In Vitro Diagnostics

The analysis of human specimens provides physicians with critical information to properly diagnose, treat, and prevent human disease. To meet this need, industry strives to produce in vitro diagnostics (IVDs) that deliver rapid, sensitive results while minimizing cost and complexity. Next generation IVDs promise to enable improved diagnosis for prevention and management of infectious and chronic diseases, but product developers and manufacturers face many challenges, 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 and effective regulatory submissions. Multidisciplinary by nature, successful IVD product launches are complex endeavors that must combine effective regulatory compliance, product development, and failure analysis with an understanding of the market and reimbursement strategies.

Whether helping refine the set up and operation of a clinical lab or assisting with the development, manufacturing, or product launch for central lab, at-home, or point-of-care (POC) diagnostics, Exponent can help clients successfully navigate challenges throughout the development and commercialization phases of IVD products. We specialize in providing rapid, focused, market-sensitive solutions to complex topics throughout the total product life cycle, from feasibility, test development, verification and validation, regulatory submission, and approval to post-market surveillance. Our expertise includes assay and instrument development support with extensive knowledge in assay and detection technologies for improved prevention and management of infectious and chronic diseases; chemical, biological, mechanical, electrical, and materials support; digital diagnostics development including Software as a Medical Device (SaMD) and artificial intelligence/machine learning (AI/ML) regulations; real-world data (RWD) sourcing; development and use of real-world evidence (RWE) to support IVD manufacturers in maximizing value over the total product life cycle; battery performance for portable IVDs/wearables; global regulatory support; user studies; and technical due diligence.

Exponent in vitro diagnostic product service areas include:

Assay and Instrument Development Support

  • Central lab IVDs
  • Decentralized testing/home testing
  • Chronic disease management
  • Software integration
  • Instrument development support (mechanical and electrical systems)
  • Reliability testing
  • Verification and validation (V&V)
  • Root-cause analysis
  • Microfluidics
  • Combination product support
  • Import strategies
  • Medical wearable device support

Materials Support: Chemical, Biological, and Mechanical

  • Disposable component development support
  • Lower cost materials and supply chain disruption support
  • Extractables and leachables (E&L) expertise
  • Material compatibility assessments
  • Biological contamination and sterility

Digital Diagnostics

  • SaMD
  • AI/ML development and regulatory support
  • RWD/RWE study design, execution, and interpretation

Medical Wearables Device support

  • Personal biometrics screening and tracking
  • Chronic disease management

Batteries in Portable In Vitro Diagnostics

  • Battery reliability support
  • Battery failure investigation
  • Lithium-ion battery failure prevention

Global Regulatory Support

  • 510(k) submissions
  • PMA submissions
  • De Novo submissions
  • IVDD/IVDR submissions
  • WHO submissions
  • Emergency use authorizations

User Studies

  • POC/at-home regulatory requirements, study designs, analysis, and execution
  • Clinical lab validation support

Technical Due Diligence

  • Mergers and acquisitions
  • Venture capital activity
  • Due diligence support
  • Intellectual property and patent analysis



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