Expert Consulting and Expert Witness Services

  home    |    expert directory    |    using intota    |    about us    |    blog    |    contact us    |    request an expert     expert login & enrollment  
  
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  728450

Expert in Implantable Cardiac Devices, Heart Rate Monitoring, Medical Device R&D, and FDA device controls


Available for your Consulting and Expert Witness Needs

Pennsylvania (PA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
• R& D of Cardiac Resynchronization Management Devices (Cleveland Clinic Foundation) • Cardiac Resynchronization therapy (CRT) and related pacing paradigms (Cleveland Clinic) • Providing preoperative, operative, and postoperative physiological monitoring and care of animal test subjects in preclinical device trials (Cleveland Clinic Foundation) • Cardiovascular signal monitoring protocols using PONEMAH physiology platform software (Cleveland Clinic Foundation) •Clinical Research Trial Design & Implementation for cardiovascular devices (Cleveland Clinic & University of Pittsburgh) •Medical device consulting (Cleveland Clinic, University of Pittsburgh, Intota Expert Witness services & Orbital research LLC) •Medical Device project management (Cleveland Clinic & University of Pittsburgh) •Medical device regulatory & quality control issues (Cleveland Clinic Foundation) •Intellectual Property Issues related to medical devices and imaging systems (Cleveland Clinic Foundation Innovation Office) •FDA/CDRH medical device submissions (Cleveland Clinic Foundation)
 • 

artificial cardiac pacemaker

 • 

cardiac arrhythmia

 • 

cardiac electrophysiology

 • 

implantable device

 • 

medical device

 • 

medical device design

 • 

medical polymer

 • 

pacemaker control

 • 

artificial cardiac pacemaker battery

 • 

sinus arrhythmia

Expert has earned M.Eng. M.S., and Doctor of Engineering Degrees in Biomedical Engineering and is an experienced Medical Device R&D Engineer who has over 20 years of experience in research & development with all types of cardiac implantable systems; vascular stents; surgical devices; cardiovascular devices & medical imaging systems. Expert is affiliated with a start-up medical imaging company Integral ElectroMagnetronic Technologies as a scientific advisor and has filed two provisional applications with the U.S Patent Office. Expert has been involved in the development of novel medical devices & medical imaging applications and medical device consulting particularly in the areas of cardiovascular device and medical imaging areas. Expert is very interested in research collaborations in the areas of: cardiac pacing devices; cardiac imaging; ventricular assist devices; and pediatric cardiovascular device development.

Expert has been involved in the following consulting scenarios as a medical device consultant and expert witness for at least 6 different consulting firms including Intota as well as John Laughlin, LLC and the Kennedy Associates where he had been involved in the following activities:

• 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 (plaintiff) • Cardiac/Neurological/Orthopedic Device Failure Analysis • Medical Imaging Modalities • Provided Expert Reports • Expert Witness • FDA Device Regulatory Issues • Provide Expert Disposition and Testimony • Patent Prosecution • Good Manufacturing Practices for Medical Device Systems • Quality Assurance Controls

Expert has been involved in the research and development of current cardiac pacing paradigms at the Cleveland Clinic where he had been involved in the following activities:

• 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 • 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

Expert has also been involved with the start up imaging firms as both a Director and FDA Compliance & Preclinical Device Expert and has been involved in the following areas:

• 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 & Trademark Office related to the imaging technology related to a novel innovative medical imaging technology

As an Adjunct Professor for Biomedical Engineering Programs at both Widener University and the Stevens Institute of Technolgy, he has been involved in the following:

• Responsible for the development and delivery of coursework in bio-instrumentation design related courses • Mentoring undergraduates in lecture and lab settings in the biomedical engineering program

Expert has done presentations for both the Rutgers University Cardiology Department related to his research in cardiac pacing paradigms and has published the following peer-reviewed journals.

 • 

510(k) document

 • 

aorta

 • 

artery

 • 

artificial heart

 • 

artificial kidney

 • 

artificial liver

 • 

artificial organ

 • 

atrial flutter

 • 

auricular fibrillation

 • 

balloon catheter

 • 

bioabsorbable material

 • 

bioactive ceramic material

 • 

biocompatibility

 • 

biocompatibility testing

 • 

biocompatible polymer

 • 

biomedical application

 • 

biomedical device

 • 

bradycardia

 • 

cannula

 • 

cardiac sinus arrest

 • 

cardiopulmonary disease

 • 

cardiovascular abnormality

 • 

cardiovascular disease

 • 

catheter

 • 

computerized electrocardiology

 • 

coronary artery

 • 

corrosion-resistant metal

 • 

Current Good Manufacturing Practice

 • 

defibrillation

 • 

defibrillator

 • 

disposable medical device

 • 

electrocardiography

 • 

electromagnetic compatibility

 • 

electronic medical device

 • 

electronic medical device design

 • 

electrophysiology catheter

 • 

governmental registration process

 • 

heart block

 • 

hospital equipment

 • 

hospital equipment safety

 • 

implant coating material

 • 

implantable defibrillator battery

 • 

in vivo biodegradable polymer

 • 

medical composite

 • 

medical device clinical research

 • 

medical device coating material

 • 

medical device corrosion

 • 

medical device endurance testing

 • 

medical device evaluation

 • 

medical device hazard analysis

 • 

medical device liability

 • 

medical device manufacturing

 • 

medical device manufacturing quality control

 • 

medical device manufacturing troubleshooting

 • 

medical device mechanical stress analysis

 • 

medical device package testing

 • 

medical device packaging material

 • 

medical device packaging process

 • 

medical device premarket approval

 • 

medical device process validation

 • 

medical device product development

 • 

medical device product improvement

 • 

medical device reporting

 • 

Medical Device Reporting regulation

 • 

medical device safety

 • 

medical device testing

 • 

medical software quality assurance

 • 

medical telemetry

 • 

medical X-ray equipment

 • 

natural cardiac pacemaker

 • 

polymer biocompatibility

 • 

polymer implantable device

 • 

premarket approval assessment

 • 

Safe Medical Devices Act of 1990


Show Only Primary Areas of Expert Consulting

Secondary Expertise
biodegradable plastic, bioethics, bioglass, breathalyzer, brugada syndrome, cardiac tamponade, cast (rigid dressing), clinical protocol, gamma radiation effect on plastic, gamma-stable plastic material, hemostat, high-pressure sterilization, hip replacement, irradiation sterilization, lidocaine, liquid silicone rubber, lithium battery, long QT syndrome, mechanical respirator, medical coating material, medical device auditing, medical device endotoxin detection, medical device irradiation sterilization, medical device manufacturing automation, medical device soldering, medical device sterility, medical device sterilization, medical electronics science, medical ergonomics, medical filter, medical oxygen concentrator, medical polymer extrusion, medical polymer molding, medical polymer selection, medical polymer sterilization, medical pressure-sensitive adhesive, medical product, medical product packaging process, medical protocol, medical pump, medical science, medical seal, medical technology, medical Teflon, medical tubing extrusion, medical-grade polyurethane, nerve stimulator, nuclear-powered artificial cardiac pacemaker, orthopedic implant, orthopedics, oxygenator, pacemaker lead, parasystole, peritoneovenous shunt, piezoelectric crystal, plastic medical device, polyethylene surface, polymeric material, pre-excitation syndrome, premature cardiac complexes, prosthesis, prosthetics, scalpel, sick sinus syndrome, silicone polymer, surgery, surgical implant device, surgical instrument, surgical product, tachyarrhythmia, tachycardia, therapeutic device, thermoplastic elastomer, transvenous lead, ventricular fibrillation, ventricular flutter

Basic Expertise
anterior cruciate ligament, antimicrobial medical device, bone mechanics, calcium phosphate, liquid silicone rubber injection molding, medical adhesive tape, medical instrument plasma cleaning, medical lexicon, medical lexicon development, orthosis, positive-displacement pipette, precision liquid dispensing, precision liquid dispensing device, surgical adhesive tape, wheelchair
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Trenton, New Jersey;  Philadelphia, Pennsylvania;  Allentown, Pennsylvania;  Reading, Pennsylvania;  and Baltimore, Maryland.

Often requested
with this expert:

Cardiac Electrophysiology, Cardiology Drugs, Pacemakers,...
Implantable and Non-Implantable Medical Device Risk,...
Cardiology, Electrophysiology and Pacing
Electrical and Biomedical Engineering, Patent Analysis

Education:
Year   Degree   Subject   Institution  
2008   Doctor of Engineering   Biomedical Engineering   Cleveland State University  
2002   MS   Bioengineering   University of Pittsburgh  
1981   MEng   Biomedical Engineering   University of Virginia  

Work History:
Years   Employer   Department   Title   Responsibilities

2013 to

 

(Undisclosed)

 

Biomedical Engineering

 

Adjunct Professor

 

Worked on revising an existing biomedical engineering instrumentation course. Responsible for the development and delivery of coursework in bioinstrumentation design related courses

2009 to 2012

 

Laughlin Engineering Firm, LLC

 


 

Senior Medical Device Consultant

 

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.

2005 to 2008

 

Cleveland Clinic

 

Biomedical Engineering

 

Post Doctoral & Pre-doctoral Fellow in Biomedical Engineering

 

Developed/designed all device modifications for pacing system related to implementation of new cardiac pacing paradigm.

Responsible for the monitoring and collection of data during implantation of pacing devices during acute and chronic phases of our study involving the utility of a new stimulation paradigm as a sustained therapy for chronic HF with or without AF.

Cardiovascular signal monitoring protocols using PONEMAH physiology platform and other software analysis modules.

Providing preoperative, operative, and postoperative physiological monitoring and care of animal test subjects in preclinical pacemaker device trials.


Career Accomplishments:
Associations/Societies

The Biomedical Engineering Society, Tau Beta Pi Honorary, IEEE Engineering in Medicine & Biology Society

Professional Appointments

Adjunct Assistant Professor, College of Staten Island/City University of New York, Engineering Science & Physics Department

Awards/Recognition

Received the Cleveland Clinic's Innovation Award (research in novel cardiac pacing paradigms); Received the Cleveland Clinic's Innovation Award (research in novel cardiac pacing paradigms); Elected into the Tau Beta Pi Engineering Honorary (University of South Florida Chapter); Received the US Patent & Trademark's Office Superior Achievement Award.


Publications:
Publications and Patents Summary

3 peer-reviewed publications in cardiac pacing and heart failure and 2 abstracts in coupled cardiac pacing.

Selected Publications and Publishers  
 - Europace  
 - The Annals of Thoracic Surgery  

Government Experience:
Years   Agency   Role   Description
1982 to 1983   United States Patent & Trademark Office   Assistant Patent Examiner   His duties as an Assistant Patent Examiner had been in the area of biomedical instrumentation, devices, and medical imaging systems including reviewing patent applications in medical imagining and physiological monitoring devices/systems, searching patents and scientific literature databases for prior art in cardiovascular medical devices and systems, and examining patent applications substantively.

1987 to 1989   United States Air Force Medical Service Corp   Clinical Engineer   His duties as a Clinical engineer for the United State Air Force Service Corp included procurement of medical devices/sytems for the Andrews AFB Medical center and facilities planning for the implementation of new radiographic systems


Consulting Services:
Selected Consulting Examples:
  • Cardiac Implantable Device Case
  • Consultant for for John Laughlin, LLC
  • GLG - Gerson Lehrman Group
  • Checkpoint Systems, Inc.
  • IP Infringement
Recent Client Requests:
  • Expert for consulting on Pacemaker-Implantable Cardiac Defibrillators-Cardiac Rhythm Therapy.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Consultant on a ICD device failure case, i.e., patient was subjected to unnecessary shock delivery. Consultant on an ICD Device failure case due to lead failures issues. Consultant Patent Infringement case related to a heart monitoring system. Consultant on a respiratory systems and biocompatibility issue. Consultant for a private firm on a the safety of a security system related to patients who wear cardiac pacing and ICD devices. Consultant on the issues related to the imaging of cardiac pacing devices and leads for a private firm.
Recent Litigation Client Requests:
  • Heart rate monitor expert for consulting in the field of heart rate monitors.
  • Expert for consulting on remote monitoring functions and VoIP technology.
  • Pacemaker expert for consulting on Medtronic Adapta DR Pacemaker and CapSure Novus Lead case.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Market Research:
Actively involved with consulting with Field Clinical engineers from Medtronic and St. Jude Medical Corporation on all programming changes and modifications to St. Jude and Medtronic Implantable Pacemakers related to his research in coupled pacing paradigms and cardiac resynchronization management therapy devices at the Cleveland Clinic. •Collaborated/Consultant with Data Science International (DSI) Imaging Specialists on their PONEMAH physiology platform software analysis modules.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Presentation- Rutgers University, Mechanical Engineering Department, “Launching a Medical Device System” Presentation-Cleveland State University, Chemical & Biomedical Engineering Department, “Intellectual property Issues in Medical Device Design”

Other Skills and Services

Specialties: Cardiac Resynchronization Management Therapy Devices, Artificial Organ Design, Cardiac Echocardiography, Cardiovascular Therapy Devices, Medical Device Project Management, Clinical Studies, Neurological Therapy Devices/Systems, Cardiology, Cardio-vascular Monitoring, Clinical Medical Device Trials, Cardiac Electrophysiology, Heart Failure Studies, Cardiac Echocardiography, Cardiac Magnetic Resonance Imaging, Pulse Oximetry, Biocompatibility Studies, Interpreting Physician Needs to Engineering Requirements, FDA Device Design Controls (510 K and PMA process), Field Clinical Engineering, and Patent Prosecution.


 

Need the right expert?  We can help!

Privacy Policy   ©2014 ORC International - All Rights Reserved.