Exponent’s Biomedical Engineering practice supports clients across many medical specialties and product sectors by developing robust scientific methodologies and protocols to characterize and evaluate the performance of biomaterials, biological tissues, and medical devices. Our staff applies engineering and scientific principles to assist clients throughout the total product lifecycle. Our well-equipped laboratories and computational modeling capabilities enable our team to perform preclinical testing, numerical modeling, and failure analysis.
As part of regulatory compliance, we perform preclinical testing and formulate a comprehensive regulatory strategy, conduct design verification and validation, and perform design and manufacturing failure analyses, recall management, and medical device explant analysis. In addition, our staff performs data analyses of healthcare and electronic medical record databases to assist our clients in market research, clinical outcomes research, risk factor identification, and cost-effectiveness modeling. Our expertise has been utilized in product liability and intellectual property litigation, as well as in support of technology acquisition and due diligence matters. In collaboration with engineers and scientists across other disciplines at Exponent, we offer a state-of-the-art multidisciplinary approach to examine complex technical issues in the medical device sector.
Our consultants have earned graduate and doctorate-level degrees in various scientific and engineering fields. Our team is active in the research, publication, and presentation of scientific studies relevant to timely topics for medical devices. Members of our group serve on various expert panels convened by professional societies, industry coalitions, and regulatory agencies, and are also involved in the development of industry standards.
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