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Market Research Report

Commercializing Novel IVDs: A Comprehensive Manual for Success

Published by Insight Pharma Reports Product code 421708
Published Content info 245 Pages
Delivery time: 1-2 business days
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Commercializing Novel IVDs: A Comprehensive Manual for Success
Published: January 13, 2017 Content info: 245 Pages


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.

About the Author

Harry Glorikian is an influential global business expert with more than three decades of experience building successful ventures in North America, Europe, Asia and the rest of the world. Harry is well known for achievements in life sciences, healthcare, healthcare IT and the convergence of these areas. He is a sought after speaker, frequently quoted in the media, and regularly asked to assess, influence, and be part of innovative concepts and trends. He holds four US patents in telecommunications, and has others pending.

He recently served as an Entrepreneur In Residence to GE Ventures - New Business Creation Group. He serves on the board of GeneNews Ltd. (a molecular diagnostic company). He also serves on the advisory board of Nucelis (a gene-editing industrial biotech company), Evidation Health (a digital health startup launched with support from GE Ventures), and several other companies. He is also a co-founder and an advisory board member of DrawBridge Health (a revolutionary diagnostics startup launched with support from GE Ventures).

Previously he co-founded and held the position of managing director and head of consulting services for Scientia Advisors, a company that became the go-to provider of strategic advice and implementation services for next-generation healthcare and life science innovators and Global 25 market leaders. Scientia Advisors was acquired by Precision for Medicine in November of 2012. Among his other professional roles, Mr. Glorikian served as senior manager for global business development at PE Applied Biosystems, founded X-Cell Laboratories, managed global sales at Signet Laboratories and held various roles at BioGenex Laboratories.

Mr. Glorikian holds an MBA from Boston University and a bachelor's degree from San Francisco State University. Harry has addressed the National Institutes of Health, Molecular Medicine Tri-Conference, World Theranostics Congress and other audiences, worldwide. He has authored numerous articles for industry publications, appeared on CBS Evening News and been quoted regularly by Dow Jones, The Boston Globe, BioWorld Today, Los Angeles Times, London Independent, Medical Device Daily, Science Magazine, Genetic Engineering News and many other media outlets.

Table of Contents

Table of Contents

  • Acknowledgements
  • Introduction


  • 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: Unsustaibanle Growth of Healthcare Spend
  • Summary


  • 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
  • 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



  • 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



  • 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 Codes
  • Reimbursement Process
  • Payment
  • Figure 5.11: PAMA's Effect on Laboratory Testing Payment Frameworks
  • Figure 5.12: The MolDX Framework for Evaluating Molecular Diagnostic Tests
  • 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



  • 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



  • 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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