Biomedical Engineering Expert Witness

UNDERGRADUATE EDUCATION:
1969-1972 “Technion” – Israel Institute of Technology Associate in Science Major: Electrical Engineering
1972-1974 West Virginia University, Morgantown, W. Virginia, B.Sc. Electrical Engineering

GRADUATE EDUCATION:
1974-1975 West Virginia University – M.Sc. Electrical Engineering – Focus in Biomedical Sciences
1979-1983 School of Graduate Studies at West Virginia University

– Inter-Disciplinary Doctorate Program

– Doctorate Education Psychology

CERTIFICATION AND REGISTRATION:

2008- Present Principal, Biomedical Engineering Consultants, L.L.C., Houston, Texas.
2018 – Board Certified Diplomate in Forensic Engineering – The National Academy of Forensic Engineers
2004 – Certified in Clinical Engineering – Healthcare Technology Commission (HTC)
1999 – Fellow of the American Board of Forensic Engineering and Technology, The American College of Forensic Examiners Institute
1989 – Certified Clinical Engineer (C.C.E.) – The International Certification Commission (ICC)
1985 – Registered Professional Engineer in Biomedical Engineering, (P.E.), State of Texas Registration
1981 – 2008 International Health Care Safety Professional (C.H.S.P.), Board Executive Level

PROFESSIONAL EXPERIENCE:

2018 – Board Certified Diplomate in Forensic Engineering – The National Academy of Forensic Engineers –
2004 – Certified in Clinical Engineering – Healthcare Technology Commission (HTC)
1999 – Fellow of the American Board of Forensic Engineering and Technology, The American College of Forensic Examiners Institute –
1989 – Certified Clinical Engineer (C.C.E.) – The International Certification Commission (ICC)
1985 – Registered Professional Engineer in Biomedical Engineering, (P.E.), State of Texas Registration
1981 – 2008 International Health Care Safety Professional (C.H.S.P.), Board Executive Level.
2008- Present Principal, Biomedical Engineering Consultants, L.L.C., Houston, Texas.
2018- Present Editor-in-Chief, Global Clinical Engineering Journal
2017- Present Capital Medical University School of Biomedical Engineering, Honorary Director
2016- Present Chinese Society of Clinical Engineering, Overseas Advisor
2016- Present Medical Bridges Advisory Council, member
2016- 2018 Inner Mongolia People’s Hospital, Visiting Professor
2015- 2018 Associate editor, IFMBE/International Journal of Clinical Engineering & Health Technology Assessment (CEHTA).
2022- Present Chairman, Device Good Manufacturing Practice Advisory Committee, Food and Drug Administration (FDA), Department of Health & Human Services, Silver Spring, Maryland.
2018 – 2021 Consultant, Device Good Manufacturing Practice Advisory Committee, Food and Drug Administration (FDA), Department of Health & Human Services, Silver Spring, Maryland.
2014- 2018 Chairman, Device Good Manufacturing Practice Advisory Committee, Food and Drug Administration (FDA), Department of Health & Human Services, Silver Spring, Maryland.
2014- 2017 Judge, Medical Device Design Excellence Award, UBM Canon,
2013-Present Member, Past Chairman, Health Technology Training Group (HTTG), International Union for Physical and Engineering Sciences in Medicine (IUPESM).
2011- Present Editorial Board Member, Journal on Health and Technology, Springer, New York, NY, USA.
2009 – 2016 Interim CEO, Canopy Edge, Inc., Houston, Texas.
2008-Present Asst. Professor (adj.), University of Texas, School of Public Health, Houston, Texas.
2008- 2015 Editorial Board advisor, Biomedical Safety & Standards, Philadelphia, Pennsylvania. 2006-Present Board member and past Chairman, Clinical Engineering Division, International
Federation of Medical and Biological Engineering (IFMBE).
2002-2008 Senior Biomedical Research Service Credentials Reviewer, Food and Drug Administration, Rockville, Maryland.
2003- 2012 Adj. Professor, Biomedical Engineering Program, Health Sciences Division, Technologico De Monterrey School of Biotechnology and Health, Mexico.
1993- 2008 Advisor, World Health Organization (WHO/PAHO) – Healthcare Infrastructure and Technology, Washington, DC.
1993- 2016 Consultant, General Hospital and Personal Use Devices Panel, Center for Devices and Radiological Health, Food and Drug Administration (FDA), Department of Health & Human Services, Rockville, Maryland.
1987-2010 Assistant Professor (Adj.), Department of Pediatrics, Baylor College of Medicine, Houston, Texas.
1982- 2008 Director, Biomedical Engineering Department, Texas Children’s Hospital, Houston, Texas.
1976- 2008 Advisor, Biomedical Engineering Consultant, Houston, Texas.
2004- 2007 Member, Advisory Board Mobile Aspects Corporation, Pittsburgh, Pennsylvania.
2004 -2006 Judge, Medical Design Excellence Awards, Canon Communications, www.MDEAwards.com.
1998- 2005 Advisor, ORBIS’ International Program Advisory Council (IPAC).
1996- 2005 President, Center for Telemedicine Law (CTL), Washington, D.C.
1982- 1996 Director, Biomedical Engineering Department, Texas Children’s Hospital/ St. Luke’s Episcopal Hospital/Texas Heart Institute, Houston, Texas.
1998- 2001 Director, Center for TeleHealth, Texas Children’s International, Houston, Texas.
1994 Consultant, Department of Health & Human Services, Food and Drug Administration (FDA), Neurological Devices, Washington, D.C.
1991-2000 Advisor, NASA Technology Applications Team, Biomedical Advisory Group, Houston, Texas.
1984-1999 Associate Professor (Adj.), University of Texas Health Sciences Center at Houston, Department of Anesthesiology, Houston, Texas.
1998 Advisor, Orthopedics and Rehabilitation Devices Advisory Panel, Food and Drug Administration (FDA), Rockville, Maryland.
1984-1986 Lecturer, Baylor College of Medicine, Department of Community Medicine, Houston, Texas.
1982-1987 Director, Biomedical Instrumentation Department, St. Luke’s Episcopal Hospital/Texas Children’s Hospital/Texas Heart Institute, Houston, Texas.
1979-1982 Research Assistant Professor, Department of Anesthesiology, West Virginia University School of Medicine, Morgantown, West. Virginia.
1976-1982 Director, Biomedical Engineering Section, West Virginia University Hospital, Morgantown, West Virginia.
1976-1979 Research Instructor, Department of Anesthesia, West Virginia University Hospital, Morgantown, West Virginia.
1975-1976 Design Engineer, Rockwell International, Collins Radio Division, Cedar Rapids, Iowa.
1974-1975 Research Assistant (Part Time), W.V.U. Department of Physiology and Biophysics (American Heart Association Grant).
1974-1975 Fulfilled the M.Sc. Degree requirements – Animal Research Investigation of New Pacemaker Electrode Design with Dr. T. J. Tarnay, M.D. Division of Thoracic Surgery – W.V.U. School of Medicine.
1974-1975 Instructor, Electrical Engineering Department, W. Virginia University College of Engineering.
1973-1974 Orderly, Operating Room, West Virginia University (W.V.U.), Medical Center, Morgantown, West Virginia.
1969-1972 Senior Electrical Technician, Advanced Systems, Design, Testing and Simulation, “Armament Authority Development,” Israel.

PROFESSIONAL SOCIETIES AND COMMITTEE MEMBERSHIPS:

Healthcare Technology Foundation (HTF)
– President Emeritus – (2008-Present)
– Founder, President – (2002-2006)

Biomedical Advisory Committee (BAC) – Chairman, (2003-2014), member (2015-2016) National

Fire Protection Association – (N.F.P.A.) – Technical Committee on:
– Health Care Facilities (NFPA-99) sections on:
– Medical Gas Delivery Systems – Chairman (2002- 2008)
– The Safe Use of Electrical Equipment (2) Medical Gases (1977 – 2010).
– Laser Safety Committee (NFPA-115) – Chairman – (1998-2008), member (2015-2019).

Association for the Advancement of Medical Instrumentation – (A.A.M.I.)
– Application of Quality Systems to Medical Device Data Systems Working Group (MDDS/QS) – Co- Chairman/member (2011-Present)
– Uniformed Terminology and Taxonomy Initiative – Chairman (2008-2012)- Electro Magnetic Compatibility (EMC) Committee (1998-Present).
– Electrical Safety Committee (1995-Present).
– Education Committee (1985).

National Society of Professional Engineers (NSPE) (1985- 2006, 2017-present). Texas Society of Professional Engineers (NSPE-TX) (2017- present).
National Academy of Forensic Engineers (NAFE), Senior member (2018) National Forensic Center Distinguished Expert (1987-2017).
American College of Clinical Engineering (ACCE)
– Healthcare Technology Foundation – Founder & 1st President (2002-present)
– Bylaws Review Committee – Chairman (2001)
– Elected Fellow (1999)
– Nominations Committee Chairman (1993)
– Charter member (1990)
– Founder & 1st President (1990)

Biomedical Engineering Advisory Council – Texas A&M University, Charter Member, (1998-2008).

Journal of Medical Engineering and Physics – Elsevier Science – Editorial Review Board (1995-2008).

Journal of Health & Technology – Springer – Editorial Review Board National Recall Alert Center – Charter Member (1991-2008).
Center for Telemedicine Law (CTL) – Charter member, 1st President (1996-2004).

Engineering in Medicine and Biology Society – (E.M.B.S.):
– Annual International Conference – Technical Program Committee (2002-2009).
– Technical Committee on Clinical Engineering – Chairman (1982-86, 1990-94, 2002-06).
– Co Chairman of the Pittsburgh Section (1982 – 1983).

American Institute of Biological Sciences (AIBS) and the United States Army Research and Material Command (USAMRMC), Peer Review Panel on the “Defense Women’s Health (DWH) Research Programs,” Baltimore, Maryland, – Scientific Grant Reviewer (1999).

American Society for Healthcare Engineering (ASHE)
– TeleHealth Committee (1996-2000).
– Clinical Engineering and Technology Management Committee (1993-1997).

International Federation of Medical and Biological Engineering (IFMBE)
– Clinical Engineering division chairman (2008-2011)
– Clinical Engineering Division Board member (2008-present)

International Union for Physical and Engineering Sciences in Medicine (IUPESM)
– Health Technology Task Group (2013- present), Chairman (2016-2019)

United States – Israel Science and Technology Commission, BiNational Committee (1996-2000).

Association of Field Service Managers International – (A.F.S.M.) (1995-2001).

Texas State Technical Institute – Biomedical Technology Program Adviser (1994).
American Heart Association-Texas Affiliate-Research Allocations and Advisory Committee-Grant Application Reviewer (1993-1996).

The Institute of Electrical and Electronics Engineers (IEEE):
– Technology policy Committee, I.E.E.E./TAB, Washington, DC (1993-1995).
– Delegate to Technical Committee – NFPA 99 – Health Care Facilities.
– Standards Coordinating Committee Panel #18.
– Accreditation Board for Engineering Technology, Evaluator (ABET) (1988-1995).

Electrical/electronics, Biomedical and Instrumentation Engineering Technology
– Delegate – Health Care Engineering Policy Committee (HCEPC) (1986-1995).
– Chairman (1993-1995).
– National Fire Protection Association – Delegate (1977-1995).

American Institute of Medical and Biological Engineering (AIMBE) 
– Inducted Founding Fellow (1992)
– Founding Member (1992-present).

University of Houston, College of Architecture – The Health Environment Institute Advisory Board (1988-1995).

Joint Commission on Accreditation of Healthcare Organization (JCAHO)
– The Committee on Health Care Safety (1987-1993).

Society of Critical Care Medicine (S.C.C.M.) (1986-1997).
International Certification Commission for Clinical Engineering and Biomedical Technology (1986-1990).

Alliance for Engineering in Medicine and Biology, (A.E.M.B.)
– Education Committee Chairman (1986).
– Project Advisory Committee – Chairman (1984-1985).

American Society for Testing and Materials – (A.S.T.M.)
– Anesthetic & Respiratory Equipment F-29 – Committee Member (1983-1995).
Houston Community College (H.C.C.) – Program Advisor Electronics Technology (1982-1993).

West Virginia University (College of Engineering and School of Medicine)
– The Bioengineering Graduate Program Committee – Member (1981-1982)
– Advisor Biomedical Engineering Program.

HOSPITALS INSTITUTIONAL COMMITTEES
Chairman:
Facility and Equipment Safety Subcommittee (2000-2008, 1992-98).

Medical Technology Evaluation Committee (1989-2008).
Equipment and Facilities Committee (1998). Television and Audiovisual Committee (1987-1995).
Advisory Committee for the Administrative and Management Forum (1986-1987).

Co-Chairman:
Cardiac Care Unit Monitoring Equipment Committee (1987-1988).
Member:
Equipment and Facilities Committee (1999-2008).
Hospital Information Systems Advisory Committee (1997- 2008, 1988-1990).

Capital Budget Committee (1991-2008).
Cardiopulmonary Resuscitation Committee (1991-2004). Product Standardization and Utilization Committee (1990-2008).

Safety Committee (1982-2008).
Quality Assurance Committee (1989-1995).
Cardiac Catheterization Laboratory Construction Committee (1985-1989).

Laser Committee (1981-2004).
Risk Management Committee (1986-1989).

GRANTS AND RESEARCH: Available Upon Request. 

HONORS AND AWARDS: Available Upon Request. 

PROFESSIONAL ACTIVITIES: Available Upon Request. 

PUBLICATIONS AND PRESENTATIONS: Available Upon Request.