Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 10
1.2 List of Figures 14
2 Introduction 16
2.1 What Is This Report
About? 16
3 Definitions of the Markets Covered in the Report 17
3.1
Patient Monitoring 17
3.2 Micro-Electromechanical Systems 17
3.3
Multiparameter Patient Monitoring 17
3.3.1 Critical Care Monitors 17
3.3.2 Perioperative Care Monitors 17
3.4 Non-Invasive Blood Pressure
Monitors 17
3.4.1 Aneroid Sphygmomanometer 17
3.4.2 Automatic
Sphygmomanometer 17
3.4.3 Mercury Sphygmomanometer 18
3.5 Remote
Patient Monitoring 18
3.6 Wireless and Ambulatory Monitoring 18
3.6.1
Cardiac Rehabilitation Ambulatory 18
3.6.2 Hospital Ambulatory 18
4
Healthcare Sector Review 19
4.1 Healthcare Expenditure 19
4.2
Healthcare Infrastructure 23
4.2.1 Healthcare Personnel Data 23
4.2.2
Healthcare Facilities Data 27
4.3 United States Healthcare Trade
Statistics 29
5 Regulation System 30
5.1 Regulation System 30
5.2
Medical Equipment Approval Process 30
5.2.1 Pre-market Approval Process
31
5.2.2 Intended use and Indications for use 31
5.2.3 Predicate
Device 32
5.2.4 Safe and Effective 32
5.2.5 Other Category Devices
34
5.2.6 Post-Market Approval Process 35
5.2.7 Compliance and
Enforcement 35
5.2.8 Registration Fee 36
5.2.9 Approval Time 36
6
Pricing and Reimbursement 37
6.1 Government Policies 37
6.2 Private
Insurance 38
6.3 Diagnosis Related Groups (DRG) 39
7 Distribution
Structure 40
7.1 Distribution Structure 40
8 Patient Monitoring In
United States 41
8.1 Patient Monitoring, Cross Country Comparison, Revenue
($ mn), 2000-2015 41
8.2 Patient Monitoring, United States, Overall
Revenue ($ mn), 2000-2015 43
8.3 Patient Monitoring, United States,
Category Volume (Units), 2000-2015 49
8.4 Patient Monitoring, United
States, Company Share (2007-2008) 51
9 Micro-Electromechanical Systems In
United States 52
9.1 Micro-Electromechanical Systems Overall Revenue
(2000-2015) 52
9.2 Micro-Electromechanical Systems Overall Volume
(2000-2015) 54
9.3 Micro-Electromechanical Systems Average Price
(2000-2015) 56
9.4 Micro-Electromechanical Systems Distribution Share
(2007-2008) 57
9.5 Micro-Electromechanical Systems, United States, Company
Share (2007-2008) 58
10 Multiparameter Patient Monitoring In United States
59
10.1 Multiparameter Patient Monitoring Overall Revenue (2000-2015)
59
10.2 Multiparameter Patient Monitoring Overall Volume (2000-2015)
61
10.3 Multiparameter Patient Monitoring Average Price (2000-2015) 63
10.4 Multiparameter Patient Monitoring Distribution Share (2007-2008) 64
10.5 Multiparameter Patient Monitoring, United States, Company Share
(2007-2008) 65
11 Non-Invasive Blood Pressure Monitors In United States
66
11.1 Non-Invasive Blood Pressure Monitors Overall Revenue (2000-2015)
66
11.2 Non-Invasive Blood Pressure Monitors Overall Volume (2000-2015)
68
11.3 Non-Invasive Blood Pressure Monitors Average Price (2000-2015)
70
11.4 Non-Invasive Blood Pressure Monitors Distribution Share
(2007-2008) 71
11.5 Non-Invasive Blood Pressure Monitors, United States,
Company Share (2007-2008) 72
12 Remote Patient Monitoring In United States
73
12.1 Remote Patient Monitoring Overall Revenue (2000-2015) 73
12.2
Remote Patient Monitoring Overall Volume (2000-2015) 75
12.3 Remote
Patient Monitoring Average Price (2000-2015) 77
12.4 Remote Patient
Monitoring Distribution Share (2007-2008) 78
12.5 Remote Patient
Monitoring, United States, Company Share (2007-2008) 79
13 Wireless and
Ambulatory Monitoring In United States 80
13.1 Wireless and Ambulatory
Monitoring Overall Revenue (2000-2015) 80
13.2 Wireless and Ambulatory
Monitoring Overall Volume (2000-2015) 82
13.3 Wireless and Ambulatory
Monitoring Average Price (2000-2015) 84
13.4 Wireless and Ambulatory
Monitoring Distribution Share (2007-2008) 85
13.5 Wireless and Ambulatory
Monitoring, United States, Company Share (2007-2008) 86
14 Overview of Key
Companies in Canada Patient Monitoring Market 88
14.1 Philips Healthcare
88
14.1.1 Company Overview 88
14.2 GE Healthcare 89
14.2.1 Company
Overview 89
14.2.2 GE Healthcare Pipeline Products 89
14.2.2.1 GE
Healthcare Pipeline Products By Equipment Type 89
14.2.2.2 GE Healthcare
Pipeline Products By Development Stage 89
14.2.2.3 GE Healthcare Pipeline
Products By Therapy Area 90
14.2.2.4 GE Healthcare Pipeline Products By
Clinical Trials 90
14.2.2.5 GE Healthcare Pipeline Products By News
Summary 90
14.3 Mindray Medical International Limited 91
14.3.1
Company Overview 91
14.4 OMRON HEALTHCARE Co., Ltd. 92
14.4.1 Company
Overview 92
14.4.2 OMRON HEALTHCARE Co., Ltd. Pipeline Products 92
14.4.2.1 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Equipment Type 92
14.4.2.2 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Development Stage
92
14.4.2.3 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area
93
14.4.2.4 OMRON HEALTHCARE Co., Ltd. Pipeline Products By News Summary
93
14.5 Draegerwerk AG & Co. KGaA 94
14.5.1 Company Overview 94
14.5.2 Drager Medical AG & Co. KG Pipeline Products 94
14.5.2.1 Drager
Medical AG & Co. KG Pipeline Products By Equipment Type 94
14.5.2.2 Drager
Medical AG & Co. KG Pipeline Products By Development Stage 94
14.5.2.3
Drager Medical AG & Co. KG Pipeline Products By Therapy Area 94
14.6 OSI
Systems, Inc. 95
14.6.1 Company Overview 95
14.7 Edwards Lifesciences
Corporation 95
14.7.1 Company Overview 95
14.8 GE Sensing & Inspection
Technologies 96
14.8.1 Company Overview 96
14.9 Fukuda Denshi Co.,
Ltd. 96
14.9.1 Company Overview 96
14.10 Criticare Systems, Inc.
97
14.10.1 Company Overview 97
14.11 Schiller AG 97
14.11.1
Company Overview 97
14.12 Nihon Kohden Corporation 98
14.12.1 Company
Overview 98
14.13 Welch Allyn Inc. 98
14.13.1 Company Overview 98
14.14 Microlife Corporation 99
14.14.1 Company Overview 99
14.15
Terumo Corporation 99
14.15.1 Company Overview 99
14.16 HARTMANN GROUP
100
14.16.1 Company Overview 100
14.17 St. Jude Medical, Inc. 100
14.17.1 Company Overview 100
14.18 Medtronic, Inc. 101
14.18.1 Company
Overview 101
14.19 Siemens Healthcare 102
14.19.1 Company Overview
102
14.20 Boston Scientific Corporation 102
14.20.1 Company Overview
102
14.21 BIOTRONIK GmbH & Co. KG 103
14.21.1 Company Overview 103
14.22 Datascope Corporation 103
14.22.1 Company Overview 103
14.23 A&D
Medical / LifeSource 104
14.23.1 Company Overview 104
14.24 Card Guard
AG 104
14.24.1 Company Overview 104
14.24.2 Card Guard AG Pipeline
Products 105
14.24.2.1 Card Guard AG Pipeline Products By Equipment Type
105
14.24.2.2 Card Guard AG Pipeline Products By Development Stage 105
14.24.2.3 Card Guard AG Pipeline Products By Therapy Area 105
14.25
Proteus Biomedical, Inc. 106
14.25.1 Company Overview 106
14.25.2
Proteus Biomedical, Inc. Pipeline Products 106
14.25.2.1 Proteus
Biomedical, Inc. Pipeline Products By Equipment Type 106
14.25.2.2 Proteus
Biomedical, Inc. Pipeline Products By Development Stage 106
14.25.2.3
Proteus Biomedical, Inc. Pipeline Products By Therapy Area 106
14.25.2.4
Proteus Biomedical, Inc. Pipeline Products By Clinical Trials 107
14.25.2.5 Proteus Biomedical, Inc. Pipeline Products By News Summary 107
14.26 NeuroSystems, LLC. 108
14.26.1 Company Overview 108
14.26.2
NeuroSystems, LLC. Pipeline Products 108
14.26.2.1 NeuroSystems, LLC.
Pipeline Products By Equipment Type 108
14.26.2.2 NeuroSystems, LLC.
Pipeline Products By Development Stage 108
14.26.2.3 NeuroSystems, LLC.
Pipeline Products By Therapy Area 108
14.26.2.4 NeuroSystems, LLC.
Pipeline Products By Clinical Trials 109
14.26.2.5 NeuroSystems, LLC.
Pipeline Products By News Summary 109
14.27 Critical Signal Technologies
110
14.27.1 Company Overview 110
14.27.2 Critical Signal Technologies
Pipeline Products 110
14.27.2.1 Critical Signal Technologies Pipeline
Products By Equipment Type 110
14.27.2.2 Critical Signal Technologies
Pipeline Products By Development Stage 110
14.27.2.3 Critical Signal
Technologies Pipeline Products By Therapy Area 110
14.27.2.4 Critical
Signal Technologies Pipeline Products By Clinical Trials 111
14.28 Unilead
International, Inc. 112
14.28.1 Company Overview 112
14.29 A C Cossor
& Son (Surgical) Ltd 112
14.29.1 Company Overview 112
14.30 Colin
Medical Technology Corporation 112
14.30.1 Company Overview 112
14.31
Bed-Check Corporation 113
14.31.1 Company Overview 113
14.32 Ivy
Biomedical Systems, Inc. 113
14.32.1 Company Overview 113
14.33 Lynn
Medical 113
14.33.1 Company Overview 113
14.34 AccuTech, LLC 114
14.34.1 Company Overview 114
14.35 Zassi Medical Evolutions, LLC 114
14.35.1 Company Overview 114
14.36 Axon Systems, Inc. 114
14.36.1
Company Overview 114
15 Financial Deals Landscape 115
15.1 Acquisition
115
15.1.1 Endress+Hauser Flowtec Acquires Minority Stake In Integrated
Sensing Systems 115
15.2 Partnerships 116
15.2.1 Masimo Enters Into An
Agreement With Oridion Systems 116
15.2.2 Aspect Medical Systems Enters
Into Licensing Agreement With LiDCO Group 117
15.2.3 Integrated Sensing
Systems Enters Into An Agreement With Endress+Hauser Flowtec 118
15.2.4
Covidien Enters Into An Agreement With Philips Healthcare 119
15.2.5
MEMSCAP Enters Into An Agreement With OrthoMEMS 120
15.2.6 Welch Allyn
Enters Into An Agreement With Schiller 121
15.2.7 Covidien Enters Into An
Agreement With Drager Medical 122
16 Recent Developments 123
16.1
Strategy And Business Planning 123
16.1.1 Aug 14, 2009: Smiths Medical to
Move And Expand Its Distribution Operations In Memphis’ DeSoto County,
Tennessee 123
16.1.2 Aug 07, 2009: Spacelabs Healthcare Opens Anesthesia
Office In Madison, Wisconsin 123
16.1.3 Jul 10, 2009: Cardinal Health
Board Approves CareFusion Spinoff 123
16.1.4 Jun 23, 2009: GE Healthcare,
HANYS And Bassett Healthcare Collaborate To Develop Technologies For Safety Of
Patients 124
16.1.5 May 28, 2009: RealtimeTechnologies To Establish
Headquarters In Massachusetts 125
16.1.6 May 18, 2009: MEI And GE
Healthcare Sign Strategic Agreement 125
16.1.7 Apr 08, 2009: Philips To
Make India Hub For Manufacturing Of Medical Equipment 125
16.1.8 Mar 24,
2009: Hospira Announces Plans To Optimize Operations, Increase Shareholder
Value 126
16.1.9 Mar 02, 2009: EarlySense To Partner With CHW To Test
Everon Patient Supervision System 127
16.1.10 Feb 03, 2009: Royal Philips
And Immunetrics Join Forces To Research Advanced Solutions For Infectious
Disease In Critical Care 128
16.1.11 Jan 28, 2009: Analogic Plans To
Reduce Workforce Worldwide 129
16.1.12 Jan 08, 2009: TMC Moves Its
Introducer Sheath Technology To A Larger Plant 129
16.2 Government and
Public Interest 129
16.2.1 Aug 10, 2009: Impedimed To Benefit From North
Carolina Reimbursement Law 129
16.2.2 Apr 09, 2009: Avera Study Shows
Positive Impact Of Remote Intensivist Care Through eICU 130
16.2.3 Mar 27,
2009: New GAO Report Notes Need For Better Data On Healthcare Associated
Infections In ASCs 131
16.3 Product News 131
16.3.1 Jul 29, 2009:
Aspect Medical Systems Sign Exclusive US Distribution And Licensing Agreement
With LiDCO Group 131
16.3.2 Jul 27, 2009: Philips Introduces SureSigns VS2
132
16.3.3 Jul 07, 2009: SunTech Medical Announces Integration Of Medical
Blood Pressure Technology In ExpressMD’s Electronic House Call Remote
Patient Monitoring 132
16.3.4 Jun 30, 2009: Hema Metrics Announces
Availability Of Crit-Line Technology In CHF Solutions' Aquadex Flexflow Device
133
16.3.5 Jun 18, 2009: HealthFrontier Introduces ecg@home 133
16.3.6
Jun 10, 2009: Healthsense Receives Wi-Fi Certification For eNeighbor Remote
Monitoring System 134
16.3.7 Jun 09, 2009: VivoMetrics Unveils First
Complete Prototype Of Next Generation LifeShirt 135
16.3.8 May 20, 2009:
Mayo Clinic Installs Covidien’s OxiNet III System 136
16.3.9 May 18,
2009: Cheetah Medical Presents Pilot Results Of Early Differential Diagnostic
Protocol For Acute Heart Failure 137
16.3.10 May 18, 2009: Researchers
Find Cheetah Medical' s BIOREACTANCE Technology To Be A Valuable Tool In Early
Detection Of Sepsis 137
16.3.11 May 14, 2009: Boston Scientific
Corporation Announced Clinical Data From Its ALTITUDE Clinical Science Program
138
16.3.12 Apr 30, 2009: Tunstall Launches Wireless Telehealth Monitor
With Built-in GSM/GPRS Mobile Phone Technology In USA 138
16.3.13 Apr 24,
2009: Philips Healthcare Introduces FlexVision XL 139
16.3.14 Apr 21,
2009: Corventis Announces Availability Of The AVIVO Mobile Patient Management
System 139
16.3.15 Apr 16, 2009: Atcor Medical’s SphygmoCor
Demonstrates Accuracy In Predicting Pre-eclampsia 139
16.3.16 Apr 14,
2009: ExpressMD Solutions Announces FDA 510(K) Clearance For Remote Patient
Health Monitoring Device 140
16.3.17 Mar 31, 2009: Study Indicates A New
Application For Atcor’s SphygmoCor Technology 141
16.3.18 Mar 13,
2009: Double Black Imaging Unveils Surgical Displays At AORN Show 141
16.3.19 Mar 09, 2009: According To New Study Published, InterCure’s
RESPeRATE Device Lowers Blood Pressure In Diabetic Patients 142
16.3.20
Mar 02, 2009: InterCure' s RESPeRATE Hypertension Treatment Device Is Now
Available At Rite Aid 142
16.3.21 Feb 24, 2009: A&D Medical' s UA-705V
Blood Pressure Monitor Receives Consumers Digest Best Buy Award 143
16.3.22 Feb 24, 2009: Hutchinson Technology Sells InSpectra StO2 Tissue
Oxygenation Monitoring System To Assistance Publique Hopitaux De Paris (AP-HP)
143
16.3.23 Feb 09, 2009: Smiths Medical Introduces SmartX Wireless
Invasive Blood Pressure Monitoring Transducer System 143
17 Appendix
144
17.1 Global Markets Direct Research Methodology 144
17.2 Secondary
Research 145
17.3 Primary Research 145
17.4 Models 146
17.5
Forecasts 146
17.6 Expert Panel Validation 146
17.7 Currency
Conversion 147
17.8 Contact Us 148
17.9 Disclaimer 148
1.1
List of Tables
Table 1: United States Healthcare Expenditure, 2000-2007
20
Table 2: United States Personal Healthcare Expenditure by Type, $
Billions, 2000-2007 21
Table 3: United States Personal Healthcare
Expenditure by Source, $ Billions, 2000-2007 22
Table 4: Total Number of
Doctors in the United States, 2003-2010 23
Table 5: Number of Doctors by
Specialty in the United States, 2003-2010 24
Table 6: Doctors by Region
(Number per 10,000 Civilian Population), 2002-2004 25
Table 7: Doctors by
Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 26
Table
8: Total Hospitals in the United States, 2000-2004 27
Table 9: Community
Hospitals by Number of Beds in the United States, 2000-2004 27
Table 10:
Number of Hospital Beds in the United States, 2000-2004 27
Table 11:
Number of Hospital Beds by Range in the United States, 2000-2004 28
Table
12: United States Healthcare Trade Statistics, 2001-2006 29
Table 13:
Medical Equipment Registration Fee in United States, 2007 36
Table 14:
Medical Device Approval Time in United States, 2007 36
Table 15:
Patient Monitoring, Cross Country Comparison, Revenue ($ mn), 2000-2015 42
Table 16: Patient Monitoring, United States, Overall Revenue ($ mn),
2000-2015 43
Table 17: Patient Monitoring, United States, Cross-Category
Analysis, 2000-2015 44
Table 18: Patient Monitoring, United States,
Overall Revenue ($ mn), Historic, 2000-2008 46
Table 19: Patient
Monitoring, United States, Overall Revenue ($ mn), Forecast, 2008-2015 48
Table 20: Patient Monitoring, United States, Category Volume (Units),
2000-2015 49
Table 21: Patient Monitoring, United States, Category
Volume (Units), Historic, 2000-2008 49
Table 22: Patient Monitoring,
United States, Category Volume (Units), Forecast, 2008-2015 50
Table 23:
Patient Monitoring, United States, Company Share by Revenue ($ mn),
2007-2008 51
Table 24: Micro-Electromechanical Systems, United
States, Revenue ($ mn), Historic, 2000-2008 52
Table 25:
Micro-Electromechanical Systems, United States, Revenue ($ mn), Forecast,
2008-2015 53
Table 26: Micro-Electromechanical Systems, United
States, Volume (Units), Historic, 2000-2008 54
Table 27:
Micro-Electromechanical Systems, United States, Volume (Units), Forecast,
2008-2015 55
Table 28: Micro-Electromechanical Systems, United
States, Average Price ($), Historic, 2000-2008 56
Table 29:
Micro-Electromechanical Systems, United States, Average Price ($), Forecast,
2008-2015 56
Table 30: Micro-Electromechanical Systems, United
States, Distribution Share by Revenue ($mn), 2007-2008 57
Table 31:
Micro-Electromechanical Systems, United States, Company Share by Revenue ($
mn), 2007-2008 58
Table 32: Multiparameter Patient Monitoring, United
States, Revenue ($ mn) by Segment, Historic, 2000-2008 59
Table 33:
Multiparameter Patient Monitoring, United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 60
Table 34: Multiparameter Patient Monitoring,
United States, Volume (Units) by Segment, Historic, 2000-2008 61
Table 35:
Multiparameter Patient Monitoring, United States, Volume (Units) by
Segment, Forecast, 2008-2015 62
Table 36: Multiparameter Patient
Monitoring, United States, Average Price ($), Historic, 2000-2008 63
Table
37: Multiparameter Patient Monitoring, United States, Average Price ($),
Forecast, 2008-2015 63
Table 38: Multiparameter Patient Monitoring,
United States, Distribution Share by Revenue ($mn), 2007-2008 64
Table 39:
Multiparameter Patient Monitoring, United States, Company Share by
Revenue ($ mn), 2007-2008 65
Table 40: Non-Invasive Blood Pressure
Monitors, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 66
Table 41: Non-Invasive Blood Pressure Monitors, United States, Revenue ($
mn) by Segment, Forecast, 2008-2015 67
Table 42: Non-Invasive Blood
Pressure Monitors, United States, Volume (Units) by Segment, Historic,
2000-2008 68
Table 43: Non-Invasive Blood Pressure Monitors, United
States, Volume (Units) by Segment, Forecast, 2008-2015 69
Table 44:
Non-Invasive Blood Pressure Monitors, United States, Average Price ($),
Historic, 2000-2008 70
Table 45: Non-Invasive Blood Pressure
Monitors, United States, Average Price ($), Forecast, 2008-2015 70
Table
46: Non-Invasive Blood Pressure Monitors, United States, Distribution
Share by Revenue ($mn), 2007-2008 71
Table 47: Non-Invasive Blood
Pressure Monitors, United States, Company Share by Revenue ($ mn), 2007-2008
72
Table 48: Remote Patient Monitoring, United States, Revenue ($
mn), Historic, 2000-2008 73
Table 49: Remote Patient Monitoring,
United States, Revenue ($ mn), Forecast, 2008-2015 74
Table 50:
Remote Patient Monitoring, United States, Volume (Units), Historic, 2000-2008
75
Table 51: Remote Patient Monitoring, United States, Volume
(Units), Forecast, 2008-2015 76
Table 52: Remote Patient Monitoring,
United States, Average Price ($), Historic, 2000-2008 77
Table 53:
Remote Patient Monitoring, United States, Average Price ($), Forecast,
2008-2015 77
Table 54: Remote Patient Monitoring, United States,
Distribution Share by Revenue ($mn), 2007-2008 78
Table 55: Remote
Patient Monitoring, United States, Company Share by Revenue ($ mn), 2007-2008
79
Table 56: Wireless and Ambulatory Monitoring, United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 80
Table 57: Wireless
and Ambulatory Monitoring, United States, Revenue ($ mn) by Segment, Forecast,
2008-2015 81
Table 58: Wireless and Ambulatory Monitoring, United
States, Volume (Units) by Segment, Historic, 2000-2008 82
Table 59:
Wireless and Ambulatory Monitoring, United States, Volume (Units) by Segment,
Forecast, 2008-2015 83
Table 60: Wireless and Ambulatory Monitoring,
United States, Average Price ($), Historic, 2000-2008 84
Table 61:
Wireless and Ambulatory Monitoring, United States, Average Price ($),
Forecast, 2008-2015 84
Table 62: Wireless and Ambulatory Monitoring,
United States, Distribution Share by Revenue ($mn), 2007-2008 85
Table 63:
Wireless and Ambulatory Monitoring, United States, Company Share by
Revenue ($ mn), 2007-2008 87
Table 64: GE Healthcare Pipeline
Products by Equipment Type 89
Table 65: GE Healthcare Pipeline
Products By Development Stage 89
Table 66: GE Healthcare Pipeline
Products By Therapy Area 90
Table 67: GE Healthcare Pipeline Products
By Clinical Trials 90
Table 68: GE Healthcare Pipeline Products By
News Summary 90
Table 69: OMRON HEALTHCARE Co., Ltd. Pipeline
Products by Equipment Type 92
Table 70: OMRON HEALTHCARE Co., Ltd.
Pipeline Products By Development Stage 92
Table 71: OMRON HEALTHCARE
Co., Ltd. Pipeline Products By Therapy Area 93
Table 72: OMRON
HEALTHCARE Co., Ltd. Pipeline Products By News Summary 93
Table 73:
Drager Medical AG & Co. KG Pipeline Products by Equipment Type 94
Table
74: Drager Medical AG & Co. KG Pipeline Products By Development Stage
94
Table 75: Drager Medical AG & Co. KG Pipeline Products By Therapy
Area 94
Table 76: Card Guard AG Pipeline Products by Equipment Type
105
Table 77: Card Guard AG Pipeline Products By Development Stage
105
Table 78: Card Guard AG Pipeline Products By Therapy Area 105
Table 79: Proteus Biomedical, Inc. Pipeline Products by Equipment Type
106
Table 80: Proteus Biomedical, Inc. Pipeline Products By
Development Stage 106
Table 81: Proteus Biomedical, Inc. Pipeline
Products By Therapy Area 106
Table 82: Proteus Biomedical, Inc.
Pipeline Products By Clinical Trials 107
Table 83: Proteus
Biomedical, Inc. Pipeline Products By News Summary 107
Table 84:
NeuroSystems, LLC. Pipeline Products by Equipment Type 108
Table 85:
NeuroSystems, LLC. Pipeline Products By Development Stage 108
Table 86:
NeuroSystems, LLC. Pipeline Products By Therapy Area 108
Table 87:
NeuroSystems, LLC. Pipeline Products By Clinical Trials 109
Table 88:
NeuroSystems, LLC. Pipeline Products By News Summary 109
Table 89:
Critical Signal Technologies Pipeline Products by Equipment Type 110
Table
90: Critical Signal Technologies Pipeline Products By Development Stage
110
Table 91: Critical Signal Technologies Pipeline Products By
Therapy Area 110
Table 92: Critical Signal Technologies Pipeline
Products By Clinical Trials 111
Table 93: Endress+Hauser Flowtec
Acquires Minority Stake In Integrated Sensing Systems 115
Table 94:
Masimo Enters Into An Agreement With Oridion Systems 116
Table 95:
Aspect Medical Systems Enters Into Licensing Agreement With LiDCO Group
117
Table 96: Integrated Sensing Systems Enters Into An Agreement
With Endress+Hauser Flowtec 118
Table 97: Covidien Enters Into An
Agreement With Philips Healthcare 119
Table 98: MEMSCAP Enters Into
An Agreement With OrthoMEMS 120
Table 99: Welch Allyn Enters Into An
Agreement With Schiller 121
Table 100: Covidien Enters Into An
Agreement With Drager Medical 122
Table 101: USD to Local Currency,
Average Exchange Rate 2008 147
1.2 List of Figures
Figure 1:
United States, Healthcare Expenditure by Source, 2007 20
Figure 2:
Healthcare Expenses Segmentation by End User, 2007 21
Figure 3: United
States, Healthcare Infrastructure, Top Level View, 2007 23
Figure 4:
Medical Equipment Approval Process in the United States, 2007 31
Figure 5:
PMA Approval Process in the United States, 2007 33
Figure 6: The 510(k)
Approval Process for Medical Devices in the United States, 2007 34
Figure
7: Reimbursement Structure in the United States, 2007 39
Figure 8:
Distribution Structure of Medical Equipment in the United States, 2007 40
Figure 9: Patient Monitoring, Cross Country Comparison, Revenue ($ mn),
2000-2015 41
Figure 10: Patient Monitoring, United States, Overall
Revenue ($ mn), 2000-2015 43
Figure 11: Patient Monitoring, United
States, Cross-Category Analysis, 2000-2015 44
Figure 12: Patient
Monitoring, United States, Overall Revenue ($ mn), Historic, 2000-2008 45
Figure 13: Patient Monitoring, United States, Overall Revenue ($ mn),
Forecast, 2008-2015 47
Figure 14: Patient Monitoring, United States,
Company Share (%), 2008 51
Figure 15: Micro-Electromechanical
Systems, United States, Revenue ($ mn), Historic, 2000-2008 52
Figure 16:
Micro-Electromechanical Systems, United States, Revenue ($ mn), Forecast,
2008-2015 53
Figure 17: Micro-Electromechanical Systems, United
States, Volume (Units), Historic, 2000-2008 54
Figure 18:
Micro-Electromechanical Systems, United States, Volume (Units), Forecast,
2008-2015 55
Figure 19: Micro-Electromechanical Systems, United
States, Company Share (%), 2008 58
Figure 20: Multiparameter Patient
Monitoring, United States, Revenue ($ mn) by Segment, Historic, 2000-2008
59
Figure 21: Multiparameter Patient Monitoring, United States,
Revenue ($ mn) by Segment, Forecast, 2008-2015 60
Figure 22:
Multiparameter Patient Monitoring, United States, Volume (Units) by Segment,
Historic, 2000-2008 61
Figure 23: Multiparameter Patient Monitoring,
United States, Volume (Units) by Segment, Forecast, 2008-2015 62
Figure
24: Multiparameter Patient Monitoring, United States, Company Share (%),
2008 65
Figure 25: Non-Invasive Blood Pressure Monitors, United
States, Revenue ($ mn) by Segment, Historic, 2000-2008 66
Figure 26:
Non-Invasive Blood Pressure Monitors, United States, Revenue ($ mn) by
Segment, Forecast, 2008-2015 67
Figure 27: Non-Invasive Blood
Pressure Monitors, United States, Volume (Units) by Segment, Historic,
2000-2008 68
Figure 28: Non-Invasive Blood Pressure Monitors, United
States, Volume (Units) by Segment, Forecast, 2008-2015 69
Figure 29:
Non-Invasive Blood Pressure Monitors, United States, Company Share (%), 2008
72
Figure 30: Remote Patient Monitoring, United States, Revenue ($
mn), Historic, 2000-2008 73
Figure 31: Remote Patient Monitoring,
United States, Revenue ($ mn), Forecast, 2008-2015 74
Figure 32:
Remote Patient Monitoring, United States, Volume (Units), Historic, 2000-2008
75
Figure 33: Remote Patient Monitoring, United States, Volume
(Units), Forecast, 2008-2015 76
Figure 34: Remote Patient Monitoring,
United States, Company Share (%), 2008 79
Figure 35: Wireless and
Ambulatory Monitoring, United States, Revenue ($ mn) by Segment, Historic,
2000-2008 80
Figure 36: Wireless and Ambulatory Monitoring, United
States, Revenue ($ mn) by Segment, Forecast, 2008-2015 81
Figure 37:
Wireless and Ambulatory Monitoring, United States, Volume (Units) by Segment,
Historic, 2000-2008 82
Figure 38: Wireless and Ambulatory Monitoring,
United States, Volume (Units) by Segment, Forecast, 2008-2015 83
Figure
39: Wireless and Ambulatory Monitoring, United States, Company Share (%),
2008 86
Figure 40: Global Markets Direct Methodology 144
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