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I have consulted with Dr. Barkalow on several occasions regarding medical device issues for medical device manufacturers I represented in litigation. I have always found Dr. Barkalow to be extremely knowledgeable and informative, yet capable of explaining technical medical device issues in a fashion understood by layman. In each case where I have consulted with Dr. Barkalow, with his assistance, we have either been able to settle the matter on terms very favorable to us or prevail entirely through summary judgment. I would highly recommend Dr. Barkalow to anyone in need of his expertise

 

Meet Our Staff

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

Bruce Barkalow serves as a Senior Clinical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. He has forty years experience as a Biomedical Engineer having served as Department Head of Biomedical Engineering for Sutter Community Hospitals in Sacramento, California, and as a consultant to the Harvard Medical Center, ECRI, and most recently, President of B. H. Barkalow, PC. Dr. Barkalow is a registered Professional Engineer, Electrical Engineer, and Safety Engineer, as well as a Certified Clinical Engineer. With the establishment of B. H. Barkalow & Associates, LLC, Dr. Barkalow continues his work providing expert technical support for medical device-related issues, and also assists other associates on cases as needed.

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Alan Lipschultz, M.S., PE, CCE, CSP, CPPS

Alan Lipschultz serves as a Clinical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. Mr. Lipschultz is a Professional Engineer (PE), Certified Clinical Engineer (CCE) and Certified Safety Professional (CSP). During his nearly forty years of experience as a Clinical Engineer, he has served as Director of Clinical Engineering for two large hospitals on the east coast. Mr. Lipschultz is the co-chair of the AAMI (Association for the Advancement of Medical Instrumentation) Standards Board and serves on several other AAMI committees (BI&T Editorial Board, Electrical Safety, Infusion Device, Medical Device Alarm and Technology Management).  He also serves as Chair of the NFPA (National Fire Protection Association)'s Technical Committee on Medical Equipment; and is a member of the ACCE (American College of Clinical Engineering) Board of Directors.

 

Mr. Lipschultz received a Bachelor of Science Degree in Electrical Engineering from the University of Maryland, and both a Master of Science Degree in Electrical Engineering as well as a Certificate in Healthcare Technology (concentrating in biomedical engineering) from Washington University.

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Matthew F. Baretich Ph.D., PE, CCE

Matthew Baretich serves as a Senior Clinical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. Dr. Baretich has over thirty years of clinical engineering and biomedical engineering experience. He has served as Director of Clinical Engineering for Children’s Hospital of the King’s Daughters as well as Director of Biomedical Engineering for the University of Colorado Health Sciences Center. He is a Certified Clinical Engineer (CCE), Certified Healthcare Facilities Manager (CHFM), as well as a Certified Professional in Healthcare Risk Management (CPHRM). Among Dr. Baretich’s credentials and professional activities are Founder and Past-President of the American College of Clinical Engineering and member of the World Health Organization’s Technical Advisory Group on Health Technology.

 

Dr. Baretich received a Bachelor of Science Degree in Electrical Engineering and a Master of Arts Degree in Biomedical Engineering from Iowa State University, as well as a Doctor of Philosophy Degree in Hospital and Health Administration from the University of Iowa.

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James D. Maatman, B.A.

James Maatman serves as a Regulatory Expert Consultant for B. H. Barkalow & Associates, LLC. Mr. Maatman has over twenty years of experience in the medical device field. Prior to joining B. H. Barkalow & Associates, LLC 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.

 

Mr. Maatman received a Bachelor of Arts Degree in English with minors in Math, Science, and Education, and has completed postgraduate studies in Library Science, Audiovisual Production, Business Administration, as well as Computer Programming. He is an experienced professional with a unique combination of business, training, management, and regulatory skills. Mr. Maatman has had a successful 40-year career as an educator, business owner, and administrator. His experience encompasses education, medical device manufacturing operations and regulatory affairs, administration, and quality assurance.

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Sean J. Kirkpatrick, Ph.D.

Sean Kirkpatrick serves as a Biomedical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. 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 & Associates, LLC. 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 & Associates, LLC. 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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Steven A. Rundell, Ph.D., PE

Steve Rundell serves as a Senior Biomedical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. Dr. Rundell has over ten years of experience with medical device failures; vehicle reconstructions; and incidents involving slips, trips, and falls. Along with conducting hundreds of investigations, he has performed extensive research in the areas of impact biomechanics, spine biomechanics, and failure analysis, and has published numerous peer-reviewed journal articles and abstracts. Dr. Rundell's areas of expertise include mechanical failure analysis, biomechanical analysis, and collision reconstruction.

 

Dr. Rundell received his Bachelor of Science and Master of Science Degrees in Mechanical Engineering from Michigan State University, as well as a Doctor of Philosophy Degree in Biomedical Engineering from Drexel University. He is a registered Professional Engineer in the states of Michigan, Illinois, and Florida.

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

Mr. Joseph Kissling provides technical support for B. H. Barkalow & Associates, LLC 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. Mr. Kissling is presently working on a Master of Science Degree in Mechanical Engineering from Grand Valley State University under a Fulbright Scholarship; he has completed his coursework and is near completion of his Master's Thesis.

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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 & Associates, LLC. 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.

 

Frank R. Painter, M.S., CCE

Frank Painter serves as a Senior Clinical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. Mr. Painter has over twenty-five years of clinical engineering and biomedical equipment service management experience. He has directed in-house programs at two large metropolitan teaching hospitals and managed two successful regional independent medical equipment service organizations. He is faculty member and Clinical Engineering Program Director in the Biomedical Engineering Graduate Program at the University of Connecticut. Mr. Painter is internationally recognized in the field of clinical engineering having published and presented on risk management, quality improvement, human factors engineering, technology assessment and technology management both nationally and internationally. He is actively involved in the profession, having been President of the American College of Clinical Engineering, Chairman of the US Board of Examiners for Clinical Engineering Certification and Chairman of the Healthcare Technology Certification Commission.

 

Mr. Painter received a Bachelor of Science Degree in Mechanical Engineering from Clarkson College of Technology and a Master of Science Degree in Mechanical and Biomedical Engineering from the State University of New York at Buffalo.

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Douglas Clink, B.S.

Douglas Clink serves as a Computer Animation Specialist for B. H. Barkalow & Associates, LLC. 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. He is presently working on a Master of Arts Degree in Graphic Design from Savannah College of Art & Design. 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 & Associates, LLC. 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 & Associates, LLC. 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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George Yanulis, D.Eng.

Dr. Yanulis serves as a Clinical Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. Dr. Yanulis is an experienced medical device Research & Development Engineer with over twenty years of experience with all types of cardiac implantable systems to include vascular stents, cardiac pacing devices, ventricular assist devices, cardiac echocardiography and electrophysiology devices, among others; physiological monitoring equipment; surgical devices; neurological therapy devices; and medical imaging systems. He is affiliated with a start-up medical imaging company, Integral ElectroMagnetronic Technologies, as a scientific advisor. Dr. Yanulis brings a solid understanding of all aspects of field research, pre-clinical trial implementation, product development, and FDA protocols and offers unique and valuable insights into product development from a variety of key perspectives. His work currently involves conscious testing of animal subjects for research studies related to the use and effectiveness of a novel cardiac pacing device. In his current role in the Departments of Cardiovascular Medicine and Biomedical Engineering at the Cleveland Clinic’s Lerner Research Institute, he provides preoperative and postoperative monitoring and care of test subjects. He also monitors and collects data during the surgical implantation of pacing devices and is working to determine the efficacy of a new stimulation paradigm as sustained therapy for chronic heart failure with or without atrial fibrillation. He is currently studying for the International Board of Heart Rhythm Examiner's Allied Professional Cardiac Electrophysiology Examination.

 

Dr. Yanulis earned a Bachelor of Science Degree in Chemistry from Syracuse University, a Master of Engineering Degree in Biomedical Engineering from the University of Virginia, a Master of Science Degree in Bioengineering from the University of Pittsburgh, and a Doctor of Engineering Degree in Biomedical Engineering from Cleveland State University.

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Larry Fennigkoh, Ph.D., PE, CCE

Larry Fennigkoh is a Clinical Engineering Fact Expert for B. H. Barkalow & Associates, LLC. Dr. Fennigkoh is a biomedical and electrical engineer who has investigated numerous injuries--especially shocks, burns, fires, and deaths--associated with a variety of medical and non-medical electrical devices. Having worked in hospitals for over 20 years, he understands not only the pathophysiology of such injuries, but the many ways in which they may be caused as well. Dr. Fennigkoh is also capable of testing and evaluating medical and electrical devices, tools, and appliances; residential and commercial electrical wiring and grounding systems; ground-fault circuit interrupters; and isolated power systems.

 

Currently, Dr. Fennigkoh is a professor of biomedical engineering at the Milwaukee School of Engineering teaching graduate and undergraduate courses in medical instrumentation, biomedical engineering design, biomechanics, biostatistics, and human physiology. He is a Registered Professional Engineer and board certified in clinical engineering. He is also a member of the Institute of Electrical and Electronic Engineers, Engineering in Medicine and Biology Society, Association for the Advancement of Medical Instrumentation, American College of Clinical Engineering, and a Fellow within the American Institute for Medical and Biological Engineering. Dr. Fennigkoh received the Bachelor of Science (Electrical Engineering Technology) and Master of Science (Engineering Management) Degrees from the Milwaukee School of Engineering, as well as a Doctor of Philosophy Degree in Industrial Engineering (human factors and biomechanics) from the University of Wisconsin, Milwaukee.

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Raymond A. Pearson, Ph.D.

Raymond Pearson serves as a Senior Materials Science Engineering Expert Consultant for B. H. Barkalow & Associates, LLC. 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 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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