Clinical Laboratory and Point-of-Care Diagnostics

The analysis of human specimens provides physicians with critical information to properly diagnose, treat, and prevent human disease. Industry strives to produce diagnostics that deliver more sensitive and more rapid results, while minimizing cost and complexity. Additionally, the high cost of hospitalization is driving the market towards greater use of point-of-care diagnostics, including those developed for the emergency department, for the physician office, and for home use.

These next generation point-of-care diagnostics will enable remote diagnosis for improved prevention and management of infectious and chronic diseases. Diagnostic product developers and manufacturers face numerous challenges delivering new products to the marketplace, including integrating sample preparation and multiplexed assay development into a low cost manufacturable design, assimilation into clinical workflows, scaling up production with appropriate material selection and manufacturing methods, and preparing persuasive regulatory submissions. Furthermore, from a business perspective, it is important to understand the market and reimbursement strategies. Given their multidisciplinary nature, successful diagnostic product launches are complex endeavors that must combine effective regulatory compliance, product development, intellectual property protection, and failure analysis.

Exponent provides the highest quality science and engineering, regulatory, and health economic services to assist our clients with matters related to clinical and point-of-care diagnostic products. We specialize in providing rapid, focused, market-sensitive solutions to complex topics.
Clinical Diagnostic Product Development Assistance

We assist with laboratory and point-of-care diagnostic product development, including assay development, device design, sample preparation, material selection, surface coatings to repel non-specific binding, biosensor optimization, manufacturing and scale-up, instrument development/validation, product performance optimization and improvement, and product safety and reliability. We also assist with failure analysis, including identification of leachates that poison assays, identification of inferents, and surface analysis and characterization.

Medical and Economic Assessment

Exponent has expertise in outcomes, economic, and clinical research for economic analysis of diagnostic products. We use simulation and modeling studies to evaluate the cost-effectiveness, along with medical hospitalization and claims data to evaluate the associated outcomes. We provide market research to identify trends in historical and projected future market demand, including technical analysis of the impact of disruptive technologies. We help our clients evaluate the impact of innovative diagnostics on treatment patterns, medical care resource utilization, and health-care costs.

Regulatory Agency Assistance

Exponent has successful experience with regulatory agency interactions and communications with healthcare professionals on behalf of our clients in the areas of product clearance/approvals and compliance.

Exponent Diagnostic Product Service Areas

Our interdisciplinary team is experienced and can assist you throughout the development and commercialization phases of diagnostic products:

  • Assay Development
  • Material Selection
  • Disposable Device Development
  • Finite Element and Computational Fluid Analysis of Microfluidic Systems
  • Intellectual Property
  • Manufacturing Process Control/Quality Assurance
  • Medical & Economic Assessment
  • Medical Device Regulatory Compliance & Recall
  • Medical Technology Acquisition
  • Regulatory and Quality Assurance Support
  • Risk Communication