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Trends Shaping U.S. Medical Devices Industry Strategies - Product Image

Trends Shaping U.S. Medical Devices Industry Strategies

  • Published: January 2013
  • Region: United States
  • 201 Pages
  • MMC International

Innovate and prosper, or as history has shown, be like most other devices companies and stagnate and perish. The “Trends Shaping U.S. Medical Devices Industry Strategies” report is a strategic analysis designed to:

1) prompt senior management to question internal assumptions in order to refine or develop strategies to better position the company and its products to capitalize on industry change,
2) challenge the thinking of marketing and product development teams/staffs, and
3) orient individuals new to the industry.

The implications listed at the end of each chapter serve to challenge the reader's thinking and basic assumptions.

The reelection of President Obama insured that the major pieces of the Patient Protection and Affordable Care Act (PPACA or ACA) will be implemented between now and 2018. PPACA serves to accelerate trends that were already underway. No U.S. healthcare industry company can afford to ignore the industry discontinuities that are occurring. Historic industry boundaries are giving way. Who the customer is will change for many products and services. The very definition of what a company sells will be brought into question. READ MORE >

Preface

Introduction
- Industry Redefinition and Revitalization
- US Healthcare Cost Containment Is A Huge Opportunity
- How To Read The Book
- Transformational Themes
- US Healthcare Expenditures and Employment
- Interrelated US Healthcare System
- Disruptive Innovation
- Unintended Consequences
- PPACA Transformational Impact
- Requirement For Medical Devices Industry Environmental Audit
- Medical Devices Industry Life Cycle Examples
- Legislators View Of Healthcare
- Industry Change Predates Legislation
- Importance Of Understanding Healthcare Stakeholders' Trends/Evolution
- Introduction – Medical Device Industry Implications

The US Has To Contain Healthcare Costs
- Growth Of US Healthcare Expenditures
- US Healthcare Inefficiencies and Inappropriate Care
- Forecasted US Per Capita Health Expenditures
- Decreasing American Disposable Income
- OECD Healthcare Expenditures As A Percentage Of GDP
- Forecasted 2020 US Healthcare Expenditures
- The US Has To Contain Healthcare Costs – Medical Device Industry Implications

Legislative Drivers
- Life Expectancy At Birth and Infant Mortality
- Unhealthy Lifestyles
- Government Lifestyle Programs Have Worked
- Preventative Health Care Services
- US Lags In Preventive Care
- Adoption and Utilization Of Costly Technologies
- Health Technology Assessments (HTAs)
- Out-Of-Pocket Healthcare Expenditures
- Uninsured Population
- Rising US Healthcare Insurance Premiums
- Forecasted Increases In US Healthcare Expenditures
- Logical US Healthcare Cost Containment Priorities
- Aging US Population
- Focus On The Population With Chronic Conditions
- Legislation Has Fragmented Healthcare
- US Is Not A Single Healthcare Market
- US Healthcare Is Inefficient
- International Healthcare Regulatory Agencies Information Exchange
- Market Transformation Requirements
- Regulatory Barriers Have To Be Removed
- PPACA Legislation, Regulation, Implementation, and Execution Timeline
- Ninety Two (92) PPACA Implementation Steps
- Legislative Drivers - Medical Device Industry Implications

Demographics
- More Ethnically Diverse Population
- Obesity Epidemic
- Longer Lifespans And Increasing Number Of Chronic Conditions
- High Utilization Of Healthcare Resources By The ?65 Population
- Aging Population Will Drive Care and Research Changes
- Demographics – Medical Device Industry Implications

Technology
- Five Technologies
- Interoperable Electronic Health Records (EHRs)
- National Health Information Network (NHIN)
- Personal Genome
- Genomics
- Pharmacogenomics
- Biomarkers
- Cybernetics
- Medical Apps
- Cybernetics, provider, patients, medical information and devices connectivity and medical “APPs” - Medical Device Industry Implications

Innovations
- International Classification of Diseases and Related Health Problems No 10 (ICD-10)
- Accountable Care Organizations (ACO)
- Patient-Centered Medical Home (PCMH)
- Retail Clinics
- Social Networking
- Cloud Computing
- Telemedicine
- Connected Home
- Biophotonics/Smart Apps
- Surgical and Mechanical Interventions
- Stem Cells
- Regenerative Medicine
- Computer/Wi-Fi/Internet Enabled and Scientific/Device/Process Advancements
- Innovations - Medical Device Industry Implications

Consumers
- Rising Healthcare Premiums
- Insurance and Pharmaceutical Industries Are Seen As The Causes For Healthcare System Problems
- One-Quarter of 19-64 Year Old Adults Had A Gap In Coverage In 2011
- Price Sensitivity of Population Is Increasing
- Acceptance of Generics Is Increasing
- Consumers Are Increasing Their Use of Retail Clinics
- Consumers Are Now Well Connected Through The Internet
- Cyberchondriacs Are On The Rise
- Medical Tourism Expected To Increase
- PPACA's Major Provisions Are Popular
- Consumers – Medical Device Industry Implications

Payers
- What Medicare Does The Rest Of The Industry Will Follow

Cost Extractions
- The Focus Of Cost Extractions

Strategic Concepts
- Industry Lifecycle
- Rule Of Three And Four
- Competition Follows The Money
- Power Shifts
- Self-Obsolescence
- Shifting Demand For Intermediaries

Prevention, Intervention And Treatment
- The Interconnected US Healthcare Enterprise

Health Insurance
- US Health Insurance Industry Is 32% Of The Way To Becoming Mature
- Health Insurers Best Positioned To Drive And Profit From Healthcare Cost Extractions
- Insurer Strategies Will In Part Be Dictated By PPACA Implementing Regulations
- Health Insurers Will Consolidate, Vertically Integrate, and Diversify
- HMO And PPO Enrollment
- Health Insurance – Medical Device Industry Implications

Providers

Introduction
- Reimbursement, Organizational Structures, and Care Delivery Will Significantly Change By 2020
- CONs In Effect Grant Monopolies
- Changing Reimbursement Will By the Key Driver In The Restructuring Of Providers
- Consumer Healthcare Shopping Will Drive Provider Quality Improvements
- Various Care Management Models And Organizational Structures Will Materialize

Physicians
- Physicians Are Moving To Group And Hospital Practices
- Physician Compensation Moving Toward Wellness And Away From Procedures
- Home Healthcare Is Least Expensive, Hospital Care Is The Most Expensive

Hospitals
- The Average American Hospital Barely Breaks Even
- Some Hospitals, Which Include Not-For-Profit Hospitals, Are Very Profitable

Integrated Healthcare Systems
- The Trend Is Toward Highly Integrated Healthcare Systems
- Highly Integrated Healthcare Systems Are Getting Bigger And Integrating Care

Alternate Care Facilities
- A Number Of Alternatives Exist For Non-Hospital Patient Care
- There were 20,858 Senior Living Providers And Nursing Homes Providing Nursing Care in 2011
- Senior Living Providers Are In The Growth Phase Of Their Industry Lifecycle

Nursing Homes
- Nursing Homes Are A Mature Industry

Home Healthcare
- Home Healthcare Is Being Redefined Into A Growth Industry
- Federal And State Governments Pay For 80% Of Home Healthcare Expenditures
- Providers – Medical Device Industry Implications

Intermediaries
- Intermediaries Will Be Under Increasing Pressure To Decrease Costs

PBMs
- Over 96 Percent of Managed Care Plans Use PBM Services

GPOs
- GPO Offerings And Business Practices Are Evolving With The Market

Wholesalers
US Healthcare Products Wholesaling Is A Consolidated Market
Drug Wholesaling Is A Mature Industry

Retail Pharmacies
- Retail Pharmacies Is A Maturing Industry Segment That Will Be Redefined Between 2012 and 2020
- The Consolidated Chain Drug Retailer Segment Is Best Positioned To Increase Its Prescriptions Share
- Intermediaries – Medical Device Industry Implications

Pharmaceuticals
- Pharmaceuticals Is An Opportunity Rich Industry
- US Pharmaceuticals, A Maturing Industry, Will Be Revitalized Between 2012 and 2020
- Biologics Are Replacing Small Molecule Products
- The Decreasing 1999 To 2010 New Drug Approvals Trend Is Indicative Of A Maturing Industry
- Average First-In-Class Therapeutic Competition Now Materializes Within Two Years After Market Entry
- Most Major Drug Classes Will Be Adequately Served By Generics By 2015
- Patent Expirations, Good News For Generics – Not For Brands Or Biologics Companies
- R&D Will Be Transformed 2012 To 2020
- R&D And The Regulatory Approval Process Are Expected To Be Redefined
- Prescription Persistence And Compliance Will Drive Value, Sales and Profitability
- Drug Reimbursement Will Dictate The Speed And Direction Of Industry Change
- Branded Companies Are Moving Into Generics
- US Generics Market Is Only 40% of the Way To Being Mature
- The Largest Companies Are The Best Positioned
- Pharmaceuticals – Medical Device Industry Implications

In Vitro Diagnostics
- In Vitro Diagnostics Is An Opportunity Rich Industry
- Traditional High-Volume Business Favors Large Competitors
- The IVD Market Is Made Up A Number Of Customer and Testing Segments – Representing Opportunities
- The Intellectual Property Landscape Is Changing
- Genomics Is In The Early Stages Of Redefining The In Vitro Diagnostics Industry
- The Value Of Companion Diagnostics Requires Pharmaceutical Companies To Access IVD Technologies
- Pharmaceutical And Diagnostics Deal Making Will Increase Between 2012 And 2020
- In Vitro Diagnostics – Medical Device Industry Implications

Medical Devices
- Medical Devices, An Opportunity-Rich Market, Will Experience Increasing Consolidation Through 2020
- The Medical Devices Sales Equation Will Shift Between 2012 And 2020
- The Migration Away From Physician Specification Favors Broad Product Line Medical Device Companies
- Myriad Technologies Will Transform The Medical Device Industry Between 2012 And 2020
- Companies Are Restructuring, Consolidating, And Globalizing
- Medical Devices – Medical Device Industry Implications

About The Author

Figures And Tables

Figures

Figure 1 Shifting US Medical Devices Marketplace
Figure 2 US Healthcare Expenditures And Employment
Figure 3 The Interconnected US Medical Devices Industry
Figure 4 Disruptive Innovation
Figure 5 History Of US Healthcare Legislation and Fragmentation Of US Healthcare
Figure 6 The Patient Protection And Affordable Care Act Is Causing And Will Cause Focus Shifts And Power Shifts
Figure 7 Redefining The US Medical Devices Industry, 2010 To 2020
Figure 8 Industry Life Cycle Example
Figure 9 Healthcare Industry Reaction To Proposed And Passed Legislation From Planning To Implementation
Figure 10 US Pharmaceutical Industry Stakeholders
Figure 11 US Health Expenditures and Their Share of GDP 1960–2020 (In Billions of US $)
Fibure 12 US Healthcare Inefficiencies 2010 versus 2020
Figure 13 US Healthcare Inefficiencies By Year, 2012 To 2020, (In $ Billions)
Figure 14 National Health Expenditures Per Capita, 1990-2020
Figure 15 Real Average Family Income Declined $3,540, 46 Percent, Between 1999 and 2009 If Uncorrected, The Quality Of Life In The United States Will Decline
Figure 16 Healthcare Expenditures as a % of GDP In OECD Countries In 2007
Figure 17 2010 Versus 2020 US Healthcare Expenditures By Major Payer Group(In $ Billions)
Figure 18 Life Expectancy At Birth In OECD Countries In 2007
Figure 19 Infant Mortality, Deaths Per 1,000 Live Births In OECD Countries In 2007
Figure 20 World Obese Population
Figure 21 Map Of Global Obese Population Distribution
Figure 22 Percent 15+ Years Old Daily Smokers
Figure 23 Liters Of Alcohol Per Capita
Figure 24 Diphtheria, Tetanus, Pertussis % of Children Immunized In 2007
Figure 25 United States Vaccination Coverage Among Children 19-35 Months
Figure 26 Influenza Immunizations For =65 Years Population In 2007
Figure 27 United States Women =40 Years Of Age Who Had A Mammogram In The Past 2 Years
Figure 28 CT Scanners Per Million Of Population, 2007
Figure 29 MRI Units Per Million Of Population, 2007
Figure 30 Health Technology Assessments (PCORI)
Figure 31 Out-Of-Pocket Expenses United States Versus OECD Countries
Figure 32 Uninsured US Population (In Millions)
Figure 33 Cumulative Changes in Health Insurance Premiums, Inflation, and Workers' Earnings, 1999-2009
Figure 34 US Health Expenditures and Their Share of GDP 1960–2020 (In Billions of US $)
Figure 35 National Health Expenditures Per Capita, 1990-2020
Figure 36 Logical Top Priorities For Reigning In Healthcare Costs
Figure 37 Aging Population Will Continue To Drive Up Healthcare Costs
Figure 38 US Chronic Disease Population (In Millions)
Figure 39 Concentration of Health Care Spending in the US Population, 2007
Figure 40 Fragmented Care Delivery
Figure 41 Geographic Differences In Healthcare Costs Percentage of National Average
Figure 42 Doctors Use of Electronic Patient Medical Records
Figure 43 Communication Between Country Healthcare Regulatory Agencies
Figure 44 US Healthcare Inefficiencies/Waste
Figure 45 PPACA Regulation and Implementation
Figure 46 Changing US Population Mix
Figure 47 Growth In Percent Of United States Obese Adults By State From 1985 To 2005
Figure 48 Number of Boomers Living with Chronic Conditions, 2000 To 2030
Figure 49 Average US Life Expectancy, 1950 to 2030
Figure 50 Share of Total RXs By Each Payer Type, By Age, 2008–2009
Figure 51 Medicare Payer Share of Hospital Inpatient Cases
Figure 52 Converging Technologies, Characteristics
Figure 53 Connecting Patients, Payers, Providers, Research Centers, Intermediaries, Manufacturers, Etc
Figure 54 NHIN and HER Industry Lifecycles
Figure 55 The Shrinking Cost of DNA Sequencing, The $1,000 Genome
Figure 56 History of the Human Genome Project
Figure 57 Genomics Applications
Figure 58 Genomics Lifecycle
Figure 59 Pharmacogenomics
Figure 60 Biomarkers
Figure 61 Cybernetics Physician Assistant
Figure 62 Cybernetics, Medical Apps and Connectivity Lifecycle
Figure 63 Connectivity and Medical APPs
Figure 64 Sample Medical APPs
Figure 65 New iPhone Health APP Launch Trends, July 2008 to December 2009
Figure 66 Data Structures Will Change Significantly, As The Number Of New ICD-10 Codes Has Increased Dramatically
Figure 67 Example ACO Structure
Figure 68 Accountable Care Organizations Lifecycle
Figure 69 Patient-centered Medical Home Lifecycle
Figure 70 Retail Health Clinics Lifecycle
Figure 71 Retail Clinic Growth By Major Players
Figure 72 Number Of Retail Health Clinics
Figure 73 Medical Center-Based Telemedicine Networks
Figure 74 Computer/Wi-Fi/Internet Enabled Lifecycles
Figure 75 Scientific/Device/Process Advancements Lifecycles
Figure 76 Average Annual Firm and Worker Premium Contributions
Figure 77 Cumulative Change In Familty Premiums and CPI, 1999-2009
Figure 78 Most Important Issues For Government To Address
Figure 79 One-Quarter of Adults Reported a Gap in Coverage in 2011
Figure 80 Average Annual Out-of-Pocket Drug Expenditures
Figure 81 Sample Average 2009 Out-of-Pocket Costs Per Prescription
Figure 82 Use Of Retail Clinics, 2009 and 2010
Figure 83 Percentage of Covered Workers Enrolled in a Plan With a High Deductible
Figure 84 Social Networking Use Continues To Grow Among Older Users
Figure 85 A Typical Day: Where Social Media Use Fits In
Figure 86 Cyberchondriacs: Trends 1998 – 2010
Figure 87 Trusted Third-Party Sources
Figure 88 2010 Comparison of Surgical Procedure In Various Countries
Figure 89 US Healthcare Expenditures By Major Payer, 2010 Versus 2020
Figure 90 US Healthcare Sectors Between The Patient and The Physician
Figure 91 Industry Lifecycle
Figure 92 The Interconnected US Healthcare Enterprise
Figure 93 Enrollment By Type fo Insurance, 2010, 2015, 2020
Figure 94 US Health Insurance Lifecycle
Figure 95 Top Five US Health Insurance Companies 2009 Relative Market Shares
Figure 96 2010 US Healthcare Expenditures In Billions of US Dollars
Figure 97 Historic Health Insurer Business Model
Figure 98 Number of HMO and PPO Operating Plans
Figure 99 HMO Operating Plans Versus Enrollment
Figure 100 Number of Medicare/Medicaid HMO Enrollees
Figure 101 2009 Insured US Population By Payer Type
Figure 102 US Patient Care Continuum
Figure 103 Providers Industry Lifecycle
Figure 104 2010 Level Of ACO Integration
Figure 105 US Physicians By Type Of Practice
Figure 106 Number Of US Hospitals In And Out Of Multihospital Systems (MHS), 2001-2009
Figure 107 Total Costs Per Admission, By MHS Ownership, 1999-2009
Figure 108 Growth Of Hospitals In Highly Integrated Healthcare Systems, 2004 To 2
Figure 109 Percent Of Nursing Care Facilities By Type
Figure 110 Senior Living Providers Lifecycle
Figure 111 Nursing Homes Lifecycle
Figure 112 Number Of Nursing Homes
Figure 113 Nursing Homes By Ownership Type
Figure 114 Nursing Homes By Bed Size
Figure 115 Home Healthcare Lifecycle
Figure 116 Number Of Medicare-Certified Home Care Agencies, By Auspice, 2000-2009
Figure 117 Home Healthcare Payers
Figure 118 US PBM Industry Lifecycle
Figure 119 US 2010 PBM Covered Lives Relative To Market Share
Figure 120 Top Nine Group Purchasing Organizations Based Upon 2011 Average Purchase Volume
Figure 121 Drug And Medical Products Wholesaler Interfaces
Figure 122 US Drug Wholesalers Lifecycle
Figure 123 US Drug Wholesalers Concentration
Figure 124 Sales And Prescription Brands And Generics Market Shares
Figure 125 Moving To A Redefined, Growth Pharmaceutical Care Industry
Figure 126 NME Versus Biologics Approvals, 1999 To 2010
Figure 127 Total NME And BLA Approvals Versus Five Year Peak Sales
Figure 128 Illustrative Pharmaceutical Lifecycle
Figure 129 Drug And 2010 Sales For NME And BLA Protection Expirations, 2010 To 2020
Figure 130 Pharmaceuticals, Private And Public R&D Spending In $ Billions
Figure 131 The United States Drug Approval Process Can Be Compressed
Figure 132 Samples Of Non-Traditional Partners
Figure 133 Branded Market Share Erosion Upon Expiration
Figure 134 Top 10 Generics Companies Relative Market Share By Dispensed Generic Prescriptions
Figure 135 In Vitro Diagnostics Industry Lifecycle
Figure 136 Global In Vitro Diagnostics Major Competitors' Relative Market Shares
Figure 137 Sample IVD Commercial Lab And Hospital Systems
Figure 138 Sample Point of Care (PoC) Diagnostic Systems
Figure 139 Demonstrating Clinical Utility And Health Economic Benefit – Increasing Returns
Figure 140 295 Genes Predict Prostate Cancer Clinical Recurrence
Figure 141 Benefits From Personalized Healthcare, Rewards Both Pharmaceutical And Diagnostic Companies
Figure 142 In Vitro Diagnostics Companies Portfolio Breadth By Market Segment
Figure 143 Medical Device Brand Choice, Shifting From Physicians To Institutions And Patients
Figure 144 Medical Device Industry Lifecycle 198 Tables

Tables

Table 1 Transformational Themes
Table 2 Healthcare Messages Being Received By Legislators
Table 3 Market Transformation Requirements
Table 4 PPACA Coordinated Implementation Steps By Year and Area of Impact
Table 5 The United States =65 Population Is Better Educated, Wealthier, More Diverse, More Mobile, More Active, and In Better Shape
Table 6 EMRs, EHRs, PHRs, and HIEs, HIOs, RHIOs Defined
Table 7 Sample Exchange and Patient Record Customers
Table 8 ARRA Meaningful Use Payment Schedule
Table 9 HER/NHIN Industry Revenues
Table 10 Pharmacogenomic Testing Required On Label
Table 11 Label Recommends Pharmacogenomic Testing
Table 12 Potential Accountable Care Organizations (ACO) Models And Their Characteristics
Table 13 PPACA Patient-centered Medical Home Initiatives
Table 14 Summary of Joint Principles of the Patient-Centered Medical Home
Table 15 Medical Home Pilot Program Savings Per Patient
Table 16 September 2009 RAND Study Findings
Table 17 Retail Health Clinics Companies, August 2010
Table 18 2010 Social Network Examples
Table 19 How Much Various Industries Are Blamed For Problems With Current Healthcare
Table 20 Preference For Generic or Brand Name Drugs
Table 21 Where People Buy Prescription Drugs Now
Table 22 21 Most Popular Health Information Sites
Table 23 Popularity of PPACA
Table 24 Insurers Complimentary Revenue and Margin Improvement Opportunities
Table 25 Medical Facilities And Services Regulated By Certificate Of Need In 2010 By State
Table 26 2011 Top Twenty US Medical Groups By Number Of Physicians
Table 27 Comparison Of Hospital, Skilled Nursing Facility, And Home Healthcare Medical Charges 2005 To 2009
Table 28 Top 20 Multihospital Systems, Ranked By Number Of Staffed Beds
Table 29 20 Selected Integrated Systems And Their Facilities
Table 30 Growth In Owned And Contracted Provider Units In Highly Integrated Healthcare Systems, 2001 Versus 2010
Table 31 Nursing Facility Ownership
Table 32 Top 20 Largest Senior Living Providers (January 1, 2011)
Table 33 Top 20 Nursing Home Groups By Number of Facilities
Table 34 Top 12 Home Healthcare Groups
Table 35 Top 10 PBM Companies Represented 748% of PBM Covered Lives And 750% Of Prescriptions As Of The 3rd Quarter 2010
Table 36 US Prescription Market By Channel Of Distribution
Table 37 Estimated Sales By Major Product Groups By Major Retail Channel
Table 38 2009 Top 25 United States Pharmacy Chains Ranked by Number of Pharmacies
Table 39 Major Drugs By Drug Class, Protection Expiration And Prescription Trends
Table 40 Dispensed Generic Prescriptions By Leading Companies
Table 41 Top 50 2010 Companies Ranked By Healthcare Revenue
Table 42 Top 100 Medical Device Companies Worldwide In 2010
Table 43 Top 20 Medical Device Technologies
Table 44 Top 20 Medical Device Companies, Estimated 2010 United States Device Sales In Billions

Edmund L. Valentine is a healthcare industry expert with over 27 years of global healthcare industry experience. He is the author of award winning Multi-Trillion Dollar U.S. Healthcare To 2020 Gold Rush, Industrializing Healthcare, multiple editions of MMC International's Trends Shaping U.S. Pharmaceutical Industry Strategies report, and is the editor of Rx Marketer's Reference Guide, 2nd Edition as well as therapeutic area reviews. Valentine is Chairman and C.E.O. of MMC International, a strategy, general management, business development, marketing, manufacturing, and technology assessment advisory firm primarily focusing on the global healthcare industry. He is a recognized authority on the trends shaping the U.S. healthcare system.

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