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Swiss Business Hub (USA) uses primary, secondary and tertiary sources of information to produce a variety
of reports on the American market for small to medium sized Swiss enterprises. For further information
about our services, please contact:
Martin von Walterskirchen
Regional Director, Americas
Switzerland Trade and Investment Promotion
Swiss Business Hub USA
737 N. Michigan Avenue, Suite 2301
Chicago, IL 60611-2615
Telephone: 1-312-915-4501
Fax: 1-312-915-0388
email: mwalterskirchen@osec.ch
www.osec.ch
www.swissbusinesshub.org
While this report is intended to provide an overview of this specific market and its opportunities at the time
of its edition, each individual manufacturer, exporter or supplier may have to conduct their own analysis to
get a better understanding of the possibilities and opportunities available to them. You are encouraged to
explore and develop your opportunities based on research and in-depth analysis.
Readers are advised that the Government of Switzerland does not guarantee the accuracy of any of
the information contained in this report, nor does it necessarily endorse the organizations, associations,
companies and individuals listed herein. Readers of this report should verify the accuracy and reliability of
the information contained herein before making a business decision.
Swiss Business Hub USA 2004 - 2010
Table of Contents
1.
1.1.
1.2.
1.3.
1.4.
EXECUTIVE SUMMARY
OPPORTUNITY
CHALLENGES
MANAGING SUCCESSFULLY IN THE U.S.
SUMMARY
5
5
5
7
11
2.
2.1.
2.2.
2.3.
2.4.
INTRODUCTION
OBJECTIVES
THE SWISSMEDTECH PROJECT
MEDTECH SWITZERLAND
ACKNOWLEDGEMENTS
11
11
11
11
12
3.
3.1.
3.2.
3.3.
3.4.
4.
4.1.
4.2.
17
17
18
5.
5.1.
5.2.
5.3.
5.4.
CARDIOVASCULAR
FACTS AND FIGURES
MAJOR PLAYERS & MARKET SHARE ESTIMATES
EMERGING TECHNOLOGIES
MAJOR COMPETITORS IN THE CARDIOVASCULAR MARKET
23
23
27
29
33
6.
6.1.
6.2.
6.3.
ORTHOPEDICS
FACTS AND FIGURES
MAJOR COMPETITORS IN THE ORTHOPEDIC DEVICES MARKET
EMERGING TECHNOLOGIES
7.
7.1.
7.2.
7.3.
DIAGNOSTICS
FACTS AND FIGURES
MAJOR COMPETITORS
EMERGING TECHNOLOGIES
8.
8.1.
8.2.
8.3.
MEDICAL IMAGING
FACTS AND FIGURES
MAJOR COMPETITORS IN THE U.S. MEDICAL IMAGING MARKET
EMERGING TECHNOLOGIES
9.
9.1.
9.2.
9.3.
REHABILITATION EQUIPMENT
FACTS AND FIGURES
MAJOR COMPETITORS
LEADING CUSTOMER GROUPS
61
61
63
65
10.
10.1.
10.2.
10.3.
DENTAL
FACTS AND FIGURES
MAJOR DENTAL MARKET PARTICIPANTS
MARKET OUTLOOK AND INDUSTRY TRENDS
67
67
71
72
11.
11.1.
11.2.
11.3.
11.4.
11.5.
73
73
74
74
77
77
12.
12.1.
12.2.
12.3.
12.4.
12.5.
12.6.
12.7.
12.8.
12.9.
12.10.
12.11.
12.12.
78
78
78
79
80
83
83
83
85
86
87
88
88
13
13
15
15
15
35
35
44
46
47
47
51
53
56
56
58
60
13.
13.1.
13.2.
13.3.
13.4.
13.5.
13.6.
13.7.
13.8.
14.
14.1.
14.2.
14.3.
14.4.
14.5.
14.6.
14.7.
14.8.
14.9.
14.10.
REIMBURSEMENT
OVERVIEW
RELATIONSHIP OF PATIENTS, PROVIDERS, AND PAYERS
REIMBURSEMENT
ROLE OF INSURANCE
PRIMARY TYPES OF PRIVATE INSURANCE COVERAGE
TRENDS IN THE MANAGED CARE INDUSTRY
MEDICARE AND MEDICAID
COVERAGE DESCRIPTIONS
LINKS TO OTHER SOURCES OF REIMBURSEMENT INFORMATION
REIMBURSEMENT SPECIALIST COMPANIES
15.
15.1.
15.2.
15.3.
15.4.
15.5.
15.6.
15.7.
15.8.
15.9.
15.10.
15.11.
15.12.
15.13.
15.14.
SUBCONTRACTING OPPORTUNITIES
INTRODUCTION
OUTSOURCING TRENDS
CONSIDERATIONS BY OEMS IN CHOOSING AN OUTSOURCE PARTNER
OUTSOURCING ARRANGEMENTS
ACCESS TO U.S. CUSTOMERS
FDA REGISTRATION OF SUBCONTRACTORS
SUBCONTRACTING OPPORTUNITIES IN ORTHOPEDIC DEVICE MANUFACTURING
U.S. MANUFACTURERS OF ORTHOPEDIC DEVICES
IMPORTANT TRADE SHOWS AND PUBLICATIONS FOR ORTHOPEDIC
DEVICE OEMS AND CONTRACT MANUFACTURERS
SUBCONTRACTING OPPORTUNITIES IN CARDIOVASCULAR DEVICE MANUFACTURING
IMPORTANT TRADE SHOWS AND PUBLICATIONS FOR CARDIOVASCULAR DEVICE OEMS
AND CONTRACT MANUFACTURERS
OEM/SUBCONTRACTOR COLLABORATION TRENDS IN
REPROCESSING SINGLE USE DEVICES (SUDS)
SUBCONTRACTING OPPORTUNITIES FOR DENTAL INSTRUMENTS
SUBCONTRACTING OPPORTUNITIES IN MEDICAL ELECTRONICS
100
100
101
101
102
102
102
103
103
16.
16.1.
16.2.
16.3.
16.4.
16.5.
16.6.
108
108
108
109
110
111
111
17.
17.1.
17.2.
17.3.
17.4.
17.5.
17.6.
17.7.
17.8.
18.
18.1.
18.2.
18.3.
18.4.
18.5.
19.
19.1.
19.2.
19.3.
19.4.
19.5.
ANNEXES
ANNEX I: LINKS TO DATA SOURCES
ANNEX II: TRADE ASSOCIATIONS, TRADE SHOWS, AND PUBLICATIONS
ANNEX III - LIST OF MEDICAL ACADEMIES, SOCIETIES, AND OTHER PLATFORMS
ANNEX IV: END NOTES
ANNEX V: THE AUTHORS OF THE STUDY
89
89
89
89
89
90
91
93
93
94
94
94
95
96
96
97
98
98
99
99
103
105
105
106
107
107
113
113
113
114
114
115
116
117
117
117
117
119
119
123
124
125
125
125
130
133
138
1. Executive Summary
Erwin Locher, President, Medtech Switzerland and
Patricia Scheller, Senior Advisor, Medtech Switzerland
1.1. OPPORTUNITY
The United States is the largest consumer of
medical devices in the world with a market valued
at more than $100 billion in 2008, roughly 42%
of the worlds total, compared to 25% for the
entire European Union.1 Medical devices sales are
projected to reach $185.9 billion by the year 2019.2
The U.S. spends a larger percentage of GDP and
more per capita on healthcare than any other
country. In 2009, a record $2.5 trillion (17.3%)
of GDP was spent on healthcare an average of
$8050 per person. National health expenditures are
projected to increase an average of 6.3% annually
through 2019 reaching 19.6% of GDP by 2019.3
Over the past decade, the value of medical devices
imported into the U.S. has steadily increased and
in 2008 imports were valued at $33.6 billion,
or one-third of the entire market. In certain
market segments, such as the surgical and medical
instruments category, double-digit growth has been
achieved for close to a decade.
For the Swiss Medtech industry access to this
large and important market can represent a
signficant opportunity to increase revenues and
gain economies of scale. However, entering the
U.S. market can be fraught with challenges and
a successful entrance into this attractive market
requires careful attention to the specific legal,
regulatory and cultural trends unique to the U.S.
And, as an unprecedented confluence of changes
converges to reshape the U.S. market, knowledge of
the forces that are impacting the market is critically
important to facilitating a smooth market entrance.
The purpose of this report is to help Swiss
companies seeking to enter the U.S. medical
technology market. In addition to highlighting
seven major market segments selected in
consultation with various experts from the
Swiss medical industry, it covers important
topics of common interest to all medical device
manufacturers and marketers.
1.2. CHALLENGES
Several seemingly disparate trends, from changes to
the regulatory and reimbursement process, to a shift
in the way hospital purchasing decisions are made,
to the implementation of comparative effectiveness
research, will ultimately force medtech companies to
be innovative not only in developing their products,
but also in the way they build their business model.
The trends fall into three major categories:
1) economic; 2) public policy; and 3) regulatory.
10
2. Introduction
Martin von Walterskirchen, Swiss Business Hub USA
2.1 OBJECTIVES.
This report has been compiled through a
collaboration of Osec, Medtech Switzerland and
esteemed partners in both the public and private
sectors. On behalf of the all the contributors to
this report I hope that the information contained
herein proves helpful to Swiss companies seeking to
enter the U.S. medical technology market. While
this report was being assembled the U.S. market was
undergoing, and continues to undergo, significant
change. It is essential for companies entering the
U.S. market to become informed of the evolving
market conditions. Both Osec and Medtech
Switzerland stand ready to assist
2.2. THE SWISSMEDTECH PROJECT.
The Swiss Minister for Economy, Federal Councilor
Joseph Deiss, initiated the governments program to
promote innovation and entrepreneurship9 in June
2003. As he said on that occasion, Innovation
is a process that transforms ideas into marketable
goods and services. The SwissMedtech project
constitutes part of this program by assisting
entrepreneurs in their critical time to access the U.S.
market.
The study The U. S. Market for Medical
Technology Opportunities and Challenges for
Swiss Companies represents the point of departure
of the SwissMedtech project. The first edition
11
12
3. U.S. Medical
Technology Industry
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
3.1. FACTS AND FIGURES.
The U.S. healthcare equipment and supplies market is the largest in the world which, according to Datamonitor,
generated approximately $121.3 billion in sales in 2009. The total healthcare equipment and supplies market
is forecast to increase at an annual growth rate of about 3.9 percent (2009-2014) to a market value of $146.7
billion. Figure 1 shows the estimated market value and growth rate from 2009-2014 as well as the market share
of the various equipment and supply categories.
Figure 1 U.S. Healthcare Equipment & Supplies Market Value Forecast, 2009-2014
Year
$ Billion
Growth (%)
Category
Share (%)
2009
121.3
3.0
40.0
2010
127.3
4.9
Other Equipment
19.2
2011
132.4
4.0
Technical Aids
13.5
2012
137.3
3.7
11.3
2013
142.1
3.5
IV Diagnostics Equipment
9.4
2014
146.7
3.3
Ophthalmic Equipment
6.6
3.9
Total
100.0
CAGR 2009-2014
Source: Healthcare Equipment & Supplies in the U.S., Datamonitor, April 2010
Figure 2 provides a more narrow view of the market and focuses on medical devices. Standard & Poors
estimates the U.S. medical device market generated $88.8 billion in sales in 2008. Assuming the same
estimated CAGR of 3.9% from 2008-2014 as show above, the U.S. medical device market will grow to
a market value of $111.7 billion in 2014. The Cardiovascular device market is the largest segment with
a market share of 28% followed by the Orthopedics device segment with 19%. These two segments are
discussed in more detail in subsequent chapters in this report.
Figure 2 The U.S. Medical Device Market by Specialty Area in 2008 ($88.8 Billion)
17% Other
5%
Hearing &
Audiology
7%
Wound Care
Cardiovascular 28%
Orthopedics
19%
12% Ophthalmic
Equipment
12% General Surgery
Source: S&P Industry Survey Healthcare: Products & Supplies, February 4, 2010
U.S. Census Bureau data show there are approximately 5,324 companies that manufacture medical
technology products in the U.S. Over 72% are small companies with less than 20 employees. (These data
refer to companies categorized under specific North American Industrial Classification System (NAICS)
codes for the medical device industry and exclude large companies classified under other primary industries
that also have medical device divisions).
13
3885
3000
2000
1323
799
1000
0
<20
20-99
100+
Figure 4 uses the same NAICS codes as Figure 3 but shows the distribution of companies by the types of
products produced.
Figure 4 Distribution of U.S. Medical Technology Manufacturers by NAICS Code
10% Electromedical
Ophthalmic 10%
14% Dental
In vitro
Diagnostics
4%
Irradiation
3%
Surgical
Appliances &
Supplies 37%
The category, surgical appliances and supplies, includes orthopedic devices, prosthetic appliances, surgical
dressings, crutches, surgical sutures, hospital beds, and operating room tables. The category, surgical and
medical instruments, includes surgical, ophthalmic, and veterinary instruments and apparatus (except
electrotherapeutic, electromedical and irradiation apparatus). Examples of products include syringes,
hypodermic needles, anesthesia apparatus, blood transfusion equipment, catheters, surgical clamps and
medical thermometers. Electrotherapeutic and electromedical devices include magnetic resonance
imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs, and
electromedical endoscopic equipment. Irradiation equipment includes X-ray, beta-ray, gamma-ray and
other ionizing radiation equipment including generators, tubes and lamps; CT/CAT scanners and nuclear
irradiation apparatus.
Figure 5 shows the total value of products shipped in 2007 by the respective medical product NAICS groups.
Figure 5 Total Value of U.S. Medical Product Shipments by NAICS Code ($ Billions)
$31.5 Surgical
Appliances &
Supplies
$4.4 Dental
Surgical &
Medical
Instruments $29.6
Electromedical $22.5
$5.7 Ophthalmic
$10.8 Irradiation
$13.0 InVitro
Diagnostics
14
Medical Devices
Production $ Billions
Consumption $ Billions
93.54
88.52
5.02
Source: USA Medical Device Market Intelligence Report- Espicom Healthcare Intelligence, January 31, 2010
In 2008, the U.S. produced more medical devices domestically than it consumed resulting in a net surplus
of about $5 billion. Figure 6 shows total U.S. production and consumption of medical devices in 2008.
Likewise, the U.S. exported about $5 billion more medical products than it imported. Nevertheless, Figure
7 shows, at a value of $30.46 billion in 2008, the U.S. imported a substantial amount of medical products
from abroad. It should also be pointed out that some of the products destined for U.S. markets are also
made abroad by U.S. owned companies.10
Figure 7 U.S. Exports and Imports of Medical Products in 2008
U.S. Exports
$35.48 billion
U.S. Imports
$30.46 billion
$5.02 billion
Source: USA Medical Device Market Intelligence Report- Espicom Healthcare Intelligence, January 31, 2010
15
16
Figure 8: On the left side, Population aged 65 and above on the right side, Life Expectancy
Year
Million
Year
At Birth
At Age 65
At Age 75
1990
31.1
1990
75.4
+17.2
+10.9
2000
35.1
2000
77.0
+18.0
+11.4
2010
40.2
2001
77.2
+18.1
+11.5
2020
54.6
2002
77.3
+18.2
+11.5
2030
71.5
2003
77.5
+18.4
+11.8
2040
80.0
2004
77.8
+18.7
+11.9
2050
86.7
2005
77.8
+18.7
+12.0
Source US Census Bureau, Population Statistics and National Center for Health Statistics
17
2025
2050
2075
Male
74.8
77.0
79.4
81.3
Female
79.6
81.2
83.2
84.9
Source: CRS Report for Congress: Life Expectancy in the United States, August 16, 2006
7%
Private
Insurance 32%
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group.
18
Where it Went
20% Physician &
Clinical Services
Nursing Home
Care
6%
Prescription
Drugs 10%
13% Other
Program Admin
& Net Cost
7%
Investment
6%
Dental Services
& Other
Professionals
7%
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group.
Where it went:
In looking at where the money went, Hospital
Care consumed the largest share of expenditures
accounting for 31 percent of the healthcare dollar,
and amounting to $759.1 billion in 2009. Physician
and Clinical Services consumed 20 percent of
the expenditures and totaled $505.9 billion.
Prescription Drugs accounted for about 10 percent
or $249.9 billion. Program and Administration
Costs accounted for about 7 percent of total
expenditures and Nursing Home Costs followed at
6 percent. The remaining 26 percent of healthcare
Figure 11 National Health Expenditures ($ Billions + 4-year compound annual growth rate)
Type of Expenditure
2005
2006
2007
2008
2009
Growth
(CAGR
%)
A)
1,890.3
2,016.9
2,135.1
2,234.1
2,330.1
5.4
1)
1,692.6
1,798.8
1,904.3
1,997.2
2,089.9
5.4
a)
Hospital Care
606.5
648.3
686.8
722.1
759.1
5.8
b)
Professional Services
559.4
588.4
619.4
652.2
674.9
4.8
i)
419.6
441.6
462.6
486.5
505.9
4.8
ii)
Dental Services
86.8
91.4
97.3
102.3
102.2
4.2
iii)
53.1
55.4
59.5
63.4
66.8
5.9
c)
96.5
102.1
108.3
113.3
122.6
6.2
d)
48.7
52.6
57.8
62.1
68.3
8.8
e)
112.1
117.0
126.5
132.8
137.0
5.1
f)
269.3
290.4
305.6
314.7
328.0
5.1
i)
Prescription Drugs
201.7
219.8
230.2
237.2
249.9
5.5
ii)
30.4
31.9
34.4
35.1
34.9
3.5
iii)
37.2
38.7
41.1
42.3
43.3
3.9
2)
Govt Administration
26.8
28.3
29.2
29.2
29.8
2.7
3)
114.7
127.2
132.8
134.8
133.2
3.8
4)
56.2
62.6
68.8
72.9
77.2
8.3
B)
Investment
130.7
135.2
148.4
157.2
156.2
4.6
1)
Research
40.3
41.4
41.9
43.2
45.3
3.0
2)
90.4
93.8
106.4
114.0
111.0
5.3
2,021.0
2,152.1
2,283.5
2,391.4
2,486.3
5.3
Total
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
19
Figure 12 Personal Healthcare Expenditures, by Type of Expenditure and Source of Funds, 2009 ($ Billions), Part 1
Total
Hospital
Care
Physician
& Clinical
Services
Dental
Services
Other
Professional
Services
Home
Health
Care
A)
Out-of-pocket
Payments
299.3
24.4
47.9
42.5
17.7
6.0
B)
Health Insurance
1,767.4
669.3
407.3
59.3
43.1
59.7
1)
Private Health
Insurance
801.2
265.9
237.7
50.0
24.7
5.0
2)
Medicare
502.3
220.4
109.4
0.3
13.7
29.8
3)
Medicaid
373.9
136.1
39.9
7.1
4.5
24.3
4)
CHIP
11.1
3.1
2.9
0.8
0.2
0.0
5)
Dept. of Defense
36.5
15.2
11.9
1.0
--
--
6)
Dept. of Veterans
Affairs
42.4
28.6
102.7
0.0
--
0.6
C)
186.1
65.3
50.6
0.5
6.0
2.5
D)
77.2
--
--
--
--
--
2,330.0
734.6
505.8
102.2
66.8
68.2v
Total
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
20
Figure 13 Personal Healthcare Expenditures, by Type of Expenditure and Source of Funds, 2009 ($ Billions), Part 2
Total
Prescription
Drugs
Other NonDurable
Medical
Products
Durable
Medical
Equip.
Nursing
Home Care
Other
Personal
Health Care
A)
Out-of-pocket
Payments
299.3
53.0
40.4
18.6
39.8
8.9
B)
Health Insurance
1,767.4
193.3
2.8
15.8
87.5
76.8
1)
Private Health
Insurance
801.2
108.6
--
4.0
10.5
5.8
2)
Medicare
502.3
54.8
2.8
7.6
28.0
4.6
3)
Medicaid
373.9
20.0
--
4.3
45.0
64.4
4)
CHIP
11.1
1.5
--
0.0
0.0
0.9
5)
Dept. of Defense
36.5
6.0
--
--
--
--
6)
Dept. of Veterans
Affairs
42.4
2.5
--
--
4.0
1.0
C)
186.1
10.0
--
0.5
10.0
36.9
D)
Public Health
Activities
77.2
--
--
--
--
--
Total
2,330.0
256.4
43.2
35.0
127.3
122.5
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
Figure 14 and Figure 15 itemize the type of product or service provided and how it was paid. In 2009,
National Health Consumption Expenditures totaled $2.330 trillion. From this amount we see that
Medicare and Medicaid (Part 1) accounted for $876.2 billion (37.6%) of the total while Private Funds (Part
2) accounted for $1,100.5 trillion (47.2%). Breaking the Private portion down further, we see that $299.3
billion was paid by consumers through out-of-pocket payments while Private Health Insurance companies
paid $801.2 billion. In the area of Durable Medical Products, total private expenditures were $22.6 billion.
However, from that amount, $18.6 billion (82.3%) was paid out-of-pocket by consumers while private
health insurance paid only $4.0 billion (17.7%). In the area of Non-Durable medical products, on the
private side, the full amount of $40.5 billion was paid by the consumer.
Figure 14 National Health Expenditures, by Source of Funds & Type of Expenditure, 2009 ($ Billions), Public (Part 1)
Public
Total
Total
Medicare
Medicaid
A)
2,330.0
876.2
502.3
373.9
1)
2,089.9
817.0
471.3
345.7
a)
Hospital Care
759.1
356.5
220.4
136.1
b)
Professional Services
674.9
175.0
123.4
51.6
i)
505.9
149.3
109.4
39.9
ii)
Dental Services
102.2
7.4
0.3
7.1
iii)
66.8
18.2
13.7
4.5
c)
122.6
69.0
4.6
64.4
d)
68.3
54.1
29.8
24.3
e)
137.0
73.0
28.0
45.0
f)
328.0
89.4
65.1
24.3
i)
Prescription Drugs
249.9
74.8
54.8
20.0
ii)
34.9
11.7
7.4
4.3
iii)
43.3
2.8
2.8
--
2)
Govt Administration
29.8
25.2
7.0
18.2
21
3)
133.2
34.2
24.1
10.1
4)
77.2
--
--
--
B)
Investment
156.2
--
--
--
1)
Research
45.3
--
--
--
2)
110.9
--
--
--
2,486.3
876.2
502.3
373.9
Total
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
Figure 15 National Health Expenditures, by Source of Funds & Type of Expenditure, 2009 ($ Billions), Private (Part 2)
Private
Total
Total
Consumer
Other Public
& Private
Insurance, 3rd
Party Payers, &
Public Health
Activity (not
included in
Total Private
Amount)
Out-of-pocket
Private
Insurance
A)
2,330.0
1,100.5
299.3
801.2
353.3
1)
2,089.9
1,011.5
299.3
712.2
261.5
a)
Hospital Care
759.1
290.3
24.4
265.9
112.3
b)
Professional Services
674.9
420.6
108.2
312.4
79.3
i)
505.9
285.6
47.9
237.7
70.9
ii)
Dental Services
102.2
92.5
42.5
50.0
2.4
iii)
66.8
42.4
17.7
24.7
6.2
c)
122.6
14.7
8.9
5.8
38.9
d)
68.3
11.0
6.0
5.0
3.1
e)
137.0
50.3
39.8
10.5
13.7
f)
328.0
224.5
112.0
112.5
14.1
i)
Prescription Drugs
249.9
161.6
53.0
108.6
13.6
ii)
34.9
22.6
18.6
4.0
0.6
iii)
43.3
40.5
40.5
--
0.0
2)
Govt Administration
29.8
--
--
--
4.7
3)
133.2
89.0
--
89.0
10.0
4)
77.2
--
--
--
--
B)
Investment
156.2
--
--
--
--
1)
Research
45.3
--
--
--
--
2)
110.9
--
--
--
--
2,486.3
1,100.5
299.3
801.2
353.3
Total
Source: Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
22
5. Cardiovascular
Patricia Scheller, Senior Advisor, Medtech Switzerland and
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
5.1.
FACTS AND FIGURES
Coronary heart disease and stroke are the two most
significant areas of cardiovascular disease, and are
the first and third leading causes of death in the
U.S. (Cancer is the second leading cause). Heart
disease and stroke combined accounted for about
one-fourth of all U.S. deaths in 2007. An estimated
813,804 Americans (33.6% of all deaths) died from
all cardiovascular diseases combined in 2007 while
about 82.6 million Americans (more than one-third
of the population) live with the disease. (From that
amount, approximately 40.4 million [49.8%] are
age 60 and older). During 2007, about 6.8 million
inpatient cardiovascular operations and procedures
were performed in the U.S. Cardiovascular disease
includes both acute conditions such as myocardial
Millions of Persons
Cardiovascular Disease
82.6
76.4
16.3
-Myocardial Infarction
7.9
-Angina Pectoris
9.0
5.7
Stroke
7.0
Congenital CV Defects
0.65 - 1.3
Source: American Heart Association. Heart Disease and Stroke Statistics 2011 Update
Coronary heart disease is the leading contributing or underlying cause of death among all types of
cardiovascular disease in the U.S. accounting for 406,351 deaths, or one of every six deaths in 2007. Stroke
is the second major cause of death among all types of cardiovascular disease in the U.S. accounting for
135,952 deaths in 2007. Interestingly, from 1997-2007 death rates from coronary heart disease decreased
26.3% and the actual number of deaths decreased 12.9%. For strokes, the death rate declined by 39.3%
and the actual number of deaths fell 18.8%. Figure 17 gives a pictorial overview of the percentage of
deaths resulting from the various types of cardiovascular disease.
Figure 17 Percentage of Deaths from Cardiovascular Diseases, U.S. 2007 (100% = 813,804)
4%
Disease of
the Arteries
7%
High Blood
Pressure
7%
Heart Failure
Other 14%
Coronary
Heart Disease 51%
17% Stroke
Source: American Heart Association. Heart Disease and Stroke Statistics 2011 Update
23
No. of Procedures
Mean Cost
Cardiac Catheterization
1,059,000
$34,198
618,000
$56,015
560,000
n/a
408,000
(232,000)
$117,094
Pacemakers
358,000
$57,633
ImplantableDefibrillators
111,000
$124,901
Valves
106,000
$164,238
Endarterectomy
91,000
$30,588
2,211
n/a
Source: American Heart Association. Heart Disease and Stroke Statistics 2011 Update
Note: These data do not reflect any procedures performed on an outpatient basis. Many more procedures are being performed on an outpatient basis.
24
Figure 19 shows the estimated direct costs of cardiovascular disease and stroke in the U.S. in 2007. (US$ Billion)
Direct Costs
Heart
Disease*
Stroke
Hypertensive
Disease
Other
Circulatory
Conditions
Total
Cardiovascular
Disease
49.8
17.9
6.2
11.8
85.7
3.9
0.6
0.6
0.2
5.3
13.7
2.5
9.8
5.0
31.0
Home healthcare
6.3
2.9
3.6
1.1
13.9
Prescribed medicines
8.5
1.3
20.4
1.2
31.4
Total Expenditures
82.2
25.2
40.6
19.3
167.4
Source: American Heart Association. Heart Disease and Stroke Statistics 2011 Update
* This category includes coronary heart disease, congestive heart failure, part of hypertensive disease, cardiac dysrhythmias, rheumatic heart disease,
cardiomyopathy, pulmonary heart disease, and other ill-defined heart diseases.
Costs due to hypertensive disease are limited to hypertension without heart disease.
25
2010
2011
2012
2013
2014
2010-2014
CAGR (%)
6,478
6,527
6,586
6,657
6,737
1.0
Pacemakers
2,304
2,217
2,135
2,057
1,984
-3.8
Dual Chamber
1,246
1,169
1,096
1,028
964
-6.6
Single Chamber
1,058
1,048
1,039
1,029
1,019
-0.9
2,652
2,726
2,803
2,882
2,963
2.8
1,848
1,914
1,982
2,053
2,126
3.6
804
812
820
828
837
1.0
1,521
1,583
1,649
1,718
1,791
4.2
1,465
1,532
1,602
1,674
1,750
4.5
55
51
47
44
40
-8.3
Interventional Cardiology
4,106
4,234
4,370
4,515
4,668
3.3
PTCA Balloons
566
611
659
712
769
8.0
121
127
133
140
148
5.2
440
479
521
567
617
8.8
0.0
Coronary Stents
2,280
2,301
2,323
2,345
2,369
1.0
362
352
341
331
321
-3.1
1,918
1,949
1,982
2,014
2,047
1.6
Cardiac Catheters
532
563
595
629
666
5.8
Guiding catheter
206
219
232
246
261
6.1
Angiography catheter
326
344
363
383
404
5.5
Coronary Guidewire
348
359
369
380
391
3.0
159
165
171
178
185
3.9
221
236
253
270
289
6.9
170
182
195
208
222
6.9
26
51
54
58
62
67
7.1
2,123
2,237
2,361
2,496
2,644
5.6
Peripheral VascularStents
634
653
673
694
715
3.1
99
111
124
138
154
11.7
62
65
69
73
77
5.6
PTA Balloon
674
698
721
746
771
3.4
312
357
408
467
534
14.4
179
191
203
216
229
6.4
Peripheral Guidewire
162
162
163
163
163
0.2
437
468
502
539
578
7.2
184
196
209
222
237
6.5
16
17
18
19
20
5.7
236
255
275
297
321
8.0
453
468
486
505
527
3.9
359
382
406
432
459
6.3
94
87
80
74
68
-8.4
Cardiovascular Surgery
676
655
636
619
603
-2.9
0.0
93
98
104
109
115
5.5
47
44
42
39
37
-6.2
Perfusion Disposables
532
510
488
468
448
-4.4
386
402
418
436
454
4.1
147
159
173
187
203
8.4
Electrophysiology
686
768
858
961
1,077
11.9
External Defibrillator
766
812
861
913
969
6.1
16,257
16,730
17,252
17,827
18,459
3.2
Recent Developments
Major drug and medical device manufacturers such
as Abbott Laboratories, Johnson & Johnson, and
others are seeking to acquire companies that are
focused on developing heart valve technology in an
effort to catch up with Edwards Lifesciences Corp.
(ELC), the global leader in heart valve technology.
ELCs new transcatheter heart valve, called Sapien,
in a clinical study cut death rates in patients too
sick to have open-heart surgery, and is now being
tested to see if it works as well in less frail patients
to reduce the recovery time from months to weeks.
If the results from the ongoing clinical trial are as
positive as the initial result, industry analysts believe
the market for the revolutionary new aortic valves
may reach $2.1 billion by 2015.25
27
Figure 21 Pacemaker Market Shares and Sales Volume in the U.S. in 2009
Market Share
$ Millions
Medtronic
50%
930
28%
519
Boston Scientific
18%
346
Others
4%
68
Likewise, in the Implantable Cardioverter Defibrillator (ICD) market, the same three companies dominate
the market. In 2009, Medtronic continued to be the worldwide market leader with a market share of about
46 percent followed by Boston Scientific with 29 percent and St. Jude Medical with 25 percent. From 20012005, the worldwide ICD market grew at an estimated 28 percent per year for the 5-year period. However,
growth declined significantly in the second half of 2005 and was flat in 2006 as a result of a number of
factors including adverse publicity relating to product recalls by Guidant and Medtronic. (In the U.S.,
the ICD market declined 6.3% in 2006). In 2007, the market stabilized and began to show slow growth.
Helping to support this growth trend was action by the Centers for Medicare and Medicaid (CMS) which
expanded the indications for ICD use that will be reimbursed by Medicare. In 2008, the ICD market was
estimated at $4.1 billion in the U.S. and $6.2 billion worldwide. The worldwide ICD market experienced
price declines of 1-2% in both 2008 and 2009 and is expected to weaken further in 2010. Nevertheless,
the worldwide ICD market is forecast to grow to $6.6 billion in 2010 and 7.0 billion in 2012 which is an
increase of about 3% per year.
Figure 22 Leading Implantable Cardiac Defibrillator (ICD) Firms in the U.S. in 2009
Market Share
US Sales ($ Millions)
Medtronic
46%
1,836
Boston Scientific
29%
1,248
25%
998
Source: 2009 annual reports from the leading 3 companies + Standard & Poors Industry Surveys Healthcare Products & Supplies, February 4, 2010
28
11
30
20
35
18
30
17
Endeavor (Medtronic)
16
15
Source: Thomson Gale Market Share Reporter: 2010 cites Med-tech Analyzer, Credit Suisse Equity Research, September 11, 2008, p.44
29
Intravascular Ultrasound
Imaging X-ray Combination
BS announced on May 24, 2010 collaborations
with Philips Healthcare and Siemens Medical
Solutions to enable the use of its iLab Ultrasound
Imaging System with the Philips Allura Xper
and the Siemens AXIOM Artis and Artis
zee interventional X-ray systems. Intravascular
ultrasound (IVUS) technology is designed to
provide physicians a 360-degree view inside the
heart and coronary vessels to assist with diagnosis
and to generate a more accurate image of the
diseased vessels than is possible with angiography
alone. The iLab System is designed to be installed
directly into a cardiac catheterization laboratory
or radiology suite alongside these X-ray systems,
enabling physicians to more readily incorporate
IVUS technology into their procedures. BS
previously announced a similar collaboration with
GE Healthcare and its Innova System.30
Peripheral Vascular Disease
BS is developing a drug-coated balloon to treat
peripheral vascular disease that would be inflated
for about a minute and allow a drug to be
transferred from the balloon to the appropriate
site within the vessel. The drug would remain
active for about three months to treat the blockage,
and there would potentially be no need for a
stent. Physicians treating this disease currently
lack adequate solutions for addressing peripheral
vascular challenges. The Company plans a first-inman study of a drug-coated balloon in 2011.
Vascular Closure
Bioresorbable Vascular Scaffold Technology
BS is working to develop a vascular closure device
that will shorten and simplify the closure process,
and will be easier to use than existing products.
Currently, many less-invasive procedures, such as
30
31
32
33
34
6. Orthopedics
Erwin Locher, President, Medtech Switzerland and
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
6.1. FACTS AND FIGURES
GlobalData estimates the global orthopedic devices
market was valued at $38.9 billion 2010. U.S.
sales of orthopedic devices totaled about $19.7
billion, or about 51 percent of worldwide sales.
Orthopedic devices are used for the treatment
of musculoskeletal diseases or injuries. The
major product groups are artificial joints, spinal
implants, devices for fracture repair (mainly intramedullary nails, plates, and screws), orthobiologic
formulations, and devices or equipment for
35
6.3% Biomet
6.7% S&N
9.4% Synthes
Other
28%
Stryker 14.5%
J&J DePuy 14.2%
10.3% Medtronic
10.6% Zimmer
36
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR %)
Joint Reconstruction
7,700
8,409
9,189
10,049
10,996
12,041
9.3
Spinal Surgery
4,168
4,441
4,732
5,045
5,381
5,741
6.6
Orthobiologics
2,731
3,121
3,574
4,102
4,720
5,442
14.8
Trauma Fixation
2,213
2,338
2,469
2,609
2,758
2,916
5.7
Arthroscopy
1,183
1,249
1,321
1,397
1,478
1,565
5.8
700
738
777
820
864
911
5.4
Orthopedic Prosthetics
430
451
473
497
521
547
4.9
316
337
361
386
414
443
7.0
Orthopedic Accessories
296
303
310
317
323
330
2.2
Orthopedic Reamers
15
16
16
17
18
18
3.7
Total
19,753
21,402
23,222
25,238
27,472
29,954
8.7
The top four segments comprise 84 percent of the of the U.S. orthopedic device market and will be
discussed in more detail in subsequent sections of this chapter. Reconstructive joint implants will remain
the largest segment in the field as an ever increasing elderly population will demand more procedures.
Figure 26 U.S. Orthopedic Device Market Segmentation, by Product Area, in 2010
21.1% Spinal
39%
Joint
Reconstruction
Orthobiolgics 12.8%
Trauma 11.2%
Arthroscopy
6%
Braces &
Supports
3.5%
Prosthetics
2.2%
Cranio
Maxillofacial
1.6%
0.1% Reamers
1.5% Accessories
Joint Reconstruction
The U.S. orthopedic reconstructive joint replacement
market had an estimated value of $7.7 billion in
2010. Knee replacement is the largest segment with
an estimated market value of just under $4.2 billion
followed by Hip replacement valued at $2.95 billion
and Shoulder replacement valued at $301 million.
Stryker Corp., one of the leading companies in
the joint reconstruction market, estimates that the
knee replacement market will grow at a rate of
about 2 percent over the next several years and
the hip replacement market will grow at a rate of
only one percent.42 The slower growth in the hip
and knee market segments is due to a relatively
high U.S. unemployment rate and related loss of
health insurance, an increase in cost sharing by
health insurance policies, and the elective nature
of these types of procedures. These factors will
increase competition among manufacturers and
lead to increased price pressure on the products they
offer.43 Hospitals accounted for 92 percent of joint
reconstruction sales in 2010. The balance went to
clinics (5%) and long term care facilities (3%).
The U.S. Market for Medical Devices.
37
Figure 27 U.S. Orthopedic Reconstructive Joint Replacement Market, by Value (US$ millions)
Market Segment
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR)
Ankle Replacement
28
30
32
35
37
40
7.4
Digits Replacement
23
24
25
27
28
29
4.7
Elbow Replacement
42
46
50
55
60
66
9.5
Hip Replacement
2,950
3,154
3,373
3,609
3,863
4,136
7.0
Knee Replacement
4,186
4,639
5,142
5,701
6,322
7,012
10.9
Shoulder Replacement
301
334
372
415
464
520
11.6
Wrist Replacement
24
25
27
28
30
31
6.6
Hip Resurfacing
146
157
168
180
193
207
7.2
Total
7,700
8,409
9,189
10,049
10,996
12,041
9.4
On the other hand, GlobalData presents a more optimistic outlook for growth in the various market
segments. The company forecasts that both the knee replacement and shoulder replacement segments
will grow at low double digit rates and the hip replacement segment will grow at a CAGR of 7.0 percent
through 2015. The forecast methodology of GlobalData is based on a combination of registry data that
is lagging behind actual data and company information. While the data for 2010 might be revised, the
underlying demographics remain intact. For hip resurfacing we estimate that the market will be negatively
affected by the recall of DePuys ASR hip system.
Figure 28 U.S. Orthopedic Reconstructive Joint Replacement Market Share 2010
38%
Hips
Shoulders
4%
Other
4%
Knees
54%
replacements is osteoarthritis, or degenerative joint disease, the wear and tear of joints. Currently, around
21 million Americans have osteoarthritis and this number is expected to increase to 30 million by 2020
as the average age of onset of this disease is 45. As the U.S. population ages, the number of cases of
osteoarthritis will increase. In 2008, surgeons performed approximately 581,000 total knee replacements,
285,000 total hip replacements, 309,000 partial hip replacements, 21,000 total shoulder replacements, and
19,000 partial shoulder replacements, and the number is expected to increase dramatically. By 2030, the
number of knee replacements is expected to increase more than six times to 3.5 million, and the number of
hip replacements will double to 573,000.44
The average (mean) cost of a knee replacement procedure is $50,000 and the average cost of a hip
replacement is $43,000.45 The average age of a knee or hip replacement patient is about 67.46 The average life
span of a hip replacement is 10-15 years whereas a knee re-placement can last up to 30 years.
38
Smith &
Nephew
12%
Biomet
Zimmer
22%
J&J/DePuy 20.8%
20.5% Stryker
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR)
Spinal Fusion
3,753
3,973
4,206
4,453
4,715
4,993
5.9
3,069
3,242
3,425
3,619
3,823
4,039
5.6
Interbody Cages
684
731
781
835
892
954
6.9
Spinal Non-fusion
416
458
526
592
665
748
12.5
Dynamic Stabilization
325
365
410
461
518
581
12.3
90
102
116
131
148
167
13.2
Total
4,169
4,441
4,732
5,045
5,381
5,741
6.6
39
In the spinal fusion market segment, the pedicle screw systems sub-segment accounted for just over $3.0
billion of market value in 2010 followed by interbody cages at $684 million. Fusion procedures make up
90% of the spinal devices market. In the spinal non-fusion market segment, the sub-segment dynamic
stabilization accounted for $325 million and artificial disc replacement $90 million. The spinal non-fusion
segment is expected to experience double digit annual growth from 2010 to 2015. Figure 30 shows the
value and projected growth rates for each of the sub-segments. Figure 31 shows the market share of each
of the sub-segments in 2010. Hospitals accounted for 94 percent of spinal surgery device sales in 2010.
The balance went to clinics (5%) and acute care centers (1%).
Figure 31 Estimated U.S. Spinal Product Market Share by Sub-segment in 2010
74%
Pedide Screw
Systems
Interbody Cages
16%
Artificial Disc
Replacement
2%
Dynamic
Stabilazation
8%
The spinal devices market is expected to grow at a rate of about 6.6% per year over the next several years.
Contrary to joint replacement, back problems primarily afflict a younger patient population. This might
be one of the reasons why the economic downturn has mostly affected the spinal implant market. Patients
age 65+ are covered by Medicare but only account for about a quarter of this market.
Figure 32 Leading Competitors in the U.S. Spinal Implants Market in 2009
Other
8%
Medtronic
35%
J&J/DePuy
17%
8.9% NuVasive
9%
Stryker
11.2% Synthes
40
Orthobiologics
Figure 33 U.S. Orthobiologics Market, by Value (US$ millions)
Market Segment
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR)
1,350
1,595
1,889
2,240
2,661
3,167
18.6
Viscosupplementation
725
814
913
1,024
1,148
1,288
12.1
DBM
275
300
327
357
390
425
9.1
215
232
251
271
293
317
8.1
Bone Allografts
165
179
194
210
227
246
8.3
Total
2,731
3,121
3,574
4,102
4,720
5,442
14.8
The Orthobiologics segment of the U.S orthopedic devices market had an estimated market value of $2.7
billion in 2010. It is the fastest growing segment of the orthopedics market and is forecast to grow at a
rate of 14.8 percent per year to $5.4 billion in 2015. The largest segment of the orthobiologics market is
bone graft substitutes. The segment had a value of $1.35 billion in 2010 and comprised 49 percent of the
market. It is forecast to grow at at very robust rate of 18.6 percent per year to $3.16 billion in 2015. The
viscosupplementation products segment had a value of $725 million in 2010 and is expected to grow to
$1.28 billion in 2015, a CAGR of 12.1 percent. A major increase is expected to come from Genzymes
Synvisc which now allows for a single injection treatment of hyaluronic acid. The DBM (demineralized
bone matrix) segment, the bone growth stimulators segment, and the bone allografts segment are also
expected to achieve a solid growth rate during the period. Figure 33 shows the value and projected growth
rates for each of the segments 2010-2015. Figure 34 shows the market share of each of the segments in
2010. Hospitals accounted for 90 percent of orthobiologic products sales in 2010. The balance went to
clinics (7%), long term care facilities (2%), and acute care centers (1%).
Figure 34 U.S. Orthobiologics Market Share by Segment in 2010
49%
BoneGraft
Substitutes
BoneAllografts
%6
BoneGrowth
Stimulators
8%
DBM
10%
27%
Viscosupplementation
The market shares of the leading companies in the U.S. orthobiologics market are considerably different
from the market shares of all the other orthopedic market segments. The market is highly fragmented and
has numerous competitors with a market share of less than 2%. This group of small competitors comprises
over 40% of the market. Medtronic is by far the market leader with a market share of 22.3%. Genzyme
(who only competes in the viscosupplementation segment) and DePuy are a distant second and third with a
market share of 9.5% and 8.0%, respectively.
41
2.5% Stryker
Others 40.9%
2.5% Allosource
Medtronic 22.3%
Trauma Fixation
Figure 36 U.S. Orthopedic Trauma Fixation Market, by Value (US$ millions)
Market Segment
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR)
External Fixators
238
247
256
265
275
285
3.7
Internal Fixators
1,976
2,091
2,214
2,344
2,483
2,631
5.9
IM Nails
700
731
764
798
834
872
4.5
IM Plates
690
746
805
870
939
1,014
8.0
IM Screws
586
614
645
677
710
745
4.9
Total
2,213
2,338
2,469
2,609
2,758
2,916
5.7
The trauma fixation segment is the fourth largest segment of the U.S. orthopedic devices market. The
segment had a market value of $2.2 billion in 2010 and is forecast to grow at a rate of 5.7 percent per year
to $2.9 billion in 2015. Compared to the other segments, fixation seems to be the most stable segment
of orthopedics and most companies showed very good growth rates. Within the trauma fixation market,
the largest segment is internal fixation devices which comprise almost 90 percent of the market. The
internal fixation segment includes the sub-segments intra-medullary (IM) nails, plates and screws. Hospitals
accounted for 70 percent of trauma fixation products sales in 2010. The balance went to acute care centers
(20%) and clinics (10%). On average, every person in the U.S. will experience two broken bones over the
course of a lifetime.
Figure 37 Leading Competitors in the U.S. Trauma Fixation Devices Market in 2009
12%
Others
3%
Biomet
Synthes 48.5%
4.5% Zimmer
6.5% J&J/DePuy
7.5% S&N
18%
Stryker
The market shares of the leading companies in the U.S. trauma fixation devices market are considerably
different from the market shares in both the joint reconstruction market and the spinal implants market.
There are six leading competitors in the fixation devices market. Synthes is by far the dominant player
with a market share of 48.5 percent. Stryker holds a distant second position with 18 percent market share
followed by Smith & Nephew with 7.5 percent, J&J/Depuy 6.5 percent, Zimmer 4.5 percent, and Biomet 3
percent. All other companies make up the remaining 12 percent.
42
Hospital Orthopedics
A 2010 survey by Merritt, Hawkins & Associates found that orthopedic doctors each generate an average
of $2.12 million annually of inpatient and outpatient revenue for a hospital. This represents an 8 percent
decrease in revenue compared with a similar survey in 2007 and a 29 percent decrease from a high of $2.99
million in 2004. In 2004, revenue generated by orthopedic doctors ranked number one among 17 specialties,
but its ranking dropped to number two in 2007 and number 3 in 2010.49 Even though orthopedics has
historically been among a hospitals most lucrative services, it is expected that emerging technologies and
competition will continue to pose a challenge for hospitals to maintain this lucrative business. Advances in
medical techniques and devices have begun pushing many procedures to outpatient settings, reducing the
need for hospital orthopedics. In addition, increasing device costs and stagnant reimbursements are making
many procedures less profitable.
Orthopedic Device Manufacturers Budget Allocation
Figure 38 Budgetary Allocation of Orthopedic Device Companies (in percent)
20%
6%
Net Income
Margin
Cost of Goods
Sold
28%
Taxes, Net
Interest
Expense &
Other
R&D
6%
Sales, Mktg.,
General &
Admin
40%
Source: Averaged data from the 2008 annual reports of leading orthopedic device manufacturers
43
44
45
46
7. Diagnostics
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
7.1. FACTS AND FIGURES
This chapter will focus primarily on the U.S. in vitro diagnostic (IVD) testing market. It covers the
traditional IVD segments (clinical chemistry, immuno chemistry, hematology, etc.) as well as the growing
molecular diagnostic testing market. It will, in particular, highlight the influence that technological
developments in molecular diagnostics are having on the direction of the pharmaceutical and diagnostics
industries. Additional information about the molecular diagnostics and imaging market can also be found
in the following chapter on Imaging.
IVD testing analyzes samples (i.e., blood, urine, tissue, etc.) outside the body in a controlled environment.
IVD medical devices include reagents, reagent products, calibrators, control materials, kits, instruments,
apparatus, equipment, or systems. The devices are used primarily for the purpose of providing information
about (1) a physiological or pathological state, (2) a congenital abnormality, (3) the safety and compatibility
with potential recipients, or (4) to monitor therapeutic measures.54 The IVD market includes tests conducted
in central laboratories as well as tests for near patient point-of-care testing.
The U.S. Market for Medical Devices.
47
Figure 39 U.S. In Vitro Diagnostic Testing Equipment & Supplies Market, by Product Type,
2010-2015 (US$ Billions)
Item
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR %)
15,752
16,611
17,520
18,478
19,492
20,563
5.5
2,929
3,090
3,258
3,439
3,629
3,830
5.5
Total
18,681
19,701
20,778
21,917
23,121
24,393
5.5
According to GlobalData, the worldwide IVD market was valued at approximately $42.5 billion in 2010.
From that amount, the U.S. accounted about 44% of the world market with $18.6 billion in sales making
it the worlds largest single market for diagnostic testing equipment and supplies. The U.S. IVD market
is expected to grow at a rate of about 5.5 percent per year through 2015 to an estimated market value of
$24.4 billion. Reagents and consumables accounted for 84% of product sales while sales of instruments
and systems comprised the remaining 16% in 2010.
2010
2011
2012
2013
2014
2015
2010-2015
(CAGR)
Immuno Chemistry
6,963
7,360
7,780
8,225
8,696
9,195
5.7
Clinical Chemistry
4,012
4,222
4,443
4,675
4,920
5,177
5.2
Hematology
2,882
3,022
3,170
3,326
3,489
3,662
4.9
Infectious Immunology
2,102
2,228
2,361
2,502
2,651
2,810
6.0
Microbiology Culture
1,443
1,515
1,590
1,669
1,753
1,841
5.0
Genetic Testing
714
760
808
859
914
972
6.4
563
594
627
662
698
737
5.5
Total
18,681
19,701
20,778
21,917
23,121
24,393
5.5
The U.S. IVD market can be divided into seven primary market segments. Immuno chemistry, the largest
segment with estimated sales revenue of $6.96 billion in 2010 is forecast to grow 5.7% per year to a market
value of just under $9.2 billion in 2015. The clinical chemistry segment is second in market size with
estimated sales of just over $4.0 billion in 2010 and is forecast to grow at a rate of 5.2% through 2015.
The third largest segment, hematology, had estimated sales of $2.88 billion in 2010 and is forecast to grow
to $3.66 billion in 2015. The nascent genetic testing segment is expected to experience the fastest growth,
increasing at a rate of about 6.4% per year from $714 million in 2010 to $972 million in 2015.
Figure 41 U.S. In Vitro Diagnostics Testing Equipment & Supplies Market, by Customer Group, 2010
1.9% Other
Hospitals 59.2%
1.6% Clinics
1.7% Drug Stores
2.0% AcuteCare
Centers
33.7% Laboratories
48
The U.S. IVD market can be divided into five primary customer groups. The two largest purchasers of
IVD products are hospitals which purchase about 59.2% of the equipment and supplies and independent
laboratories which purchase about 33.7%. Distribution varies by segment; within the immuno chemistry
segment for example, hospitals purchased 55% of the equipment and supplies, while labs purchased
45%. However, in the clinical chemistry segment, hospitals and labs each accounted for about 45% of the
distribution while clinics purchased 6% and acute care centers 4%. The distribution split in other market
segments varies as well. Freedonia Group forecasts the hospital segment will grow at a rate of about 4.6%
per year through 2013 while the independent lab segment will grow at bit faster at a rate of 5.3% per year.
Figure 42 The U.S. Self-testing Clinical Chemistry Products Market, by Product Type,
2008-2013 ($ Billions)
Item
2008
2009
2010
2011
2012
2013
2008-2013
(CAGR)
2,235
2,425
2,631
2,854
3,097
3,360
8.5%
Blood Glucose
1,975
2,147
2,333
2,536
2,756
2,995
8.7%
Other
260
278
298
319
341
365
7.0%
385
401
417
434
452
470
4.1%
Total
2,620
2,827
3,050
3,290
3,550
3,830
7.9%
Source: Based on Freedonia Group, In-Vitro Diagnostics in the U.S. to 2013, March 1, 2009
49
Figure 43 Projected Molecular Diagnostic Test Sales in North America by Application Segment,
2008-2012 ($ Millions)
Item
2008
2009
2010
2011
2012
2008-2012
(CAGR %)
Infectious Diseases
1,084
1,226
1,387
1,570
1,776
13.1
Blood Screening
578
597
618
638
660
3.4
Histology
307
337
371
408
448
10.0
Oncology
98
112
127
145
165
13.9
Prenatal
90
95
100
105
110
5.0
Coagulation
78
82
86
91
96
5.3
Tissue Typing
37
41
45
50
55
10.1
Inherited Diseases
21.7
Pharmacogenomics
37
48
64
84
110
31.5
Total
2,322
2,559
2,821
3,110
3,428
10.2
Source: Data extrapolated by Swiss Business Hub USA by cross referencing two data tables from
The World Market for Molecular Diagnostics, Kalorama Information, January 1, 2009
50
Extrapolated data from Kalorama Information show the overall North American molecular diagnostic
tests market had an estimated value of $2.3 billion in 2008, and that the market will grow at a rate of
about 10.2% per year to a value of $3.4 billion in 2012. The first molecular diagnostics applications
were in the infectious diseases areas and this is currently the largest segment of the market. The segment
has been dominated by tests for sexually transmitted diseases and hepatitis. The market value of the
infectious disease tests segment was estimated at just over $1.0 billion in 2008 and is expected to grow to
over $1.7 billion in 2012. This represents a strong 13.4% compound annual growth rate over the 4-year
period. The blood screening segment is the second largest segment, and is expected to grow from $578
million in 2008 to $660 million in 2012, however at a much slower annual rate. Molecular test sales in the
pharmacogenomics segment are expected to experience explosive growth, increasing over 31% per year
during the 4-year period. This newly emerging area of molecular diagnostics is bringing together the fields
of pharmaceuticals and diagnostics, and advancing the field of personalized medicine by enabling drug
manufacturers to optimize drug therapies and minimize adverse effects by more closely matching drugs and
drug combinations to each patients unique genetic makeup.
An overview of a comprehensive report about the molecular diagnostics market titled Molecular
Diagnostics: A Dynamic and Rapidly Broadening Market can be found at the following Website:
www.healthtech.com/uploadedFiles/Reports/Reports/Molecular_Diagnostics/Molecular_Diagnostics_
brochure.pdf
The Age of Personalized Medicine is a source that can provide information about policy issues, reports and
publications, and events related to the advances in personalized medicine.
www.ageofpersonalizedmedicine.org/center/
The FDA provides various lists of the IVD and molecular tests that have been approved for use in the U.S.
and the companies that received the approval.
A complete list of FDA approved tests of Donor Screening Assays for Infectious Agents and HIV
Diagnostic Assays can be found at the following Website:
www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/
BloodDonorScreening/InfectiousDisease/UCM080466
Alphabetical List of FDA Licensed Products:
www.fda.gov/downloads/BiologicsBloodVaccines/UCM149970.pdf
Complete List of FDA Licensed Products and Establishments (by product or by company)
www.fda.gov/BiologicsBloodVaccines/ucm133672.htm
7.2. MAJOR COMPETITORS
The top seven in vitro diagnostics (IVD) equipment
and supplies manufacturers in the U.S. represented
about 41% of overall industry sales in 2009. The
market shares of the major competitors vary by
the specific market segment (i.e., clinical chemistry,
hematology, immuno chemistry, etc.), and not all
the companies compete in every market segment.
In the U.S., the clinical chemistry segment is a
somewhat concentrated market which is largely
dominated by five key competitors. The top three
companies, Siemens Healthcare Diagnostics,
Ortho-Clinical Diagnostics, and Abbott Diagnostics
comprise about 36.5% of the market while
Beckman Coulter and Roche Diagnostics make up
another 16% of the segment
The hematology segment, on the other hand, is
highly fragmented and has numerous competitors.
The market leader in hematology is Beckman
Coulter with a market share of 14.1% followed by
Siemens Healthcare Diagnostics with 8.5%. Roche
51
Figure 44 The U.S. In Vitro Diagnostics Testing Equipment & Supplies Market,
Company Market Shares by Revenue in 2009 (All segments combined)
Company
% Share
9.2
Abbott Diagnostics
9.0
Roche Diagnostics
6.7
Beckman Coulter
6.2
4.4
Alere
2.9
Becton Dickinson
2.7
Others
58.9
Total
100.0
52
bioMrieux is a major player in the field of invitro infectious disease diagnostics. The company
designs, develops, manufactures and markets
reagents and automated instruments for medical
analyses. (Other product applications include
product quality control in the agri-food, cosmetics
and pharmaceutical industries). The company
had net sales of $1.76 billion in 2009, and ranks as
the eighth largest biological diagnostics company
worldwide. Over 85 percent of its activity takes
place on an international level. The company
employs 6,140 people worldwide, is present in over
170 countries through 39 subsidiaries and a large
network of distributors, and has 17 production
sites located in France, the Netherlands, the United
Kingdom, Italy, Spain, Sweden, the United States,
Brazil, China and Australia.
www.biomerieux.com
Ortho-Clinical Diagnostics, Inc., a subsidiary
of Johnson & Johnson, provides professional
diagnostic products to hospital laboratories,
commercial clinical laboratories and blood donor
centers. Its products include reagents used in
blood transfusions and blood screening; reagents
and instrument systems for clinical chemistry; and
RhoGAM, an injectable drug used to prevent
hemolytic disease of the newborn. Ortho-Clinical
Diagnostics had net sales of $1.96 billion in 2009.
www.orthoclinical.com/
Roche Diagnostics is a division of F.
Hoffmann-La Roche Ltd, Basel, Switzerland, and is
the world's leading provider of diagnostic systems.
The company offers a broad range of IVD and
molecular diagnostic products which are sold to key
research and production locations in more than 50
countries. Products include early detection, targeted
screening, evaluation and monitoring of disease.
Roche Diagnostics employs a total of 25,967
people worldwide. The North American division
employs over 6,700 people, and is one of five global
centers for Roche Diagnostics. The companys
Indianapolis site in the U.S. is a key manufacturing
site for Roche's blood glucose monitoring strips,
and is responsible for the marketing, sales, service
and distribution of all Roche Diagnostics' products
sold within North America. www.roche-diagnostics.
com Roche Group reported sales of $47.6 billion in
2009. Within the Roche Group, Roche Diagnostics
had net sales of $9.7 billion.
Siemens Healthcare Diagnostics, Inc. (SHD)
was formed by the merger of Diagnostic Products
Corp., Bayer Healthcare Diagnostics and Dade
Behring. SHD is a wholly owned subsidiary of
Siemens Medical Solutions USA, Inc., and is the
largest clinical diagnostic businesses in the world.
The Companys diagnostic products division offers
a wide range of laboratory, self-testing, molecular
testing, and near patient (critical care and pointof-care) diagnostics systems which are focused on
the areas of cardiovascular and kidney disease,
oncology, virology, women's health, and diabetes.
53
54
55
8. Medical Imaging
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
equipment, which include gamma camera, positron
emission tomography (PET), and single photon
emission computed tomography (SPECT); (7) Angio
suite, (8) Bone densitometry; (9) C arms; and
(10) Contrast media injectors.
Figure 45 U.S. Diagnostic Imaging Equipment Market by Type of Equipment (US$ Billions)
Type of Equipment
2010
2011
2012
2013
2014
2015
2010-2015
CAGR (%)
Ultrasound Systems
1,425
1,493
1,566
1,645
1,731
1,825
5.1
MRI Systems
1,251
1,313
1,383
1,463
1,553
1,655
5.8
1,080
1,126
1,177
1,234
1,297
1,367
4.8
X-Ray Systems
916
942
969
997
1,027
1,058
2.9
Mammography Equipment
441
461
484
508
534
562
5.0
382
412
447
484
526
571
8.4
Angio Suite
279
280
280
280
282
282
0.2
Bone Densitometry
267
271
275
279
284
288
1.5
C arms
146
150
154
158
162
166
2.6
72
73
74
75
76
77
1.4
Total
6,259
6,520
6,808
7,123
7,471
7,849
4.6
56
Figure 46 Market Share of the Leading Diagnostic Imaging Equipment Manufacturers in 2009
27%
GE Healthcare
Hospitals 59.2%
27.3% Others
4.9% Toshiba
Medical
Systems
18.5% Siemens
Healthcare
The U.S. diagnostic imaging market can be divided into four primary customer groups. The largest
customer group of imaging equipment is hospitals which purchased about three-fourths of all the imaging
equipment in 2010. Laboratories were a distant second with a distribution share of 14.1% followed by
clinics with 7.6% share and acute care centers with 3.9% share. Actual distribution in each specific market
segment varies somewhat, but in all cases hospitals were the primary customer group where they accounted
for 70-75% of all purchases.
Figure 47 U.S. Diagnostic Imaging Equipment Market, by Customer Group, 2010
74.4% Hospitals
Laboratories 14.1%
Clinics
7.6%
AcuteCare
Centers
3.9%
3D Imaging
The 3D imaging market is becoming one of
the highest growth areas in the field of medical
imaging Magnetic Resonance Imaging (MRI),
Computed Tomography (CT), and Ultrasound.
The technology provides physicians with three
dimensional images of internal body structures
and enables them to more precisely detect and
diagnose diseases. Industry experts expect most of
the applications will help improve the standard of
care for patients by reducing the need for invasive
imaging technologies, however, the technology is
currently limited to large hospitals due to its high
price and lack of reimbursement. (3D imaging
is not recognized as a separate procedure, but is
instead bundled together with other diagnostic
procedures as a Diagnosis-Related Group [DRG]).
Growth in this market is expected to accelerate as
applications become more affordable. According
to Global Industry Analysts, the U.S. market for
3D imaging equipment was valued at $807 million
in 2008 and is forecast to grow at a CAGR of
11.5% to $1.39 billion in 2013. In 2008, the U.S.
comprised about 35% of the world market.
57
58
Siemens Healthcare
Siemens Healthcare (SH) is one of the largest
suppliers of healthcare equipment in the world.
The companys Imaging and IT division offers
innovative products, services and complete
solutions, ranging from imaging systems for
diagnosis and therapy equipment for treatment,
to electromedicine and hearing instruments, to
IT solutions that optimize workflow and increase
efficiency in hospitals, clinics and doctors' offices.
Product areas include fluoroscopy, angiography,
ultrasound, nuclear medicine, computed
tomography, magnetic resonance imaging,
radiography, molecular imaging, patient monitoring
systems, clinical IT, and mammography. In 2009,
SH reported worldwide sales of $17.2 billion of
which $6.5 billion came from its U.S. operations.
SHs Imaging and IT division generated U.S. sales
of approximately $3.9 billion in 2009. SH employs
approximately 48,000 persons worldwide in 130
countries. www.siemensmedical.com
TomTec Imaging Systems
TomTec Imaging Systems, GmbH is the worldwide
leader for 2D-, 3D- and 4D- solutions in the area
of medical ultrasound, and seeks to be a worldwide
leader in medical imaging software solutions.
The Company is based near Munich, Germany.
TomTecs North American market is handled by
its subsidiary, TomTec Corp., which is located in
Chicago. Since 1990, the company has developed
as a pioneer in 3D/4D ultrasound, Stress Echo and
Image Management technology. The companys
product line encompasses a wide range of 2D
and 3D/4D technology for visualization, analysis,
quantification and information-processing as well
as for management of multimodality image data.
TomTecs products are applicable to the fields of
adult and pediatric cardiology as well as obstetrics,
gynecology, radiology, and vascular diagnostics.
www.tomtec.de
Toshiba America Medical Systems, Inc.
Toshiba America Medical Systems, Inc. is a
leading developer, manufacturer and supplier of
diagnostic and medical imaging systems. The
Companys product line includes diagnostic X-ray
systems, medical X-ray CT systems, magnetic
resonance imaging systems, diagnostic ultrasound
systems, radiation therapy systems, diagnostic
nuclear medicine systems, medical sample testing
equipment, and information systems for medical
equipment. medical.toshiba.com/
Vital Images, Inc.
Vital Images, Inc. is a leading provider in the area
of advanced visualization and image analysis
solutions. The companys software enables the
visualization and analysis of 2D, 3D and 4D images
of anatomy and physiological function using
The U.S. Market for Medical Devices.
59
EMERGING TECHNOLOGIES
60
9. Rehabilitation Equipment
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
9.1. FACTS AND FIGURES
According to Patterson Medical, the worldwide rehabilitation medical supplies and assistive products
market was valued at about $5.6 billion in 2009. Primary product areas include: (1) Orthopedic products,
such as braces, splints and continuous passive motion machines; (2) Aids to daily living, such as dressing,
dining, and bathing devices; (3) Rehabilitation equipment, such as treatment tables, mat platforms, and
stationery bicycles; (4) Clinical products, such as exercise bands, weights, balls, and mats; and (5) Mobility
products, such as walkers, canes, crutches, scooters, wheelchairs and wheelchair accessories. The value of
the U.S. rehabilitation medical supplies and assistive products market is estimated at $4.1 billion in 2009.
Patterson expects the total market will grow faster than the overall economy over the next several years.
The U.S. Market for Medical Devices.
61
Favorable demographic trends including increased life expectancy, active life styles and a general
willingness to spend discretionary income on healthcare and well being should contribute to continued
growth in demand for products.
Figure 48 U.S. and Worldwide Rehabilitation Medical Supplies
and Assistive Products Market, 2009-2013 ($Billions)
2009 U.S.
2013 U.S.
2009 WW
2013 WW
2009-2013
(AAGR)
2.6
2.9
3.4
3.8
3.0
1.5
1.7
2.2
2.5
3.0
Total
4.1
4.6
5.6
6.3
3.0
Source: Extrapolated data from Patterson Companies, Inc., Fiscal 2009 and 2010 Annual Reports
62
Competition
The rehabilitation equipment and supplies market
is both highly competitive and highly fragmented.
Most of the companies that distribute rehabilitation
products in the U.S. are generally either locally
or regionally focused with a few exceptions such
as Invacare and Patterson Medical which have
national distribution. The average order size in this
market is only about $225.
Successful companies offer value to the customer
which can be achieved by a combination of
variables. Product quality, performance, and price
are important attributes in the perceived value to
the customer. In addition, the range of products
offered, the technical expertise of the companys
sales force, the strength and effectiveness of the
dealer and distributor network, and the availability
of prompt and reliable service are also important
factors that can affect a companys success in this
market.
Marketing and Distribution
There are a number of avenues that manufacturers
and distributors of rehabilitation equipment are
using to reach customer groups. Some of the
leading companies use a combination of these
methods while others may use only one method.
Sales and marketing efforts to both institutions
and end-users include using a direct sales force,
telesales, manufacturers agents, catalog sales, and
on-line sales. Also, because of the growing demand
for rehabilitation products in the home healthcare
market, there is an increased effort by companies to
reach the end-user. The distribution network has
expanded to include retail dealers of rehabilitation
supplies and equipment, surgical supply houses,
hospital and HMO-based stores, home health
agencies, retail drug stores, mass merchandisers,
rental companies, direct sales, and the Internet, in
addition to the traditional hospital clinics, longterm care facilities, nursing homes, outpatient
rehabilitation clinics, and physician offices. Leading
customer groups include physical and occupational
therapists in acute care hospitals, long-term care
facilities and rehabilitation clinics, and major
national providers of rehabilitation services such as
the Veterans Administration, HCA, HealthSouth,
Horizon Health Corp., Kindred Healthcare,
Rehabcare Group, Tenet, and others. In addition,
some companies are using pull-through marketing
strategies to medical professionals, including
physical and occupational therapists, who refer their
patients to home medical equipment providers to
obtain specific types of home medical equipment, as
well as to consumers, who have a particular product
or brand preference.
Reimbursement Issues
The Centers for Medicare and Medicaid Services
(CMS) has developed general criteria for Medicare
63
64
65
66
10. Dental
Erwin Locher, President, Medtech Switzerland and
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
10.1. FACTS AND FIGURES
The Centers for Medicare and Medicaid Services
(CMS) estimates that U.S. expenditures for Dental
Services were valued at $102.2 billion or about
4.1% of total national health expenditures in
2009. CMS forecasts the total amount spent on
dental services will grow to $145.2 billion in 2015,
an increase of about 6.0% per year. Since older
patients spend more for dental services, especially
for implantology, aging is the major long-term
driver; however the demand for functional and
aesthetic dental services has been increasing for
patients of all ages. Continued technological
developments, especially digitalization, will also
help propel growth, as will the increasing demand
for preventive dentistry or specialty services such as
endodontic, orthodontic or periodontic procedures.
Finally, the combination of private or patient pay
and increased coverage by dental insurance plans
will tend to increase demand for dental services as
the economy improves.
The dental market is highly diversified and
segmented into the following categories: prevention,
regenerative dentistry, restorative dentistry, and
implant dentistry. Products for all segments are
differentiated as consumables, materials, which
includes implants, and equipment. Unlike other
medical technology markets, dental products are
not sold primarily to hospitals, but to office based
practitioners. Due to the large number of dental
clinics and laboratories, distributors are a crucial
component of the North American dental market.
The two large U.S.-distributors and numerous
regional full-service and local dealers play a major
role in the marketing of consumables, materials and
equipment. They also act as consultants to dentists,
providing office design assistance, equipment
financing, and many other value-added services.
The dental market declined in 2009 and only
partially rebounded in 2010. Due to the signficant
economic downturn, the market experienced a
reduction in patient demand as dentists and dental
laboratories reduced their purchases of equipment
and supplies to compensate for the loss in business.
The market contraction was also felt in the area
of dental materials. According to GlobalData, the
dental device market in the U.S. had an estimated
value of $2.4 billion in 2010. The market is
expected to eventually recover and is forecasted to
grow at a rate of 7.3% per year to just under $3.2
billion in 2014.74 While the dental consumable
market stayed flat in 2010, the high tech end of the
equipment market declined to pre-recession levels.
Implant sales only started to increase again in the
last quarter of 2010.
67
2010
2011
2012
2013
2014
2010-2014
(CAGR %)
113
122
133
144
156
8.4
85
92
100
108
117
8.3
28
30
33
36
39
8.6
701
751
804
862
923
7.1
Dental Chairs
457
491
528
567
610
7.5
Hand Pieces
207
220
243
248
264
6.3
Scaling Units
15
16
17
19
20
7.5
22
24
26
28
30
8.1
Dental Implants
852
906
963
1,023
1,088
6.3
850
904
961
1,021
1,085
6.3
0.0
Dental Lasers
39
42
46
49
54
8.5
Dental Biomaterials
147
160
173
189
205
8.7
18
20
22
24
27
10.7
70
77
85
94
103
10.1
59
62
66
71
74
5.8
551
597
647
701
760
8.4
449
487
528
572
620
8.4
101
110
119
129
140
8.5
Total
2,402
2,577
2,765
2,967
3,184
7.3
68
From approximately 2000 to 2005, the dental market went through a period of transition as the focus of
services shifted from conventional repair and restoration to prevention. During that time, the American
Dental Association reported a 51.7% decrease in metal amalgams (fillings), a 5.7% reduction in plastic
restorations, and 41.2% fewer extractions. In addition, periodic oral exams increased by 12.1% as
consumer demand for preventive dental care was on the rise and insurance covered more preventive
treatment. However, following the recent global recession and continued slow economic conditions in
the U.S., procedure volumes have decreased from previous years. In 2007, the number of procedures per
visit was estimated at 3.9 versus 2.7 in 2009. Also, even though the demand for diagnostic and preventive
services remains the largest segment of the market, its rate of growth has slowed while the demand for
repair and restorative procedures has remained steady. The following table shows the demand for repair
and restorative services for patients is forecast to increase about 2.4 % per year whereas demand for
diagnostic and preventive services will increase only about 1.9% per year through 2013. Previously the
demand for diagnostic and preventive services was growing at a rate of about 2.8% per year.
Figure 50 Projected Dental Patient Activity & Procedures 2009-2013 (in $ Millions)
2009
2010
2011
2012
2013
AAGR
1,618
1,653
1,688
1,725
1,766
2.2%
1,059
1,079
1,099
1,120
1,144
1.9%
493
505
517
530
543
2.4%
Cosmetic
11
12
12
13
14
6.2%
Other
54
57
59
62
65
4.7%
Procedures/visit
2.7
2.7
2.8
2.9
2.9
1.8%
Dental Visits
533
556
580
605
614
3.6%
(2009-2013)
Dental Procedures
Source: Based on Freedonia Group, Inc: Dental Products & Materials, March 1, 2008
63.6
62
60
58
57.2
56
54
2000
2020
69
more frequently used for posterior cases and allceramic materials for anterior cases. Interestingly,
the decision process for choosing the material and
technique provides great insight into how dentists
make their decisions. Personal clinical experience
is a key driver in the decision to perform certain
techniques in dentistry, therefore education and
marketing can be instrumental in changing dentists
choice of procedures.
Recent trends show that the materials of choice are
starting to change. Materials manufacturers have
made significant progress in developing composite
materials that look natural, have improved wear,
and last longer. Progress has been made in small
steps that have added to longer stability and
usefulness of restorations. The introduction of
nanotechnology advancements has created a new
generation of composites with improved aesthetics,
increased translucency and vitality, better wear,
and reduced shrinkage. The significantly improved
composite materials combined with increased
patient demand for esthetics has caused many
dentists to switch away from using amalgam. A
survey in the March 2008 Dental Products Report
states that about 80% of dentists are using at least
one of the newer generation nano-composites. Of
those dentists still using amalgam, 81% placed fewer
than they did three years ago. The 2008 DPR
survey also stated that 57% of the respondents still
use amalgam, while 43% do not.79
Patient Education
Dentists are making an extra effort to educate
their patients about oral healthcare and treatment
options. An August 2008 Dental Products Report
survey showed that 35% of dentists are spending
11-25% of their chair time with patients for
education. This extra patient education has
been shown to improve patientsacceptance of
procedures by as much as 80%. In many cases,
even patients who initially said no to the
treatment come back several months or even years
later requesting the treatment they had seen in a
patient education presentation.80
Materials
One of the most prevalent and costly consumables
in the dental industry is the material that is used
for tooth restoration. Dentists and dental labs
that perform restoration procedures traditionally
use metal materials (such as gold), ceramic, or
porcelain-fused-to-metal (PFM). Ease of use
and longevity are the primary drivers in the use
of PFM implants. Although PFM products and
metal restoration dominate the market, metal-free
products are on the rise. For example, porcelain
veneers/laminates are used by over two-thirds of
dentists and lab clinicians, and metal free crowns by
over half. In addition, the use of all ceramic CAD/
CAM crowns and bridges is starting to be used
more frequently. Because aesthetics are a concern,
the location in the mouth plays a key role in the
choice of restorative materials. PFM materials are
70
71
72
11. Drug-device
combination products
Frank Ustar, Trade Commissioner, Swiss Business Hub USA
11.1. DEFINITION
AND PRODUCT CATEGORIES
According to the U.S. Code of Federal regulations
(21CFR part 3.2.e), combination products are
defined as consisting of two or more regulated
components (e.g. drug/device, biologic/device, drug/
biologic or drug/device/biologic) that are physically,
chemically, or otherwise combined or mixed and
produced as a single entity. The importance of this
emerging product category was underscored by the
creation of the Office of Combination Products
(OCP) within the FDA in 2002.
The above definition indicates that pharmaceutical,
biotechnology, nanotechnology, and mechanical/
electronic manufacturing processes may be involved
in some combination in the final product. Such
medical products are becoming increasingly
important by:
providing innovative ways to extend lifecycles of
existing products for manufacturers
reducing the level of toxicity in patients
allowing for fewer side effects for patients
73
74
Figure 52 gives an overview of the number and type of combination product applications submitted in 2008.
Figure 52 Number of Original Drug/Device Combination Applications Submitted in 2008,
by Application Type and Type of Combination Product
Convenience kit or
Co-package
Prefilled drug
delivery system
Total
Application type
10
14
Original
Biologics
license
Premarket approval
510(k)
11
83
11
14
120
49
18
15
38
15
158
Investigational Device
Exemption (IDE)
13
32
Humanitarian
device
exemption
Total
13
59
23
106
20
15
16
48
30
330
Diagnostic-Drug Conversion
75
76
Marketing Stage
Convergence at this level involves mainly joint
packaging, labeling, advertising, sales, and distribution
of related products. Some products may be packaged
together such as glucose monitors with removable and
refillable insulin pumps. Others may be labeled for
joint use but packaged separately such as diagnostic
kits and related drugs. The time horizon at this stage
is much shorter and existing structures and processes
can be utilized. The market value of the converged
product may be only incrementally larger than that of
the separate products.
11.5. REGULATIONS
The FDAs Office of Combination Products has
primary jurisdiction over the implementation
of the rules established in 2004. In reviewing
product submissions this Office is guided by the
principle of Primary Mode of Action (PMOA)
which is defined as the single mode of action
of a combination product that provides the most
important therapeutic action of the combined
product. Depending on the classification of the
submitted product, the further processing of the
application may be assigned to one of the following
agencies:
The marketing costs associated with entering
the U.S. medical device sector can be substantial
as is the time necessary, but once overcome, the
opportunities can be great. This chapter will discuss
some of the most relevant marketing dynamics
of the medical device industry. We will look at
the purchasing process and marketing tools that
are standard (in some cases required) to help the
decision maker decide about a new product. The
chapter will also address the question of how to
access the individuals who make the purchasing
decision.
Center for Biologics Evaluation and Research
(CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health
(CDRH)
In case there is a dispute over the jurisdiction of the
combination product, the applicant can file a formal
Request for Designation (RFD) to the OCP.
Combination products are typically subject to one
of two different but parallel initial FDA evaluations:
CDRHs investigational device exemption (IDE)
and CDERs investigational new drug (IND)
processes. However, they rarely require both.
Depending on center jurisdiction, a sponsor must
formally follow the IDE process for combination
products regulated as medical devices or the IND
process for products regulated as drugs. Regardless
of jurisdiction, the sponsor typically needs to
provide FDA with data to support both processes.
For example, drug-eluting stents are regulated by
CDRH as medical devices and therefore follow
The U.S. Market for Medical Devices.
77
78
Targeting Surgeons
Targeting OEMs
Trade Shows
Orthopedic Manufacturing
Technology Expo and Conference
(OMTEC)
Publications
AAOS Now
JAAOS
BONEZONE
79
80
81
Innovatix:
www.innovatix.com/NewVendorInfo.aspx
MedAssets:
www.medassets.com/vendor/Pages/
VendorResources.aspx
Medbuy Corporation:
www.medbuy.ca/en/suppliers/becomesupplier.asp
MMCAP:
www.mmd.admin.state.mn.us/mmcap/current.htm
Novation:
http://www.novationco.com/suppliers/become_a_
supplier.asp
Permier:
http://www.premierinc.com/about/suppliers/
index.jsp
PRIME: Send a letter of introduction to PRIME,
6820 Deerpath Road, Elkridge, MD 21075-6234.
Please include information about your company
and the products/services you are offering.
http://www.pr1me.org/frm_vendor_part.html
Provista: GPO services are handled through
Novation (See above)
http://www.novationco.com/suppliers/become_a_
supplier.asp
Yankee Alliance:
http://www.yankeealliance.com/content/
contracting-process
There is also the possibility to reach these GPOs
through their industry association HIGPA (Health
Industry Group Purchasing Association) www.
higpa.org. Vendors can advertise to GPO member
organizations via the HIGPA International Expo
event, the HIGPA National Pharmacy Forum event,
the HIGPA Daily eNews, or the www.HIGPA.org
Website banner advertising.
http://www.higpa.org/advertise/default.aspx
82
Engagement of
Medical Doctors/
Purchasers
Production
Standards
Opinion Leader
Evaluations
Clinical Trials
Use of Medical
Devices on
Patents
Evaluation
Results
Citations
Sales &
Distribution
83
84
Circulation
Significance of
Scientific Breakthrough
85
86
Doctors
Regulatory Environment
Company
Research
Insurers
Exports to
Foreign
Customer
Independent
Representative
Agency
Distribution
Network
Joint
Venture:
Sales and
Service
Partnership
Wholly
owned
Sales and
Service
Entity
Wholly
owned
Manufacturing Sales
and Service
Own
Manufacturing Sales,
Service and
R&D
A major vehicle for strong customer service is the presence of an aggressive sales and service team which works
very closely with the doctors, engineers and other purchasers in the field. The closeness of customer service
was so strong that the federal government recently took action to limit the customer service techniques and
training by suppliers that was perceived as ethically inappropriate. For example, some companies provided allexpense-paid training courses and other offers to entice doctors into endorsing their products.
When introducing new products, the relationship between the doctor and the sales/customer service
representative can be a vital communication channel. And, as hospitals move more towards a Just-In-Time
inventory system, delivery times become more and more important, necessitating high levels of communication
and interaction. All these indicators point to committed, eager, and proactive customer relations.
The U.S. Market for Medical Devices.
87
88
89
90
Consulting Agreements
91
92
Supply Agreements
93
14. Reimbursement
Scot Orgish, Trade Commissioner, Swiss Business Hub USA
14.1. OVERVIEW
Reimbursement by public and/or private insurance
is one of the primary drivers that can affect the
successful introduction (or failure) of new medical
devices in the U.S. market. Since most patients
cannot afford to pay for medical devices and
procedures on their own, they rely on insurance to
pay about 88 percent of all healthcare expenses.
(Figure 10, page 27). This being the case, public
insurance (through federal and state Medicare and
Medicaid programs) as well as a large number of
private insurance companies have a major voice in
deciding which medical devices and procedures they
agree to pay for, and how much they are willing
to pay. The public and private sectors operate
independently from each other, and each makes
its own decisions regarding which devices and
procedures it considers eligible for reimbursement.
On the public side, The Centers for Medicare and
Medicaid (CMS) takes the leading role in making
decisions while on the private side the individual
companies conduct their own reviews and make
their own decisions. It is also important to point
out that CMS is making a steady drive to become
an active purchaser rather than a passive payer of
healthcare.
In order for Swiss medical device manufacturers to
94
95
96
Cigna
www.cigna.com
Coventry Health Care
www.coventryhealthcare.com
HealthSmart Preferred Care
www.healthsmart.net
Humana
www.humana.com
Kaiser Permanente
www.kaiserpermanente.org
PacifiCare Health Systems
www.pacificare.com
United Healthcare Group
www.uhc.com
WellPoint Health Networks
www.wellpoint.com0
14.6. TRENDS IN THE
MANAGED CARE INDUSTRY
According to the Wall Street Journal, the managed
care industry has been experiencing consolidation
over the past decade and it is expected to become
more concentrated in the coming years. In 1995,
the top 10 U.S. health plans accounted for 27%
of medical membership, however in 2008; they
accounted for about 56% of medical membership.
Some of the nations independent nonprofit Blue
Cross and Blue Shield (BCBS) organizations that
did not seek for-profit status back in the 1990s
and early 2000s are starting to feel pressure from
large national health insurers to convert to forprofit status or merge with other independent
organizations. Nonprofit BCBS organizations
and smaller health insurers are having a more
difficult time competing against larger providers
because of the need for economies of scale and the
requirement for greater investments in expensive
technologies and tools to comply with laws. Even
if they do not merge with other independents,
conversion to for-profit status could lead to
acquisitions by large insurers. The independent
BCBS organizations are attractive acquisition
candidates for the large insurers because they are
considered to have the best operations and the most
people covered.93
Cost containment is also a high priority. Payers are
focusing on healthcare cost containment to control
spending. Some of the leading efforts include: (1)
Evidence based medicine; (2) Consumer-driven
healthcare plans; (3) Step therapy; and (4) High
deductible health plans.
Effective no later than January 1, 2013 the newly
passed Affordable Care Act establishes a national
pilot program to encourage hospitals, doctors, and
other providers to work together to improve the
The U.S. Market for Medical Devices.
97
98
99
100
101
102
15.7. SUBCONTRACTING
OPPORTUNITIES IN ORTHOPEDIC
DEVICE MANUFACTURING
The orthopedics device market accounts for about
19 percent of the U.S. medical device industry
sales, and is projected to experience an annual
growth rate of about 4% over the next several
years 97. Orthopedic devices are used for the repair
and replacement of skeletal problems and include
products such as joint replacement, trauma products
used for repairing broken bones (splints, pins,
screws, plates, etc.), devices for spinal column repair,
and arthroscopic equipment for vision and camera
applications. As an industry, orthopedic OEMs
outsource more than half of their manufacturing to
suppliers.
103
104
105
106
Sensors
Sensors have found widespread applications in the
medical device field, and offer good outsourcing
opportunities for Swiss companies. Sensors are used
in equipment for surgical procedures, intensive care
units, hospital recuperative care, and home care.
107
108
Invoicing
Invoices presented to Customs must be properly
prepared and meet regulatory requirements. The
commercial invoice should show the port of entry to
which the merchandise is destined; the name of the
party to which the merchandise is sold and the place
from where it was shipped; a detailed description
of the merchandise, in English, including the name
by which each item is known; the grade or quality,
marks, numbers and symbols under which they are
sold by the seller; the quantity of merchandise; the
purchase price of each item; the currency in which
the transaction is made; and all charges itemized
by name and amount including freight, insurance,
commissions, coverings, costs of packing, and
related expenses.
Rulings by Customs and
Administrative Appeal
109
110
111
112
17. FDA:
Bringing a Medical Device to
Market: Premarket Review
John Lemker, The Wood Burditt Group
The Federal Food, Drug and Cosmetic Act (the
Act)101 establishes comprehensive requirements
for the regulation of medical devices which are
intended for human use. The current regulatory
scheme was added to the Act by the Medical Device
Amendments of 1976102.
Class III products that are life-supporting, lifesustaining or carry a high risk of illness or injury.
113
114
115
3) Abbreviated 510(k)
Recent Developments
FDA Actions
When the FDA has accepted the submission as
administratively complete, the review begins. If the
submission is determined to be incomplete, notice
is given to the submitter and an opportunity to
provide the elements missing from the submission.
Once the 510(k) is deemed complete and accepted,
the review begins. When the review is complete,
the FDA may issue an order declaring the device
to be substantially equivalent to a predicate device,
or declaring the device to be not substantially
equivalent, or requesting additional information.
Requests for additional information occur
regularly. As soon as an order declaring a device
to be substantially equivalent to the predicate is
received, the device may be marketed.
There are two features of the 510(k) process which
require special mention; user fees and third party
review.
User Fees
The 510(k) submitter must pay a fee at the time of
submission. The standard fee for fiscal year 2011
is $4,348. The small business fee, for companies
with $100 million or less in gross receipts or sales, is
$2,174. There is no fee for a third-party reviewed
510(k) but that reviewer usually charges a fee125.
Third Party Review
Under the Accredited Persons Program, devices
designated by the FDA may be reviewed by a party
accredited by the FDA for that device126.
This program permits the primary review of a
510(k) to be accomplished outside of the agency. It
is an alternative to the FDA review although the
FDA makes the final decision.
Upon completion of the review by the accredited
entity, the 510(k) and a recommendation are
forwarded to the FDA. The FDAs decision
must be made within 30 days of receiving the
recommendation.
116
117
118
119
Pleadings
Pleadings under United States procedure tend to
be short and concise and need only provide the
parties with notice of the claim or defenses. United
States pleadings will not contain references to the
evidence that may prove the pleadings allegations.
A complaint must only include a description
of the parties, a statement justifying the courts
subject matter jurisdiction, a brief description of
the plaintiff s claim and a request for relief. The
exact amount in dispute generally does not have
to be stated; it is usually sufficient to state that the
amount of the claim exceeds the minimum amount
required in order to establish the courts jurisdiction.
However, under a pair of recent decisions, the
Supreme Court has made clear that a plaintiff
must do more than solely recite the elements of a
violation and must plead with sufficient particularity
so that the right to relief is more than mere
conjecture, Bell Atlantic Corp. v. Twombly, 550 U.S.
544 (2007), and that the plaintiff must plead facts
that, when accepted as true, show the plausibility
of the claim for relief, Ashcroft v. Iqbal, 129 S.
Ct. 1937, 1947 (2009). Similarly, a defendants
answer need only provide a short response to each
allegation in the complaint, indicating whether
the allegation is admitted or denied, or whether
the manufacturer lacks sufficient information to
answer the allegation, together with any affirmative
defenses that the defendant may wish to raise.
Service of Process
A Swiss medical device manufacturer has no
obligation to defend against the complaint until
a copy of the summons and complaint has been
properly served upon the manufacturer. If the
Swiss manufacturer has a branch or other agent
in the United States, the summons and complaint
generally can be served upon the branch or the
agent. If the Swiss manufacturer does not have
a branch or other agent in the United States, the
summons and complaint must be served upon the
foreign manufacturer in the foreign jurisdiction
where it is located. Under Volkswagenwerk AG
v. Schlunk, 486 U.S. (1988), such service must be
made under the Hague Service Convention. The
Hague Service Convention is an international treaty
to which the United States and approximately
35 other countries, including Switzerland, are
signatories. Under the Hague Service Convention,
the principal method of service requires the United
Class Actions
120
121
122
123
Summary
Two important points emerge from the foregoing
for Swiss medical device manufacturers who are
contemplating a merger/consolidation with, or
an acquisition of, a U.S. company. First, the Swiss
manufacturer should conduct very careful due
diligence to determine the extent to which product
liability claims have been or may be asserted against
the U.S. company. Second, Swiss manufacturers
should seek expert legal advice regarding structuring
the transaction so as to minimize the likelihood that
its assets will become subject to product liability
claims resulting from the U.S. companys operations.
18.5. REDUCING THE RISK
OF PRODUCT LIABILITY
Any Swiss medical device manufacturer selling its
products into the United States should institute
programs in order to reduce its U.S. product liability
risks. The program should include the following:
State of the Art Design
All medical devices sold in the United States
should fully meet all design standards set by the
FDA as well as by trade associations, professional
societies and technical organizations and other
standard setting groups. In addition, Swiss medical
device manufacturers should strive for their
product designs to meet the highest state of the art
prevailing in the industry.
Quality Control
Careful attention should be given to every phase of
manufacturing medical devices including materials
and component selection, assembly, testing and
inspection, packaging, storage and handling.
Comprehensive and effective quality control of
manufacturing standards is absolutely essential.
124
19. Annexes
19.1. ANNEX I: LINKS TO DATA SOURCES
American Heart Association:
www.americanheart.org
BCC Research, Inc.:
www.bccresearch.com
Biomet, Inc.:
www.biomet.com/corporate/index.cfm
Centers for Medicare and Medicaid:
www.cms.hhs.gov
DataMonitor:
www.datamonitor.com
Dental Products Report:
www.dentalproductsreport.com
Espicom Business Intelligence:
www.espicom.com
Freedonia Group:
www.freedoniagroup.com
Frost & Sullivan:
www.frost.com
GlobalData:
www.globaldata.com
Global Industry Analysts:
www.strategyr.com
Global Markets Direct:
www.globalmarketsdirect.com
IBISWorld:
www.ibisworld.com
Kaiser Family Foundation:
www.kff.org
Market Strategy Group:
www.mkt-strat.com
National Center for Health Statistics:
www.cdc.gov/nchs
Stryker Corp.:
www.stryker.com/en-us/index.htm
U.S. Census Bureau:
www.census.gov
125
126
127
FIME 2011
10-12 August 2011
Miami Beach Convention Center
Miami Beach, FL
www.fimeshow.com
Association for the Advancement of Medical
Instrumentation AAMI 2011 Conference & Expo
25-27 June 2011
Henry B. Gonzalez Convention Center
San Antonio, TX
www.aami.org/meetings/aami2011/theexpo.html
Investment In Innovation (In3) East
21-23 June 2011
Hyatt Regency Hotel
Boston, MA
www.medtechinsight.com/conferences.html
OMTEC Orthopedic Manufacturing
Technology Exposition & Conference
15-16 June 2011
Donald E. Stephens Convention Center
Chicago, IL
www.orthoworld.com/site/index.php/products/
omtec
Medical Design & Manufacturing, East
7-9 June 2011
Jacob K Javits Convention Center
New York, NY
www.canontradeshows.com/expo/east10/
Society of Nuclear Medicine - 58th Annual
Meeting
4-8 June 2011
Henry B. Gonzalez Convention Center
San Antonio, TX
interactive.snm.org/index.cfm?PageID=9794
Heart Rhythm 2011 32nd Annual Scientific
Sessions
4-7 May 2011
The Moscone Center
San Francisco, CA
www.hrsonline.org/Sessions/futscisessions/
Medtrade Spring 2011
12-14 April 2011
Sands Expo and Convention Center
Las Vegas, NV
www.medtrade.com/medtrade_spring/
BIOMEDevice 2011
6-7 April 2011
Boston Convention & Exhibition Center
Boston, MA
www.canontradeshows.com/expo/bioboston10/
American College of Cardiology
ACC.11 & i2 Summit 2011
3-5 April 2011
New Orleans, LA
acc10.acc.org/Pages/ACC2010Home.aspx
128
129
130
131
132
Englander, JW and Seligman, PM;Standard & Poors Industry Surveys: Healthcare: Products & Supplies, February
4, 2010.
2.
3.
4.
http://links.heritage.org/hostedemail/email.htm?h=2d87a570f962a7bbda7b5393ad924089&CID=7937511093&ch=
F23BC7B57C78F60DB1C54EF68E7B050B
5.
6.
7.
FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies, by
Josh Makowe, Aabed Meer, and Lyn Denend, Stanford University, November 2010, http://www.advamed.org/NR/
rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf
8.
Das U.S. Markt Paradoxon by Dr. Marvin Baker, High Technology Associates http://www.high-technologyassociates.de/
9.
10. USA Medical Device Market Intelligence Report- Espicom Healthcare Intelligence January 31, 2010
11. Value of deals for medical technology firms rises by David Olmos, Bloomberg News, October 20, 2010 online
reference: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/10/19/BU8D1FUJFM.DTL&feed=rss.business
12. Medical Device M&A Activity up 154%, by Growthink, Feb. 15, 2010, online reference: www.growthink.com/
print/content/medical-device-ma-activity-154
13. M&A Market Rebounds from Lows by Clyde A. Burkhardt, HT Capital, LLC and MDDI Magazine, December 1,
2009 online reference: www.mddionline.com/print/6738
14. VC Heats Up, Sort Of, by Tomio Geron, The Wall Street Journal, July, 22, 2010, p. B6
15. Economy improves, but medical device IPO market still flounders, The Free
Library by Farlex, May 1, 2010, online reference: http://www.thefreelibrary.com/
Economy+improves,+but+medical+device+IPO+market+still+flounders%3A...-a0227652528
16. 2007 Economic Census: Economy-wide Key Statistics: 2007, U.S. Census Bureau http://factfinder.census.gov/
servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0762I1&-_lang=en
17. Kaiser Family Foundation,online reference: http://facts.kff.org/chart.aspx?ch=1390
18. Health Costs Could Balloon as Baby Boomers Age, Press Release by Watson Wyatt Worldwide, http://www.
watsonwyatt.com/news/press.asp?ID=6958
19. Centers for Medicare and Medicaid Services, Highlights National Health Expenditures-2009, online posting
January 2011: http://www.cms.gov/NationalHealthExpendData/02_NationalHealthAccountsHistorical.
asp#TopOfPage
20. Centers for Medicare and Medicaid Services, Highlights National Health Expenditures, 2009 online posting:
January 2011 http://www.cms.hhs.gov/NationalHealthExpendData/02_NationalHealthAccountsHistorical.asp
http://www.cms.hhs.gov/NationalHealthExpendData/downloads/highlights.pdf
21. Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Statistics Group. January 2011
22. American Heart Association, Heart Disease and Stroke Statistics 2011 Update.
23. American Heart Association. Heart Disease and Stroke Statistics 2011 Update, p. e182. http://circ.ahajournals.
org/cgi/reprint/CIR.0b013e3182009701
24. Standard & Poors: Healthcare Industry: Products & Supplies, April 2007
25. Heart-Valve Win May Prod J&J, Abbott to Buy Companies, by David Olmos, Bloomberg, November 10, 2010
online reference: http://www.bloomberg.com/news/2010-11-10/heart-valve-win-may-prod-j-j-abbott-to-shop-fortechnology.html
26. Boston Scientific 2009 Annual Report
27. Standard & Poors Surveys Healthcare: Products & Supplies, February 4, 2010
28. Drug-coated stents safe for large heart arteries, by Debra Sherman and Ransdell Pierson, Reuters, November 16,
2010, online reference: http://www.reuters.com/article/idUSTRE6AF2ZF20101116
29. Diabetes Study Questions Expensive Treatments, The Wall Street Journal, June 8, 2009 p. B1
30. Boston Scientific Press Release, May 24, 2010
The U.S. Market for Medical Devices.
133
31. Medtronic to Roll Out 60Major Products, by Jon Kamp, The Wall Street Journal, June 8, 2010, p. B6
32. Edwards Lifesciences Corp. Press Release January 25, 2010
33. Medtronic Press Release March 17, 2010
34. Abbott Laboratories Press Release March 15, 2010
35. Edwards Lifesciences. Press Release March 2, 2010
36. Bioheart, Inc. online reference, http://www.bioheartinc.com/about.php http://www.bioheartinc.com/products.html
37. Osiris Therapeutics, online reference, http://investor.osiris.com/
38. San Diego Stent Maker Will Test Device In People by Keith Darce, Union Tribune, August 19, 2010 online
reference: http://www.signonsandiego.com/news/2010/aug/19/san-diego-stent-maker-will-test-device-people/
39. St. Jude Medical Press Release, May 12, 2010
40. Standard & Poors Industry Survey Healthcare: Products & Supplies, February 4, 2010
41. The burden of musculoskeletal diseases in the United States: www.usbjd.org, 2008
42. Stryker Corp. 2009-2010 Fact Book
43. Standard & Poors Surveys Healthcare: Products & Supplies, February 4, 2010
44. Fit Future for Hip, Knee Makers, The Wall Street Journal, March 6, 2007, p. C1 and Total Hip Replacement:
What you Need to Know by Carol Eustice, May 18, 2008, online reference: http://osteoarthritis.about.
com/b/2008/05/18/total-hip-replacement-what-you-need-to-know.htm
45. PearlDiver http://www.pearldiverinc.com/pdi/code_results.jsp?code=81.54&x=36&y=26
46. American Academy of Orthopedic Surgeons www.aaos.org
47. Keeping Tabs on Implants, by Jon Kamp, The Wall Street Journal, October 13, 2010 online reference: http://
online.wsj.com/article/SB10001424052748704164004575548121765310614.html?mod=dist_smartbrief
48. CDC National Center for Injury Prevention and Control http://www.cdc.gov/ncipc/factsheets/scifacts.htm
49. Merritt, Hawkins & Associates 2010 Physician Inpatient/Outpatient Revenue Survey http://www.merritthawkins.
com/pdf/2010revenuesurvey.pdf
50. A good overview of 510(k) approved orthopedic products is available at https://www.orthoworld.com. Membership
at orthoworld is recommended for all interested in the U.S. orthopedic industry.
51. FDA impact on U.S. Medical technology Innovation: A Survey of Over 200 Medical Technology Companies
November 2010
52. Medical Device Technology Forecast 2008, Future Trends in Medical Device Technologies, William A. Herman and
Gilbert B. Devey. Center for Devices and Radiological Health, January 3, 2011
53. Specialty Update: Whats new in spine surgery by Keith H. Bridwell et al J Bone Joint Surg. Am. 2010;92:2017-28
54. Official Journal of the European Communities L331/1 de 7 december 1998
55. Molecular Diagnostic Market Heating Up, by K.K. Jain, MD, Genetic Engineering & Biotechnology News, April
1, 2010, online reference: http://www.genengnews.com/gen-articles/molecular-diagnostic-market-heatingup/3234/?page=1
56. Ibid.
57. Ibid.
58. Fully Automated MDx: Automated platforms address the needs of multiplexing and personalized medicine for any
size laboratory, by Carl T. Wittwer, MD, PhD, Advance Laboratory, April 13, 2010 online posting: http://laboratorymanager.advanceweb.com/Archives/Article-Archives/Fully-Automated-MDx.aspx
59. BD Diagnostics Press Release June 2, 2010
60. Gene Test for Tumors Offers Hope of Aiding Treatment, by Ron Winslow, The Wall Street Journal, February 19,
2010, p. A3
61. NinePoint Medical drums up $33 million MassDevice, October 14, 2010, online reference: http://www.
massdevice.com/news/ninepoint-medical-drums-33-million
62. New Chip Captures Specialized Immune Cells, by Emily Singer, MIT Technology Review, September 8, 2010
online reference http://www.technologyreview.com/biomedicine/26231/?a=f
63. Device could aid detection of flesh-killer, Clarionledger.com, November 8, 2010, online reference: http://www.
clarionledger.com/article/20101108/NEWS/11080312/Device-could-aid-detection-of-flesh-killer
64. Iris International Press Release, May 18, 2010
134
65. GE Is Latest to Make Handheld Ultrasound, by Paul Glader, The Wall Street Journal, February 12, 2010, p. B1
66. 3D Real-Time Medical Imaging Dominion Vi 3D Medical Imaging Scanner Medical Imaging Technology, online
reference http://www.medicalnewstoday.com/articles/111411.php, June 16, 2008
67. Hologic press release, February 11, 2011 http://www.hologic.com/en/news-releases/173-id.234881803.html
68. GE to develop sequential PET+ MR imaging online reference: Healthimaging.com, October 11, 2010
69. Medtronic Press Release April 26, 2010
70. SonoSite Press Release, May 27, 2010
71. Patterson Companies, Inc. Fiscal 2010 10k annual report
72. Horizon Health Corp. online reference http://www.horizonhealth.com/prs/programs/index.php
73. Invacare Corp. 2009 annual report
74. North American Dental Devices Market Outlook to 2016, December 2010 www.medicaletrack.com
75. Dental Implant Market to Recover from Economic Crisis by 2010, Osseo News, online reference: http://www.
osseonews.com/drosseo/content/78779-dental-implant-market-recover-economic-crisis-2010
76. The American Way of Dentistry: The Oral Cost Spiral, by June Thomas, Slate.com, September 29, 2009 online
reference: http://www.slate.com/id/2229632/
77. Paradigm Stretch, by Richard Palmer, Dental Products Report, March 10, 2008
78. New Twists on Implants, by Richard Palmer, Dental Lab Products, September 2009
79. Dental Products Report: Materials Survey, by Stan Goff, March 2008 online reference http://www.dprworld.com/
articles/show/dpr0308_tid_materials-survey
80. Dental Products Report: Patient Education, by Stan Goff, August 2008 online reference http://www.dprworld.
com/articles/show/dpr0808_tr_patient-education
81. Sirona Dental Systems Inc: 2010 Annual Report 2010, Form 10-K p.5
82. Concept: CAD/CAM, by Pam Johnson, Dental Lab Products, March 2009
83. Tech Tomorrow: 3D Virtual Patient, by Stan Goff, Dental Lab Products, Tech Guide 2010, online reference: http://
www.dentalproductsreport.com/articles/show/dlp0710_TechTomorrow-Lead
84. Drug-Device Combinations: The Global Market BCC Research, January 2010
85. The Value of Group Purchasing - 2009: Meeting the Needs for Strategic Savings, by Eugene S. Schneller, Ph.D.,
online reference: http://www.higpa.org/assets/1/workflow_staging/AssetManager/235.PDF
86. Miller, Richard K., 2008 Healthcare Business Market Research Handbook, June 12, 2008
87. Introduction to Consulting Services by Lisa King, Ron Warren, and Gail Radcliffe, IVD Technology, October 2009,
online reference: http://www.ivdtechnology.com/article/consulting-services-10
88. SR 0.672.933.61
89. FDA to review medical products alongside Medicare Reuters, September 17, 2010 online reference: http://www.
reuters.com/article/idUSTRE68F3F320100916
90. Centers for Medicare and Medicaid, online Medicare Information Resource http://www.cms.hhs.gov/home/
medicare.asp
91. Centers for Medicare and Medicaid, online Medicare Information Resource http://www.cms.gov/ICD10/
92. Push to Compare Treatments Worries Drug, Device Makers, by Jane Zhang, The Wall Street Jouranal, April 14,
2009, pA5
93. Blue Cross Plans Feeling Pressure to Consolidate The Wall Street Journal, August 25, 2008 p. B7
94. Understanding the Affordable Care Act: Timeline: Whats Changing and When, online reference: http://www.
healthcare.gov/law/timeline/index.html
95. New healthcare model: Accountable Care Organizations, by Tim Eaton, American Statesman, September 21,
2010, online reference: http://www.statesman.com/news/texas-politics/new-health-care-model-accountable-careorganizations-930378.html?viewAsSinglePage=true
96. Coverage Descriptions obtained from the Centers for Medicare and Medicaid, online Medicare Information
Resource, http://www.cms.hhs.gov/center/coverage.asp
97. Standard & Poors Industry Survey Healthcare: Products & Supplies, February 4, 2010 and Stryker Corp, 20092010 Fact Book
98. Reprocessed Single-Use Medical Devices from the US Government Accountability Office (GAO), January 2008
99. OEMs Best Third Parties With Own Reprocessing Programs by Shannon Tillman, Orthopedic Design &
Technology, September 2005, online reference: http://www.odtmag.com/articles/2005/09/reprocess.php
100. FDA online reference: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingleUseDevices/ucm121218.htm
The U.S. Market for Medical Devices.
135
136
137
arthroplasty that eventually was merged into Sulzermedica and Zimmer. Mr. Locher holds a degree in
Economics from the University of Basel and an MBA from the Rotmann Business School in Toronto.
Contact: erwin.locher@medtech-switzerland.com
Patricia K. Scheller is a Senior Advisor for Medtech Switzerland for the U.S. market. Ms. Scheller
also serves as the CEO of Prescient Medical, Inc. an interventional cardiology company. Prior to joining
Prescient Medical, she served as CEO of Somalogic, Inc., a proteomic company developing protein signature
arrays. Ms. Scheller also managed several business units at Ortho-Clinical Diagnostics and was director of
cardiology systems at Cordis, a Johnson & Johnson company. There she was responsible for launching the first
PALMAZ-SCHATZ Stent. Ms. Scheller also served in key executive positions at Dade Behring, a clinical
diagnostics firm. She received her BSE degree in Biomedical Engineering from Duke University and has
completed executive education programs at the Massachusetts Institute of Technology, Harvard, Columbia
and Northwestern Universities. Contact: p.scheller@medtech-switzerland.com
Frank Ustar is Deputy Director of the Swiss Business Hub USA and Trade Commissioner for Los Angeles.
Mr. Ustar holds a BA in Economics and a MA in Marketing. Before joining the Swiss government in 1984,
Mr. Ustar worked as a Research Associate for Ohio State University. Prior he held various positions in the
private sector. Mr. Ustar can be reached via email at: frank@swissbusinesshub.org, Tel 310 575 1145 or Fax
310 575 1982.
Martin von Walterskirchen, Regional Director of the Americas and Director of Swiss Business
Hub USA, is a graduate (honors) of the University of St.Gallen, Switzerland. Previously he has served
as Councilor of the Swiss Embassy in Moscow, Swiss Chief Negotiator for Services (GATS) during the
Uruguay Round of the GATT, General Secretary of the Swiss Federal Office for foreign economic affairs,
and Personal Advisor to the Swiss Minister of Justice and Police, and to the Swiss President. On September
21, 2001 the Swiss Government conferred upon him the title of Minister. Contact:
martin@swissbusinesshub.org
Daniel A. Wuersch, is the Managing Partner of Wuersch & Gering LLP, an international boutique firm
with 15 lawyers in New York. His practice focuses on corporate law, mergers & acquisitions, corporate
finance and strategic partnerships and marketing agreements. He is admitted to the bar in New York and
Zurich, Switzerland. He acquired his Dr. iur. degree at the University of Zurich Switzerland in 1989. In
1991, he obtained an LL.M. degree at the Georgetown University Law Center, Washington, D.C. In
addition, he attended graduate and post-graduate courses in international law and EU law at the University
of Lausanne, Switzerland and the London School of Economics. Prior to co-founding Wuersch & Gering
LLP in 1997, he practiced international corporate and securities law with Morgan Lewis & Bockius (19961997) and Fried, Frank, Harris, Shriver & Jacobson (1991-1996) in New York, as well as Homburger /
Baker & McKenzie in Zurich, Switzerland (1988-1990). He has written and co-authored books and articles
on United States and Swiss corporate and contract law and the law of the European Union. Mr. Wuersch
is a frequent speaker on legal issues involving business activities of foreign companies in the United States.
He is the President of the Swiss Society of New York and a member of the Chapter Board Doing Business
in USA of the Swiss American Chamber of Commerce. Contact: daniel.wuersch@wg-law.com
Other Reports of Swiss Business Hub USA
Doing Business in the United States A Handbook for Swiss Business Women, by Ally
Gunduz with contributions by Suzanne H. Ambrose, Ursula Day, Monika Howden, Karen Monroe, and
Karin Vibe-Stewart
The US Market for Biotechnology Opportunities and Challenges for Swiss Companies,
by Daniel Bangser, with contributions by W. David Braun, Richard M. Franklin, Claudine M. Haeni, John
F. Lemker, Scot Orgish, Ulice Payne Jr, Michael S. Rosen, Donald J. Silvert, Frank Ustar, and Martin von
Walterskirchen
The US Food Industry Opportunities and Challenges for Swiss Companies, by Claudine M.
Haeni, with contributions by Paul S. Anderson, Ally Gunduz, John F. Lemker; Frank Ustar, Martin von
Walterskirchen, and Daniel A. Wuersch
The Automotive Industry by Kimberly Corradi
The US Nanotechnology Environment Where is the Business, by Philipp H. Buff
138
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