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Biomedical Design Expert Consultant Resume

Resume of SFI, Ph.D., PE - Biomedical Consultant
Principal Industries Served:
  • Biomedical Design
  • Medical
  • Manufacturing

Education:

This expert has a Ph.D. in Civil Engineering from the University of Minnesota in Minneapolis.

This expert received an M.S. in Civil Engineering from the University of Denver, Colorado.

This expert has a B.S. in Aeronautical Engineering from the University of Illinois.


Expertise and Services:

Biomedical Design Expert Consultant Resume

This expert specializes in biomedical design, product design, analysis, test protocols, design verification tests and product documentation for FDA IDE submission of novel biomedical devices.

This expert has performed preliminary design and FEA solutions for Dacron mesh covering the heart ventricles. The mesh was designed to limit further expansion or dilation for the ventricles, reduce heart wall stress and improve ejection fraction. This expert has also provided consulting services for the development of full 3-D FEA model of the human heart and simulation of an implanted heart pacing lead dynamic response to heart wall motion.

This expert has provided analysis and design modification for pacing lead interface to the pacemaker header and evaluated pullout forces, screw torque requirements and other parameters verified by product tests.

This expert has analyzed pacing lead heart wall anchoring tip design for insertion and removal forces as well as analyzed and redesigned extruded pacing lead geometry to meet flex and crush test product design criteria. This expert designed enhanced RF based ablative catheter design improved field distribution and tissue penetration by approximately 30%. This expert provided design and analysis support for the evaluation of electrostatic (RF) field strengths in human upper thoracic cavity.

This expert developed full 3-D FEA model of upper thoracic cavity and provided 3-D plots of potential surface distributions in heart structure due to source-sink device locations on or in the thoracic cavity model. Support effort required development of thoracic cavity model including heart and device geometry and materials.

Furthermore, this expert performed analysis for evaluation of electrostatic field distribution in human tissue for the proposed treatment of cancerous tumors. Devices included in the study consisted of flat plates, pins, and other proposed designs both external and implanted.


Professional Experience:

Consultant, Kevin Kennedy Associates Inc.

Providing biomedical design consulting, biomedical design analysis and testing, product design verification, FMECA, MTBF, and MTTR consultant, patent infringement expert witness testimony, and related expertise to a wide variety of clients.

 

Principal Consultant, Biomedical Services Consulting firm

Provided biomedical device design, analysis and testing services for various biomedical clients. Product design, analysis, test protocols, design verification tests and product documentation for FDA IDE and 510K submission of novel biomedical devices.

 

Director of Design and Analysis, Cardiovascular Systems, Inc.

Was responsible for analysis and design verification testing of novel orbital atherectomy device for removal of stenotic tissue in cardiovascular and peripheral applications. Developed test protocols, performed verification tests and produced test reports and supporting documentation for FDA IDE submission.

 

Research Fellow R&D Product Design, Boston Scientific, SciMed Division, Maple Grove, MN

Performed non-linear finite element analysis of catheter mounted stents, plain and drug coated; angioplasty catheter designs and related products. Applications required non-linear materials (stainless steel, shaped memory, Titanium, extruded and injection molded plastics and others) for three dimensional (3-d) contact, and complex assemblies.

 

Senior Staff Scientist, Medtronic, Inc., Promeon Div. Biomaterials Research Ctr.

Primary responsibility for implementation of numerical simulation methods using finite element and computational fluid dynamics techniques for product design and analysis. Product categories: pacing leads, angioplasty stents, catheters, and balloons; modeling of ablation catheter RF field distributions in fluids and tissue; CFD applications blood oxygenator designs, blood pumps, heart valves; implantable drug pumps and other bio-mechanical products.

Additional Experience:

Specific Design and Analysis Projects

Performed preliminary design and FEA solutions for Dacron mesh covering the heart ventricles. The mesh was designed to limit further expansion or dilation for the ventricles, reduce heart wall stress and improve ejection fraction.

Provided consulting services for the development of full 3-d FEA model of the human heart; simulation of implanted heart pacing lead dynamic response to heart wall motion.

Provided analysis and design modification for pacing lead interface to the pacemaker header. Evaluated pullout forces, screw torque requirements and other parameters verified by product tests.

Analyzed pacing lead heart wall anchoring tip design for insertion and removal forces.

Analyzed and redesigned extruded pacing lead geometry to meet flex and crush test product design criteria.

Designed enhanced RF based ablative catheter design improved field distribution and tissue penetration by approximately 30%.

Design and analysis support for the evaluation of electrostatic (RF) field strengths in human upper thoracic cavity. Developed full 3-D FEA model of upper thoracic cavity and provided 3-D plots of potential surface distributions in heart structure due to source-sink device locations on or in the thoracic cavity model. Support effort required development of thoracic cavity model including heart and device geometry and materials.

Performed analysis for evaluation of electrostatic field distribution in human tissue for the proposed treatment of cancerous tumors. Devices included in the study consisted of flat plates, pins, and other proposed designs both external and implanted.

Developed non-linear, large displacement simulation for winding of pacing lead coils using stainless steel and shape memory alloy wire for pacing lead designs.

Designed and performed design verification analysis of a cardiovascular bypass flow devices intended to pass through the ventricular wall directly into the coronary arteries downstream of the arterial occlusion. The analysis used computational fluid dynamics (CFD) analysis to evaluate flow velocities, pressure distributions and other flow effects in the ventricle, the capillary device, and the coronary artery.

Designed and performed non-linear FEA analysis of guided flexible core stylet.

Provided analysis support for the Mayo-Splint®, a device intended to be used to improve the ejection fraction of the human heart by mechanically altering the shape of the human heart, thereby improving its efficiency.

Designed and analyzed sutureless connector for cardiac bypass applications using shaped memory alloys.

Performed design modification and design verification analysis for peripheral stent designs fabricated from stainless steel and shape memory alloys.

Design and analysis of implantable neural stimulation leads for pain control, non-linear analysis of spinal cord lead and attachment contact tips for mechanical anchorage and electrical field contact.

Developed simulation methods for catheter mounted RF device designed to minimize or prevent arterial restenosis due to angioplasty and stent placement. Support included coolant fluid flow volume and flow channel design, assembly heat transfer and temperature distribution in arterial walls due to coolant flow velocities. Design was later modified X-Ray source device for cancerous tumor applications and being evaluated for potential ablative catheter applications.

Stent and catheter mounted stent/balloon design and analysis for stainless steel, shaped memory alloys and non-metallic materials-cardiac & peripheral applications. Provided technical support and documentation for FDA IDE and PMA submissions.

Non-linear materials for device design and analysis: stainless steel alloys; shaped memory alloys; composite materials; injection molded and extruded plastics; rubber; ceramics

Developed and patented a modified design of an orbital atherectomy device to enhance product design safety and performance.

Developed test protocols, performed verification tests and produced test reports and supporting documentation for FDA IDE submission.

Academic Appointments

Adjunct Research Professor Oregon Health Sciences, Department of Biomaterials & Biomechanics, Portland, Oregon

Invited Lecturer and Adjunct Professor, Department of Civil Engineering and Construction, North Dakota State University, Fargo, ND

Research Associate University of Minnesota, Dept. of Laboratory Medicine & Pathology, Biomedical Engineering Center, Minneapolis, MN

Adjunct Professor University of Minnesota, Dental College, Minneapolis, MN


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