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The Swiss Medical Technology Industry
2010 Report – "MedTech at the Crossroads"



                                            1
On the mind of the SMTI CEO community


  "The MedTech business of non-reimbursed
                                                                "The MedTech pioneer era is
  products has started to reach a plateau in
                                                                over, the industry is now mature
  traditional markets. The business is now cyclical
                                                                and competition is global."
  and growth is not endless."


  "Our business model will
  change – We need to grow from
  a simple box-mover to a full                                  "IP protection and proprietary
  solution provider."                                           systems have become essential
                                                                to secure market shares."
  “Pace of innovation and
  changes in health care system
  are faster than a decade ago.”

 "The crisis has demanded to set
                                                      "Market access management is key for
 priorities and to constantly remain
                                                      growth – start-ups should engage in out-
 focused on optimizing these
                                                      licensing deals to Big MedTech."
 priorities."

Source: SMTI 2010, Advisory Board                                                                  2
SMTI 2010 – At the crossroads to adapt current business models


In recent years, this report helped to provide better insights on the importance of the Swiss Medical Devices Industry (SMTI). We have
monitored this industry closely since 2005, have seen it mature and are now in a position to derive first lessons from a vast data set.
Thus, we are now able to analyse trends that may shape SMTIs mid- to long-term future. This report intends to provide a general
outlook on the industry. However, it is highly heterogeneous and therefore our conclusions may vary based on a company's product
portfolio and economic situation.
As already identified in Spring 2009, mainly manufacturers of non-reimbursed products and suppliers with a high proportion of non-
healthcare clients were strongly exposed to the downturn. As external pressures grew, other players were exposed to the effects of the
economic crisis. High price pressure in export healthcare markets, adverse currency effects of the Euro and US-Dollar against the Swiss
Franc, reduced investments by the Swiss cantons for hospital equipment, or a declining demand in non-reimbursed products are a few
examples. Paired with increased pressure by payers and governments in major markets towards cost effectiveness and treatment
outcome, the Life Sciences industry is now faced with a paradigm shift in its future business model. Today, the "crisis resistance" due
to cash-rich reimbursement systems may be history as healthcare markets are changing rapidly.
Therefore, cost consciousness continues to influence many management actions. The management of SMTI companies increasingly
find themselves at the crossroads, refocusing their R&D spending. Today, manufacturers either drive full cutting-edge network
innovations or they focus on incremental innovation.
The first group are "network innovators". Their strengths reside in a cross-industries (e.g. MedTech/pharmaceutical/biotech/IT) as well as
cross-academia (e.g. local and international universities and hospitals) collaboration network allowing radical innovation and obtaining
market premium prices for the novel niche products in major markets.
The second group are "renovators". They focus less on innovation, but rather drive bundling (device/technology, software, single-use
materials, local maintenance/service, and/or training) or incremental product innovations (e.g. line-extensions). This secures their mature
product portfolio in mature markets. Additionally, renovators increasingly shift their attention to emerging economies to extend the life-
cycle of their products, catering to a growing and quality conscious middle class.

Peter Biedermann, Dr. Patrick Dümmler, Beatus Hofrichter
Publisher and authors of the SMTI 2010 Report August 2010


                                                                                                                                              3
Contents                                       Page


Management Summary                                5

A.   State of the MedTech Industry                9

B.   Trends and Challenges                       24

C.   Strategic Actions                           29

D.   Winning through Innovation                  34

E.   Collaboration and Bundling                  44

F.   International Opportunities and Threats     51

G.   International Positioning                   59

H.   Outlook                                     65

Appendix 1: Additional Data                      69
     Abbreviations                               70
Appendix 2: SMTI Knowledge Base                  88




                                                      4
Management Summary



                     5
MANAGEMENT SUMMARY



Management summary (1/2)
This report was written in the summer of 2010 involving 252 companies in the field of medical devices in Switzerland. It makes use of the
database of the Medical Cluster, Advisory Board input, additional expert interviews and desk research
            • The SMTI consists of 720 - 740 suppliers and manufacturers, as well as 630 - 660 traders and distributors and service
              providers
            • The manufacturing base is highly diversified across all product categories, many companies are among international
              thought and market leaders
            • The SMTI value chain is well established and is facilitated by a vast network of academia, specialized service providers,
              suppliers and institutions, forming a national MedTech cluster
            • The Swiss MedTech cluster is highly attractive for leading international MedTech companies, not only for headquarter
              functions but also for development and manufacturing

            • Total gross revenue is CHF 22.9bn, own value added is CHF 11.1bn, representing 2.0% of the Swiss GDP
 CHF        • The turnover per employee is about CHF 460,000; manufacturers realize 81% of their turnover with medical devices
            • The expected SMTI growth rate is 10% and 12% for 2010 and 2011 respectively; this is significantly above expected
              growth rates for the Life Sciences industry (6.5%) and Swiss GDP (1.9%)
            • Above 75% of SMTI CEOs are still focusing on crisis management activities
            • However, engaging in the right strategic actions will drive above-average growth, i.e. strengthening R&D know-how,
              establishing new production/service facilities, and engaging in new business models

            • Today around 49,000 employees work for the SMTI, this equals 1.4% of the Swiss workforce
            • 75% of SMTI companies have less than 50 employees, building a strong innovation basis
            • The total number of employees during the last two years increased by 10%
            • In the next two years SMTI companies expect further growth in headcount; the authors anticipate approximately 55,000
              employees by 2013
            • Especially micro and small companies hire predominantly in Switzerland while large companies also expand their
              workforce abroad




Source: SMTI 2010                                                                                                                           6
MANAGEMENT SUMMARY



Management summary (2/2)


            • 10.6% of the turnover is invested into research and development (R&D)1)
            • Approximately 25% of the overall SMTI product portfolio was developed in the last three years
            • Shortening of the innovation cycle is of significant relevance especially to medium and large sized companies
            • Focusing on R&D and fostering a young product portfolio leads to an additional 6% of above-average growth expectation
            • However, today companies need to spend more on R&D to generate strong growth rates
            • More than 50% of SMTI companies are engaged in network innovation across industry and academia functions
            • Collaboration along the value chain is excessive between suppliers and manufacturers, especially large companies tend to
              renovate and bundle their current product portfolio
            • Many companies focus on collaboration for applied research, quality control and to a lesser extent, on post-launch activities

            • The average rate of export is 63%; manufacturers and suppliers export 78% and 53% of products, respectively
            • For more than 70% of SMTI companies, registration and introduction of new products are perceived as less difficult in
              Europe than in other markets
            • Compared to 2008 higher growth in 2010 is expected from Switzerland, the EU and the BRIC countries
            • International opportunities will continue to drive SMTI growth; export-oriented manufacturers expect a growth rate of 18%

            • The SMTI is well positioned for the future
            • Two megatrends influence the industry
              – the triple challenge of price and cost pressures and intensifying competition
              – the clinical evidence requirements for cost-benefit of treatment
            • The focus on profitability to meet current challenges is at the cost of potentially losing the competitive innovative edge
            • Larger companies may review their current business models, the R&D strategy as well as offerings to improve future
              growth potential
            • The authors anticipate increased global consolidation activities impacting SMTI companies as well


1) The average R&D expenditure is not weighted to turnover, thus is may be skewed upwards by the large number of small companies in our sample
Source: SMTI 2010                                                                                                                                7
MANAGEMENT SUMMARY



The house of MedTech by 2012 – Our working hypotheses1)



                                                               SMTI
                        PRODUCT VIEW                                                      MARKET VIEW
                                       COLLABORATION &                   INTERNATIONALI-
          INNOVATION                                                                                        POSITIONING
                                          BUNDLING                           SATION
 • Above-average growth            • Price pressure leads           • Growth in international       • Smaller companies lack
   expectations due to an            companies to push                markets correlates with         export strength due to
   innovative, young product         bundled offerings in order       innovation                      shortage of know-how and
   portfolio or best in class        to maintain their turnover                                       commercial co-operations
                                                                    • Success in emerging
   products                          level and market share
                                                                      economies is highly           • Sound, long-term patient
 • Higher cost pressure leads      • Companies that focus on          correlated to strong            outcome data will ensure
   to a shift from radical           bundling tend to reduce          regulatory affairs              positive sales impact in
   innovation towards                their R&D expenditures           capabilities                    mature markets
   incremental innovation in
                                   • A bundling strategy            • Healthcare system             • Improved market
   established/mature
                                     favours collaboration within     changes and arising             orientation becomes a
   segments
                                     the same value chain for         opportunities propel export     priority due to an increase
 • Companies that focus on           incremental innovation           levels of suppliers and         of competitiveness
   network innovation can                                             manufactures                    amongst providers and
                                   • Demand of buyers will
   expect above-average                                                                               pressures from payers
                                     drive “solutions”, forcing
   growth
                                     companies to change their
                                     business models


1) Are addressed in chapters D-G
Source: SMTI 2010                                                                                                                   8
A. State of the MedTech Industry



                                   9
A         STATE OF THE MEDTECH INDUSTRY



Switzerland is among the global hotspots for MedTech


INTERNATIONAL MEDTECH FOCUS [% of respective total]1)                                  COMMENTS

                                1,1                                      Switzerland   • Switzerland possesses an active medical
                    0,3                                                  Germany         technology industry that can rely on a strong
Employment         0,2                                                   UK              network of related companies and institutions
                                                                         EU              that create an ideal breeding ground for the
                   0,2
                                                                         USA             industry (cluster)
                   0,2
                                                                                       • Compared to other countries the relative
                                        1,9                                              domestic share of the SMTI is significantly higher
                          0,7                                                          • Remarkable – and in line with several other
GDP                      0,6                                                             Swiss industries – is the high relative share of
                      0,5                                                                exports reflecting the international strength of
                      0,5                                                                Swiss MedTech products

                                                                 5,0
                                  1,4
Exports                               1,7
                    n.a.
                                              2,8




1) Data from 2008 or, where not available, from 2007
Source: SMTI 2010, Destatis, Eucomed, Eurostat, UK National Statistics                                                                        10
A         STATE OF THE MEDTECH INDUSTRY



Switzerland is highly attractive for international companies –
Top 10 companies employ around ¼ of SMTI employees1)

                                                                                             1 Year sales       R&D                         Sales/
                                                        Head-     Employees in    Sales                                   R&D/sales
  No.    Company          Sub-section of market                                                 growth       expenses                     employee
                                                       quarters    Switzerland   [CHFm]                                     [%]                   3)
                                                                                                  [%]         [CHFm]                       [CHFk]

   1    Synthes       Orthopedics                       USA           2'900          3'523              6          175                5           329

        Roche
   2                  In-vitro diagnostics               CH           1'750         10'055              4          987            10              387
        Diagnostics

        J&J
   3            2)    Orthopedics                       USA           1'400         24'492              2         1'830               7           556
        Medical

   4    Zimmer        Orthopedics                       USA           1'150          4'250              -1         213                5           518

   5    Sonova        Hearing systems                    CH           1'030          1'500             20           87                6           221

   6    Ypsomed       Injection systems                  CH           1'000           254               -8          32            12              212

                      Active and passive implants,
   7    Medtronic                                       USA           900           15'151              8         1'406               9           399
                      vascular diseases and diabetes

   8    B. Braun      Orthopedics, hospital aids         DE           840            5'992              6          207                3           152

   9    Straumann     Dental implants                    CH           800             736               5           39                5           339

  10    Stryker       Orthopedics                       USA           600            6'977              0          349                5           375

                                                                   ∑ 12'020                          Ø 4                         Ø 7



1) Approximately, manufacturers only, figures for reporting year 2009/10, exchange rates: USD/CHF: 1.03, EUR/CHF: 1.49 on 31.12.2009
1) J&J Medical: Numbers are the total for orthopaedics, surgery, cardiology and diagnostics
Source: SMTI 2010, Annual reports, Companies press offices, Factiva, Oanda                                                                              11
A          STATE OF THE MEDTECH INDUSTRY



Switzerland is a strong medical technology cluster –
Several organizations and institutions support the industry

                                                   Greater Zurich   COMMENTS
                                      Basel Area   Area             • Switzerland has a strong
                                                                      medical technology network,
                                                                      supported by several
                                                                      organisations and institutions
Berne Capital                                                       • Regional support
                                                                      organisations are e.g.
Area
                                                                      – Basel Area
                                                                      – Berne Capital Area
                                                                      – Bio Alps
                                                                      – Biopolo Ticino
BioAlps                                                               – Greater Zurich Area
                                                                    • National institutions are e.g.
                                                                      – CTI/KTI
                                                                      – FASMED
                                                                      – Medical Cluster
                                                                      – Medtech Switzerland
                                                                      – Osec
                                                    Biopolo
                                                                      – SIX Swiss Exchange
                                                    Ticino            – Swiss Life Science
                                                                        Marketing Alliance
     Location of suppliers
     Location of manufacturers

Source: SMTI 2010, relief swisstopo                                                                    12
A        STATE OF THE MEDTECH INDUSTRY



The SMTI has a strong home market – Investments in high-class
medical infrastructure meets patients demands

SWISS HEALTHCARE EXPENDITURES [CHF bn per year]                                  COMMENTS

                                                                                 • Continuous investments in up-to-date medical
                                                                                   infrastructure leads to rising healthcare
                                                                                   expenditures – during the last ten years by
                                     CAGR                                 63,3     nearly 50%
                                      4,0%                         61,0
                                                            58,1                 • The CAGR of healthcare expenditures of
                                                    55,2
                                        52,8                                       4.0% is significantly higher than the
                              51,0 52,0
               47,4
                       49,3                                                        respective GDP growth of 1.1%
        45,6
 42,8                                                                            FURTHER OBSERVATIONS

                                                                                 • Today Switzerland has the third highest GDP
                                                                                   share of healthcare expenditures (10.6%)
                                                                                   after the USA (16% in 2007) and France
                                                                                   (11% in 2007)
                                                                                 • To constrain rising national healthcare costs,
                                                                                   policies will increasingly focus on cost-
                                                                                   benefit comparison of treatments
                                                                                 • The SMTI companies will have to monitor
                                                                                   upcoming policy changes and be ready to
 2000   2001   2002    2003   2004    2005   2006   2007 2008E1) 2009E 2010F1)
                                                                                   adapt the business model accordingly
1) E = Expected 2) F = Forecast

Source: SMTI 2010, BAG, BfS, Healthcare Monitor 2009, KOF                                                                           13
A         STATE OF THE MEDTECH INDUSTRY



The established SMTI value chain is highly cross-institutional1)


Basic                     Applied                    Suppliers                 Manufacturers                 International          Customers and
research                  research                                                                           sales                  stakeholders

Basic research for        Developing                 Highly specialized        Manufacturing                 Worldwide sales of     Worldwide
radical product           and prototyping            and internationally       industry with broad           Swiss medical          customers and
innovations               supported by               sought-after              range of high-tech            technology products    stakeholders, e.g.
• National                • CTI/KTI MedTech          suppliers in key          products, e.g.                by traders and         • Patients, esp. in
   universities and       • R&D programs             technologies, e.g.        • Active- and non-            distributors              out-of-pocket
   international            e.g. ManuFuture-         • Information- and           active implants            supported by              markets
   knowledge                CH                         Communication           • Anaesthetic and             • Company              • Individual
   networks               • Universities and           technology (ICT)           respiratory                   affiliates             hospitals, hospital
• Five university           universities of          • New materials,             devices                    • Export Platform         chains and
   hospitals in             applied sciences,          surface                 • Dental                         Medtech                purchasing
   Geneva,                  incl. technology           technology              • Electro-                       Switzerland            associations
   Lausanne, Berne,         transfer                 • Robotics and               mechanical                 • Osec together        • Healthcare
   Basel and Zurich         organizations              nanotechnology             equipment                     with its Swiss         professionals
• National research       • Specialized              • Micro-technology        • Hospital hardware              business hubs       • Diagnostic
   organizations like       companies, e.g.          • Metal-, plastics-,      • Diagnostics                    abroad                 laboratories
   PSI and EMPA             for contract               and ceramic             • Ophthalmology               • Swiss pavilions at   • Research
• National research         engineering                processing              • Reusable and                   international          laboratories
   programs               • International            • Automation and             single-use                    exhibitions/fairs   • Key Opinion
• European                  knowledge                  assembly                   instruments                • International           Leaders (KOLs)
   framework                networks                 • Tool and mould          • Technical aids for             industry            • Reg. authorities
   programs                                            manufacturers              disabled                      associations        • Certification
                                                                                                                                       support

1) Service providers, depending on their specialization are part of any of the value chain building blocks
Source: SMTI 2010                                                                                                                                            14
A         STATE OF THE MEDTECH INDUSTRY



SMTI manufacturers are evenly segmented across the different
industry categories

MANUFACTURERS BY CATEGORY [%, 2010]                                                      COMMENTS

                                                                                         • The manufacturing base of SMTI is
                                                                                           segmented into 16 categories, ranging from a
                                                                   Hospital                share of 16% for hospital hardware to 1% for
Others1)
                                                                   hardware
                                                                                           biological products
                                                16%
                           19%                                                           • SMTI manufacturers exhibit a broad
                                                                                           technological knowledge base and
Reusable                                                           Dental                  diversification
instruments                                                        technology               – Bulk risks are reduced
                    5%
                                                          14%
                                                                                            – Benefits interdisciplinary R&D
Radiotherapy
                    5%                                                                        collaborations
devices
                                                                                            – Strengthens network innovation
Disposable           6%
items                                                 11%
                                                                   Inactive
                                                                                         FURTHER OBSERVATIONS
Technical aids            7%
                                                                   implants
for disabled                       8%        8%                                          • There exists a high degree of collaboration
In-vitro                                                           Electro-                amongst suppliers, manufacturers, and
diagnostics                                                        mechanical              academia to
                                                                                           – broaden the offering scope
n = 320                                                                                    – obtain key skills and know-how

1) Others include, in descending order: lab equipment, ophthalmology, patient aids, anaesthetic and respiratory technology,
   active implants and biological products
Source: SMTI 2010                                                                                                                         15
A          STATE OF THE MEDTECH INDUSTRY



Suppliers and service providers support the MedTech industry with
essential know-how within augmentable value chain processes

SUPPLIERS BY CATEGORY [%, 2010]                                               SERVICE PROVIDERS BY CATEGORY [%, 2010]

                                                       Components,
Others1)                                                                       Financing                                 HR
                                                       systems
Auxiliary material,            11%                                                                        5%
                                                                               Analytics                                 IT
green ware                                                                                                  1%
                          5%                25%
                                                                                                    18%            30%
Electronics            7%
Surface
                      8%
treatment
                                             19%                                                    20%
Machines, auto-            11%                         Metal                   Engineering,
mated devices                                          processing              planning,                         26%
                                  13%                                                                                    Management
                                                                               design
                                                      Plastics                                                           consulting
                                                      processing

n = 410                                                                        n = 410




• The SMTI supplier base is broadly specialized,                               • IT and management consulting are the most
  although components, systems and material                                      prominent categories among service providers
  processing contribute to more than 55%                                       • Support SMTI with growth capabilities

1) Others (in descending order) include: medical packaging, measuring, ceramics and sterilization
Source: SMTI 2010                                                                                                                     16
A        STATE OF THE MEDTECH INDUSTRY



Manufacturers and traders/distributors are highly focused on
medical devices sales

SHARE OF TURNOVER [%, 2009]                                                 COMMENTS

                                                                            • Many SMTI companies are not exclusively
                      100         100          100         100                focused on medical technology – the share
                                                15
                                                                              of sales to other industries and consumers is
                                   19
Turnover from
                                                                              39%
                                                           47
other products         56                                                   • Traders and distributors as well as suppliers
and services                                                         Ø 61     show an increased focus on MedTech
                                                                              compared to 2007
                                   81           85
                                                                            • Suppliers are more diversified in their
Turnover from                                               53
                       44                                                     customer portfolio
medical devices

                                                                            FURTHER OBSERVATIONS
                    Suppliers   Manu-         Traders     Service
                                facturers       and      providers          • A high focus on medical devices is needed in
                                            distributors                      order to meet the industry specific traits
Turnover                                                                      and sales requirements
from medical                                                                • On the whole, SMTI remains unchanged
                      39%         84%          80%         59%       Ø 65
devices in                                                                    since 2007, indicating that consolidation has
2007                                                                          not been triggered yet by the financial crisis
                                                                            • For many suppliers from other industries,
2009 n = 212     2007 n = 122                                                 MedTech became highly attractive

Source: SMTI 2010                                                                                                              17
A             STATE OF THE MEDTECH INDUSTRY



Manufacturers form the backbone of the industry –
Average turnover per company is CHF 68 million

AVERAGE COMPANY TURNOVER1) [CHF m, 2009]                              COMMENTS

                                                                      • The SMTI has a manufacturer centric market
                                                                        model
                         68
                                                                      • Turnover with medical devices is driven by
                                                                        – Offering/portfolio strategy, i.e. niche vs. big
                                                                          player
                                                                        – Company size
                                                                        – Upfront investments, i.e. machinery, IP
                                                                        – Position within the value chain
                                                                        – Competitive landscape, i.e. number of
                                                                          competitors within/adjacent to the industry
                                           22                         FURTHER OBSERVATIONS

                                                                      • Future sustainable turnover is mainly
          11
                                                                        determined by the following influencers
                                                                 3      – Overcome critical mass
                                                                        – Achieve higher expertise to maintain
     Suppliers        Manu-           Traders and         Service         compliance
                      facturers       distributors        providers     – Anticipate power shift towards payers
                                                                        – Meet changes in sourcing strategies of
n = 171                                                                   payers
1) Only with medical devices or components for medical devices
Source: SMTI 2010                                                                                                           18
A         STATE OF THE MEDTECH INDUSTRY



Manufacturers and suppliers provide the highest employment,
accounting for 92% of the total SMTI workforce

DISTRIBUTION OF EMPLOYEES [%, 2009]                        COMMENTS

                                                           • The surveyed companies employ around
                                                             27% of the total SMTI sector workforce
                      56%
                                                           • Traders, distributors and service providers
                                                             account for 8% of the surveyed workforce
                                                           • Across all SMTI firms approximately an
                                                             average of 59 people are employed
       36%                                                   – 126 by manufacturers
                                                             –    55 by suppliers
                                                             –    25 by traders and distributors
                                                             –     7 by service providers
                                                           • However, a significant bandwidth has to be
                                                             taken into account; of all surveyed companies
                                                             – 94% employ less than 250 employees
                                    5%                       – 75% employ less than 50 employees
                                                 3%
                                                             – 42% employ less than 10 employees

     Suppliers      Manu-       Traders and    Service
                    facturers   distributors   providers

n = 199


Source: SMTI 2010                                                                                            19
A          STATE OF THE MEDTECH INDUSTRY



Average turnover was influenced by high staff levels – This led to
an underperformance of turnover per capita for manufacturers

AVERAGE TURNOVER PER EMPLOYEE                                 AVERAGE GROWTH IN NUMBER OF EMPLOYEES
[CHF k]                                                       [% change vs. previous two years]

                                                                2008/2009 Ø = +10%   2006/2007 Ø = +20%


                           244                                                 11
Suppliers
                           246                                            7
                                        530                                                                30
Manufacturers
                                     465                              5
Traders and                                   683                                    15
distributors                                        818                         12
                              301        2007 n = 185                                     18               2007 n = 186
Service providers
                             287         2009 n = 163                                          21          2009 n = 164



• Traders/distributors experienced growth in turnover per capita, the others remained stable or declined vs. 2007
• The build-up of employees in 2006/2007 led to an overcapacity in 2008/2009, SMTI companies responded by
  adapting their recruitment policies
• Unlike many other Swiss industries the SMTI continue to hire above market average, but at a slower pace,
  continuing to provide attractive jobs for skilled employees, especially in the fields of R&D, regulatory affairs and
  international marketing & sales

Source: SMTI 2010                                                                                                         20
A        STATE OF THE MEDTECH INDUSTRY



Putting past SMTI growth expectations into perspective –
Adjustments were taken fast and early in the downturn

GROWTH EXPECTATIONS FOR 2008 AND 2009 [%]                                       COMMENTS

Growth                 Share of responses                                       • In 2008, SMTI expected an average growth of
expectations                                                           100%       6%. 77% of CEOs predicted a positive growth
                                                                                  rate1)
Strong growth                                                                   • The "crisis resistance" of the MedTech
(> 10%)                                                                           industry became attractive for non-industry
                                                                                  players (mainly suppliers), they were
                                                                                  – Trying to enter a profitable market
                                                                                  – Broaden sales channels and offerings
                                                                                • As the market turned in Q3 2008 and took its
Moderate growth                                                                   full impact in 2009 on a global scale, SMTI
(0 to 10%)                                                                        companies adjusted their growth expectations
                                                                                  – Then, only 54% of companies expected a
Neutral (0%)                                                                        positive growth rate
Moderate decline                                                                  – The number of companies expecting a
(-5 to 0%)
                                                                                    negative impact on sales doubled
Strong decline
                                                                                  – Suppliers with a higher non-MedTech
(< -5%)
                                                                                    product portfolio proportion were hit harder
                             2008                      2009                       – Manufacturers of non-reimbursed product
                       n = 280, Ø = 6%           n = 21, Ø = 0.1%                   suffered

1) SMTI 2008 data collected in spring and report released end of August 2008
Source: SMTI 2010 (based on SMTI survey May 2010), CS Economic Research, OECD                                                      21
A         STATE OF THE MEDTECH INDUSTRY



The global economic crisis also hit the MedTech industry –
Fears exist regarding severe cuts in public healthcare spending

STOCK MARKETS – SELECTED INDICES                                      GLOBAL AND CH MANUFACTURING – PMI INDEX

110                                                                   90
100                                                                   80
 90                                                                   70
 80                                                                   60
 70                                                                   50
 60                                                                   40
 50                                                                   30
 40                                                                   20
  Jul 08         Jan 09          Jul 09         Jan 10       Jul 10    Jul 08      Jan 09          Jul 09          Jan 10        Jul 10

           SIX Bio and Medtech            Europe-DS Pharm & Bio                 Swiss PMI Index             Global New Order Index
           SMI                            MSCI World                            Global PMI Index            Global Price Index
           DJ Euro Stoxx 50




Compared to the SMI, shares of SIX listed MedTech                      Since June 2008, the global manufacturing
companies declined stronger. It anticipates market                     production rose steadily for 13 month in a row but
fears of e.g. tightening healthcare budgets negatively                 slowed since the beginning of 2010. The Swiss PMI
affecting MedTech companies                                            is currently stable, outperforming other markets

Source: SMTI 2010, Bloomberg, Credit Suisse, JP Morgan                                                                                    22
A                     STATE OF THE MEDTECH INDUSTRY



Review of crisis 2008/09 and impact on SMTI – Lessons learned


                                                                                                         TRADERS &
                              SUPPLIERS                         MANUFACTURERS                                                           SERVICE PROVIDERS
                                                                                                        DISTRIBUTORS
                   • Right customer and portfolio mix     • Focus on relevant R&D projects       • Sales force excellence           • Investing/acquiring know-how
                   • Innovation leadership fosters a        and innovative products              • Good product mix with high         and teams
                     special, high value product and      • Positioning in markets and             reimbursement                    • Proactive positioning to
 "To strengthen"




                     component portfolio                    preparing NPIs consistently          • High focus on industry segment     anticipate revitalization of sector
                   • Networked innovation applying        • Acquiring know-how                   • High service competency          • Develop solution offerings
                     unconventional know-how              • Continue to recruit, especially      • Very good understanding of         copying other industry
                   • Closeness to IT industry and to        abroad                                 buyer‟s needs and buying           successes
                     new materials                        • Focus on business model                culture                          • Engage SMTI interfaces
                   • Continuous recruitments                optimization                         • Profit from strong CHF (as         management
                   • Scouting and M&A                     • Lean/efficient processes               importer)                        • Strong skill set and high value
                   • Well managed S-curve of core         • Strong regulatory capabilities                                            return offerings
                     competencies                         • Closeness to pharma/biotech                                             • High flexibility to support
                                                          • Foreign exchange issues with                                              challenges
                                                            an impact on margins

                   • Depending on single large            • Weak or reactive attitudes (e.g.     • Mismanagement of currency        • "Copy cat" and no sound track
                     customers and reactive market          engaging too late in cost cutting)     hedges                             records
                     strategy                             • Lack of listening to customers       • No product portfolio             • "Me-too" approach
                   • Over-capacities in production        • Mismanaged generation jump
 "To avoid"




                                                                                                   differentiation
                   • Large capital investments made         within product portfolio             • High inventories
                     based on boom forecasts              • Non value based pricing              • Decline in demand for
                   • Tight EBIT margins                     strategy                               commodities
                   • High diversity of client portfolio   • High OPEX/Sales ratio                • Lack of service offerings
                     (non-LS/non-core business)           • Me-too product sales decline
                   • Lack of international clients          with non proprietary goods
                   • High inventories and poor            • Late shift in crisis management
                     liquidity management                 • High COGS & inventory

Source: SMTI 2010                                                                                                                                                           23
B. Trends and challenges



                           24
B        TRENDS AND CHALLENGES



Taking the pulse of the SMTI – Top buzzwords




Source: SMTI 2010, www.wordle.net              25
B        TRENDS AND CHALLENGES



Imminent growth of SMTI companies is shaped by major trends in
three categories

COMPANY                                     REGULATION1)                                   MARKET
• Solutions will meet future offering       • Tightening of regulatory                      • Patient centric models arise due to
  demand                                      requirements2) in mature markets on              – external/remote patient monitoring
• Networked innovation is rising              quality, testing, safety and off-label           – ICT and improved RFID technology
  (led by micro/start-up firms)               usage                                         • Bundling of purchasing power among hospitals,
• Broader know-how is needed to             • Growing/tightening regulatory                   clinics, and specialists; they will
  meet regulatory requirements                requirements in Asian markets                    – drive margin erosion
  (e.g. market access, conformity,          • Introduction of DRGs will                        – favour broader offerings
  patent infringements, out-                   – increase pressure on pricing                  – seek solution providers
  licensing)                                   – delay or decrease investments into         • Convergence (MedTech & pharma/biotech)
• Improved clinical trial design                  radical innovation                           – drives innovation opportunities
  needed to demonstrate cost-               • Demonstrating comparative                        – exposes the MedTech industry to additional
  benefit                                     effectiveness drives the need to                    compliance/regulatory measures
• Institutional patient registries            generate relevant treatment outcome           • Export shift to emerging markets due to growing
  arising in multiple core markets,           data                                            middle-class with rising public and private health
  driving segmentation                      • Non-reimbursed/cosmetic/or capital              expenditures
                                              intensive investments products face a         • Consolidation of "Big MedTech" towards
                                              stronger toll in sales                          conglomerates ("The winner takes it all")
                                                                                            • Growing niche potentials for start-ups,
                                                                                              especially with new technologies (e.g. ICT)

                                           IMMINENT GROWTH OF THE SMTI

1) Harmonization between EU-Directive and Swissmedic leads to faster implementation of new requirements
2) Introduction of EUDAMED leads to growing transparency, both at agencies level and towards the companies
Source: SMTI 2010, SMTI Advisory Board                                                                                                             26
B        TRENDS AND CHALLENGES



Competition for the SMTI intensified severely since 2008 –
Costs and prices are under pressure in a changing market

RANKING OF MAJOR CHALLENGES
[% of answers, 2010]1)                                                                  COMMENTS
                                                                   Ranking              • As of 2009, SMTI companies experienced
                                                                   2008
​1. Increasing price
                                                                                          intensifying competitive pressures
                                                              79   3.
    competition                                                                            – Suppliers with a high proportion of non-
                                                                                             healthcare clients were hit first
2. Increasing cost pres-
                                                              77   4.                      – Manufacturers of non-reimbursed products
   sure from purchasers
                                                                                             were hit by tighter consumer spending
3. Intensified competition                                75       5.                   • Today, the majority of SMTI managers are still
                                                                                          in the "crisis mode" observing operational
4. Increasing pressure to
                                                                                          challenges, e.g. higher price competition, cost
                                                         68        -                      pressure and an intensified competition2)
   reduce production costs

5. Availability of                                                                      FURTHER OBSERVATIONS
                                                         68        1.
   skilled employees
                                                                                        • Current management thinking may fuel
6. Access to specialized                                                                  consolidation to maintain critical mass to
                                                    59             2.
   know-how
                                                                                          obtain
7. Organizational issues                                                                   – A more diverse/innovative product portfolio
                                                  53               6.
   resulting from growth                                                                   – Better access to knowledge pools
n = 232; multiple answers possible
1) Challenge is of "high relevance" or "very high relevance" to SMTI companies 2) These represent a "triple challenge" to the SMTI
Source: SMTI 2010                                                                                                                           27
B        TRENDS AND CHALLENGES



Megatrend – Clinical based evidence requirements force
companies to focus on higher product efficacy and communication

DEVELOPMENTS IN HEALTHCARE MARKET
[% of answers, 2010]1)                                                                   COMMENTS

                                                                                         • Increasing competition and tightening public
Higher requirements for evidence                                                           healthcare budgets force companies to invest
of product efficacy                                                             87
                                                                                           more into proofing product efficacy
                                                                                         • Gaining data from comparative effectiveness
Increasing communication needs with                                                        research and cost-benefit-analyses will gain
with authorities/healthcare institutions                                   73
                                                                                           in importance for many SMTI companies
                                                                                         • The communication efforts with customers and
Growth of purchasing cooperatives
                                                                      61                   authorities need to be intensified in order to
(among customers)
                                                                                           optimally position own products

Higher competition for reim-                                                             FURTHER OBSERVATIONS
bursement entitlement                                               56
                                                                                         • Recent healthcare developments will drive
Higher requirements for product                                                             – Higher costs to register and fulfil increasing
positioning among DRGs                                           51                           compliance requirements
                                                                                            – Substantial price decreases in mature markets
Negative impact of DRG introduction
                                                               45                        • EU wide harmonization of pharma prices is
on average product price
                                                                                           currently discussed; this will also influence the
                                                                                           SMTI
n = 134
1) Companies describing the development "applicable" or "partially applicable"; no 2008 data exist
Source: SMTI 2010                                                                                                                              28
C. Strategic Actions



                       29
C        STRATEGIC ACTIONS



SMTI companies are focusing on profitability to meet current
challenges at the cost of potentially losing their innovative edge

RANKING OF ACTIONS 2010
[% of answers]1)                                                                        COMMENTS
                                                                      Ranking           • In contrast to 2007 CEOs express a strong
                                                                      2008
                                                                                          shift in priorities
1. Improving profitability                                       85   6.
                                                                                        • To support future growth, three rather
                                                                                          operational actions are in focus
2. Optimizing marketing                                         77    3.
                                                                                            – Improving profitability
3. Further development of
                                                                77    7.                    – Optimizing marketing & sales effectiveness
   org. structure and processes
                                                                                            – Enhancing organizational structures and
4. Optimizing distribution                                 67         4.                      processes

5. Strengthening                                                                        FURTHER OBSERVATIONS
                                                        63            1.
   product innovation
                                                                                        • SMTI companies seem to approach business
6. Developing new
   business models
                                                        62            5.                  conservatively before returning to a "growth
                                                                                          mode"
7. Integrating new partners                            59             8.
                                                                                        • An international Life Sciences survey2)
8. Geographic expansion/                                                                  indicated contrary management responses
                                                      56              2.
   internationalization                                                                     – Developing a robust R&D pipeline
                                                                                            – Accelerating geographical expansion
n = 232; multiple answers possible                                                          – Forming alliances with pharma/biotech
1) Strategic actions mentioned as being relevant to SMTI companies 2) Deloitte/The future of the Life Science industries
Source: SMTI 2010                                                                                                                          30
C         STRATEGIC ACTIONS



SMTI companies expect 10-12% growth p.a. in the next two years


EXPECTED GROWTH FOR 2010 AND 2011 [%, p.a.]                       COMMENTS

                                                                  • On average SMTI CEO's are highly confident
                        Ø =10%              Ø =12%
                                                           100%     – 10% growth for 2010
                                                                    – 12% growth for 2011
                                                                  • Some caution should remain; these
                                                                    expectations are related to the economic
Strong growth                                                       situation in May 2010
                           55%                 59%
(> 10%)
                                                                  • Start-ups are particularly enthusiastic
                                                                  • Established companies expect moderate
                                                                    growth as they face stronger price pressures
Moderate growth
(0 to 10%)
                                                                  FURTHER OBSERVATIONS
Neutral (0%)               28%
                                               26%
Moderate decline
(-5 to 0%)                                                        • If such up-turn is achievable, a shift towards
                                6%                                  strategic investments and increased
Strong decline         1%                      13%
(< -5%)                  10%                                        convergence will occur
                                            1%        1%          • Current economic forecast for the Swiss Life
                           2010               2011                  Sciences sector as a whole is 6.5%
                         n = 194            n = 188


Source: SMTI 2010, Credit Suisse, SwissRe                                                                            31
C        STRATEGIC ACTIONS



Engaging in the right strategic actions correlates with above-
average growth expectations

EXPECTED GROWTH RATES 2010 AND 2011
[%, companies having the respective strategic action in focus]                    COMMENTS
                                            16
     Companies focusing
                                                             15                   • Several CEOs focus on a set of strategic
     on strengthening                                                      Ø 12     actions to enhance their growth potential
     regulatory know-      Ø 10
     how/studies, e.g.
                                                                                    – Strengthening regulatory know-
     cost-benefit analyses                                                            how/studies
                                                                         n = 51
                                                                                    – Establishing new production/service
                                                                                      facilities
                                                             17                     – Engaging in new business models
     Companies focusing
     on establishing new
                                            12
                                                                           Ø 12
                                                                                  • If a company focuses e.g. on strengthening
     production/service     Ø 10                                                    of regulatory know-how/studies, they expect
     facilities, e.g. in                                                            a growth rate that is 6% above the average
     emerging markets
                                                                         n = 42     for 20101)


                                                             15                   FURTHER OBSERVATIONS
     Companies focusing
     on engaging in new
                                            10                             Ø 12
     business models,
                            Ø 10                                                  • Companies focusing on new business models
     e.g. new kind of                                                               do not expect an immediate above-average
     services                                                            n = 64     effect on their growth rate
                                           2010             2011
Ø = average growth expectations across all survey participants
1) Data does not support a cumulative growth impact of combining the actions
Source: SMTI 2010                                                                                                                 32
C         STRATEGIC ACTIONS



The majority of SMTI companies face increasing challenges –
Negative impact on growth is expected

EXPECTED GROWTH RATE [%, companies that are
affected by the mentioned challenges]                                            COMMENTS

                                                       Ø 12                      • 50% of SMTI companies face a triple
                                                                                   challenge
                                       10                                           – Increasing price pressure
Ø 10                                                                                – Increasing cost pressure
                    8
                                                                                    – Intensifying competition
                                                                                 • These companies
                                                                                    – Expect a below average growth rate for
                                                                                      2010/2011
                                                                                    – Cannot hope for a fast improvement of their
                                                                                      situation
                                                                                 • All survey participants face at least one of the
                                                                                   three mentioned challenges
                                                                                 FURTHER OBSERVATIONS

                                                                                 • Tighter public healthcare expenditures will
                  2010                2011
                                                                                   – Keep the pressure on prices
     Companies experiencing the "triple challenge"1)                               – Intensify competition among companies
Ø = Average growth expectations across all survey participants                     – Force them to decrease their costs basis
                                                                                 • Within this setting companies tend to invest
2010 n = 128, 2011 n = 221                                                         more in product line extensions/renovations
1) Companies stating that increased pressure on prices, costs and intensifying
   competition were of "high relevance" or "very high relevance" to them
Source: SMTI 2010                                                                                                                     33
D. Winning through Innovation



                                34
D                     WINNING THROUGH INNOVATION



Innovation is the major success factor for the SMTI – Depending
on company maturity, different innovation behaviours apply

THE INNOVATION BEHAVIOUR MODEL                                                     COMMENTS
                                                                                   Currently three different innovation behaviours can be observed:
                                      1 Network                                        1 • "Network innovators" are innovation winners and
                                          innova-
               extended




                                          tors                                             – Responsible for product innovations, accounting for 25%
                              ~25%                                                           of the total SMTI products on the market (20% by start-
                                                     2 Renovators                            ups and micro/small companies; 5% by mature, larger
Network type




                                                                                             firms)
                                                                                           – Are considered to be the innovation engine of the SMTI
                                                    ~25%                                   – Strengthen the SMTI long-term value growth
                                                                                       2 • "Renovators"
                                                                                           – Contribute 25% to the total of SMTI products
                                                                       ~50%
                                                                                           – Adopt a fast renovator strategy for early line extensions
               restricted




                                                                  3 Commodity          3 • "Commodity exploiters/bundlers"
                                                                     exploiters/           – 50% of total SMTI products, that were neither innovated
                                                                     bundlers                nor renovated during the last three years
                            explorative                            exploitative            – Adopt a niche/market expansion strategy per product
                                            Innovation type

   1• Use extended networks of adjacent industries,explorative way, leading
                                                    institutions and               FURTHER OBSERVATIONS
      academia to develop radical innovations in an
                to product innovation
                                                                                   •     Larger companies tend to acquire innovation as they are
   2• Focus on the innovation network within their value chain (e.g. suppliers,
      traders) to exploit the current portfolio with product renovation, i.e.            cash-rich to balance their lack of own product innovations
                incremental innovation to expand the product life cycles
                                                                                   •     Smaller and start-up companies are averse to out-licensing
   3• Focus only on exploiting the current product portfolio                             and desire to exploit their product innovations themselves

Source: SMTI 2010, Kyburz                                                                                                                                35
D         WINNING THROUGH INNOVATION



The SMTI shows a balanced product portfolio maturity –
Especially smaller companies drive product innovation

AGE OF PRODUCT PORTFOLIO BY COMPANY SIZE1, 2)
[in %, 2010]                                                                      COMMENTS

Years
                                                                                  • In general, the maturity of the product
                                                                                    portfolio is well balanced – but the larger the
                                                                           100%
                                                                                    company, the more mature the portfolio
+10       20%
                           26%               27%                                  • 25% of the (weighted) SMTI product portfolio
                                                              33%                   is younger than three years
                                                                                  • 81% of the product portfolio of larger
5-10      21%                                                                       companies is older than three years
                           27%                                                    FURTHER OBSERVATIONS
                                             33%              20%

3-5       25%                                                                      • Lower priority of product innovation
                                                                                     combined with cost constraining measures
                           20%
                                                              25%                    is likely to
                                             24%                                     – Lead to fewer novelties
0-3       34%                                                                        – Prompt more renovation activities
                           27%                                                     • Close attention should be paid to the
                                                              22%
                                             16%
                                                                                     maturing product portfolio (see strategic
                                                                                     actions) in order not to fall into an
         Micro             Small           Medium            Large                   innovation gap, as average product
                                                                                     development time is around three years
n = 124
1) Only manufacturers and suppliers 2) In proportion of their product portfolio
Source: SMTI 2010                                                                                                                     36
D           WINNING THROUGH INNOVATION



Relative R&D expenditure is highest for small companies –
Manufacturers spend more on innovation than suppliers

                                                                BENCHMARKS
R&D EXPENDITURES [% of                     turnover]1,2)        [in % of turnover, 2009]4)          COMMENTS

BY COMPANY TYPE                                                                                     • R&D expenditures remained
                 12                        12                                                         stable or even increased since
                               10                               Biotech                 22            2007, but were increasingly
      5                                                                                               shifted to incremental innovation
                                                                                                    • Manufacturers drive SMTI
                                                                                                      innovation; their share of R&D
                                                                Pharma             16
          2007                      2009                                                              spending is higher than for
                                                      n = 90
                                                                                                      suppliers
                                                                                                    • The less turnover a SMTI
                                                                Medical
BY TURNOVER                                                                                           company has, the higher the
                                                                technology        11
[in CHF and % of turnover 2009]3)                               industry                              relative spend on R&D
          14
                                                                                                    FURTHER OBSERVATIONS
     11                   10
                                                9      Ø 10.6   Electronics
                      7                7                                      5                     • Compared with adjacent
                                                                industry
                                                                                                      industries, the SMTI spends
                                                                                                      less on R&D than the biotech
                                                                                                      and pharma industry, but
      < 5m            5-10m           11-50m          n = 90    Machine                               significantly more than the
                                                                              4
                                                                industry                              mechanical engineering and
    Suppliers     Manufacturers                                                                       electronics industry
1) Only manufacturers and suppliers 2) R&D expenditure was not weighted to turnover
3) Companies with more than CHF 50m turnover were omitted due to a limited sample size 4) Based on a sample of selected companies
Source: SMTI 2010                                                                                                                         37
D          WINNING THROUGH INNOVATION



Shortening of the innovation cycle is of significant relevance,
especially to medium and large sized companies

SIGNIFICANCE OF A SHORTENED INNOVATION CYCLE [2010, in %]1)
BY COMPANY TYPE                                           BY COMPANY SIZE

Manu-
                         45           25        30        Micro          36             26         38
facturers


Suppliers                     62           17    21       Small               60              16        24


     No or low significance                               Medium                   80                   16   4
     High significance
     Very high significance
                                                          Large                    78                   22   0
n = 129



• The majority of companies feel the market and           • Micro companies seem to be flexible enough to adapt
  competitive pressures to shorten innovation               to shortened innovation life cycles. Their dependency
  cycles in order to launch new or improved products        on often only one or two products makes it a critical
  more rapidly                                              task to stay ahead of competitors
• It seems that manufacturers are partly passing on       • The larger a company is, the less flexible it seems to
  this pressure, evaluating different suppliers for the     speed-up the innovation cycle, mainly because of
  most innovative and cost effective solution               internal processes and compliance requirements
1) Only manufacturers and suppliers
Source: SMTI 2010                                                                                                    38
D          WINNING THROUGH INNOVATION



Launches during the last three years were difficult – On average
new products achieved less than 30% of companies turnover

REVENUE SHARE OF PRODUCTS THAT WERE LAUNCHED
SINCE 20071) [in % of each company class, 2010]                                   COMMENTS

                                                    29                            • Product launches in the last three years
Very small                         16                                               were also affected by the global economic
(0%-10%)                      13                                                    setbacks
                                   16
                                                                                  • A majority of companies stated that new
                                                     31                             products contribute only to a minor part
Small                                                     37                        (less than 30%) to the current turnover
(10%-30%)                                                      42
                                                                    45            • For micro companies there seems to be a
                                                                                    clear split:
                    3
Medium                                        25                                    – Either they are older companies with a
(30%-50%)                                      26                                      mature "cash-cow" product portfolio
                                   16                                               – Or they are start-ups with a successful
                                        20
                                                                                       product launch just on the brink of
High                                  18                                               growing rapidly
(50%-70%)                     13                                                  • The other companies capture less returns
                                             23                                     from new product launches
                                      17                                 Micro
Very high           4
(>70%)                  6                                                Small
              0                                                          Medium
                                                                         Large
n = 128
1) Only manufacturers and suppliers
Source: SMTI 2010                                                                                                               39
D          WINNING THROUGH INNOVATION



Companies with a young product portfolio show above-average
growth expectations

EXPECTED GROWTH RATES OF COMPANIES ACCORDING
TO PRODUCT PORTFOLIO MATURITY1) [%]                                                       COMMENTS

                                                                                          • Companies with a young product portfolio
                                                       17
                                                                                            have significantly higher growth expectations
                            16                                                            • Companies with a more mature product
                                                                                            portfolio may face – especially if combined
                                                                                            with decreased R&D rates – an innovation
                                                                  Ø 12
                                                                                            gap that harms future growth rates
                                                                                          • In order to increase growth rates again, these
Ø 10                                        9                                               companies need to take into account an
                 7                                                                          average "idea to launch" time of approx. three
                                                                                            years
                                                                                          FURTHER OBSERVATIONS

                                                                                          • The SMTI is an innovation-centred
                                                                                            industry based on network innovation
                     2010                       2011                                          – Launching new products is an essential
                                                                                                growth factor
       Older portfolio (companies with less than 15% of the product portfolio
       younger than three years), n = 42                                                      – High priority on profitability2) drives bottom-
       Younger portfolio (companies with more than 15% of the product portfolio
                                                                                                line improvements, but does not lead to
       younger than three years), n = 56                                                        higher growth rates
1) Only manufacturers and suppliers 2) 85% of survey participants stated improving profitability is a key strategic action
Source: SMTI 2010                                                                                                                                 40
D          WINNING THROUGH INNOVATION



Companies with a high focus on innovation show above-average
growth expectations

EXPECTED GROWTH RATES AND INNOVATION FOCUS1)
[%]                                                                    COMMENTS

                                                                       • Compared to 2008, strategic priority moved
                                                                         away from strengthening product innovation
                            15                                           to profitability improvement measures
                                                      14
                                                                       • Additionally, relative R&D expenditures have
                                                                         – on average – declined
                                                                Ø 12
                                                                       • Both of these two findings lead to assume a
Ø 10                                       9                             lower focus on innovation
                 8
                                                                       • However, firms that still focus on innovation
                                                                         expect significantly higher growth rates
                                                                       • They outperform expected average growth by
                                                                         6% and 3% for 2010 and 2011 respectively,
                                                                         assigning them a leading role in the further
                                                                         development of the SMTI

                     2010                      2011
                                                                       FURTHER OBSERVATIONS
       Low focus on innovation (low R&D ratio and strengthening of
       product innovation not a priority), n = 33
                                                                       • Listen to/involve patient groups in prototyping
       High focus on innovation (high R&D ratio and strengthening of     reviews to enable product generation jumps
       product innovation a priority), n = 18

1) Only manufacturers and suppliers
Source: SMTI 2010                                                                                                          41
D          WINNING THROUGH INNOVATION



R&D contribution to growth expectations –
Increased R&D expenditure

GROWTH EXPECTATIONS BY R&D EXPENDITURES
[% of turnover]                                                        COMMENTS

Growth              R&D expenditures 2009               R&D            • The focus of many companies on profitability
expectation                                             expenditures
2011                                                    2007
                                                                         improvement measures lead to a decrease of
                                                                         average R&D spend to 10.6%1) from 15% in
                                                        0%
                                                                         2007
Neutral               1
(0% p.a.)                                                              • However, a few exceptions exist: suppliers
                    n.a.                                5%               and manufacturers must invest more in order
                                                                         to achieve moderate growth
                                          8             2%             • Companies that hardly invest in R&D do not
Moderate growth
(0-10% p.a.)
                                                                         expect a positive growth rate, strengthening
                                              10        6%               the assumption that R&D is a key driver for
                                                                         SMTI growth
                                      7                 10%            FURTHER OBSERVATIONS
Strong growth
(> 10% p.a.)
                                                   16   15%            • Suppliers needed to invest heavily into R&D
                                                                         to meet shorter innovation cycle time
     Suppliers' expenditures on R&D
                                                                       • They may find themselves in a R&D trap due
     Manufacturers' expenditures on R&D
                                                                         to a high dependency on MedTech
2010 n = 61, 2008 n = 154                                                manufacturers
1) R&D expenditure was not weighted to turnover
Source: SMTI 2010                                                                                                       42
D        WINNING THROUGH INNOVATION



The Innovation Promotion Agency CTI – From Science to Market


                               The CTI is the Confederations Innovation Promotion Agency

                               As such its main three areas of activities are the following:
                                      • Market-oriented R&D projects, in which companies and universities work together
                                        to develop products and services
                                      • The creation and expansion of scientifically-based companies
                                      • Knowledge and technology transfer through platforms and networks

 KEY                    • In 2009 CTI had an absolute record year by processing a total of 717 R&D funding
 FIGURES                     applications
                        • 25 Entrepreneurs received the CTI Start-up Label in 2009
                        • The total of generated venture capital by the CTI-coached Start-ups was CHF 170m last year
                        • Start-ups with the CTI Start-up Label have an above-average success rate of 85%
                        • 2800 students and graduates participated in the venturelab courses in 2009
                        • Fifteen regional and thematic networks help SME‟s and universities to better share
                             knowledge and efficiently convert their ideas into products and services


Source: SMTI 2010, CTI/KTI                                                                                                43
E. Collaboration and Bundling



                                44
E        COLLABORATION AND BUNDLING



SMTI companies focus on collaborations between manufacturers
and suppliers – Strengthening incremental innovation

SHARE OF COMPANIES WITH COLLABORATIONS
[% of answers, by inter-industry collaboration type, 2010]          COMMENTS

                                                                    • The majority of SMTI companies closely
Manufacturers/                                                 88     collaborate with other manufacturers and
suppliers                                                 82          suppliers, positioning themselves often as
                                                                      "Renovators" working on improvements of
                                                43                    existing products
Universities
                                                     59
                                                                    • Already second are collaborations with
Technology/IT service                13                               universities; there SMTI companies often act
providers                                  28                         as "Network innovators", working on
                                                                      product innovations
                                     12
Support organizations
                                          24                        • On average manufacturers show a higher
                                                                      degree of collaboration – this is mainly due to
Private research                 9
institutes                                24                          – Technology leadership in projects with
                                                                        several collaborating parties
Strategy                         9                                    – Higher value chain integration
consultants                  4                                      • Not very widespread are collaborations with
                                                                      service providers
     Suppliers
     Manufacturers                                                  • Roughly less than a quarter of SMTI
                                                                      companies have respective collaborations
n = 122, multiple answers possible
Source: SMTI 2010                                                                                                       45
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Swiss medical technology industry 2010 report

  • 1. The Swiss Medical Technology Industry 2010 Report – "MedTech at the Crossroads" 1
  • 2. On the mind of the SMTI CEO community "The MedTech business of non-reimbursed "The MedTech pioneer era is products has started to reach a plateau in over, the industry is now mature traditional markets. The business is now cyclical and competition is global." and growth is not endless." "Our business model will change – We need to grow from a simple box-mover to a full "IP protection and proprietary solution provider." systems have become essential to secure market shares." “Pace of innovation and changes in health care system are faster than a decade ago.” "The crisis has demanded to set "Market access management is key for priorities and to constantly remain growth – start-ups should engage in out- focused on optimizing these licensing deals to Big MedTech." priorities." Source: SMTI 2010, Advisory Board 2
  • 3. SMTI 2010 – At the crossroads to adapt current business models In recent years, this report helped to provide better insights on the importance of the Swiss Medical Devices Industry (SMTI). We have monitored this industry closely since 2005, have seen it mature and are now in a position to derive first lessons from a vast data set. Thus, we are now able to analyse trends that may shape SMTIs mid- to long-term future. This report intends to provide a general outlook on the industry. However, it is highly heterogeneous and therefore our conclusions may vary based on a company's product portfolio and economic situation. As already identified in Spring 2009, mainly manufacturers of non-reimbursed products and suppliers with a high proportion of non- healthcare clients were strongly exposed to the downturn. As external pressures grew, other players were exposed to the effects of the economic crisis. High price pressure in export healthcare markets, adverse currency effects of the Euro and US-Dollar against the Swiss Franc, reduced investments by the Swiss cantons for hospital equipment, or a declining demand in non-reimbursed products are a few examples. Paired with increased pressure by payers and governments in major markets towards cost effectiveness and treatment outcome, the Life Sciences industry is now faced with a paradigm shift in its future business model. Today, the "crisis resistance" due to cash-rich reimbursement systems may be history as healthcare markets are changing rapidly. Therefore, cost consciousness continues to influence many management actions. The management of SMTI companies increasingly find themselves at the crossroads, refocusing their R&D spending. Today, manufacturers either drive full cutting-edge network innovations or they focus on incremental innovation. The first group are "network innovators". Their strengths reside in a cross-industries (e.g. MedTech/pharmaceutical/biotech/IT) as well as cross-academia (e.g. local and international universities and hospitals) collaboration network allowing radical innovation and obtaining market premium prices for the novel niche products in major markets. The second group are "renovators". They focus less on innovation, but rather drive bundling (device/technology, software, single-use materials, local maintenance/service, and/or training) or incremental product innovations (e.g. line-extensions). This secures their mature product portfolio in mature markets. Additionally, renovators increasingly shift their attention to emerging economies to extend the life- cycle of their products, catering to a growing and quality conscious middle class. Peter Biedermann, Dr. Patrick Dümmler, Beatus Hofrichter Publisher and authors of the SMTI 2010 Report August 2010 3
  • 4. Contents Page Management Summary 5 A. State of the MedTech Industry 9 B. Trends and Challenges 24 C. Strategic Actions 29 D. Winning through Innovation 34 E. Collaboration and Bundling 44 F. International Opportunities and Threats 51 G. International Positioning 59 H. Outlook 65 Appendix 1: Additional Data 69 Abbreviations 70 Appendix 2: SMTI Knowledge Base 88 4
  • 6. MANAGEMENT SUMMARY Management summary (1/2) This report was written in the summer of 2010 involving 252 companies in the field of medical devices in Switzerland. It makes use of the database of the Medical Cluster, Advisory Board input, additional expert interviews and desk research • The SMTI consists of 720 - 740 suppliers and manufacturers, as well as 630 - 660 traders and distributors and service providers • The manufacturing base is highly diversified across all product categories, many companies are among international thought and market leaders • The SMTI value chain is well established and is facilitated by a vast network of academia, specialized service providers, suppliers and institutions, forming a national MedTech cluster • The Swiss MedTech cluster is highly attractive for leading international MedTech companies, not only for headquarter functions but also for development and manufacturing • Total gross revenue is CHF 22.9bn, own value added is CHF 11.1bn, representing 2.0% of the Swiss GDP CHF • The turnover per employee is about CHF 460,000; manufacturers realize 81% of their turnover with medical devices • The expected SMTI growth rate is 10% and 12% for 2010 and 2011 respectively; this is significantly above expected growth rates for the Life Sciences industry (6.5%) and Swiss GDP (1.9%) • Above 75% of SMTI CEOs are still focusing on crisis management activities • However, engaging in the right strategic actions will drive above-average growth, i.e. strengthening R&D know-how, establishing new production/service facilities, and engaging in new business models • Today around 49,000 employees work for the SMTI, this equals 1.4% of the Swiss workforce • 75% of SMTI companies have less than 50 employees, building a strong innovation basis • The total number of employees during the last two years increased by 10% • In the next two years SMTI companies expect further growth in headcount; the authors anticipate approximately 55,000 employees by 2013 • Especially micro and small companies hire predominantly in Switzerland while large companies also expand their workforce abroad Source: SMTI 2010 6
  • 7. MANAGEMENT SUMMARY Management summary (2/2) • 10.6% of the turnover is invested into research and development (R&D)1) • Approximately 25% of the overall SMTI product portfolio was developed in the last three years • Shortening of the innovation cycle is of significant relevance especially to medium and large sized companies • Focusing on R&D and fostering a young product portfolio leads to an additional 6% of above-average growth expectation • However, today companies need to spend more on R&D to generate strong growth rates • More than 50% of SMTI companies are engaged in network innovation across industry and academia functions • Collaboration along the value chain is excessive between suppliers and manufacturers, especially large companies tend to renovate and bundle their current product portfolio • Many companies focus on collaboration for applied research, quality control and to a lesser extent, on post-launch activities • The average rate of export is 63%; manufacturers and suppliers export 78% and 53% of products, respectively • For more than 70% of SMTI companies, registration and introduction of new products are perceived as less difficult in Europe than in other markets • Compared to 2008 higher growth in 2010 is expected from Switzerland, the EU and the BRIC countries • International opportunities will continue to drive SMTI growth; export-oriented manufacturers expect a growth rate of 18% • The SMTI is well positioned for the future • Two megatrends influence the industry – the triple challenge of price and cost pressures and intensifying competition – the clinical evidence requirements for cost-benefit of treatment • The focus on profitability to meet current challenges is at the cost of potentially losing the competitive innovative edge • Larger companies may review their current business models, the R&D strategy as well as offerings to improve future growth potential • The authors anticipate increased global consolidation activities impacting SMTI companies as well 1) The average R&D expenditure is not weighted to turnover, thus is may be skewed upwards by the large number of small companies in our sample Source: SMTI 2010 7
  • 8. MANAGEMENT SUMMARY The house of MedTech by 2012 – Our working hypotheses1) SMTI PRODUCT VIEW MARKET VIEW COLLABORATION & INTERNATIONALI- INNOVATION POSITIONING BUNDLING SATION • Above-average growth • Price pressure leads • Growth in international • Smaller companies lack expectations due to an companies to push markets correlates with export strength due to innovative, young product bundled offerings in order innovation shortage of know-how and portfolio or best in class to maintain their turnover commercial co-operations • Success in emerging products level and market share economies is highly • Sound, long-term patient • Higher cost pressure leads • Companies that focus on correlated to strong outcome data will ensure to a shift from radical bundling tend to reduce regulatory affairs positive sales impact in innovation towards their R&D expenditures capabilities mature markets incremental innovation in • A bundling strategy • Healthcare system • Improved market established/mature favours collaboration within changes and arising orientation becomes a segments the same value chain for opportunities propel export priority due to an increase • Companies that focus on incremental innovation levels of suppliers and of competitiveness network innovation can manufactures amongst providers and • Demand of buyers will expect above-average pressures from payers drive “solutions”, forcing growth companies to change their business models 1) Are addressed in chapters D-G Source: SMTI 2010 8
  • 9. A. State of the MedTech Industry 9
  • 10. A STATE OF THE MEDTECH INDUSTRY Switzerland is among the global hotspots for MedTech INTERNATIONAL MEDTECH FOCUS [% of respective total]1) COMMENTS 1,1 Switzerland • Switzerland possesses an active medical 0,3 Germany technology industry that can rely on a strong Employment 0,2 UK network of related companies and institutions EU that create an ideal breeding ground for the 0,2 USA industry (cluster) 0,2 • Compared to other countries the relative 1,9 domestic share of the SMTI is significantly higher 0,7 • Remarkable – and in line with several other GDP 0,6 Swiss industries – is the high relative share of 0,5 exports reflecting the international strength of 0,5 Swiss MedTech products 5,0 1,4 Exports 1,7 n.a. 2,8 1) Data from 2008 or, where not available, from 2007 Source: SMTI 2010, Destatis, Eucomed, Eurostat, UK National Statistics 10
  • 11. A STATE OF THE MEDTECH INDUSTRY Switzerland is highly attractive for international companies – Top 10 companies employ around ¼ of SMTI employees1) 1 Year sales R&D Sales/ Head- Employees in Sales R&D/sales No. Company Sub-section of market growth expenses employee quarters Switzerland [CHFm] [%] 3) [%] [CHFm] [CHFk] 1 Synthes Orthopedics USA 2'900 3'523 6 175 5 329 Roche 2 In-vitro diagnostics CH 1'750 10'055 4 987 10 387 Diagnostics J&J 3 2) Orthopedics USA 1'400 24'492 2 1'830 7 556 Medical 4 Zimmer Orthopedics USA 1'150 4'250 -1 213 5 518 5 Sonova Hearing systems CH 1'030 1'500 20 87 6 221 6 Ypsomed Injection systems CH 1'000 254 -8 32 12 212 Active and passive implants, 7 Medtronic USA 900 15'151 8 1'406 9 399 vascular diseases and diabetes 8 B. Braun Orthopedics, hospital aids DE 840 5'992 6 207 3 152 9 Straumann Dental implants CH 800 736 5 39 5 339 10 Stryker Orthopedics USA 600 6'977 0 349 5 375 ∑ 12'020 Ø 4 Ø 7 1) Approximately, manufacturers only, figures for reporting year 2009/10, exchange rates: USD/CHF: 1.03, EUR/CHF: 1.49 on 31.12.2009 1) J&J Medical: Numbers are the total for orthopaedics, surgery, cardiology and diagnostics Source: SMTI 2010, Annual reports, Companies press offices, Factiva, Oanda 11
  • 12. A STATE OF THE MEDTECH INDUSTRY Switzerland is a strong medical technology cluster – Several organizations and institutions support the industry Greater Zurich COMMENTS Basel Area Area • Switzerland has a strong medical technology network, supported by several organisations and institutions Berne Capital • Regional support organisations are e.g. Area – Basel Area – Berne Capital Area – Bio Alps – Biopolo Ticino BioAlps – Greater Zurich Area • National institutions are e.g. – CTI/KTI – FASMED – Medical Cluster – Medtech Switzerland – Osec Biopolo – SIX Swiss Exchange Ticino – Swiss Life Science Marketing Alliance Location of suppliers Location of manufacturers Source: SMTI 2010, relief swisstopo 12
  • 13. A STATE OF THE MEDTECH INDUSTRY The SMTI has a strong home market – Investments in high-class medical infrastructure meets patients demands SWISS HEALTHCARE EXPENDITURES [CHF bn per year] COMMENTS • Continuous investments in up-to-date medical infrastructure leads to rising healthcare expenditures – during the last ten years by CAGR 63,3 nearly 50% 4,0% 61,0 58,1 • The CAGR of healthcare expenditures of 55,2 52,8 4.0% is significantly higher than the 51,0 52,0 47,4 49,3 respective GDP growth of 1.1% 45,6 42,8 FURTHER OBSERVATIONS • Today Switzerland has the third highest GDP share of healthcare expenditures (10.6%) after the USA (16% in 2007) and France (11% in 2007) • To constrain rising national healthcare costs, policies will increasingly focus on cost- benefit comparison of treatments • The SMTI companies will have to monitor upcoming policy changes and be ready to 2000 2001 2002 2003 2004 2005 2006 2007 2008E1) 2009E 2010F1) adapt the business model accordingly 1) E = Expected 2) F = Forecast Source: SMTI 2010, BAG, BfS, Healthcare Monitor 2009, KOF 13
  • 14. A STATE OF THE MEDTECH INDUSTRY The established SMTI value chain is highly cross-institutional1) Basic Applied Suppliers Manufacturers International Customers and research research sales stakeholders Basic research for Developing Highly specialized Manufacturing Worldwide sales of Worldwide radical product and prototyping and internationally industry with broad Swiss medical customers and innovations supported by sought-after range of high-tech technology products stakeholders, e.g. • National • CTI/KTI MedTech suppliers in key products, e.g. by traders and • Patients, esp. in universities and • R&D programs technologies, e.g. • Active- and non- distributors out-of-pocket international e.g. ManuFuture- • Information- and active implants supported by markets knowledge CH Communication • Anaesthetic and • Company • Individual networks • Universities and technology (ICT) respiratory affiliates hospitals, hospital • Five university universities of • New materials, devices • Export Platform chains and hospitals in applied sciences, surface • Dental Medtech purchasing Geneva, incl. technology technology • Electro- Switzerland associations Lausanne, Berne, transfer • Robotics and mechanical • Osec together • Healthcare Basel and Zurich organizations nanotechnology equipment with its Swiss professionals • National research • Specialized • Micro-technology • Hospital hardware business hubs • Diagnostic organizations like companies, e.g. • Metal-, plastics-, • Diagnostics abroad laboratories PSI and EMPA for contract and ceramic • Ophthalmology • Swiss pavilions at • Research • National research engineering processing • Reusable and international laboratories programs • International • Automation and single-use exhibitions/fairs • Key Opinion • European knowledge assembly instruments • International Leaders (KOLs) framework networks • Tool and mould • Technical aids for industry • Reg. authorities programs manufacturers disabled associations • Certification support 1) Service providers, depending on their specialization are part of any of the value chain building blocks Source: SMTI 2010 14
  • 15. A STATE OF THE MEDTECH INDUSTRY SMTI manufacturers are evenly segmented across the different industry categories MANUFACTURERS BY CATEGORY [%, 2010] COMMENTS • The manufacturing base of SMTI is segmented into 16 categories, ranging from a Hospital share of 16% for hospital hardware to 1% for Others1) hardware biological products 16% 19% • SMTI manufacturers exhibit a broad technological knowledge base and Reusable Dental diversification instruments technology – Bulk risks are reduced 5% 14% – Benefits interdisciplinary R&D Radiotherapy 5% collaborations devices – Strengthens network innovation Disposable 6% items 11% Inactive FURTHER OBSERVATIONS Technical aids 7% implants for disabled 8% 8% • There exists a high degree of collaboration In-vitro Electro- amongst suppliers, manufacturers, and diagnostics mechanical academia to – broaden the offering scope n = 320 – obtain key skills and know-how 1) Others include, in descending order: lab equipment, ophthalmology, patient aids, anaesthetic and respiratory technology, active implants and biological products Source: SMTI 2010 15
  • 16. A STATE OF THE MEDTECH INDUSTRY Suppliers and service providers support the MedTech industry with essential know-how within augmentable value chain processes SUPPLIERS BY CATEGORY [%, 2010] SERVICE PROVIDERS BY CATEGORY [%, 2010] Components, Others1) Financing HR systems Auxiliary material, 11% 5% Analytics IT green ware 1% 5% 25% 18% 30% Electronics 7% Surface 8% treatment 19% 20% Machines, auto- 11% Metal Engineering, mated devices processing planning, 26% 13% Management design Plastics consulting processing n = 410 n = 410 • The SMTI supplier base is broadly specialized, • IT and management consulting are the most although components, systems and material prominent categories among service providers processing contribute to more than 55% • Support SMTI with growth capabilities 1) Others (in descending order) include: medical packaging, measuring, ceramics and sterilization Source: SMTI 2010 16
  • 17. A STATE OF THE MEDTECH INDUSTRY Manufacturers and traders/distributors are highly focused on medical devices sales SHARE OF TURNOVER [%, 2009] COMMENTS • Many SMTI companies are not exclusively 100 100 100 100 focused on medical technology – the share 15 of sales to other industries and consumers is 19 Turnover from 39% 47 other products 56 • Traders and distributors as well as suppliers and services Ø 61 show an increased focus on MedTech compared to 2007 81 85 • Suppliers are more diversified in their Turnover from 53 44 customer portfolio medical devices FURTHER OBSERVATIONS Suppliers Manu- Traders Service facturers and providers • A high focus on medical devices is needed in distributors order to meet the industry specific traits Turnover and sales requirements from medical • On the whole, SMTI remains unchanged 39% 84% 80% 59% Ø 65 devices in since 2007, indicating that consolidation has 2007 not been triggered yet by the financial crisis • For many suppliers from other industries, 2009 n = 212 2007 n = 122 MedTech became highly attractive Source: SMTI 2010 17
  • 18. A STATE OF THE MEDTECH INDUSTRY Manufacturers form the backbone of the industry – Average turnover per company is CHF 68 million AVERAGE COMPANY TURNOVER1) [CHF m, 2009] COMMENTS • The SMTI has a manufacturer centric market model 68 • Turnover with medical devices is driven by – Offering/portfolio strategy, i.e. niche vs. big player – Company size – Upfront investments, i.e. machinery, IP – Position within the value chain – Competitive landscape, i.e. number of competitors within/adjacent to the industry 22 FURTHER OBSERVATIONS • Future sustainable turnover is mainly 11 determined by the following influencers 3 – Overcome critical mass – Achieve higher expertise to maintain Suppliers Manu- Traders and Service compliance facturers distributors providers – Anticipate power shift towards payers – Meet changes in sourcing strategies of n = 171 payers 1) Only with medical devices or components for medical devices Source: SMTI 2010 18
  • 19. A STATE OF THE MEDTECH INDUSTRY Manufacturers and suppliers provide the highest employment, accounting for 92% of the total SMTI workforce DISTRIBUTION OF EMPLOYEES [%, 2009] COMMENTS • The surveyed companies employ around 27% of the total SMTI sector workforce 56% • Traders, distributors and service providers account for 8% of the surveyed workforce • Across all SMTI firms approximately an average of 59 people are employed 36% – 126 by manufacturers – 55 by suppliers – 25 by traders and distributors – 7 by service providers • However, a significant bandwidth has to be taken into account; of all surveyed companies – 94% employ less than 250 employees 5% – 75% employ less than 50 employees 3% – 42% employ less than 10 employees Suppliers Manu- Traders and Service facturers distributors providers n = 199 Source: SMTI 2010 19
  • 20. A STATE OF THE MEDTECH INDUSTRY Average turnover was influenced by high staff levels – This led to an underperformance of turnover per capita for manufacturers AVERAGE TURNOVER PER EMPLOYEE AVERAGE GROWTH IN NUMBER OF EMPLOYEES [CHF k] [% change vs. previous two years] 2008/2009 Ø = +10% 2006/2007 Ø = +20% 244 11 Suppliers 246 7 530 30 Manufacturers 465 5 Traders and 683 15 distributors 818 12 301 2007 n = 185 18 2007 n = 186 Service providers 287 2009 n = 163 21 2009 n = 164 • Traders/distributors experienced growth in turnover per capita, the others remained stable or declined vs. 2007 • The build-up of employees in 2006/2007 led to an overcapacity in 2008/2009, SMTI companies responded by adapting their recruitment policies • Unlike many other Swiss industries the SMTI continue to hire above market average, but at a slower pace, continuing to provide attractive jobs for skilled employees, especially in the fields of R&D, regulatory affairs and international marketing & sales Source: SMTI 2010 20
  • 21. A STATE OF THE MEDTECH INDUSTRY Putting past SMTI growth expectations into perspective – Adjustments were taken fast and early in the downturn GROWTH EXPECTATIONS FOR 2008 AND 2009 [%] COMMENTS Growth Share of responses • In 2008, SMTI expected an average growth of expectations 100% 6%. 77% of CEOs predicted a positive growth rate1) Strong growth • The "crisis resistance" of the MedTech (> 10%) industry became attractive for non-industry players (mainly suppliers), they were – Trying to enter a profitable market – Broaden sales channels and offerings • As the market turned in Q3 2008 and took its Moderate growth full impact in 2009 on a global scale, SMTI (0 to 10%) companies adjusted their growth expectations – Then, only 54% of companies expected a Neutral (0%) positive growth rate Moderate decline – The number of companies expecting a (-5 to 0%) negative impact on sales doubled Strong decline – Suppliers with a higher non-MedTech (< -5%) product portfolio proportion were hit harder 2008 2009 – Manufacturers of non-reimbursed product n = 280, Ø = 6% n = 21, Ø = 0.1% suffered 1) SMTI 2008 data collected in spring and report released end of August 2008 Source: SMTI 2010 (based on SMTI survey May 2010), CS Economic Research, OECD 21
  • 22. A STATE OF THE MEDTECH INDUSTRY The global economic crisis also hit the MedTech industry – Fears exist regarding severe cuts in public healthcare spending STOCK MARKETS – SELECTED INDICES GLOBAL AND CH MANUFACTURING – PMI INDEX 110 90 100 80 90 70 80 60 70 50 60 40 50 30 40 20 Jul 08 Jan 09 Jul 09 Jan 10 Jul 10 Jul 08 Jan 09 Jul 09 Jan 10 Jul 10 SIX Bio and Medtech Europe-DS Pharm & Bio Swiss PMI Index Global New Order Index SMI MSCI World Global PMI Index Global Price Index DJ Euro Stoxx 50 Compared to the SMI, shares of SIX listed MedTech Since June 2008, the global manufacturing companies declined stronger. It anticipates market production rose steadily for 13 month in a row but fears of e.g. tightening healthcare budgets negatively slowed since the beginning of 2010. The Swiss PMI affecting MedTech companies is currently stable, outperforming other markets Source: SMTI 2010, Bloomberg, Credit Suisse, JP Morgan 22
  • 23. A STATE OF THE MEDTECH INDUSTRY Review of crisis 2008/09 and impact on SMTI – Lessons learned TRADERS & SUPPLIERS MANUFACTURERS SERVICE PROVIDERS DISTRIBUTORS • Right customer and portfolio mix • Focus on relevant R&D projects • Sales force excellence • Investing/acquiring know-how • Innovation leadership fosters a and innovative products • Good product mix with high and teams special, high value product and • Positioning in markets and reimbursement • Proactive positioning to "To strengthen" component portfolio preparing NPIs consistently • High focus on industry segment anticipate revitalization of sector • Networked innovation applying • Acquiring know-how • High service competency • Develop solution offerings unconventional know-how • Continue to recruit, especially • Very good understanding of copying other industry • Closeness to IT industry and to abroad buyer‟s needs and buying successes new materials • Focus on business model culture • Engage SMTI interfaces • Continuous recruitments optimization • Profit from strong CHF (as management • Scouting and M&A • Lean/efficient processes importer) • Strong skill set and high value • Well managed S-curve of core • Strong regulatory capabilities return offerings competencies • Closeness to pharma/biotech • High flexibility to support • Foreign exchange issues with challenges an impact on margins • Depending on single large • Weak or reactive attitudes (e.g. • Mismanagement of currency • "Copy cat" and no sound track customers and reactive market engaging too late in cost cutting) hedges records strategy • Lack of listening to customers • No product portfolio • "Me-too" approach • Over-capacities in production • Mismanaged generation jump "To avoid" differentiation • Large capital investments made within product portfolio • High inventories based on boom forecasts • Non value based pricing • Decline in demand for • Tight EBIT margins strategy commodities • High diversity of client portfolio • High OPEX/Sales ratio • Lack of service offerings (non-LS/non-core business) • Me-too product sales decline • Lack of international clients with non proprietary goods • High inventories and poor • Late shift in crisis management liquidity management • High COGS & inventory Source: SMTI 2010 23
  • 24. B. Trends and challenges 24
  • 25. B TRENDS AND CHALLENGES Taking the pulse of the SMTI – Top buzzwords Source: SMTI 2010, www.wordle.net 25
  • 26. B TRENDS AND CHALLENGES Imminent growth of SMTI companies is shaped by major trends in three categories COMPANY REGULATION1) MARKET • Solutions will meet future offering • Tightening of regulatory • Patient centric models arise due to demand requirements2) in mature markets on – external/remote patient monitoring • Networked innovation is rising quality, testing, safety and off-label – ICT and improved RFID technology (led by micro/start-up firms) usage • Bundling of purchasing power among hospitals, • Broader know-how is needed to • Growing/tightening regulatory clinics, and specialists; they will meet regulatory requirements requirements in Asian markets – drive margin erosion (e.g. market access, conformity, • Introduction of DRGs will – favour broader offerings patent infringements, out- – increase pressure on pricing – seek solution providers licensing) – delay or decrease investments into • Convergence (MedTech & pharma/biotech) • Improved clinical trial design radical innovation – drives innovation opportunities needed to demonstrate cost- • Demonstrating comparative – exposes the MedTech industry to additional benefit effectiveness drives the need to compliance/regulatory measures • Institutional patient registries generate relevant treatment outcome • Export shift to emerging markets due to growing arising in multiple core markets, data middle-class with rising public and private health driving segmentation • Non-reimbursed/cosmetic/or capital expenditures intensive investments products face a • Consolidation of "Big MedTech" towards stronger toll in sales conglomerates ("The winner takes it all") • Growing niche potentials for start-ups, especially with new technologies (e.g. ICT) IMMINENT GROWTH OF THE SMTI 1) Harmonization between EU-Directive and Swissmedic leads to faster implementation of new requirements 2) Introduction of EUDAMED leads to growing transparency, both at agencies level and towards the companies Source: SMTI 2010, SMTI Advisory Board 26
  • 27. B TRENDS AND CHALLENGES Competition for the SMTI intensified severely since 2008 – Costs and prices are under pressure in a changing market RANKING OF MAJOR CHALLENGES [% of answers, 2010]1) COMMENTS Ranking • As of 2009, SMTI companies experienced 2008 ​1. Increasing price intensifying competitive pressures 79 3. competition – Suppliers with a high proportion of non- healthcare clients were hit first 2. Increasing cost pres- 77 4. – Manufacturers of non-reimbursed products sure from purchasers were hit by tighter consumer spending 3. Intensified competition 75 5. • Today, the majority of SMTI managers are still in the "crisis mode" observing operational 4. Increasing pressure to challenges, e.g. higher price competition, cost 68 - pressure and an intensified competition2) reduce production costs 5. Availability of FURTHER OBSERVATIONS 68 1. skilled employees • Current management thinking may fuel 6. Access to specialized consolidation to maintain critical mass to 59 2. know-how obtain 7. Organizational issues – A more diverse/innovative product portfolio 53 6. resulting from growth – Better access to knowledge pools n = 232; multiple answers possible 1) Challenge is of "high relevance" or "very high relevance" to SMTI companies 2) These represent a "triple challenge" to the SMTI Source: SMTI 2010 27
  • 28. B TRENDS AND CHALLENGES Megatrend – Clinical based evidence requirements force companies to focus on higher product efficacy and communication DEVELOPMENTS IN HEALTHCARE MARKET [% of answers, 2010]1) COMMENTS • Increasing competition and tightening public Higher requirements for evidence healthcare budgets force companies to invest of product efficacy 87 more into proofing product efficacy • Gaining data from comparative effectiveness Increasing communication needs with research and cost-benefit-analyses will gain with authorities/healthcare institutions 73 in importance for many SMTI companies • The communication efforts with customers and Growth of purchasing cooperatives 61 authorities need to be intensified in order to (among customers) optimally position own products Higher competition for reim- FURTHER OBSERVATIONS bursement entitlement 56 • Recent healthcare developments will drive Higher requirements for product – Higher costs to register and fulfil increasing positioning among DRGs 51 compliance requirements – Substantial price decreases in mature markets Negative impact of DRG introduction 45 • EU wide harmonization of pharma prices is on average product price currently discussed; this will also influence the SMTI n = 134 1) Companies describing the development "applicable" or "partially applicable"; no 2008 data exist Source: SMTI 2010 28
  • 30. C STRATEGIC ACTIONS SMTI companies are focusing on profitability to meet current challenges at the cost of potentially losing their innovative edge RANKING OF ACTIONS 2010 [% of answers]1) COMMENTS Ranking • In contrast to 2007 CEOs express a strong 2008 shift in priorities 1. Improving profitability 85 6. • To support future growth, three rather operational actions are in focus 2. Optimizing marketing 77 3. – Improving profitability 3. Further development of 77 7. – Optimizing marketing & sales effectiveness org. structure and processes – Enhancing organizational structures and 4. Optimizing distribution 67 4. processes 5. Strengthening FURTHER OBSERVATIONS 63 1. product innovation • SMTI companies seem to approach business 6. Developing new business models 62 5. conservatively before returning to a "growth mode" 7. Integrating new partners 59 8. • An international Life Sciences survey2) 8. Geographic expansion/ indicated contrary management responses 56 2. internationalization – Developing a robust R&D pipeline – Accelerating geographical expansion n = 232; multiple answers possible – Forming alliances with pharma/biotech 1) Strategic actions mentioned as being relevant to SMTI companies 2) Deloitte/The future of the Life Science industries Source: SMTI 2010 30
  • 31. C STRATEGIC ACTIONS SMTI companies expect 10-12% growth p.a. in the next two years EXPECTED GROWTH FOR 2010 AND 2011 [%, p.a.] COMMENTS • On average SMTI CEO's are highly confident Ø =10% Ø =12% 100% – 10% growth for 2010 – 12% growth for 2011 • Some caution should remain; these expectations are related to the economic Strong growth situation in May 2010 55% 59% (> 10%) • Start-ups are particularly enthusiastic • Established companies expect moderate growth as they face stronger price pressures Moderate growth (0 to 10%) FURTHER OBSERVATIONS Neutral (0%) 28% 26% Moderate decline (-5 to 0%) • If such up-turn is achievable, a shift towards 6% strategic investments and increased Strong decline 1% 13% (< -5%) 10% convergence will occur 1% 1% • Current economic forecast for the Swiss Life 2010 2011 Sciences sector as a whole is 6.5% n = 194 n = 188 Source: SMTI 2010, Credit Suisse, SwissRe 31
  • 32. C STRATEGIC ACTIONS Engaging in the right strategic actions correlates with above- average growth expectations EXPECTED GROWTH RATES 2010 AND 2011 [%, companies having the respective strategic action in focus] COMMENTS 16 Companies focusing 15 • Several CEOs focus on a set of strategic on strengthening Ø 12 actions to enhance their growth potential regulatory know- Ø 10 how/studies, e.g. – Strengthening regulatory know- cost-benefit analyses how/studies n = 51 – Establishing new production/service facilities 17 – Engaging in new business models Companies focusing on establishing new 12 Ø 12 • If a company focuses e.g. on strengthening production/service Ø 10 of regulatory know-how/studies, they expect facilities, e.g. in a growth rate that is 6% above the average emerging markets n = 42 for 20101) 15 FURTHER OBSERVATIONS Companies focusing on engaging in new 10 Ø 12 business models, Ø 10 • Companies focusing on new business models e.g. new kind of do not expect an immediate above-average services n = 64 effect on their growth rate 2010 2011 Ø = average growth expectations across all survey participants 1) Data does not support a cumulative growth impact of combining the actions Source: SMTI 2010 32
  • 33. C STRATEGIC ACTIONS The majority of SMTI companies face increasing challenges – Negative impact on growth is expected EXPECTED GROWTH RATE [%, companies that are affected by the mentioned challenges] COMMENTS Ø 12 • 50% of SMTI companies face a triple challenge 10 – Increasing price pressure Ø 10 – Increasing cost pressure 8 – Intensifying competition • These companies – Expect a below average growth rate for 2010/2011 – Cannot hope for a fast improvement of their situation • All survey participants face at least one of the three mentioned challenges FURTHER OBSERVATIONS • Tighter public healthcare expenditures will 2010 2011 – Keep the pressure on prices Companies experiencing the "triple challenge"1) – Intensify competition among companies Ø = Average growth expectations across all survey participants – Force them to decrease their costs basis • Within this setting companies tend to invest 2010 n = 128, 2011 n = 221 more in product line extensions/renovations 1) Companies stating that increased pressure on prices, costs and intensifying competition were of "high relevance" or "very high relevance" to them Source: SMTI 2010 33
  • 34. D. Winning through Innovation 34
  • 35. D WINNING THROUGH INNOVATION Innovation is the major success factor for the SMTI – Depending on company maturity, different innovation behaviours apply THE INNOVATION BEHAVIOUR MODEL COMMENTS Currently three different innovation behaviours can be observed: 1 Network 1 • "Network innovators" are innovation winners and innova- extended tors – Responsible for product innovations, accounting for 25% ~25% of the total SMTI products on the market (20% by start- 2 Renovators ups and micro/small companies; 5% by mature, larger Network type firms) – Are considered to be the innovation engine of the SMTI ~25% – Strengthen the SMTI long-term value growth 2 • "Renovators" – Contribute 25% to the total of SMTI products ~50% – Adopt a fast renovator strategy for early line extensions restricted 3 Commodity 3 • "Commodity exploiters/bundlers" exploiters/ – 50% of total SMTI products, that were neither innovated bundlers nor renovated during the last three years explorative exploitative – Adopt a niche/market expansion strategy per product Innovation type 1• Use extended networks of adjacent industries,explorative way, leading institutions and FURTHER OBSERVATIONS academia to develop radical innovations in an to product innovation • Larger companies tend to acquire innovation as they are 2• Focus on the innovation network within their value chain (e.g. suppliers, traders) to exploit the current portfolio with product renovation, i.e. cash-rich to balance their lack of own product innovations incremental innovation to expand the product life cycles • Smaller and start-up companies are averse to out-licensing 3• Focus only on exploiting the current product portfolio and desire to exploit their product innovations themselves Source: SMTI 2010, Kyburz 35
  • 36. D WINNING THROUGH INNOVATION The SMTI shows a balanced product portfolio maturity – Especially smaller companies drive product innovation AGE OF PRODUCT PORTFOLIO BY COMPANY SIZE1, 2) [in %, 2010] COMMENTS Years • In general, the maturity of the product portfolio is well balanced – but the larger the 100% company, the more mature the portfolio +10 20% 26% 27% • 25% of the (weighted) SMTI product portfolio 33% is younger than three years • 81% of the product portfolio of larger 5-10 21% companies is older than three years 27% FURTHER OBSERVATIONS 33% 20% 3-5 25% • Lower priority of product innovation combined with cost constraining measures 20% 25% is likely to 24% – Lead to fewer novelties 0-3 34% – Prompt more renovation activities 27% • Close attention should be paid to the 22% 16% maturing product portfolio (see strategic actions) in order not to fall into an Micro Small Medium Large innovation gap, as average product development time is around three years n = 124 1) Only manufacturers and suppliers 2) In proportion of their product portfolio Source: SMTI 2010 36
  • 37. D WINNING THROUGH INNOVATION Relative R&D expenditure is highest for small companies – Manufacturers spend more on innovation than suppliers BENCHMARKS R&D EXPENDITURES [% of turnover]1,2) [in % of turnover, 2009]4) COMMENTS BY COMPANY TYPE • R&D expenditures remained 12 12 stable or even increased since 10 Biotech 22 2007, but were increasingly 5 shifted to incremental innovation • Manufacturers drive SMTI innovation; their share of R&D Pharma 16 2007 2009 spending is higher than for n = 90 suppliers • The less turnover a SMTI Medical BY TURNOVER company has, the higher the technology 11 [in CHF and % of turnover 2009]3) industry relative spend on R&D 14 FURTHER OBSERVATIONS 11 10 9 Ø 10.6 Electronics 7 7 5 • Compared with adjacent industry industries, the SMTI spends less on R&D than the biotech and pharma industry, but < 5m 5-10m 11-50m n = 90 Machine significantly more than the 4 industry mechanical engineering and Suppliers Manufacturers electronics industry 1) Only manufacturers and suppliers 2) R&D expenditure was not weighted to turnover 3) Companies with more than CHF 50m turnover were omitted due to a limited sample size 4) Based on a sample of selected companies Source: SMTI 2010 37
  • 38. D WINNING THROUGH INNOVATION Shortening of the innovation cycle is of significant relevance, especially to medium and large sized companies SIGNIFICANCE OF A SHORTENED INNOVATION CYCLE [2010, in %]1) BY COMPANY TYPE BY COMPANY SIZE Manu- 45 25 30 Micro 36 26 38 facturers Suppliers 62 17 21 Small 60 16 24 No or low significance Medium 80 16 4 High significance Very high significance Large 78 22 0 n = 129 • The majority of companies feel the market and • Micro companies seem to be flexible enough to adapt competitive pressures to shorten innovation to shortened innovation life cycles. Their dependency cycles in order to launch new or improved products on often only one or two products makes it a critical more rapidly task to stay ahead of competitors • It seems that manufacturers are partly passing on • The larger a company is, the less flexible it seems to this pressure, evaluating different suppliers for the speed-up the innovation cycle, mainly because of most innovative and cost effective solution internal processes and compliance requirements 1) Only manufacturers and suppliers Source: SMTI 2010 38
  • 39. D WINNING THROUGH INNOVATION Launches during the last three years were difficult – On average new products achieved less than 30% of companies turnover REVENUE SHARE OF PRODUCTS THAT WERE LAUNCHED SINCE 20071) [in % of each company class, 2010] COMMENTS 29 • Product launches in the last three years Very small 16 were also affected by the global economic (0%-10%) 13 setbacks 16 • A majority of companies stated that new 31 products contribute only to a minor part Small 37 (less than 30%) to the current turnover (10%-30%) 42 45 • For micro companies there seems to be a clear split: 3 Medium 25 – Either they are older companies with a (30%-50%) 26 mature "cash-cow" product portfolio 16 – Or they are start-ups with a successful 20 product launch just on the brink of High 18 growing rapidly (50%-70%) 13 • The other companies capture less returns 23 from new product launches 17 Micro Very high 4 (>70%) 6 Small 0 Medium Large n = 128 1) Only manufacturers and suppliers Source: SMTI 2010 39
  • 40. D WINNING THROUGH INNOVATION Companies with a young product portfolio show above-average growth expectations EXPECTED GROWTH RATES OF COMPANIES ACCORDING TO PRODUCT PORTFOLIO MATURITY1) [%] COMMENTS • Companies with a young product portfolio 17 have significantly higher growth expectations 16 • Companies with a more mature product portfolio may face – especially if combined with decreased R&D rates – an innovation Ø 12 gap that harms future growth rates • In order to increase growth rates again, these Ø 10 9 companies need to take into account an 7 average "idea to launch" time of approx. three years FURTHER OBSERVATIONS • The SMTI is an innovation-centred industry based on network innovation 2010 2011 – Launching new products is an essential growth factor Older portfolio (companies with less than 15% of the product portfolio younger than three years), n = 42 – High priority on profitability2) drives bottom- Younger portfolio (companies with more than 15% of the product portfolio line improvements, but does not lead to younger than three years), n = 56 higher growth rates 1) Only manufacturers and suppliers 2) 85% of survey participants stated improving profitability is a key strategic action Source: SMTI 2010 40
  • 41. D WINNING THROUGH INNOVATION Companies with a high focus on innovation show above-average growth expectations EXPECTED GROWTH RATES AND INNOVATION FOCUS1) [%] COMMENTS • Compared to 2008, strategic priority moved away from strengthening product innovation 15 to profitability improvement measures 14 • Additionally, relative R&D expenditures have – on average – declined Ø 12 • Both of these two findings lead to assume a Ø 10 9 lower focus on innovation 8 • However, firms that still focus on innovation expect significantly higher growth rates • They outperform expected average growth by 6% and 3% for 2010 and 2011 respectively, assigning them a leading role in the further development of the SMTI 2010 2011 FURTHER OBSERVATIONS Low focus on innovation (low R&D ratio and strengthening of product innovation not a priority), n = 33 • Listen to/involve patient groups in prototyping High focus on innovation (high R&D ratio and strengthening of reviews to enable product generation jumps product innovation a priority), n = 18 1) Only manufacturers and suppliers Source: SMTI 2010 41
  • 42. D WINNING THROUGH INNOVATION R&D contribution to growth expectations – Increased R&D expenditure GROWTH EXPECTATIONS BY R&D EXPENDITURES [% of turnover] COMMENTS Growth R&D expenditures 2009 R&D • The focus of many companies on profitability expectation expenditures 2011 2007 improvement measures lead to a decrease of average R&D spend to 10.6%1) from 15% in 0% 2007 Neutral 1 (0% p.a.) • However, a few exceptions exist: suppliers n.a. 5% and manufacturers must invest more in order to achieve moderate growth 8 2% • Companies that hardly invest in R&D do not Moderate growth (0-10% p.a.) expect a positive growth rate, strengthening 10 6% the assumption that R&D is a key driver for SMTI growth 7 10% FURTHER OBSERVATIONS Strong growth (> 10% p.a.) 16 15% • Suppliers needed to invest heavily into R&D to meet shorter innovation cycle time Suppliers' expenditures on R&D • They may find themselves in a R&D trap due Manufacturers' expenditures on R&D to a high dependency on MedTech 2010 n = 61, 2008 n = 154 manufacturers 1) R&D expenditure was not weighted to turnover Source: SMTI 2010 42
  • 43. D WINNING THROUGH INNOVATION The Innovation Promotion Agency CTI – From Science to Market The CTI is the Confederations Innovation Promotion Agency As such its main three areas of activities are the following: • Market-oriented R&D projects, in which companies and universities work together to develop products and services • The creation and expansion of scientifically-based companies • Knowledge and technology transfer through platforms and networks KEY • In 2009 CTI had an absolute record year by processing a total of 717 R&D funding FIGURES applications • 25 Entrepreneurs received the CTI Start-up Label in 2009 • The total of generated venture capital by the CTI-coached Start-ups was CHF 170m last year • Start-ups with the CTI Start-up Label have an above-average success rate of 85% • 2800 students and graduates participated in the venturelab courses in 2009 • Fifteen regional and thematic networks help SME‟s and universities to better share knowledge and efficiently convert their ideas into products and services Source: SMTI 2010, CTI/KTI 43
  • 44. E. Collaboration and Bundling 44
  • 45. E COLLABORATION AND BUNDLING SMTI companies focus on collaborations between manufacturers and suppliers – Strengthening incremental innovation SHARE OF COMPANIES WITH COLLABORATIONS [% of answers, by inter-industry collaboration type, 2010] COMMENTS • The majority of SMTI companies closely Manufacturers/ 88 collaborate with other manufacturers and suppliers 82 suppliers, positioning themselves often as "Renovators" working on improvements of 43 existing products Universities 59 • Already second are collaborations with Technology/IT service 13 universities; there SMTI companies often act providers 28 as "Network innovators", working on product innovations 12 Support organizations 24 • On average manufacturers show a higher degree of collaboration – this is mainly due to Private research 9 institutes 24 – Technology leadership in projects with several collaborating parties Strategy 9 – Higher value chain integration consultants 4 • Not very widespread are collaborations with service providers Suppliers Manufacturers • Roughly less than a quarter of SMTI companies have respective collaborations n = 122, multiple answers possible Source: SMTI 2010 45