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The global in vitro diagnostics (IVD) market is evolving rapidly, driven by growing demand for faster, more accessible testing across clinical and consumer settings. As healthcare systems shift toward earlier detection, personalised treatment, and decentralised care, the need for innovative diagnostics has never been greater. Yet turning a concept into a market-ready product remains a lengthy process. For sponsors looking to successfully launch their diagnostic products, creating an effective go-to-market strategy (GTM) and partnering with specialized contract research organizations (CROs) can make the difference between market success and costly delays.
IVD development follows a structured, multi-phase process that typically spans several years and involves significant investment. The complexity stems from the diverse nature of IVDs themselves. Screening tests require extremely high sensitivity to avoid missing disease cases, while diagnostic tests prioritize accuracy and specificity for symptomatic patients. Monitoring tests focus on precision for tracking disease progression, and prognostic tests require long-term outcome validation. User needs must also be considered, which is especially crucial for point-of-care testing or diagnostic tests for home use.
Clinical validation timelines vary significantly depending on the IVD type, with screening tests often requiring large-scale studies of thousands of patients with extended follow-up, while diagnostic tests typically need hundreds to thousands of samples. One of the first steps in designing an effective clinical validation study is determining whether a standard of care (SOC) or gold standard test exists. This benchmark sets expectations for test performance, especially sensitivity, specificity, and clinical utility. If a gold standard is available, your study must demonstrate non-inferiority or superiority. In areas with no clear SOC, developers must work closely with regulators to define suitable comparators and endpoints Regulatory timelines add another layer of complexity with varying approval timeframes depending on device classification and regulatory pathway, including FDA 510(k) clearances, pre-market approvals (PMA), and EU IVDR submissions to Notified Bodies.
A successful diagnostic launch isn’t just about generating evidence and regulatory approval; it’s about real-world adoption. Developers must ask early: How will this test actually be used? Will it be run in central labs, used by clinicians at the point of care, or self-administered by patients at home? These choices affect everything: from usability design and analytical performance requirements to sample collection logistics and digital infrastructure.
Aligning product design with real-world use improves adoption, strengthens your reimbursement case, and reduces costly rework downstream.
Your therapeutic focus significantly impacts development strategy, timelines, and resource requirements. Oncology IVDs present unique challenges with complex biomarkers requiring advanced techniques like next-generation sequencing and liquid biopsy technologies. These tests often require large, lengthy clinical studies and face high regulatory scrutiny, with most requiring PMA approval and extensive real-world evidence for clinical utility demonstration.
Infectious disease IVDs often follow more predictable development paths. Established reference standards enable faster validation, smaller sample sizes provide clearer endpoints, and many tests qualify for the 510(k) pathway with shorter review times. The straightforward nature of most infectious disease testing—detecting the presence or absence of a pathogen, creates clear clinical utility arguments that resonate with both regulators and payers. Additionally, the urgent clinical need during outbreaks can accelerate adoption timelines, while existing laboratory workflows for microbiology testing reduce implementation barriers. Point-of-care infectious disease tests benefit from particularly favorable reimbursement landscapes, especially when they can demonstrate improved patient outcomes through faster diagnosis and treatment initiation.
The regulatory landscape has undergone significant transformation, particularly in Europe, with IVDR implementation in 2022. The FDA classifies IVDs into three risk-based categories: Class I devices are mostly exempt from premarket notification, Class II devices require 510(k) clearance, and Class III devices require comprehensive PMA submissions. For some diagnostics, developers can consider launching first as a lab-developed test (LDT) in a CLIA-certified lab before pursuing FDA approval. While this can speed up early market entry, new FDA regulations will require LDTs to meet similar standards as commercial IVDs, removing much of the historical regulatory flexibility.
The EU IVDR has fundamentally transformed the European market, and categorizes medical devices into four risk classes: A, B, C, and D, with D representing the highest risk and A the lowest. These classes determine the level of scrutiny and conformity assessment required for a device before it can be placed on the EU market. Devices in classes B, C and D require conformity assessment by a Notified Body, an independent third-party organization authorized to assess the device's compliance with IVDR.
Choosing the right regulatory pathway is not just a compliance task, it's a foundational element of a successful GTM strategy. Early and strategic planning aligned with the appropriate regulatory requirements can accelerate time to market, reduce costs, and avoid regulatory rework.
Reimbursement remains one of the most challenging aspects of IVD commercialization. Recent Medicare payment policy changes for 2025 present both opportunities and challenges, with the Medicare Physician Fee Schedule facing a 2.93% reduction in average payment rates.
Successful reimbursement strategies require early payer engagement during clinical development to understand coverage requirements and demonstrate value propositions. Coverage requires demonstrating clinical utility—proving that the test meaningfully influences clinical decision-making by providing actionable insights that directly affect how physicians diagnose, treat, or manage patient care. Health economic evidence has become critical, with payers demanding robust cost-effectiveness data showing improved patient outcomes and reduced overall healthcare costs.
The unique requirements of IVD studies make partnering with specialized CROs essential rather than optional. Unlike traditional clinical trials, IVD studies require specific expertise in diagnostic validation, analytical performance testing, clinical performance studies, and complex sample logistics. The rise of decentralized clinical trials (DCTs) is also shaping diagnostics research, especially for tests designed for home use or point-of-care settings. These designs demand additional planning around remote sample collection, device usability, patient training, and digital infrastructure for data capture.
IVD studies often involve multiple sites, such as hospitals, pathology centers, and reference labs, and include considerations like usability, patient training, and digital infrastructure for data capture. This adds significant logistical and operational complexity. Many sponsors choose to outsource these studies to specialized CROs with deep diagnostics expertise to ensure coordinated oversight, accelerate timelines, and access capabilities not available in-house.
The IVD market is full of opportunity, but reaching it requires navigating complex development, evolving regulations, and demanding clinical validation. With FDA reclassifications, IVDR enforcement, and rising expectations for clinical utility, strategic execution is more important than ever.
Success depends on early planning, cross-functional alignment, and the right partnerships. Sponsors that integrate regulatory, clinical, and go-to-market strategies and work with diagnostics-focused CROs can accelerate timelines, reduce risk, and deliver real value to patients and providers.
The future of diagnostics is fast, precise, and patient-focused. At Lindus Health, we support your IVD journey from start to finish. Ready to bring your diagnostic innovation to market faster? Get started with our team today.
