Biomedical Engineering Expert Witnesses

The SEAK Expert Witness Directory contains a comprehensive list of biomedical engineering expert witnesses who testify, consult and provide litigation support on biomedical engineering and related issues. Biomedical engineering expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these biomedical engineering expert witnesses testify regarding may include: Biomedical Engineering, Medical Devices, Product Liability, Intellectual Property, Biomechanics, Cardiovascular Disease, Failure Analysis, Fda Compliance, Mechanical Engineering, Bioengineering, Biomaterials, Fda Inspections, Fluid Mechanics, Forensic Science, and Imaging.

Medical Devices
  • Biomedical Engineering
  • Patents &Intellectual Property
  • Clinical and Regulatory
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Michelle R Hoffman, MS

Forensic Injury Analysis, LLC

Chandler, Arizona
Biomechanics, Biomedical Engineering - Injury Analysis, Injury Causation, Motor Vehicle Accidents, Child Seat Related Injuries, Use of Force Incidents, Helmet/Restraint Issues, Domestic Altercations, Falls from Heights, Product Liability, Diving Accidents, Backover/Runover Accidents, Aircraft Accidents, Personal Watercraft Accidents
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Morten O Jensen, PhD, DrMed

Biomedical Engineering and Medical Devices

Jexpert LLC

Fayetteville, Arkansas
Medical Devices, Biomedical Engineering - Biomedical Engineering, Medical Engineering, Biomechanics, Medical Equipment, Intellectual Property (IP), Patent Infringement, Inter Partes Review (IPR), Patent Invalidity, Surgery, Medical Malpractice, Medical Instrument, Prosthetic Device, Medical Device, Blood, Medical Electronics, Device Failure
Dr. Jensen is a Professor of Engineering and has been retained by representation for both plaintiffs and defendants in cases involving medical devices and equipment, including their failure modes, design/manufacturing issues, usage, and IP litigation issues (infringement, invalidity, etc.). He has testified at trials and depositions, and participated in on-site interrogations. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has more than two decades of academic and industry experience in both Europe and the US. He worked for six years with a global measurement, automation, and instrumentation provider in the company’s consulting services and business development departments. He has 20 years of faculty member experience at highly renowned universities in Europe and the US, winning numerous prestigious awards for his work with research, teaching, and service. The results from some of his work has been adopted by th...
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Patrick Jurney, PhD, FAHA

Bio/Mech Eng (PhD, FAHA) – Cardiovascular Expert

San Jose State University

San Jose, California
Biomedical Engineering, Medical Devices - Cardiovascular Devices, Vascular Biomaterials, Cardiovascular Disease, Fluid Mechanics, Nanoparticles, Drug Delivery, Biomedical Device Manufacturing, Microfluidics, Bypass Grafts, Mammalian Cell Culture, Biotransport Phenomena, Mechanotransduction, Thrombogenicity and Hemostasis, Endothelial Cells
Kordestani Endowed Chair & Associate Professor of Biomedical Engineering San José State University Visiting Scholar, Department of Chemical and Systems Biology, Stanford University Dr. Patrick Jurney is both a Biomedical and Mechanical Engineer specializing in cardiovascular devices, microfluidics, and vascular biomaterials. As the Kordestani Endowed Chair and Associate Professor of Biomedical Engineering at San José State University, and a Visiting Scholar in the Department of Chemical and Systems Biology at Stanford University, Dr. Jurney integrates engineering innovation with translational biomedical research. His Stanford affiliation expands his expertise into pharmacological and molecular approaches, strengthening his ability to evaluate how medical devices and engineered biomaterials interface with complex biological systems. He has been recognized as a Fellow of the American Heart Association (FAHA) and has secured funding from the National Institutes of Health (NIH), the Am...
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Alison Marsden, PhD

Biomedical engineer - Stanford Faculty

Stanford University

Stanford, California
Biomedical Engineering, Medical Devices - digital health, finite element modeling, cardiovascular disease, surgical devices, biomechanics, fluid mechanics, pediatric cardiology, pediatric devices, machine learning, artificial intelligence, computational modeling, coronary artery disease, congenital heart disease, artificial heart, stents
Dr. Marsden is a full professor at Stanford and head of the Cardiovascular BioComputational Lab. Dr. Marsden has broad expertise in cardiovascular disease biomechanics and computational modeling. She trained as a mechanical engineer (Princeton BS, Stanford PhD) with expertise in computational science and fluid mechanics before moving into the biomedical field. She has extensive experience with cardiovascular medical devices, including stents, ventricular assist devices, hemolysis and thrombosis, pediatric devices, catheters, and heart valves. She has a particular focus on computational fluid dynamics simulations and finite element modeling of the cardiovascular system, including the incorporation of machine learning and artificial intelligence into clinical decision making. She has worked extensively in pediatric cardiology, applying computational modeling to congenital heart disease for surgical planning and medical device evaluation. She has served as a consultant for medical...
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Peter Crosby

>45 years experience in medical devices & patents

Biomedical Business Resources, LLC

Aliso Viejo, California
Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering
Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 13 companies, and is currently serving as a member of the Board of three companies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable...
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Brian McVerry, PhD

Medical Devices/Materials - Founder and CTO

Axiom Scientific

Marina del Rey, California
Chemistry & Chemicals, Medical Devices - Polymer Chemistry, Surface Modification, Surface Chemistry, Medical Device Complications, Material Properties, Material Characterization, Catheters, Stents, Implant Coatings, Chemical Characterization, Pathogenesis, Medical Device Manufacturing, Chemistry Intellectual Property, Formulating Chemistry, Biomedical Engineering
Brian T. McVerry, Ph.D., is a scientist, inventor, entrepreneur, and medical device executive with deep expertise in biomaterials, anti-fouling surface chemistry, medical device design, regulatory strategy, and clinical evidence generation. He is the Co-Founder and Chief Scientific Officer of Silq Technologies, where he conceived and developed a clinically demonstrated zwitterionic surface treatment for implantable medical devices and led its translation from laboratory concept to FDA-cleared commercial products. Dr. McVerry holds a Ph.D. in Chemistry from the University of California, Los Angeles (UCLA). His doctoral work produced multiple high-impact publications, patents, and licensed technologies, including a universal anti-fouling surface modification licensed to Silq Technologies and a non-flammable electrolyte technology licensed to a private energy storage company. He is a recipient of the National Science Foundation Graduate Research Fellowship, a Finalist in the U.S. Pate...
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Jeffrey Brown, PhD

Device/biologic design and manufacturing failures

Compass Consulting Engineers

Westminster, Colorado
Medical Devices, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science
10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles
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George T Gitchel, Ph.D.

Quantitative, accurate TBI assesments.

TBI litigation support

Wilmington, Delaware
Neurology, Biomedical Engineering - Traumatic Brain Injury, TBI, eye movements, concussion, head injury, oculomotor, RIghtEye, Right Eye, movement disorders, eye tracking, quantitative anaylsis, remote IME, objective TBI, malingering, slip and fall, worker's compensation, motor vehicle accident, preclinical diagnosis
We believe that any litigation involving life-altering injuries like TBI requires evidence of the highest caliber in order to provide justice. We offer expert witness testimony along with objective, quantifiable, and repeatable data to TBI cases that have historically relied on evidence that is qualitative, subjective, and often speculative. Through two decades of in-depth human research on the neurophysiological "wiring" of eye movements, we have developed a novel, patented technology capable of supporting or refuting the presence or history of TBI with very high accuracy. Utilizing eye movement data collected from thousands of Veterans at the VA hospitals, we are able to conclusively support or refute a diagnosis of TBI through eye movement analysis. Further, these head injuries can be stratified from normal (i.e. healthy), to concussions, mild TBI, through moderate and severe TBI. Critically, this test cannot be faked in any way, which often provides a recording of crystal clea...
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Bradley T Cook, PE, MSE, CXLT

Kimley-Horn

Sarasota, Florida
Accident Reconstruction, Biomedical Engineering - Auto Accident, Accident Reconstruction, Biomedical, Biomechanical, Collision Analysis, Crash Data Retrieval, Human Factors, Motorcycle, Occupational Safety, Premises Liability, Product Liability, Slip Trip & Fall
Bradley is a Biomedical and Mechanical engineer with extensive experience in accident reconstruction. Bradley is a licensed professional engineer (PE) in Michigan and Florida. He specializes in vehicular accident reconstruction and has investigated hundreds of vehicle accidents involving cars, trucks, pedestrians, bicyclists, motorcycles, etc. The investigations have involved issues of nighttime visibility, downloading of crash data (black box data), reaction time, and blind spots. He holds a Bachelor of Science in Mechanical Engineering from the University of Michigan and a Masters of Science in Engineering with a concentration in Biomedical from Purdue University. Bradley has co-authored a chapter in Forensic Human Factors and Ergonomics: Case Studies and Analysis and Occupational Health and Safety Management in the Handbook of Human Factors & Ergonomics. He is also currently a committee member of the Underwriters Laboratories (UL) Standards Technical Panel (STP) 2201: Engi...
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J. Lawrence Stevens, RAC

FDA Medical Device Expert

ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints
A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...
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Eric Anttila, PhD

Medical Device Expert Witness

MED Institute

West Lafayette, Indiana
Medical Devices, Intellectual Property - MRI, Medical Devices, Cardiovascular Disease, MRI Safety, Intellectual Property, Patent Analysis, Medical Imaging, Medical Device Failure Analysis, Endovascular Repair, Mechanical Engineering, Demagnetization, ISO 13485, Biomedical Engineering, Medical Device Testing, Fluoroscopy, Failure Analysis
Eric Anttila, PhD is the Manager of Advanced Engineering at MED Institute. He graduated from Hastings College in 2015 with his bachelor’s degree in Engineering Physics. Eric completed his Ph.D. in Engineering (Specialization in Biomedical Engineering) from the University of Nebraska-Lincoln in 2021 with a concentration in cardiovascular biomechanics and devices. Eric has worked for the past 4+ years as a medical device consultant, working on development and testing for a multitude of devices spanning many medical specialties.
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David C. Gross, PhD, PE

Medical Device Expert Witness

MED Institute Inc.

West Lafayette, Indiana
Biomedical Engineering, Intellectual Property - Medical Devices, Failure Analysis, Products Liability, Mechanical Engineering, Biomechanics, Laboratories & Testing, MRI safety, FDA and Regulatory, Finite Element Analysis, Electromagnetic Compatibility, Magnetic Resonance Imaging, MRI, Patent Analysis, ISO 13485
David Gross, PhD, PE, is Vice President of MED Institute, a Medtech contract research organization (CRO). As a graduate research associate, he was awarded a Pre-Doctoral Fellowship from the American Heart Association (AHA) for his research focusing on improving the MRI safety of patients with implanted cardiovascular devices. He is a member of numerous societies, including the International Society for Magnetic Resonance in Medicine (ISMRM) where he received the Magna Cum Laude Merit Award at the 2016 ISMRM Annual Conference. Additionally, he was a member of the Ethics Subcommittee for the Biomedical Engineering Society. He graduated from Purdue University with a B.S. in Biomedical Engineering and M.S.E. in Interdisciplinary Engineering. He also holds M.S. and Ph.D. degrees in Biomedical Engineering from Ohio State University and is a licensed Professional Engineer.
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Christopher M Byrd, PhD

Extensive Laboratory and Forensic DNA Experience

BSquared Consulting, LLC

Bethesda, Maryland
DNA, Laboratories & Testing - Forensic Science, Pharmaceutical Research, Bioengineering, Biomedical Engineering, Biochemistry, Chemistry, Bacteria, Infection, DNA, Biological Engineering, Testing and Laboratories, Infectious Disease research, Laboratory, Vaccine, Vaccine development, Military, Department of Defense, DNA transfer
Dr. Byrd is an scientific executive and former senior military officer with 23+ years pf civil and criminal legal consulting experience including deposition and trial testimony. He has held multiple scientific lead positions including Director of Biosciences at the Army Research Laboratory and Lead Scientific Advisor to the Chief of Staff of the Army and has extensive expertise in biotechnology, chemistry, and life science research processes. . He has also worked as a professor of chemistry, biochemistry, and biology and has collaborated in research efforts with federal, academic, and industry partners such as DARPA, DHS, FBI, MIT, UCSB, and MedImmune, among others. His areas of expertise include: ➢ Bioengineering ➢ Biochemistry ➢ Forensic Science ➢ Microbiology ➢ DNA and Nucleic Acids ➢ Vaccine Development ➢ Research and Development ➢ Biotechnology ➢ Pharmaceutical Development ➢ Bacteria and infection ➢ Laboratory documentation and research review
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Rouzbeh R. Taghizadeh, Ph.D.

Regenerative Medicine Expert - MIT Trained

Kendall Innovations

Cambridge, Massachusetts
Regenerative Medicine, Biomedical Engineering - Regenerative Medicine, Cellular Therapies, Stem Cells, Extracellular Matrix, Perinatal Tissues (Placenta, Amnion, Chorion, Umbilical Cord Blood/Tissue), Transplantation, Cellular & Tissue Engineering, Biotechnology, Bioengineering, Medical Devices, Tissue Processing/Banking, HSCs, MSCs
Rouzbeh R. Taghizadeh, PhD, is a Cellular Therapy, Regenerative Medicine and Biomedical Engineering Expert offering more than 20 years of expertise as a Scientist, Innovator, and Entrepreneur in the development, processing, manufacturing of tissues, including bone marrow, umbilical cord (blood & tissue), amnion, chorion, placenta, adipose (fat), and other organs for clinical and non-clinical use, while considering the complex regulatory, trade secret, patent claims that arises from these areas. Litigation Support - Dr. Taghizadeh provides subject matter expertise and expert witness testimony for scientific, technical, regulatory, trade secret and patent claims in the areas of: Regenerative Medicine Blood / Tissue Banking Cellular and Tissue Based Therapeutics Stem Cell Bioengineering Extracellular Matrix HSCs / MSCs Processing Cryopreservation Longevity Cellular and Tissue Engineering Biotechnology Medical Devices Perinatal Tissues Transplantation Quality Control Regulatory and Po...
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Bradley E Layton, PhD PE MLE

Biomechanics and Biomedicine Expert - 30+ cases

Human Powered Future PLLC

Missoula, Montana
Accident Reconstruction, Biomedical Engineering - accidents, biomechanics, diabetes, dynamics, energy, engineering, failure, forensics, imaging, injury, materials, mechanics, nanotechnology, neurology, neuropathy, patents, personal injury, physics, proteins, slip trip & fall
American Concrete Institute Member ASME member IEEE-EMBS Editor Author - Molecular and Cellular Biomechanics Associate Teaching Professor - Drexel University Associate Professor - University of Montana Elite Athlete - United States Rowing Team 1995 & 1997 Fire Protection Engineer - US Department of Energy - Savannah River Site Founding Member - Insurance Engineering Blockchain Consortium International Code Council Member Inventor - AFM Nanomanipulation & Surgical Patents Licensed Professional Engineer - CO, GA, IA, ID, IN, KS, MI, MT, NV, PA, UT Lunar Scientist - US Department of Energy - Office of Space Machinist - Merlin Metalworks - titanium bicycle design & Stillwater - Kevlar boat design Model Law Engineer Oath of the Engineer - Engineer's equivalent of Hippocratic Oath National Society of Professional Engineers Post-doctoral Fellow - University of Michigan MRI laboratory Recipient - Montana Governor's Innovator Award Scientist - 100+ papers and abstracts
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Jay Vincelli, PhD, PE

Medical Device Expert - Dartmouth - Design & FDA

Quantify Engineering, LLC

Orford, New Hampshire
Medical Devices, Biomedical Engineering - Failure Analysis, Design History File (DHF), FDA Regulatory, Orthopedic Implants, Hip Implants, Knee Implants, Cardiovascular, Neurological Devices, Urological, Surgical Tools, Surgical Mesh, Warming Systems, EEG, Biosensors, Biomaterials, Polymers, Metals, ISO Standards, Patent Litigation, Rehab Devices
Dr. Jay Vincelli, PhD, PE, is a licensed Professional Engineer (PE) in mechanical engineering and a PhD-level biomedical engineer specializing in the forensic analysis and development of medical devices for manufacturers, product liability, and patent litigation matters. Litigation Support & Forensic Leadership Dr. Vincelli has directed the technical investigation and forensic strategy for over 110 medical device matters. As a former Laboratory Director, he managed the protocol development and testing for complex litigation involving orthopedic implants, surgical mesh, IVC filters, forced-air warming systems, and many other devices. He combines this high-volume experience with deep technical rigor, notably conducting a large-scale retrieval study at Dartmouth College involving the failure analysis of over 500 metal-on-metal hip implants. Dr. Vincelli has served as the designated expert witness in multiple depositions, including the Christiansen v. Wright bellwether trial. Regulat...
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Dr. Ediuska Laurens, M.S, EngD.

Medical Device FDA Regulation & Quality Expert

Genius Shield LLC

New York City , New York
Medical Devices, Pharmaceutical Regulation - Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering
Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...
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David Schmidt, PhD

Mechanical Engineer - Case Support

Applied Science Consultants

Pittsurgh, Pennsylvania
Mechanical Engineering, Biomedical Engineering - FEA, CFD, Simulation
Engineer and computational modeling specialist with more than 30 years of experience in applied predictive modeling across aerospace, defense, automotive, biomedical, power generation, and additive manufacturing sectors. Brings deep expertise in Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) to support simulation-driven engineering workflows, mechanical failure analysis, root cause investigation, expert opinion engagements and product liability litigation across a broad range of complex systems. In his academic role, Dr. Schmidt developed a certification program in Applied Simulation in Engineering Design and remains actively engaged in advancing simulation tools to support modern engineering practice. Dr. Schmidt is a nationally invited speaker on simulation-driven design, advanced computational methods and the integration of simulation tools into established engineering workflows.
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Gary D Fletcher, PhD

Medical Device Bioengineering & Patent Litigation

RnDDx Solutions LLC

Media, Pennsylvania
Medical Devices, Biomedical Engineering - Mechanical Engineering, R&D, Product Development, Clinical diagnostics, Blood collection, Biospecimens, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics, Imaging, Mathematics, Laboratories & Testing, Lasers
Dr. Fletcher is Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm focused on industrial biomedical and mechanical engineering, and research and product development, in medical devices, diagnostics, optical devices, point-of-care blood sample testing, and on expert witness patent litigation, including subject matter expertise in medical device mechanical engineering, and subject matter expertise in medical devices for blood collection and blood sample processing for diagnostics and therapeutics. He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for both diagnostic and therapeutic applications, including the development of sample collection devices, needles, and lancets. He is co-inventor on 23 patents for devices and methods in blood collection and processing. Yale educated Ph...
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Eric A. Bharucha, B.Sc. , B.Eng., M.Eng., PhD Eng.(ABD)

Biomedical Systems Expert - 25+ Yrs, 10 Patents

Research staff Universite Laval

Saint-Augustin-de-Desmaures, Quebec
Biomedical Engineering, Electrical Engineering - Medical device failure, Neuromodulation, Power electronics, Design defect, Olympus, FDA compliance, Electronics failure, Instrumentation, Failure forensics, Boston Scientific, Patent infringement, Biomedical patents, Regulatory analysis, Medical instrumentation, Implantable devices, Space electronics, Product recalls, Device safety
Eric A. Bharucha is a multidisciplinary systems engineer with 25+ years solving complex technical challenges across biomedical, aerospace, and industrial sectors. Currently completing PhD in Electrical Engineering (ABD) with expertise spanning electronics, biology, physics, and systems integration. TECHNICAL EXPERTISE: - Medical device design, safety, and regulatory compliance (FDA/CE) - Neuromodulation systems and implantable devices (Boston Scientific, St. Jude) - Electronic system failure analysis and forensic investigation - Silicon photonics and advanced sensor systems - Aerospace electronics and environmental testing - Manufacturing quality control and process analysis - Patent analysis and intellectual property disputes COMMERCIAL EXPERIENCE: - Led design teams for commercial medical devices (Olympus, Boston Scientific) - Developed products from research prototype to manufacturing transfer - Resolved critical failures saving clients $75M+ in offshore robotics - Expert in re...
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Eric S Heinz, MBA, MEM

MedTech Expert - 23 Years of Experience

Heinz Ventures, LLC

Memphis, Tennessee
Medical Devices, Marketing - M&A, Product Liability, Intellectual Property, Commercial Disputes, Mergers & Acquisitions, Venture Capital, Robotic Surgery, Spine, MedTech, Branding, Trademarks, Biomedical Engineering, Trade Secrets, da Vinci Surgery, Securities, Shareholder Litigation, Governance
With 23+ years of broad and deep functional experience in the MedTech/medical device industry, Eric Heinz provides litigation consulting and expert witness testimony related to commercial disputes, marketing, mergers & acquisitions, product liability, and intellectual property. Over his career, he has become a expert in the development and commercialization of surgical robotics, most notably through his past position as product manager for the da Vinci Surgical System at Intuitive Surgical. He is a registered patent agent, and is named as an inventor on 19 Issued US patents. His knowledge across product development engineering, marketing and M&A provide a unique perspective when understanding complex situations in this highly regulated industry. His extensive network in the industry (Top 1% LinkedIn Social Selling Index) facilitates warm introductions between engaged counsel and hard to source subject matter experts. He is known for his expertise in translating complex techn...
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Denise S. Holliday

Medical Device Quality and FDA Regulatory Expert

Capwell Consulting Group LLC

Frisco, Texas
Medical Devices, Biomedical Engineering - Ophthalmology, Spinal Implants, Non-Active Implants, Cardiology, Ventilators, General Hospital, Orthopedic, Gynecology/Obstetrics, General Surgical Equipment, In-Vitro Diagnostics, Dental, Software, Neurology, Prosthetics, Sterilization, 483 Warning Letters, FDA Regulatory Compliance, FDA Approvals
Denise Holliday is a proven strategic innovator and tactical leader in highly regulated environments, including quality management systems, international regulatory compliance, and medical device risk management. As a leading medical device regulatory consultant for Capwell Consulting Group, she provides strategic support to medical technology businesses, healthcare organizations, and startups. She delivers expert testimony for medical device litigation, guiding attorneys and organizations through the complexities of the global medical device industry. Manufacturers and attorneys trust Ms. Holliday to help navigate the complex regulatory landscape of medical device manufacturing and ensure compliance with standards and guidelines. Spanning almost two decades, Ms. Holliday’s career in medical device regulatory compliance and quality assurance showcases her extensive leadership experience. She conducts ISO 13485Medical Device and ISO 9001Quality Management certification audits, spear...
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