Medical Devices Consultants: 15

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. 

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. 

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Consulting Services: 

Global Regulatory Filing Review / Writing Agency Negotiation Strategic Advisories

Contracted Management Services Current Good Manufacturing Practices Compliance Quality Systems

View Timothy Anderson's Expert Witness Profile.

Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. Dr Daft has deposition and trial testimony experience. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 23 U.S. Patents with several pending. Completed more than 98 hours of SEAK Expert Witness Seminars, including patent-specific training. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. Extensive international consulting experience. IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

View Dr. Christopher Daft's Expert Witness Profile.

Quality Forensic Engineering, LLC is a full-service forensic engineering firm, providing engineering support to clients in the areas of accident reconstruction, biomechanics, fire investigations, patent litigation analysis, premises liability, product liability, and tire failure analysis. We use the latest technology and industry proven techniques to provide thorough analysis and conclusions for the most difficult engineering questions. Our forensic engineers support clients throughout the U.S. Our locations include Tallahassee, FL; Jacksonville, FL; Tampa, FL; New Orleans, LA; San Diego, CA; and Tucson, AZ.

Dr. Brian Pfeifer, P.E. - Dr. Pfeifer is an Engineering Expert with over 25 years of experience investigating thousands of cases involving a variety of forensic engineering issues. He is a leading expert in accident reconstruction, roadside safety, maintenance of traffic, commercial vehicle accidents, pedestrian accidents, bicycle accidents, and the analysis of mechanical systems and product failures. Dr. Pfeifer has a strong background in the design, development, and implementation of roadside safety hardware including guardrails, bridge rails, and crash cushions. Over 33 patents have been filed worldwide on behalf of Dr. Pfeifer and associated colleagues who invented safer guardrail systems, vehicle storage systems, shipping container handling systems, and material handling and storage methods. He has also utilized his technical knowledge and understanding of patents to assist in a number of matters involving patent litigation.

Dr. Pfeifer has published numerous papers to various organizations, covering topics such as new guardrail systems, energy absorbing guardrail terminals, breakaway sign mechanisms, and material handling technology. He has shared his expertise with many organizations on topics including vehicle collisions, bicycle accidents, roadway construction zones, and accident reconstruction expert witness utilization. Dr. Pfeifer is a registered Professional Engineer in nine states and he continues to refine his skills and knowledge of accident reconstruction and roadside safety by staying current with new technology and best practices. Dr. Pfeifer has extensive experience with providing deposition and trial testimony as an Engineering Expert.

See Full Bio & CV.

Expertise:

Automobile Collisions Tractor-Trailer Collisions Guardrails / Bridge Rails Construction Zones Bicycle Accidents Pedestrian Accidents Motorcycle Accidents Occupant Kinematics

Roadside Safety Airbag Control Module (ACM) Analysis Tractor Trailer Electronic Control Module (ECM) Analysis Product Failure Analysis Maintenance of Traffic (MOT) Evaluation Restraint System Analysis Patent Litigation Technical Analysis

Dr. Ian M. Zeller, PhD, ACTAR, is an accomplished engineer with more than 10 years of experience in Biomechanics and Computational Dynamics fields. He has investigated hundreds of cases ranging from motor vehicle accidents, recreational incidents, medical device designs, as well as injuries from product liability all across the United States. 

Dr. Zeller has graduate level experience in computational dynamics and orthopedic biomechanics with a specific emphasis in dynamics, vibrations, joint contact mechanics, and muscle control during static and dynamic loading applications. Dr. Zeller’s past research includes clinical and computational analysis of the human body with respect to the design and implantation of orthopedic devices for the knee, hip, and spine. He has published in peer-reviewed journals and presented research at both technical and surgical conferences in North America, Europe, and Asia. Dr. Zeller also worked with surgeons across the United States in the design and assessment of knee replacement devices, including personalized and prototype devices to optimize for efficacy and safety. 

Dr. Zeller is also accredited as a traffic accident reconstructionist and continues to conduct research as well as maintain a current knowledge of developing trends and best practices in the biomechanics and engineering fields. Dr. Zeller has published to various organizations on topics ranging from knee replacement design, forward solution modeling, joint mechanics, personalized joint replacements, material structures and properties as well as biological modeling of disease distributions. He also has an extensive testifying history including depositions, trials, and arbitrations. 

See Full Bio & CV.

Expertise:

Biomechanical Analysis Accident Reconstruction Injury Consistency Mechanism of Injury Analysis Vehicle Occupant Kinematics Falling Object Mechanics and Analysis Bicycle Accidents Pedestrian Accidents Amusement Park and Playground Accidents Crash Data Retrieval and Analysis

Product Failure Analysis Seat Belt Analysis Restraint System Occupant Position Determination Sequential Events Analysis Speed Analysis Vehicle Damage Consistency Collision Avoidance Material Fracture Analysis

 Michael R. Hill, PhD, PE, is a Biomechanical Engineer passionate about applying biomechanics techniques to solve diverse problems in forensics, medical research, engineering, biology, science, and mathematics. He is an expert in experimental, theoretical, and computational Tissue Biomechanics, with a focus on injury mechanisms, human tissue damage, and nonlinear soft tissue mechanics.

Dr. Hill’s core strengths are in orthopedic and cardiovascular biomechanics, vehicle accident reconstruction, injury consistency analysis, mechanical design, instrumentation,
experimental analysis, numerical methods, simulation, statistics, and image processing. Dr. Hill has lectured in the field of biomechanics and numerical methods, and his research has been published in 16 academic articles and presented at 40 international and national scientific conferences.

See Full Bio & CV.

Expertise:

Vehicle Accident Reconstruction Occupant Kinematics Orthopedic and Cardiovascular Biomechanics Human Tissue Damage Mechanics Slip, Trip, and Fall Analysis

Computational Mechanics  Experimental Biomechanics Image Analysis Computational Modeling Event Date Recorder (EDR) Data Retrieval and Analysis Automobile Restraint Analysis

View Quality Forensic Engineering Industrial Forensic Engineering Consulting Profile.

OrthoBioMech LLC provides Medical Device Development and Injury Biomechanics Analysis services to the orthopedic and legal fields. The founder, Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

While working for and with the major US Orthopaedic companies, she designed numerous instruments and implants for repair of skeletal injury. Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Ms. Truman founded and ran ArthroMotion (1993-1997) and Seabrook International LLC's Midwest Design Center (1999-2002). Her project experience (non-inclusive):

• Total and Hemi Joint Resurfacing Systems: Hip, Knee, Wrist, Ankle, Hand/Toe, CMC, PIP, DIP, Shoulder
  
• Trauma Systems: Plates, specialty screws, intramedullary nails, wires, cables, external fixation systems, spinal fusion systems
  
• Soft Tissue Reattachment Systems

Speaking Venues: ASME Congress, North American Spine Society, Southern Biomedical Engineering Conference, International Society of Biomechanics, National Manufacturing Week Conference, American Society for Surgery of the Hand, International Hand and Wrist Biomechanics Symposium, International Federation of the of the Societies for Surgery of the Hand, Vth International Symposium on Computer Simulation in Biomechanics, Indiana Medical Device Manufacturer’s Council, Ohio Bar Association and the Ohio Trial Lawyer’s Association.

View Mari S. Truman's Expert Witness Profile.

Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies. 

Mr. Stevens has 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, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.

View Mr. Stevens' Expert Witness Profile.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Dr. Mayer is an independent consultant and scholar that (for identification only) holds the position of Visiting Fellow in Human Flourishing,  Harvard University. He has been a full-time tenured professor with recent appoints in statistics, biostatistics, epidemiology, biomedical informatics, public health and medicine (psychiatry). He held various titles including, Professor (Part-time), Bloomberg School of Public Health and School of Medicine, Johns Hopkins University, Affiliated Professor, Mayo Clinic/ASU joint program in Biomedical Informatics, a member of the Research Staff at Mayo Clinic, and Professor at Arizona State University. 

Dr. Mayer continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observation studies and clinical trials. His consulting projects often focus on model development, execution and inferences. He is one of the few MD/PhD epidemiologists. He led a  group of 6000 physicians and epidemiologists that reviewed the science of COVID-19 

Rouzbeh R. Taghizadeh, PhD, has been researching, developing, and bringing to market Cellular and Tissue based Products and Medical Devices for clinical use – as a researcher, scientist, entrepreneur, innovator, and key opinion leader. Dr Taghizadeh is a Scientist, Entrepreneur, Innovator and Subject Matter Expert offering Business Consultant services in the following areas:

Regenerative Medicine Blood and Tissue Banks Blood and Tissue Manufacturing Cellular and Tissue Based Therapeutics Umbilical Cord Blood / Bone Marrow

Stem Cell Bioengineering Longevity Cellular & Tissue Engineering Biotechnology Medical Devices

Dr. Taghizadeh's research has focused on developing aand patenting a new method to increase the number of hematopoietic (blood forming) stem cells (master cells that produce working cells for the lifespan of an organism) ex vivo (outside the body) for treatment of patients afflicted with blood disorders and cancers. He has investigated various sources containing blood-forming stem cells, including umbilical cord blood, bone marrow, and mobilized peripheral blood.

Dr. Taghizadeh also co-founded a biotechnology company that pioneered the processing and banking of umbilical cord tissue for clinical use. He's worked with various groups including umbilical cord blood & tissue banks, organ procurement organizations (OPO), academic, biotechnology, pharmaceutical, contract manufacturing and medical device groups. Due to the diverse nature of the groups that he has worked with, he has experience in developing, manufacturing and innovating cellular therapeutics, regenerative medicine, allografts (tissue products developed from different donors & recipients), bioengineering, cellular and  tissue engineering products.

View Dr. Rouzbeh R. Taghizadeh's Expert Witness Profile.

With a diverse background in the financial markets, real estate, and health care, I discovered that my true passion and satisfaction is helping others to uncover and achieve financial dreams and build a legacy. I understand the financial markets and the importance of individualized risk management and portfolio planning.  

Finity Engineering, LLC comprises highly-accomplished engineers and industrial practitioners that work alongside leading researchers to provide design, analysis, consulting, and litigation support services. Associates are subject-matter experts in the areas of Automation, Mechatronics, Robotics, and Consumer Products.

Finity Engineering professionals have served scores of industry-leading companies and research institutes, and have developed and provided technical oversight for the implementation of hundreds of robotic, automation, and controls systems deployed within the facilities of high-profile end users. Collectively, Finity Engineering professionals are named inventors on over 60 patents and have founded dozens of successful entrepreneurial ventures, demonstrating pragmatic and marketable engineering innovation.

Clients Include: Alcoa, Apple, BMW, Boeing, Cargill, Caterpillar, Chernobyl, Cummins, Ford Motors, Fukushima, General Motors, Gestamp, Google, Honda, Hundai, Jet Propulsion Laboratory, Johnson Controls, Kia Motors, Lockheed Martin, and many more.

Design, Analysis & Business Consulting Specialties:

Additive Manufacturing Aerospace Engineering Biomedical Engineering Consumer Product Design Control Systems Cranes Design Methodology Dynamics Electrical Engineering Failure Analysis Fluid Power / Hydraulics Haptics Hazard Analysis Image Processing Industrial Control Systems Industrial Design

Machine Design Machine Learning Machine Vision Manufacturing Mechanical Engineering Mechatronics Motion Control Optics Photogrammetry Product Design Rapid Prototyping Robotics Signal Processing Traction Control & Wheel Slip Vibrations Warnings

 Founder, Khalid Sorensen, PhD, is a highly accomplished technology leader in Automation, Mechatronics, Motion Control, Manufacturing, Machine Vision, and Human-Machine Interaction. He has over 20 years of experience developing and deploying world class, mechatronic, motion control, and automation solutions.

Dr. Sorensen has directed the development and implementation of 100s of complex, multi-disciplinary mechatronic systems for high-profile industry leaders including Toyota, Ford, Alcoa, Caterpillar, Boeing, NuScale, and many others, and high-profile facilities including Fukushima and Chernobyl.

Previously, Dr. Sorensen Founded a technology company where he invented and was the Chief Architect of Expertoperator^TM, Safemove^TM, Automove^TM, and Cranevision^TM – technology known within the primary metals, automotive, and heavy-equipment sectors for enhancing crane safety, productivity, and ease-of-use; Developed state-of-the-art, on-line, time-optimal trajectory synthesis software for Cartesian machines - key drivers in the acquisition of his company 5 years after inception by a global leader in automation.

View Dr. Khalid Sorensen's Expert Witness Profile.

Envista Forensics is a global leader in Forensic Engineering & Recovery Solutions. They provide Cause & Origin, Failure Analysis, Fire and Explosion Investigations, Accident Reconstruction, Damage Evaluations and Equipment Restoration Services following disasters of all kinds. Envista has offered Consulting Services to the insurance, legal and risk management industries, as well as businesses, public entities, and universities for over 25 years. Their Experts travel globally from 30 offices located across the U.S., Canada, Mexico, the U.K., Australia and Singapore.

Insurance Industry / Claims Professionals - Envista understands the need to save money and expedite the claim, to serve the insured and reduce uncertainty. They offer a menu of services that address insurers’ needs for timely, reliable information, as well as their need to satisfy the policyholders. Envista's insurance clients include Property Adjusters, Casualty and Liability Adjusters and Examiners, Boiler & Machinery Specialists, Inland and Ocean Marine Surveyors, Subrogation and Recovery Professionals, SIU (Special Investigation Units), Forensic Accountants, and Lloyd's & London Market.

Businesses - Envista understands that buildings, equipment, data and other assets are critical to the profitable operation of any business. They are proud to offer a variety of services that help businesses protect themselves when they need it most. Envista offers specialized expertise with all types of business, especially Manufacturers, Technology Companies, Food Processing, Hospitals, Medical / Dental Care, Laboratories, R&D (Research & Design), Schools and Universities, Law, Accounting, and other Professional Service Firms, Banking, Securities, Financial, Energy, Transportation, Retail, and Broadcast and Entertainment.

Universities & Public Entities - Risk Managers and Business Officers responsible for the operations of colleges, universities, local government and other entities have the challenging role of working to prevent financial exposure following disasters involving business-critical equipment, buildings/structures, data/networks, as well as safety. Envista engineers and technicians have over a quarter century’s worth of experience providing forensic consulting for college risk professionals, as well as the insurance carriers and legal professionals who serve them.

Consulting Services:

• Equipment Damage Assessments
• Forensic Engineering / Causation Analysis
• Building & Structure Damage Assessments
• Equipment Restoration & Preservation
• Evaluation of Repair and Replacement
• Project Management of Repair and Recovery Efforts Options
• Data Recovery
• Computer Forensics
• Forensic Video Services
• Cyber Incident Analysis

View Envista's Expert Witness Profile.

Kenneth "Kenny" Stein, MD
Board Certified Emergency Medicine & Internal Medicine 
Subspecialty Certified in NeuroCritical Care 

Kenneth "Kenny" Stein, MD, is Assistant Professor in the Department of Emergency Medicine, St. Louis University School of Medicine (a Level 1 Trauma Center). Dr. Stein has practiced Emergency Medicine for 29 years and Critical Care / Intensive Care Medicine for 27 years. For 20 years, Dr. Stein was an Emergency Physician at St. Anthony's Medical Center of St. Louis, one of the busiest emergency departments in the State of Missouri.

Dr. Stein has extensive experience in providing medical-legal expert services, having reviewed over 500 cases (both plaintiff and defense) and having given testimony over 200 times. Dr. Stein furnishes an unbiased opinion on medical malpractice/negligence cases. He also provides medical opinion concerning causation. Dr. Stein does not guarantee a favorable outcome but provides an honest assessment.

Dr. Stein has lectured nationally, and consults in the area of Pharmaceutical and Biomedical Product Development and Marketing.

Dr. Stein reviews cases (for both Plaintiff and Defense) of alleged Medical Malpractice / Negligence in areas including:

• Emergency Medicine        
• Critical Care Medicine / Intensive Care Medicine          
• Internal Medicine

Services provided include:

• Medical chart review and analysis   
• Providing opinion concerning the presence or absence of Negligence / Breach of the Standard of Care, Damages / Injury and Causation
• Survey of case for merit 
• Preparation of reports and / or affidavits        
• Preparation for opposing expert deposition and cross-examination        
• Medical literature search    
• Expert witness testimony at deposition and trial

Call 314-495-7009 for a complete CV, including presentations.

Elite Medical Experts works with attorneys to provide 100% Board-Certified physicians and surgeons practicing at the professorial level at the nation's leading universities. From Stanford to Yale, and from every medical and surgical specialty, Elite secures full-time practicing high-level experts from the nation’s most respected medical institutions. Each specialist is truly unique – a Board Certified professor with a dedicated clinical practice, extensive publications, and top-tier credentials from a major U.S. medical center. 

Complex Consulting at the Intersection of Medicine & Business
Elite Medical Experts also consults on complex strategic and tactical issues for enterprises of any size, and has extensive experience securing top-tier Professors of Medicine and Surgery for a range of complex consulting engagements. Elite Medical Experts is mission-critical to:

Corporate Consulting Occupational Health Special Projects Product Development Legislative Issues FDA Navigation Television, Film, Print News, and Other Media

FTC Rules and Regulations Lobbying Intellectual Property Focus Groups and Due Diligence Keynote Addresses, Endorsements Executive Search for Strategic Advisors, Directors, and Board Members Device & Drug Insight for Hedge Funds and Private Equity

To learn how you can align with nationally recognized thought leaders from myriad areas of expertise, call Elite today and ask for our Director of Complex Consulting:

Dr. Burton Bentley II, M.D., FAAEM
CEO, Elite Medical Experts, LLC.

View Elite Medical Experts' Expert Witness Profile.

Peter Crosby has over 45 years experience in the medical device industry. He has served as CEO of six medical device companies in four countries (public and private), and brought many products to the world market through clinical trials and regulatory approval.

Through Biomedical Business Resources LLC, he provides many services including:

• Advisory - helping clients with strategy, operations, execution, and business building\
• Mentoring, especially first time CEOs
• Expert Witness - assisting attorneys with multiple expert reports, depositions, and testimony at trial and arbitration. Cases include disputes about intellectual property , product liability, and commercial contracts
• Board Services - offering Independent Board Member services for companies, public or private, with experience in building companies, and helping management teams in times of high growth and rapid change

Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostimulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.

View Peter Crosby's Expert Witness Profile.

ATech Designs, Inc. is a five-time award winning Product Development, Design and Consulting company. They have worked with clients in many different fields of work including the Medical Product Device Design and Development industry. The types of medical products ATech Designs, Inc. has developed include medical disposables, medical devices, laparoscopic devices, anastomotic connectors, catheters, intravenous (IV) devices, mitral valve repair devices, non-invasive surgical instruments, and knitted multi-pole pockets for RF endometrial ablation. Services Include:

Product Design and Development Machine Design Polymer Selection Detail Drafting Finite Element Analysis (FEA) Manufacturing FACTTM Molding

Product Assembly Product Testing Root Cause Analysis / Dynamic Mechanical Analysis Animal Studies Clinical Studies Expert Court Witness Design Prototyping

Karl R. Leinsing, MSME, PE, President of Atech Designs, Inc., is a Professional Mechanical Engineer who specializes in Medical Device Product Development from concept to production. Mr. Leinsing has been granted over 20 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, knitting machines) and excels in solving the most complicated problems and design challenges. The winner of five design awards, Mr. Leinsing is recognized as one of the top 100 medical device professionals in the nation by MD&DI. For dedication to his industry, he was made the 2014 Chairman of the Medical Device and Manufacturing Conference in Anaheim, CA. Mr. Leinsing has also been acknowledged for his work in a publication by Life Magazine.

View Karl Leinsing's Expert Witness Profile.