Medical Devices Biomedical Engineering Expert

Expertise

• Cardiac resynchronization management therapy devices.
• Cardiac echocardiography.
• Medical device design, project management and research and development.
• Industrial product development in the medical industry.
• Heart failure studies and heart failure therapy devices.
• FDA device controls and regulatory issues.

Expert Witness Experience

• ICD device failure: Patient was subjected to unnecessary shock delivery.
• ICD Device failure due to lead failures.
• Patent Infringement case related to a heart monitoring system.
• Safety of a security system for patients who wear ICD and pacing devices.

Experience

Undisclosed College, Professor, Bioengineering Engineering Department, 2016 - Present

• Developed cardiac device and physiology course.
• Developed and delivered coursework in cardiac devices, cardiac imaging and cardiac physiology.

Undisclosed University, Veterinary, Department, 2015 - Present:

Research Cardiovascular Device Development

• 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.

Independent Consultant, 2013 - Present

• Clinical Engineering and Medical Device Consultant Expert for hospitals, medical device companies, legal firms, and insurance carriers.
• Providie 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 Project: Therakos, Inc

• As an onsite consultant, 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.

B. H. Barkalow & Associates, LLC, Newaygo, MI, Clinical Engineering Expert, 2014 - Present

• Consultant for hospitals, medical device companies, legal firms, and insurance carriers.
• Provide 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.
• 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.

Widener University, Chester, PA, Professor, Biomedical Engineering Department, 2013 - Present

• 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.

Stevens Institute of Technology, Hoboken, NJ, 2013 - Present

Professor - Biomedical Engineering

• Collaborated with a fellow Professor on the revisions of an existing biomedical engineering instrumentation course.
• 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.

Integral ElectroMagnetronic Technologies, 2011 - 2014

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 and Trademark Office related to the imaging technology related to a novel innovative medical imaging technology.

Laughlin Engineering Firm, LLC, Houston, TX, Senior Medical Device Consultant, 2010 - 2011

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.
• ICD Device failure due to lead failures.
• Patent Infringement case related to a heart monitoring system.
• Safety of a security system for patients who wear ICD and pacing devices.

College of Staten Island, Staten Island, NY, 2009 - Present

Professor (Engineering Science and Physics)

• Collaborated with Associate Professor on developing a new biomedical engineering course, entitled "Biomedical Medical Engineering Instrumentation Design Theory and Applications," for senior undergraduate students.
• Responsible for the development and delivery of course work in engineering science and physics courses.

Cleveland Clinic Foundation, Cleveland, OH, 2005 - 2008

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.

Military

United States Air Force, Active Reserves, Clinical Engineer

Honors & Publications

Credentials

• Software Proficiencies: MS Office, DSI Ponemah and Assembly Language programming.
• Lab Proficiencies: Animal surgery (large and small models), physiological monitoring, pressure volume loop analysis and cardiovascular bench studies.
• Medical device consulting, MRI and CT analysis, clinical trial formulation, FDA design controls, and writing grant proposals and intellectual property issues.
• Additional Coursework: Medical Device Design, Biomedical Transducer Design, Biomaterials, Tissue Engineering, Biomechanics, Medical Imaging, Polymers, Human Anatomy & Physiology, Biochemistry, Feedback Control Theory and MRI/CT analysis.

Academic and Professional Affiliations

• The Biomedical Engineering Society
• Heart Rhythm Society
• The Institute of Electrical and Electronic Engineers (IEEE)
• Engineering and Medicine and Biology Society IEEE
• The American College of Clinical Engineers

Awards

• Cleveland Clinic's Innovation Awards, (2).
• Superior Achievement Award, United States Patent Office

Publications

• Author and Co-Author of national and international publications in peer reviewed medical and surgeons journals, (and presentations).

Patents

Patent Activities

• Claim Drafting in patent applications
• Review of prior art for different medical device systems
• Potential infringement (Rule 11) from competing technologies.
• Providing testimony in federal court on patent infringement case(s)

Education

• D. Eng. Applied Biomedical Engineering, Cleveland State University, Cleveland, OH
• M.S. Bioengineering, University of Pittsburgh, Pittsburgh, PA
• M.E. Biomedical Engineering, University of Virginia, Charlottesville, VA
• B.A. Premedical Sciences, Syracuse University, Syracuse, NY