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Commercializing Novel IVDs: A Comprehensive Manual for Success

  • ID: 4033262
  • Report
  • January 2017
  • Region: Global
  • 243 Pages
  • Insight Pharma Reports

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.

Note: Product cover images may vary from those shown

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: Unsustaibanle 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 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

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 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 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
  • 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 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 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

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 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?
Note: Product cover images may vary from those shown

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.

  • Global and regional trends have a tremendous effect on the IVD industry. Rising healthcare costs have led to a greater emphasis on evidence-based medicine and a focus on improved patient outcomes. An aging population along with the growing epidemic of chronic diseases and (re)emergence of infectious diseases are creating a demand for diagnostic devices for a variety of conditions. The growth of emerging economies and the push for decentralized healthcare are opening the IVD market to a wider audience. Healthcare delivery systems are changing, with growing numbers of integrated delivery networks and accountable care organizations, while smaller physician and hospital networks are being acquired by larger corporations and/or are aligning themselves with other small groups. How can your company enjoy success in a market that is both larger in market size yet increasingly smaller in terms of actual players? Demonstrable value in your product is essential.
  • IVD product concept development relies on understanding the patient experience and translating those needs into product design. It’s not enough to develop a test for an indication without understanding if there’s a need for the test and how it will be integrated into clinical care. This involves learning about the patient population and other key stakeholders, identifying the unmet need your product fills, and creating a powerful value proposition.
  • Development is an iterative process that must conform to specific manufacturing and design requirements. Good Manufacturing Practices and the FDA’s Design Control Guidance are frameworks that can be used in IVD development. Knowing which specific requirements may apply to the development of your device means making sure your company has the right team in place. Working closely with the FDA and/or other regulatory agencies early in the process can ensure your device meets not only the initial design requirements, but also any regulations that will be imposed on the final product. Given the different departments and individuals involved in the development stage, it’s not hard to see how competing interests could derail the project. An experienced project manager who can keep the process on track should be an essential part of your team.
  • The regulatory space around IVDs is evolving rapidly. Regulation of IVDs in the U.S. largely falls to the FDA, though other federal and state agencies play a role. There are multiple development pathways to consider (e.g., analyte-specific reagent, lab-developed test), and each has specific requirements. It is essential to understand and comply with those requirements. In the U.S., the FDA’s release of multiple draft guidance documents in the past several years has generated vigorous debate and uncertainty for the IVD industry, particularly as final LDT guidance appears to be on hold for some time to come. Consulting with, or hiring, an individual who is well-versed in the regulatory sphere is an essential component to compliance.
  • Planning for market access begins early in product development, and successful coverage determination and reimbursement are built on meeting the expectations and requirements of agencies and payers. The overall healthcare system in the U.S. is moving toward payment for performance. This shift will be enabled by greater use of novel IVD products and the data they generate. Development of a market access strategy shouldn’t be treated as an afterthought at the end of the development process. Unless you plan to market directly to consumers (and maybe even then), obtaining a positive coverage determination and a fair reimbursement price should be at the top of your market access concerns. It is critical to demonstrate that your product can reduce overall costs and improve patient outcomes. The success of programs like the Precision Medicine Initiative and the Cancer Moonshot Project will be based largely on the use of IVDs to determine which patient should receive what intervention and when in the patient journey.  Leveraging data, performing the right clinical trials and cost effectiveness studies, and understanding how the system is structured are vital to market access planning.
  • As IVDs become increasingly prescriptive, commercialization strategies must evolve. From the moment you identify the intended patient population, it’s time to start thinking about how you’ll direct sales and marketing toward them and/or their healthcare providers (HCPs). Here’s where the IVD industry can take a page from pharma’s playbook by including greater reliance on individuals in medical affairs roles, engaging with key opinion leaders, and developing the ability to adapt key sales, marketing, and customer service staff to meet evolving client needs. Standing out in today’s growing and crowded IVD market will require some level of agility to respond to changing market demands and flexibility in job roles.

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.

Note: Product cover images may vary from those shown
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