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Medical Devices Expert Witnesses

Medical device litigation arises across a wide range of disputes, including product liability claims tied to device failure, patent infringement actions between competing manufacturers, and regulatory enforcement matters involving FDA approval and labeling requirements. These cases often involve implanted or invasive devices such as catheters, insulin pumps, or cardiac devices, where a malfunction or design flaw is alleged to have caused patient harm. Because medical devices sit at the intersection of engineering, biology, and federal regulation, the central issue is frequently whether a device was designed, manufactured, or labeled in a manner consistent with applicable safety and regulatory standards. Attorneys on both sides need a technical account of how the device was supposed to function and where, if anywhere, it departed from that design.

A medical device expert helps attorneys evaluate whether a device's design, materials, or manufacturing process met applicable engineering and regulatory standards, and whether any deviation caused the harm alleged. This analysis frequently draws on biomedical and mechanical engineering principles, failure analysis of the physical device, and a close reading of FDA submissions, warning letters, and compliance records. The expert's opinion can support or rebut causation theories tied to device failure, evaluate the adequacy of labeling and instructions, and inform damages calculations in patent or product liability disputes. In FDA enforcement matters, the expert can also clarify whether a manufacturer's conduct aligned with recognized good manufacturing practices.

Because medical device cases require experts who understand both the underlying engineering and the regulatory framework that governs the device, matching the right technical background to the assignment is critical. Round Table Group's medical device network includes biomedical and mechanical engineers with experience in FDA regulatory law, preclinical safety testing, and device categories ranging from cardiac catheters to drug delivery systems, several of whom have testified repeatedly in patent and product liability matters. With more than 75,000 expert searches completed for litigators, we work to identify an expert whose specific device experience aligns with your case. Let us help you find the right medical device expert for your matter by calling us at (202) 908-4500.

Kinds of Cases We Work On

Round Table Group helps our clients find a wide variety of Medical Devices expert witnesses for cases like:

01

Faulty Solenoid Valve Recall Triggers Indemnification Fight With Supplier

A medical device manufacturer sued its longtime component supplier after a batch of solenoid valves used in infusion pumps failed at a rate far above historical norms, forcing a field corrective action affecting tens of thousands of devices and driving substantial costs in recall logistics, replacement units, and lost sales. The manufacturer retained a medical device expert with engineering and quality systems experience to review the supplier's incoming inspection records, process control charts, and the failure analysis performed on returned valves. The expert found that the supplier had relaxed a critical dimensional tolerance on the valve seat roughly eighteen months before the failure rate spike, a change that had not been communicated or re-validated under the parties' quality agreement. That finding established the supplier's responsibility for the nonconformance and was central to a settlement in which the supplier funded the majority of the recall costs.
02

Surgical Instrument Design Comparison Anchors a Patent Infringement Verdict

A device manufacturer sued a competitor alleging that its newly launched laparoscopic stapling instrument infringed patents covering a distinctive jaw-closure mechanism, in a dispute affecting a product line generating substantial annual sales. The plaintiff retained a medical device expert with mechanical design experience to compare the accused device's internal mechanism, disassembled and reverse-engineered, against the patent claims and the plaintiff's own commercial embodiment. The expert's analysis showed that the accused device's cam-and-linkage arrangement performed the same function through a substantially similar sequence of motion, despite superficial differences in housing geometry. That technical comparison supported the jury's infringement finding and contributed to a damages award calculated on a reasonable royalty basis.
03

Contract Manufacturer's Process Deviation Exposed After an FDA Warning Letter

A device company sued its contract manufacturer after an FDA inspection triggered a warning letter citing manufacturing nonconformances in an implantable device line, forcing a production halt that cost the device company significantly in lost sales and remediation expenses. The device company retained a medical device expert in quality systems and manufacturing compliance to review batch records, the contract manufacturer's corrective action history, and the specific nonconformances cited in the warning letter. The expert found that the contract manufacturer had been operating a critical sterilization step outside validated parameters for several months without notifying the device company, in violation of the manufacturing agreement's change-control provisions. That finding was decisive in establishing breach of contract and supported the device company's recovery of remediation costs.
04

Surgical Robot Performance Shortfall Leads to a Capital Equipment Breach Claim

A hospital system sued the manufacturer of a surgical robotics platform after the system experienced a rate of intraoperative faults well above what the manufacturer's marketing materials and performance specifications had represented, disrupting surgical schedules and contributing to significant losses from cancelled and delayed procedures. The hospital system retained a medical device expert with experience in surgical robotics and device performance validation to analyze the platform's fault logs, the manufacturer's own reliability testing data, and the performance benchmarks cited in the purchase agreement. The expert found that the platform's fault rate was roughly three times the rate the manufacturer's own pre-launch testing had documented, and that the manufacturer had not disclosed a known firmware issue contributing to the faults. That finding supported the hospital system's breach of warranty claim and contributed to a settlement including equipment replacement and service credits.
05

Field Failure Rate Dispute Unwinds a Device Distribution Agreement

A device manufacturer terminated its distribution agreement with a regional distributor after the distributor withheld a shipment of orthopedic implants, alleging the manufacturer had concealed a known elevated failure rate; the manufacturer countersued for breach of the distribution agreement, in a dispute involving unfulfilled orders and reputational damages. The distributor retained a medical device expert to analyze post-market surveillance data, complaint files, and the implant's failure rate compared to published benchmarks for similar devices. The expert found the implant's fracture rate was roughly double the rate reported for comparable devices in the manufacturer's own post-market surveillance database, and that this data had been available to the manufacturer for several months before the distributor raised concerns. That analysis supported the distributor's defense and contributed to a settlement releasing it from further purchase obligations.
06

Reverse-Engineered Design Comparison Uncovers Stolen Implant Geometry

A device manufacturer sued a former senior engineer and the competing company he joined, alleging he had taken proprietary implant geometry and manufacturing process specifications and used them to accelerate a competing hip implant to market roughly a year ahead of its expected development timeline, in a dispute over a valuable product line. The plaintiff retained a medical device expert with orthopedic implant design experience to compare the accused implant's surface geometry, coating specifications, and manufacturing tolerances against the plaintiff's proprietary design files. The expert found that several idiosyncratic design features with no functional necessity, including a distinctive porous coating transition zone, appeared identically in both implants. That comparison became central evidence of trade secret misappropriation and contributed to a settlement that included a market exclusivity period and a licensing payment.
07

Defect Classification Dispute Resolves a Product Liability Coverage Fight

A device manufacturer and its product liability insurer disputed coverage for a series of claims involving a cardiac lead product, with the insurer arguing the claims fell under a policy exclusion for known defects existing before the policy period, a dispute affecting coverage for a substantial volume of claims and defense costs. The manufacturer retained a medical device expert to review the product's design history file, complaint trending data, and internal risk assessments to determine when the specific failure mode at issue was first identified as a known risk. The expert found that the failure mode driving the majority of claims had only been identified through a design change made after the policy incepted, and was mechanistically distinct from an earlier, unrelated issue the insurer had pointed to. That finding undercut the insurer's exclusion argument and was central to a settlement restoring coverage for the bulk of the disputed claims.
08

Undisclosed Adverse Event Trends Cut a Device Company Acquisition Price

The buyer of a specialty device company sought to rescind a portion of the purchase price after discovering, post-closing, that adverse event reports for the company's flagship product had been trending upward for more than a year before the acquisition closed, a trend the buyer alleged had not been disclosed during due diligence, in a dispute over a substantial portion of the purchase price. The buyer retained a medical device expert in post-market surveillance to analyze the seller's complaint database, MDR filings, and internal quality trending reports against what had been disclosed in the data room. The expert found that internal quality reports had flagged a statistically significant increase in a specific failure mode roughly nine months before closing, and that this data had not been included among the materials produced during diligence. That finding supported the buyer's fraud and misrepresentation claims and contributed to a negotiated purchase price adjustment.
09

Biocompatibility Testing Gap Traced to Implant Failures

A device manufacturer sued the independent testing laboratory it had engaged to perform biocompatibility testing on a new wound care implant after a cluster of adverse tissue reactions forced a market withdrawal, alleging the lab's testing protocol had failed to detect a reactive coating component, in a dispute over recall and remediation costs. The manufacturer retained a medical device expert in biocompatibility and materials testing to review the lab's test protocols, raw data, and the applicable testing standards for the device's tissue contact classification. The expert found the lab had applied a testing protocol appropriate for short-term surface contact rather than the prolonged implant contact classification the device actually required, omitting an extraction study that would likely have flagged the reactive component. That finding established the lab's departure from the applicable standard of care and was central to the manufacturer's recovery of costs from the lab's professional liability coverage.
10

Embedded Software Defect Analysis Resolves an Infusion Pump Recall Dispute

An infusion pump manufacturer sued its embedded software vendor after a dosing calculation error traced to the vendor's firmware triggered a nationwide recall affecting tens of thousands of pumps and costing the manufacturer significantly in recall execution and lost contracts. The manufacturer retained a medical device expert with embedded systems and software validation experience to review the vendor's source code, unit test records, and the software requirements specification governing the dosing algorithm. The expert found that a rounding function in the vendor's code diverged from the documented specification under a specific combination of infusion rate and volume inputs, and that the vendor's test suite had not included that input combination despite it being clinically common. That finding established the software defect as the root cause and supported the manufacturer's recovery of recall costs from the vendor.

Here are a few of our favorite Medical Devices Expert Witnesses:

California Medical Devices Expert #260

I have 20 years of experience, and specialize in the field of orthopedic hand surgery with specific knowledge in the areas of distal radius, wrist kinematics and postoperative pain control. I have published on such topics as distal radius fractures, complications of distal radius fractures and fly fishing. I have testified on medical malpractice.

 

Wisconsin Medical Instrumentation, Tasers Expert #1879

I have 43 years of experience, and specialize in the field of medical devices and instrumentation with specific knowledge in the areas of tasers, ablation and pacemakers. I have published on such topics as tasers, ablation and pacemakers. I have testified 13 times on topics such as tasers, ablation and pacemakers. Developed 17 books, 200 peer-reviewed journal articles. I teach 2 courses each semester.

 

California Medical Devices Expert #6021

I have 40 years of experience and specialize in the field of biomedical and clinical engineering with specific knowledge in the areas of medical equipment, critical care and surgery. I have published on such topics as investigating medical injuries, medical equipment safety and maintenance, and risk management. I have testified 80 times on topics such as patient injuries related to medical equipment, medical equipment design defects and medical equipment failures.

 

California Advertising, Medical Devices Expert #6840

I have 25 years of experience, and specialize in the field of consumer products with specific knowledge in the areas of sporting goods, medical devices and international markets. I have testified on medical industry, golf industry and publicly traded companies. It has been my great pleasure to work with tremendous leaders in the fields of consumer goods, medical industry and international markets.

 

California Medical Device Design Expert #7255

I have 11 years of experience, and specialize in the field of engineering with specific knowledge in the areas of medical and consumer products, FDA part 820 requirements, research and development, design and intellectual property. I have testified 17 times on topics such as medical devices, consumer products and patent infringement.

 

Your Case Deserves The Best Medical Devices Expert Witnesses

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The right expert witnesses and consulting experts can make your case. That’s why we have spent so many hours over the past quarter century making sure our clients have just the right expert team — whether one expert or many, early-stage advice or expert reports and testimony. Across over 50,000 expert search assignments, we have honed a unique, customized approach to identifying, analyzing and connecting with expert talent so you can focus on winning your case.

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Texas Medical Devices Expert #7726

I have 30 years of experience and specialize in the field of biomedical engineering with specific knowledge in the areas of medical devices, maintenance, safety and risk mitigation. I have published on such topics as medical equipment selection, medical technology management, telemedicine and equipment safety. I have testified on device failure, inspection responsibility and design defect.

 

California Medical Devices, Pharmacy Expert #7863

I have 10 years of experience in the field of healthcare product sales, with specific knowledge in the areas of pharmacy and supply automation solutions, diagnostic ultrasound (imaging) and orthopedic devices.

 

California Medical Devices, Electrosurgery Expert #10092

I have 27 years of experience, and specialize in the field of biomedical device development with specific knowledge in the areas of electrosurgery, ophthalmology and respiratory care. I have testified 12 times on topics such as patent infringement, medical porduct liability and business practices. I recently testified for the plaintiff in a medical device patent infrigement case that resulted in the plaintiff being awarded $247 million.

 

Pennsylvania Medical Devices, Blood Flow Expert #11754

I have 25 years of experience, and specialize in the field of biomedical engineering with specific knowledge in the areas of medical devices, cardiovascular and respiratory. I have published on such topics as artificial lungs, blood purification and medical devices.

 

Texas Chip Design, Medical Devices Expert #13936

I have 18 years of experience, specializing in the field of electrical engineering and computer science. I have specific knowledge in the areas of chip design, VLSI design, system level design, computer architecture, wireless networks, medical devices, software design, operating systems and electronic system design. I have published on such topics as medical devices, computer aided design, software design, VLSI IC design, computing, programmable chips, and design of electronic embedded systems.

 

Maryland Medical Devices Expert #17022

I have 40 years of experience in the field of engineering, with specific knowledge of electronics, computer sciences, and electrical energy. I have published on such topics as energy conservation, cardiac pacemakers, and solar thermal energy. I have testified on transportation and energy.

 

California Medical Devices Expert #20596

I have 30 years of experience, and specialize in the field of mechanical engineering with specific knowledge in the areas of medical devices, patents and intellectual property and heavy-truck crashworthiness. I have published on such topics as medical device applications, finite element analysis and simulation and crashworthiness. I have testified on heavy-truck crashworthiness, product failure and reliability.

 

Pennsylvania Medical Devices Expert #21043

I have 20 years of experience in the field of medical devices, with specific knowledge of catheters, biomaterials and radiation therapy. I have published on such topics as microfluidic devices, radiation therapy and targeted drug delivery. I have testified on catheter design, catheter applications and patents involving medical devices.

 

New Jersey Biotechnology, Medical Devices Expert #21443

I have 25 years of experience, and specialize in the field of health care and life sciences with specific knowledge in the areas of professional liability, biotechnology and devices. I have published on such topics as medical malpractice, ADR and equestrian sport. I have testified on equestrian and professional standards..

 

California Bioengineering, Medical Devices Expert #23993

I have 16 years of experience and specialize in the fields of bioengineering, mechanical engineering and system engineering, with specific knowledge of biochips, microfluidics, nanotechnology and medical devices. I have published on such topics as pathogen detection systems, DNA, protein chips, solar cells, micro and nano fabrication, micro-electro-mechanical systems (MEMS), nanotechnology and micro-pumps.

 

Medical Devices, Medicine Expert #26508

I have 25 years of experience and specialize in the field of oral microbiology, with specific knowledge of biofilms, infections and oral health. I have published on such topics as bacterial signaling, infection mechanisms and antimicrobial research. I have testified on infections, medical devices and oral health.

 

New York Medical Devices, Research Expert #26948

I have 30 years of experience, and specialize in the field of marketing with specific knowledge in the areas of medical devices, life sciences and diagnostics. I am an expert in devising strategy, driving marketing initiatives, managing product life cycles, strategic planning, and improving marketing process. For the last 18 years as a vice president of marketing, I have leveraged my sales, marketing, and leadership expertise to build corporate value for medical device and life science firms. My hands-on experience in new customer acquisition, commercialization of new products, developing early phase businesses and high performance teams has contributed to the…

 

California Dentistry, Medical Devices, Expert #28030

I have 19 years of experience and specialize in the field of periodontology, with specific knowledge of dentistry, periodontology and dental implants. I have published on such topics as microbiology of periodontitis.

 

Washington Medical Device Design Expert #31567

I have 40 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of patent infringement, product liability and personal injury. I have testified 16 times on topics such as patent infringement, product liability and personal injury. I have been involved in the design, development and commercialization of medical devices for 40 years and over the past twelve have been called upon to provide expert testimony in 16 legal cases.

 

New York Medical Devices, Transdermal Expert #32179

I have 30 years of experience in the field of medical device development, with specific knowledge of transdermal drug delivery, iontophoresis, and sterilization. I have published on such topics as materials for medical devices, synthesis, and production of materials. I have testified on drug delivery.

 

California Medical Devices, Design Defects Expert #32519

I have 35 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of sterile disposables, diagnostics and surgical instruments. I have published on such topics as risk management, SBIR grant preparation and development partnerships. I have testified on medical device failure analysis, surgical instrument design and development. Few if any of my expert witness cases have ever been on the losing side. Perhaps I just know how to pick them.

 

Massachusetts Medical Devices, Laser Expert #36019

I have 18 years of experience, and specialize in the field of aesthetic laser technology marketing with specific knowledge in the areas of laser lipolysis, laser hair removal and fractional skin rejuvenation. I have published on such topics as laser hair removal, fractional skin rejuvenation and laser lipolysis. I worked on the commercial launch of the very first products for both laser hair removal and laser lipolysis.

 

Florida Acoustics, Medical Devices Expert #36632

I have 35 years of experience, and specialize in the field of otolaryngology and neurotology with specific knowledge in the areas of hearing restoration, cochlear implantation, auditory prosthetic devices, ear surgery and development of surgical techniques, hearing loss, deafness, dizziness and vertigo and Meniere’s disease. I have published on such topics as cochlear implants, ear surgery, hearing loss, vertigo, Meniere’s disease, tinnitus, medical devices, noise and drug induced hearing loss and surgical complications. I have testified 30 times on topics such as hearing loss, cochlear implants and noise induced hearing loss. From a busy private practice I became chairman of…

 

Biomaterials, Medical Devices Expert #38773

I have 30 years of experience and specialize in the field of cardiovascular surgery research and development with specific knowledge of biomaterials, blood contact initiated events and medical devices. I have published on such topics as medical devices, filtration, biomaterials, molecular adsorption, and plastic and reconstructive surgery, including fat mobilization and otoplasty, and neurological consequences of cardiac surgery. I have testified on medical incidents and accidents.

 

California Medical Devices Expert #39214

I have 30 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of cardiovascular, neurovascular and peripheral vascular.

 

California Medical Devices, Quality Systems Expert #42468

I have 21 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of product development, manufacturing and quality systems and regulation. I have published on such topics as electronic devices, system engineering and quality systems. I have testified on medical device regulation, quality and employment contracts. I have extensively interacted with the Federal Drug Administration on audits and field corrective actions for Class III medical device companies.

 

Wisconsin Medical Devices Expert #42859

I have 36 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of FDA regulation, combination products and software products.

 

Illinois Medical Devices, Medicine Expert #44860

I have 30 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of hemodialysis, peritoneal dialysis and continuous renal replacement therapy. I have published on such topics as kinetics of intradialytic disequilibria, automation and redesign in medical devices, automatic monitoring and control of intradialytic disequilibria. I have testified on user interface methods for dialysis systems, control methods in dialysis machines and profiling systems for dialysis equipment.

 

Texas Urology, Medical Devices Expert #44913

I have 11 years of experience, and specialize in the field of urology with specific knowledge in the areas of incontinence, neurogenic bladder and trauma. I have published on such topics as incontinence, trauma and neurouroloyg. Serve as a consultant/reviewer for Texas State Board of Medical Examiners (3 years).

 

Ohio Medical Devices, Surgery, Health Expert #48183

I have 41 years of experience, and specialize in the field of total joint medical devices with specific knowledge in the areas of total hip, total knee and professional ethics. I have published on such topics as modular total hips, total knees and medical ethics. I have testified 6 times on total joint surgery.

 

Maryland Biomechanics, Medical Devices Expert #53079

I have 20 years of experience, and specialize in the field of medical devices with specific knowledge in the areas of spine, total joints and behavior modification. I have published on such topics as behavior modification, nitinol and motion preservation. Several of my patents are known and used around the world and have earned more than $100 million.

 

New Jersey Medical Devices, Medicine Expert #47125

I have 30 years of experience, and specialize in the field of healthcare with specific knowledge in the areas of clinical diagnostics, medical devices and life sciences. I have published on such topics as methicillin-resistant staphylococcus aureus molecular diagnostic tests, nex-gen sequencing and cancer biomarkers. I have testified on Methicillin resistant staph aureus. I am one of the leading opinion leaders in the field of clinical diagnostics and rated among the top 50 clinical lab professionals.

 

California Catheter Disposable Medical Devices Expert Witness #6918

Expert is a consulting engineer specializing in medical products design and development with a focus on medium and high volume disposable devices and components. Expert has designed numerous products and holds multiple patents. Expert has extensive experience in litigation support including deposition and trial testimony.

 

Illinois Biomedical Engineering and Medical Devices Expert Witness #2510

Technical expert in medical devices including dialyzers, oxygenators, IV products, blood banking products. Expertise in fluid mechanics and heat transfer. Over 44 years experience with 23 patents and patent litigation experience. Ph.D., Mechanical Engineering .

 

California Biotechnology and Medical Device Expert Witness #1049

This expert is an industry consulting and patent holder. He develops biotech and medical products from concept to production and provides strategic hands-on assistance to entrepreneurs.

 

Put Our Medical Devices Expert Network to Work for You

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Our huge network of experts – eminent university professors and practitioners who have achieved renown as thought leaders in their fields – combined with unparalleled research capabilities puts the experts you need at your disposal when and where you need them.

If you’re a litigator or general counsel, we want to put this network to work for you and your clients. Let us know how we can help by calling us at (202) 908-4500 or filling out the form on this page. We’re so confident you’ll love what we do that unless you retain an expert we present there’s no charge!

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Questions Attorneys Ask About Medical Devices Expert Witnesses:

A medical device expert is typically needed when a case turns on whether a device's design, manufacturing, or labeling caused patient harm, or when patent claims require a technical account of how the device operates. Attorneys also retain these experts in FDA compliance disputes where regulatory standards are contested.
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Medical Devices Workshops

A few of the courses and workshops led by our Medical Devices experts:

  • A Module in Investment & Options Analysis
  • Accounting as an Internal and External Information Source
  • Accounting for Derivatives
  • Accounting for the Non-Financial Manager
  • Asphalt Pavement Design and Management
  • Biomedical Imaging
  • Business Combinations
  • Corporate Governance and Disclosures Analysis
  • Disclosure 2.0: How Technology is Revolutionizing Securities Law
  • Evaluation & Rehabilitation of Asphalt Pavement
  • Financial Accounting
  • Financial Disclosures for Public Companies: A Fundamental Overview
  • Financial Reporting for Non-Financial Executives
  • Financial Statement Valuation
  • Fundamentals of Concrete
  • Fundamentals of Cost Engineering
  • Fundamentals of Pricing and Revenue Management
  • How Can a Restructuring Enhance Shareholder Value?
  • How to Detect Financial Statement Fraud
  • How to Solve the Problem of Multiple Internal Rates of Return in Capital Budgeting
  • International Financial Reporting Standards: An Update
  • Introduction to Managerial Accounting Concepts
  • Introduction to SVA (Shareholders' Value Added): Is It A Sound Compensation and Performance Measure?
  • Managerial Accounting Foundations
  • Medical Device Development: The MD Perspective
  • Medical Device Engineering
  • Medical Diagnostics & Devices: Bringing a Product to the Market
  • Mergers & Acquisitions Accounting
  • Pavement Preservation
  • Success & Failure in Medical Device Entrepreneurship
  • Taxation
  • Using Cost Information for Decision Making
  • Vicarious Liability of US Audit Firms For Overseas Client Fraud
  • What Are The Advantages of Using Real Options For Capital Budgeting?
  • What is Auditor Liability & Exposure When Non-US Firms Employ US Reverse Mergers to “Go Public”?

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