A medical device expert witness typically has extensive experience and expertise in mechanical engineering, medical device technology, and/or biomedical engineering. Most often the expert witness chosen is member of an industry organization such as the Advanced Medical Technology Association (AdvaMed) or the American Society for Quality (ASQ) Biomedical Division.
Litigation support by a medical device expert witness could include reverse engineering, expert opinion, and courtroom testimony. In a high-profile case, or litigation involving a significant financial stake, a law firm may request a subject matter expert with prior expert testimony experience. A medical expert witness needs to not only have expertise, an expert witness must possess the ability to explain technology to a judge and jury. In addition, clients may seek a medical device industry expert for pre-litigation consulting work.
The term medical device encompasses any device or product intended for healthcare, which includes diagnosis and treatment, surgical, and over-the-counter. 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. 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, or a product liability case involving the failure analysis of a product or system. Cahn Litigation Services has completed numerous searches for a medical expert witness with specialized knowledge in a particular medical device, providing candidates for each case to the specifications provided by the law firm. Cahn Litigation Services has the experience required to turn a search for an expert witness around quickly. The firm provides the right balance of expertise and testimony, sourcing the right expert for the job at hand.
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 attorneys a sense of the Medical Device landscape.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.