CAPABILITY | HEALTH SCIENCES

Medical Technology Assessment Program

An engineer in Exponent's Philadelphia lab performs tests on medical devices as part of our Medical Technology & Assessment Program.

Strategic and tactical support for developing medical devices

When developing new medical devices, surgical implants, or wearable medical technologies, turn to Exponent's Medical Technology Assessment Program (MTAP) for rapid, thorough, and independent assessments of medical devices and technologies.

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

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.

Young patient going into MRI machine. Exponent evaluates the safety, performance, biocompatibility of medical technology.

Multidisciplinary Expertise to Support the Life Sciences Industry

Support for next-gen medical devices, wearable technologies, and pharmaceutical products.

Red specimen in science petri dish. Exponent conducts rigorous epidemiological research to evaluate emerging diseases.

Emerging Infectious Diseases

Scientific research, strategy, and tactics to support strategic planning related to numerous aspects of emerging infectious diseases.

Medical worker registesr patients on tablet device. Exponent studies real - world outcomes for new medical devices and pharmaceuticals.

Healthcare & Life Sciences Value & Outcomes Assessment

Strategic guidance for medical product value and access, including drugs, vaccines, and medical devices.

Medical lab coat and employee badge. Exponent assists with pharmaceutical research for medical innovators.

Multidisciplinary Expertise for Pharmaceutical Testing & Modeling

Evaluate pharmaceuticals with pharmacodynamic modeling, clinical epidemiology, and pharmacoepidemiology studies.

Crowd of people wearing coats and walking on sidewalk. Exponent conducts epidemiological and biostatistical research.

Occupational & Environmental Epidemiology

Advanced epidemiological research and evidence-based insights from leading epidemiologists and biostatisticians.

A row of orange industrial hard hats in a row. Exponent provides occupational and industrial workplace safety assessments

Occupational Health

Occupational and environmental health risk assessment and mitigation strategies to help protect employee health and wellness.

A person sampling fresh water using a test beaker in open environment. Evaluation exposure assessments and toxicity evaluations.

Chemical Toxicology & Health Risk Assessments

Exposure assessments, toxicity evaluations, and support for issues of toxicology and mechanistic biology.