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Home Medical Testing Devices

Published by: Trimark Publications

Published: Jan. 1, 2008 - 123 Pages


Table of Contents


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



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

Abstract

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.

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