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Home Medical Testing Devices

TriMark Publications
January 1, 2008
123 Pages - SKU: TRI2207048

Abstract Table of Contents Related Reports

Home healthcare is defined by the U.S. Centers for 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.

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; 3.3 The U.S. Market; 3.4 World Markets
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; 4.7 EMI/EMC; 4.8 Risk Management (ISO 14971:2007); 4.9 Categories of Products; 4.10 Future Directions
5. Business Trends: 5.1 Market Drivers; 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; 6.2 Customer Needs; 6.3 Competitor Analysis; 6.4 Pricing Pressures (Based on the U.S. Model); 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; 6.10 Third-Party Reimbursement; 6.11 Regulation Trends; 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
INDEX OF TABLES: Table 3.1: Comparison of Procedure Costs—U.S. and Overseas, 2006 and 2007; Table 5.1: Market Drivers; Table 5.2: Market Restraints

Home Medical Testing Devices

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