Software as a Medical Device Support

Software is increasingly central to using technologies in enhancing care delivery across the healthcare system. Applications encompassing clinical decision support (CDS) software to image processing driven by artificial intelligence (AI) position software as a medical device (SaMD) as a tool for improving delivery, access, and personalization in care. Product development necessitates concurrently addressing multiple challenges to bring SaMD to market. This applies whether the SaMD treats or diagnoses a condition, drives clinical management, or simply informs practitioners on care options. Complex challenges include evolving regulations, cybersecurity concerns, and public perception of risk related to using these technologies. Successful SaMD launches require multidisciplinary engagement combining regulatory strategies, product development, and risk management with an understanding of market dynamics.

Exponent helps clients navigate challenges throughout the development and commercialization process for SaMD products. Our solutions –

  • Define disease pathways and progression targeted by algorithm specification
  • Inform data strategies supporting algorithm and software development
  • Assess usability in practice through user interface (UI) and experience assessments
  • Facilitate information verification, validation, and capture for evaluating use in practice
  • Integrate information with analytics to define product economics and value in use
  • Generate real world evidence (RWE) supporting clinical, economic, and humanistic outcomes
  • Provide independent review of a product’s regulatory and commercial strategies.

We specialize in delivering rapid, focused, market-driven solutions for complex issues over the total product life cycle. Client support informs efforts spanning feasibility, test development, verification and validation, regulatory submission, and approval to post-market surveillance, updates, maintenance, and decommissioning.

Our expertise includes global regulatory support, verification and validation testing, user studies, failure analysis, code review, risk management, cybersecurity and reliability analysis, root-cause analysis, and technical due diligence. Exponent further works with clients to define, source, and use real world data (RWD) to create the RWE demonstrating clinical, economic, and patient experience value in practice.

Exponent Software as a Medical Device service areas include:

Global Regulatory Support

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

Product Development

  • Verification and validation support
  • Usability, user interface, user experience
  • GUI testing
  • Failure analysis
  • Code review
  • Risk management
  • Cybersecurity
  • Root-cause analysis

Strategy, Value, and Payment

  • Commercial strategy
  • Economic strategy
  • Real world data (RWD) definition, sourcing, and integration
  • Real world evidence (RWE) and outcomes study design, execution, and application
  • Product economics & value in use—development, initial dissemination, tracking, and dynamic refinement

Technical Due Diligence

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



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