Forensic, General & Medical
Expert Witnesses

Medical Devices Consultant and Failure Analysis Expert Witness

Medical Device Consulting LLC

Medical Device Consulting LLC

7921 Reflection Cove Drive
Suite #305

Fort Myers, Florida 33907

Phone(216) 571-1532

Website https://gymedicaldeviceconsulting.com/

► Contact Medical Device Consulting LLC

Expert WitnessForensic ExpertSpeaker
Dr. Yanulis provides expert testimony, reports, and opinions on medical device liability cases. He is a Cardiovascular Device Product Development and Research Engineer and possesses a MEng, MS, DEng (all in biomedical engineering) and have conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in CRT.

Dr. Yanulis has both published articles about, 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. 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.

Services

With his extensive experience in medical research, development, and medical device failure analysis, Dr. Yanulis has earned the trust of various clients in the health care industry, some of whom are repeat clients. His areas of expertise include:

• Medical Device Design
• Cardiac Pacing Devices
• Cardiac Implantable Systems
• Cardiac Imaging
• Ventricular Assist Devices
• Pediatric Cardiovascular Devices
• Vascular Stents
• Surgical Devices
• Product Research & Development
• FDA Medical Device Regulatory Issues
• Product Liability
• Interventional Radiology Device
• Intellectual Property Related to Medical Devices


Litigation Support Services

Involved in the following cases as an Expert Witness:

Cardiac Pacing Device Failure
Implantable Cardiac Defibrillator Lead Failure
Total Shoulder Implant Failure
Total Knee Implant
Magnetic Resonance System Failure case
Surgical Biopsy Forceps Case
Heart rate monitoring system (IP infringement)
Neonatal Support System (IP infringement)
Phillips Monitoring System Case (alarm system failure)
Total Knee Implant Failure
Surgical Suture System Failure
Total Knee Implant Failure
Total Shoulder Implant Failure
Cardiac Pacemaker Device Failure
Cardiac Ablation System
Cardiac Surgical Stapler System Failure
Implantable Cardioverter-defibrillator (ICD) System Failure
Metal Infusion System (Infringement/Invalidity Analysis)
Heart Bypass System Failure
Orthopedic Cement(s) for Orthopedic Implants
Pediatric Ventilator System (alarm failure)
Portable Oxygen Cart Liability Case
ICD System Failure

Areas of Expertise

Additional Expertise:

Cardiac Resynchronization Therapy (CRT) Device; Medical Device R&D; Cardiac Echo; Cardiac MRI; Clinical Engineering; Neurological Therapy Device; Artificial Organ Design; Medical Products Liability; Clinical Device Trials; Patient Monitoring Systems; Cardiology; FDA Device Design Control; Cardiac Pacemaker Device; Medical Device Design; Interventional Radiology Device;

Profile

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 particularly in the implantable cardiac device area; and involved in cardiac implantable device research & development as well in the following activities:

• Provides expert witness testimony/services for all types of medical devices (30 cases to date)
• Reviews FDA regulatory and Current Manufacturing Practices for medical devices
• Involved in medical device liability issues for both the plaintiff and defendant sides
• Reviews both 510k's and Pre-market approvals for several medical devices
• Development of Expert Reports (20 to date written)
• Provides input to start-up medical device start-ups
• Involved in the Research & Development in cardiac implantable systems
• Reviews and provides expert opinions on adverse medical device reports
• And Involved as a medical device consultant on post surveillance remediation issues.

Consulting Practice

All States

Medical Device Consulting LLC in the Social Networks

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Professional Experience

1. Cardiac Pacing Device Failure
2. Implantable Cardiac Defibrillator Lead Failure
3. Provided Cardiovascular CRT Expertise for a security screening system
4. Total Shoulder Implant Failure
5. Total Knee Implant
6. Magnetic Resonance System Failure case
7. Surgical Biopsy Forceps Case
8. Heart rate monitoring system (IP infringement)
9. Neonatal Support System (IP infringement)
10. R&D of a new ECG electrode system
11. Phillips Monitoring System Case (alarm system failure)
12. Diabetic Patient Monitoring System
13. Developed an FDA Validation and Verification for a post market visit
14. Medical Imaging Consult for Boston Scientific
15. Diabetic Monitoring System R&D for start-up firm
16. Total Knee Implant Failure
17. Surgical Suture System Failure
18. Total Knee Implant
19. Total Shoulder Implant Failure
20. Surgical Stapler System Failure
21. Cardiac Pacemaker Device Failure
22. Cardiac Ablation System
23. Cardiac Surgical Stapler System Failure
24. Implantable Cardioverter-defibrillator (ICD) System Failure
25. Metal Infusion System (Infringement/Invalidity Analysis)
26. Heart Bypass System Failure
27. Orthopedic Cement(s) for Orthopedic Implants
28. Pediatric Ventilator System
29. Portable Oxygen Cart Liability Case
30. ICD System Failure


Legal Experience & Services

Depositions to date:

Hitachi Medical Systems v. South West Mississippi Anesthesia, P.A.
United States District Court
Middle District of Louisiana
Civil Action No. 12-273-BAJ-SCR July 31, 2013
South West Mississippi Anesthesia, P.A.


Robert Bowie and Susan Bowie v. Arthrex, Inc. and Surgical Systems, Inc.
Superior Court of Maine
Androscoggin County
Civil Action No. CV-2014-74 April 25, 2014

Thomas R. Ruxlow v. DePuy Orthopedics, Inc. and Johnson & Johnson
United States District Court Southern District of Iowa Central Division
Civil Action 4:13-CV-428 October 8, 2013
Thomas Ruxlow

George Koulas v. DePuy Orthopedics, Inc.
United States District Court
District of Hawaii
Civil No. 13-00713 BMK
Dec 27, 2013

Theotis Latimore v.
Botsford Hospital,
John Parmely, D.O., John Parmely,D.O.,P.C., Specialist in General Surgery,
Harun Zekirovski, D.O, Covidien LP and/or
Covidien PLC, Formerly known as Covidien LTD, and Medtronic, Inc., successor corp.
STATE OF MICHIGAN
IN THE CIRCUIT COURT FOR THE COUNTY OF OAKLAND
Case No. 14-138209-NH
October 30, 2014

Jake Lovato, Individually Lovato and as Personal Representative of the Wrongful Death
Estate of Altagracia Gloria Lovato (Plaintiffs),
vs.
Board of Regents of the University of New Mexico
Board of regents of
The University of New Mexico, Defendants.
First Judicial District Court
County of Santa Fe
State of New Mexico
No. D-101-CV-2013-01167
04/24/2013


Affiliations

IEEE Engineering in Medicine & Biology Society
Pharmaceutical, Medical Device & Biotech Subcommittee of the ABA
Society of Critical Care Medicine (SCCM)
Heart Rhythm Society
The Association for the Advancement of Medical Instrumentation


Qualifications

Areas of Medical Device Expertise-

• Biomedical Engineering Research & Development
• Medical Device Expert Witness
• Medical Devices Research & Development (R&D)
• R&D Bridge to transplantation devices for patients in heart failure
• Food & Drug Medical (FDA) Device Regulatory Protocols
• Echocardiography
• Cardiac MRI
• Cardiac Electrophysiology (EP)
• Interventional Cardiology
• Orthopedic Device Implants
• Clinical Engineering
• Heart Failure Studies
• Atrial Fibrillation Studies
• Therapeutic Radiological Physics
• Nuclear Cardiology
• Pediatric Critical Care Medicine Devices
• Medical Polymers & Plastics
• Medical Device Failure Analysis


Awards & Honors

• 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


Seminars & Training

EAS Webinar: FDA’s Transition from CFR 820 to the ISO 13485:2016 - Instituting a New Quality Management System (QMS), September, 2019
Rutgers Medical School, Cardiology Department, March, 2013
Rutgers College of Engineering, Biomedical Engineering, 2012
Cleveland State University, April 2008


Publications

• Lim, Pascal; George E. Yanulis; David Verhaert; Neil L. Greenberg; Richard A. Grimm; Patrick J. Tchou; Nicolas Lellouche; and Don W. Wallick. Coupled Pacing Improves Left Ventricular Function during Simulated Atrial Fibrillation without Mechanical Dyssynchrony. Euro pace. 2010 Mar; 12(3): 430-6.

• Yanulis, George E.; Pascal Lim; Ali Ahmad; Zoran B. Popovic; and Don W. Wallick. Coupled Pacing Reverses the Effects of Persistent Atrial Fibrillation on the Left Ventricle. The Annals of Thoracic Surgery. 2008 Sep; 86(3): 984-7.

• Yanulis, George E. A Novel Cardiac Pacing Paradigm for Atrial Fibrillation and Heart Failure Patients. Doctoral dissertation, Fenn College of Engineering, Cleveland State University. 2008 May; 1-106.

https://etd.ohiolink.edu/!etd.send_file?accession=csu1216064065&disposition=inline

• Cingoz, Faruk; George E. Yanulis; Elizabeth Ching; Kiyotaka Fukamachi; and Don W. Wallick. Use of Conventional Dual Chamber Pacemakers with Custom Lead Adapters to Induce Atrial Fibrillation or Heart Failure in Dogs. The Annals of Thoracic Surgery.2007 May; 83(5): 1858-62.


Professional References

James Furmato, D.PM, PhD (Biomedical Engineeing)
Assistant Professor, Department of Medicine
Chief Engineer, Gait Study Center
Adjunct Assistant Professor
Temple University, Bioengineering
Mobile Phone: (609) 933-2017
Email: jfurmato@temple.edu

Bryan Coleman, BS, Colonel, Army National Guard
Senior Director Pharmaceutical and Device Consulting Services
bcoleman@easconsultinggroup.com

Johnson, Eric E., Esq.
Member, Sherman & Howard
Denver, Colorado
Phone: 303.299.8376
Fax: 303.298.0940
ejohnson@shermanhoward.com

Frank Marino, M.S. Construction Engineer
Sr. Management & Estimating services at NY Asphalt Inc.
Mobile Phone: (718) 702-6429
nydconstruction@msn.com

Stephen Ruble, PhD
Fellow, Senior Clinical Trial Manager
Boston Scientific
6515824397 (Work)
stephen.ruble@bsci.com

Erin E. Jordan, Esq.
Partner
Lewis Brisbois
Erin.Jordan@lewisbrisbois.com
702.693.4354


Education

D.Eng Biomedical Engineering, 2008
Cleveland State University/Cleveland Clinic Foundation
Cleveland, OH

M.S. Bioengineering, 2002
University of Pittsburgh
Pittsburg, PA

M.Eng Biomedical Engineering, 1981
University of Virginia
Charlottesville, VA

B.A. Chemistry, 1977
Syracuse University
Syracuse, NY




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