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.