Home Medical Testing Devices

Home Medical Testing Devices

Home healthcare is defined by the U.S. Centers of Disease Control and Prevention’s (CDC) National Center for Health Statistics as, “healthcare provided to individuals and families in their places of residence for the purpose of promoting, maintaining, or restoring health or for maximizing the level of independence while minimizing the effects of disability and illness, including terminal illness.” Last year, an estimated 18 million people received home healthcare in the U.S., and most of these individuals also used associated home care products. With the aging of the “baby boom” generation and the increase in patient life spans--a trend not limited to the U.S.--the numbers of home care patients will continue to grow. As patient life spans are extended with more sophisticated medical care and new technologies, and home care becomes an increasingly important and accepted means to contain healthcare costs for managed care providers, this market segment is poised for significant growth in the near future. The purpose of this TriMark Publications report is to describe the specific segment of the home medical testing devices markets, with particular emphasis on the United States market. The U.S. market for home care products, testing, devices and equipment continues to post steady gains, primarily as a result of: 1) the aging population, 2) a growing trend to out-patient care and the corresponding shift of chronic care patients from hospitals, and 3) extended care facilities to the home. In other areas of the world, the results vary depending on the economies of the country and the health sophistication of the consuming public. This analysis presents an overview of the home medical testing devices market with the latest information regarding emerging new products, new markets for older products/technologies and industry trends.

Table of Contents:


1. Introduction 4
1.1 Statement of Report 4
1.2 Objectives of this Report 4
1.3 Scope of the Report 6
1.4 Methodology 6
1.5 Executive Summary 7

2. Home Medical Testing Devices Markets 9
2.1 Overview 9

3. Home Medical Testing Devices Market Segments 10
3.1 Overview 10
3.2 World Markets 10
3.2.1 Major Markets for the Home Medical Testing Devices Segment 10
3.2.2 Global Trends 10
3.3 The U.S. Market 11
3.4 World Markets 12
3.4.1 Asia/Southeast Asia 12
3.4.1.1 Japan 13
3.4.1.2 China 14
3.4.1.3 Taiwan 14
3.4.1.4 India 14
3.4.2 Australia/New Zealand 16
3.4.3 Western Europe 16
3.4.4 Eastern Europe 21
3.4.5 Middle East 23

4. Technology Issues 24
4.1 Component Issues 24
4.2 Production Methods 24
4.3 cGMPs in Use 24
4.4 Testing 24
4.5 Shipping/Handling/Storage Environment Concerns 24
4.6 Use Environment-Unique Issues 25
4.6.1 IFUs 25
4.6.2 Electro Magnetic Compatibility 25
4.6.3 Product Support-Helpline 25
4.6.4 Preventive Maintenance 25
4.6.5 Back-up 25
4.6.6 Family Support 26
4.6.7 Medical Review 26
4.7 EMI/EMC 26
4.8 Risk Management (ISO 14971:2007) 26
4.9 Categories of Products 28
4.9.1 Alcohol Test Kits 28
4.9.2 Allergy Test Kits 28
4.9.3 Amniotic Fluid Leak Detectors 30
4.9.4 Anemia Meters 30
4.9.5 Apnea Therapy Equipment 31
4.9.6 Asthma Monitors 31
4.9.7 Blood Pressure Monitors 32
4.9.8 Breast Self-Examination Tools 34
4.9.9 Blood Typing Kits 38
4.9.10 Chlamydia 38
4.9.11 Cholesterol Tests 38
4.9.12 Defibrillators (Patient Use) 39
4.9.13 Diabetes Test Kits 40
4.9.14 Drugged Drink Test Kits 40
4.9.15 Electro Cardiogram 40
4.9.16 Gonorrhea Test 41
4.9.17 Hepatitis C Test 41
4.9.18 HIV (AIDS) 42
4.9.19 Influenza (Flu) Test Kits 44
4.9.20 Infusion Pumps 44
4.9.21 Kidney Dialysis 46
4.9.22 Kidney Disease Test Kits 47
4.9.23 Occult (Stool) Blood Screening Test Kits 47
4.9.24 Paternity (DNA) Test Kits 48
4.9.25 Pregnancy and Fertility Diagnostics 48
4.9.26 Pressure Pump and Pad System (for Bed Sores) 49
4.9.27 Prostate Cancer Screening Test Kit 50
4.9.28 Remote Monitoring Services 50
4.9.29 Spirometers 51
4.9.30 Thermometers 51
4.9.31 Thyroid Test Kits 51
4.9.32 Urinalysis Test Kit 51
4.9.33 Vaginal Infections 51
4.9.34 Wheelchairs 52
4.10 Future Directions 56
4.10.1 New Diabetes Testing Technologies 56
4.10.2 Quick Cholesterol Testers 57
4.10.3 Adsorbers 57
4.10.4 Remote Health Monitoring/Screening 57

5. Business Trends 58
5.1 Market Drivers 58
5.1.1 Medical/Clinical Studies 59
5.1.2 Sports 59
5.1.3 Demographics 59
5.1.4 Market Restraints 60
5.2 Market Prospects 60
5.3 Marketing and Distribution 60
5.4 Competitive Landscape 61
5.5 Business Developments 61
5.6 Acquisitions and Partnerships 61

6. Home Medical Testing Kits and Devices, Regulation and Reimbursement 63
6.1 Market Segments 63
6.1.1 Test Kits/Diagnostics 63
6.1.2 Devices 63
6.1.3 Equipment 63
6.2 Customer Needs 63
6.3 Competitor Analysis 63
6.4 Pricing Pressures (Based on the U.S. Model) 64
6.4.1 "Big Box" Retailing 64
6.4.2 Internet 64
6.4.3 Mail Order 64
6.4.4 Chain Retail Outlets (Grocery, Dedicated) 64
6.4.5 "Mom and Pop" (Stand Alone) Health (Food) Stores 65
6.4.6 MLM (Multi Level Marketing) 65
6.5 BSE and Gelatin-based Ingested (or Body Fluid Contact) Products 65
6.6 Home Care Providers 66
6.7 Medicare-certified Agencies 66
6.8 Types of Home Healthcare Organizations 66
6.9 Non-Medicare-certified Agencies 67
6.9.1 Medicare Home Health Prospective Payment 67
6.9.2 U.S. Medicaid Home Care 67
6.9.3 Managed Care 67
6.10 Third-Party Reimbursement 69
6.11 Regulation Trends 69
6.11.1 U.S. FDA Policy 69
6.11.2 GMPs 70
6.11.3 Current Progress 73
6.11.4 Future Regulatory Trends 73
6.11.5 Key Issues 74
6.11.6 Labeling Requirements 75
6.12 Market Trends 75

7. Corporate Profiles 77
7.1 Abbott Laboratories 77
7.2 Apria Healthcare 77
7.3 Baxter International, Inc. 77
7.4 Braun 78
7.5 Del Mar Reynolds Medical Ltd. 79
7.6 Fresenius Medical Care 79
7.7 Gambro AB 81
7.8 Graham-Field Health Products 82
7.9 Gentiva Health Services, Inc. 83
7.10 General Nutrition Centers, Inc. 85
7.11 Invacare Corporation 86
7.12 Kimberly-Clark Corporation 87
7.13 Lincare 87
7.14 Matria Healthcare 89
7.15 Respironics 92
7.16 Sunrise Medical 94

Appendix 1: Overview of the U.S. FDA Good Manufacturing Practices (GMP)/Quality System (QS) Regulation (21 CFR Part 820) 96
Appendix 2: The U.S. FDA GMPs, 21 CFR Part 820 102
Appendix 3: FDA Guidelines for Device Use in the Home 117
Appendix 4: ISO 14971 Medical Device Risk Management 119

INDEX OF TABLES

Table 3.1: Comparison of Procedure Costs-U.S. and Overseas, 2006 and 2007 12
Table 5.1: Market Drivers 59
Table 5.2: Market Restraints 60