Acknowledgements v
 
 
Introduction 
 
 
CHAPTER 1:
An Overview of the IVD Industry and Market 
Figure 1.1: The Importance of IVD in healthcare
What does “healthcare” mean? 
Healthcare trends and why they matter
Figure 1.2: Macro Healthcare Trends 
The world’s population is getting older 
Figure 1.3: Growth in the Aging Population 
Emerging economies are continuing to grow 
Figure 1.4: Improved Access to Healthcare in Emerging Economies 
The word is facing an epidemic of chronic diseases
Figure 1.5: Growth of Chronic Disorders 
The Affordable Care Act is redefining the business of healthcare 
Figure 1.6: Healthcare Reform Overview 
Healthcare delivery is becoming increasingly decentralized 
Figure 1.7: Decentralization of Healthcare 
 
 
Figure 1.8: The Rise of Retail Health Clinics
Integration is making personalized healthcare a reality 
Figure 1.9: Personalization of Care - Targeted Therapies 
Global healthcare spending is out of control 
Figure 1.10: Unsustainable Growth of Healthcare Spend 
Summary 
 
 
SECTION TWO: THE IVD INDUSTRY TODAY 
Figure 1.11: IVD Definition 
What do we mean by IVD? 
Figure 1.12: IVD Market Segmentation 
Figure 1.13: IVD Market 
Who are IVD’s clients? 
Applications of IVD 
Figure 1.14: Key Trends/Drivers Within IVD 
Figure 1.15: Recent Activity in the IVD Market
 
 
SECTION 3: LOOKING FORWARD 
Integrated delivery networks and consolidation will be the rule, rather than the exception 
Figure 1.16: Growth of Integrated Delivery Networks (IDNs)
Figure 1.17: Consolidation of Healthcare 
Characteristics of Integrated Health Delivery Networks 
Figure 1.18: Growth of ACOs 
Figure 1.19: ACO Objectives 
Remote patient care and monitoring will become indispensable components of healthcare 
Figure 1.20: Personalization of Care - Remote Patient Monitoring 
Figure 1.21: Personalization of Care - Remote Patient Monitorin
Health information technology will grow ever more integrated 
Figure 1.22: Personalization of Care - Healthcare Data Analytics 
Have you heard about “Patients Like Me”? 
Data-driven and evidence-based medicine will become the new reality 
Figure 1.23: Personalization of Care - Healthcare Data Analytics 
Figure 1.24: Improved Outcomes and Cost Effective Care 

 
 
CHAPTER 1 REFERENCES 
 
 
CHAPTER 2:
 
Product Concept Development and Validation 
 
SECTION 1: Understanding the current clinical paradigm 
Overview of the patient care cycle/clinical paradigm 
What is the Patient Care Cycle? 
Figure 2.1: Mapping the Patient Journey to Key Diagnostic Steps 
Figure 2.2: Clinical Care Pathway Analysis - Getting Started 
Using the care cycle to map patient flow 
Figure 2.3: Analyzing the Workflow 
Figure 2.4: Clinical Care Pathway Overview 
Figure 2.5: Prostate Cancer Diagnostic Workflow 
Identifying relevant stakeholders 
Mapping parallel diagnostics workflows 
 
SECTION 2: Identifying unmet needs and opportunities 
Identifying underlying clinical needs 
Figure 2.6: Identifying Unmet Needs and Opportunities 
Figure 2.7: Identifying Unmet Needs - Breast Cancer Example 
Figure 2.8: Opportunity Identification and Characterization 
Value proposition development
Figure 2.9: Assessing Buyer Values and Requirements 
Figure 2.10: Mapping Buyer Values to Opportunities 
Example analysis: Philips 
Figure 2.11: Case Example - Philips Stroke Care 
 
 
SECTION 3: Characterizing and prioritizing opportunities for selection 
 
Defining the addressable patient population 
Figure 2.12: Market Sizing
Figure 2.13: Opportunity Prioritization
Figure 2.14: Competitive Landscape Assessment 
3.2 Understanding the diagnostic requirements 
Defining clinical utility for the opportunity 
Figure 2.15: Evaluation Framework for Diagnostic Tests 
 
CHAPTER 2 REFERENCES 
 
 
CHAPTER 3:
  
Diagnostic Development 
What is an IVD? 
IVD Classification 
Marketing Diagnostic Tests 
ASRs 
IVDs 
LDTs 
Figure 3.1: Comparison of Diagnostic IVD and LDT Development Pathways 
Clinical Laboratory Improvement Amendment (CLIA) 
 
Overview of Laboratory Developed Tests (LDTs) 
 
Types of IVD technologies 
Technology and platform considerations 
Design process and control—a brief overview 
Figure 3.2: Design Control Process Overview 
Why Design Controls? 
Stage-gate Product Development 
Figure 3.3: Product Development Management
Figure 3.4: Stage Gate Process for Diagnostic Development
Figure 3.5: Needs Identification and Assessment 
Figure 3.6: Deliverables and Decisions by Stage-Gate Phase 
Figure 3.6: Deliverables and Decisions by Stage-Gate Phase 
Project management 
Development process 
Design & development planning 
Design input 
Design output 
Design review 
Design verification and validation 
Design transfer 
Design changes 
Design history file 
Precision Medicine 
Beyond the U.S. 
LDT guidance 
 
 
CHAPTER 3 REFERENCES 
 
    
CHAPTER 4:
 
 
Regulatory Considerations and Pathways 
Regulatory Overview 
Figure 4.1: Regulation of Diagnostics - Key Regulatory Authorities (US) 
US FDA overview 
Risk-based Classification of Devices 
Figure 4.2: FDA IVD Regulation Overview - The Three Classes 
Devices used in clinical trials 
Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
Figure 4.3: CLIA - Oversight 
Figure 4.4: Oversight Example - California 
FDA and CMS Comparisons 
European IVD Directive
FDA Approval Pathways 
510(k) Clearance 
Figure 4.5: 510(k) Approval Process 
Pre-market approval (PMA)
Figure 4.6: PMA Approval - Overview Pathways and Timeline
Humanitarian Device Exemption (HDE) 
Lab-developed tests (LDTs) 
Analyte specific reagents (ASRs) 
Companion diagnostics (CDx) 
Complementary diagnostics 
FDA draft guidelines 
 
Laboratory developed tests (LDTs) 
Figure 4.7: LDT Approval - Proposed Level of Oversight 
Figure 4.8: LDT Proposed Timeline for Regulatory Oversight 
Companion Diagnostics (CDx) 
Co-development of CDx with Therapeutic Products
 
NGS-based IVDs and Diagnosis of Germline Disease 
Public Genetic Databases for Clinical Validity for NGS-based IVDs 
Emerging issues over IVD regulations and genomic testing
 
Overview—genetic testing and regulations 
The Genetic Information Nondiscrimination Act of 2008 
History of GINA 
Protections by GINA and other Laws 
Limitations of GINA 
Ethical, legal, and social issues related to the use of genetic information 
Genetic testing in children 
Genetic tests and medical records 
Direct to consumer (DTC) testing 
Summary 
 
 
CHAPTER 4 REFERENCES 
 
CHAPTER 5:
 
 
Market access planning 
U.S. Health Insurance and Reimbursement Overview 
 
 
 
Figure 5.1: U.S. Health Insurance Structure
Figure 5.2: Health insurance coverage by type. (Source: healthinsurance.org) 
Early health insurance plans
 
The Rise of Medicare and Medicaid 
ACA/Healthcare reform 
Figure 5.3: Relationship Between Payment Reform, Provider Organization Models, and Feasibility
Reimbursement overview 
Figure 5.4: Flow of funds in the U.S. healthcare system. 
Payer coverage decision influences 
 
 
Figure 5.5: Coverage Decision Influences
The Role of Evidence 
HTA Process 
Figure 5.6: Health Technology Assessment Organizations by Frequency of Use by Payers and Intended Audience. 
Evidence Generation for Diagnostics 
Figure 5.7: Study Design Hierarchy of Evidence
Real-World Data 
Coding: Molecular Pathology codes 
Figure 5.8: Generic Code Types for Molecular Diagnostics 
Figure 5.9: Changes in Coding of Molecular Diagnostics 
Figure 5.10: Molecular Diagnostic CPT Codes45 
Reimbursement Process 
Payment 
Figure 5.11: PAMA’s Effect on Laboratory Testing Payment Frameworks45 
Figure 5.12: The MolDX Framework for Evaluating Molecular Diagnostic Tests45 
Contracting for Payment
Figure 5.13: Payer Contracting Process
Functional roles and capabilities 
 
Outlook and What’s to Come
Outlook for Molecular Diagnostics 
Evidence and reimbursement in CDx 
Summary 
 
 
CHAPTER 5 REFERENCES 
 
CHAPTER 6:
 
Commercialization planning and operations 
Market planning and operations 
 
Brand planning 
Customer segmentation
Brand positioning and brand marketing
 
Key opinion leaders: Identification and strategy
Forecasting 
Marketing channel mix 
Figure 6.1: Marketing Strategies for the IVD Industry
Sales planning and operations 
Sales force structure and size
Account planning and detailing
Compensation design 
Medical affairs
Figure 6.2: Medical Affairs Key Roles and Responsibilities 
 
Overview of medical affairs and medical science liaison (MSL) roles
Scientific writing 
Commercialization support: Thought leader management and sales/marketing support
 
Customer service/support 
Setting up an effective client services/support strategy and unit 
Summary 
 
 
CHAPTER 6 REFERENCES 
 
 
CHAPTER 7:
 
Wrapping Up and Looking Ahead
A look backward
Healthcare trends 
The clinical paradigm and product conception
Diagnostic development 
Regulatory frameworks 
 
Market access and reimbursement
Commercialization planning
New technologies 
Big data and analytics 
 
What comes next? 
 
 

CHAPTER 7 REFERENCES