![Medical Device Design & Development Support [BES]](/sites/default/files/styles/fifty_node/public/media/images/GettyImages-1273852738.jpg.webp?itok=agkpoZT_)
How do Exponent's multidisciplinary assessments help you understand the market for medical device manufacturing and innovation?
When making strategic investment and development decisions regarding medical devices, surgical implants, and biopharmaceutical products, Exponent delivers fast, thorough assessments and support. We help clients identify unmet needs in the marketplace, understand clinical indications, evaluate patient-reported and physician-reported outcome measures, assist in materials selection, and conduct engineering analysis and technical reviews. We also support clients in meeting FDA and regulatory requirements, developing global market strategies, tackling issues of pricing and medical insurance reimbursements, and we provide guidance on medical device testing and testing protocols.
Research and analysis.
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.
Strategic insights based on sound science.
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, litigation, and due diligence.
The MTAP program provides analysis of the following:
Unmet needs determination
Clinical indications
Patient-reported and clinician-reported outcome (ClinRos) 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
Services
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• 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 clinical trials and post-market surveillance programs
• Business risk assessment
• Analyses of cost-effectiveness relative to the standard of care
Insights
Experts
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Group Vice President and Principal Engineer
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
