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The Medical Device Market: USA
Publication Date March 2006
Publisher Espicom
Product Type Report
Pages 182
ISBN Number not applicable
Product Code ESP002
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Summary
The main barrier to entry in the US market is satisfying the regulatory requirements of the Food and Drug Administration. Once this hurdle has been cleared, companies are faced with a huge decentralised market which demands that manufacturers new to the market, seek the services of professional distribution agencies, or form an alliance with a US manufacturer with an established sales and distribution network.
The US healthcare market is the world's largest in terms of total expenditure. In 2003, US health expenditure reached US$1,678.9 billion, equal to US$5,670 per capita. The importance of the health sector to the US economy is immense, being one of the largest individual industry sectors, providing employment to over ten million people and equal to 15.3% of GDP.
Some of the highest standards of medical care anywhere in the world can be found in the US, encompassing the utilisation of leading edge technology and the development and adoption of the latest innovative methods of treatment. And yet, while many US patients can expect the very highest standards of treatment, this does not extend to the entire population, although more recently, this problem has been given more serious consideration by the government. The US is the only major industrial nation which does not guarantee health coverage to all its citizens and, as a result, around 41 million Americans find themselves uninsured and unlikely to receive the full benefit of the nation's excellent medical facilities. As a consequence, wealth and development of the US is belied by data showing overcrowding in many public healthcare facilities, and relatively poor performance with regard to demographic indicators such as infant mortality.
Political reform of the healthcare sector, to guarantee a basic level of healthcare provision for the entire population, has been a topic of political debate for many years. Certain reforms, such as extending pharmaceutical coverage for the elderly have led to new legislation being passed, such as the Medicare prescription drug benefit bill. Original Congressional Budget Office (CBO) estimates put the cost of the new legislation at US$400 billion over the period 2004-2013. CBO estimates rose swiftly to US$771 billion (February 2005), and the final cost is likely to be far higher. The new drug overage came into effect in January 2006 amid much confusion: reports since have been more positive, although it is still early days for the scheme.
These medical device market reports are ideal for executives wanting to understand the key drivers in medical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.
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Content
Background Data
Geography
Map of the USA
Political Overview
Economic Overview
Gross Domestic Product, 1990-05
Population
Population by Region & State, 1st July 2000-05
Population by Age & Sex as of 1st July, 2000-05
Population Projections
Population Projections by Age & Sex, 2010-30
Demographic Indicators
Demographic Indicators, 1995-04
Mortality
Selected Causes of Death by Sex, 2001-03 (ICD 10)
15 Leading Causes of Death, 2003-04 (Preliminary)
Infant Mortality
Infant Mortality Rate per 1,000 Live Births, 1990-02
Infant, Neonatal and Postneonatal Mortality, 2000-03
Leading Causes of Infant Mortality, 2004 (Preliminary)
Morbidity
Notifiable Diseases
Selected Notifiable Diseases, 1995-03
Hiv/Aids
Reported AIDS Cases by Sex, 1999-03
Charts
Population by Age Group, 2005
Leading Causes of Death, 2003 (%)
Healthcare System
Organisation & Administration
Centres for Medicare & Medicaid Services (CMS)
Medicare
Medicare Enrolment and Trends, 1995-05 (Persons*)
Total Medicare Beneficiaries with Drug Coverage, 7th May 2006 (Millions)
Prospective Payment System
Medicaid
Medicaid Enrolment Trends, 1996-04
State Children's Health Insurance Programme
SCHIP Enrolment by Programme Type, 1999-04
Health Insurance Portaility and Accountability Act of 1996
Clinical Laboratory Improvement Amendments
Private Health Provision
Blue Cross/Blue Shield Association
Managed Care
HMO Plans & Enrolment by Type of Plan, 2000-04
Health Expenditure
National Health Funding by Sector, 1990-04 (US$ Billions)
Total Expenditure by Type and Funding Source, 2003-04 (US$ Billions)
Health Expenditure by Programme & Type, 2000-04 (US$ Millions)
2005 & 2006 Projections
Medicare
Medicare Expenditure by Type, 1990-04 (US$ Billions)
Medicaid
Net Reported Medicaid and SCHIP Expenditures, 2000-04 (US$)
State Children's Health Insurance Programme
Department of Veterans Affairs
Dept. VA Trends in Expenditure & Usage, 1970-03
2002 Healthcare Census
Healthcare Establishments & Revenue, 1997 & 2002
Spending Projections
National Health Expenditure Projections, 2005-15
Health Expenditure Projections by Sector, 2005-15
Hospital Services
Hospitals & Beds by Sector & Hospital Type, 1993-03
Hospital Activity
Hospital Admissions & Average Length of Stay by Sector, 1993-03
Healthcare Cost and Utilisation Project
Diagnoses by CCS Category, 2003
Clinical Procedures by CCS Code, 1993-03 (All Listed)
Community Hospital Activity
Selected Community Hospital Statistics, 1993-03
Selected Community Hospital Statistics by Region & State, 2003
Community Hospital Surgical Procedure Rate by Region & State, 2003 (Per 1,000 Pop.)
Selected Services in Reporting Community Hospitals, 2000-03
Organ Transplants
Number of Organ Transplants & Grafts, 1990-04
National Hospital Discharge Survey
Discharges from Short Stay Hospitals by Sex & Diagnosis, 2001-04 (000s)
Discharges from Short-Stay Hospitals by Age & Procedure, 2004 (000s)
Ambulatory Care
Ambulatory Care Visits by Setting, 1995-03 (000s)
Hospital Emergency Departments
Emergency Dept. Visits by Primary Diagnoses, 1995-03 (000s)
Emergency Department Visits by Type of Examination or Procedure, 2001-03 (000s)
Availability of Paediatric Services & Equipment in EDs, 2002-03
Hospital Outpatient Departments
Visits by Clinical Type & Source of Payment, 2000-03 (000s)
Outpatient Department Visits by Primary Diagnosis, 1995-03 (000s)
Outpatient Department Visits by Type of Examination/Procedure, 2001-03 (000s)
Physicians' Offices
Visits by Physician Speciality & Source of Payment, 2000-03 (000s)
Physician Offices Visits by Primary Diagnosis, 1995-03 (000s)
Physician Offices Visits by Type of Examination/Procedure, 2001-03 (000s)
Nursing Homes
Nursing Home Trends, 1995-03
Medical Personnel
Active Health Personnel by Occupation, 1995-01
Active Registered Doctors by Sector & Activity, 1995-03
Registered Community Hospital Personnel by Region & State, 2000-03
Charts
National Health Expenditure Trends by Sector, 1990-04
National Health Funding by Sector, 2004 (%)
Total Health Expenditures by Type, 2004 (%)
Hospitals by Number of Beds, 2003 (%)
Transplant Centres by Speciality, 1990-04
Accessing The Medical Device Market
Introduction
Regulatory Environment
Medical Device User Fee and Modernisation Act of 2002
Performance Goals
Reprocessed Single-Use Devices
Third Party Reviews
FDA Modernisation Act of 1997
Pre-Marketing Requirements
510(k) Pre-Market Notification
510(k) Paradigm
Pre-Market Approval Application
Humanitarian Device Exemption
Investigational Device Exemptions
Third Party Review
Product Development Protocol
Post-Marketing Requirements
GMP/QS Regulations
Compliance
Requirements for Record Keeping
Product Liability
FDA Review
CDRH Performance - Submissions Received by Type, 1999-04
CDRH Performance - Submissions Completed by Type, 1999-04
Medical Device Approvals
Mutual Recognition Agreement with EU
Market Access
Trade Fairs
Distributors
Health Industry Distributors Association (HIDA)
Independent Medical Distributors Association (IMDA)
Domestic Production
Key Market Data, Production & Trade, 1994-03 (US$ Billions)
Medical Manufacturing in 2002
Summary Sector Trends, 1997-02 (US$ million)
Establishments by Top 5 States & Industry Sector, 2002
Electromedical & Electrotherapeutic Apparatus
Irradiation Apparatus
Surgical & Medical Instrument
Surgical Appliances & Supplies
Dental Equipment & Supplies
Ophthalmic Goods
Domestic Producers
Top 50 US Manufacturers by Medical Device Revenue, 2003-05
1. Johnson & Johnson
2. General Electric
3. Baxter International
4. Medtronic
5. Tyco Healthcare
6. Boston Scientific
7. Stryker
8. Guidant
9. Zimmer
10. Eastman Kodak
Trade Associations
Directory
Healthcare Organisations
Health Care/Managed Care Systems
Distributors
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