Home Medical Testing Devices

1. Introduction

• 1.1 Statement of Report
• 1.2 Objectives of this Report
• 1.3 Scope of the Report
• 1.4 Methodology
• 1.5 Executive Summary

2. Home Medical Testing Devices Markets

• 2.1 Overview

3. Home Medical Testing Devices Market Segments

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

4. Technology Issues

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

5. Business Trends

• 5.1 Market Drivers
  • 5.1.1 Medical/Clinical Studies
  • 5.1.2 Sports
  • 5.1.3 Demographics
  • 5.1.4 Market Restraints
• 5.2 Market Prospects
• 5.3 Marketing and Distribution
• 5.4 Competitive Landscape
• 5.5 Business Developments
• 5.6 Acquisitions and Partnerships

6. Home Medical Testing Kits and Devices, Regulation and Reimbursement

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

7. Corporate Profiles

• 7.1 Abbott Laboratories
• 7.2 Apria Healthcare
• 7.3 Baxter International, Inc.
• 7.4 Braun
• 7.5 Del Mar Reynolds Medical Ltd.
• 7.6 Fresenius Medical Care
• 7.7 Gambro AB
• 7.8 Graham-Field Health Products
• 7.9 Gentiva Health Services, Inc.
• 7.10 General Nutrition Centers, Inc.
• 7.11 Invacare Corporation
• 7.12 Kimberly-Clark Corporation
• 7.13 Lincare
• 7.14 Matria Healthcare
• 7.15 Respironics
• 7.16 Sunrise Medical

Appendix 1: Overview of the U.S. FDA Good Manufacturing Practices (GMP)/Quality System (QS) Regulation (21 CFR Part 820)

Appendix 2: The U.S. FDA GMPs, 21 CFR Part 820

Appendix 3: FDA Guidelines for Device Use in the Home

Appendix 4: ISO 14971 Medical Device Risk Management

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