Medical Devices Expert Witnesses

Medical devices expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on medical devices. The medical devices expert witness listings on this page are typically from fields/areas of expertise such as: Agriculture Engineering, Allergy & Immunology, Aviation & Aerospace, Biomedical Engineering, Cardiothoracic Surgery, Cardiovascular Disease, Chemistry & Chemicals, Electrical Engineering, Emergency Medicine, Engineering, Financial, Hospital Administration, Human Factors, Infectious Diseases, and Intellectual Property.

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Peter Crosby

>45 years experience in medical devices & patents

Biomedical Business Resources, LLC

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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Shishir Shah, DO, CWS, ABPM

Top Doctor Award Winning Wound Expert

SCOTTSDALE, Arizona
Wound Care, Medical Devices - bedsores, skin injuries, surgical wounds, burns, pressure ulcers, venous ulcers, hyperbaric oxygen, infections, nursing home, medical devices, telemedicine, scar, qui tam, medical necessity, fraud, patents, medical director, decubitus ulcers, diabetic ulcers, regenerative medicine
Award-winning wound care physician in active clinical practice. Wound care clinical, safety ,and leadership experience in acute care, skilled nursing (nursing homes), rehabilitation, and home health settings. Certified Wound Specialist (CWS) with additional Board Certifications in Hyperbaric Medicine and Family Practice. Has served as the medical director of several wound programs. Over twenty years of medical necessity/utilization review and expert witness experience. Midwestern University Medical School faculty. Significant private equity, medical device, startup, and consulting experience. Undergraduate degree in aeronautical engineering, Rensselaer Polytechnic Institute. Deposition and trial experience in multiple states. Over 85,000 wound encounters. Key roles have included medical director oversight of several level 1 hospital trauma wound programs, 5 community hospital wound programs, and over 15 SNF/LTACHs. Co-implemented one of the largest wound care/hyperbaric clinical de...
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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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Roberto Contreras II, MD, CLCP

California Life Care Planning Association

Seal Beach, California
Life Care Planning, Internal Medicine - medical billing, life care planner, hospitalist, medical devices, medical management, medical coding, legal medicine, legal nurse consulting, nurse practitioner, obstetrics and gynecology, addiction medicine, family medicine, general practice, gynecology, consultative examinations
The California Life Care Planning Association was created by experts in the field of Life Care Planning, with more than 30 years of experience working in the health care industry. All of our professionals are Certified Life Care Planners, as well as active medical practitioners dedicated to assessing lifetime cost of care for individuals with catastrophic injuries/illness. What sets us apart from many other Life Care Planning organizations and individuals is that all of our Life Care Planners have active direct experience with patient care. We hold ourselves to a higher standard and hold all of our affiliates to that same higher standard. Whether it be plaintiff, defense , or any other client, our methodology is transparent and consistent. Given the healthcare backgrounds of our founders, all Life Care Plans and services are overseen by a Physician. Similar to a hospital setting, many of our services go through "rounding" with senior partners and physicians to make sure we are keep...
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Jason C. Goodwin, RN, MS, MPH, CNOR

Procedural, CNOR, Pre / Post Op Director Expert

Granite Bay, California
Nursing Administration, Nurse - AAAHC Surveyor, Professor of Nursing at Sacramento City College, Operating Room Nurse, Ambulatory Surgery Nurse, Legal Nurse Consultant, Falls, Perioperative Services Administration, Post Anesthesia Nurse, Procedural Sedation Nurse, GI procedures RN, CNOR, RN, Med Surg, Medical Devices, Nurse, Preoperative, Endoscopy
Clinical Experiences include:  Medical Surgical Nursing  Shock / Trauma Intervention  Procedural Services  Preoperative, Intraoperative, and Postoperative Care  Procedural Sedation  Clinical Educator Operational / Leadership Experiences include:  2003 Iraqi War Veteran  Multi-site surgical venues - UC Davis Medical Center, Kaiser Permanente  Level 1 Trauma academic medical center – UC Davis Medical Center  Military – Naval Hospital Camp Pendleton, Operation Iraqi Freedom  Fee for service ambulatory surgery and procedural services – ABSMC Surgery Center  Clinic management – Perioperative Medicine Clinic, Kaiser Permanente -As a procedural department administrator and clinician, I have personally supervised the safe care in and around various procedures and operating room venues for 18 years, totaling approximately 300,000 individual patient encounters. As a Registered Nurse, Operating Room Manager, Director, and Administrator, I have extensive experience with reg...
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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

California
Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma
Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...
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Alexander Marmureanu, MD

Cardiothoracic Surgeon - Faculty - Top Doctor 2024

UCLA

Los Angeles, California
Cardiothoracic Surgery, Vascular Surgery - Cardiac Surgery, Thoracic Surgery, Vascular & Endovascular Surgery, Trauma Surgery, Minimally Invasive Cardiovascular Surgery, Cardiovascular Disease, Pulmonary Critical Care, VATS, Lung Cancer, Minimally Invasive Thoracic Surgery, Robotic Surgery, Medical Devices, Hospital Administration
Current Positions: President Elect, Chief of Staff – Hollywood Presbyterian Medical Center Cardiothoracic Surgeon – Board Certified in Thoracic, Cardiovascular & General Surgery President & CEO – California Heart & Lung Surgery Center 2024 Top Doctors, LA Magazine & Angeleno Magazine Assistant Professor of Surgery – School of Medicine at California University of Science & Medicine Director of Cardiothoracic Surgery – Centinela Hospital Medical Center Director of Cardiothoracic Surgery – Southern California Hospital at Culver City Board Certified in Cardiothoracic Surgery and General Surgery and licensed to practice in the states of California and New York. Currently practice Thoracic and Cardiovascular Surgery in Los Angeles, CA. Assistant Professor of Surgery and Member of the Bylaws Committee at the School of Medicine at California University of Science and Medicine. I have a busy practice, performing over 300 procedures per year among 6 hospitals in Los Angeles. I am ...
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Gavin Huntley-Fenner, Ph.D.

Human Factors and Cognitive Sciences Expert

Rimkus

Irvine, California
Human Factors, Safety - Risk Analysis, Risk Perception, Hazard Communications, Safety and Human Development, Human Perception-Response Time, Decision Making, Cognitive Psychology, Consumer Electronics, Pharmaceuticals, Professional Products, Medical Devices, Human Behavior, Literature Reviews, Incident Database Reviews, Surveys and Human Subject Test
Dr. Gavin Huntley-Fenner is a nationally recognized expert in human factors and safety whose problem-solving skills and communication style have made him widely sought after as a consultant. Along with providing comprehensive risk analyses for a wide variety of product types, Dr. Huntley-Fenner often serves as an expert witness for matters relating to risk perception, hazard communications, safety and human development, human perception-response time, and decision-making. With a background of over 25 years as a researcher, author, educator, and business consultant, Dr. Huntley-Fenner applies the latest findings and research methods in cognitive psychology and related disciplines to real-world, often life-and-death, situations. Dr. Huntley-Fenner’s recent consulting and forensic projects have involved diverse products such as consumer electronics, pharmaceuticals, professional products, and medical devices. He has conducted investigations into human behavior in home, school, workpl...
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Eric C Beppler, PE

Embedded Systems and Software Expert

Ringtail Labs

Broomfield, Colorado
Electrical Engineering, Software Engineering - Source Code Analysis, Firmware, Forensic Engineering, Product Liability, Trade Secret Misappropriation, Wireless Communications, Internet of Things (IoT), Medical Devices, Electronics, Software Development, Signal Processing, ​​Root Cause Analysis, Digital Health Devices, Life Sciences Instrumentation
Eric C. Beppler, PE is a Colorado-based electrical and software engineer with extensive hands-on experience in embedded systems development and firmware programming. A licensed Professional Engineer in Colorado, Mr. Beppler has led multi-disciplinary engineering teams and co-founded a biomedical device R&D firm, spearheading the creation of wearable health devices and IoT sensor systems for continuous data monitoring. He has served as Director of Software & Electrical Engineering for a life-sciences instrumentation startup (acquired by a Fortune 500 company), where he architected complex electronic control systems and oversaw product compliance under FDA and IEEE/IEC standards. Mr. Beppler’s technical expertise spans circuit design, wireless communications (Bluetooth Low Energy, LTE-M), and software development, enabling him to analyze and troubleshoot devices ranging from consumer electronics to medical devices. He is the co-inventor of a patented continuous methane monitoring devi...
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Jeffrey Brown, PhD

Finding the cause of biomedical product failures

Compass Consulting Engineers

Westminster, Colorado
Products Liability, 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 patentsQualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles
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Steven B Levine, MD

Steven Levine

Milford, Connecticut
Otolaryngology, Allergy & Immunology - Audiology, ear, Ear Nose & Throat, ENT, delayed diagnosis, causation, hearing, hearing loss, vertigo, dizziness, Otology, sleep apnea, snoring, tinnitus, patent, medical devices, intellectual property, voice, loss of smell, anosmia
Actively practicing award-winning board-certified Otolaryngologist-Head & Neck Surgeon (Ear, Nose & Throat). Former Yale, Cornell and Penn faculty. Medical degree from University of Rochester and residency at University of Pennsylvania. National and international invited speaker with publications related to hearing, sinus, allergy and throat disorders. Patent holder in hearing diagnostic device. Castle Connolly Top Doctor for >20 consecutive years. Leadership positions at state and national medical societies. Experienced expert witness (both deposition and trial).
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Timothy Hawkins, FACHE

Experienced direct facility negligence expert

Hospital Experts

Cape Coral , Florida
Medical Management, Medical Devices - Hospital Administration, Hospital Liability, Joint Commission Standards, IRB, Medical Devices, daVinci Robot Credentialing, Operating Room, Informed Consent, Negligent Credentialing, Patient Safety, Environment of Care, Hospital Negligence, Sexual assault and abuse, Policies and procedures
Mr. Hawkins is an accomplished Hospital Executive with experience in hospital departmental operations and regional healthcare systems. He held the positions of Chief Executive Officer, Executive Vice President, and Chief Operating Officer. He is Board Certified in Healthcare Administration, and a Fellow of the American College of Healthcare Executives.
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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Florida
Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma
Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...
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Macarthur Drake, Jr., M.D., M.S.

Miami Beach, Florida
Neuroradiology, Radiology - Brain, head and neck, spine imaging, CT, CTA, MRI, MRA, Myelography, Diagnostic Radiology, Teleradiology, Mammography, Internal Medicine, Medical Devices, Biomedical Engineering, Mechanical Engineering
16 Medical Licenses including FL, CA, NY, OH, IL. Neuroradiology Fellowship Trained & Board Certified. Neuroradiology lecturer. Diplomat, American Board of Radiology. Former NASA Engineering Intern. Former GE Aircraft Engineering Intern.
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Lloyd A Marks, MD, MBS, FACC, FAIMBE

Medical Device Inventions, IP & Commercialization

Medical Invention Consulting, LLC

Tampa, Florida
Medical Devices, Intellectual Property - Medical Devices, Medical Technology, Patents, Intellectual Property, Inventions, Entrepreneurship, Due Diligence, Medical Device Assessment, Medical Device Protection, Medical Device Commercialization, Human Factors, Medical Twechnology Assessment, Medical Technology Protection, Medical Technology Commercialization
I’m an electrical engineer (MIT), physician (University of Michigan), pediatric cardiologist (Johns Hopkins), MBA (UTK), inventor with 20 medical device and 5 sporting equipment patents, and entrepreneur with three startup companies, one of which, MGI Medical, LLC (www.mgimedical.com), is commercializing an invention of mine, the Pulse Flowmeter, which can detect hemodynamically significant occult blood loss well before the blood pressure drops. This is for the management of trauma, post-operative bleeding, battlefield triage, GI bleeders and battlefield injuries). I am a fellow of the American College of Cardiology and the American Institute of Medical and Biological Engineering. Honors include membership in Tau Beta Pi (Engineering Honorary) , membership in Eta Kappa Nu (electrical engineering honorary), a listing in Marquis Who's Who in America and Physician Leader of the year at the Physician's Executive MBA Program at the University of Tennessee, Knoxville. Because of my ba...
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Willa L Carter

CQG

Conyers, Georgia
Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components
Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.
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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Georgia
Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma
Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...
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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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Vipul M Kella, MD, MBA FACEP

Emergency and Hospital Administration Expert

Vipul Kella

Potomac, Maryland
Emergency Medicine, Hospital Administration - COVID, overdose, anaphylaxis, appendicitis, fraud, hospital administration, mental health, aortic dissection, sexual assault, myocardial infarction, fractures, negligence, sepsis, wound care, trauma, cardiac arrest, brain hemorrhage, stroke, medical devices, aneurysm
Background: Dr. Kella is a board-certified emergency medicine physician who practices in the Washington, D.C. area. In his twenty years of practice, he has worked both clinically and as a hospital executive in large hospital systems and has received awards for hospital safety and quality initiatives. He currently practices in the Washington, D.C. area and has been retained in high-profile civil and federal matters by firms across the country. Dr. Kella has both a clinical and executive background, with an MBA in hospital administration and 15 years of experience in hospital administrative and consulting roles. He is frequently retained for his expertise in corporate negligence and complex hospital administrative matters. He is also a chief medical officer and an experienced health tech expert, and he has been retained for his experience with medical devices and products. Board-certified in Emergency Medicine, and a highly experienced expert witness, having reviewed over 400 ...
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Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO

Kohler Healthcare Consulting, Inc.

Woodstock, Maryland
Investigation, Medical Management - Acute Care, Ambulatory Surgery Centers, Dermatology, Internal Medicine, Medical Devices, Medical Management, Orthopedic Surgery, Pain Medicine Management, Physical Medicine & Rehab, Radiation Oncology, Radiology, Healthcare Compliance
Healthcare Consultant, Litigation Support, Certified Valuator, CPA [RN] Retired RN. ACS Advanced Coding Specialist -Board of Medical Specialty (BMSC) CPA Certified Public Accountant -State of Maryland CVA Certified Valuation Analyst - National Association of Certified Valuators and Analysts CRCE Certified Revenue Cycle Executive -American Association of Healthcare Administrative Management (AAHAM) CPC Certified Professional Coder -American Academy of Professional Coders (AAPC) CHBC Certified Healthcare Business Consultant -National Society of Certified Healthcare Business Consultants CPCO Certified Professional Compliance Officer
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Steven W Opolski, MS

Atlantic Engineering, Inc.

Ipswich, Massachusetts
Medical Devices, Engineering - Stent, Septal Occluder, Medical Devices, Vena Cava, Filter, heart, brain, colon, valve, mitral, aortic, finite element, FEA, AAA, disposables, nitinol, percutaneous, aneurysm , failure analysis, surgical instrument
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Ilonna J. Rimm, MD PhD CFA

Healthcare Valuation Expert - Physician

Rimm Healthcare Capital Advisory LLC

Newton Center, Massachusetts
Financial, Pediatric Hematology Oncology - Appraisal and Valuation, Banking, Business Valuation, DNA, Financial, Securities and Investments, Biotechnology, Medical Devices, Healthcare Services, Life Science Tools, Pharmaceuticals, Entrepreneurial Companies, Start-up companies
Ilonna Rimm, MD PhD CFA, is a healthcare investor who has significant expertise related to the valuation of healthcare companies. She recently served as an expert witness related to the valuation of early-stage biotechnology companies. In addition to drafting the expert report and rebuttal, she served as a deponent, and she testified in the trial. As the CEO and Founder of Morninglight Healthcare Capital, LLC, a family office, she invests in small cap public companies (0 to $4B market cap). She also serves as an Advisor to Life Sciences CEO’s who are raising a Seed or Series A Round of capital, as Rimm Healthcare Capital Advisory, LLC. She recently provided services to Immuneering Corp., who raised a Series A round of $20M in January, 2020, and a Series B round of $62M in January, 2021. Immuneering is now a public company (IMRX). Ilonna currently works as a Financing Expert at the Harvard Innovation Lab, which is associated with Harvard Business School. Ilonna's advisory s...
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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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James M. Miller, PE, PhD

Engineering Safety, Agricultural, Batteries, Nano

J.M. Miller Engineering, Inc.

Ann Arbor, Michigan
Safety, Agriculture Engineering - Accidents, Auto ADAS, Agriculture, Battery Fires, Cannabis Processing, Chemical Exposure, Child Safety, Construction, Electrocution, Ergonomics, Fitness Equipment, Fires/Explosions, HazCom, Human Factors, HVAC, Mechatronics/Nano, Medical Devices, OSHA, Recalls, RV/ATV
There are four PhD and registered Professional Engineers at Miller Engineering who are celebrating 40 years of Professorships at three universities along with providing services to Government, Insurance, and Industry—through research, publications, presentations, and expert testimony. These co-founders and associates are James M. Miller, PE, PhD; Mark R. Lehto, PhD; David R. Clark, PE, PhD; Adam M. Olshove, PE, MSE; and Jeffrey D. Rupp, MSE. Miller Engineering has a dedicated office with a full-time staff of engineers, researchers, and technical writers. The span of our collective academic and experiential expertise includes the Mechanical, Electrical, Chemical, Agricultural, Industrial, Human Factors, Ergonomic and Safety fields of engineering. Miller Engineering’s principle engineers wrote the original books on warnings and instructions, have published in several other areas, have participated in product designs and patents, and have analyzed, reconstructed and/or animated numerou...
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Tamanna Nahar, MD, MBA, FACC, FASE

Englewood Cliffs, New Jersey
Cardiovascular Disease, Interventional Cardiology - Vascular/Interventional Cardiology, Cardiovascular Ultrasound, Preventive Medicine, Medical Management, Medical Devices, Cardiac Electrophysiology, Cardiovascular Genetics, Heart Failure, Interventional Cardiology, Onco-Cardiology, Peripheral Artery Disease (PAD), Structural Heart Disease
I am a board certified well rounded cardiologist with a broad range of skills spanning over 20 years. My experience has encompassed academic and clinical medicine with a focus on noninvasive cardiology for the past 23 years at premier Institutions. I have strong leadership and mentorship skills in addition to budgeting and revenue cycle management. I have been a Co-PI for Phase 2 and 3 clinical trials for Ultrasound Enhancing Agents and participated in clinical trials for various antihypertensive, lipid lowering, oral anticoagulant and heart failure drugs. In addition to serving as a Co-PI for Phase 3 trials for PFO/ASD device deployment trials. My expertise includes formulating and reviewing IRB protocols and serving on CRO committees. Previously served at the Harlem Hospital, Columbia Affiliate, NY as Chief of Cardiology and was also involved in the training of medical students, residents and nurse practitioners. Current Medical Licenses: • Pennsylvania • New York • New Jersey ...
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David M. Lehmann, PhD

Toxicologist - Drugs, Alcohol, & Chemicals

Intertox

Raleigh, North Carolina
Toxicology, Infectious Diseases - Alcohol & drug impairment, Liquor liability & dram shop, Immunology, Allergic reactions, Skin & eye irritation, Inhalation toxicology, Medical devices, Postmortem toxicology, Metals, Air pollutants, Pesticides, Lead poisoning, Carbon monoxide poisoning, Solvents, Volatile organic compounds (VOCs), Toxic torts, Infectious diseases
Dr. Lehmann is an accomplished toxicologist with nearly 20 years of cross-sector experience spanning academia, industry, and government. He brings deep expertise in human and ecological risk assessment, toxicological mechanisms, pharmacology, and drug-related signal transduction pathways. Dr. Lehmann applies his scientific expertise to complex questions involving alcohol, drugs, environmental exposures, consumer products, and medical devices. His work integrates experimental toxicology, exposure assessment, and weight-of-evidence evaluation to assess potential health effects and causation. Drawing on his extensive research background and teaching experience, he is skilled at translating complex toxicological concepts into clear, accessible explanations for attorneys, courts, and other non-scientific audiences. Experience & Expertise: -Alcohol and Drug Toxicology: Expertise in the toxicology and pharmacology of alcohol, opioids, stimulants, cannabinoids, benzodiazepines, and other...
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Jon Washington, BSME, MBA, PMP

Engineering, Design, Manufacturing & Patent Expert

The Innovation Garage, LLC

Clinton, Ohio
Engineering, Mechanical Engineering - Automotive, Aerospace, Gaming, Casinos, Financial Self Service, Manufacturing, Design, Systems, Polymers, Project Managment, Contracts, Security, Software, Metal Forming Processes, Patent Process, Business Process, Operations, Medical Devices, Supply Chain, Consumer Products
Jon Washington is the Founder and Proprietor of The Innovation Garage, a business consulting firm he has operated since 2012. The Innovation Garage focuses on providing education, tools, technology, and expert consulting in change management related to Strategy, Innovation, and Supply Chain. The Innovation Garage provides organizational leadership teams with resources, education, and consulting services to design strategies, develop internal capabilities, and implement systems, processes and solutions. Its diverse client base includes startups, nonprofits, mid market privately held and recognized publicly traded organizations such as Fortune 500 companies and large international entities, including DoD-based support organizations. Since its inception, The Innovation Garage has collaborated with over 100 organizations, with Mr. Washington personally training more than 2,000 organizational leaders and their extended teams. His expertise spans various sectors, including medical, ...
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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Ohio
Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma
Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...
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James E Alexander, Jr., MD

Specializes in Medicare Qui Tam False Claims Cases

Healthcare Compliance Management, LLC

Fort Worth, Texas
Medical Billing, Medical Coding - Qui Tam, Health Insurance Fraud, Health Insurance Abuse, Medicare, Medicare Fraud, Medicare Abuse, Medical Policy, Medical Necessity in Medicare, Medicare LCDs, Medicare NCDs, Medicare Coding, Medicare Billing, Health Insurance Coding, Upcoding, Medical Devices, New Medical Technology
Completed SEAK Expert Witness Training. Experience working on 4 large qui tam cases. Retired Captain (O-6) United States Navy. Board Certified General Surgeon. Partner in Healthcare Compliance Management, LLC, a consulting firm incorporated in Texas. Dr. Alexander and his partners established HCM in early 2002 and since that time he has been involved in numerous healthcare compliance consulting projects for major pharmaceutical and medical device manufacturers, large and small hospitals, cancer centers, large and small physician groups, other consulting entities as a special consultant, and legal firms (both as a consultant and as an expert witness).
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Brian Arenare, MD, MBA, MPH

Occupation Medicine Physician - Aeromedical Expert

SAME DAY RESPONSE : : Email -or- Call/Text

Houston , Texas
Occupational Medicine, Aviation & Aerospace - Aviation Medicine, Certification Standards, Aeromedical Transport, Aeronautical Decision Making, Travel Medicine, Worker Injury, Risk and Hazards, Human Factors and CRM, Cabin Environment, Pilot Crew Flight Attendant, Commercial Pilot, CFI AME FAA, Air Safety, DOT FMCSA, Public Health, Pharmaceutical Drugs, Medical Devices, Patents
Dr. Arenare brings a broad and in-depth background to expert witness work in aviation medicine and occupational injury evaluation and prevention, in the workplace and other settings. He is an experienced board-certified physician, consultant, and medical opinion leader. After graduating Yale Medical School, he completed residency training in general surgery, then practiced trauma surgery and emergency medicine, performing thousands of surgical operations and procedures. He also completed an MBA degree and provided medical, healthcare, and management consulting for a wide range of healthcare industry companies, regulatory agencies, and investors. He has advised and led strategic growth for several biopharma and medical device firms and served on the board of a public biotech company. He held a vital public health leadership role as the Director of Disease Control and Prevention for Harris County, Texas. Upon completing further preventive medicine residency training, with a focu...
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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Plano, Texas
Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma
Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...
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Bradley N Plank, PE

MME Forensic Consulting, Inc.

Dallas, Texas
Mechanical Engineering, Metallurgy - Product Liability, Failure Analysis, HVAC, Oilfield, Heavy Equipment, Cranes, Cables, Medical Devices, Plastics, Boilers, Water Heaters, Plumbing
Using his combination of mechanical and metallurgical (including plastics) experience and education, Mr. Plank provides forensic and consulting engineering services to attorneys, insurance professionals, and manufacturing companies. A registered engineer in Texas and 23 other states, his experience includes 32 years in manufacturing in the metals processing industries, 29 years performing failure analyses, and 26 years investigating claims. Mr. Plank has testified in a wide variety of matters including personal injury and property damage, in both state and federal court, and his testimony has never been excluded. Assignments have involved mechanical equipment, appliances, oil and gas transmission equipment, plumbing, HVAC, heavy equipment, machine tools, cranes and wire cables, manufacturing processes, and thermal processes, among many others.
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Peter Coderre, PhD

Antimicrobial Regulatory Consulting

Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP
25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...