We offer a variety of services including Biomedical and Clinical Engineering, as well as forensic investigations to include search, recovery, and identification of remains. Click here to see how we can be of service to you.

 

I am an attorney who specializes in representing victims of injuries caused by defective medical devices. I have found Dr. Barkalow knowledge, skill, experience and training invaluable in determining the biomedical engineering causes of various medical device product failures. My experience with Dr. Barkalow includes both biomedical engineering analysis and testimony at trial, deposition and a Daubert hearing. I have always found his work to be unbiased and appropriately focused on the engineering and scientific aspects of the case. Dr. Barkalow is effective at communicating complex biomedical engineering facts and opinions and I endorse his involvement in any biomedical engineering matters.

 

Meet Our Staff

Bruce H. Barkalow, Ph.D., PE, CCE

Bruce Barkalow is the President and Senior Clinical Engineering Expert Consultant for B. H. Barkalow, PC. He has forty years of experience as a Biomedical Engineer, having served as Department Head of Biomedical Engineering for Sutter Community Hospitals in Sacramento, California; as a consultant to the Harvard Medical Center; and as an expert for ECRI. Dr. Barkalow is a registered Professional Engineer, Electrical Engineer, and Safety Engineer, as well as a Certified Clinical Engineer.

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James D. Maatman, B.A.

James Maatman serves as a Regulatory Expert Consultant for B. H. Barkalow, PC. Mr. Maatman has over twenty years of experience in the medical device field. Prior to joining B. H. Barkalow, PC he held a leadership position at Michigan Instruments, Inc., a manufacturer of medical devices related to the fields of cardiopulmonary resuscitation and human lung simulation. He also served as a senior regulatory consultant with R.M. Baldwin, Inc. Mr. Maatman’s expertise includes:  FDA and ISO13485 Quality System requirements, CAPA implementation and evaluation, 510(k) submissions, and compliance assessment.

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Sean J. Kirkpatrick, Ph.D.

Sean Kirkpatrick serves as a Biomedical Engineering Expert Consultant for B. H. Barkalow, PC. Dr. Kirkpatrick has twenty years of experience in the field of biomedical engineering. His primary area of research is biomedical optics, with a specialization in the biophysical applications of light scattering. He is especially interested in the theory and application of the laser speckle phenomenon, along with other features of coherent imaging.

Dr. Kirkpatrick received a Bachelor of Science Degree in Biology from Gannon University and a Doctor of Philosophy Degree in Biomechanics from the University of Miami, Coral Gables. He was also a post-doctoral fellow at Johns Hopkins University. Dr. Kirkpatrick serves as Professor and Chair of the Biomedical Engineering Department at Michigan Technological University.

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Alan K. Woelfel, M.D.

Alan Woelfel serves as a Senior Electrophysiology Expert Consultant for B. H. Barkalow, PC. Dr. Woelfel is a Cardiologist who is board certified in Internal Medicine, Cardiovascular Diseases, and Clinical Electrophysiology. He has over thirty-five years of experience in his field, clinical and academic. Dr. Woelfel has held director positions within several electrophysiology labs at North Carolina Memorial Hospital, and has served as Assistant Professor of Medicine at the University of North Carolina School of Medicine. He has numerous publications, primarily in the area of ventricular tachycardia, and is currently conducting research on both microvolt T wave alternans testing as well as molecular biomarkers for risk stratification of post myocardial infarction patients (MASTER and MAPP studies, respectively).
 
Dr. Woelfel received his Doctor of Medicine Degree from the University of Texas Southwestern Medical School. He conducted his internship and residency in Internal Medicine at North Carolina Memorial Hospital, and held two fellowships (Cardiovascular Disease and Clinical Electrophysiology) at the University of North Carolina School of Medicine.

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Theodore Cohen, MS, CCE, FACCE

Ted Cohen serves as a Clinical Engineering Expert Consultant for B. H. Barkalow, PC. Mr. Cohen is a Certified Clinical Engineer (CCE) and Fellow of the American College of Clinical Engineering (ACCE). He has more than thirty-six years of hospital-based experience in the field of clinical engineering, and served as Manager of Clinical Engineering at the University of California Davis Health System. Mr. Cohen served as an Adjunct Professor in Electronics Technology at American River College and both co-developed and co-taught a Biomedical Engineering Technician (BMET) education program for the local community college district. Mr. Cohen presently serves as a co-editor of the ACCE News.
 
Mr. Cohen is familiar with the design, application and uses of most FDA-regulated medical devices and technology. This includes such areas of application as for patient monitoring, surgery, clinical laboratory, cardiology, radiology, pulmonary (including respiratory therapy) as well as compliance with Joint Commission, CMMS and FDA standards and regulations. Mr. Cohen is familiar with, and has experience in, teaching application of medical devices for physicians, nurses, and technicians. Among his accomplishments and professional activities are a Lifetime Achievement Award from the American College of Clinical Engineering, serving as co-editor of ACCE News, and subject matter expert for the AAMI HTM Benchmarking Solutions and AAMI HTM Levels projects.
 
Mr. Cohen received a Bachelor of Science Degree in Electrical Engineering from UCLA, and a Master of Science Degree in Biomedical Engineering from California State University Sacramento. He is a nationally-recognized Clinical Engineer.

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Joseph M. Kissling, Jr., B.S.M.E.

Mr. Joseph Kissling provides technical support for B. H. Barkalow, PC investigations by means of engineering analysis, designs for incident simulations, and mathematical modeling to include assistance with graphic/animated presentations. He is experienced using programs such as SolidWorks, ANSYS, MATLAB, Mathematica, Scilab, and LaTex. Mr. Kissling holds a Bachelor of Science in Mechanical Engineering Degree from the University of Texas at San Antonio, and is a recent Master of Science graduate in Mechanical Engineering from Grand Valley State University.

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William E. Grant, M.A., M.L.I.S.

William Grant serves as a Forensic Anthropology Expert Consultant and as an Information Resource Manager. Mr. Grant has over ten years of experience as a practicing Forensic Anthropologist and over ten years of experience as a Medical Librarian and researcher. He holds two masters degrees, one in Anthropology from the University of Tennessee, Knoxville, and one in Library and Information Science from Wayne State University. Mr. Grant offers forensic anthropological assistance to local law enforcement agencies and county Medical Examiner systems, including search and recovery of human remains and skeletal analysis/identification. In addition, as Information Resource Manager, Mr. Grant serves as the case file coordinator, managing all aspects of cases to include medical literature reviews; case-related FDA database searches and summaries; deposition summaries; Bates document organization, searching, and extraction of relevant information; support with engineering reports including report initiation in Federal Rule 26 format with accompanying citations to assist associate experts with proper basis of opinions. He is also responsible for handling of case-related evidence and ensuring proper chain-of-custody procedures are maintained.

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Travis J. Barkalow, A.A.S.

Travis Barkalow is the Financial Manager for B. H. Barkalow, PC. He also maintains server files, test equipment and its calibration, as well as shipping and receiving. Mr. Barkalow has an Associate in Arts and Sciences Degree from Grand Rapids Community College with training in accounting. He supports both clients and associates with assistance with case file management, evidence handling, and assistance regarding medical device inspections.

 

 


Douglas Clink, B.S.

Douglas Clink serves as a Computer Animation Specialist for B. H. Barkalow, PC. He is a graphic designer and computer animator with over twenty-five years of graphic design experience. His work with our team is to graphically depict medical device failure scenarios related to current cases. Mr. Clink has an Associate in Arts Degree in Illustration from Lansing Community College, as well as a Bachelor of Science Degree in Technical Education from Ferris State University. Mr. Clink has been teaching graphic design and computer animation for over twenty-five years.

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Andrea M. Hodge, Ph.D.

Andrea Hodge serves as a Materials Science Engineering Expert Consultant for B. H. Barkalow, PC. Dr. Hodge is an Assistant Professor in the Department of Aerospace and Mechanical Engineering at the University of Southern California where she leads the Materials Nanotechnology group, which includes a physical vapor deposition processing lab and a nanomechanics lab. She is also the Philip and Cayley MacDonald Early Career Chair in the Department. Her research interests range from processing of nanocrystalline and nanoporous materials to nanomechanics of metals and biomaterials. Prior to her academic position, Dr. Hodge worked at Lawrence Livermore National Laboratory as a Staff Scientist.

 

Dr. Hodge received a Bachelor of Science Degree in Mechanical Engineering from the University of Nevada, Las Vegas, and a Doctor of Philosophy Degree in Materials Science from Northwestern University. She is an active member of The Minerals, Metals and Materials Society (TMS), the Materials Research Society (MRS), and the Society of Hispanic Professional Engineers (SHPE).

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Wojciech Z. Misiolek, Ph.D.

Wojciech Misiolek serves as a Senior Materials Science Engineering Expert Consultant for B. H. Barkalow, PC. Dr. Misiolek has over twenty years of experience in independent research project management and teaching in the field of materials science and engineering and is an internationally-recognized leader in the field of materials forming and processing. His research interests focus on deformation, powder and machining processes, along with applications for structural and bio-materials.
 
Dr. Misiolek received a Master of Science Degree and a Doctor of Science Degree in Metallurgy from AGH-University of Science and Technology in Krakow, Poland. He serves as Loewy Professor of Materials Forming and Processing, as well as Director of the Institute for Metal Forming at Lehigh University.

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Raymond A. Pearson, Ph.D.

Raymond Pearson serves as a Senior Materials Science Engineering Expert Consultant for B. H. Barkalow, PC. Dr. Pearson is a Professor of Materials Science and Engineering at Lehigh University, where he serves as Director of the Center for Materials Science and Engineering and the Microelectrics Packaging Materials Lab, as well as the Associate Dean for Graduate Studies and Research of the P.C. Rossin College of Engineering and Applied Science. Dr. Pearson has over twenty-five years of experience in the field of materials science and engineering. His research focuses on processing, deformation, yield, and fracture mechanisms of polymeric material; as well as adhesion and interfacial issues in microsystems packaging. He is also involved in developing polymeric materials for 3D printing. Dr. Pearson received a Bachelor of Science Degree in Chemistry from the University of New Hampshire, as well as a Doctor of Philosophy Degree in Materials Science and Engineering from the University of Michigan.

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