Chapter 1: An Overview of the IVD Industry and Market
This chapter will provide an overview of the IVD industry, beginning with the current macro trends in healthcare. From there, we’ll focus on the IVD industry specifically, looking at IVD market segmentation and current applications of IVDs, before finishing the chapter with emerging trends.


Chapter 2: Product Concept Development and Validation
We’ve already seen in Chapter 1 that the healthcare industry is at a point of transition. Patient demographics are shifting, new models of care are being introduced, chronic diseases are reaching epidemic proportions, and technology is expected to play an increasing role in the future. IVD companies are not immune to these changing market forces.  To stay relevant in the IVD industry requires understanding the current clinical paradigm, correctly identifying unmet clinical needs and opportunities, and positioning your company to prioritize your product based on potential clinical utility while defining your patient population.  How do we start to understand the current clinical paradigm and where your product fits? Let’s start with a closer look at the patient care cycle.


Chapter 3: Diagnostic Development
Before we begin to discuss IVD development, we should establish exactly what we mean by medical devices and IVDs. These are important points to make, as they will have broad-reaching effects, from design and development to the regulatory process.  


Chapter 4: Regulatory Considerations and Pathways
Now that we’ve covered the basics of product concept and diagnostic development, it’s time to delve into the regulatory space around IVDs. As previously mentioned, regulatory requirements for certain categories of IVDs may be changing. Before jumping into the development of your device, it’s essential to verify the current laws and guidelines that are applicable to your product. We begin this chapter with an overview of IVD regulations, including those of the FDA, the Centers for Medicare and Medicaid Services (CMS), the Clinical Laboratory Improvements Amendment of 1988 (CLIA), and the European Union’s IVD Directive. We expand on the previous discussion of the evolving regulatory environment for some categories of IVDs and the FDA’s draft guidance for LDTs.  Finally, we address some emerging issues pertaining to genomic testing, such as the Genetic Information Nondiscrimination Act of 2008 (GINA) and the ethical, legal, and social issues related to the use of genomic information. We also touch on the relationships between genomic information, medical records, and the role of direct-to-consumer genetic testing.


Chapter 5: Market Access Planning
Before moving to commercialization strategies, we need to focus our attention on market access planning.  Understanding how the U.S. health insurance industry is structured is critical to knowing what you will need to do in order to receive reimbursement for your IVD.  We’ll begin this chapter with an overview of the complex U.S. healthcare system, from its historical beginnings to the Affordable Care Act. Payer coverage influences underlie how reimbursement works and what is required to receive it. We end the chapter looking ahead to changes on the horizon that affect molecular diagnostics reimbursement.


Chapter 6: Commercialization Planning and Operations
Planning your commercialization strategy is the final component required before launching your product. Though presented last, successful product launches have well-developed sales and marketing strategies, solid medical affairs teams, and a company focus on the customer experience in place well in advance. In this chapter, we’ll briefly describe some of the best practices associated with each of these topics.


Chapter 7: Wrapping Up and Looking Ahead
The past six chapters have covered a lot of information about IVD development. Several different forces currently influence the industry: demographic and economic pressures, a changing regulatory environment, difficulties with reimbursement, and increased competition. Although I’ve described each of these topics in the preceding chapters at some length and several could merit an entire book on their own, this manual was designed to provide an overview of the topic. Think of IVD development and commercialization like a jigsaw puzzle. Every piece and the way it joins with other pieces is unique, but each contributes to the overall picture. Each IVD is also uniquely designed for a purpose. The mode of action, the patient population, and the technology used are all specific to that product. Even though a proteomics assay developed for tumor profiling is inherently different than a test for serum sodium levels, both face similar issues in the development and commercialization process. Before concluding, I’ll examine some emerging technologies and novel ways of using established technologies that may play a role in future IVD development.