Biomedical Expertise for Disputes

Gloved, medical professional in green scrubs with stethoscope around neck (shown from neck to mid torso) holding an implanted medical device

Thought leadership

When you have a high-stakes dispute, turn to Exponent for accurate, fact-based technical support.

With over 50 years of experience, Exponent's multidisciplinary approach to biomedical disputes helps clients clearly understand the facts and evidence. We tell clients not what they want to hear, but what they need to know. Our team handles a variety of disputes ranging from intellectual property claims, device failures, and hospital fires from medical equipment to regulatory and contractual disputes involving product liability, alleged breach of contract, technical aspects of insurance coverage and more.

Exponent is internationally recognized for our insightful analysis and significant experience in all aspects of intellectual property, including patent infringement, trademarks, copyrights, trade secrets, valuation of intellectual capital, and International Trade Commission cases. We also leverage our experience to help international and domestic companies navigate the complex regulatory and technical landscape associated with medical and wellness devices and interventions. For example, when it comes to biomedical product evaluation, our multidisciplinary teams assess how a failure may have occurred, which products may have been affected and whether they are salvageable, the valuation of an irreplaceable research product, and how to prevent future losses.

Capabilities

Biomedical companies, contract manufacturers, healthcare facilities, attorneys, inventors, and innovators rely on Exponent's multidisciplinary expertise to provide clarity and confidence in evaluating technical and regulatory issues that are often part of disputes.

Exponent's biomedical consultants support insurance companies, pharmaceutical and biotechnology companies, medical device manufacturers, contract manufacturers, and hospitals in investigating a wide range of product losses with proactive scientific services and engineering support. Exponent's expertise in materials characterization and toxicology can also help clients understand the potential risks to product performance.
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When intellectual property is at stake, biomedical companies require top-notch specific knowledge and versatile technical expertise to protect their products and research. For more than 50 years, Exponent has assisted businesses, attorneys, and inventors with issues pertaining to infringement, validity, claim interpretation, prior art, trade secrets, due diligence, technology transfer, and valuation, including work performed under the stringent deadlines of ITC Section 337 cases.
From product liability to manufacturing processes/supply chain troubleshooting to FDA compliance disputes, our unique blend of technical and regulatory experience allows us to provide the expertise and insight clients need when they are facing allegations about their product's safety and performance. Whether the dispute stems from a design or manufacturing problem, third-party supplier or contract manufacturer, clinical research organization (CRO), or some other source, we generate customized, evidence-based insights and analysis for thoroughly evaluating disputes.
Exponent also has significant experience supporting internal company investigations involving whistleblower allegations related to medical product performance and safety, helping clients meet patient, market, and regulatory expectations. Specific examples of support we have provided include choice of testing methods, analysis of results, and assessment of relevance of particular regulatory requirements and industry standards. Working closely with internal and external counsel, Exponent's multidisciplinary team of scientists and engineers can rapidly evaluate the basis of whistleblower complaints and their potential impact on current and ongoing operations. Our team provides strategic insight from a regulatory and technical perspective, conducts targeted product evaluations and data analysis, and supports interactions with relevant government agencies including the U.S. Food and Drug Administration and the U.S. Department of Justice. Additionally, evaluating allegations in the context of more broadly available product safety information can inform stakeholders as investigations are conducted to provide input for strategic decisions.

What Can We Help You Solve?

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.

Exponent biomedical scientists conduct due diligence of medical devices by examining aspects of design and invivo applications on smart screen

Related Expertise

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.