Medical device consulting requires a unique combination of scientific rigor, regulatory fluency, and litigation-ready technical analysis. ESi brings together biomedical engineers, scientists, and regulatory specialists with advanced degrees and decades of hands-on industry experience to support life sciences clients across the Total Product Life Cycle (TPLC), from conceptual design and manufacturing support through post-market surveillance.
ESi's nationwide network of laboratories and multidisciplinary consulting team provides the depth and breadth of knowledge the life sciences industry requires. Whether the matter involves preclinical testing, design verification and validation, a product liability dispute, intellectual property litigation, or an FDA regulatory submission, ESi assembles the right team for the specific engagement to deliver findings that are actionable, regulatory-ready, and technically defensible.
Facing a product failure claim or regulatory challenge? ESi's life sciences consultants are ready to respond.
Meet Our Life Sciences TeamLife Sciences Applications
ESi partners with medical device manufacturers, pharmaceutical companies, insurers, and legal teams across the full scope of technical challenges that the life sciences industry presents. Our consultants provide the expertise and laboratory resources clients need to confidently move through all stages of a product’s life cycle.
FDA Authorization & Regulatory Compliance
Navigating the FDA's regulatory framework is one of the most significant challenges a medical device manufacturer faces. ESi's consultants bring extensive experience with FDA submissions across Class I, II, and III devices, as well as international regulatory requirements. We guide clients through the full regulatory process, reducing submission risk and supporting a more efficient path to market.
Design Verification, Validation & Testing
Thorough design verification and validation is the foundation of a defensible product development record. ESi's laboratory capabilities include computational fluid dynamics (CFD), finite element analysis (FEA), computational modeling and simulation, ISO 17025-accredited testing, and more. We support clients in building the rigorous technical record required for regulatory submissions, litigation defense, and product improvement decisions.
Product Liability & Litigation Support
When a medical device is implicated in an injury, illness, or adverse event, the quality of the technical investigation can determine the outcome of the matter. ESi's consultants conduct root cause analyses, failure investigations, and biomechanical assessments to establish the factual record, supporting both plaintiffs and defendants in product liability disputes with objective and defensible findings.
Failure Analysis & Root Cause Investigation
Understanding why a device failed and whether that failure was foreseeable is central to litigation defense and product improvement. ESi's laboratories are equipped for retrieval analysis, corrosion testing, materials characterization, and CT imaging. These capabilities produce results that are reproducible, well documented, and built to withstand regulatory and legal scrutiny.
Intellectual Property & Technology Transactions
ESi's consultants provide expert insight into patent disputes, intellectual property litigation, and technology acquisitions, including patent and technical due diligence, validity assessments, and infringement analysis. Life sciences companies engaged in intellectual property matters benefit from our deep technical expertise and experience in litigation support contexts.
Post-Market Surveillance & Risk Management
Regulatory obligations extend beyond market authorization. ESi supports clients with post-market surveillance, adverse event analysis, and risk management strategy to help manufacturers identify emerging issues and assess remediation options while maintaining ongoing compliance. For every engagement, the goal is a stronger, more defensible product safety record over the full lifecycle of the device.
Ready to discuss your case? Submit a confidential inquiry and our expert consultants will be in touch.
Expert Support Throughout the Product Lifecycle
Contact our Life Sciences Team
Jorge A. Ochoa, Director, Principal
ESi Life Sciences Capabilities
- Compliance and Safety
- Computation Fluid Dynamics (CFD)
- Computational Modeling and Simulation
- Corrosion Testing (ISO 17025)
- CT (ISO 17025)
- Diagnostic Devices
- Drug Delivery Devices
- FDA Medical Device Authorization Support (Class I, II, and III)
- Finite Element Analysis (FEA)
- Intellectual Property Disputes
- Litigation Support
- Medical Devices, Diagnostic and Drug Delivery Devices
- Patent and Technical Due Diligence
- Pharmaceutical Packaging
- Product Liability
- Prototyping and Testing
- Regulatory Support and Compliance
- Retrieval Analysis (ISO 17025)
- Risk Management
- Root Cause Analysis
- Test Method Development
- Total Product Life Cycle Management
- 3rd Party Design Assessments
Why Clients Choose ESi
ESi's approach to medical device consulting is defined by capabilities that make a measurable difference for clients across the laboratory, the regulatory process, and the courtroom.
Laboratories That Support the Full Product Lifecycle
ESi's nationwide laboratory network provides testing and analysis capabilities that meet the highest standards of documentation and reproducibility. Accredited results mean findings are defensible in regulatory submissions and legal proceedings.
Regulatory Experience Across the Full FDA Spectrum
ESi's consultants have guided clients through submissions for Class I, II, and III devices, as well as international regulatory frameworks. That experience translates into practical, efficient compliance strategy.
Multidisciplinary Depth Under One Roof
Medical device matters involve biomechanics, materials science, human factors, computational modeling, and regulatory compliance. ESi's integrated team addresses every dimension of a matter in a coordinated way, eliminating the gaps that arise when multiple specialist firms work in isolation.
Objectivity That Holds Up Under Scrutiny
Whether supporting a regulatory submission, a product liability defense, or an intellectual property dispute, ESi's findings are grounded in documented methodology and reproducible data. That objectivity makes ESi's analysis credible and valuable in any context.
Consultants With Direct Industry Experience
ESi's life sciences team includes biomedical engineers and scientists who have held technical and leadership roles within the industry. That operational background informs every engagement, producing insights that are technically rigorous and grounded in real-world medical device development and manufacturing.
