Medical Device Biomedical Engineer Expert Witness

 

PROFESSIONAL PROFILE

Technical medical device leader and development engineer with over 20 years experience in teaching and mentoring engineering students, medical device research, medical product research & development, industrial product development, medical device consulting and advancement of new innovative technologies in heart failure therapy devices. I have a successful record of identifying and developing talent by promoting team collaboration, while challenging individuals to exceed expectations. Extensive experience and proven success developing strategies and teams to drive medical product design and development.

Educational Background:

Doctorate in Engineering    Cleveland State University    2008
Biomedical Engineering    Cleveland, OH

Master of Science    University of Pittsburgh    2002
Bioengineering    Pittsburg, PA

Master of Engineering    University of Virginia    1981
Biomedical Engineering    Charlottesville, VA

Bachelor of Arts    Syracuse University    1977
Premedical Studies    Syracuse, NY

Professional Services:

01/2016 – Present: Temple University, Philadelphia, PA
Adjunct Professor, Bioengineering Engineering Department
•    Developed cardiac device and physiology course
•    Developed and delivered coursework in cardiac devices, cardiac imaging and cardiac physiology

11/2015 – Present: University of Pennsylvania, PA
Research Cardiovascular Device Development, University of Pennsylvania School of Veterinary
•    Research collaborative effort in cardiac device development
•    Developed and delivered coursework in bioinstrumentation design-related
•    Mentoring undergraduates in lecture and lab settings in the biomedical engineering program

06/2014 – Present: Private Company – President/Principal Engineer, Philadelphia, PA- Clinical Engineering/Medical Device Consultant Expert for hospitals, medical device companies, legal firms, and insurance carriers. Responsibilities consist of providing biomedical, clinical, and forensic engineering support to clients, that can include incident investigations, reports of findings, as well as expert witness testimony. Medical technology experience consists of familiarity with the design, use, and applications associated with a variety of medical devices and software used for: cardiac pacing, ventricular assist, cardiac echocardiography and electrophysiology, vascular stents, physiological monitoring, medical imaging, neurological therapy, surgery, among others.
Contracted by Therakos, Inc to consult on-site, West Chester, PA (6/15/14 – 7/18/14)
•    Utilized expertise in Risk Management to review and update FMEAs as was needed.
•    Reported and worked directly with the Research Director and Quality Engineering Personnel
•    Assessed production lines and determined where quality checks and controls were needed to be implemented.
•    Reviewed validations and documents in the Thoraces document management system and researched all materials that were applicable to the FMEAs
•    Utilized statistical process and control and test method validations to support the implementation of the required quality checks and process controls
•    Identified root cause and implemented effective solutions to prevent event recurrence.
•    Reviewed MDR(s), Complaint Investigations, CAPA(s), Non-conformance(S) and Change Control(s).
•    Analyzed and organized data from multiple sources in support of weekly updates and management review
•    Developed a Final Evaluation Report related to their current validation and verification tasks and provided recommendations as part of their submission to the FDA subsequent to a FDA site visit which had been approved by Therakos Research & Development and Quality Review Divisions

03/2014 – Present: B. H. Barkalow & Associates, LLC, Newaygo, MI. Clinical Engineering Expert Consultant for hospitals, medical device companies, legal firms, and insurance carriers.
Responsibilities consist of providing biomedical, clinical, and forensic engineering support to clients, that can include incident investigations, reports of findings, as well as expert witness testimony. Medical technology experience consists of familiarity with the design, use, and applications associated with a variety of medical devices and software used for: cardiac pacing, ventricular assist, cardiac echocardiography and electrophysiology, vascular stents, physiological monitoring, medical imaging, neurological therapy, surgery, among others.
Contracted by Expert Witness Institute, Inc. to consult on orthopedic implant device liability case (5/19/14-present-representing the plaintiff)
•    Utilized expertise in FDA Device Controls and Risk Management for total knee implant systems.
•    Reviewed 510K related to this specific knee implant system.
•    Reviewed MDR(s) and other adverse events related to implant device failure.
•    Working directly with Barkalow Engineering Personnel and legal support staff representing plaintiff
•    Assessed GCMP practices used for present implant system failures
•    Reviewed Total Knee Implant and Bone Cement validation and verification activities and document system and researched all materials that were applicable to liability case issues
•    Utilized statistical process and control and test method validations in investigation root cause of implant failure.
•    Reviewed MDR(s), Complaint Investigations, CAPA(s), Non-conformance(S) and Change Control(s).
•    Analyzed and organized data from multiple sources in support of weekly updates and management review.

08/2013 – 08/2014: Widener University, Chester, PA
Adjunct Assistant Professor, Biomedical Engineering Department
•    Developed biomedical engineering instrumentation course
•    Developed and delivered coursework in bioinstrumentation design-related
•    Mentoring undergraduates in lecture and lab settings in the biomedical engineering program
•    Involved in ABET certification preparation for students within the department

01/2013 – 12/2013: Stevens Institute of Technology, Hoboken, NJ
Adjunct Assistant Professor, Biomedical Engineering Program
•    Collaborated with Dr. Arthur Ritter (Professor) on the revisions of an existing biomedical engineering instrumentation course
•    Was responsible for the development and delivery of coursework in bioinstrumentation design courses
•    Mentored undergraduates in lecture and lab settings in the biomedical engineering program
•    Filed two provisional applications related to a novel innovative medical imaging technology

01/2011 – 08/2014: Integral ElectroMagnetronic Technologies
IEMT-Medical Imaging Consultant and Scientific Advisory Board Member
•    Development of preclinical device studies on a low-cost, low-power high-resolution medical imager with the accuracy of existing imaging technology
•    Co-development of two provisional applications with the U.S. Patent & Trademark Office related to the imaging technology related to a novel innovative medical imaging technology

11/2010 – Present: Laughlin Engineering Firm, LLC
Senior Medical Device Consultant, Forensics Engineering Division
•    Provided expertise to clients in the following areas: cardiac resynchronization devices, including both pacemaker devices and ICD devices from Medtronic, St Jude Medical, and Boston Scientific
•    Provided intellectual property advice on cardiac devices to patent attorneys and have provided expertise in the area of FDA device controls
•    Served as an expert witness on cardiac device failure-related cases

08/2009 – 12/2013: College of Staten Island, Staten Island, NY
Adjunct Assistant Professor
Engineering Science and Physics Department

10/2005 – 08/2008: Cleveland Clinic Foundation, Cleveland, OH
Post-Doctoral Associate and Research Assistant
•    Development of novel medical devices involving new cardiac pacing paradigms
•    Collaborated with the Data Science Corporation (DSI) on several projects that included advanced ECG signal detection and pressure-volume loop analysis
•    Performed cardiac device implants in the canine model
•    Performed physiological monitoring sessions post operatively
•    Cleveland Clinic’s Innovation Awards (research in the use of novel cardiac pacing paradigms for heart failure patients, co-developed by Don Wallick, Ph.D. & Expert 3660, 8/2007 and 10/2008)

08/2000 – 07/2002: University of Pittsburgh, Pittsburgh, PA
Research Assistant/Teaching Assistant
Department of Surgery/McGowan Institute of Regenerative Medicine
•    Development of a respiratory assist device using elastomeric polymers as actuators
•    Coordinated senior bioengineering design projects with different clinical mentors within the University of Pittsburgh

05/1999 – 06/2000: University of Pennsylvania Health System
Philadelphia, PA
Clinical Engineering Consultant

Additional Employment:

05/1997 – 06/1999: Drexel University
Philadelphia, PA
Research Assistant/Teaching Assistant

01/1995 – 08/1997: University of South Florida
Tampa, FL
Research Assistant

05/1992 – 12/1994: Sears
Birmingham, AL
Sales professional, Sears Business Systems Division

08/1990 – 1992: University of Alabama at Birmingham
Birmingham, AL
Research Assistant/Teaching Assistant

08/1989 – 08/1990: State University of New York at Upstate
Syracuse, NY
Research Assistant-Physiology Department
05/1987 – 2/1989: Clinical Engineer/1st Lt, Active Reserves
Malcolm Grow Medical Center, Malcolm Grow AFB, MD
Clinical Engineer/1st Lt

05/1985 – 05/1986: United States Navy, Philadelphia Naval shipyard
Philadelphia, PA
Logistics/Electronics Engineer

05/1982 – 08/1982: United States Patent Office
Crystal City, VA
Assistant Patent Examiner for patent applications in patient monitoring systems

05/1981 – 5/1982: SUNY at Upstate Center, Operating Room
Syracuse, NY
Operating Room Technician

04/1980 – 8/1980: University of Virginia Health System,
Charlottesville, VA
Admitting Clerk-Emergency Room Department

06/1977 – 12/1978: St Joseph’s Medical Center,
Syracuse, NY
Orderly/Patient Transport-Radiology Department

Publications:

Available Upon Request

Abstracts:

•    Two abstracts presented on my research in heart failure at the 2008 American College of Cardiology meeting, Chicago, 3/2008.

Presentations:

•    Rutgers Medical School, Cardiology Department, March, 2013
•    Rutgers College of Engineering, Biomedical Engineering, 2012
•    Cleveland State University, April 2008

Honors/Awards:

•    Cleveland Clinic Research Innovation Award
September, 2008
•    Cleveland Clinic Research Innovation Award
October, 2007
•    Honorable Discharge, USAF Medical Service Corp, 1st Lt, 3/1989
•    Superior Achievement Award, United States Patent Office, 1983
•    Member of Tau Beta Pi Engineering Honorary

Professional Affiliations/Societies

•    Association for the Advancement of Medical Instrumentation
o    Peer reviewer
•    Society of Care Medicine
o    Peer reviewer
•    Heart Rhythm Society

Selected Portion of Medical Device Case List Summary:

Available Upon Request

Depositions/Trial Testimony:

Available Upon Request

Professional References:

Available Upon Request

Research Projects List:

Available Upon Request

Additional Research and Development Experiences

Available Upon Request

Patent Related Expertise for Medical Devices

Expert 3660 has been involved and continues to be involved in consulting on IP cases related to a heart rate monitoring; monitoring system neonatal system, as well as been a consultant for patent attorneys on the development of claims and patent searches. I have also been employed by the U.S. Patent Office as an assistant patent examiner. Additionally, his IP experiences cited previously, he also submitted two provisional claims and have been actively involved in prior art and am well versed in this area as well through my employment as an Assistant Patent Examiner, US Patent Office (1981-1983).
Patents which I have been involved with as a patent examiner at the US Patent Office
•    Medical-electronic body fluid accounting system, U.S. Patent
•    Apparatus for determining changes in limb volume
•    Fluid pump, U.S. Patent
•    Apparatus and method for monitoring the oestrus cycle in animals…,U.S. Patent
Note (1): Expert 3660 received a Superior achievement award (3/15/1983) during my tenure as an Assistant patent examiner and I was primarily involved in examining patent applications in the areas of-
1.    Medical Monitoring Systems for cardiovascular diagnosis
2.    Medical Infusion systems
3.    Therapeutic Devices
4.    Radiology Systems for Diagnostic and Therapeutic purposes
Note (2): He also has extensive patent related experiences in the following areas-
1.    Claim Drafting in patent applications
2.    Review of prior art for different medical device systems
3.    Potential infringement (Rule 11) from competing technologies.
4.    Providing testimony in federal court on patent infringement case(s)-April 26, 2013, Biosig Instruments, Inc.