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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 program includes analysis of:
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Clinical indications |
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Materials selection |
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Technology
(engineering analysis and review) |
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Target condition epidemiology
(size of market U.S. and worldwide)
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FDA and other regulatory hurdles |
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Pricing and reimbursement issues |
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Competing technologies |
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Cost effectiveness |
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Complications and/or
failure modes (liability) |
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Marketing strategy |
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Testing and testing protocols |
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.
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:
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Clinical and regulatory support
(e.g., FDA liaison) |
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Strategic direction for companies
acquiring new technology or developing new devices and
therapeutics |
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Appraisal of markets for product
introduction |
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Design and conduct of clinical trials and postmarket
surveillance programs
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Business risk assessment |
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Analyses of cost
effectiveness relative to the prevailing technology |
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Clinical research strategies |
Medical Technology
Assessment Case Studies | top
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