Commercializing Novel IVDs: A Comprehensive Manual For Success

Commercializing Novel IVDs: A Comprehensive Manual For Success



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5th Jan 2017



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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.

• 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.
Table of Contents: Commercializing Novel IVDs: A Comprehensive Manual for Success

Acknowledgements v


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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