Medical Device Expert Witnesses
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What is a medical device expert witness?
Medical devices expert witness candidates typically have extensive experience in mechanical engineering, biomechanical engineering, medical device technology, electrical engineering, product design, cardiology, orthopedic surgery, and/or biomedical engineering. Electronic medical devices expert witnesses have a unique combination as an electric engineer and biotechnology. The selected expert witness may be a member of an industry organization such as the Advanced Medical Technology Association (AdvaMed) or the American Society for Quality (ASQ) Biomedical Division.
What types of cases require a medical device expert witness?
The definition of medical device is very broad, as are the types of legal cases involving medical equipment and devices. Oftentimes, matters requiring medical device expert witness service involve intellectual property, such as patent infringement litigation, inter partes review or trade secret disputes. A forensic engineer can reverse engineer components to prove (or disprove) intellectual property infringement or theft. A medical device expert could also be called in on a medical malpractice case, medical device accident reconstruction for a personal injury case, or a product liability case involving a medical device failure analysis.
The term medical device encompasses any device or product intended for healthcare, which includes diagnosis and treatment, surgical, and over the counter (OTC). Medical devices range from tongue depressors and hospital gowns to complex pacemakers and robotic surgical systems. To assure safety and effectiveness, FDA regulation applies to all medical devices sold in the United States.
Medical device expert witness case examples
Example cases that Cahn Litigation Services has performed expert witness searches for have involved:
- orthopedic device patent infringement litigation,
- implantable cardioverter-defibrillators clinical trial,
- a cardiologist to opine on a cardiac pacemaker device failure,
- infusion pump labeling,
- catheters materials degradation case in California,
- vascular stent manufacturing matter in Florida,
- In vitro fertilization dispute in Maryland,
- over the counter consumer products,
- ureteral stents class action in Illinois,
- biomechanics expert for an orthopaedic implant suit, and
- bone marrow ablation malpractice case in New Jersey.
What litigation support work might a medical device expert witness be expected to perform?
Litigation support by a medical device or implantable medical device expert witness could include reverse engineering, research and authoring expert reports, and courtroom testimony. In addition, clients may seek a medical device industry expert or mechanical engineer for pre-litigation consulting work. In a high-profile case, a law firm may request a medical device specialist with prior expert witness experience. A medical device expert witness needs to not only have expertise, but also possess the ability to explain technology to a judge and jury.
Cahn Litigation Services has the experience required to turn a search for a medical device expert witness around quickly, providing the right balance of expertise and testimony experience.
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Medical Device Expert Witness - Representative Bios
Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.
The below expert witness bios represent a small fraction of those Medical Device experts known by Cahn Litigation Services. These bios are provided to give lawyers a sense of the Medical Device landscape.
Expert Witness #210251
This expert has many years of experience in the Cardiovascular Therapeutics and Medical Device industry, and was the Vice-President of Research for a company that developed a drug-eluting medical device. Prior to that this expert directed the Cardiovascular Therapeutics Groups at two pharmaceutical giants, and led cardiovascular drug discovery teams at others. This expert established a Cardiovascular Research Consulting Firm and serves small, mid and large pharma in many aspects of drug discovery and medical device development. This expert also has extensive IP litigation experience.
This expert is well known and has been complimented for trial presence and a clear command of science. This expert is of high integrity and supreme scientific knowledge with the ability to relate the science of the case to the jurors in a clear and understandable way. Finally, a Judge expressed publicly that this expert is one of the best expert witnesses he's ever seen at trial.
Start Medical Device Expert SearchExpert Witness #211579
This expert has spent many years in the medical device marketplace combined with twenty years in diverse areas of wireless and mobility technologies. This expert's core expertise is from software development and device integration to include all phases of wireless from licensed and unlicensed both in the indoor and outdoor space. This domain knowledge space has been gained with Fortune 50 and international companies and has included both hands on design, implementation, and solution deployments on a global level. As President of a global-reach healthcare, medical device, and wireless engineering consultancy, this expert specializes in medical device mobility and wireless connectivity communications. This expert has worked on several projects involving BTLE (4.0), and has also worked with ANT on design projects and FDA 510(k) approval. This expert is very familiar with authentication schemas. Most of this expert's work regarding BTLE has been with the connectivity of medical devices to smart devices and the cloud. This expert has also been involved with legal and patent work surrounding these technologies. Highly skilled at designing, implementing and supporting wireless enterprise and critical mobility applications, this expert has developed projects that range from multi-floor environments, outdoor campus environments, and co-existence strategies with various wireless standards. This includes the ability to develop the capability to have a complex ecosystem of different business and clinical applications with the right security and performance requirements. This was developed through this expert's work with a major patient monitoring company, which laid the foundation for the first patient monitoring system that provided mission-critical data in a shared wired and wireless VLAN design.
Start Medical Device Expert SearchExpert Witness #246726
This expert holds a PhD in Electrical Engineering and Computer Science and served as Senior Scientist and Distinguished Member of the Technical Staff for a large medical device manufacturer. This Imaging and Computer Vision expert specializes in Medical Imaging and Image Guided Radiation Therapy. This expert was responsible for investigational and translational innovations in the field of Imaging and Computer Vision. Contributions include Megavoltage Cone Beam CT, Image Guided Radiation Therapy, Advance radiotherapy treatment techniques, novel imaging devices and methods for radiotherapy, 3D Visualization, Augmented and Virtual Reality, Computed Tomography, Tomosynthesis imaging, X-Ray imaging systems, and medical device development. This expert has many years of experience in theoretical, as well as practical aspects of Cone-Beam CT. This expert has been involved in two patent litigations.
Start Medical Device Expert SearchExpert Witness #261650
This expert has a Master's degree in Biomedical Engineering, and another in Engineering Management. This expert currently leads a medical device design and consulting firm and provides services to corporations and law firms as a manufacturing consultant and expert witness. Before founding this company, this expert supervised Manufacturing and Research and Development for a medical device manufacturer and had responsibility for Product Development at another. This expert is well acquainted with manufacturing and deviation tolerances, and other characteristics of machining and the manufacturing process. This expert boasts over 60 medical device (US) patents. This expert is well-published and serves as an adjunct professor at a University. As an expert witness this expert has provided services in patent infringement litigations, IPR post-grant proceedings and an array of products and injury matters involving medical devices. This expert has specific experience in validity, infringement claim construction and Markman hearings.
Start Medical Device Expert SearchExpert Witness #261666
This expert is the principal owner of a biomechanical engineering company providing design and development of medical devices. With many years' experience in the medical devices industry, this expert also serves as a technical and testifying expert in patent and products matters involving medical devices, and biomechanical issues. This expert has specific experience with surgical cutting tools. As Vice President of Product Development, and as Mechanical Engineer for medical device companies, this expert provided both design and development of mechanical tools used in surgical procedures. This expert holds a Master's in Mechanical Engineering and is a Professional Engineer; this expert can speak with authority on issues of machine tolerances and dimensional variances in the manufacturing process. This expert holds over a dozen US patents in the orthopedic medical device field, has twenty publications and is a frequent presenter at industry conferences.
Start Medical Device Expert SearchExpert Witness #261687
This expert is a mechanical engineer held in high regard in the medical device industry. This expert has provided consulting services, fabricating in-house prototypes for medical device manufacturers in the dental, orthopedic, and gynecological fields. This expert has served in industry in design and engineering capacities including as Chief Technical Officer and Director of Engineering for surgical instrument and medical device firms.
Start Medical Device Expert SearchExpert Witness #261725
This expert is a biomaterials and medical device product development expert with many years of experience. This expert leads a global team that develops pediatric Craniomaxillofacial implants from concept to global commercialization at a Fortune 500 medical firm. This expert has successfully developed, FDA cleared, and launched Bioresorbable, Bone Cement, and Distraction technologies.
This expert is the author of several published scientific articles and inventor of patents on Craniomaxillofacial products. This expert conducted a doctoral research in Biomaterials. This expert's degrees are Aerospace Engineering B.S., Mechanical Engineering M.S., and Biomedical Engineering Dr. Eng.
Start Medical Device Expert SearchExpert Witness #262782
For many years this expert has focused on medical implant devices, and is a named inventor on many patents, including 28 issued US patents in the field of spinal hardware. This expert has represented a medical company's spine division as a technical witness in patent litigation, and has given numerous patent-related depositions.
Currently, this expert is President/Founder of a medical device company focused on providing orthopedic implants. Prior to this, this expert was CEO/Founder of a medical device company that developed innovative spinal implants. This expert is a member of the International Society for the Advancement of Spine Surgery, Society for Biomaterials, and ASTM International. This expert holds a Bachelor of Science in Biomedical Engineering.
Start Medical Device Expert SearchExpert Witness #218101
This expert is a Registered Professional Engineer with many years of experience in the biotechnology field. This expert holds PhD and MS degrees in Mechanical Engineering, is an ASME Fellow, and an IEEE Senior Member. This expert is also a member of ASM International (the Materials Information Society) and SAE (Society of Automotive Engineers). Currently, this expert is the Principal and Founder of an engineering consulting firm that focuses on providing support for early stage medical device and technology companies. Specializing in mechanical engineering design and behavior of biomedical devices, shape memory metals, bio-absorbable polymers and MEMs, this expert consults actively in these areas, as well as in failure analysis and reliability. This expert has extensive experience in the use of finite element analysis and simulation of structures, heat transfer, fluid flow and Mechanical Design for Reliability. This expert led the design and development of diagnostic and therapeutic devices, and has skills honed in researching and analyzing IP and competing technologies.
This expert has direct experience with implantable, cardiovascular stents, with early work related to finite element analysis and fatigue life prediction as part of the client company's FDA IDE submission. Early projects were generally balloon expandable coronary stents and the analysis went through the steps of roll-down from the as-manufactured geometry, balloon expansion, balloon deflation, and coronary cyclic pressure fluctuations. This expert also worked with self-expanding stents. Other projects involved devices such as stent-grafts for AAA application and stents for other applications such as renal, etc. Failure analysis projects involving stents came along periodically with issues such as fatigue failures during life testing, corrosion, or other metallurgical issues. Litigation projects involving stents followed. The cases were generally patent matters involving various aspects of stent technology and design. This expert has served as a testifying expert witness in medical device patent litigation and has provided deposition and trial testimony for a total of 18 IP cases, 7 IP Depositions (>20 depositions total), 1 IP Trial (4 Trials all together), and 7 IPR Declarations. This expert has taught undergraduate and graduate courses in the Mechanical Engineering Department at a prestigious universities, including courses on Materials, Manufacturing, and Mechanical Design.
Start Medical Device Expert SearchExpert Witness #243852
This expert is a Professional Engineer (PE). This expert's focus is in devices and device manufacturing quality control. This expert's degrees are in Mechanical and Electrical Engineering. This expert has specific experience in the development and testing of new medical devices and accessories, managing quality control and maintaining regulatory compliance.
Start Medical Device Expert SearchExpert Witness #125909
This medical device engineering expert holds a PhD and has over 35 years of hands-on healthcare technology life-cycle experience supporting forensic engineering investigations and litigation, intellectual property validation, healthcare technology management operations, regulatory compliance, including FDA regulations, and global innovation involving medical devices. This expert provides medical device consulting and helps educate attorneys and courts on healthcare technology-related matters, including complex regulatory requirements, labeling compliance, design and manufacturing, intellectual property processes, device-owner roles and maintenance obligations, interoperability, networking, and device risk management programs.
This expert can investigate product life stages from design considerations, medical device development, and manufacturing quality control through post-market complaint management and fulfillment of owner responsibilities. This expert provides clear explanations of causation for judges and juries.
This expert has experience in intellectual property litigation strategy, where product evolution and the strength of a competitor's patent can affect claim validity. This expert has performed novelty searches to help determine the state of patent-claim novelty and develop evidence relevant to alleged infringement. Knowledge of prior art from the perspective of a "person skilled in the art" is additional critical information this expert can address in matters involving medical products.
Start Medical Device Expert SearchExpert Witness #209802
This medical device expert has served as a consultant to the medical device industry for over 45 years and is a former U.S. FDA field investigator and field operations supervisor, with over 50 years of FDA experience.
This expert has worked with numerous medical device start-ups and assisted with device development and testing requirements for FDA clearance, including IVD tests.
This expert has testified on several occasions.
Start Medical Device Expert SearchExpert Witness #211488
This medical device expert has significant experience with medical devices, currently holds dozens of patents, and has been recognized by an industry publication as a notable person in the medical device field.
This expert has been inducted into a medical device industry hall of fame, has chaired medical device industry conferences, and continues to assist others with successful medical device product development through webinars.
This expert has been involved in several inter partes review proceedings and has extensive litigation support experience.
Start Medical Device Expert SearchExpert Witness #231538
This medical device expert holds a PhD and, after completing post-doctoral research, served as a lead medical device reviewer in a federal cardiovascular medical device review division.
Since leaving federal service, this expert has worked as a forensic expert witness and medical device consultant, with additional experience at federal agencies focused on consumer product safety and intellectual property.
This expert has also served as a faculty member at multiple universities and developed courses in mechanical and biomechanical engineering.
Start Medical Device Expert SearchExpert Witness #261631
This medical device expert is a professor of Biomedical Engineering at a public research university, holds a PhD and a doctorate in Medical Science, and is an engineer with extensive experience in medical devices, biomechanics, electronics, heat transfer, and fluid and gas flow. This expert has experience with CPAP intellectual property matters and other medical device matters.
This expert has worked with both defendants and plaintiffs in medical device matters.
Start Medical Device Expert SearchExpert Witness #261645
This medical device expert holds a Ph.D. and is a Cardiovascular Device Product Development and Research Engineer with experience in medical device research and development. This expert has published peer-reviewed articles and abstracts in heart failure device therapy R&D and has an ongoing interest in the R&D of medical devices used in atrial fibrillation (AF), heart failure (HF), cardiac pacing, and congestive heart failure devices.
This expert has extensive knowledge of the design, manufacturing, and related issues associated with IVC filters used to prevent pulmonary embolisms, including stainless steel, nitinol, and cobalt-chromium-nickel alloys used in IVC strut construction. This expert has taught coursework in biomedical engineering design theory to biomedical engineering students at well-regarded universities, including aspects of IVC filter design and the structural properties of these materials, and has been involved in product-liability matters involving several implantable devices, including cardiac pacemakers and stents. This expert is also writing a textbook on medical device design, development, and research for biomedical engineering students, with chapters related to the design, development, and use of biomaterials used in the construction of IVC filter stents, including stainless steel, nitinol, and cobalt-chromium-nickel alloys, as well as medical polymers used in various implantable devices such as IVC filters, stents, Watchman devices, and related implanted devices.
This expert is an experienced expert witness and litigation consultant with experience in medical device design, analysis, evaluation, and medical device liability matters.
Start Medical Device Expert SearchExpert Witness #268159
This robotics and medical device design expert has over 35 years of experience in robotics and medical device design and development, as well as safety and efficacy testing across a broad range of devices.
This expert has a background in medical devices, primarily endoscopic devices that make use of trocars and obturators. This expert is familiar with medical device standards and requirements, including IEC-60601 (Medical Electrical Equipment), 21 CFR 820 (Quality Systems and Design Controls), IEC-62304 (Medical Device Software), IEC-62366 (Medical Device Usability), 510(k) submissions, risk management, ISO-10993 (Biocompatibility), and MDD 93/42/EEC (EU regulations).
This expert has experience in both civil cases and IPRs and holds several patents in the medical device arena.
Start Medical Device Expert SearchExpert Witness #272472
This medical device expert specializes in US FDA and international regulatory services and continues to consult for the medical products industry, including experience with test kits for multiple clients. This expert also served for over 15 years as a professor in a university Master's Degree in Regulatory Affairs program, specializing in medical device and diagnostic regulations.
This expert is a medical device regulatory and quality systems expert with over 40 years of experience in Class III implantable device design, manufacturing, and compliance with FDA regulations. Experience includes overseeing the development, evaluation, and failure analysis of high-risk implantable devices, with extensive knowledge of product construction, material properties, and mechanical performance, including fatigue and fracture mechanisms relevant to inferior vena cava (IVC) filters. This expert is familiar with the failure modes of cardiac devices, including IVC filters, and the engineering, metallurgical, and quality factors that contribute to such failures and their potential patient safety consequences. Expertise includes hands-on inspection and forensic analysis of explanted medical devices using methods such as microscopy, metallurgical examination, and fracture surface analysis to determine causes of structural failure, including strut fracture. This expert has served as an expert witness in state and federal courts for decades, providing technical opinions, expert reports, and testimony on device defects, regulatory compliance, and manufacturing quality. This experience, combined with scientific training and direct involvement in device design, quality systems, and forensic failure investigations, supports inspection of recovered IVC filters and struts and scientifically grounded opinions on their failure.
This expert is an experienced expert witness and litigation consultant. Exemplar previous medical device matters include cardiac valves, Left Ventricular Assist Devices (LVADs), multiple types of implants, aneurysm embolization devices, intravascular stents, implantable cardioverter defibrillators (ICDs), pelvic mesh, and external pumps.
Start Medical Device Expert SearchExpert Witness #277971
This orthopaedic medical device design, testing, and failure expert holds a PhD in Bioengineering, an MS in Biomedical Engineering, and Licensed Professional Engineer credentials in multiple states, with over 20 years of experience and a senior leadership role at an engineering consultancy specializing in orthopaedic medical device failure analysis, independent medical device design and review, and medical device testing.
This expert has direct experience in spine implant biomechanics and research, including research involving cervical spine fixation devices and scoliosis rod systems using human cadavers. This expert has investigated spinal device failure and has trial testimony experience, including work for both plaintiff and defense sides in medical device cases.
This expert assists academic institutions, legal teams, and other clients in developing testing protocols for biomechanics in areas related to product liability, computer animation and simulation, structural analysis, sports injury, orthopedic biomechanics, and patent application, evaluation, comparison, infringement, and validity issues.
This expert also serves as an adjunct professor in mechanical engineering and orthopaedic surgery departments at a university.
Start Medical Device Expert SearchExpert Witness #278014
This orthopaedic biomedical engineering and medical device expert holds a PhD in Engineering Mechanics with a specialty in Orthopedic Biomechanics and has over 40 years of experience leading an independent engineering consultancy specializing in orthopaedic medical device analysis and medical device design, review, and testing. This expert assists clients with injury mechanics and causation, biomechanical analysis, product design and evaluation, structural analysis, dynamic analysis, and medical and mechanical device design and testing.
This expert has experimentally tested, designed, redesigned, and testified about medical devices, including fixation plates, screws, rods, lumbar and cervical spine fixation devices, total knee replacements, and total hip replacements. This expert also holds academic roles in Mechanical and Biomedical Engineering and directs a biomechanics laboratory at a university.
This expert has extensive prior litigation experience involving medical device design and failure.
Start Medical Device Expert SearchExpert Witness #291885
This medical device design and development expert has more than 35 years of medical device product development experience, primarily as a project manager, and recently managed development of a combination medical device and drug product for an early-stage company.
This expert has served as an expert in a number of business disputes involving medical device product development.
Start Medical Device Expert SearchExpert Witness #304001
This FDA process expert has over 5 years of experience as a medical device reviewer at the FDA, including service in a supervisory review role and extensive experience with De Novo medical device pathways, with more recent experience involving several De Novo products as well.
This expert has expertise in medical device clinical issues, study protocols, and study reports, and has performed Kaplan-Meier analysis. This expert also worked in the gastroenterology devices group at FDA and has experience with GI devices from work at a medical device company.
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