Dr. George E. Yanulis, M.ENG., M.S., D.ENG.
Medical Device R&D Engineer
- Dr. George Yanulis earned a Doctor of Engineering Degree (D.ENG.) in Applied Biomedical Engineering from a joint program offered through the Washkewicz College of Engineering and the Cleveland Clinic Foundation (Cleveland, OH)- August, 2008.
- Dr. Yanulis has been Medical Device Product Development and Research Engineer for over 25 years and has been an Expert Witness for over 10 years and is currently the Owner & Medical Device Consultant for Medical Device Consulting, LLC in Fort Myers, FL (2014-Present).
- Dr. Yanulis also possesses M.S. in Bioengineering from the University of Pittsburgh-May, 2002; M.Eng. from the University of Virginia-January, 1981; and a Bachelor of Arts in Chemistry from Syracuse University-May, 1977.
- He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used on heart failure patients (2005-2009) and the use Medical Polymers as elastomeric polymeric actuators used in respiratory assist devices at the University of Pittsburgh Medical Center (2000—2002).
- Dr. Yanulis has both published (4 peer review publications & 2 abstracts) and has an on-going interest in the R&D of medical devices used in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices. His cardiovascular device technology experience has consisted 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 cardiac electrophysiology, vascular stents, physiological monitoring, neurological; cardiovascular; and respiratory assist systems. Dr. Yanulis has also been involved in the development of cardiac device, bio signals; engineering physiology bioinstrumentation and medical imaging courses at both Temple University (Philadelphia, PA) and the Stevens Institute of Technology Biomedical Engineering Program (Hoboken, New Jersey).
- Dr. Yanulis has provided testimony in 6 depositions in the last 4 years (without a Daubert Challenge) and has been an Expert Witness and medical device consultant for 10 years and has been involved in numerous medical device liability and patent infringement cases for both the Plaintiff and the Defendant sides.
- He has been involved in these product defect(s) as an Expert Witness and has provided advice to attorneys, health care systems and insurance carriers related to FDA medical device controls, the 510k process; Premarket Approvals (PMAs), Current Good Manufacturing Practices (CGMPs), Quality Assurance Issues, Device Design, Post-market Surveillance Issues, and Medical Device Failures including those related to the following medical device/imaging systems:
- Implantable Cardioverter Defibrillator (ICD) Device Systems
- ICD Lead Design and Failures
- Cardiac Pacemaker Systems Research and Development
- Cardiac Pacing Lead Design and Development
- Cardiac Pacing Lead Failures
- Heart Failure Therapy Devices
- Cardiac Stents
- Catheter Delivery Systems for AF Systems
- Cardiovascular Imaging (including cardiac echo and MRI system design and maintenance)
- Atrial Fibrillation Therapy Device Systems
- Ventricular Assist Devices: Cardiac Stents; and Cardiac Valves (Biological, Prosthetic & Bio-prosthetic types)
- Human Factors Engineering
- Knee Replacement Systems
- Hip Replacement Systems
- Shoulder Replacement Systems
- Medical & Surgical Equipment
- Sutures for Cardiovascular Applications
- Thoracic surgical Stapler Systems
- Medical Equipment Implantable Medical Devices, & Surgical Implants
- Pediatric Ventilators
- Surgical Navigation Systems
- Physiological Monitoring Systems
- Clinical Engineering Systems
- Critical Care Systems
- Pain Control Systems
- Deep Brain Stimulation Systems