standard-title Professional Experience

Professional Experience

MEDICAL DEVICE CONSULTING LLC

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 device 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.

Services Include:

  • Medical Device incident investigations & reports of findings
  • Expert witness testimony for all types of medical devices and medical imaging systems
  • FDA regulatory and Current Manufacturing Practices for all types of medical systems
  • Medical Device Liability issues
  • Research & Development collaborations in cardiac implantable systems
  • Intellectual Property Support related to medical devices and medical imaging systems
  • Medical device technology expertise
  • Research and development experience at the Cleveland Clinic & University of Pittsburgh
  • Expertise with the design, use, and applications associated with a variety of medical devices

B. H. Barkalow & Associates, LLC, Newaygo, MI.
Clinical Engineering Expert Consultant for hospitals, medical device companies, legal firms, and insurance carriers.

Medical Device Consultant
Kevin Kennedy Associates

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

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

Medical Device incident investigations & reports of findings

  • Expert witness testimony for all types of medical devices and medical imaging systems
  • FDA regulatory and Current Manufacturing Practices for all types of medical systems
  • Medical Device Liability issues
  • Research & Development collaborations in cardiac implantable systems
  • Intellectual Property Support related to medical devices and medical imaging systems
  • Medical device technology expertise
  • Research and development experience at the Cleveland Clinic & University of Pittsburgh
  • Expertise with the design, use, and applications associated with a variety of medical

Medical Device Expert
Thomson Reuters Expert Witness Services

Responsibilities consist of providing biomedical, clinical, and forensic engineering support to clients, including hospital systems, medical device companies, e.g., Therakos, Inc., legal practitioners in both medical device liability and patent cases, and insurance carriers. Some of the medical device consulting activities that Medical Device Consulting, LLC, that can be provided to clients include:

  • Medical Device incident investigations & reports of findings
  • Expert witness testimony for all types of medical devices and medical imaging systems
  • FDA regulatory and Current Manufacturing Practices for all types of medical systems
  • Medical Device Liability issues
  • Research & Development collaborations in cardiac implantable systems
  • Intellectual Property Support related to medical devices and medical imaging systems
  • Medical device technology expertise
  • Research and development experience at the Cleveland Clinic & University of Pittsburgh

Medical Imaging Consultant and Scientific Advisory Board Member
Integral ElectroMagnetronic Technologies (IEMT)

New York City

  • Coordinating preclinical device/system studies for the FDA/CDRH
  • Involved in the R&D of a low-power, low-cost, high resolution of a full body imaging system
  • Filed two provisional applications with the U.S. Patent & Trademark Office
  • Presently serving as IEMT’s FDA Compliance Officer and Consultant

Senior Medical Device Consultant
Laughlin Engineering Firm, LLC

  • Provided medical device consulting on cardiac implantable devices
  • Served as an Expert Witness
  • Provided recommendations in order for systems to adhere to FDA device regulations
  • Reviewed FDA device regulatory issues

College of Staten Island, Staten Island, NY
Adjunct Assistant Professor

  • Engineering Science and Physics Department

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. and George Yanulis, D.Eng., 8/2007 and 10/2008)

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