

reaching a different classification. If this is the case, the Euro pean

products are usually assigned one class

higher. If the device is assigned

to risk class II or III, the next

step of the registration pro-

cess comprises the crea-

tion of the Technical

Requirements (former-

ly: Registration Stand-

ard), which map out

the requirement to

agree on type tests

with a Chinese test lab-

oratory. Active medical

devices are subject to per-

formance, electrical safety, and

electromagnetic compatibility (EMC) inspections in China. China

has its own system of standardisation. Obligatory Chinese stand-

ards are called GuoBiao (GB), which is literally translated as “na-

tional standard”. Chinese industry standards for medical devices

are called YY standards. The test standard for electrical safety is

called GB 9706.1-2007. It is based on IEC 60601-1: 1988, 2005,

2012. The standards are equivalent but not completely equal.

The test standard for EMC in China is YY 0505-2012 and is

identical to IEC 60601-1-2: 2004. Nevertheless, tests must be

carried out at a test laboratory accredited by the NMPA in China.

In China, biocompatibility tests for devices which come into con-

tact with the patient’s body are carried out in accordance with

GB/T 16886.1-2011, which is in turn identical to ISO 10993-

1:2009. Here, there exists the opportunity of having a test which

was carried out abroad recognised if the test was performed in

accordance with ISO 10993-1:2009 and the test report issued

was by a test laboratory approved following Good Laboratory

Practices (GLP).

Preparation of the application dossier can begin in parallel to

the type tests. The type test reports and the Clinical Evaluation

Report (CER) are the cornerstones of the application. Whether

a clinical trial in China is required for the CER can be determined

using various exclusion criteria. The NMPA has published mul-

tiple lists of medical products and IVD of Classes II and III which

do not require clinical trials in China for registration. The third

version of the Exception List is already available for medical

technology, as is the second extended version for IVD. These

lists comprise 855 exempted medical devices and 393 exempt-

ed IVD products for which a highly simplified CER suffices on

application.

In other instances, clinical data which were collected in a

clinical trial performed outside of China can be used to create

the CER if these meet Chines rules. If such data are not availa-

ble, there still is the option of finding a predicate device approved

in China and use its data. The applicant must have obtained the

Stefan Fischer,

Dipl. Ing. Electrical Engineering

Cisema (Hong Kong) Limited


35

clinical data in a legal manner. A clinical trial for the product is

only unavoidable if these three approaches are fruitless.

Class I medical products don’t need to be put to a type test or

undergo a clinical trial in China; for these, simple notification of

the NMPA suffices.

The guidelines on technical lifetime examination, updated on

14 May 2019, form a new challenge in the registration of active

medical products. As part of the registration process, applicants

must prove the lifetime of their products. Here, the lifetime is

the period during which safe operation of the product is guar-

anteed.

Under the NMPA provisions, only a legal person with residen-

cy in China can apply for the registration of medical technology

devices. For the registration of their products, foreign producers

thus require a legal representative, the NMPA Legal Agent. The

producer must issue a written power of attorney for representa-

tion at the NMPA. The NMPA Legal Agent plays a decisive role

in applying for, changing, and extending certificates as well as

importing devices to China. Therefore, this position should be

selected carefully, with the most important decision criteria being

experience in dealing with regulatory matters, the relevant prod-

uct standards, and the competent authorities. There are gener-

ally three options available:

» 1. The Chinese subsidiary of the producer assumes the function

of legal agent.

» 2. The distributor is appointed as the legal agent; in this case,

however, a company is to a large extent dependent on the

distributor, who is virtually given exclusivity.

» 3. A consultancy company responsible for the NMPA registra-

tion is appointed as the NMPA Legal Agent. This has the ad-

vantage of remaining independent and being able to use as

many distributors as required, as well as change them.

On 7 May 2019, the Center for Medical Device Evaluation (CMDE)

announced the introduction of an electronic platform to submit

the application dossier (http://erps.cmde.org.cn). The system

serves electronically managed medical product registrations; in

future, all documents for the NMPA registration are to be sub-

mitted through this eRPS system, with the paper form no longer

being necessary.

Since 10 May 2019, it is thus possible to apply for a Certificate

Authority (CA). The CA certificate is required to log into the eRPS

system. With imported medical products, the NMPA Legal Agent

must apply for a CA certificate on behalf of the foreign producer.

The application dossier is to be submitted in complete form,

together with all accompanying documents such as test reports,

certificates, evidence, etc., in Chinese.

The National Medical Products Administration checks the sub-

mitted documents for compliance with the formal requirements

within a week. For Class II products, the CMDE requires approx-

imately 60 working days for the technical evaluation of the doc-

uments and 90 working days for Class III products. After this

initial technical evaluation, the NMPA expert issues a Supple-

mentary Notice. In response to this notice, the producer must

make all supplementary documents available within a year and

submit these to the NMPA. Then follows the final technical eval-

uation, which will again take around 60 working days. The NMPA

requires another 30 working days for administrative approval of

the registration and to issue the certificate.

Certificates for Class II and III medical products are valid for

five years. Certificate extensions must be applied for at least six

months before the expiration date at the latest. There is no ex-

piration date for certificates for Class I products.

To safeguard product quality in the life science sector, the NMPA

expects proactive cooperation of the local legal representative

of foreign producers. The NMPA published a guideline on re-

sponsibilities – the Guideline for Imported Medical Device Legal

Agent. This includes supporting the producer in the approval of

its products and regulation-compliant Chinese operating instruc-

tions. From 1 January 2019, the Chinese company name of all

imported Class II and III medical products must be included in

the Chinese operating instructions and on the Chinese label, and

the name must match the name on the NMPA certificate. This

request is illustrative of the importance of a well-informed, pro-

active, and cooperative NMPA Legal Agent for the timely imple-

mentation of current regulations in China. Further responsibilities

of the legal representative comprise monitoring and reporting

adverse events in China as well as notifying the supervisory

authorities and supporting the supervisory authorities in quality

control.

To this end, the NMPA has released Decree No. 1 on the re-

porting of adverse events for medical products on 31 August

2018. The Decree states that adverse events that occur overseas

must be reported to the NMPA, and a report must be created

by the local legal representative in China. This regulation assigns

the responsibility for controlling, proactive monitoring, and pro-

viding information on quality problems to the producer and the

NMPA Legal Agent in equal parts. The system serves to improve

risk management of medical products by targeting the monitor-

ing, evaluation, and remedying of adverse events for this prod-

uct group. The NMPA Legal Agent plays a much more important

role than before. As the local legal representative, they are re-

sponsible for meeting requirements after the product is brought

to market, without the producer having to establish its own

Chinese office.

With regards to the issue of adverse events, the State Admin-

istration of Market Regulation (SAMR) published a joint decla-

ration together with the General Administration of Customs of

China (GACC) on 30 October 2018, announcing closer cooper-

ation in the recall of defective imported goods. With this reform,

the SAMR was given the main responsibility for product recalls

in China, with greater focus placed on life science products and

foodstuffs, such as medical products, medicines, and cosmetics,

in addition to health food and infant milk. The GACC reports to


36 Regulatory Affairs | Successful approval of medical products in China – a road with many obstacles

Guest article

the SAMR on products identified as defective during the customs

inspection. The SAMR in turn informs the GACC on infringements

in the event of recalls, to allow the GACC to initiate measures

against the involved companies. Moreover, producers and con-

sumers can find information about recalls on the website of

SAMR. The WeChat Messenger services of the SAMR and GACC

also regularly publish information on recalls.

Further reinforcement of product safety controls was enacted

in the Directive on the Administration of Medical Products and

Medicine Overseas, passed on 28 December 2018. This regula-

tion specifies that the NMPA will also carry out factory inspections

for producers in other countries in the future, to guarantee the

safety and effectiveness of imported medical products and med-

icines.

Comprehensive inspection of all producers is not envisioned;

sampling will take place on the basis of risk assessments. To date,

primarily Chinese producers were regularly inspected. In January

and March 2019, the production sites of 24 foreign companies

were already subjected to an inspection. Deficiencies were iden-

tified in all instances. The respective problems can be looked up

online on the NMPA website. Producers then have 50 working

days to take corrective measures.

On 23 August 2020, the NMPA announced the introduction

of the UDI system (Unique Device Identification) for medical

products in China. The new UDI regulation took effect on

1 October 2019. This important requirement will already affect

the registration and import of medical products in China in the

very near future. To date, four important documents have been

published on the UDI (NMPA Announcement on Issuing the Rule

of UDI System for Medical Devices, Rule for UDI System of Med-

ical Devices in China, YY/T 1630-2018 Fundamental Require-

ments for the UDI and the NMPA UDI Interpretation Rule). Foreign

producers of medical products must carry out the following steps:

» 1. Creation of a DI code (Device Identification) in line with the

UDI code standard of the Chinese approval authority ANCC

(Article Numbering Center of China) and determining the PI

code structure (Production Identification)

» 2. From 1 October 2019, the applicant must submit the rele-

vant DI code to the NMPA for applications for approval of

medical products – such as new approvals, renewed approvals,

and changes to the approval of medical products.

» 3. Selection of a suitable data carrier – such as a barcode, QR

code, or RFID code – in accordance with the ANCC Standard

and applying it to the product or packaging.

» 4. Uploading the DI code and the associated information to

the UDI database for medical products before the product is

imported to China. Important – this UDI database has not yet

been made available by the NMPA.

» 5. If there are changes to the DI code and the associated in-

formation, the applicant must update the information in the

UDI database.

Major regulatory challenges must be overcome to enter the Chi-

nese market. Therefore, companies should schedule plenty of

time and arrange for an appropriate budget. After successfully

going through the required tests and creating a solid application

dossier, the path into this very promising market is wide open.

37


Health spending

Institutions 2016 2017

Health expenditure ................................................................................................................... 358.7 .................375.6» Investments ...............................................................................................................................7.0 ..................... 7.0

» Ongoing healthcare expenditure ........................................................................................351.7 .................368.6

» Health protection ...............................................................................................................2.0 .....................2.0

» Outpatient institutions ..................................................................................................180.3 .................185.5

» Medical practices ............................................................................................................53.0 ...................55.0

» Dental practices ..............................................................................................................26.3 ................... 26.7

» Practices of other medical professions ............................................................................. 13.1 ................... 14.0

» Pharmacies .................................................................................................................... 48.4 ...................49.3

» Health trade professions/retail.........................................................................................20.8 ................... 21.2

» Outpatient care ..............................................................................................................18.9 ................... 19.4

» Inpatient/short-term inpatient institutions ................................................................... 132.9 .................138.4

» Hospitals ........................................................................................................................92.5 ...................94.7

» Preventive/rehabilitation institutions ..................................................................................9.5 ..................... 9.7

» Inpatient/short-term inpatient care ................................................................................. 30.9 ...................34.0

» Emergency services .............................................................................................................4.5 .....................4.8

» Administration .................................................................................................................. 18.9 ...................19.3

» Other institutions and private households ...................................................................... 11.4 ...................16.8

» Care abroad ......................................................................................................................... 1.7 ..................... 1.7

German healthcare expenditure by institution

» Source: Federal Statistics Office

in billion €

* preliminary figures

» Source (introductory text and figures):

Federal Statistics Office 50.856.0

15.616.1

31.632.2

5.75.9

4.74.8

214.2221.3

375.6387.2

German healthcare expenditure by cost bearer in billion €

Private households and private

non-profit organisations

Total cost bearers

Employers

Statutory accident insurance

Long-term care insurance

Public budgets

Private health insurance

Statutory pension

Statutory health insurance

Cost bearer Expenditures

15.815.4

37.239.4

20172018

38

w

Guest article

Regulatory Affairs | “Hazardous substances” under the Medical Device Regulation

“Hazardous substances” under the Medical Device Regulation

Legal requirements

Substances and devices in scope

The requirements of MDR Section 10.4. apply if the following

conditions are met simultaneously:

» The substance is classified as carcinogenic, mutagenic or

toxic to reproduction (CMR) of category 1A or 1B; or has

endocrine-disrupting properties.

» The substance is contained in a device, or a part or material

thereof, which is invasive and comes into direct contact with

the human body; or which (re)administers medicines, body

liquids or other substances, including gases, to/from the

body; or which transports or stores such medicines, body

fluids or substances, including gases, to be (re)administered

to the body.

» The substance is contained at a concentration of 0.1% or

more by weight of the device, part or material concerned.

Manufacturer obligations

A manufacturer of devices containing substances which fulfil

the three above-mentioned conditions have two key obligations

to fulfil:

» Risk justification: The manufacturer must conduct a benefit-

risk assessment which proves that the benefits of using

the substance outweighs the risks. This assessment must

be documented in the technical file to allow scrutiny by

the Notified Body. The MDR requires that the justification

consists of (a) an analysis of potential exposure to the

substance, being a patient or user, (b) an analysis of possible

alternative substances, materials or designs; (c) the actual

risk-benefit assessment comparing the current device with

identified alternatives in terms of functionality, performance

and risk-benefit ratio, taking into account the intended use

of the device. The manufacturer must base the risk-benefit

assessment on the latest relevant scientific committee

guidelines. For phthalates, there will be the forthcoming

Guidelines of the Scientific Committee on Health and

Environmental Risks (SCHEER).

» Labelling: The presence of substances in scope of MDR

Section 10.4. must be labelled on the device itself and/or

on the packaging for each unit or, where appropriate, on

the sales packaging, with the list of such substances. The

acceptability of symbols to meet this labelling requirement is

still to be determined (see challenges below). If the intended

use of such devices includes treatment of children, pregnant,

breastfeeding woman or other patient groups considered

particularly vulnerable to such substances and/or materials,

information on residual risks for those patient groups and, if

applicable, appropriate precautionary measures shall be given

in the instructions for use.

Comparison with the Medical Device Directive

The following table compares the new requirements in the

Medical Device Regulation (MDR) with the existing requirements

for certain phthalates in the Medical Device Directive (MDD).

This shows that the MDR is much wider in scope than the MDD:

EU Regulation 2017/745 on medical devices (hereafter “Medical Device Regulation” or “MDR”)

introduces new legal requirements for certain “hazardous substances” in medical devices.

These requirements are established in Section 10.4. of Annex I (General Safety and Performance

Requirements). Section 10.4. specifies that the use of certain chemical substances in medical

device parts or materials in a concentration of 0.1% by weight or more will need to be justified in

the technical file. The presence of such substances will also need to be indicated on the device label.

Nathalie Buijs, Manager Regulations & Industrial Policy

MedTech Europe


39

w


been classified as hazardous for human health, even if they

do not necessarily pose a risk to the patient. The European

Commission’s factsheet for healthcare professionals states

in this regard that: “The MDR foresees that device labels

will have to indicate the presence of CMR substances or

endocrine-disrupting substances in medical devices above

certain concentrations. This labelling requirement does not

mean that a device is unsafe. The fact that it has been CE

marked means that both the manufacturer and the Notified

Body have established a positive risk-benefit ratio (MDR

Annex I, Chapter II, section 10.4.1).”2

» Finally, the MDR requirements come on top of existing

regulations on chemicals, several of which apply wholly

or partially on medical devices, e.g. Regulation (EC) No

1907/2006 on REACH, Regulation (EU) No 528/2012 on

Biocidal Products, Directive 2011/65/EU on the Restriction of

Hazardous Substances (RoHS). This means that one substance

may be subject to multiple requirements under each of these

regulations.

MedTech Europe has developed industry guidance to support

manufacturers with the MDR obligations related to hazardous

substances. The guidance is available to SPECTARIS members

free of charge. To obtain a copy, please contact regulatory@

medtecheurope.org.

not only has the number of substances

which are covered increased drastically;

also the obligations in terms of risk

justification and labelling have become

more stringent.

Key challenges

The medical technology industry is

strongly committed to the new Medical

Device Regulation and its full and

timely implementation. Medical device

manufacturers are investing heavily to

comply with the new requirements.

However, they are likely to face several

challenges when implementing the new

requirements on hazardous substances:

» Difficulty to define which devices are

in scope of the requirements (e.g.

meaning of ‘invasive’, ‘administering

substances to/from the body’).

» Challenge to establish the level (device,

material, part) at which to calculate

» Requirement Medical Device Directive Medical Device Regulation 93/42/EEC (EU) 2017/745

» Type of substances in scope

» Number of substances in scope

» Justification of the use of substances in scope

» Labelling of the presence of substances in scope

» Phthalates which are classified as CMR, of category 1 or 2

» 11 substances

» Justification about compliance with essential requirements, in particular risk of leaking

» Only if intended use includes treatment of children or treatment of pregnant or nursing women

» To be labelled as a device containing phthalates

» All substances which are classified as CMR, of category 1A and 1B, and all substances having endocrine-disrupting properties identified in accordance with REACH or BPR

» + 1200 substances

» Justification must consist of analysis of exposure, analysis of alternatives and risk-benefit assess-

ment» Justification always

required

» To be labelled with ‘the list of substances’

the hazardous substance concentration.

» Knowledge of which substances are present in parts or

materials and at which concentration will require improved

communication with and information from suppliers and/or

testing by the medical device manufacturer.

» Keeping track of the list of substances classified as CMR 1A,

CMR 1B and endocrine disruptors. This includes monitoring

Adaptation to Technical Progress to the CLP Regulation (for

CMR substances) as well as updates of the REACH Candidate

list and identification of substances with endocrine-

disrupting properties under the Biocidal Products Regulation

(for endocrine disruptors).

» Meeting the requirements for risk justification (including

assessment of potential alternatives) and ensuring that the

relevant scientific committee guidelines are met. In certain

cases, this may require manufacturers to implement design

changes in order to keep the device compliant with the law.

» Updating the list of substances on the label. To avoid multiple

label updates, MedTech Europe has developed a hazardous

substance symbol which could be used instead of a substance

list (which would require continuous updating of the label).

This symbol is currently subject to approval for inclusion in the

revised ISO 15223-1 standard and may eventually become

harmonised against the MDR. MedTech Europe developed

guidance on symbols under the MDR which is publicly

available on our website.1

» Potentially addressing concerns from patients and/or

healthcare professionals who will, by means of device labels,

be made aware of the presence of substances which have

» Classification: Refers to harmonised classification in accordance with Annex VI of the CLP Regulation (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures), formerly Annex I of Dangerous Substances Directive 67/548/EEC

» CMR: Carcinogenic, mutagenic or toxic to reproduction; Category 1A: ‘Known to have CMR potential for humans’; Category 1B: ‘Presumed to have CMR potential for humans’; Category 2: ‘Suspected human CMR’

» REACH: Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals» BPR: Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

1 https://www.medtecheurope.org/resource-library/use-of-symbols-to-indicate-compliance-

with-the-mdr/ 2 https://ec.europa.eu/growth/sectors/medical-devices/getting-ready-new-regulations/

healthcare-professionals-and-health_en

40

Regulatory Affairs | Connecting medical devices across manufacturers

Guest article

Connecting medical devices across manufacturers The series of interoperability standards IEEE 11073 SDC

Digitalisation in healthcare has the objective of improving

the efficiency and quality of patient treatment. Increasing

cost pressure, higher service demands, as well as limited

resources require the continuous development of hospitals as

overall systems. A crucial part of this strategy is the IT connecti-

on of the medical technology devices of different manufacturers

in order to quickly collect data at the location at which they are

generated and forward them without any media disruptions.

Hospitals can gain a significant cost advantage – and thus com-

petitive advantage – by connecting to technologies involved in

the value-added chain. To date, the integration of medical tech-

nology systems is implemented by the providers of proprietary

systems solutions. This strategy comes with the disadvantage of

giving this provider a virtual monopoly, with adjustments to the

configuration up to the end of the ongoing investment cycle

only possible with significant (financial) efforts. This prevents the

continuous implementation of efficiency improvements, e.g.

through the integration of new technologies, and massively

restricts the creative freedom of hospitals. The publication of the

series of standards IEEE 11073 SDC represents a milestone in the

elimination of bottlenecks. The standardisation of interfaces for

complex medical technology devices allows for the integration

of devices from different producers into an overall system, as

well as a large number of value-added features across devices

Thomas Neumuth (left), Martin Kasparick (right),

OR.NET e. V.

Contact:OR.NET e. V. · Kaiserstrasse 100 · 52134 Herzogenrath


Illustration 1: Examples of value-added features in a connected operating room

» Sources: ICCAS Leipzig /Max Rockstroh

(see Illustration 1).

IEEE 11073 service-oriented device connectivity (SDC)

The IEEE 11073 SDC series of standards

(see Illustration 2) is maintained and de-

veloped by the user’s association OR.NET

e. V. The non-profit association develops

usage scenarios for connectivity-based

value-added services, creates guidelines

on their implementation, and offers sup-

port in the software-side implementation

of interfaces.

Since the beginning of 2019, OR.NET

e.V. has integrally published three core

standards of the IEEE 11073 SDC series of

standards which can be implemented by

industry players. The core of the series is

made up by the Domain, Information, and

Service Model (IEEE 11073-10207). This

allows for the description of each medical

41

In connectivity solutions on the basis of standard hardware and

software, patient safety is not possible without information

security. Therefore, the IEEE 11073 SDC series contains mecha-

nisms for the encryption of communication, authorisation and

authentication of network partners, etc.

Sustainable technology with future potential

With the continuous evolution of digitalisation in healthcare, all

clinical disciplines are also facing new challenges. Complex dia-

gnostics and therapy tailored to patients place great demands

on clinical personnel as regards the collection and processing of

information and the controlling of supporting technical systems.

As a result of the interoperability of devices across producers,

data or features are no longer merely made available to the de-

ployed systems themselves, but also to the overarching infra-

structure or other devices.

Handling this technology thus makes working in clinics easier,

significantly reduces the risk of missing essential information,

and frees up time to focus on the core tasks of patient treatment.

device together with its features, measurement values, adjust-

ment and trigger operations, etc. within the network. Together

with the use of semantic description tags, which are based on

a nomenclature (e.g. IEEE 11073-1010x series), this opens up

the possibility for medical devices to “understand” each other

independently of the producers. In other words, the devices are

capable of correctly interpreting information and commands,

without any knowledge at the time of development of which

devices they would communicate with in the field later on.

To make sure that these semantically interpretable data can

be shared between the various devices, the so-called Medical

Devices Communication Profile for Web Services, or MDPWS

(IEEE 11073-20702), was developed. It builds on the established

DPWS standard and defines expansions and restrictions to meet

medical requirements. Each IP-capable standard network can be

used for data transmission, for example ethernet (IEEE 802.3

series) or Wi-FI (IEEE 802.11 series). Such standard technologies

reduce costs and efforts for use in hospitals.

The SDC core standards are complemented by the IEEE 11073-

20701 standard. On the one hand, this defines the overall archi-

tecture on the basis of the core principles of service-oriented

architecture (SOA), and on the other hand, it specifies the connec-

tion between the two other core standards and other standards.

The strict separation between the data model and data trans-

mission in the two standards makes it future-proof: If a more

suitable transmission technology is established in the future, it

can be used without changing the modelling of the devices.

Moreover, the use of other established standards is described for

aspects such as time synchronisation or Quality of Service (QoS).

Illustration 2: Interoperable, producer-independent connection of medical devices: IEEE 11073 SDC core standards

» Sources: ICCAS Leipzig /Max Rockstroh


42

» Source: European Patent Office

European patent applications in the field of medical technology

2008 – 2018

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

3,000

5,000

4,000

6,000

7,000

8,000

9,000

10,000

11,000

12,000

13,000

14,000

8,01

8

7,65

8

11,1

36

10,6

28

10,5

02

10,7

82 11,2

34

12,5

31

12,3

82

13,1

34

13,7

95

The innovative force of German medical technology producers


SPECTARIS e. V.

Around one-third of revenues realised with German med-

ical technology stem from products which are less than

three years old. The industry invests a great amount of

capital and personnel in research and development (R&D). With

R&D expenditures amounting to around 9% of revenue and with

around 15% of employees active in R&D, the R&D intensities of

producers clearly exceeded the industry average.

In 2018, the medical technology segment made the most

successful patent applications with the European Patent Office:

13,795 (+5%) of a total of around 174,000 applications.

Germany takes second place with 1,336 applications, behind

the UAS (5,175 applications) and ahead of Japan (1,184).

Research & Innovation | The innovative force of German medical technology producer


43

» Source: European Patent Office

European patent applications in the field of medical technology

Origin of applicants 2018

USA

Germany

Israel

Japan

United Kingdom

The Netherlands

France

Korean Republic

China

Others

5,175

1,336

841

545

Switzerland 753

417

338

305

2,481

1,184

420

44 Public health | Cooperation agreements with medical institutions and healthcare professionals

Guest article

Cooperations with medical institutions and healthcare pro-

fessionals are very important to the medical technology

industry. Only in this way can medical applications be

tested in practice and can companies gather information from

users and patients. Examples of such necessary cooperations

include conducting clinical trials, studies, presentation activities,

and advisory boards. Demand for close exchange with users is

set to increase even further with a look to the enhanced require-

ments placed on clinical data before and after certification under

the MDR.

Over the past years, however, several forms of cooperation

have also been subjected to public scrutiny. They were in part

used to grant unlawful remuneration to healthcare professionals

under the guise of a cooperation. For this reason, it is now more

important than ever for medical technology companies to design

cooperations with healthcare professionals in a legally sound

manner from the very beginning. The legal framework is provid-

ed by the prohibitions of undue benefits under the Act on ad-

vertising in the healthcare sector (Heilmittelwerbegesetz) and

professional regulations, as well as criminal related to corruption

(above all §§ 299a, b of the Penal Code StGB), but members of

SPECTARIS are also bound by the SPECTARIS Code of Conduct

since 2017.

Cooperations with medical institutions and healthcare profes-

sionals should particularly comply with the following criteria:

1. Actual need for cooperation

Remunerated cooperations are only allowed whenever medical

technology companies actually have a real need on their perfor-

mance. In practice, this means that companies are allowed to

enter into those cooperations which are reasonable for the com-

pany in line with objective and factual standards. For example,

this may apply to gathering information on further product

developments, issues in patient care, as well as the collection of

medical opinions in fields in which the company is active. The

regulatory requirements placed on clinical product data under

the MDR can particularly substantiate the objective need for

cooperation. The actual need should be communicated to the

outside world in a visible manner, e.g. by specifying it in the

cooperation agreement or in the letter of invitation. Already

during the planning phase, the concrete use of the results of the

cooperation in the company should be taken into consideration.

Later implementation should also be carried through and docu-

mented.

2. Concrete implementation with the selected cooperation partners

When selecting partners to support the medical technology com-

panies, the abstract requirements placed on the partner must

be defined in advance (size of the hospital, specification, physi-

cian’s qualification, etc.), in order to ensure that the company

obtains useful results. Accordingly, the specific partner must be

selected on the basis of the pre-defined criteria. Selection on the

basis of revenue figures or similar is not permissible. The required

number of partners must additionally be specified in advance.

The company must, for example, ask itself how many statements

from different partners are statistically required in market research

in order to obtain conclusive results. Only this number of partners

may actually be included in the market research. The question

of how many partners are necessary may, among other things,

depend on the complexity of the issues to be dealt with or the

plurality of available opinions.

Maria Heil, M.C.L.

(Mannheim/Adelaide)

attorney at law, Partner,

NOVACOS Law Practice

Contact:Email:

[email protected]

www.novacos-law.com

Cooperation agreements with medical institutions and healthcare professionals

45


3. Appropriate remuneration

If there exists an actual need for cooperation and after specifi-

cally selecting the partners following the criteria specified above,

the company is allowed to pay the cooperation partner an

appropriate remuneration for the performed services. Various

criteria can generally be used to calculate the remuneration,

above all depending on the type of performance to be remu-

nerated.

» If the performance is of a service nature, e.g. participation

in an advisory board, speaking activities, etc., focus should be

placed on the time required for performing the service. Speaker’s

agreements regularly require a set hourly rate to calculate an

appropriate remuneration. To determine the rate, criteria such

as the qualification and experience of the service provider,

industry reputation (national/international), the difficulty or

scientific demand of the task, etc. are decisive on a case-by-case

basis. Many medical technology companies have worked out

various general categories and defined a matrix in advance which

includes the hourly rates for service activities.

» If the service is of a more “factual” nature, e.g. sponsor-

ing an external event for continued education, the calculation

of the appropriate remuneration does not or not primarily depend

on the personal criteria associated with the performing party,

contrary to the services specified above. To name an example,

in calculating the appropriate value of a sponsoring service,

decisive factors are not the time spent and expertise required

to hang up an advertising banner. Other criteria are relevant

here, such as the value of the advertisement to the com-

pany, the size and importance of the event, the exclu-

sivity of the advertisement, and so on. The company

must evaluate these external factors for each project

and “fill it with life”. An appropriate remuneration

can then be determined on this basis. In both cas-

es, the proper documentation of applied criteria

is important to make sure that the objective and

factual criteria used to calculate the remuneration

can still be understood after granting the remu-

neration.

4. Formal requirements

A written agreement should always be concluded

between the cooperation partners, mapping out the

cooperation, background (company need, partner’s

qualifications, etc.), the service, and above all the remu-

neration. Only then can un equivocal proof of the legal

grounds for payment to medical institutions or healthcare

professionals be provided to third parties. If the agreement is

concluded with one individual healthcare professional who is

an employee (for example of a hospital or medical centre), the

approval of the employer for this specific cooperation is addi-

tionally required – as is the case with all economic performances.

A general approval for secondary employment does not suffice.

Documentation on the observance of compliance principles

plays a crucial role in designing the cooperation, as it can serve

as evidence in case of disputes.

Therefore, companies should have a uniform electronic procedure

in place for each cooperation, in which not only the written

agreement, but also the need, calculation of the remuneration,

etc. are laid out and substantiated in writing.

5. One-sided support payments in line with the SPECTARIS Code of Conduct

If, in exceptional cases, a medical institution is to be supported

without performing a service in return, for example for research

purposes, this is generally possible under German law in the

form of a donation. The requirements from the SPECTARIS Code

of Conduct must additionally be observed. This is governed by

Chapter 4, Clause 3 on one-sided support payments for educa-

tion purposes. Companies can support external continuing

46

Guest article

Public health | Cooperation agreements with medical institutions and healthcare professionals

education events, award grants and fellowship programmes, as

well as promote disease awareness campaigns following the

requirements specified therein. Chapter 4, Clause 4 covers

sponsoring for research purposes. The Code allows for (materi-

al or financial) support of earmarked research contributions for

clearly defined research studies initiated by third parties for

clinical or non-clinical research programmes.

If the company has an interest in the results of the research,

a mutual cooperation agreement with the purpose of transferring

the rights to the results might be the proper solution. Here, the

parties should ensure that the appropriateness of the remuner-

ation does not depend on the financial research requirements,

but should rather be in line with the value the data have for the

company.

6. Bottom line

A legally sound cooperation with medical institutions and health-

care professionals is possible under observance of the applicable

principles. This requires thorough planning in advance on the

part of the company as well as the inclusion of departments that

can capably handle the cooperation. For example, a clinical study

should not be managed by the Marketing team. On the other

hand, market research on new advertising statements can be

planned and carried out by the Marketing department. There

have not been any significant changes to the requirements placed

on cooperations in the previous years. Changes to the risk pro-

file, above all in the field of primary care (§§ 299a, b StGB), have

further increased the importance of comprehensive requirement

documentation; nevertheless, cooperations can be planned and

carried out under observance of the framework conditions

mapped out above.

Especially as a result of the relevance of clinical data to prod-

uct approval and monitoring under the MDR, cooperation

between the industry and users in certain areas is actually ex-

pressly promoted by the legislator.

47Health spending

» Source: Federal Statistics Office

German healthcare expenditure by service type

Type of service 2016 2017

Overall health expenditure ...................................................................................................... 358.7 375.6» Investments ............................................................................................................................. 7.0 ................... 7.0

» Ongoing healthcare expenditure ....................................................................................... 351.7 .............. 368.6

» Prevention/health protection ........................................................................................... 11.8 ................. 12.1

» Health promotion ............................................................................................................ 3.9 .................. 4.0

» Health promotion ............................................................................................................ 4.7 ................... 4.9

» Early detection of diseases .................................................................................................1.9 ................... 2.0

» Opinions and coordination ................................................................................................1.3 ................... 1.2

» Medical services ............................................................................................................... 95.2 ................ 98.0

» Basic services ..... ........................................................................................................... 26.0 ................. 27.0

» Special services ... .......................................................................................................... 49.7 ................. 51.1

» Laboratory services ........................................................................................................... 9.4 ................... 9.7

» Radio-diagnostic services .................................................................................................10.1 ................. 10.4

» Care/therapeutic services ................................................................................................. 95.6 ...............105.8

» Care services ..................................................................................................................70,9 ................. 79,8

» Therapeutic service ........................................................................................................ 23.5 ................ 24.8

» Maternity services .............................................................................................................1.1 ................... 1.2

» Accommodation/care ....................................................................................................... 27.8 ................ 28.7

» Goods ................................................................................................................................ 97.4 ................ 99.3

» Medicines ...................................................................................................................... 55.8 ................. 57.3

» Devices ...........................................................................................................................19.4 ................. 19.6

» Dentures (material/laboratory costs) ...................................................................................7.5 ................... 7.5

» Other medical needs .......................................................................................................14.7 ................. 14.9

» Transport ............................................................................................................................. 7.1 ................... 7.5

» Administrative services .....................................................................................................16.8 ................. 17.2

..............

in billion €

48 Public health | Ethical aspects in nursing bed care

Ethical aspects in nursing bed care

T he nursing bed plays a very crucial role in care. As a point

of care, the nursing bed forms the foundation of main-

taining what is usually someone’s last personal space,

allowing for care in line with current standards and representing

how our society deals with “those in need of care”. Against this

backdrop, there is an ethical and moral obligation to refrain from

bringing nursing beds with minimal furnishings to market out

of short-term, economic considerations.

Ethics has always played a major role in care, and profession-

al codes of conduct have been in place since the dawn of pro-

fessional care. Nevertheless, principles of medical ethics have

recently grown even more relevant. Not in the least because of

several “care scandals”, some of which were the subject of

public debate.

The rights of those in need of care and assistance are laid

down in the eight articles of the Care Charter (see box). This

Charter is intended to strengthen the rights of people in need

of long-term care and assistance by summarising the fundamen-

tal and indisputable rights of people in need of support, care,

and assistance. These rights are an expression of respect for the

dignity of people, and they are thus embedded in numerous

national and international legal texts. Comments on the rights

are added in explanations on the articles, exploring the central

aspects and situations of the lives of people in need of care and

assistance. Moreover, the Charter specifies quality characteristics

and objectives to be aspired to and implemented as part of good

care and assistance.

The producers of nursing beds organised within the industry

association SPECTARIS explicitly want to direct focus of care

discussions to the nursing bed as a “point of care”, in which

residents or those in need of care often spend most of their time,

in line with these ethical and moral aspects. They are currently

developing a declaration of commitment with the objective of

illustrating how the producers of nursing beds observe and im-

plement the ethical requirements laid out in the Care Charter in

nursing bed features, to the benefit of both residents as well as

care professionals and relatives.

Nursing beds are medical products that guarantee the utmost level of safety

Nursing beds are medical products that comply with the strict

regulatory market approval regulations. In terms of quality and

design, they are always developed to guarantee the utmost

level of safety for both the care professionals as well as residents.

Nursing beds support the nursing staff and at the same time serve as a nursing aid to residents

Nursing beds are both medical product and furniture, supporting

the daily work of nursing staff with their numerous functions as

well as residents as a care aid. The most recent findings from

nursing science on positioning, mobilisation, and decubitus pre-

vention must be taken into consideration.

A good balance between the best possible protection against falls while at the same time allowing for the greatest freedom and self-determination

On the one hand, producers of nursing beds must always

strike a good balance between offering the resident the

best possible protection against falling from the bed to

prevent (in part dramatic) consequences (fall consequence

prevention), and on the other hand, the basic rights of resi-

dence to self-determination and freedom.

Contact: Marcus

KuhlmannSPECTARIS e. V.

49


Nursing beds contribute to homeliness at the “point of care”

As a “point of care”, many patients spend most of their time in

the nursing bed. Producers contribute to improvements in their

quality of life by creating a comfortable ambiance through the

selection of materials and with high-quality, modern designs.

Producers contribute to environmental protection

The basic ethical requirements entail that producers consider the

overall lifecycle of the nursing bed, also under consideration of

environmental and sustainability aspects. The selection of mate-

rials, production process, logistics, deployment, and the easiest

possible disposal at the end of the lifecycle play a crucial role

here. High-quality nursing beds additionally ensure that there

are very few returns, and thus a low replacement and scrap rate.

A fixture of the overall process is trying to minimise the burden

placed on the environment. This extends far beyond the standard

requirements, for example by refraining from the use of tropical

timbers or only using coatings which are harmless to the envi-

ronment.

Code of Conduct, professional ethics, and data privacy

Regardless of the product, the ethical approach of producers

also comprises the consistently fair treatment of employees, sup-

pliers, and customers in daily operations. Fairness, transparency,

honesty, as well as – naturally – observing all legal regulations

and preventing all types of discrimination, are part of day-to-day

activities.

In light of the advancing digitalisation, which also impacts the

field of nursing beds, data privacy plays a key role. Producers

undertake to comply with all data protection requirements under

the General Data Protection Regulation (GDPR) as part of the

digitisation of their products.

As a member of the German Industry Association SPECTARIS,

producers are also bound to the SPECTARIS Code of Conduct

for cooperations in healthcare.

Care Charter:

» Article 1: Self-determination and self-help

support

Everyone in need of long-term care and assistance

has the right to self-help support and to assistance

to enable them to live a life which is as self-deter-

mined and independent as possible.

» Article 2: Physical and mental integrity, freedom, and security


has the right to protection against any physical or

mental threats.

» Article 3: Privacy Everyone in need of long-term care and assistance

has the right to the safeguarding and protection of

their privacy and intimate personal space.

» Article 4: Care, support, and treatment Everyone in need of long-term care and assistance

has the right to qualified, health-promoting care, sup-

port and treatment that is tailored to their personal

needs.

» Article 5: Information, counselling, and informed consent


has the right to be fully informed of the possibilities

and opportunities available for counselling, support,

care, and treatment.

» Article 6: Respect, communication, and social participation


has the right to respect, interaction with others, and

to participate in society.

» Article 7: Religion, culture, and beliefs Everyone in need of long-term care and assistance

has the right to live in keeping with their culture and

beliefs, and to practice their religion.

» Article 8: Palliative care, end-of-life care, and death Everyone in need of long-term care and assistance

has the right to die with dignity.

50 Digitalisation | Requirement for the digitalisation of the healthcare system: the further development of assessment procedures

Requirement for the digitalisation of the healthcare system: the further development of assessment procedures Digital medical products are set to revolutionise healthcare. They goal is to ensure that all

processes are carried out faster, better, and above all at lower costs.

P atients can better manage their illnesses, doctors can

carry out remote treatments and make remote diagnoses

on the basis of data transmitted by patients. They can

then decide whether a patient need not worry and can stay home,

or should visit the hospital instead. Data can be compiled to

prevent unnecessary examinations and an overview can be giv-

en of the entire medical history of the patient, as well as their

provision of medication, therapeutic products, and supporting

products. Moreover, artificial intelligence can assist in making

diagnoses and expedite treatment recommendations. Doctors

can even discuss findings over long distances and bundle their

expertise in consulting patients.

However, the emergence of this brave new world of medicine,

simple yet efficient, is often obstructed, not just by ethical, pro-

fessional, and legal discussions.

Above all, the requirements of the German healthcare system

pose a challenge to digital medical products such as software

and apps.

The German statutory healthcare system is generally divided

into two segments: the inpatient and outpatient segments. Each

of these care processes has its own rules for accepting a health-

care service into the reimbursement process. Many digital supply

offers, however, work across industry sectors with a single process.

For example, a patient collects data on their heart rhythm at

home using a mobile ECG and provides them to their treating

specialist for analysis, as well as a hospital physician, through an

app. These then jointly make a decision on whether hospitalisa-

tion is necessary. The patient and specialist operate in the out-

patient segment, whereas the hospital physician makes their

diagnosis decision in the inpatient segment. The patient can also

store different measurements in the app. It might give instructions

on when measurements are useful and when to urgently contact

a physician. The patient might feel more secure in spite of their

cardiac failure and enjoy greater participation in life by even

going on a trip abroad. Whenever the patient is feeling insecure

about their health condition, they can collect data and send them

to their German physicians who then consult with the patient

and treat them from Germany. In this case, treatment not only

spans various segments but also countries. Now, the question

must be addressed where the service was performed for bill

settlement.

Digital applications often offer benefits in the care process that

exceed the typical patient benefits within the framework of a

treatment.

The topic of benefit analysis is crucial to all producers of med-

ical products whenever they want to have their products reim-

bursed by the statutory health insurers as part of new examina-

tion or treatment methods or the product itself represents a new

examination or treatment method.

There are strict criteria in place for providing evidence of ben-

efits. Randomised control studies (RCT) are usually required to

effectively prove benefits. Here, only benefits to patients are

relevant to the evaluation, as is specified in Book 5 of the German

Social Code. Mortality, morbidity, and health-related quality of

life are evaluated. Further benefits of a method are only taken

into consideration when answering the final question of wheth-

er it can be included for reimbursement as an alternative to

existing examination and treatment methods.

The requirements described here, however, do not constitute

specific challenges in the evaluation of methods based on digital

medical products – they apply to the entire industry.

Special features of digital care offers on the one hand result

from the “innovation cycles” of digital medical products, such

as apps and software for therapy or diagnosis. These are subject

to much more rapid change than classical medical products, be-

cause experiences made with the product can instantly by taken

over in a new version. Apps and software are continuously up-

dated and their quality developed further during use. The prod-

uct does not have one set functional status which is used as part

of the method. The identified user learning curve, which makes

it harder to evaluate medical products as part of a medical meth-

od, is joined by the “improvement curve” of the digital product.

Contact: Cordula Rapp SPECTARIS e. V.

51


On the other hand, products also adapt to usage behaviour,

generate outcomes and recommendations – depending on the

available data – which they can use in combination with user

data. As the product is used more and more, the quantity of

data from which decision recommendations can be calculated

for this individual patient increases.

In short, the product available at the beginning of the

study is no longer the same at the end of the study.

New evaluation methods must be created to account

for these special features, new study designs which

pay tribute to the characteristics of continuous further

development.

Often, however, process changes are the most

important benefits offered by a digital product.

Patients are only asked to visit the physician if the

transmitted data change. Examinations by robotic

physician assistants of course come with the benefit

of having them carried out at home, in the patient’s

familiar environment. Physicians must no longer be

motivated to move their practice to rural areas to ensure

local care or only seldomly have to pay house visits to

people with reduced mobility. Treatments might become less

onerous for patients, but the same high quality is still guaran-

teed.

This also means that a method assessment must be replaced

by a process evaluation. A first approach can be found in the

draft of the planned Digitalisation Act, in which “positive care

effects” to be proven are mentioned.

However, the development of adequate assessment procedures

for digital care offers is and remains necessary. The special char-

acteristics of study design, new categories of benefits, and short

innovation and product lifecycles must be taken into account

here.

What’s more, providers of digital care offers must be informed

and consulted in a binding manner on options to access the

reimbursement system, to make sure that good and innovative

ideas do not fail because of the selection of the wrong access

option.

If Germany wants to use digital care offers to the benefit of

insured persons, not only individual players must be involved,

but all stakeholders should all work together on new concepts

as partners – and not just for assessment.

Access paths should be clearly defined and evaluation methods

explained and developed collaboratively during an exchange.

Patients must be better included into the process of further de-

velopment of the health system. After all, a risk-benefit analysis

for patient care always takes place at the end of an assessment

process. They should therefore be given a voice.

52 Digitalisation | Digitalisation and lack of skilled labour

Digitalisation and lack of skilled labour

A lmost 8 million employees, or around one-fifth of all

employees subject to make social security contributions,

are faced with the risk of their jobs being rendered either

completely obsolete or at least changing fundamentally by 2025.

This is the conclusion of a study conducted by the Boston Con-

sulting Group. Headlines such as this one shape the perception

of advancing digitalisation and create unease in the general pub-

lic at first glance, with people perceiving an acute threat for their

own jobs.

Alexander Mischner, Director, Service Line Executive Search

Practice Group Head MedTech/Life Sciences

Contact:Kienbaum Consultants International GmbH

Speditionstrasse 21 (Hafenspitze) · 40211 Düsseldorf

Email: [email protected] · www.kienbaum.de

In this context, we struggle to reconcile this insight with the

apparent contradiction of digitalisation being massively slowed

down by a lack of skilled labour. The Association of German

Engineers (VDI) reports that the German job market depends

heavily on experts from the fields of engineering and computer

science to keep pace with international competition when it

comes to digitalisation. The SPECTARIS study “Health 4.0” draws

similar conclusions for the German healthcare industry. It paints

a picture of an industry still only realising a minor share of rev-

enue with digital products and services, lagging in an industry

and international comparison. The main reason given for this is

a lack of suitable employees with the right digital qualifications

who could help design the transformation. We can confirm

this observation from our daily operations in executive

search. The search for excellent managers with dig-

ital expertise, who can push forward digitalisation

for our healthcare clients, now forms a signifi-

cant and continuously growing share of our

business.

The authors of the “Health 4.0” study as-

sert that a significant net plus of jobs can

be created over the coming years by rem-

edying this obstacle to growth. This could

amount to around 10,000 additional jobs.

Even if there are great worries about the

state of digitalisation in Germany, the pos-

itive conclusion can be drawn that the health

industry can continue to serve as a job motor

for overall economy in the future as well –

if suitable measures are taken, already laying

the foundation for long-term success today.

Let’s start by looking at the current and imme-

diate need for action. Difficulties already arise from the

fact that the “Health 4.0” study indicates that less than

40% of medical technology companies have defined an express

Guest article

53


Digitalisation | Digitalisation and lack of skilled labour

digitalisation strategy. These contrasts to the observation that

most companies seem to agree that digitalisation is the future

and “something has to be done” in this field. Many companies

fail to properly implement these insights, however, experiencing

difficulties with grasping the specific issues at hand, dividing

them into manageable chunks, and deriving specific fields of

action from them. Nevertheless, this should be at the beginning

of the entire process. Only in this way companies can start es-

tablishing firm foundations as part of their strategic staff planning

today in order to use their digital key competences to draw

employees to their company on the highly competitive specialised

job market of the future, thus gaining decisive competitive

advantages.

This “laying the tracks for long-term success” is unfortunately

not sufficiently emphasised in public discussions. In light of the

fundamental changes digital transformation will bring

about, also on the job market, looking for prop-

erly qualified employees externally and winning

their commitment to the company is no

longer enough. In fact, competences will

be required in the future which are not

yet widely available on the job market in

this combination and form. The German

Stifterverband provides a good overview

with their “Higher Education Report

2020”, differentiating between three

types of “future skills”. On the one hand,

these include technological skills such as

complex data analysis and user-centred design,

which are necessary to design transformative

technologies and require the education of technol-

ogy experts. However, employees must gain “future skills”

on a wide scale as well to be able to hold their own on the job

market of the future. This includes digital key qualifications such

as agile working and digital learning as well as other overarching

key qualifications such as creativity and capacity for adaptation.

This also implies that entirely new job profiles will emerge over

the coming five to ten years that will bundle these competences.

Vocational schools and universities (of applied science) are already

today facing this challenge and will have to further reinforce

their efforts to develop suitable new training and education

programmes. By creating suitable framework conditions, politics

can very effectively support digitalisation. Nevertheless, broader

social changes are also necessary. The importance of profession-

al further education is set to increase significantly. Companies

must offer their employees with suitable opportunities and

actively demand the willingness to commit to “lifelong learning”.

We are of the firm conviction that companies which prioritise

instilling in their employees the competences specified above,

while making use of their own digital experts, will have a con-

siderable competitive edge in the future!

When studying the headline at

the beginning of the article on

jobs being threatened by digital-

isation from different angles, it

becomes apparent that not all is

gloom and doom – if politics and in-

stitutions and bearers of (continued) edu-

cation, as well as companies, take the measures

outlined above quickly and with courage. And if every individ-

ual takes charge of their own “employability” through contin-

uous further education.


54 Digitalisation | A strong domestic market as a driver of global success – how Germany can defend its edge in medical technology

A strong domestic market as a driver of global success – how Germany can defend its edge in medical technology

Mr Kaltenbach, in your study you are looking at the cur-

rent state of digitalisation in German healthcare, and

how this impacts medical technology. The sector was for

a long time considered a model German industry. Does

this still ring true?

This is certainly still the ambition, and rightfully so. German med-

ical technology is in high demand across the globe, with 64%

of medical products produced in the country exported. Taken as

a whole, the German producers still take second place in the

global ranking, with revenues of 32 billion euros and a share of

around 10%; behind the US but ahead of Japan. I use the world

“still”, because we are currently experiencing a worrying devel-

opment: The strength of German medical technology is attrib-

utable to the strong domestic market. And this market is facing

pressure, with Germany lagging behind when it comes to digi-

talisation. Currently, we can rightfully claim to be ahead of the

pack, but we must now take action to ensure that it stays that

way in the future. Only if Germany manages to develop into the

leading market for digital healthcare can the country defend its

leadership position.

Interview with Dr Thilo Kaltenbach, Senior Partner at Roland Berger and author of the study

jointly published with SPECTARIS on “Health 4.0 – why Germany must become the leading

market for the digital healthcare economy and medical technology, and steps to take now.”

(available online – in German – at https://www.rolandberger.com/de/Publications/Digitalisi-

erung-der-Gesundheitswirtschaft-in-Deutschland.html)

Contact:Phone: +49 (0) 89 92 30 86 51 · Email: [email protected]

Why is the digital transformation more successful in other

countries?

Countries such as the Netherlands, Denmark, Sweden, as well

as Austria and Estonia, above all have one thing in common: The

political determination to act emerged at an early stage, setting

the course for digitalisation – for example in Austria, with the

introduction of the Electronic Patient File (ELGA) following the

opt-out principle: Insured persons participate in the plan unless

they actively object to it. Of course, this gives them a significant

advantage in experience with digital methods. In Germany, po-

litical actors delegated responsibility for the issue to stakeholders

of the healthcare system for a long time – in line with the prin-

ciple of self-administration. However, this actually slows down

innovation, because the slowest player sets the pace.

What opportunities does digitalisation bring for German

medical technology producers?

Let me illustrate this using the three most significant threats in

the event that Germany continues to make such hesitant progress

in digitalisation, as pointed out by the medical companies

Guest article

Roland Berger, founded in 1967, is one of the only globally leading management consultancies

with German origins and European roots. The company is successfully active on all important

global markets, with around 2,400 employees in 35 countries. The Competence Center Pharma

& Healthcare advises customers from the pharmaceutical industry, medical technology, as well as

health insurers and healthcare providers in the fields of digital transformation, regulative changes,

reorganisation, and growth strategies.

55Digitalisation | A strong domestic market as a driver of global success – how Germany can defend its edge in medical technology

surveyed by us: displacement by new competitors, more difficult

foreign market access, loss of market shares. Digital innovations

are indispensable to even retain market competitiveness of com-

pany products, otherwise producers will lose customers to com-

petitors from countries such as the USA and China. On the oth-

er hand, digitalisation also offers the opportunity to provide new

services in addition to conventional product sales, reinforcing

the company’s position on the market and boosting revenues.

This is joined by further effects, for example in development and

production, because producers directly monitor their devices

during use through digital methods and can immediately inte-

grate user feedback into further development.

What can companies do to tap into this potential?

For our study, we not only collected the current impressions on

digitalisation and the medical industry, but also developed rec-

ommendations for actions for politics and companies. There is

one crucial issue for medical technology producers. They should

first and foremost recognise the importance of digitalisation and

set their priorities properly – a lot of companies still haven’t

managed to do so. Above all, this entails developing a clearly

defined strategy for handling the issue. Key questions are, to

name some examples, how and where digital technologies can

be used in the company’s business, which competences are re-

quired for this, and how staff can be suitably qualified. After

working out the strategy, companies should then invest massive-

ly in digitalisation projects in a targeted manner – for new prod-

ucts as well as services. Ideally, this would amount to between

three and 5% of revenue – currently, this usually falls short of

2%. Politics is, however, partially to blame for this reluctance as

well; officials still have their work cut out for them.

For example?

Politics must take control and create regulatory requirements to

establish a framework in which companies can pursue their own

path towards digitalisation. Our recommendation therefore com-

prises, in addition to the development of a national e-Health

strategy with electronic patient files, a comprehensive infrastruc-

ture programme to connect inpatient and outpatient care. Besides

this, we need legal standards, such as technical baseline require-

ments and data protection regulations. Moreover, the approval

of new digital products and services must be expedited and

health insurers must introduce reimbursement processes. With

all these measures, focus should always be placed on patient

benefits.

Are the current legislative proposals sufficient?

Numerous measures have been initiated over the past months,

which is a positive development; nevertheless, the laws often

remain too superficial and once again leave too much to self-ad-

ministration. Instead, they should describe in greater detail which

measures should lead to attainment of the aspired objectives.

This also includes clear specifications, e.g. obligations for physi-

cians and pharmacists to participate in the electronic patient file.

What is your vision for the German healthcare economy

in 2030?

Even with less-than-optimal conditions in place for the rapid

digitalisation of German healthcare, I remain optimistic. Germa-

ny is currently a leading market in medical technology and can

still assume a leadership role in 2030. As previously mentioned,

the legislative proposals are already a step in the right direction.

Another important factor is that more and more stakeholders –

from physicians to hospital operators and health insurers to pa-

tients – are demonstrating openness towards digitalisation. This

is partially the result of a generational change, but also attribut-

able to the fact that digital technologies are increasingly playing

a role in many parts of everyday life, which in turn gives rise to

greater acceptance in healthcare as well. For this reason, an

increasing number of companies and start-ups are working on

relevant projects. Germany might be late to the game, but we

haven’t missed our opportunity, and I expect the industry to

retain or even consolidate its competitive edge on the market in

the coming ten years.

The interview was conducted by Mike Bähren, Head of Business

Administration and Market Research at SPECTARIS e. V.


56 Profile | Medical Technology in the German Industry Association SPECTARIS

Medical Technology in the German Industry Association SPECTARIS

S PECTARIS is the German Industry

Association for optics, photonics,

and analysis and medical technology

with headquarters in Berlin. The associa-

tion represents 400 German high-tech

companies, primarily small and medi-

um-sized enterprises. Overall revenue of

the optics, photonics, medical technology,

as well as analysis, bio-, and laboratory

devices industries amounted to almost 72

billion euros in 2018, employing around

316,000 individuals.

The Medical Technology segment of the

German Industry Association SPECTARIS

unites companies in medical technology,

an industry characterised by strong exports

and SMEs. The objective is to improve na-

tional and international competitiveness

as well as the innovative strength of mem-

ber companies through a targeted service

offer, above all in the fields of regulatory

affairs, foreign trade, and export promo-

tion. The association is particularly valued

as a powerful representative of interests

because it bundles well-founded and re-

liable information, building on the exper-

tise of its member companies, and brings

it into political discussion as an industry

stance.

The members of the Medical Technolo-

gy segment of the German Industry As-

sociation SPECTARIS are German medical

technology companies – primarily SMEs.

The member companies research and de-

velop products and methods for medical

and nursing care for the benefit of pa-

tients. In the field of respiratory home

therapy, the Industry Association also has

service providers – so-called homecare

providers – among its members, in addi-

tion to producers.

The companies active in medical tech-

nology operate on the future-oriented and

growing healthcare market with their in-

novative products, which are in high de-

mand across the globe. The industry is

renowned for a range of global market

leaders in demanding niche markets and

characterised by small and medium-sized

enterprises. They invest great effort in the

development of products and methods

for medical and nursing care, for the ben-

efit of patients.

With the three pillars of SPECTARIS –

representing interests, networks, service

offers – at its foundation, the Industry As-

sociation brings together stakeholders in

the medical technology industry by active-

ly connecting its members through various

event formats and by forming alliances at

the national, European, and international

level. The Medical Technology segment of

the German Industry Association SPEC-

TARIS maintains close ties to politics, at

the national level as well as at the Euro-

pean level through the European umbrel-

la association Medtech Europe. Moreover,

the Medical Technology segment of the

German Industry Association SPECTARIS

is a partner of the national Federal Minis-

tries, particularly of the Federal Ministry

of Health, which is very relevant to the

medical technology industry, but also to

the Federal Ministry of Economics and not

least the Federal Ministry of Research.

There are partnerships and close ties to

the associated industry and specialist as-

sociations as well as to the numerous

Marcus KuhlmannHead of Medical [email protected]

health institutions (G-BA, IQWiG, ZLG,

GKV-SV, BfArM, etc.). The Medical Tech-

nology segment of the German Industry

Association SPECTARIS offers its members

a platform and forum to form opinions

and competently represents their interests

in politics and society, towards customers

and further partners along the value-add-

ed chain.

57


Iris DietzeProject Assistant / SPECTARIS reception

Phone +49 30 414021-0 [email protected]

Marcus KuhlmannHead of Medical Technology

Phone +49 30 [email protected]

Jana MallokJunior Advisor Medical Technology


Cordula RappAdvisor Medical Technology

Phone +49 [email protected]

Professional Association for Medical Technology

SPECTARIS core competences

Benedikt WolbeckHead of Association Communication

Phone +49 30 414021-66 [email protected]

Dr. Markus SafariczHead of Research & Innovation


Corinna MutterHead of Regulatory Affairs


Jennifer GoldenstedeHead of Foreign Trade and Export Promotion


Mike BährenHead of Business Administration, Economy, and Market Research


Madeleine WendtAdvisor Medical Technology and Regulatory Affairs


Jörg MayerManaging Director


SPECTARIS – Management

58 Profile | Medical Technology in the German Industry Association SPECTARIS

Board Medical Technology

Chairman Dr Martin Leonhard Department Head Technology Management, Karl Storz SE & Co. KG

Deputy Chairman Michael Koller Managing Partner and President, Münchener Medizin Mechanik GmbH

Deputy Chairman Thorsten Weide Senior Consultant, Drägerwerk AG & Co. KGaA

Further members of the Board

Dr Steffen Gebauer Managing Director, MELAG Medizintechnik oHG

Hubertus Lasthaus Regulatory Affairs & Risk Management, VitalAire GmbH

Louise Meiners Managing Director, b o n Optic Vertriebsgesellschaft mbH

Michael Scherf Head of Sales & Marketing, GETEMED Medizin- und Informationstechnik AG

Ludolf Schmitz Managing Director, SCHMITZ u. Söhne GmbH & Co. KG

André Schulte Managing Director, WEINMANN Emergency Medical Technology GmbH + Co. KG

Hans-Peter Welsch Managing Director AESCULAP AKADEMIE AG

Ralf Wiedemann Managing Director, Joh. Stiegelmeyer GmbH & Co. KG

Co-opted Members Alexander Schmitt Division Manager, Ofa Bamberg GmbH

Christian Grapow Managing Director Abbott Deutschland GmbH & Co. KG

» From left to right: Mr Welsch, Mr Weide, Mr Dr Leonhard, Mr Dr Gebauer, Ms Meiners, Mr Schulte, Mr Lasthaus, Mr Kuhlmann, Mr Wiedemann

59


Profile | German Industry Association SPECTARIS

SPECTARIS at a glance Benefit from our services

S PECTARIS is the German Industry Association for optics,

photonics, and analysis and medical technology. The ma-

jority of its 400 member companies are German small and

medium-sized producers, operating in their segments as “hidden

champions” on the global markets.

To ensure that the key technologies underpinning their success

can continue to be developed and produced in Germany, the

Industry Association SPECTARIS is investing efforts to ensure

framework conditions conductive to growth and innovation. The

association provides information on market developments, offers

consulting services with regulatory and foreign trade issues, con-

nects companies to partners in business or politics, and puts the

most important industry topics on the public agenda.

Voice» Influence laws

and regulations relevant to the industry, whether in

Berlin or Brussels.

Service and Support» Tap into new foreign

markets with our support.

News» Read industry news

which impacts decision-making

before everyone else.

Continuous education» Add to your expertise in seminars on

current industry topics.

Company visibility» Present your company

to a broad audience and

potential business partners.

Contact» Establish contacts with decision-makers from industry and politics.

Current information» Receive current information

on legislative change and have

an exchange with others on

implementation.

Statistics and analyses» Access exclusive domestic and foreign

economic and market data.

Exchange knowledge» Share ideas in the committees of the industry associations.

Maintain network links» Make contact with cooperation and research partners.

60 Profile | Medical Technology in the German Industry Association SPECTARIS – Members

Medical Technology in the German Industry Association SPECTARISMembers

Abbott GmbH & Co. KGBei Abbott setzen wir uns dafür ein, dass Menschen ihr Leben durch die Kraft der Gesundheit in bestmöglicher Weise führen können. Seit über 130 Jahren bringen wir der Welt neue Pro-dukte und Technologien – unter anderem im Bereich des Diabetes-Managements – und eröff-nen dadurch mehr Menschen in all ihren Lebensphasen mehr Möglichkeiten, um nicht nur länger, sondern auch besser leben zu können.

Aesculap AGAesculap ist verlässlicher Partner für Behandlungskonzepte in Chirurgie, Orthopädie und interventioneller Gefäßmedizin. Das Unternehmen strebt nach Innovationen, die medizinischen Fortschritt bringen. Seit 1976 gehört Aesculap zur B. Braun-Gruppe und ist damit Teil eines familiengeführten Konzerns mit rund 64.000 Mitarbeitern in 64 Ländern.

air-be-c Medizintechnik GmbHDie air-be-c Medizintechnik GmbH ist ein bundesweit tätiger Hilfsmittelversorger für die Heim-therapie. Als Anbieter aller mobilen Sauerstoffkonzentratoren besitzt das mittelständische Unternehmen ein Alleinstellungsmerkmal. Beratung vor Ort und Kundendienst rund um die Uhr zählen ebenso zum Service wie Testmieten, Privatverkäufe und Kassenversorgungen.

Alcon Pharma GmbHAls weltweit führender Anbieter in der Augenheilkunde mit mehr als sieben Jahrzehnten Tradition bietet Alcon das umfassendste Produktportfolio zur Verbesserung der Sehkraft und zur Steigerung der Lebensqualität.Der Geschäftsbereich Vision Care konzentriert sich auf den Vertrieb und die Vermarktung von hochwertigen Kontaktlinsen und Pflegeprodukten. Alcon legt hier seinen Schwerpunkt auf ganzheitliche Kampagnen und Konzepte mit dem Fokus auf den stationären Fachhandel und eine partnerschaftliche Zusammenarbeit mit den Kontakt-linsenspezialisten.

ALS Automated Lab Solutions GmbHALS Automated Lab Solutions ist Spezialist für innovative, maßgeschneiderte Automatisie-rungslösungen. Durch Automatisierung + Standardisierung vormals manueller Verfahren sorgen die Lösungen von ALS für mehr Effizienz in verschiedensten Bereichen der Forschung und ebnen den Weg für neue Methoden + Möglichkeiten der Wissenschaft von Morgen.

Alu Rehab ApSDurch Lösungen, die für den einzelnen Benutzer angepasst sind, trägt Netti zu der Erhöhung der Lebensqualität der Rollstuhlfahrer bei. Das Ziel ist, dass der Benutzer sich auf alles andere als den Rollstuhl konzentrieren kann – einfach das Leben genießen. Für Netti ist das wichtigste Ziel neben einer neuen Rollstuhlanpassung für eine Verbesserung der Lebensqualität zu sorgen.

ASANUS Medizintechnik GmbHSeit nahezu 20 Jahren entwickelt ASANUS mit langjährig erfahrenen Informatikern ausgereif-te Software für die Krankenhaus-Logistik. Die ASANUS BarCon Logistiksoftware regelt und steuert intelligent den Transport, Umschlag, die Lagerung, Bereitstellung, Beschaffung und Verteilung von Medizinprodukten, Personen, Kosten und Informationen. Optimierungspoten-ziale werden aufgezeigt und dienen als Grundlage für weitere wertvolle Managemententschei-dungen. Mit der ASANUS BarCon Logistiksoftware erzielen Sie nachhaltig hochwertige Leis-tungen, Qualität und Kostensenkung in Ihrem Haus.

ATMOS MedizinTechnik GmbH & Co. KGATMOS hat seinen Sitz in Lenzkirch im Schwarzwald. Die Unternehmensgeschichte reicht bis in das Jahr 1888 zurück. Neben Lösungen für alle denkbaren medizinischen Absauganwen-dungen gehören zum Portfolio Produkte und Systeme für die HNO-Diagnostik und -Chirurgie sowie für die Gynäkologie. Idee, Entwicklung, Produktion sowie Produktmanagement und Vertrieb liegen dabei in einer Hand.

www.de.abbott/

www.aesculap.de

www.air-be-c.de

www.de.alcon.com

www.als-jena.de

www.my-netti.de

www.asanus.de

www.atmosmed.de

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aXcent medical GmbHZiel der aXcent medical GmbH ist es, einer der weltweit führenden Anbieter für Patientenüber-wachungssysteme, Anästhesiearbeitsplätze sowie Intensiv- und Transportbeatmungsgeräte zu werden. Unser professionelles Team arbeitet mit großem Engagement, Kunden- und Markt-verständnis und hohem Fachwissen daran, die gemeinsamen Ziele zu erreichen und die Ge-sundheit der Patienten zu verbessern.

Bauer und Häselbarth-Chirurg GmbH

B. Braun AvitumB. Braun Avitum ist einer der weltweit führenden Anbieter von Produkten und Dienstleistungen für Menschen mit chronischem und akutem Nierenversagen. Als Systempartner in der Dialyse fokussiert sich B. Braun Avitum auf die drei Therapiefelder Hämodialyse, Akutdialyse und Apherese. B. Braun Avitum versorgt in mehr als 375 Dialysezentren über 31.000 Patienten in mehr als 30 Ländern.

Metallwarenfabrik Walter H. Becker GmbHAls Spezialist in der Produktion von Stahlmöbeln für die Medizintechnik setzt die Metall-warenfabrik Walter H. Becker GmbH nunmehr seit 40 Jahren neue Maßstäbe. Durchdachte langlebige Einrichtungen für Kliniken und Krankenhäuser werden für die Bereiche ZSVA, Endoskopie, OP und Behandlungsräume exakt abgestimmt.

Belimed GmbHBelimed ist ein weltweit führender Anbieter von innovativen Systemlösungen für Reinigung, Desinfektion und Sterilisation Medizin Sektor. Das Unternehmen beschäftigt rund 1.200 Mitarbeitende in zehn Ländern und ist mit einem Netz eigener Vertriebsgesellschaften und autorisierter Geschäftspartner in mehr als 80 Ländern vertreten.

Berliner Glas KGaA Herbert Kubatz GmbH & Co. KGMit der Entwicklung, Fertigung und Montage leistungsfähiger optischer, elektronischer und mechanischer Präzisionskomponenten, Baugruppen und Systeme treibt Berliner Glas die Weiter-entwicklung in der Medizintechnik mit voran. Berliner Glas ist ein langfristiger OEM Partner für ihre Kunden – von der Idee bis zur Serienfertigung.

bon Optic Verbtriebsgesellschaft mbHDie Firma bon ist seit 1982 ein starker Partner von Augenoptikern, Augenärzten und Kliniken.Das breit aufgestellte Unternehmen im Familienbesitz zeichnet sich besonders durch seinenherausragenden Service und seine kunden- und lösungsorientierte Arbeitsweise aus.bon ist als Medizinproduktehersteller gemäß DIN EN ISO 13485 zertifiziert.

BOSCH + SOHN GmbH u. Co. KGPremium-Qualität für Arzt, Klinik und Patienten.boso ist weltweit ein Synonym für präzise Blutdruckmessung. Seit über 90 Jahren ist das mittelständische Unternehmen aus Süddeutschland als Premium-Anbieter für hohe und aus-gezeichnete Qualität sowie seine innovativen Technologien bekannt und wird den hohen Ansprüchen der professionellen Anwender gerecht.

BREAS Medical GmbH Die BREAS Medical GmbH mit Hauptsitz in Herrsching ist eine Tochtergesellschaft der BREAS Medical AB, Göteborg/Schweden. Das Unternehmen produziert und vertreibt weltweit seit über 25 Jahren Beatmungs- und Schlaftherapiegeräte für den Homecare Bereich. Zur Breas Gruppe gehören die Firmen Human Design Medical/USA sowie B&D Electromedical / UK (seit 2017 „BREAS Medical ltd/UK“).

Carl Zeiss Meditec AGAls eines der weltweit führenden Medizintechnikanbieter in den Bereichen Ophthalmologie und Mikrochirurgie, bietet das Unternehmen innovative Technologien und applikationsorien-tierte Lösungen. Diese ermöglichen es Ärzten, die Lebensqualität ihrer Patienten zu verbessern.

Christoph Miethke GmbH & Co. KGWas mit einer guten Idee 1992 begann, hat sich bis heute zu einem weltweit agierenden Unter-nehmen entwickelt. Die Christoph Miethke GmbH & Co. KG ist ein Medizintechnik unternehmen, das innovative neurochirurgische Implantate für Hydrocephalus-Patienten entwickelt. Jedes Im-plantat wird mit modernster Fertigungstechnik und Sorgfalt einzeln produziert und weiterentwickelt.

www.axcentmedical.com

www.bh-chirurg.de/

www.bbraun.de

www.becker-triftern.de

www.belimed.com/de

www.berlinerglas.de

www.bon.de

www.boso.de

www.breas.com/de

www.zeiss.de/meditec

www.miethke.com


Condor® MedTec GmbH„Expand your possibilities“ – das ist der neue Claim von Condor® MedTec, der unsere Philo-sophie verdeutlicht. Seit der Gründung im Jahr 1997 entwickelte sich Condor® MedTec zu einem erfolgreichen, mittelständischen Familienunternehmen am Standort Salzkotten in Ostwestfalen. Mit dem orthopädischen Portfolio und als deutscher Marktführer für Wund- Spreizer-Systeme agiert Condor® MedTec weltweit.

DeVilbiss Healthcare GmbHDeVilbiss Healthcare GmbH ist ein weltweit führender Hersteller von medizinischen Produkten der respiratorischen Atemwegstherapie für den Homecare-Bereich. Schwerpunkt ist die Erar-beitung innovativer Lösungen für die Behandlung von Atemwegsstörungen. Hierzu gehören Geräte zur Sauerstoffversorgung, Schlaftherapie, Sekretabsaugung und Aerosolverneblung sowie ein breites Spektrum an Zubehör.

DMB Apparatebau GmbHWir stehen für umfassende Kompetenz in den Bereichen EO-Lohnsterilisation, EO-Sterilisatoren und Beratung. Unser EO-SteriVIT-Verfahren steht für moderne, zeitgemäße Sterilisation und ermöglicht eine schonende und effiziente Behandlung Ihrer Medizin-/pharmazeutischen Pro-dukte. Die Anforderungen der Kunden sind unsere Antriebskraft für permanente Weiterent-wicklung.

DOCERAM Medical Ceramics GmbHDOCERAM Medical Ceramics GmbH befasst sich seit über 20 Jahren mit der Entwicklung und Herstellung von Zirkonoxid-Komponenten für die Dentaltechnik. Mit der Marke Nacera® erhält der Zahntechniker ein Zirkonoxid, das eine hohe Biegefestigkeit und das Maximum an Ästhetik vereint. Fräszentren und Dentallabore weltweit sind überzeugt. Hochwertige Nacera® Prozess-optimierungs-Produkte und Zubehör zum Finalisieren vollmonolithischer Restaurationen komplettieren das Produktportfolio.

Dornier MedTech GmbHDie Dornier MedTech GmbH hat ihren Hauptsitz in Weßling bei München und ist Weltmarkt-führer für Lithotripter. Sie bietet unterschiedliche Stoßwellengeräte und medizinische Laser für die Steintherapie an. Auf der ganzen Welt steht die Marke Dornier für wissenschaftlich fun-dierte und richtungsweisende Produkte und Lösungen für die Urologie.

Dr. Hönle Medizintechnik GmbHDas bayrische Unternehmen Dr. Hönle Medizintechnik GmbH ist seit über 40 Jahren spezialisiert auf die Entwicklung, Produktion, den weltweiten Vertrieb und Service von qualitativ hochwer-tigen UV-Bestrahlungsgeräten sowie der Leitungswasser-Iontophorese zur Behandlung von Hauterkrankungen und Hyperhidrose. Besonderes Augenmerk gilt der sicheren und einfachen Bedienung der Medizinprodukte.

Dr. Mach GmbH + Co. KGDr. Mach steht im Bereich der medizinischen Untersuchungs- und Operationsleuchten für höchste Qualität und modernste Technik. Unsere Fertigungstiefe beträgt 85 Prozent und reicht von Metallbearbeitung über Herstellung von Elektronikbauteilen bis hin zur Endmontage. Unseren Kunden bieten wir ein Höchstmaß an Flexibilität und eine gleichbleibend hohe Produktqualität.

Drägerwerk AG & Co. KGaADräger ist ein international führendes Unternehmen der Medizin- und Sicherheitstechnik. Ob im Operationsbereich, auf der Intensivstation, bei der Feuerwehr oder im Rettungsdienst: Unsere Produkte schützen, unterstützen und retten Leben. Dräger beschäftigt weltweit mehr als 14.000 Mitarbeiter und ist in über 190 Ländern der Erde vertreten. „Technik für das Leben“ ist die Leitidee des Unternehmens.

Eppendorf AG Die Eppendorf AG ist ein international führendes Unternehmen der Life Sciences und entwickelt und vertreibt Geräte, Verbrauchsartikel und Services für Liquid Handling, Sample Handling und Cell Handling weltweit. Die Erzeugnisse von Eppendorf werden in akademischen oder indus-triellen Forschungslaboren, z. B. in Unternehmen der Pharma- und Biotech- sowie Chemie- und Lebensmittelindustrie, eingesetzt.

www.condor-medtec.de

www.drivedevilbiss-int.com

www.dmb-apparatebau.de

www.nacera.de

www.dornier.com/de

www.drhoenle.de

www.dr-mach.de

www.draeger.com

www.eppendorf.com

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ERKA. Kallmeyer Medizintechnik GmbH & Co. KGERKA. ist ein traditionsreiches Familienunternehmen, das seit über 130 Jahren mit besonderer Leidenschaft Geräte zur Blutdruckmessung von höchster Präzision und Qualität entwickelt. Un-ser Anspruch bei ERKA ist es, Medizinern die exaktesten und effizientesten Geräte in die Hand zu geben, die sie zur Ausübung ihrer professionellen Tätigkeit benötigen. MADE IN GERMANY

Ernst Krauskopf – Fabrik für chirurgische und zahnärztliche Instrumente

Eschenbach Optik GmbHEschenbach Optik zählt weltweit zu den führenden Herstellern optischer Erzeugnisse. Das Produktportfolio reicht von Brillenfassungen und Sonnenbrillen über Ferngläser bis zu vergrö-ßernden Sehhilfen. Insbesondere mit letzteren gilt das Unternehmen als Garant für Innovation und hochwertige Markenqualität „Made in Germany“.

EsCo Orthopädie-Service GmbH

Essilor GmbHEssilor ist weltweit führend in der Entwicklung, Herstellung und Personalisierung von Brillen-gläsern. Auf fünf Kontinenten vertreibt Essilor eine umfassende Auswahl an Brillengläsern für Kurz-, Weitsichtigkeit und Presbyopie. Darüber hinaus entwickelt und vertreibt Essilor Instru-mente sowie Serviceleistungen für Augenoptiker.

Ferdinand Menrad GmbH +Co. KGIn vierter Generation im Familienbesitz ist MENRAD seit 120 Jahren im Fassungsgeschäft aktiv. Die Fassungen und Sonnenbrillen aus dem Markenportfolio werden in eigenen Werken pro-duziert und in über 100 Ländern verkauft. MENRAD ist eines der führenden Unternehmen dieser Branche.

FISBA AGSeit 1957 bietet FISBA weltweit führend optische Komponenten & Systeme für kunden spezifische Applikationen in den Bereichen Life Sciences, Luftfahrt & Verteidigung und Produktionstech-nologie an. Spezialisierte Teams erfüllen hochkomplexe Anforderungen und begleiten ihre Kunden als Partner von der Idee bis hin zur Serienfertigung.

Fisher & Paykel Healthcare GmbHFisher & Paykel Healthcare ist ein Hersteller, Entwickler und Vermarkter von Produkten und Systemen für den respiratorischen Einsatz in der Akutversorgung bei Kindern und Erwachsenen und der Behandlung von obstruktiver Schlafapnoe. Mit Sitz in Neuseeland werden die Produk-te und Systeme von über 4.000 Mitarbeitern in rund 120 Ländern weltweit vertrieben.

FLO Medizintechnik GmbH

FMB Care GmbHFMB care legt seit 2001 den Fokus auf die Entwicklung und Herstellung von hochwertigen und innovativen Pflegebetten. Die Pflegebetten und Einrichtungen von FMB Care für die sta-tionäre Altenpflege und für den Reha-Bereich zählen zu den besten auf dem internationalen Markt. Alles getreu unserem Leitspruch: Gut liegen. Gut pflegen. Gut wohnen.

Fraunhofer-Institut für Lasertechnik ILTMit über 540 Mitarbeitern zählt das Fraunhofer-Institut für Lasertechnik ILT in Aachen zu den führenden Auftragsforschungs- und Entwicklungsinstituten seines Fachgebiets. Seit mehr als 30 Jahren entwickeln und optimieren unsere Experten Laserstrahlquellen und Laserverfahren für Produktion, Medizintechnik, Messtechnik, Energie und Umwelt.

Fritz Stephan GmbH – MedizintechnikSeit mehr als 40 Jahren bietet die Firma Fritz Stephan GmbH innovative Medizintechnik an und begeistert immer wieder mit innovativen Lösungen in den Bereichen Beatmung und Sauer-stofferzeugung. Ein besonderes Augenmerk liegt auf dem Bereich der Herstellung von Be-atmungsgeräten für Früh- und Neugeborene, wobei auch das mobile Beatmungssystem EVE neue Maßstäbe im Erwachsenenbereich setzt.

Galifa Contactlinsen AGDas Schweizer Unternehmen Galifa ist spezialisiert auf die Entwicklung und Produktion von individuell gefertigten Präzisionskontaktlinsen nach Maß. Als Partner von Augenoptikern bietet das Schweizer Hightechunternehmen eine vielseitige Auswahl innovativer Kontaktlinsen für natürliches und gesundes Sehen, die nur im Fachhandel vertrieben werden.

www.erka.org

www.eschenbach-optik.de

www.esco-orthopaedie.com/

www.essilor.de

www.menrad.de

www.fisba.com/de

www.fphcare.com/de

www.flo-medizintechnik.de/

www.fmb-care.de

www.ilt.fraunhofer.de

www.stephan-gmbh.com

www.galifa.ch


Gebrüder Martin GmbH & Co. KG

GETEMED Medizin- und Informationstechnik AGMit über 30 Jahren Erfahrung entwickelt, produziert und vertreibt GETEMED Medizinproduk-te für die kardiologische Funktionsdiagnostik, das ambulante Vitalfunktions-Monitoring von Risikopatienten sowie für das Telemonitoring. Am Anfang stand die häusliche Überwachung von Neugeborenen im Vordergrund. Heute behauptet sich GETEMED als anerkannter Spezia-list für das ambulante Monitoring von Risikopatienten aller Altersgruppen.

GIMMI GmbHSeit 1932 konzentriert man sich bei der Gimmi GmbH auf die Entwicklung und den Vertrieb von medizinischen Produkten. Neben der herausragenden Qualität unserer Produkte war es uns schon immer wichtig, unseren Kunden und ihren Patienten die bestmöglichen Lösungen anzubieten. Mit strategischen Allianzen, wie mit dem mexikanischen Unternehmen Vitalmex, ist man bestens gerüstet für die Zukunft.

Greiner GmbH

GTI medicare GmbHGTI medicare mit Hauptsitz in Hattingen sowie einem bundesweiten Filialnetz ist seit dem Jahr 2000 für die stationäre und mobile Sauerstoffversorgung erfolgreich auf dem deutschen Markt tätig und gehört seit Mai 2019 zur Sapio-Gruppe. Seinen Partnern – u. a. dem medizinischen Fachhandel, Sanitätshäusern und dem Rettungsdienst – bietet die GTI die komplette appara-tive Ausrüstung zum Thema Sauerstoff und med. Gase an.

HÄLSA Pharma GmbH

Handicare Group ABDie Handicare Gruppe produziert und liefert verschiedene Hilfsmittel zur Verbesserung der Mobilität im und um das Haus. Diese Produkte werden für Menschen mit einer Funktions-beeinträchtigung und Senioren entwickelt, aber auch für Betreuer wie Familienmitglieder, Pfleger und Therapeuten. Handicare legt den Fokus in Deutschland auf Treppenlifte.

Hans Müller HMP Medizintechnik GmbHAls Homecare-Spezialist setzt sich die Hans Müller Unternehmensgruppe dafür ein, dass Pati-enten auch außerhalb der Klinik von höchsten Standards profitieren. Mit den Bereichen Heim-beatmung, Schlafapnoe, Monitoring und Flüssigsauerstoff stehen wir als verlässlicher Partner an der Seite von Patienten, Angehörigen, Ärzten und Krankenkassen.

Hecht Contactlinsen GmbH HECHT ist eine Premiummarke mit hochwertigen individualisierten Produkten. Durch innova-tive Technologie und qualifizierte Anpassung durch unsere Anpasspartner erfüllen HECHT Kontaktlinsen die verschiedenen Erwartungen der Kontaktlinsenkunden optimal. Als mittel-ständisches Unternehmen leben wir diesen Anspruch seit nahezu 40 Jahren. Jeden Tag.

Heidelberg Engineering GmbHHeidelberg Engineering entwickelt nachhaltige Lösungen für die Augenheilkunde, die es Ärzten ermöglichen, die Patientenversorgung zu verbessern. Die eingesetzten Technologien für Bildgebung und Healthcare-IT werden ständig optimiert und weiterentwickelt. Seit der Gründung im Jahr 1990 arbeitet das Unternehmen mit Wissenschaftlern, Ärzten und Industrie-partnern daran, den klinischen Nutzen von innovativen Produkten zu maximieren.

HEINE Optotechnik GmbH & Co. KG Als ein weltweit führender Hersteller von Primärdiagnostik-Instrumenten ist HEINE Optotech-nik seit mehr als 70 Jahren ein zu 100 Prozent inhabergeführtes Familienunternehmen. HEINE entwickelt und fertigt Instrumente in den Produktionseinrichtungen in Deutschland, wo Erfahrung und Handwerkskunst mit modernsten Fertigungstechnologien vereint werden.

Andreas Hettich GmbH & Co. KGHettich ist Premiumhersteller von Laborzentrifugen sowie Brut- und Kühlbrutschränken. Mit austauschbaren und vielseitigen Zubehör erfüllen Hettich Produkte sowohl Standard- als auch Spezialanforderungen und erleichtern die tägliche Routine in den Laboren weltweit.

www.getemed.net/de

www.gimmi.de

www.greiner-gmbh.de/home.html

www.gti-medicare.de

www.haelsa.de/

www.handicare-

treppenlifte.de

www.hmp-

medizintechnik.de

www.hecht-

kontaktlinsen.de

www.heidelbergengineering.com/de

www.heine.com

www.hettichlab.com

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Hermann Bock GmbHHermann Bock ist ein international führender Entwickler und Hersteller von Pflegebetten. Die hoch funktionalen Betten des Familienunternehmens sind weltweit im Einsatz – in Reha-Ein-richtungen und Seniorenheimen ebenso wie in der häuslichen Pflege. Mit einer Vielzahl zu-kunftsweisender, patentierter Lösungen setzt bock neue Maßstäbe für verantwortungsvolle Pflege im Bett.

HEYER Medical AGHEYER Medical ist ein international führendes Unternehmen mit mehr als 130 Jahren Erfahrung in der Entwicklung, Herstellung und im Vertrieb von innovativen Medizinprodukten. Ein hoch-qualitatives Produktportfolio rund um die Kernkompetenz „Beatmung“ umfasst Produkt gruppen der Anästhesie-Arbeitsplätze, Patientenüberwachungssysteme, Intensivbeatmungsgeräte und Systeme zur Inhalations- und Atemtherapie.

Hillrom GmbHHillrom ist ein weltweit führendes Medizintechnikunternehmen, das sich auf die ständige Weiterentwicklung der vernetzten Gesundheitsversorgung konzentriert. Unsere Innovationen ermöglichen eine frühere Diagnose und Behandlung, optimieren die chirurgische Effizienz und beschleunigen die Genesung der Patienten. Gleichzeitig vereinfachen unsere vernetzten intel-ligenten Betten, Patientenlifter, Technologien zur Patientenbewertung und -überwachung die klinische Kommunikation.

Hittech Group BVHittech Group BV ist ein Systemlieferant und Partner von OEM-Unternehmen. Die Gruppe ist spezialisiert auf die Entwicklung und Herstellung von Baugruppen und Geräten in den Be-reichen Medizintechnik, Mikroelektronik und Halbleiterindustrie, Labor- und Analyse-ausrüstungen und Verpackungsmaschinen.

Hoffrichter Medizintechnik GmbH

HP Medizintechnik GmbHDie HP Medizintechnik GmbH entwickelt, fertigt und vertreibt Geräte für den Labor-, Analyse- und Medizinbereich. Mit mehr als 40 Jahren Know-how in der Herstellung von Laborgeräten und Medizinprodukten bieten wir dafür eine optimale Entwicklungs- und Fertigungsstruktur.

Hu-Friedy Mfg.Co., LLC.Als einer der weltweit führenden Hersteller bietet Hu-Friedy über 10.000 hochwertige Instru-mente und Produkte auf dem Gebiet der konservierenden und prothetischen Zahnheilkunde, der Kieferorthopädie, der Oralchirurgie sowie der Instrumentenwiederaufbereitung (IMS) an. Zudem offeriert Hu-Friedy fachspezifischen Fortbildungskurse und Serviceangebote, um Ihre hochwertigen Hu-Friedy Instrumente wiederaufzubereiten.

Industrieverband Schneid- und Haushaltswaren e.V.

Infors GmbH Deutschland INFORS bietet Geräte zur Kultivierung von Zellen im weitesten Sinne an. Die Schüttler und Bioreaktoren von INFORS werden im Wesentlichen in der Labor-Biotechnologie, sprich in Forschung und Entwicklung, eingesetzt. Die neue Software eve ist eine Laborsoftware, weil man damit nicht nur die INFORS-Geräte steuern kann, sondern auch 3. Geräte wie z. B. Massen-Spektrometer. Möglich ist die 3. Gerätesteuerung, weil sowohl OPC-Protokolle als auch Geräte mit analogen Schnittstellen eingebunden werden können. INFORS ist weltweit durch Tochterfirmen oder Händler aktiv.

infoteam Software AG Die infoteam Software AG ist langjähriger Anbieter von normativ regulierten Software lösungen für Labor- und Medizintechnik gemäß MDR, IVDR, FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1. Das Leistungsportfolio umfasst die Entwicklung von Embedded- und Stand alone Software bis hin zur Inverkehrbringung von z. B. Medical Apps. infoteam beschäftigt 300 Mitarbeiter an Standorten in Deutschland, der Schweiz und China.

Insulet Germany GmbHInsulet ist ein innovativer Hersteller von Medizinprodukten und unser Ziel ist es, Menschen mit Diabetes das Leben zu erleichtern. Wir sind der Entwickler und Hersteller des Omnipo-d®-Insulin-Management-Systems und unsere Technologie hat bereits mehr als 150.000 Men-schen geholfen, besser mit ihrem Diabetes umzugehen. Insulet ist in den USA, Kanada und in Europa tätig.

www.bock.net

www.heyermedical.de

www.hillrom.com

www.hittech.de

www.hp-med.com

www.hu-friedy.de

www.ivsh.de

www.infors-ht.de

www.infoteam.de

www.insulet.com


INTERCO GmbHDie interco Group! bietet verschiedene Möglichkeiten der Zusammenarbeit: mit innovativen und hochwertigen Rehalösungen mehr Lebensqualität im Sitzen und Positionieren: ganzheit-lich, individualisiert und patientengerecht optimiert. Ganzheitliche Sitzsysteme und Reha 4.0 Lösungen werden aus einer Hand geboten und nach individuellen Kundenwünschen ange-fertigt.

INTERSPIRO GmbH

Invacare GmbHDie Invacare GmbH gehört zur global agierenden Invacare Gruppe, Hersteller und Weltmarkt-führer häuslicher und institutioneller Hilfsmittel. Das Portfolio reicht von Mobilität über Reha bis hin zu Pflege und Therapie. Mit internationalen Standorten und über 4.700 Mitarbeitern zählt das Unternehmen zu den größten Herstellern von Reha-Hilfsmitteln.

Johnson & Johnson Medical GmbHJohnson & Johnson Vision sorgt mit einem breiten Spektrum an augenheilkundlichen Lösun-gen dafür, dass Millionen Menschen auf der ganzen Welt besser sehen können. Unter anderem mit der Kontaktlinsenmarke ACUVUE® sowie im Bereich der refraktiven Chirurgie ist das Un-ternehmen weltweit führend. Insgesamt beschäftigt es 10.000 Mitarbeiter in 103 Ländern.

Jüke Systemtechnik GmbHFür unsere Kunden sind wir erfahrener Dienstleister für Systementwicklung, Produktion und Regulatory Affairs in der Medizintechnik. Wir haben langjähriges Know-how mit komplexen mechatronischen Baugruppen und Geräten, der Programmierung von Firm- und Software, der Systemintegration und der normgerechten Dokumentation. Jüke ist ISO 13485 zertifiziert und kümmert sich um alle Phasen im Produktlebenszyklus.

Karl Kaps GmbH & Co. KGDas weltweit agierende Medizintechnikunternehmen Karl Kaps GmbH & Co. KG ist spezialisiert auf die Entwicklung und Herstellung von modernen Operations- und Diagnosemikroskopen. Als innovatives deutsches Traditionsunternehmen ist Karl Kaps in mehr als 100 Ländern mit einem sehr gut ausgebauten Händlernetz erfolgreich tätig.

Karl Leibinger Medizintechnik GmbH & Co. KG

KARL STORZ SE & Co. KGDas Familienunternehmen ist weltweit führender Anbieter von Endoskopen, endoskopischen Instrumenten und Geräten für humanmedizinische Fachdisziplinen. KARL STORZ entwickelt, fertigt und vertreibt seine Produkte mit Fokus auf funktionelles Design, handwerkliches Können und kontinuierlichen Fortschritt. Die neuesten Entwicklungen präsentiert KARL STORZ im Bereich Dokumentationssysteme und Operationssaal-Konzepte.

KEK GmbH

Kendrion Kuhnke Automation GmbHKendrion bietet Herstellern medizinischer und analytischer Geräte die Entwicklung und Ferti-gung von Komponenten oder kompletten Funktionsmodulen. Das Unternehmen kann auf ein breites Portfolio eigener Produkte zurückgreifen. Dazu zählen u. a. mediengetrennte Ventile, Proportionalventile, hochpräzise Druckregler sowie innovative Anschlussplattentechnologie.

KaWe – KIRCHNER & WILHELM GmbH + Co. KGKaWe – KIRCHNER & WILHELM GmbH + Co. KG ist seit 1890 in der deutschen Medizin technik etabliert. Unsere kleindiagnostischen Produkte wie Otoskope, Laryngoskope und Stethoskope zeichnen sich durch hochwertige Qualität und besondere Zuverlässigkeit aus. Weltweit werden unsere Produkte in über 100 Ländern über den medizinischen Fachhandel angeboten.

KLS Martin GroupDie KLS Martin Group ist eine international agierende Unternehmensgruppe für innovative Medizintechnik. Seit 1923 widmet sich die Gruppe der Chirurgie und ist heute in über 140 Ländern aktiv. Mit dem Anspruch „Surgical Innovation is our Passion“ entwickelt und vertreibt die Unternehmensgruppe eine Vielzahl von hochwertigen medizintechnischen Produkten.

www.interco.gmbh

www.interspiro.de

www.invacare.de

www.jnj.de

www.jueke.de

www.kaps-optik.de/

medizintechnik

www.karlstorz.com

www.kek-dresden.com/

www.kuhnke.kendrion.com

www.kawemed.de/de

www.klsmartin.com

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Koberg & Tente GmbH + Co. KGSeit über 70 Jahren bieten wir hochwertige Brillenfassungen mit einem guten Preis-Leistungs-Ver-hältnis an. Wir bedienen Augenoptik-Fachgeschäfte in Deutschland, Benelux, Frankreich, Ös-terreich und der Schweiz. Unser Verkaufsteam unterstützt Sie vor Ort oder telefonisch. Um-fangreiche Marketing- und Werbematerialien für den Optiker runden unser Dienst leistungsangebot ab. Derzeit führen wir sieben verschiedene Kollektionen für verschiedene Zielgruppen.

Kröber Medizintechnik GmbH

Labotect Labor-Technik Göttingen GmbH Labotect entwickelt, produziert und vertreibt eine große Auswahl an Produkten für den Einsatz im Bereich assistierte Reproduktion, in der Medizin und in naturwissenschaftlichen Laboren. Das herausragende Qualitätsmanagementsystem ist durch EC- und ISO 13485-Zertifikate belegt. Zudem wird mit unseren qualitativ hochwertigen Produkten – Made in Germany – in mehr als 60 Ländern gearbeitet.

Landesinnung Chirurgiemechanik

LAP GmbH Laser ApplikationenLAP ist ein weltweit führender Anbieter von Systemen zur Steigerung von Qualität und Effizienz durch Laserprojektion, Lasermessung und weiterer Verfahren. Jährlich liefert LAP 15.000 Einheiten an Kunden unter anderem aus den Branchen Strahlentherapie, Stahlerzeu-gung und Composite-Verarbeitung. 350 Mitarbeiterinnen und Mitarbeiter sind an acht Stand-orten in Europa, Amerika und Asien tätig.

F. & M. Lautenschläger GmbH & Co. KGVor über 130 Jahren baute Mathias Lautenschläger den weltweit ersten Dampfsterilisator – ein Meilenstein in der Asepsis der Wundversorgung. Heute ist Lautenschläger einer der führen-den Spezialisten für Sterilgutaufbereitung und liefert individuelle Systemlösungen im Bereich der Reinigungs-, Desinfektions- und Sterilisationstechnik für Medizin, Forschung und Industrie.

Leica Microsystems CMS GmbHLeica Microsystems entwickelt innovative optische und digitale Lösungen für die Bildgebung und Analyse von Mikro- und Nanostrukturen. Mikroskope, Software und wissenschaftliche Instrumente von Leica Microsystems ermöglichen Kunden in aller Welt neue Erkenntnisse zu gewinnen in Forschung, Medizin, Materialwissenschaft, Industrie und der Forensik.

LEJ || Systempartner der PhotonikDie Leistungselektronik JENA GmbH ist Ihr Anbieter für professionelle Beleuchtungs- und Leistungselektronik-Lösungen in den Bereichen Mikroskopie, Analytik, Halbleiter, Industrie sowie Medizintechnik. Neben einem dezidierten Portfolio an eigenen Markenprodukten bietet die LEJ ein Höchstmaß an Flexibilität und Geschwindigkeit in der Umsetzung kundenspezifisch modifizierter Produkte. Namhafte OEMs zählen auf LEJ als Systemlieferant für bspw. Laser- und System-Stromversorgungen, LED-Hochleistungstreiber sowie als Partner in der Entwicklung & Fertigung komplexer opto-mechanischer und opto-elektronischer Baugruppen und Geräte im Kundenauftrag.

Linde Gas Therapeutics GmbH / Linde HealthcareLinde Healthcare Deutschland ist ein führender Anbieter für die Arzneimittelversorgung mit Gasen und den dazugehörigen Medizinprodukten. Wir versorgen Patienten zu Hause sowie in spezialisierten Beatmungspflege-Centern und vereinen die Bereiche Homecare und Hospital Care der Linde Gas Therapeutics GmbH sowie das Beatmungspflegekonzept der Linde Remeo Deutschland GmbH.

Löwenstein Medical GmbH & Co. KGLöwenstein Medical mit Sitz in Bad Ems agiert als weltweit tätiger Hersteller und Produzent hochwertiger Geräte und Medizinprodukte in Anästhesie, Intensivbeatmung und Neonatolo-gie und Diagnostik sowie in ausgewählten Ländern als Vertriebspartner international führender Hersteller und Leistungserbringer in der außerklinischen respiratorischen Therapie.

Löwenstein Medical Innovation GmbH & Co. KGSeit über 50 Jahren entwickelt und produziert LMI lebenserhaltende Systeme für die klinische Anwendung und gehört zu den weltweit technologisch führenden Anbietern auf diesem Gebiet. Ein wesentlicher Fokus liegt dabei auf der Entwicklung von Intensivbeatmungs- und Atemtherapiegeräten für den Einsatz in Intensivstationen und Akutbehandlungseinheiten.

www.koberg-tente.de

www.kroeber.de

www.labotect.com

www.lap-laser.com

www.lautenschlaeger.net

www.leica-microsystems.com/de/

www.lej.de

www.linde-healthcare.de

www.hul.de

www.loewensteinmedical.com


Löwenstein Medical Technology GmbH + Co. KGLöwenstein Medical Technology mit Sitz in Hamburg und weiteren Standorten in Deutschland ist Hersteller von Therapie- und Diagnosesystemen zur Behandlung respiratorischer Störungen. Schwerpunkte im Produktportfolio des international ausgerichteten Unternehmens sind die außerklinische Beatmung, die Schlafatemtherapie sowie telemedizinische Anwendungen.

Luneau Technology Deutschland GmbH

MAICO Diagnostics GmbHDie MAICO Diagnostics GmbH ist Teil der internationalen Demant Holding. Seit mehr als 80 Jahren entwickeln und vertreiben wir innovative Geräte für Hörtests: vom Hörscreening für Neugeborene über Klinikbedarf bis hin zu Softwarelösungen für die Audiologie. Unser ge-samtes Portfolio verbindet hierbei die intuitive Nutzerführung und einfache Handhabung. Unsere Vision: eine frühzeitige Erkennung von Hörverlusten heute für ein gesundes und glückliches Leben morgen.

Matachana Germany GmbHMATACHANA ist seit mehr als 55 Jahren als eines der global führenden Unternehmen im Healthcare- und Life-Science-Bereich tätig. Wir bieten Systemlösungen für die zentrale Steril-gutversorgungsabteilung (ZSVA/AEMP) sowie für den Wissenschaftssektor in Laboren und der Pharmaindustrie. Entwickelt werden Komplettlösungen mit hervorragendem Support für ein erstklassiges Anwendererlebnis. Wir sind mit unserem Service weltweit und über Distributoren in mehr als 110 Ländern vertreten.

MEDICARE Medizinische Geräte GmbH

Medicon eG Chirurgiemechaniker-GenossenschaftSeit 1941 bündelt die Medicon eG die Stärken von Herstellerbetrieben innerhalb der Genos-senschaft und bietet ein Komplettprogramm von chirurgischen Instrumenten und Implantaten. Die Produkte unserer Kernbereiche SURGICAL, CMF und NEURO+SPINE genießen weltweit einen exzellenten Ruf hinsichtlich Ihrer Verlässlichkeit, Qualität und Verfügbarkeit.

MELAG Medizintechnik oHGÜber 60 Jahren bieten wir Komplettlösungen im Bereich Desinfektion und Sterilisation für Praxen und Kliniken. Unsere Mitarbeiter entwickeln und produzieren unsere Thermodesinfek-toren, Siegelgeräte, Dampfsterilisatoren, Wasseraufbereitungsanlagen und Softwarelösungen und über 500.000 installierte Geräte weltweit sind Anerkennung und Antrieb, um unseren Kunden noch bessere Lösungen zu bieten.

Memmert GmbH + CO. KGIn der dritten Generation entwickelt und produziert Memmert an zwei Standorten in Deutsch-land Temperiergeräte. Die Produktpalette umfasst Wärme-/Trockenschränke, Vakuumschränke, Sterilisatoren, Brutschränke, Kompressor-/Peltier-Kühlbrutschränke, CO2-Brutschänke, Konstantklima-Kammern, Feuchtekammern, Klimaschränke, Umweltprüfschränke und Wasser-/Ölbäder.

Die Messer GruppeDie Messer Group ist der größte privat geführte Spezialist für Industrie-, Medizin- und Spezial-gase. Unter der Marke Messer – Gases for Life ist das Unternehmen in über 35 Ländern aktiv. Messer ist nicht nur als Industriegase-, sondern auch als pharmazeutisches Unternehmen mit einem differenzierten Gaseprogramm speziell für den medizinischen Bereich aktiv.

MEYER-HAAKE GmbH OBERMÖRLEN Medical InnovationsMeyer-Haake ist bekannt für qualitativ hochwertige Produkte, die mit Ärzten & Wissenschaft-lern entwickelt werden. EPIGLU, der Gewebekleber, revolutioniert das Wundmanagement; wirtschaftliche, infektionssichere & schmerzlose Wundversorgung. Das Radiochirurgie-Gerät radioSURG 2200 bietet die neueste Technologie und sollte daher in keinem OP fehlen. Weitere innovative Produkte befinden sich im Sortiment.

Miele & Cie. KGEine starke strategische Aufstellung: Miele und Steelco.Während sich Miele auf innovative Lösungen für die Instrumenten- und Laborglasaufbereitung in Arztpraxen und Laboren fokussiert, bietet das Tochterunternehmen Steelco kundenspezifische High-class-Systemlösungen für den Hospital-, Pharma- und Life-Science-Bereich.

www.loewensteinmedical.com

www.luneautech.de

www.maico-diagnostics.de/

www.matachana.de

www.medicare-cpap.de

www.medicon.de

www.melag.com/de

www.memmert.com

www.messergroup.com

www.meyer-haake.com

www.miele.de

technology

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Mikrop AG

MMM Group Die MMM Group ist weltweit einer der führenden Systemanbieter für Lösungen zur Steril-gutaufbereitung. Mit einem Produkt- und Dienstleistungsangebot rund um Reinigung, Des-infektion und Sterilisation für den Bereich Healthcare und Life Science hat sich die MMM als entscheidender Qualitäts- und Innovationsträger im Markt positioniert. MMM. Protecting human health.

MÖLLER-WEDEL GmbH & Co.KGMöller-Wedel GmbH & Co. KG befasst sich mit der Entwicklung und Produktion hochpräziser optischer Geräte für den Einsatz in der Mikrochirurgie. Die Bedürfnisse der Neuro- & HNO- Chirurgen sowie der Ophthalmologen und Zahnärzte sind die Inspiration der Produktentwick-lungen. Möller-Wedel wurde 1864 gegründet und 1990 in die Haag-Streit-Gruppe mit Sitz in Köniz, Schweiz, eingegliedert. Seit 2018 ist die Haag-Streit-Gruppe Teil der Metall-Zug- Gruppe aus Zug in der Schweiz.

MPV MEDICAL GmbH MPV MEDICAL konzentriert sich mit seinen hochwertigen Medizinprodukten seit 1997 auf den Bereich Respiratory Care (z. B. Inhalationstherapie). Gemäß dem Grundsatz „Qualität, mit der Sie rechnen können“ bieten wir Apotheken, Sanitätshäusern und dem medizinischen Fachhandel innovative Hochqualitätsprodukte zu attraktiven Preisen.

Mühle Müller Pflegebetten | M2 handels- und vertriebs GmbH Wir sind Hersteller von Pflegebetten für die häusliche, private wie auch die öffentliche Alten-pflege. Neben den Standardpflegebetten werden Sonder-Pflegebetten entwickelt und produ-ziert. Das Sortiment umfasst Pflegebetten, Lagerungsbetten, Niedrigbetten, Schwerlastbetten, Betteinsätze sowie Patientenlifter, Deckenlifter und weitere Produkte.

NDI Europe GmbH NDI ist ein weltweit führender Hersteller von 3-D-Messtechnik für den Einsatz in Industrie, Forschung und Medizintechnik. NDI Navigations-Systeme ermöglichen es dem Chirurgen, Instrumente im Körper des Patienten in Bezug auf medizinische Bilder (z. B. CT, MRT, etc.) zu navigieren, und machen dadurch minimalinvasive Eingriffe möglich.

nova:med GmbH & Co. KGnova:med verbessert nachhaltig die Lebensqualität seiner Patienten und bietet Ihnen die geeignete Unterstützung zur Aufrechterhaltung oder Verbesserung der Atmung. Mit unseren Service- und Dienstleistungen wenden wir uns an Patienten mit Atemwegserkrankungen, Kliniken sowie Kostenträger. Durch unsere Arbeit möchten wir das Leben von chronisch kranken Menschen verbessern.

nova motum Services & Consulting GmbHnova motum erstellt Apps für Gerätekommunikation und Mobile Konnektivität sowie Server-lösungen zur Digitalen Transformation. Die BeMobil-App motiviert Kinder mit Orthesen bei Skoliose im Trageverhalten, die Phonak „Tinnitus Balance App” zur Klangtherapie. Mit unse-rem AppQualifier sorgen wir für Durchblick im Dickicht der vielen „medizinischen“ Apps.

OBERON GmbH Fiber TechnologiesOBERON Fiber Technologies entwickelt und produziert ausschließlich in Deutschland sterile medizinische Lasersonden für operative Anwendungen in der endovaskulären Chirurgie, Urologie, Orthopädie, Proktologie, Ophthalmologie, Gastroenterologie, Gynäkologie, Dental-medizin und HNO. OBERON Fiber Technologies ist zertifizierter Medizinproduktehersteller nach ISO 13485 und verfügt über die notwendigen Zulassungen in der EU/EWR (CE) sowie in den USA (FDA), Australien (TGA), Brasilien (ANVISA) und Israel (AMAR).

OCULUS Optikgeräte GmbHSeit 1895 sind wir Partner für Ophthalmologen, Optometristen, Augenoptiker und Arbeits-mediziner weltweit. Die hohen Ansprüche der Medizintechnik sind für uns der Maßstab in Entwicklung, Vertrieb und Schulung. Diagnostik und Therapie von morgen basieren auf zu-kunftsorientierten, vernetzten Technologien. Fortschrittliche Hightech-Entwicklung schreiben wir bei OCULUS groß.

www.mikrop.com

www.mmmgroup.com

www.haag-streit.com/

moeller-wedel

www.mpvmedical.com

www.muehle-mueller.de

www.ndigital.com

www.novamed.de

www.novamotum.net

www.oberonfiber.com

www.oculus.de


Ofa Bamberg GmbHOfa Bamberg ist ein führender deutscher Hersteller für medizinische Kompressionsstrümpfe, orthopädische Bandagen und Orthesen. Vorbeugende Gesundheitsprodukte, darunter Vital- und Reisestrümpfe sowie wohltuende Wärmekissen, runden das Produktportfolio ab. Seit 1928 verfolgt Ofa Bamberg einen klaren Anspruch: maximaler Komfort und attraktive Optik bei optimaler Wirksamkeit.

OLYMPUS SURGICAL TECHNOLOGIES EUROPE | Olympus Winter & Ibe GmbH Olympus Surgical Technologies Europe ist als Hightech-Spezialist das Entwicklungs- und Produktionszentrum für Endoskopie, bipolare Hochfrequenz-Chirurgie, Systemintegration und Aufbereitung. Mit 1.700 Mitarbeitern steht das Unternehmen für Spitzenleistungen in Diagnostik und Therapie und bietet die gesamte Bandbreite modernster endoskopischer Anwendungen vom Produkt bis zur Systemlösung.

Ottobock SE & Co. KGaAFür Menschen mit eingeschränkter Mobilität entwickelt Ottobock medizintechnische Produk-te und Versorgungskonzepte in den Bereichen Prothetik, Orthetik, Human Mobility und MedicalCare. Tochtergesellschaften in über 50 Ländern bieten Qualität „Made in Germany“ weltweit an und beschäftigen mehr als 7.000 Menschen. Ottobock ist seit der Gründung 1919 ein familiengeführtes Unternehmen.

Otto Rüttgers GmbH + Co. KG

Ovesco Endoscopy AGDie Ovesco Endoscopy AG ist ein innovatives und internationales Medizintechnikunter nehmen mit den Standorten in Deutschland und den USA, welches in der flexiblen und der endo-luminalen Chirurgie tätig ist. Wir entwickeln, produzieren und vertreiben Produkte für die Behandlung von gastrointestinalen Erkrankungen. Markenzeichen sind endoskopische Clip- Systeme wie z. B. der OTSC® – Over-the-scope-Clip.

PARI GmbH Spezialisten für effektive InhalationPARI ist als Hersteller von Medizinprodukten und Arzneimitteln im Bereich Atemwege mit dem Schwerpunkt auf Inhalationsgeräten seit vielen Jahrzehnten die Marke des Vertrauens für Ärzte, Apotheker und Patienten. Ein breites Produktportfolio findet seinen Einsatz von der Diagnose über die Behandlung bis zum Monitoring, um Patienten eine umfassende Versor-gung zu bieten. Die PARI Unternehmensgruppe hat ihren Sitz in Starnberg mit weiteren Standorten in Weilheim, Gräfelfing und Gilching.

PENTAX Europe GmbHPENTAX Medical ist ein Geschäftsbereich der Hoya Corporation und Anbieter flexibler Endos-kope, die weltweit entwickelt werden. Der Anspruch von PENTAX Medical ist es, bevorzugter Partner für Krankenhäuser und Ärzte zu sein. Hierfür bieten wir endoskopische Systeme, Lösungen und therapeutische Produkte an. Dies erfolgt über Plattformen von Früherkennung über Diagnose bis Therapie und dient der Optimierung der Patientenversorgung.

phenox GmbHDas Bochumer Unternehmen phenox entwickelt, produziert und vertreibt Produkte zur Be-handlung von Aneurysmen und Schlaganfällen. Die hochinnovativen Instrumente wie Stents, Flow Diverter und Katheter werden von Neuroradiologen weltweit in Kliniken zur interventi-onellen Behandlung in Hirnarterien eingesetzt.

Philips GmbH RespironicsPhilips Respironics ist ein führender Hersteller von Produkten für Schlaftherapie, außerklinische Beatmung sowie für Sauerstoff- und Aerosoltherapie. Bei der Entwicklung neuer Produkte stehen die Bedürfnisse der Patienten im Mittelpunkt. Dank über 25 Jahren Erfahrung haben Fachhändler und medizinisches Fachpersonal mit uns einen starken Partner an ihrer Seite.

Radimed GmbHDie Radimed GmbH entwickelt und vertreibt Produkte zur Schmerztherapie an der Wirbel säule mit dem Fokus auf Methoden zwischen konventioneller Therapie und operativen Eingriffen. Die Spezialisierung der Radimed GmbH auf Methoden und nicht nur auf reine Pro dukte macht sie zu Ihrem kompetenten Zulieferer für minimalinvasive Eingriffe an der Wirbelsäule.

RAYLYTIC GmbH

www.ofa.de

www.olympus-oste.eu

www.ottobock.de

www.otto-ruettgers.com

www.ovesco.com

www.pari.com

www.pentaxmedical.com

www.phenox.net

www.respironics.com/de

www.radimed.de

www.raylytic.com/

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ResMed Deutschland GmbH Die ResMed Deutschland GmbH ist die deutsche Vertriebs- und Servicegesellschaft für das Fachhandelsgeschäft des Medizintechnikherstellers ResMed Inc., San Diego (USA). Die ResMed Deutschland GmbH ist ein langjähriger und etablierter Ansprechpartner für ihre Kunden im Bereich der Schlaf- und Beatmungsmedizin. Bundesweit tätige Homecare Provider, regional agierende Medizintechnikhändler sowie der qualifizierte Fachhandel werden durch ein kom-petentes Team optimal betreut.

ResMed GmbH & Co. KG / ResMed Medizintechnik GmbH ResMed Healthcare steht als Homecare-Unternehmen für Kompetenz im Bereich der Schlaf- und Beatmungsmedizin. Das Unternehmen bietet Patienten, Ärzten, medizinischem Fachpersonal, Kliniken und Kostenträgern innovative Produkte sowie ausgezeichnete Service-leistungen. Deutschlandweit ist das Unternehmen mit über 50 Filialen bzw. Dienstleistungs-zentren vertreten.

ReWalk Robotics GmbHReWalk Robotics ist seit sechs Jahren ein global führender Hersteller der Exoskelett-Techno-logie. Das etablierte ReWalk Personal 6.0 ermöglicht es Querschnittgelähmten wieder zu stehen, gehen sowie Treppen zu steigen und ist als Pionier das erste Exoskelett mit Hilfsmit-tellistung. Als neueste Entwicklung bringt ReWalk 2019 den ReStore Soft Exo-suit für Schlaganfall patienten auf den Markt.

Richard Wolf GmbHRichard Wolf GmbH ist ein mittelständisches Medizintechnikunternehmen, das ein breites Spektrum an Produkten und Lösungen für die Endoskopie und extrakorporale Stoßwellen-behandlung anbietet. Integrierte OP-Systeme runden das Produkt-Portfolio ab. Das Unter-nehmen beschäftigt weltweit rund 1.500 Mitarbeiter und ist mit 15 Niederlassungen sowie 130 Auslandsvertretungen weltweit präsent.

ROWIAK GmbHUnsere Entwicklungen unterstützen Augenärzte weltweit bei der Diagnose und Behandlung von Patienten. Solide Innovation, Forschung und Entwicklung sind die Grundlage zur Herstel-lung ultrapräziser Femtosekunden-Laser und hochsensibler Opto-Elektronik. Wir bauen Ihren Prototypen und entwickeln die passende Steuerungssoftware. Wir managen Ihr Projekt zu-verlässig und dokumentieren lückenlos Prozesse und Ergebnisse. Wir unterstützen laufende Projekte lösungsorientiert und liefern einzelne OEM-Module nach Ihren Vorgaben.

Rudolf Riester GmbHRudolf Riester hilft Dienstleistern in der Gesundheitsvorsorge und Krankenversorgung mit innovativen und diagnostischen Instrumenten das Leben ihrer Patienten zu verbessern. Wir reagieren auf die Bedürfnisse unserer Kunden mit Flexibilität, jedoch auch mit Innovationskraft, fortschrittlichen Fertigungsmethoden und dem qualifizierten Vertrieb eines Global Players.

Rupp + Hubrach Optik GmbHDie Rupp + Hubrach Optik GmbH fertigt seit 1922 Qualitätsbrillengläser. Eine eigene Entwick-lungsabteilung sowie ausgeprägte fachliche Kompetenz stellen die hohe Qualität der Gläser und Veredelungen sicher. Mehrfach wurden die Bamberger ausgezeichnet – z. B. mit dem German Brand Award – und in den Kreis der Top 100 innovativsten Unternehmen Deutschlands gewählt.

SAPIO Life – Spezialist in der respiratorischen Heimtherapie SAPIO Life ist ein Teil der ital. SAPIO-Gruppe mit europaweit rund 1.500 Mitarbeitern in fünf Ländern. Als Spezialist und Full-Service-Anbieter in der respiratorischen Heimtherapie sind wir seit 1989 mit heute elf Standorten am deutschen Markt aktiv und für unsere Patienten jeder-zeit direkt vor Ort.

Sartorius AGDer Sartorius-Konzern ist ein international führender Partner der biopharma zeutischen For-schung und Industrie. Die Sparte Lab Products & Services konzentriert sich mit innovativen Laborinstrumenten und Verbrauchsmaterialien auf Forschungs- und Qualitätssicherungs labore in Pharma- und Biopharmaunternehmen und akademischen Forschungseinrichtungen. Die Sparte Bioprocess Solutions trägt mit einem breiten Produktportfolio mit Fokus auf Einweg- Lösungen dazu bei, dass Biotech-Medikamente und Impfstoffe sicher und effizient hergestellt werden.

www.resmed.com

www.resmed-healthcare.de

www.rewalk.com/de

www.richard-

wolf.com/de

www.rowiak.de

www.riester.de/de

www.rh-brillenglas.de

www.sapiolife.de

www.sartorius.com


Schmidt + Haensch GmbH & Co.Seit 1864 verbindet SCHMIDT+HAENSCH Tradition mit Innovation bei der Herstellung und dem weltweiten Vertrieb von qualitativ hochwertigen opto-elektronischen Messgeräten. Das Produktportfolio umfasst u. a. Polarimeter, Refraktometer, Laborgeräte, Laborautomation und Prozessanalytik. Eine neue Generation von Dichtemessern vervollständigt das Programm der quantitativen Flüssigkeitsanalyse.

SCHMITZ u. Söhne GmbH & Co. KGFast 90 Jahre Erfahrung in der Herstellung medizintechnischen Mobiliars zeichnen uns aus. Unser Produktportfolio umfasst Operationstische, Patiententransporter, Ambulanz- und OP- Mobiliar, gynäkologische Arbeitsplätze, Full-HD-Videokolposkope mit Monitor, Funktionswagen, all gemeines medizinisches Mobiliar sowie Entbindungsbetten.

SCHWIND eye-tech-solutions GmbH SCHWIND eye-tech-solutions ist der führende Anbieter von Augenlasern zur Behandlung von Fehlsichtigkeit und Hornhauterkrankungen. Zum Produktportfolio gehören Excimer Laser, ein Femtosekundenlaser, Planungssoftware für ein einzigartig breites Anwendungsspektrum und Diagnosesysteme. Renommierte Augenchirurgen in mehr als 100 Ländern behandeln ihre Patienten mit SCHWIND Lasern.

seca gmbh & co. kgseca ist Weltmarkführer für medizinische Messsysteme und Waagen und bietet Anwendern wissenschaftlich validierte Präzision auf höchstem Niveau. Das Portfolio umfasst innovative Lösungen wie medizinische Waagen, Längenmessgeräte, vernetzte Vitaldatenmonitore, Mess-stationen, die miteinander kommunizieren, Service- und Softwaresysteme und medical Body Composition Analyzer zur Erfassung der Körperzusammensetzung.

Semeda GmbH

SomnoMed® Germany GmbHSomnoMed® ist ein weltweit tätiges Unternehmen der Medizintechnik und ist auf Entwicklung, Herstellung und Vertrieb von intraoralen Schienen zur Behandlung des obstruktiven Schlaf apnoe-Syndrom spezialisiert. SomnoMed bietet eine komfortable und hochwertige Lösung, damit Sie wieder erholsame Nächte genießen und die Tage ausgeschlafen und aktiv erleben können!

Sonovum AGDie Sonovum AG mit Sitz in Leipzig entwickelt und produziert Medizinprodukte auf Basis ihrer Ultraschalltechnologie, der Akustocerebrografie (ACG). Mit ACG lassen sich pathologi-sche Zustandsänderungen im Gehirn nicht invasiv, schnell und kostengünstig erfassen. Wir nutzen hierbei die aktuellen Forschungsergebnisse im Bereich Ultraschall sowie Gehirndiag-nostik und -monitoring.

Söring GmbHDie Söring GmbH wurde 1985 von Holger Söring mit Hauptsitz in Quickborn gegründet. Seitdem stellt das Familienunternehmen hochwertige Produkte für die Ultraschall-Chirurgie her. Mit seinen etablierten Anwendungen für die Leber-, Neuro- und Wirbelsäulenchirurgie sowie die Wundbehandlung steht es mittlerweile an der Weltspitze der Ultraschall-Technolo-gie. Bei Söring ist alles „Made in Germany“.

Stiegelmeyer GmbH & Co. KGStiegelmeyer beschäftigt sich seit 119 Jahren mit der Entwicklung innovativer Betten und Einrichtungslösungen für den Klinik- und Pflegebereich. Unsere Kernprodukte produzieren wir selbst. Der Hauptsitz des Familienunternehmens ist in Herford – von dort aus agieren wir als einer der führenden Hersteller von Medizinprodukten in Deutschland, Europa und der Welt.

Sutter Medizintechnik GmbHSeit über 45 Jahren steht Sutter Medizintechnik für innovative Produkte im Bereich der mini-malinvasiven Elektrochirurgie. Das Freiburger Familienunternehmen ist international als Pionier für die Non-stick-Technologie bipolarer Pinzetten bekannt und führend in der RF-Chirurgie. Bei der Herstellung setzt Sutter auf höchste Qualität „Made in Germany“.

Textilia Stahlwaren-Manufaktur GmbH & Co. KG

www.schmidt-

haensch.com/de

www.schmitz-soehne.com

www.eye-tech-solutions.de

www.seca.com

www.semeda.de

www.somnomed.com/de

www.sonovum.de

www.soering.de

www.stiegelmeyer.com

www.sutter-med.de

www.textilia-solingen.de/

73


Thomashilfen für Körperbehinderte GmbH & Co. Medico KGAls Pionier ist Thomashilfen seit 50 Jahren eine Leitmarke im internationalen Pflege- und Rehamarkt. Mit dem zukunftsweisenden digitalen Pflege-Cockpit beweist man erneut Pio-niergeist, neben der weiteren Spezialisierung auf Lagerung in der Pflege und vor allem Be-wegung und Mobilität. Ein Netzwerk lizensierter Vertriebspartner in 40 Ländern garantiert die kompetente Versorgung mit eigenen Produkten.

UniTransferKlinik Lübeck GmbHDie Non-profit-UniTransferKlinik befördert Projekte, Produktentwicklungen und Start-ups auf der Plattform „www.industrie-in-klinik.de“, „www.Klinik.de“ und stellt die Testumgebung für Medizintechnik/Krankenhaus-4.0 Anwendungen bereit. Eng vernetzt mit ihren Gesellschaftern und Medizintechnikhersteller überführt sie die breiten Kompetenzen des BioMedTec-Campus Lübeck in Entwicklung- und Erprobungskooperationen.

VacuTec Messtechnik GmbHGegründet im Jahr 1956, leistet VacuTec Messtechnik GmbH Pionierarbeit bei der Entwicklung von Detektoren für ionisierende Strahlung. VacuTec ist heute ein weltweit tätiges Unternehmen mit mehr als 50 hoch qualifizierten, engagierten Mitarbeitern und entwickelt, produziert und vertreibt ein breites Spektrum an Detektoren zur Messung ionisierender Strahlung.

VISTEC AG Vision Technologies Die Vistec AG ist bekannt für Ihre Zuverlässigkeit und Fachkompetenz und für die „Rundumbe-treuung“ der Kunden in der Arbeits- und Verkehrsmedizin. Dieser Service, der unsere Kunden in Ihrem Arbeitsalltag unterstützt, sorgt gleichzeitig für einen kontinuierlichen Erfahrungsaustausch. Dies hilft uns wiederum, unsere Leistungen noch enger an deren Bedürfnissen auszurichten.

VitalAire GmbHIn Zusammenarbeit mit Ärzten, Pflegediensten, Pflegeheimen und Angehörigen realisiert VitalAire eine zuverlässige Versorgung im außerklinischen Bereich. Das Versorgungsspektrum umfasst Monitoring, Sauerstoff-Langzeittherapie, Schlafapnoe-Therapie und Beatmungs-versorgung. Ergänzt wird das Angebot durch ein abgestimmtes Service-Konzept und zertifi-ziertes Qualitätsmanagement.

Vivisol Deutschland GmbHWir sind ein bundesweiter spezialisierter Homecare-Dienstleister mit den Serviceschwerpunkten in den Bereichen Langzeit-Sauerstofftherapie, außerklinische Beatmung, Schlafapnoe-Therapie, Monitoring und künstliche Ernährung. Unser Ziel ist die Verbesserung der Lebensqualität, vor allem für chronisch kranke Patienten, deren Behandlung zu Hause oder in spezialisierten Ein-richtungen durchgeführt werden muss.

Völker GmbHDie Völker GmbH aus Witten entwickelt und fertigt multifunktionale und zugleich komforta-ble Pflege- und Klinikbetten. Dabei setzt das 1912 gegründete Traditionsunternehmen auf Qualität aus Deutschland. Auf der eigenen Produktionsfläche produziert Völker zahlreiche Produkte für Pflegeeinrichtungen und Kliniken, die in die ganze Welt exportiert werden.

WEINMANN Emergency Medical Technology GmbH + Co. KGWEINMANN Emergency ist ein international tätiges Medizintechnikunternehmen in Familien-besitz. Mit unseren mobilen Systemlösungen für die Bereiche Notfall-, Transport- und Katastrophen-medizin setzen wir Maßstäbe beim Retten von Menschenleben. Seit über 100 Jahren bieten wir unseren Kunden ein Höchstmaß an Verlässlichkeit, Erfahrung und Qualität Made in Germany.

WILAmed GmbHWILAmed ist ein international agierender Hersteller und Händler von medizinischen Geräten und Zubehör auf dem Gebiet der invasiven und nicht invasiven Beatmung. Das mittelständische Unternehmen betreut über autorisierte Fachhandelspartner den Homecare-Bereich ebenso wie Kliniken, Krankenhäuser und Reha-Einrichtungen.

WILD GruppeWILD ist Auftragsentwickler und -fertiger anspruchsvoller optomechatronischer Systeme und Komplettgeräte für Medical & Life Sciences, Labortechnik, ln-vitro-Diagnostik & Analytik, Laser technik sowie Lichtquellen & Operationsleuchten. Als Systempartner ist WILD dort gefragt, wo es auf Präzision ankommt und Innovationen stattfinden.

Xenios AG

www.thomashilfen.de

www.unitransferklinik.de

www.vacutec-gmbh.de/de

www.vistec-support.de

www.vitalaire.de

www.vivisol.de/

www.voelker.de

www.weinmann-

emergency.com

www.wilamed.com

www.wild.at

www.xenios-ag.com/

74

» Photo credits Title: iStock / Martin Barraud; p. 3: Bundesministerium fur Wirt-

schaft und Energie; p. 6: SPECTARIS e. V.; p. 15: Andreas Hettich

GmbH & Co. KG; ARRI Medical GmbH; p. 16: Messe Dusseldorf

GmbH; p. 17: ATMOS MedizinTechnik GmbH & Co. KG; p. 18:

B. Braun-Gruppe; p. 19: bon Optic Verbtriebsgesellschaft mbH;

HEINE Optotechnik GmbH & Co. KG; p. 20: Condor MedTech

GmbH; p. 21: Elke Carolin Demtschuck; p. 22: Germany Trade

and Invest; p. 24: Deutsch- Brasilianische Industrie- und Han-

delskammer (AHK); p. 26: MERICS gGmbH; p. 27: Carl Zeiss

AG; DeVilbiss Healthcare GmbH; p. 28: DOCERAM Medical

Ceramics GmbH; ERKA. Kallmeyer Medizintechnik GmbH & Co.

KG; p. 29: Essilor GmbH; Fritz Stephan GmbH – Medizintechnik;

p. 30: Invacare GmbH; p. 33: ERKA. Kallmeyer Medizintechnik

GmbH & Co. KG, Philips GmbH Respironics, F. & M. Lauten-

schlager GmbH & Co. KG; S. 34: Cisema (Hong Kong) Limited;

Lowenstein Medical GmbH & Co. KG; p. 36: B. Braun-Gruppe;

p. 38: MedTech Europe; p. 40: OR.NET e. V.; ICCAS Leipzig /

Max Rockstroh; p. 43: WEINMANN Emergency Medical Tech-

nology GmbH + Co. KG; MAICO Diagnostics GmbH; p. 44:

NOVACOS Rechtsanwalte; p. 45: Ofa Bamberg GmbH; p. 46:

Miele & Cie. KG; OBERON GmbH Fiber Technologies, Ovesco

Endoscopy AG; p. 47: PARI GmbH; Philips GmbH Respironics;

p. 48: Volker GmbH; p. 51: Muhle Muller Pflegebetten, Stiegel-

meyer GmbH & Co. KG; WILD GmbH; p. 52: Kienbaum Consul-

tants International GmbH; Heidelberg Engineering GmbH;

p. 53: Hermann Bock GmbH; WILAmed GmbH; p. 54: Roland

Berger; p. 55: Schmitz u. Sohne GmbH; p. 56 – 58: SPECTARIS

e. V.

» ISBN-Number 978-3-9817205-7-0

» EditorSPECTARIS

Deutscher Industriebverband für Optik, Photonik,

Analysen- und Medizintechnik e.V.

Werderscher Markt 15, 10117 Berlin

phone: +49 (0) 30 41 40 21- 0

fax: +49 (0) 30 41 40 21- 33

e-mail: [email protected]

www.spectaris.de

» DeadlineFebruary 2020

» Conception and editorial managementJana Mallok, Junior Advisor Medical Technology

» Editorial staffMarcus Kuhlmann, Head of Medical Technology

Cordula Rapp, Advisor Medical Technology

Mike Bahren, Head of Business Administration, Economy

and Market Research

Corinna Mutter, Head of Regulatory Affairs

Jennifer Goldenstede, Head of Foreign Trade and

Export Promotion

Dr. Markus Safaricz, Head of Research & Innovation

» Concept and designsku:l communication, www.sku-l.de

» PrintKöllen Druck+Verlag, www.koellen.de

» DisclaimerThe data, information and calculations of this study were

created with great care. Still everyone Information is without

awareness.

Translations: lengoo GmbH, www.lengoo.de

» Unauthorized reproduction of the publicationThe reproduction of the study (in whole or in part) and the use

of the images contained in the study is only with the express

approval of the publisher or the Permission for the respective

image rights allowed. The publication results with source are

permitted.

Imprint and photo credits

74 Imprint and photo credits

Media partners

ISBN: 978-3-9817205-7-0We are SPECTARIS

A A. SCHWEIZER / Abbott Deutschland / Adolf Thies / ADOS / AESCULAP / Agilent Technologies Deutschland / air-be-c Medizintechnik / ALCON Pharma /

ALS Automated Lab Solutions / Alu Rehab / AMO Germany / Analytik Jena / Andreas Hettich / AOYAMA Optical Germany / Arnold & Richter / ARRI

Lightning Stephanskirchen / ARRI Media / ARRI Medical / art photonics / ASANUS Medizintechnik / asecos / asphericon / ATMOS MedizinTechnik / aXcent

medical / Axel Semrau B B. Braun Avitum Saxonia / Bauer und Häselbarth-Chirurg / Bausch & Lomb / BeamXpert / Walter H. Becker / Befort Wetzlar OD /

Belimed / Berghof Products + Instruments / Berliner Glas / Bierther Submikron / Blue Ocean Nova / bon Optic / BOSCH + SOHN / BOW Berliner Optikwelt /

BRAND / Braunwarth Optic Service / BREAS Medical / Breitfeld & Schliekert / Bresser / BÜCHI Labortechnik / Burmeier C Carl Martin / Carl Zeiss Jena / Carl

Zeiss Meditec / Carl Zeiss Microscopy / Carl Zeiss Sports Optics / Carl Zeiss Surgical / Carl Zeiss Vision / CETONI / Christoph Miethke / Clearlab / Coherent /

Coherent Kaiserslautern / Coherent LaserSystems / CONDOR MedTec / CooperVision / CRYSTAL / CULLMANN GERMANY D Deutsche Augenoptik AG /

DeVilbiss Healthcare / DITABIS / DMB Apparatebau / DOCERAM Medical Ceramics / Domino Laser / Dornier MedTech / DR. JOHANNES HEIDENHAIN /

Dr. Hönle Medizintechnik / Dr. Mach / Dräger Safety / Drägerwerk / DÜPERTHAL Sicherheitstechnik / DWK Life Sciences E eagleyard Photonics / EBM DE-

SIGN / EDDYCAM / Edmund Optics / Elementar Analysensysteme / EMCLAB / Eppendorf / ERKA Kallmeyer / Ernst Krauskopf / ERWEKA / Eschenbach Optik /

EsCo Orthopädie-Service / ESSILOR / ESW / Etuis Duggert / Eugen Stratemeyer / ewa-marine F F. W. Breithaupt & Sohn / Ferdinand Menrad / ficonTEC

Service / FISBA / Fisher & Paykel Healthcare / FLAIR Modellbrillen / FLO Medizintechnik / FMB Care / FPM Holding / FRANK OPTIC PRODUCTS / Fraunhofer-

Institut für Angewandte Optik und Feinmechanik IOF / Fraunhofer-Institut für Lasertechnik ILT / Fraunhofer-Institut für Nachrichtentechnik, Heinrich-

Hertz-Institut HHI / Fraunhofer-Institut für Photonische Mikrosysteme IPMS / Fraunhofer Institut für Physikalische Messtechnik IPM / Fraunhofer-Institut für

Produktionstechnologie IPT / Fraunhofer-Institut für Schicht- und Oberflächentechnik IST / F & W Frey & Winkler / FRIO international optics / Fritsch / Fritz

Stephan G Galifa Contactlinsen / Gardner Denver Thomas / GD Optical Competence / Gebrüder Martin / Gerstel / GETEMED Medizin- und Information-

stechnik / Gilson International BV Deutschland / Gimmi / Goebel Instrumentelle Analytik / Greiner / GTI medicare H HÄLSA Pharma / HAMAMATSU

PHOTONICS Deutschland / Handicare Accessibility / Hans Müller HMP Medizintechnik / Hans-Joachim Marwitz / Haver & Boecker / HECHT Contactlinsen /

Heidelberg Engineering / Heidolph Instruments / HEINE Optotechnik / Heliopan Lichtfilter Technik / Hellma / Hellma Optik Jena / Hemovent / HENSEL-VISIT /

Heraeus Noblelight / Hermann Bock / Hermle Labortechnik / Herolab / HEYER MEDICAL / Hill-Rom / HiperScan / Hirschmann Laborgeräte / Hittech Prontor /

HNP Mikrosysteme / Hoffrichter Medizintechnik / Hohenloher Spezialmöbelwerk / Hombrechtikon Systems Engineering / HOYA LENS Deutschland / HP

Medizintechnik / Hu-Friedy I ILUDEST Destillationsanlagen / Image Engineering / IMT Masken und Teilungen / Industrieverband Schneid- und Haushalt-

waren / INFICON / Infors / infoteam Software / INGENERIC / InProcess Instruments / Instrument Systems / INSULET Germany / INTEGRA Biosciences /

INTERCO / INTERSPIRO / INVACARE Deutschland / IVKO J J&M ANALYTIK / JENOPTIK Advanced Systems / JENOPTIK Automatisierungstechnik / JENOPTIK

Defense & Civil Instruments / JENOPTIK Diode Lab / JENOPTIK Industrial Metrology Germany / JENOPTIK Laser / JENOPTIK Optical Systems / JENOPTIK

Polymer Systems / JENOPTIK Robot / Johnson & Johnson Vision Care / Jos. Schneider Optische Werke / Jüke Systemtechnik / JULABO K Kaiser Fototechnik /

Karl Kaps / Karl Leibinger Medizintechnik / Karl Endoskope / KARL STORZ / KEK / Kendrion Kuhnke Automation / Kirchner & Wilhelm / KLS Martin Group /

KNAUER Wissenschaftliche Geräte / Koberg & Tente / Komet Medical / Kögel / Kowa Optimed Deutschland / Kröber Medizintechnik / Krüss L Labotect

Labor-Technik Göttingen / Landesinnung Chirurgiemechanik / LAP Laser / Laser 2000 / Laser Components / laservision / LASOS Laser Service und optische

Systeme / LASOS Lasertechnik / LAUDA DR. R. WOBSER / F. & M. Lautenschläger / LEICA Camera / Leica Geosystems / Leica Microsystems CMS / LEJ II

Lighting & Electronics Jena / LIMO / Linde Gas Therapeutics / Linde Remeo Deutschland / LLS Rowiak LaserLabSolutions / Löwenstein Medical / Löwenstein

Medical Innovation / Löwenstein Medical Technology / Luneau Technology M m2 Handels- u. Vertriebsgesellschaft / MAICO Diagnostics / mark’ennovy /

Martin Christ Gefriertrocknungsanlagen / Matachana Germany / Maui Jim Germany / Medical Communications / MEDICARE Medizinische Geräte / Medicon /

MELAG Medizintechnik / Memmert / Menicon / MERSEN Deutschland / Messer Group / Metrolux Optische Messtechnik / Mettler Toledo / MEYER-HAAKE /

Miele & Cie. / Mikrop / MINOX / MMM Münchener Medizin Mechanik / MMM Medcenter Einrichtungen / MÖLLER-WEDEL / MÖLLER-WEDEL-OPTICAL /

MPG&E Handel und Service / MPV MEDICAL / Müller WELT Contactlinsen / Mühle Müller Pflegebetten N NanoFocus / NDI Europe / NEOSTYLE / Netzsch

Gerätebau / Neumaier Logistics / Newport Spectra-Physics / NIKA Optics / Nikon / Noblex / Novacel / nova:med / nova motum Services & Consulting /

Novoflex Präzisionstechnik O OASYS / OBE-Präzision / OBERON Fiber Technologies / Oculus Optikgeräte / Ofa Bamberg / OHARA / OLYMPUS Deutschland /

Olympus Europa / OLYMPUS Winter & Ibe / op Couture Brillen / opdo Walter Sengespeick / Optics Balzers Jena / Optische Werke G. Rodenstock / Optiswiss /

ORAFOL Fresnel Optics / Ottobock HealthCare / Otto Rüttgers / Ovesco Endoscopy / OWIS / OWP Brillen P PAC / PARI / PENTAX Europe / Peter Huber

Kältemaschinenbau / PHARMA TEST Apparatebau / phenox / Philips Respironics / Photonic Sense / PMA / POG Präzisionsoptik Gera / Polytec / Pricon /

Primetta / Prinz Optics / Protect Laserschutz Q Qioptiq Photonics R RADIMED / Ratiolab / RAYLYTIC / Reichmann Feinoptik / ResMed Deutschland /

ResMed Medizintechnik / Restek / Retsch / ReWalk Robotics / Richard Wolf / Robert Riele / Rodenstock / Rowiak / Rudolf Riester / Rupp + Hubrach S S+M

Rehberg / S1 Optics / Sapio Life / Sartorius Lab Instruments / Satisloh / Schmidt & Bender / Schmidt + Haensch / SCHMITZ u. Söhne / SCHÖNE OPTIK /

SCHOTT / Schulz Optische Fabrik / SCHWIND eye-tech-solutions / seca / Semeda / Shimadzu Deutschland / SHP Steriltechnik / Sigma Laborzentrifugen /

Signet Armorlite Optic / Silhouette Deutschland / Sill Optics / SomnoMed® Germany / Sonovum / son-x / Söring / SpectroNet / Starna / STEINER-OPTIK /

Stiegelmeyer / Sutter Medizintechnik / SWAROVSKI OPTIK / Swiss Eye International / Swiss Optic / Systec T tec5 / Textilia Stahlwaren-Manufaktur / Thales

Deutschland / Thales Electronic Systems / THEIS FEINWERKTECHNIK / Thermo Fisher Scientific / Thomas Sabo / Thomashilfen für Körperbehinderte /

Toptica Photonics / TOPTICA Projects / Trimble Jena U UniTransferKlinik Lübeck V VacuTec Messtechnik / VACUU BRAND / VIN-CORION JENOPTIK

Advanced Systems / VIN-CORION JENOPTIK Power Systems / VISIBILIA / Vistan Brillen / VISTEC / VitalAire / VITRON Spezialwerkstoffe /

Vivisol Deutschland / Vixen Europe / Völker / Volpi / Voyou W Wagner & Kühner / Waldner Laboreinrichtungen / Walter Binde

Optik / WEINMANN Emergency Medical Technology / WEISS Klimatechnik / WILAmed / WILD Electronics /

WITEG Labortechnik / Wobatech / Wöhlk Contact-Linsen X Xenios // 2mag / 5micron

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The German Medical Technology Industry · 6 The high-tech industry at a glance Revenues 2017 – 2018 2017 » 63,7% 2018 Export rate 65,4% Overall revenue €30.28 billion 2018 2017