Medical Technology Assessment

Exponent offers a Medical Technology Assessment Program (MTAP) that provides rapid, comprehensive, and independent assessments of medical devices and technologies through a skilled team of physicians, scientists, and engineers. Our clients use these assessments when making strategic investment and development decisions. The breadth of our expertise makes assessments thorough, efficient, and cost effective. Our findings and opinions will satisfy the scrutiny of peer review, regulatory agencies, and the litigation process.

The MTAP medical staff has extensive experience in clinical, scientific, and regulatory arenas throughout the world. Our biomechanical engineers assess structural mechanics as applied to the human body and are experienced in orthopedic and cardiovascular devices, implant design, and stress analyses. MTAP's materials scientists work extensively with the medical device industry in studying the mechanical behavior and environmental degradation of materials, polymer mechanics, material lifetime prediction, corrosion testing, and fatigue and fracture mechanics. Our electrical engineers investigate medical device software validation and circuit integrity, as well as assess the reliability of medical device components and power supplies. Complementing our technical expertise, MTAP team members are well versed in regulatory, intellectual property, and product liability issues.

The MTAP program includes analysis of:

  • Unmet needs determination
  • Clinical indications
  • Patient reported and Physician reported outcome measures
  • Materials selection
  • Technology (engineering analysis and review)
  • Target condition epidemiology (size of market U.S. and worldwide)
  • FDA and other regulatory hurdles
  • Pricing and reimbursement issues
  • Competing technologies
  • Cost effectiveness
  • Complications and/or failure modes (liability)
  • Marketing strategy
  • Testing and testing protocols

Exponent also provides in-depth assessments of health economics. We help companies and venture capitalists alike analyze the competitive environment, and refine a company's strategies for venture capital financing, research and development, and product marketing. Our science-based analyses provide a foundation for both investor funding and, later, for payor reimbursement. We provide advice to investment banks and investment funds in a wide range of areas, including mergers and affiliations, corporate acquisitions, technology licensing, reimbursement planning, portfolio analysis, patent prosecution and litigation, and due diligence.

We also offer:

  • Clinical and regulatory support (e.g., FDA liaison)
  • Strategic direction for companies acquiring new technology or developing new devices and therapeutics
  • Appraisal of markets for product introduction
  • Design and conduct of clinical trials and post-market surveillance programs
  • Business risk assessment
  • Analyses of cost effectiveness relative to the standard of care



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