Expert Witnesses in Medical Devices

Biomedical Engineering Consultants, LLC

Houston, Texas
1111 Hermann Drive, Suite 12 B, 77004

Contact: David Yadin, P.E., Ed.D., C.C.E., C.N.A.F.E.
http://www.biomedeng.com
713-522-6666 Or Toll Free
david@biomedeng.com

Biomedical Engineering Consultants, LLC

1111 Hermann Drive, Suite 12 B
Houston, Texas 77004

Contact: David Yadin, P.E., Ed.D., C.C.E., C.N.A.F.E.
http://www.biomedeng.com
713-522-6666
david@biomedeng.com

Over the past 35 years, Dr. David has developed, directed and taught healthcare life cycle technology management focusing on risk mitigation of medical devices and of their accessories.

Dr. David's expertise includes successful completion of close to two hundred adverse events investigations associated with medical and surgical and telehealth products, dozens of depositions and court testimonies as a qualified expert.

Dr. David established award-wining hospital-based technical services program and regulatory compliance knowledge supported by experience, licensure as register professional engineer in Texas, certification in clinical engineering and in the field of forensic engineering and technology. Biomedical Engineering Consultants, LLC (BEC) provides expert services in the safe and effective management of healthcare technology throughout its life cycle from development through obsolesce. As a member of the FDA advisory panel and of standards writing bodies, BEC brings unique expertise with regulatory and compliance requirements to hospitals, industry, service providers, and the legal professional.

Information:

Accident Investigations, Biomedical Engineering, Failure Analysis, Medical Devices, Patents, Product Liability, Product Warnings, Telemedicine,

Over the past 35 years, Dr. David has developed, directed and taught healthcare life cycle technology management focusing on risk mitigation of medical devices and of their accessories.

Dr. David's expertise includes successful completion of close to two hundred adverse events investigations associated with medical and surgical and telehealth products, dozens of depositions and court testimonies as a qualified expert.

Dr. David established award-wining hospital-based technical services program and regulatory compliance knowledge supported by experience, licensure as register professional engineer in Texas, certification in clinical engineering and in the field of forensic engineering and technology. Biomedical Engineering Consultants, LLC (BEC) provides expert services in the safe and effective management of healthcare technology throughout its life cycle from development through obsolesce. As a member of the FDA advisory panel and of standards writing bodies, BEC brings unique expertise with regulatory and compliance requirements to hospitals, industry, service providers, and the legal professional.

mdi Consultants, Inc.

Great Neck, New York
55 Northern Blvd. , 11021

Contact: Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001 Or Toll Free
alan@mdiconsultants.com

mdi Consultants, Inc.

55 Northern Blvd.
Great Neck, New York 11021

Contact: Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001
alan@mdiconsultants.com

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 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)

Information:

Food Manufacturing, Food Safety, Food Service, Medical Devices, Pharmaceuticals, Product Liability, Product Warnings,

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 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)

David C. Gross, PhD, PE

West Lafayette, Indiana
1330 Win Hentschel Blvd, 47906

Contact: David C. Gross, PhD, PE
medinstitute.com
765-404-4692 Or Toll Free
dgross@medinstitute.com

David C. Gross, PhD, PE

1330 Win Hentschel Blvd
West Lafayette, Indiana 47906

Contact: David C. Gross, PhD, PE
medinstitute.com
765-404-4692
dgross@medinstitute.com

Cell: 765-404-4692

David Gross, PhD, PE, is the Director of MRI Safety Evaluations and Engineering Simulations at MED Institute. 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.

Information:

Accident Analysis, ANSI Standards, Biomechanics, Biomedical and Biomechanical Injury Analysis, Biomedical Engineering, Electromagnetic compatibility (EMC), Failure Analysis, Intellectual Properties, Medical Devices, MRI, Product Failure Determination, Product Liability,

Cell: 765-404-4692

David Gross, PhD, PE, is the Director of MRI Safety Evaluations and Engineering Simulations at MED Institute. 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.

Polymer Testing of St. Louis, Inc.

Climax Springs, Missouri
44 Alley Lane, 65324

Contact: Stephen J. Callan
polymertesting.com
636-394-1480 Or Toll Free
polymertesting@msn.com

Polymer Testing of St. Louis, Inc.

44 Alley Lane
Climax Springs, Missouri 65324

Contact: Stephen J. Callan
polymertesting.com
636-394-1480
polymertesting@msn.com

Stephen J. Callan's CV

Thirty seven year career in Polymer Chemistry. Founder, President & Technical Director of Polymer Testing of St. Louis, Inc. since 1989. Personally conducted more than 3,000 Military and Industrial Failure Analyses. Mr. Callan has had a twenty six year career as an Expert Legal Witness. He has been used as an Expert Legal Witness in more than 50 cases involving Product Failure, Medical Malpractice, Pharmaceutical Contamination, Violation of FDA regulations, Failure to Warn, Fire, Explosion, Chemical Exposure, Personal Injury, Death, Murder, Environmental Contamination, Patent Infringement and IP theft. He has testified in State Court, State Supreme Court and Federal Court. Mr. Callan has been used as an Expert in Polymer Chemistry/Materials Analysis/Failure Analysis & Reverse Engineering by 64 Independent Testing Laboratories, 35 Automotive Component Manufacturers, 26 Coatings/Adhesives Manufacturers, 30 Composite/Aerospace/Military Manufacturers, 12 Environmental/Agricultural Product Manufacturers, 20 Packaging Manufacturers, 14 Electronics Manufacturers, more than 260 Plastic Manufacturers/Raw Material Suppliers, The U.S. Navy, The U.S. Army and NASA. EDUCATION B.S. Analytical Chemistry/Physics - Southwest Missouri State University M.S. Polymer Chemistry - University of Missouri Rolla (Missouri Science & Technology) M.S. Engineering Management - University of Missouri Rolla (Missouri Science & Technology) PRIMARY AREA OF EXPERTISE Military and Industrial Failure Analysis Product Contaminant Identification Reverse Engineering Expert Legal Testimony

Information:

Chemicals, Chemistry, Coatings, Sealants, and Paints, Construction Claims, Corrosion Engineering, Failure Analysis, Forensic Chemistry, Forensic Engineering, Intellectual Properties, Materials Science, Medical Devices, Personal Injury, Plastics, Product Failure, Product Warnings, Roofing and Waterproofing, Structural Failure,

Stephen J. Callan's CV

Thirty seven year career in Polymer Chemistry. Founder, President & Technical Director of Polymer Testing of St. Louis, Inc. since 1989. Personally conducted more than 3,000 Military and Industrial Failure Analyses. Mr. Callan has had a twenty six year career as an Expert Legal Witness. He has been used as an Expert Legal Witness in more than 50 cases involving Product Failure, Medical Malpractice, Pharmaceutical Contamination, Violation of FDA regulations, Failure to Warn, Fire, Explosion, Chemical Exposure, Personal Injury, Death, Murder, Environmental Contamination, Patent Infringement and IP theft. He has testified in State Court, State Supreme Court and Federal Court. Mr. Callan has been used as an Expert in Polymer Chemistry/Materials Analysis/Failure Analysis & Reverse Engineering by 64 Independent Testing Laboratories, 35 Automotive Component Manufacturers, 26 Coatings/Adhesives Manufacturers, 30 Composite/Aerospace/Military Manufacturers, 12 Environmental/Agricultural Product Manufacturers, 20 Packaging Manufacturers, 14 Electronics Manufacturers, more than 260 Plastic Manufacturers/Raw Material Suppliers, The U.S. Navy, The U.S. Army and NASA. EDUCATION B.S. Analytical Chemistry/Physics - Southwest Missouri State University M.S. Polymer Chemistry - University of Missouri Rolla (Missouri Science & Technology) M.S. Engineering Management - University of Missouri Rolla (Missouri Science & Technology) PRIMARY AREA OF EXPERTISE Military and Industrial Failure Analysis Product Contaminant Identification Reverse Engineering Expert Legal Testimony

Bowley Inc.

Sunnyvale, California
773 E. El Camino Real Suite 151, 94087

Contact: Dr Susan M Bowley, Ph.D.
www.bowleyconsulting.org
800-273-5170 Or Toll Free
bowleyconsulting@gmail.com

Bowley Inc.

773 E. El Camino Real Suite 151
Sunnyvale, California 94087

Contact: Dr Susan M Bowley, Ph.D.
www.bowleyconsulting.org
800-273-5170
bowleyconsulting@gmail.com

Bowley Inc. is a family company and a small woman-owned engineering firm.

Susan M. Bowley, Ph.D. has been a practicing engineer since 1988. Dr. Bowley grew up in Ashford, CT and completed her B.S. in Mechanical Engineering at the University of Connecticut. She then started her professional engineering career at NASA Ames Research Center in Northern California where she worked in various capacities for over 13 years. While at NASA, Dr. Bowley earned her M.S. in Mechanical Engineering at Stanford University with a concentration in Thermosciences, including completion of an independent research study on Transpired Epidermal Water Loss in Premature Infants.

After competitive selection for a NASA Full-time Graduate Study Fellowship, Dr. Bowley earned her Ph.D. in Biomedical Engineering at the University of Virginia. Her Doctoral Dissertation, with the help of a grant awarded by the National Osteoporosis Foundation, consisted of two human research studies to investigate the effect of physical activity on bone density in humans. Dr. Bowley then completed a Post-Doctoral Fellowship at the Food and Drug Administration where she studied blood hemolysis via mechanical fragility of red blood cells in various medical devices.

After completing her Post-Doctoral research, Dr. Bowley served as a lead medical device reviewer at the FDA in the Cardiovascular Division for over 3 years, including serving on the ASTM F04.30.06 Task Group as Co-Chair. Dr. Bowley has also served as a faculty member at multiple universities where she has developed her own courses.

Since leaving the FDA, Dr. Bowley has been working as a Forensic Expert Witness and Medical Device Consultant. In 2008, Dr. Bowley started her own engineering consulting firm. Corporate offices are located in Connecticut (HQ), Maryland, and Northern California. Dr. Bowley also worked at the Consumer Product Safety Commission (CPSC), U.S. Patent and Trademark Office (USPTO), and Transportation Security Administration (TSA). Dr. Bowley teaches Engineering courses at local Universities and Community Colleges.

We specialize in:

• Mechanical and Biomedical Engineering
• Injury Causation Biomechanics & Personal Injury
• Consumer Product Liability
• Medical Product Liability
• Medical Device Regulatory Affairs
• Slip, Trip & Falls
Accident Reconstruction:
* Auto, Motorcycle, Bicycle, Pedestrian, Railroad, Marine, and Aviation
• 3D Laser Scanning and Drone Aerial Mapping
• Premises Liability
• Criminal Cases & Shooting Reconstruction
• Patent Infringement
• Engineering Analysis/R&D/FEA
• Training & Mentoring

Other US Offices:

773 E. El Camino Real Suite 151
Sunnyvale, CA 94087

325 Ellington Blvd. Suite 156
Gaithersburg, MD 20878

Information:

Biomechanics, Biomedical and Biomechanical Injury Analysis, Mechanical Engineering, Medical Devices, Premises Liability, Product Liability,

Bowley Inc. is a family company and a small woman-owned engineering firm.

Susan M. Bowley, Ph.D. has been a practicing engineer since 1988. Dr. Bowley grew up in Ashford, CT and completed her B.S. in Mechanical Engineering at the University of Connecticut. She then started her professional engineering career at NASA Ames Research Center in Northern California where she worked in various capacities for over 13 years. While at NASA, Dr. Bowley earned her M.S. in Mechanical Engineering at Stanford University with a concentration in Thermosciences, including completion of an independent research study on Transpired Epidermal Water Loss in Premature Infants.

After competitive selection for a NASA Full-time Graduate Study Fellowship, Dr. Bowley earned her Ph.D. in Biomedical Engineering at the University of Virginia. Her Doctoral Dissertation, with the help of a grant awarded by the National Osteoporosis Foundation, consisted of two human research studies to investigate the effect of physical activity on bone density in humans. Dr. Bowley then completed a Post-Doctoral Fellowship at the Food and Drug Administration where she studied blood hemolysis via mechanical fragility of red blood cells in various medical devices.

After completing her Post-Doctoral research, Dr. Bowley served as a lead medical device reviewer at the FDA in the Cardiovascular Division for over 3 years, including serving on the ASTM F04.30.06 Task Group as Co-Chair. Dr. Bowley has also served as a faculty member at multiple universities where she has developed her own courses.

Since leaving the FDA, Dr. Bowley has been working as a Forensic Expert Witness and Medical Device Consultant. In 2008, Dr. Bowley started her own engineering consulting firm. Corporate offices are located in Connecticut (HQ), Maryland, and Northern California. Dr. Bowley also worked at the Consumer Product Safety Commission (CPSC), U.S. Patent and Trademark Office (USPTO), and Transportation Security Administration (TSA). Dr. Bowley teaches Engineering courses at local Universities and Community Colleges.

We specialize in:

• Mechanical and Biomedical Engineering
• Injury Causation Biomechanics & Personal Injury
• Consumer Product Liability
• Medical Product Liability
• Medical Device Regulatory Affairs
• Slip, Trip & Falls
Accident Reconstruction:
* Auto, Motorcycle, Bicycle, Pedestrian, Railroad, Marine, and Aviation
• 3D Laser Scanning and Drone Aerial Mapping
• Premises Liability
• Criminal Cases & Shooting Reconstruction
• Patent Infringement
• Engineering Analysis/R&D/FEA
• Training & Mentoring

Other US Offices:

773 E. El Camino Real Suite 151
Sunnyvale, CA 94087

325 Ellington Blvd. Suite 156
Gaithersburg, MD 20878