In Vitro Diagnostics Consulting

How does Exponent bridge the gap between IVD innovation, regulation, safety, and performance?

With lives on the line, innovations that support healthcare demand the highest levels of scientific rigor. The analysis of human specimens provides medical practitioners with critical information to properly diagnose, treat, and prevent disease. Whether you are operating a clinical lab or developing in vitro diagnostic (IVD) kits and instruments for the central lab, in-home use environments, or point-of-care, you need clear answers to complex questions, quickly.

Exponent consultants support our IVD clients across the total product lifecycle by solving critical design, regulatory, safety, and market access challenges. We can collaborate with you throughout your journey, helping you navigate risks and opportunities — and optimize outcomes — with science-based strategies and specialized expertise. Exponent helps clients push the envelope on the development, deployment, safety, and effectiveness of cutting-edge wearable, bench-top, and at-home IVDs — concomitantly balancing benefits and risks. Count on our multidisciplinary, data-driven, evidence-based assessments to give you the clarity you need on your most complex product needs and challenges.

Capabilities

Our IVD consultants support the full range of in vitro and companion diagnostics, including high-throughput clinical laboratories, point-of-care, wearable, and at-home testing products. Our expertise includes analysis of real-world evidence (RWE), identifying IVD safety risks including use-related errors, assay and instrument development support, human factors, chemical, biological, mechanical, electrical, and materials support, microfluidics and disposables support, and technical due diligence.

IVD development is dynamic and complex, accompanied by increasing pressure to develop new tests and protocols quickly under changing user requirements. Since there are often no specific standardized processes to assess functionality, creating innovative approaches and methodologies is necessary to develop testing strategies with tailored approaches. Exponent provides rigorous analyses of assay kits to verify their performance against targeted biomarkers and pathogens. We assess their sensitivity and specificity to evaluate manufacturing failures and the impact of damage that occurs during transit or storage. Exponent's bioassay scientists provide assessments for detecting and quantifying nucleic acid, proteins, enzyme activity, and pathogens with tailored protocols.
Smart, connected medical devices demand power, and the number and types of these devices are increasing dramatically. Similar to the consumer electronics space, batteries enable functionality in wearable technology, at-home testing devices, and remote services such as telemedicine. In healthcare, though, expectations for reliability, durability, and biocompatibility compound the demands on stored energy systems, especially for wearable devices. Exponent helps clients understand the performance and limitations of batteries in IVDs and health monitoring devices, assess battery-critical functionality, and confirm compatibility of powered systems with sterilization processes. Exponent is experienced in all aspects of the product development cycle for battery-containing IVDs and wearables, including support for verification and validation, supply chain assessment, and failure analysis.
With more than fifty years of experience analyzing failures of all types of products, components, and structures, Exponent experts are uniquely positioned to advise clients on material selection and performance throughout the entire product lifecycle. Whether choosing a material for a new connected medical device, evaluating the chemical compounds of an existing product, or analyzing the cause of failure in a damaged component, Exponent provides extensive consultation, testing, research, and evaluation at each stage of the product lifecycle. For example, we help our clients source and test materials based on design goals, indications for use, sterilization compatibility, biocompatibility, strength, corrosion resistance, and other criteria; validate material composition; evaluate electrochemistry, chemical stability, and degradation mechanisms; and investigate product failures such as contamination.
IVD instruments use various detection technologies, often involving complex optical systems. As the field shifts towards point-of-care and home settings, new technologies are being developed to reduce the cost of light sources and optical systems. Exponent supports the design, characterization, modeling, and simulation of electronic and optoelectronic devices, including optical systems. Our expertise covers colorimetry, luminance, reflectance, visual defect quantification, laser and LED radiation safety, functional safety, optical and electromagnetic system design, raytracing, ruggedizing optical systems, depth sensing technologies, and custom optical metrology solutions.
Combining our knowledge of anatomy, physiology, clinical applications, and numerical modeling, Exponent provides customized simulations of our clients' products in the IVD sector to understand mechanical performance, fluid flow, pharmacokinetic behavior, and other physico-chemical processes. We regularly employ finite element analysis (FEA), computational fluid dynamics (CFD), and multiphysics modeling using tools such as ANSYS, ABAQUS, and COMSOL to support product development and device failure analysis. Our evaluations help our clients generate insight into the function of their designs in the clinical environment and enable accelerated product development, informed failure analysis, and scientifically grounded risk mitigations. For example, our services include evaluating the efficacy of designs before prototyping, reducing the volume of in vitro tests with blood and other biological fluids, minimizing the need for preclinical testing, assessing the product function at and beyond the established design boundaries, and elucidating failure mechanisms during root-cause analysis.
IVDs and LDTs often rely on software algorithms to acquire, process, and analyze IVD signals. Sophisticated AI/ML algorithms digest and analyze these signals to provide test results and clinical interpretations. Data Science provides insights and actionable intelligence. Exponent has expertise in applying data science, AI, and ML to health data. Exponent also has specific expertise in helping our clients create effective premarket verification and validation packages (e.g., LDTs) and FDA submissions (510(k), De Novo, PCCPs, etc.), including devices that incorporate AI/ML software.
Diagnostic test results are often delivered through web or mobile apps. This requires safe and compliant data storage, processing, and transmission. Exponent's software and computer engineering team consults on many aspects of software analysis and design, ranging from evaluating software products and intellectual property to resolving issues related to identifying cybersecurity risks and implementing the security controls needed to effectively manage them. We perform complex software reviews, study the interaction of hardware and software layers, and evaluate safety and reliability issues related to device control for safety-critical applications such as medical devices.
Whether adapting to new regulatory frameworks or entering new diagnostic areas, manufacturers are continually challenged with meeting new or evolving regulatory requirements for bringing innovative products to market. Exponent provides extensive expertise in U.S. and international IVD and companion diagnostics product regulations (including those that impact software-based digital products) to help you overcome regulatory challenges for a range of applications and needs. Life science companies count on Exponent's decades of experience and objective, science-backed analyses and insights to support regulatory strategy, health authority engagement, preclinical testing, clinical strategies, manufacturing, and submission preparation to help enable a more informed and streamlined path to commercialization.
Exponent human factors scientists are well-equipped to investigate use-related aspects for a wide range of wearable and IVD products through a variety of techniques, including surveys, focus groups, formative usability studies (in-person or remote), and human factors summative or validation studies for all identified user groups (e.g., physicians, medical assistants, or at-home users), along with evaluation of manufacturer-developed documents, such as the use-related risk analysis (URRA), safety and instructional information provided on the product or instrument itself, instructions for use (IFU), training, and other supporting materials. Potential human behavior and performance attributes considered or assessed include physical and sensory processes, like vision, hearing, ergonomics, and proprioception, and cognitive functions, like attention, memory, information processing, and decision-making, across the developmental life span. Understanding human capabilities and limitations in expected use environments can help with assessing what or why use errors may occur, factors influencing adherence and compliance, and likely interactions with a product or environment to better inform design decisions and safety communications.
Our consultants assist clients in a wide range of IVD-related disputes, including intellectual property and patent disputes, contract disputes, insurance claims and loss management disputes, and international arbitration and product liability disputes, including mass torts. Our multidisciplinary experts offer unbiased, science-based evaluations of product function, product performance assessments, and root-cause failure analyses, providing clients, along with juries, judges, and other finders of fact in litigation and arbitration, with clear answers to complex technical questions.

What Can We Help You Solve?

Exponent's multidisciplinary team of IVD experts assist industry clients across the full IVD product lifecycle. With decades of industry experience, our scientists and engineers help clients with assay development, regulatory compliance, accident and failure investigations, dispute support, and more.

Collegues at a computer. Exponent biomedical experts consult on medical products and regulatory compliance.

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