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 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: 
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 both research & development and serving as an Expert Witness on all types of cardiac implantable systems; arthroplasty systems, vascular stents; elastomeric polymers, bone cements, surgical devices; cardiovascular devices & medical imaging systems. Expert has been involved in the development of novel medical devices & medical imaging applications and medical device consulting particularly in the areas of cardiovascular, orthopedic implants, neurological devices, implantable devices, stents, cardiac pacing systems, artificial organ design and development, R& D for drug/device combinations, and medical imaging areas. Expert is also very interested in research collaborations in the areas of: cardiac pacing devices; cardiac imaging; ventricular assist devices; and pediatric cardiovascular device development.

Expert specialties include the following:

Medical Device R D Engineer, Biomedical Engineering, Cardiovascular Signal Analysis, Medical Device Design for Cardiovascular and Neurological Pacing Devices, Wireless Medical Communications Strategies, Interventional Cardiovascular Devices, Cardiac Pacemaker Devices, Cardiac Stents, Drug-Device Combination Devices/Systems, Preclinical and Clinical Device Design, Artificial Organ Design, Neuro Modulation Devices, Biocompatibility Studies, FDA Device Controls Regulatory Issues, 510K and Premarket Approval Process, FDA Verification and Validation Protocols, CNS Epilepsy Device R&D, Neurology, Pain Control Devices, Cardiology, Cardiovascular Surgery, Orthopedic Surgery, Arthroplasty Devices, Cardiac Echo Imaging, Nuclear Medicine, Nuclear Magnetic Imaging Systems Design and Development, CT Imaging System Design and Development, Cardiac Echocardiography, Patent Prosecution for Medical Systems, Echocardiography, Patent Testimony, Medical Device Deposition, Federal Court Depositions in Medical Devices, Physiology, Cardiac Physiology, Cardiac Resynchronization Management Therapy Devices, Artificial Organ Design, Cardiac Echocardiography, Medical Device Project Management, Neurological Therapy Devices, Cardiac Electrophysiology, FDA Device Design Controls, Patent Prosecution, Implantable Cardiac Devices, Implantable Cardiac defibrillator (ICD) Devices , Cardiac Resynchronization Device Research & Development including both pacemaker ICD devices from Medtronic Boston Scientific and St. Jude Medical Corporations, Heart Failure, Atrial Fibrillation, Medical device Failure Cases, Expert Report Writing Experience, Orthopedic Implant Systems for the Knee, Shoulder and Hip, Ventilator, Respiratory Monitoring Equipment for Pediatric, Neonate and Adults, Dialysis Systems, Medical Polymers, Human Anatomy, Surgical Biopsy Forceps,, Neurosurgery, Operating Room Experience, Clinical Engineering, Medical Polymers Research and Development, Biomedical Engineering Instrumentation and Transducer Design Theory, Surgery, Critical Care Monitoring, and Peer Review Publications in Heart Failure Devices.

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artificial cardiac pacemaker

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cardiac arrhythmia

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cardiac electrophysiology

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implantable device

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medical device

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medical device design

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medical polymer

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pacemaker control

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artificial cardiac pacemaker battery

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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 Expert's 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.

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510(k) document

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aorta

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artery

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artificial heart

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artificial kidney

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artificial liver

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artificial organ

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atrial flutter

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auricular fibrillation

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balloon catheter

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bioabsorbable material

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bioactive ceramic material

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biocompatibility

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biocompatibility testing

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biocompatible polymer

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biomedical application

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biomedical device

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bradycardia

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cannula

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cardiac sinus arrest

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cardiopulmonary disease

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cardiovascular abnormality

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cardiovascular disease

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catheter

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computerized electrocardiology

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coronary artery

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corrosion-resistant metal

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Current Good Manufacturing Practice

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defibrillation

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defibrillator

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disposable medical device

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electrocardiography

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electromagnetic compatibility

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electronic medical device

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electronic medical device design

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electrophysiology catheter

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governmental registration process

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heart block

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hospital equipment

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hospital equipment safety

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implant coating material

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implantable defibrillator battery

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in vivo biodegradable polymer

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medical composite

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medical device clinical research

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medical device coating material

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medical device corrosion

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medical device endurance testing

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medical device evaluation

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medical device hazard analysis

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medical device liability

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medical device manufacturing

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medical device manufacturing quality control

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medical device manufacturing troubleshooting

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medical device mechanical stress analysis

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medical device package testing

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medical device packaging material

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medical device packaging process

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medical device premarket approval

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medical device process validation

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medical device product development

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medical device product improvement

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medical device reporting

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Medical Device Reporting regulation

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medical device safety

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medical device testing

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medical software quality assurance

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medical telemetry

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medical X-ray equipment

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natural cardiac pacemaker

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polymer biocompatibility

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polymer implantable device

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premarket approval assessment

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Safe Medical Devices Act of 1990

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clinical protocol


Show Only Primary Areas of Expert Consulting

Secondary Expertise
biodegradable plastic, bioethics, bioglass, breathalyzer, brugada syndrome, cardiac tamponade, cast (rigid dressing), 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:

Electrical and Biomedical Engineering, Patent Analysis
Medical Devices and Diagnostics; Life Sciences Products...
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers,...
Implantable and Non-Implantable Medical Device Risk,...

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

2014 to 2014

 

(Undisclosed)

 


 

President/Principal Engineer, Philadelphia, PA- Clinical Engineering/Medical Device Consultant Exper

 

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 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.

2014 to 2014

 

(Undisclosed)

 


 

Senior Clinical Engineering Consultant

 

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 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.

2013 to 2014

 

(Undisclosed University)

 

Biomedical Engineering

 

Adjunct Professor

 

•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

2011 to 2013

 

(Undisclosed University)

 


 

Senior Medical Device Consultant

 


2005 to 2008

 

Cleveland Clinic Foundation

 


 

Predoctoral Fellow

 

• 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


Career Accomplishments:
Associations/Societies

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

Professional Appointments

Expert has been appointed the following professional appointments:

1. Adjunct Professor, Expert's University, BME

2. Adjunct Professor, Stevens Institute of Technology, Biomedical Engineering

3. City University of New York, Adjunct Professor, Engineering Science

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

Expert has 4 peer-reviewed publications in cardiac pacing and heart failure and 2 abstracts in coupled cardiac pacing.

Expert has also filed a provisional patent with the US PTO related to a novel improvement in 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:
  • Expert in cardiac devices for consulting on post-mortem pacemaker evaluation.
  • 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.


 

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