Medical Device Devices
Resume:
OMID SOURESRAFIL
Unit *
Del Mar CA 92014
*******@*******.***
A medical device professional with experience with large and start up medical device firms holding a variety of key assignments focused on rapid development of electroceuticals for medical device technology (cardiovascular, neurovascular, neuromodulation, interventional radiology Orthopedic and Spine, Cardiac, Interventional Radiology, Robotic Surgery and Navigation), Sensors, Image processing and Artificial Intelligence cybersecurity, for medical devices, Predictive Analytics Tools. Expert in the design of clinical studies, and regulatory approval of innovative Class II and III medical devices through 510(k) and PMA. Demonstrated success and experience needed to develop compliant systems and bring new medical products to market in the shortest time possible for any size medical device firm, start up to large established companies.
Summary of Specialized Skills
Development of implantable cardiac, neuro and orthopedic devices, implantable and External Sensors, Artificial Intelligence and Predictive Analytics tools
Design, development and conduct of device based Clinical and Pre-Clinical Research projects.
Experience in educating of physicians and support staff.
Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies.
Management of scientific/animal studies and clinical projects.
Hands-on experience obtaining Regulatory Approvals for medical devices, CE, PMA, IDE and 510(k), Australia, Asia Pacific and other regions
Quality assurance ISOand EN and FDA and specialty documentation needs for GMP GLP and GCP compliance.
Software as Medical Device (SaMD)
Tertiary Education University of NSW -Australia:
1991 Bachelor of Science – Computer Science
1994 Bachelor of Engineering Electrical Engineering
1996 PhD (Doctor of Philosophy) Biomedical Engineering
2023- Artificial Intelligence in Healthcare MIT – Sloan School of Management
Quality Training:
1.Good laboratory Practice (GLP)
2.Good Manufacturing Practice (GMP)
3.Good Clinical Research Practice (GCP).
4.Internal Auditor Training
5.Lead Auditor Training
6.Implementation of an ISO13485 Quality System
7.Introduction to ISO 9000:2000
8.Six Sigma Champion Level
9.Six Sigma Green Belt
10.Design and Implementation of an ISO 13485 Quality System
11.Risk Analysis for Medical Devices – (AAMI) October 2003
12.IEC 60601 compliance
13.Introduction to ISO 14155
14.Clinical Trials Design & Analysis Workshop
15.Monitoring of Clinical Trials.
16.CTMS
17.Oracle Clinical
18. EU MDRs
EMPLOYMENT BACKGROUND
May 2021-Current
Independent Regulatory, Clinical and Product Development Consultant
1.Consulted to several medical device companies for the development of clinical trials, regulatory approvals and product development, including 510(k) (Traditional and Denovo), PMA (including IDE investigational development), European MDRs.
2.Developed and filed Intellectual Property for new product development of Neuromodulation, cardiovascular, and Artificial Intelligence based and Software As Medical Device (SaMD) medical devices for the treatment of several disease states.
3.Development of Intellectual property and prototypes for neurmodulation technology for the treatment of chronic pain (pain sensors).
March 2018- September 2020
Senior Principal Regulatory Affairs Specialist – Smiths Medical (Contract)
Maintenance and compilation of regulatory documentation (510K), for Drug Pumps.
Compilation and maintenance of Clinical Evaluation Reports
Regulatory core team member for the development, upgrade and maintenance of device files including Clinical Evaluation Reports for notified bodies and the FDA.
Led efforts to improve cybersecurity of medical devices across the company
November 2016 – March 2018
Regulatory Clinical/Quality Director -CEO SmartImplantSystems Inc
Developed Intellectual property and prototypes for a combined neuromodulation/spine fusion device
Managed a team of engineers, scientists, regulatory and quality staff on the development of an active spine fusion device.
Assisted in the development of technology and clinical strategies for initial clinical testing of implantable devices.
Partnered with Scientists and engineers in the development of pre-clinical protocols and animal laboratories to develop and conduct the trials
Developed Cadaver studies at various labs
Assisted in the development of an ISO13485 quality system and took part in the original risk Developed Pre-Submission and clinical study plans for negotiations with the FDA.
Developed several project plans and managed a core team timelines, for the development, quality assurance processes
February 2012 – August 2016 –
Clinical/Regulatory Expert -CEO EmboMedics
EmboMedics (www.embomedics.com) is an early Stage company involved in the development of resorbable embolization and targeted drug delivery materials.
Major Accomplishments
Developed and implemented company quality management system from the ground up, including the development of an ISO13485 system.
Developed clinical and regulatory programs to get a device/ drug combination. Designed various clinical and pre-clinical programs for the testing of new products.
Developed regulatory pathway and clinical and negotiated with the FDA.
Developed quality programs including Documentation and quality systems.
February 2012 – February 2013– Senior Scientific Reviews – Food and Drug Administration - CDRH
oReview of regulatory submissions including 510(k), PMA, IDE and other regulatory documentation for the approval of implantable pulse generators
February 2009 – February 2012 Senior Advisor of Clinical Affairs/Clinical Project Manager – Sorin Group
Designed clinical trials from the strategy phase to development and implementation•
• Nominated and selected sites for the conduct of clinical trials
Developed data management and monitoring plans.
• Evaluated clinical data for the compilation of providing interim and final reports,
convening and directing investigator conferences to review findings and advise on direction.
Provides input and support for planning post-clinical activities and market launch of products.
Developed and presented publications.
Developed budgets for several clinical projects
Controlled device distribution and allocation.
Liaise with the FDA during Pre-IDE s and investigational device protoco
Liaise with physicians on the design and development of several Novel Research Projects
Trained field personnel and Physicians on the use of new technologies.
February 2008-February 2009
Field Clinical Engineer - St. Jude Medical (Irvine Biomedical)
Managed clinical sites for the Atrial Fibrillation division –
Took Part in Electrophysiology Studies using NavX Electroanatomical Mapping System
Worked with Research and Development Team on the Design and Validation of catheters and RF generators
September 2004- February 2008 Field Clinical Engineer Impulse Dynamics
Managed and Took part in the .
Selection, training and monitoring of IDE Clinical sites
Collected and processed clinical data.
-Facilitate Physician Protocol generation
-Liaison between R & D and Physicians
Liaise with the FDA during Pre-IDE meeting and investigational device protocol approvals.
Publication Development
-Work with Company and physicians to prepare scripts..
Training/Field Education
-Lecture at and participate in Regional and National training programs.
-Aid Physicians with technology
- Controlled device distribution and allocation.
June 2003 September 2004 Senior Clinical Research Manager – Medtronic EP Systems Inc
Clincal Study Manager – MRI Safe Systems. Compiled the original clinical strategy for Medtronic’s MIR safe systems.
Worked with the FDA on the Pre-IDE meetings for the design of clinical trials and regulatory strategy of MRI safe systems.
Oversee the direction, planning, execution, and interpretation of clinical research projects.
Core Team member for the development of LocaLisa II project and MRI safe Systems.
Worked with the R&D group in the development of GLP studies for the development of an irrigated linear ablation catheter.
Established and approved scientific methods for design and implementation of clinical strategies, clinical protocols, data management plans, monitoring plans and final reports.
Monitored and/or interpreted results of clinical investigations in preparation for new drug and device application.
Compiled publication ideas with Investigators.
Jul 2001- September 2003- Clinical, Quality and Regulatory Affairs Manager– Tuta Healthcare
Liaised with various regulatory bodies, such as the TGA, FDA, and European bodies, in the approval, registration and listing of the company’s pre-existing and new products.
CE and CA marked a series of devices.
Obtained approval via 510(k) for various devices.(4)
Devised various clinical protocols for device evaluation.
o Post and Pre-market.
Managed a serious of projects including
oElectrophysiology Catheters.
oInterventional Cardiology Disposables.
Managed the everyday running of the quality department.
Nov 2000-July 2001 – Research and Development Manager – Sunshine Heart Company
Led a team of experts in the development of a fully implantable counterpulsation device for the treatment of Congetive heart Failure
Sep 1999-Nov 2000 Senior Technical Services Engineer – ResMed Australia
Development of Technical Service Documentation for Sleep Apnea and Sleep Diagnostic Devices
Aug 1995-June Sep 1999 Senior Research Fellow- Electrophysiology Lab and Pacemaker Clinic–SCH Cardiac Hospice
Taught transcatheter EP techniques to cardiology residents and fellows.
Designed and oversaw pre-clinical testing of pacemaker/ICD and CRT devices.
Established transcatheter techniques for Electrophysiology Laboratory.
Designed several novel imaging techniques for evaluating the hemodynamic affects of pacing therapies.
Conducted several animal research and human research projects in pacing, and defibrillation therapies.
1.Defibrillation Thresholds.
2.Atrial fibrillation Burden.
3.AF and Flutter Ablation.
4.Detrimental effects of VVI Pacing
5.VVI Pacing and AF.
Feb1992- Jun 1995 Research Engineer-(Biomedical Engineering) Department of Applied Research Telectronics Pacing Systems (Sydney Australia)
Wrote clinical protocols for clinical studies:
Co-designed Myo-defib: A combined implantable myostimulator defibrillator for use in animal and clinical studies. A Project partially funded by the (CRC) Centre for Cardiac Technology, Royal North Shore Hospital.
Designed several Arrhythmia detections algorithms for an implantable defibrillator.
Designed an off-line image processing workstation for the assessment of chronic Dynamic Cardiomyoplasty using echocardiography. This involving the use of specialized imaging algorithms for the PhD dissertation.
Re-implemented Telectronics CRS (Clinical Research System) software adding the muscle stimulation and combined defibrillation myostimulation routines.
Assisted and performed the implanting of medical (pacemakers, defibrillators and Myostimulators) devices in animal models at Westmead Vivarium, Westmead Hospital, Sydney Australia and at the CRC. Centre for Cardiac Technology, The Royal North Shore Hospital, Sydney Australia
Induced a Rapid Pacing, and Drug Induced Heart Failure Models .
Evaluated a heart failure model using the microembolization technique.
Extensive use of assessment tools (i.e. Millar Pressure Volume Technique, sonomicrometry for the evaluation of chronic Heart Failure and Dynamic cardiomyoplasty in experimental animals.
Patents and Patent Applications
1.An Bioresorbable Implantable Pain Sensor
2.BIODEGRADABLE MICROSPHERES INCORPORATING RADIONUCLIDES
a.Publication number: 202********
3.Biodegradable microspheres
a.Patent number: 10182979
4.SYSTEMS, DEVICES AND METHODS THAT AFFECT NEURAL TISSUE THROUGH THE DELIVERY OF A PULSED RADIO FREQUENCY SIGNAL GENERATED BY AN IMPLANTABLE MEDICAL DEVICE
a.Publication number: 201********
b.Abstract: Radio frequency (RF) energy is transmitted through the application of a SYSTEMS, DEVICES AND METHODS THAT AFFECT NEURAL TISSUE THROUGH THE DELIVERY OF A PULSED RADIO FREQUENCY SIGNAL GENERATED BY AN IMPLANTABLE MEDICAL DEVICE
c.Publication number: 201********
5.ACTIVE IMPLANTABLE MEDICAL DEVICE ASSOCIATED WITH, OR INTEGRATED INTO, AN ORTHOPEDIC IMPLANT DEVICE
6.Systems, devices and methods that affect neural tissue through the delivery of a pulsed radio frequency signal generated by an implantable medical device
7.BIODEGRADABLE MICROSPHERES
a.Publication number: 201********
8.BIODEGRADABLE MICROSPHERES INCORPORATING RADIONUCLIDES TECHNICAL FIELD
a.Publication number: 201********
b.Abstract: A crosslinked NATURAL POLYMER POLYMER/NATURAL POLYMER AUTOMATED POSTURE CORRECTION SYSTEM
c.Publication number: 201********
9.METHOD AND SYSTEM FOR ALLEVIATING JOINT PAIN
a.Publication number: 201********
Publications:
1.Weng L1,2, Seelig D3, Souresrafil OLong-Term Implantability of Resorbable Carboxymethyl Cellulose/Chitosan Microspheres in a Rabbit Renal Arterial Embolization Model. Cardiovasc Intervent Radiol. 2018 Mar 14. doi: 10.1007/s00270-018-1931-2
2.Effect of AV-VV optimization on Central Sleep Apnea in patients implanted with a Cardiac Resynchronization Device. HRS 2011.
3.Effect of Dual Site Pacing Left Ventricular Pacing on Left Ventricular Hemodynamics Adjacent and Distant to the Site of Infarction, in the Sheep Heart Failure Model Using Three Dimensional Echocardiography. HRS 2007.
4.Cardiac Resynchronization Therapy Reverses Left Ventricular Dysynchrony Created by Right Ventricular Apical Pacing in the Sheep Heart Failure Model . HRS 2006.
5.Effect of CPAP therapy on Atrioventricular Interval and QRS Duration in Heart Failure Patients and Obstructive Sleep Apnea implanted with a DDD Implantable Pulse Generator
6.Effect of CPAP therapy on Atrial Fibrillation Burden in pacemaker patients with Heart failure and Cheyne Stokes Breathing. NASPE 2005
7.Effect of cardiac resynchronization therapy on atrial reverse remodeling using three dimensional echocardiography. Europace 2005.
8.CPAP therapy reduces atrial fibrillation burden in Pacemaker patients with Cheyne-Stokes breathing. Europace 2005.
9.QUANTIFICATION OF LEFT VENTRICULAR DYSYSNCHRONY USING SEGMENTATION AND THREE DIMENSIONAL ECHOCARDIOPHY. XI INTERNATIONAL SYMPOSIUM ON PROGRESS IN CLINICAL PACING – Rome – Italy 2004
10.Souresrafil O, Long Term Hemodynamic Studies of Bi-Ventricular Pacing in the Sheep Heart Failure Model, Using a Three Dimensional Echocardiographic Workstation - A Comparative Study – Cardiostim 2004. Europace Volume 6, Supplement 1, Pages 1-203 (June 2004).
11.Souresrafil O, Sanati A, Coronary Flow as a Marker for Hemodynamic Improvement and Ventricular Reverse Remodeling in Bi-Ventricular Pacing, using a Three dimensional echocardiograpic workstation, in the Sheep Heart Failure Model.. HeartRhythm May 2004 (Vol 1, Issue 1 (Supplement).
12.Souresrafil O, Sanati A, TITLE: Assessment of Ventricular Resynchronization Therapy and Increased Coronary Blood Flow,Using a Three dimensional echocardiograpic workstation, in the Sheep Heart Failure Model – PACE-
13.A FINITE ELEMENT MODEL ANALYSIS OF THE LEFT VENTRICLE IN THE SHEEP HEART FAILURE MODEL, WITH AND WITHOUT BI-VENTRICULAR – NASPE 2001.
14.HAEMODYNAMIC STUDIES OF THE SHEEP HEART FAILURE MODEL UNDRGOING BI- VENTRICULAR PACING, USING THREE DIMENSIONAL VENTRICULAR RECONSTRUCTION – NASPE 2001.
15.Comparison of Bi -Ventricular Pacing versus Intra-aortic Balloon Counterpulsation, on Coronary Blood Flow in the Sheep Heart Failure Model – NASPE 2002
16.Souresrafil O, Sanati A, Ventricular Reverse Remodeling in Bi-Ventricular Pacing Using Three Dimensional Reconstruction in The Sheep Heart Model – NASPE 200.
17.Prediction of Atrial Fibrillation in Patients with Paroxysmal Atrial Fibrillation, using an Automatic P- wave Signal Averaged Electrocardiogram Predictor. IX INTERNATIONAL SYMPOSIUM ONPROGRESS IN CLINICAL PACING ROME (ITALY), DECEMBER 5-8, 2000
18.Assessment of the Hemodynamic benefits of BI-Ventricular Pacing Therapy, using an automated Echocardiographic Border Detection, in the Sheep Heart Failure Model. IX INTERNATIONAL SYMPOSIUM ONPROGRESS IN CLINICAL PACING ROME (ITALY), DECEMBER 5-8, 2000.
19.EFFECTS OF A MULTI LEVEL POSITIVE PRESSURE THERAPY ON PATIENTS IMPLANTED WITH A PACEMAKER – IX International Symposium on Progress in Clinical pacing – Dec 2000.
20.Haemodynamic Benefits of Biventricular pacing in the Sheep Heart Failure Model. IX INTERNATIONAL SYMPOSIUM ON PROGRESS IN CLINICAL PACING ROME (ITALY), DECEMBER 5- 8, 2000.
21.Efficacy of a combined implantable Cardiomyostimulator defibrillator – The 11th Annual Congress of the Iranian Heart Association – October 2000.
22.Effect of Electrical Stimulation of the Latissimus Dorsi on Defibrillation Thresholds. Eurokongress, Berlin –Germany, June 1999.
23.Comparison of Left Ventricular Function by Echocardiographic Automated Border Detection, using Variable Threshold Settings and by Automated Edge Detection. The 8th Annual International Biomedical Engineering Conference, Singapore, Dec 1994.
24.Reflected Changes in Left Ventricular Volume using Two Dimensional Echocardiographic Border Detection. The 7th Annual Iranian Biomedical Engineering Conference, Tehran, Iran Dec 1994.
25.A Storage and data Analysis and data Processing System for the Hemodynamic Echocardiographic Evaluation of Dynamic Cardiomyoplasty. Abstract presented in Computers in Cardiology, Vienna Austria September 1995.
26.Variability of Pacing Thresholds in a Large patient Populaiton. The 11th Congress of the Asian/Pacific Society of Cardiology – October 1998.
27.VVI Pacing and Prevalence of Paroxysmal Atrial Fibrillation . The 11th Congress of the Asian/Pacific Society of Cardiology. October 1998.
28.The Use of RR Intervals as a method of the Detection of Atrial Fibrillation – Preliminary Results with a New Detection System . The 11th Congress
Contact this candidate