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Table of Contents :
1 Table of Contents 2 1.1 List of Tables 10 1.2 List of Figures 13 2 Introduction 14 2.1 What Is This Report About? 14 3 Executive Summary 15 4 Definitions of Markets Covered in This Report 16 4.1 Diabetes Care Devices 16 4.2 Glucose Monitoring Devices 16 4.2.1 Blood Glucose Meters 16 4.2.1.1 Traditional Glucose Meters 16 4.2.1.2 Continuous Glucose Monitoring Systems 16 4.2.2 Blood Glucose Strips 16 4.3 Insulin Delivery 16 4.3.1 InsulinPens 16 4.3.1.1 Reusable Insulin Pens 16 4.3.1.2 Disposable Insulin Pens 16 4.3.2 Insulin Syringes 17 4.3.3 Insulin Pumps 17 4.3.3.1 Traditional Insulin Pumps 17 4.3.3.2 Disposable Insulin Pumps 17 4.3.4 Traditional Insulin Pump Accessories 17 5 Healthcare Sector Review 18 5.1 Healthcare Expenditure 18 5.2 Healthcare Infrastructure 22 5.2.1 Healthcare Personnel Data 22 5.2.2 Healthcare Facilities Data 26 5.3 United States Healthcare Trade Statistics 28 6 Regulation System 29 6.1 Regulation System 29 6.2 Medical Equipment Approval Process 29 6.2.1 Pre-market Approval Process 30 6.2.2 Intended use and Indications for use 30 6.2.3 Predicate Device 31 6.2.4 Safe and Effective 31 6.2.5 Other Category Devices 33 6.2.6 Post-Market Approval Process 34 6.2.7 Compliance and Enforcement 34 6.2.8 Registration Fee 35 6.2.9 Approval Time 35 7 Pricing and Reimbursement 36 7.1 Government Policies 36 7.2 Private Insurance 37 7.3 Diagnosis Related Groups (DRG) 38 8 Distribution Structure 39 8.1 Distribution Structure 39 9 Diabetes Care Devices In United States 40 9.1 Diabetes Care Devices, United States, Overall Revenue ($ mn), 2000-2015 40 9.2 Diabetes Care Devices, United States, Category Volume (Units ‘000), 2000-2015 42 9.3 Diabetes Care Devices, United States, Cross-Category Analysis, 2000-2015 44 9.4 Diabetes Care Devices: Key Market Trends 45 9.4.1 Diabetes Care Devices: Growth Drivers 45 9.4.2 Diabetes Care Devices: Growth Restraints 45 9.5 Diabetes Care Devices, United States, Company Share (2007-2008) 46 9.6 Future Outlook 47 10 Glucose Monitoring In United States 48 10.1 Glucose Monitoring Overall Revenue (2000-2015) 48 10.1.1 Blood Glucose Meters Revenue (2000-2015) 50 10.2 Glucose Monitoring Overall Volume (2000-2015) 52 10.3 Glucose Monitoring, United States, Cross Segment Analysis, 2000-2015 53 10.4 Glucose Monitoring Average Price (2000-2015) 54 10.5 Glucose Monitoring Market Dynamics 55 10.5.1 Market Drivers 55 10.5.2 Market Restraints 55 10.6 Glucose Monitoring Distribution Share (2007-2008) 55 10.7 Glucose Monitoring, United States, Company Share (2007-2008) 56 11 Insulin Delivery In United States 58 11.1 Insulin Delivery Overall Revenue (2000-2015) 58 11.2 Insulin Delivery Overall Volume (2000-2015) 61 11.3 Insulin Delivery, United States, Cross Segment Analysis, 2000-2015 63 11.4 Insulin Delivery Average Price (2000-2015) 64 11.5 Insulin Delivery Market Dynamics 66 11.5.1 Market Drivers 66 11.5.2 Market Restraints 66 11.6 Insulin Delivery Distribution Share (2007-2008) 67 11.7 Insulin Delivery, United States, Company Share (2007-2008) 68 12 Overview of Key Companies in United States Diabetes Care Devices Market 70 12.1 LifeScan, Inc. Company Profile 70 12.1.1 Company Overview 70 12.1.2 LifeScan, Inc. Pipeline Products 70 12.1.2.1 LifeScan, Inc. Pipeline Products By Equipment Type 70 12.1.2.2 LifeScan, Inc. Pipeline Products By Development Stage 70 12.1.2.3 LifeScan, Inc. Pipeline Products By Therapy Area 71 12.1.2.4 LifeScan, Inc. Pipeline Products By Clinical Trials 71 12.1.2.5 LifeScan, Inc. Pipeline Products By News Summary 71 12.2 F. Hoffmann-La Roche Ltd. Company Profile 72 12.2.1 Company Overview 72 12.2.2 Value Chain Analysis 73 12.2.2.1 Manufacturing 73 12.2.2.2 Product Development 74 12.2.2.3 Sales and Marketing 75 12.2.3 F. Hoffmann-La Roche Ltd Pipeline Products 76 12.2.3.1 F. Hoffmann-La Roche Ltd Pipeline Products By Equipment Type 76 12.2.3.2 F. Hoffmann-La Roche Ltd Pipeline Products By Development Stage 76 12.2.3.3 F. Hoffmann-La Roche Ltd Pipeline Products By Therapy Area 76 12.3 Novo Nordisk A/S Company Profile 77 12.3.1 Company Overview 77 12.3.2 Novo Nordisk A/S Pipeline Products 77 12.3.2.1 Novo Nordisk A/S Pipeline Products by Equipment Type 77 12.3.2.2 Novo Nordisk A/S Pipeline Products by Development Stage 77 12.3.2.3 Novo Nordisk A/S Pipeline Products By Therapy Area 77 12.3.2.4 Novo Nordisk A/S Pipeline Products By Clinical Trials 77 12.4 Abbott Laboratories Company Profile 78 12.4.1 Company Overview 78 12.4.2 Value Chain Analysis 79 12.4.2.1 Manufacturing 79 12.4.2.2 Product Development 79 12.4.2.3 Sales and Marketing 81 12.4.3 Abbott Laboratories Pipeline Products 82 12.4.3.1 Abbott Laboratories Pipeline Products By Equipment Type 82 12.4.3.2 Abbott Laboratories Pipeline Products By Development Stage 82 12.4.3.3 Abbott Laboratories Pipeline Products By Therapy Area 82 12.4.3.4 Abbott Laboratories Pipeline Products By Clinical Trials 82 12.4.3.5 Abbott Laboratories Pipeline Products By News Summary 83 12.5 Bayer HealthCare AG Company Profile 84 12.5.1 Company Overview 84 12.5.2 Bayer HealthCare AG Pipeline Products 85 12.5.2.1 Bayer HealthCare AG Pipeline Products By Equipment Type 85 12.5.2.2 Bayer HealthCare AG Pipeline Products By Development Stage 85 12.5.2.3 Bayer HealthCare AG Pipeline Products By Therapy Area 85 12.5.2.4 Bayer HealthCare AG Pipeline Products By News Summary 85 12.6 Medtronic, Inc. Company Profile 86 12.6.1 Company Overview 86 12.6.2 Value Chain Analysis 87 12.6.2.1 Manufacturing 87 12.6.2.2 Product Development 87 12.6.2.3 Sales and Marketing 88 12.6.3 Medtronic, Inc. Pipeline Products 89 12.6.3.1 Medtronic, Inc. Pipeline Products By Equipment Type 89 12.6.3.2 Medtronic, Inc. Pipeline Products By Development Stage 89 12.6.3.3 Medtronic, Inc. Pipeline Products By Therapy Area 90 12.6.3.4 Medtronic, Inc. Pipeline Products By Clinical Trials 90 12.7 Eli Lilly and Company Company Profile 91 12.7.1 Company Overview 91 12.7.2 Eli Lilly and Company Pipeline Products 91 12.7.2.1 Eli Lilly and Company Pipeline Products by Equipment Type 91 12.7.2.2 Eli Lilly and Company Pipeline Products by Development Stage 91 12.7.2.3 Eli Lilly and Company Pipeline Products by Therapy Area 92 12.7.2.4 Eli Lilly and Company Pipeline Products by Clinical Trials 92 12.7.2.5 Eli Lilly and Company Pipeline Products by News Summary 92 12.8 Becton, Dickinson and Company Company Profile 93 12.8.1 Company Overview 93 12.8.2 Value Chain Analysis 94 12.8.2.1 Manufacturing 94 12.8.2.2 Product Development 95 12.8.2.3 Sales and Marketing 95 12.9 Home Diagnostics, Inc. Company Profile 96 12.9.1 Company Overview 96 12.10 Metrika, Inc. Company Profile 96 12.10.1 Company Overview 96 12.11 Nipro Diabetes Systems,Inc. Company Profile 96 12.11.1 Company Overview 96 12.12 AgaMatrix, Inc. Company Profile 97 12.12.1 Company Overview 97 12.12.2 AgaMatrix, Inc. Pipeline Products 97 12.12.2.1 AgaMatrix, Inc. Pipeline Products By Equipment Type 97 12.12.2.2 AgaMatrix, Inc. Pipeline Products By Development Stage 97 12.12.2.3 AgaMatrix, Inc. Pipeline Products By Therapy Area 97 12.13 DexCom, Inc. Company Profile 98 12.13.1 Company Overview 98 12.13.2 DexCom, Inc. Pipeline Products 98 12.13.2.1 DexCom, Inc. Pipeline Products By Equipment Type 98 12.13.2.2 DexCom, Inc. Pipeline Products By Development Stage 98 12.13.2.3 DexCom, Inc. Pipeline Products By Therapy Area 99 12.13.2.4 DexCom, Inc. Pipeline Products By News Summary 99 12.14 Freedom Meditech, Inc. Company Profile 100 12.14.1 Company Overview 100 12.14.2 Freedom Meditech, Inc. Pipeline Products 100 12.14.2.1 Freedom Meditech, Inc. Pipeline Products By Equipment Type 100 12.14.2.2 Freedom Meditech, Inc. Pipeline Products By Development Stage 100 12.14.2.3 Freedom Meditech, Inc. Pipeline Products By Therapy Area 100 12.15 GlucoLight Corporation Company Profile 101 12.15.1 Company Overview 101 12.15.2 GlucoLight Corporation Pipeline Products 101 12.15.2.1 GlucoLight Corporation Pipeline Products By Equipment Type 101 12.15.2.2 GlucoLight Corporation Pipeline Products By Development Stage 101 12.15.2.3 GlucoLight Corporation Pipeline Products By Therapy Area 101 12.15.2.4 GlucoLight Corporation Pipeline Products By Clinical Trials 102 12.15.2.5 GlucoLight Corporation Pipeline Products By News Summary 102 12.16 iSense Corporation Company Profile 103 12.16.1 Company Overview 103 12.16.2 iSense Corporation Pipeline Products 103 12.16.2.1 iSense Corporation Pipeline Products By Equipment Type 103 12.16.2.2 iSense Corporation Pipeline Products By Development Stage 103 12.16.2.3 iSense Corporation Pipeline Products By Therapy Area 103 12.16.2.4 iSense Corporation Pipeline Products By News Summary 103 12.17 Sensys Medical, Inc. Company Profile 104 12.17.1 Company Overview 104 12.17.2 Sensys Medical, Inc. Pipeline Products 104 12.17.2.1 Sensys Medical, Inc. Pipeline Products By Equipment Type 104 12.17.2.2 Sensys Medical, Inc. Pipeline Products By Development Stage 104 12.17.2.3 Sensys Medical, Inc. Pipeline Products By Therapy Area 105 12.17.2.4 Sensys Medical, Inc. Pipeline Products By Clinical Trials 105 13 Financial Deals Landscape 106 13.1 Acquisition 106 13.1.1 Mediscience Technology Acquires SensiVida Medical Systems 106 13.2 Partnerships 107 13.2.1 Edwards Lifesciences Enters Into an Agreement with DexCom 107 14 Recent Developments 108 14.1 Strategy and Business Planning 108 14.1.1 Mar 10, 2009: Medtronic MiniMed Considers San Antonio and Kansas City for Expansion 108 14.2 Legal and Regulatory 109 14.2.1 Mar 11, 2009: Medtronic Announces Dismissal of Lawsuit 109 14.2.2 Jan 07, 2009: BD Settles Lawsuit with Ultimed 109 14.2.3 Nov 25, 2008: Bayer HealthCare Reaches $97.5 Million Settlement With US DOJ 109 14.3 Government and Public Interest 110 14.3.1 Mar 19, 2009: FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared 110 14.3.2 Nov 11, 2008: New Nanomaterial Could Be Breakthrough for Implantable Medical Devices 111 14.3.3 Nov 04, 2008: Georgia Researchers to Study Impact Of Insulin Pump 111 14.3.4 Oct 27, 2008: Researchers Developing Artificial Pancreas to Treat Type 1 Diabetics 113 14.4 Product News 114 14.4.1 Mar 25, 2009: Smiths Medical Announces Intent to Stop Selling Deltec Cozmo Insulin Pumps 114 14.4.2 Feb 26, 2009: FDA Approves Sanofi-aventis' Apidra SoloSTAR 114 14.4.3 Feb 11, 2009: Insulet Corporation’s OmniPod System Selected as Finalist for the 2009 Edison Best New Product Awards 115 14.4.4 Feb 09, 2009: ARKRAY Announces FDA Approval to Market GLUCOCARD 01-mini Blood Glucose Monitoring System 115 14.4.5 Dec 23, 2008: Generex Receives Approval for Oral-lyn 116 14.4.6 Nov 13, 2008: Echo Therapeutics to Present Clinical Study Results Of Its Symphony Transdermal Continuous Glucose Monitoring System 116 14.4.7 Oct 02, 2008: Tosoh G8 HPLC Analyzer for Diabetes Monitoring and HbA1c Testing Cleared By FDA 116 15 Appendix 118 15.1 GlobalData Research Methodology 118 15.2 Coverage 119 15.3 Secondary Research 120 15.4 Primary Research 120 15.5 Models 121 15.6 Forecasts 121 15.7 Expert Panel Validation 122 15.8 Currency Conversion 123 15.9 Contact Us 124 15.10 Disclaimer 124
1.1 List of Tables Table 1: United States Healthcare Expenditure, 2000-2007 19 Table 2: United States Personal Healthcare Expenditure by Type, $ Billions, 2000-2007 20 Table 3: United States Personal Healthcare Expenditure by Source, $ Billions, 2000-2007 21 Table 4: Total Number of Doctors in the United States, 2003-2010 22 Table 5: Number of Doctors by Specialty in the United States, 2003-2010 23 Table 6: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 24 Table 7: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 25 Table 8: Total Hospitals in the United States, 2000-2004 26 Table 9: Community Hospitals by Number of Beds in the United States, 2000-2004 26 Table 10: Number of Hospital Beds in the United States, 2000-2004 26 Table 11: Number of Hospital Beds by Range in the United States, 2000-2004 27 Table 12: United States Healthcare Trade Statistics, 2001-2006 28 Table 13: Medical Equipment Registration Fee in United States, 2007 35 Table 14: Medical Device Approval Time in United States, 2007 35 Table 15: Diabetes Care Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 40 Table 16: Diabetes Care Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 41 Table 17: Diabetes Care Devices, United States, Category Volume (Units ‘000), Historic, 2000-2008 42 Table 18: Diabetes Care Devices, United States, Category Volume (Units ‘000), Forecast, 2008-2015 43 Table 19: Diabetes Care Devices, United States, Portfolio Analysis, 2000-2015 44 Table 20: Diabetes Care Devices, United States, Company Share by Revenue ($ mn), 2007-2008 46 Table 21: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 48 Table 22: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 49 Table 23: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 50 Table 24: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 51 Table 25: Glucose Monitoring, United States, Volume (Units ‘000), Historic, 2000-2008 52 Table 26: Glucose Monitoring, United States, Volume (Units ‘000), Forecast, 2008-2015 52 Table 27: Glucose Monitoring, United States, Cross Segment Analysis, 2000-2015 53 Table 28: Glucose Monitoring, United States, Average Price ($), Historic, 2000-2008 54 Table 29: Glucose Monitoring, United States, Average Price ($), Forecast, 2008-2015 54 Table 30: Glucose Monitoring, United States, Distribution Share by Revenue ($mn), 2007-2008 55 Table 31: Glucose Monitoring, United States, Company Share by Revenue ($ mn), 2007-2008 56 Table 32: Insulin Delivery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 58 Table 33: Insulin Delivery, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 60 Table 34: Insulin Delivery, United States, Volume (Units ‘000), Historic, 2000-2008 61 Table 35: Insulin Delivery, United States, Volume (Units ‘000), Forecast, 2008-2015 62 Table 36: Insulin Delivery, United States, Cross Segment Analysis, 2000-2015 63 Table 37: Insulin Delivery, United States, Average Price ($), Historic, 2000-2008 64 Table 38: Insulin Delivery, United States, Average Price ($), Forecast, 2008-2015 65 Table 39: Insulin Delivery, United States, Distribution Share by Revenue ($mn), 2007-2008 67 Table 40: Insulin Delivery, United States, Company Share by Revenue ($ mn), 2007-2008 68 Table 41: LifeScan, Inc. Pipeline Products by Equipment Type 70 Table 42: LifeScan, Inc. Pipeline Products By Development Stage 70 Table 43: LifeScan, Inc. Pipeline Products By Therapy Area 71 Table 44: LifeScan, Inc. Pipeline Products By Clinical Trials 71 Table 45: LifeScan, Inc. Pipeline Products By News Summary 71 Table 46: F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 76 Table 47: F. Hoffmann-La Roche Ltd Pipeline Products By Development Stage 76 Table 48: F. Hoffmann-La Roche Ltd Pipeline Products By Therapy Area 76 Table 49: Novo Nordisk A/S Pipeline Products by Equipment Type 77 Table 50: Novo Nordisk A/S Pipeline Products By Development Stage 77 Table 51: Novo Nordisk A/S Pipeline Products By Therapy Area 77 Table 52: Novo Nordisk A/S Pipeline Products By Clinical Trials 77 Table 53: Abbott Laboratories Pipeline Products by Equipment Type 82 Table 54: Abbott Laboratories Pipeline Products By Development Stage 82 Table 55: Abbott Laboratories Pipeline Products By Therapy Area 82 Table 56: Abbott Laboratories Pipeline Products By Clinical Trials 82 Table 57: Abbott Laboratories Pipeline Products By News Summary 83 Table 58: Bayer HealthCare AG Pipeline Products by Equipment Type 85 Table 59: Bayer HealthCare AG Pipeline Products By Development Stage 85 Table 60: Bayer HealthCare AG Pipeline Products By Therapy Area 85 Table 61: Bayer HealthCare AG Pipeline Products By News Summary 85 Table 62: Medtronic, Inc. Pipeline Products by Equipment Type 89 Table 63: Medtronic, Inc. Pipeline Products By Development Stage 89 Table 64: Medtronic, Inc. Pipeline Products By Therapy Area 90 Table 65: Medtronic, Inc. Pipeline Products By Clinical Trials 90 Table 66: Eli Lilly and Company Pipeline Products by Equipment Type 91 Table 67: Eli Lilly and Company Pipeline Products by Development Stage 91 Table 68: Eli Lilly and Company Pipeline Products by Therapy Area 92 Table 69: Eli Lilly and Company Pipeline Products by Clinical Trials 92 Table 70: Eli Lilly and Company Pipeline Products by News Summary 92 Table 71: AgaMatrix, Inc. Pipeline Products by Equipment Type 97 Table 72: AgaMatrix, Inc. Pipeline Products By Development Stage 97 Table 73: AgaMatrix, Inc. Pipeline Products By Therapy Area 97 Table 74: DexCom, Inc. Pipeline Products by Equipment Type 98 Table 75: DexCom, Inc. Pipeline Products By Development Stage 98 Table 76: DexCom, Inc. Pipeline Products By Therapy Area 99 Table 77: DexCom, Inc. Pipeline Products By News Summary 99 Table 78: Freedom Meditech, Inc. Pipeline Products by Equipment Type 100 Table 79: Freedom Meditech, Inc. Pipeline Products By Development Stage 100 Table 80: Freedom Meditech, Inc. Pipeline Products By Therapy Area 100 Table 81: GlucoLight Corporation Pipeline Products by Equipment Type 101 Table 82: GlucoLight Corporation Pipeline Products By Development Stage 101 Table 83: GlucoLight Corporation Pipeline Products By Therapy Area 101 Table 84: GlucoLight Corporation Pipeline Products By Clinical Trials 102 Table 85: GlucoLight Corporation Pipeline Products By News Summary 102 Table 86: iSense Corporation Pipeline Products by Equipment Type 103 Table 87: iSense Corporation Pipeline Products By Development Stage 103 Table 88: iSense Corporation Pipeline Products By Therapy Area 103 Table 89: iSense Corporation Pipeline Products By News Summary 103 Table 90: Sensys Medical, Inc. Pipeline Products by Equipment Type 104 Table 91: Sensys Medical, Inc. Pipeline Products By Development Stage 104 Table 92: Sensys Medical, Inc. Pipeline Products By Therapy Area 105 Table 93: Sensys Medical, Inc. Pipeline Products By Clinical Trials 105 Table 94: Mediscience Technology Acquires SensiVida Medical Systems 106 Table 95: Edwards Lifesciences Enters Into An Agreement With DexCom 107 Table 96: USD to Local Currency, Average Exchange Rate 2008 123
1.2 List of Figures Figure 1: United States, Healthcare Expenditure by Source, 2007 19 Figure 2: Healthcare Expenses Segmentation by End User, 2007 20 Figure 3: United States, Healthcare Infrastructure, Top Level View, 2007 22 Figure 4: Medical Equipment Approval Process in the United States, 2007 30 Figure 5: PMA Approval Process in the United States, 2007 32 Figure 6: The 510(k) Approval Process for Medical Devices in the United States, 2007 33 Figure 7: Reimbursement Structure in the United States, 2007 38 Figure 8: Distribution Structure of Medical Equipment in the United States, 2007 39 Figure 9: Diabetes Care Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 40 Figure 10: Diabetes Care Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 41 Figure 11: Diabetes Care Devices, United States, Category Volume (Units ‘000), Historic, 2000-2008 42 Figure 12: Diabetes Care Devices, United States, Category Volume (Units ‘000), Forecast, 2008-2015 43 Figure 13: Diabetes Care Devices, United States, Cross-Category Analysis, 2000-2015 44 Figure 14: Diabetes Care Devices, United States, Company Share (%), 2008 46 Figure 15: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 48 Figure 16: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 49 Figure 17: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 50 Figure 18: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 51 Figure 19: Glucose Monitoring, United States, Cross Segment Analysis, 2000-2015 53 Figure 20: Glucose Monitoring, United States, Company Share (%), 2008 56 Figure 21: Insulin Delivery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 58 Figure 22: Insulin Delivery, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 60 Figure 23: Insulin Delivery, United States, Cross Segment Analysis, 2000-2015 63 Figure 24: Insulin Delivery, United States, Company Share (%), 2008 68 Figure 25: F. Hoffmann-La Roche Ltd Value Chain Analysis 73 Figure 26: Abbott Laboratories Value Chain Analysis 79 Figure 27: Medtronic, Inc. Value Chain Analysis 87 Figure 28: Becton, Dickinson and Company Value Chain Analysis 94 Figure 29: GlobalData Methodology 119
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