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Commercializing Novel IVDs: A Comprehensive Manual for Success

Commercializing Novel IVDs: A Comprehensive Manual for Success

Does your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be? 
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you’re unsure of which regulatory pathway to pursue? 
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market. 

This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including: 
How do I approach the regulatory process? 
How can I plan for market access, and what can I do to make sure my IVD will be reimbursed? 
Specific chapters in the manual:
An Overview of the IVD Industry and Market
Product Concept Development and Validation
Diagnostic Development
Regulatory Considerations and Pathways
Market Access Planning
Commercialization Planning and Operations
Wrapping Up and Looking Ahead
This is not a checklist or how-to manual with step-by-step instructions to build an IVD. It is meant to provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process: How do I approach the regulatory process? How can I plan for market access, and what can I do to make sure my IVD will be reimbursed? These ideas don’t exist in a silo, but people are so focused on individual steps in the process they are responsible for, that the overall picture is sometimes missed. This is understandable—no one person can be an expert on every aspect of the IVD development process. The scientists in the lab may have little to no understanding about the different regulatory options and requirements that influence an IVD, and the sales staff may not completely understand the engineering process; neither is expected to! But it’s essential to understand and identify the necessary job functions to move an IVD from product ideation through successful commercialization. This book attempts to do that by describing the overall process of IVD development, who needs to be involved, and highlighting challenges and points to consider along the way. 

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 
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
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 Monitoring 
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 
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 
Diagnostic Development 
What is an IVD? 
IVD Classification 
Marketing Diagnostic Tests 
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 
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 
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: 
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 
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
Commercialization planning and operations 
Market planning and operations  
Brand planning 
Customer segmentation
Brand positioning and brand marketing 
Key opinion leaders: Identification and strategy
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 
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? 

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