George Yanulis

Dr. George Yanulis

GY Medical Device Consulting, LLC
19103 Cresenzo Ct, Suite 306
Fort Myers , FL 33967
Mobile: 216-571-1532
Office: 216-571-1532
Introduction

Dr. George Yanulis provides expert testimony, reports, and opinions on medical device liability and patent infringement cases. He is a Cardiovascular Device Product Development and Research Engineer and possesses a Master of Engineering, Master of Science, and Doctor of Engineering (all in biomedical engineering) and has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in cardiac resynchronization therapy (CRT) for both heart failure and atrial fibrillation patients.

Dr. Yanulis has both published peer reviewed articles and abstracts in heart failure device therapy and has an on-going interest in, the R&D of medical devices used in the areas of atrial fibrillation (AF), heart failure (HF), cardiac tissue repair systems, cardiac pacing, and congestive heart failure therapy devices. He is interested in maintaining the highest level of quality in the design, development and therapeutic, safe and effective use of all types of cardiac implants and all other types of medical devices.

Dr. Yanulis has a Doctorate in Engineering from a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

Dr. Yanulis’ Medical Device Consulting, LLC provides research, development expertise on all types of medical devices & imaging systems; consults on biomedical, clinical, and forensic engineering issues to hospital systems, medical device companies, insurance carriers and legal practitioners on medical device liability cases and patent infringement particularly in the implantable cardiac device area; pulse oximetry, and involved in cardiac implantable device research & development as well having an expertise in:

• Providing expert witness testimony/services and consulting for all types of medical devices (50 cases to date)
• Reviewing FDA regulatory and Current Manufacturing Practices for various medical devices
• Involved in medical device liability issues for both the plaintiff and defendant sides
• Reviewing and assisting in the preparation of both 510k's and Pre-market approvals for several medical devices
• Developing Expert Witness Reports (40 to date written)
• Providing input to start-up medical device start-ups
• Actively participating in the research & development of cardiac implantable systems, cardiac pacemakers, cardiac imaging and stents
• Reviewing and providing expert opinions on adverse medical device issues
• And providing opinions on post surveillance remediation, SOP's and ISO regulatory training issues.

Email: georgeyanulis55@gmail.com


Areas of Expertise
  • Design Engineering
  • Electrical
  • Electrical Engineering
  • Ergonomics
  • Failure Analysis
  • Forensic Engineering
  • Human Factors
  • Materials Engineering
  • Medical Devices
  • Products Liability

Expert Background
Q: Please list your professional accreditations, degrees, licenses, and certificates granted:
A: Doctor of Engineering in Applied Biomedical Engineering (Joint program offered between Cleveland State University and the Cleveland Clinic Foundation - received Doctor of Engineering in August 2008; Master of Science in Bioengineering at the University of Pittsburgh - degree received in May 2002; and a Master of Engineering in Biomedical Engineering received from the University of Virginia in January, 1981.
Q: Please list your affiliations or memberships in any professional and/or industry organizations:
A: Dr. Yanulis is currently a member of BMES, Heart Rhythm Society, IEEE, American Heart Association, Society of Critical Care Medicine, Engineering in Medicine & Biology, and the Tau Beta Pi Engineering Honorary.
Q: Please list any teaching or speaking experience you have had, including subject matter:
A: I have taught coursework in instrumentation design, medical imaging, and physiology in 3 different biomedical engineering departments at Widener University ; the Stevens Institute of technology and Temple University.

Dr. Yanulis is also in the process of co-authoring a biomedical engineering text suited for upper level students and 1st year graduate students in biomedical engineering and the text book proposal has been accepted by Springer Nature Publishers.

Dr. Yanulis has spoken to cardiologists at Rutgers University as well as senior level design students at Rutgers University.
Q: Have any of your accreditations ever been investigated, suspended or removed? (if yes, explain)
A: Dr. Yanulis has never been investigated related to his accreditations.
Q: On how many occasions have you been retained as an expert?
A: I have been retained as an expert over 40 times.
Q: For what area(s) of expertise have you been retained as an expert?
A: Dr. Yanulis has been retained as an Expert in cases involving cardiac devices; ICDs, cardiac pacemakers, medical imaging systems (both CT and MRI); orthopedic devices including shoulder, hip and knee implant systems; coronary stents; FDA regulatory and ISO regulatory issues, patent infringement; cancer treatment system, diabetic monitoring systems, pediatric ventilators, temporary pacing systems, revising standard operating procedures, heart bypass systems, pulse oximetry systems, ambulatory monitoring systems, clinical engineering matters, suture devices.
Q: In what percentage of your cases were you retained by the plaintiff?
A: Dr. Yanulis has been retained 70% by the plaintiff.
Q: In what percentage of your cases were you retained by the defendant?
A: Dr. Yanulis has been retained 30% by the defendant.
Q: On how many occasions have you had your deposition taken?
A: Dr. Yanulis has been deposed on 10 different occasions to date.
Q: When was the last time you had your deposition taken?
A: The last deposition given by Dr. Yanulis occurred in February, 2021.
Q: On how many occasions have you been qualified by a court to give expert testimony?
A: None at this time.
Q: On how many occasions have you testified as an expert in court or before an arbitrator?
A: None at this time. But am completely familiar with all the protocols required to provide expert trial testimony.
Q: For how many years have you worked with the legal industry as an expert?
A: I have been an Expert Witness for over 15 years to date.
Q: What services do you offer? (E.g.: consulting, testing, reports, site inspections etc.)
A: Medical device consulting; preparation of expert reports; site inspections, and supervised testing by 3rd party colleagues
Q: What is your hourly rate to consult with an attorney?
A: $400/hour (normal consulting rate) and $525 (testimony/depoitions)
Q: What is your hourly rate to review documents?
A: $400/hour (normal consulting rate) for reviewing all related case related documents.
Q: What is your hourly rate to provide deposition testimony?
A: $525/hour.
Q: What is your hourly rate to provide testimony at trial?
A: $525/hour.
Q: Please list any fees other than those stated above (E.g.: travel expenses, copy fees, etc.)
A: A nonrefundable retainer of $4000 is required after being initially retained. And all travel related fees, site visits are expected to be covered by the client.


References

Attorney References:

Steven N. Williams, Esq.
Shareholder
500 N. Akard Street, Suite 3800
Dallas, TX 75201-6659
214.855.7544
swilliams@munsch.com

Eric E. Johnson, Esq.
Member
Denver, Colorado
Phone: 303.299.8376
ejohnson@shermanhoward.com

Patrick Loughren, Esq.
Partner
Loughren Loughren & Loughren, P.C.
310 Grant St, Ste 2800 Grant Bldg
Pittsburgh, PA 15219
P: (412) 232-3530
F: (412) 232-3535
patrick@loughren.com

Erin E. Jordan
Partner
Las Vegas, NV
6385 South Rainbow Boulevard
Suite 600
Las Vegas, NV 89118
Erin.Jordan@lewisbrisbois.com
702.693.4354

Additional Professional References:

Bryan J. Coleman
Senior Director, Pharmaceutical & Device Consulting Services
EAS Consulting Group
571-447-5504
bcoleman@easconsultinggroup.com
Relationship: Directly Managed by Consulting Work as an Independent Consultant

John Laughlin, M.ENG., P.E.
Laughlin Engineering Firm, LLC
P: (281) 630-2281 (mobile)
john@laughlinfirm.com
http://www.laughlinfirm.com/consultant-john.html
Relationship: Directly Managed by Consulting Work as an Independent Consultant

James Furmato, D.PM, PhD (Biomedical Engineering)
Temple University, Faculty
Assistant Professor of Instruction
Bioengineering Department
(609) 933-2017 (mobile)
james.furmato@temple.edu
215-204-1953 (work)
https://engineering.temple.edu/about/faculty-staff/bioengineering
Relationship: Teaching Colleague/Research Collaborator

Michel A Lemay, PhD
Department of Bioengineering at Temple University
michel.lemay@temple.edu
215-707-9407 (work)
Relationship: Collaborated on course work in bioinstrumentation and served as co-advisor for a senior design bioengineering student group project
https://engineering.temple.edu/about/faculty-staff/bioengineering

Frank Marino
Phone: 718-966-2447 (Work)
Email: nydconstruction@msn.com
Relationship: Teaching College at the City University of New York