PROFILE Over ••••• years experience in business and technology development for non-invasive cardiac acoustic technology startups. Extensive understanding of systems and methods, balancing medical, regulatory and commercial options. Meticulous attention to detail, astute observation and strong technical understanding. Highly effective communicator, specific to complex issues, including research and FDA clearance process for commercialization of Class II devices. Liaison with various levels of management and academia, across medical, financial and engineering disciplines.
EXPERIENCE SonoMedica, Inc. - McLean, VA Consultant ••••• 6/••••• – •••••/••••• · Prepared reports summarizing performance issues, design history and recommendations on Cardiovascular Sonospectrographic Analyzer (CSA) system for new management team. · Developed demonstration scripts, training course and produced video for setup and running CSA for new staff.
CardioSports4Life, Inc. - McLean, VA Chief Technology Officer / Founder••••• 3/••••• – 6/••••• · Served dual roles with SonoMedica and its sports medicine licensee as CTO and developer. · Collaborated in research and marketing efforts to tailor system for sports medicine and first responder applications. · Briefed Senior Management and Boards of both companies, developing and executing strategic and tactical market driven directives for complementary business opportunities.
SonoMedica, Inc. - McLean, VA Senior Clinical Research Scientist / Engineer ••••• 6/••••• – •••••/••••• · Collaborated with Rutgers University on $•••••,••••• Phase II NIH Grant (awarded •••••) on Device for Non-Invasive Detection of Coronary Artery Disease · NYU School of Medicine protocol and study oversight and analysis: o Validation of Cardiac Sonospectrographic Digital Electronic Stethoscope versus CT Angiography and Radionuclide Stress Testing o Validation of Cardiac Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease versus CT Angiography. · Technical liaison with CardioSports4Life, Inc. · Developed corporate websites, email communications and FDA compliant electronic data transfer capability supporting local and non-local test sites. · Technology featured in Paintball Sports and NY Sportscene Magazines April •••••, television news feature New York WPIX••••• Empowered Doctor segment, April ••••• and Heartbeat of America’s national television show, October •••••
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SonoMedica, Inc. - McLean, VA Consultant – Clinical Research Associate / Field Engineer ••••••••••/••••• – 2/••••• · Managed all clinical research: Georgetown UMC, George Washington UMC, Medical College of Virginia VCU and beta test sites. · Trained all clinical personnel and support staff in operation of CSA. · Collaborated with Rutgers University on $•••••,••••• Phase I NIH Grant (awarded •••••) for Improved Acoustic Detection of Coronary Blockages research. · Aided in development of Cardiovascular Sonospectrographic Analyzer (CSA), granted FDA •••••(k) clearance K••••• May ••••• · Contributed to patents issued for: o System and Method of Detecting and Processing Physiological Sounds o Method and System for Generating a Likelihood of Cardiovascular Disease, Analyzing Cardiovascular Sound Signals Remotely from the Location of Cardiovascular Sound Signal Acquisition, and Determining Time and Phase Information from Cardiovascular Sound Signals o Method and System for Modeling Cardiovascular Disease Using a Probability Regression Model · Europace Journal •••••: Detection of Microbubble Formation During Radiofrequency Ablation using Phonocardiography co-author. · Collaborated with clinical research sites for May ••••• Heart Rhythm Society Conference poster session study results for microbubble formation in RF catheter ablation and S3 and S4 reduction with bi-ventricular pacing. · Aided in authoring and executing protocols for engineering studies using CSA to detect changes in cardiac activity with bi-ventricular pacing and comparison to echocardiography. · Continued research, development created marketing material and demonstrations of CSA resulting in private equity fundraising greater than $5MM. · Assisted in production of ••••• iterative prototypes, software and hardware improvements.
TransMedica, Inc. – Vienna, VA Consultant – Clinical Data Analyst ••••• ‘••••• – ‘••••• · Examined and interpreted cardiac acoustics for components associated with coronary artery disease and other flow disruption characteristics, cataloging findings for further system development. · Aided in development of TransMedica Model ••••• Digital Electronic Stethoscope, granted FDA •••••(k) clearance K••••• May ••••• · Device featured in National Navy Medical Center Journal February ••••• · Contributed to patents issued for Cardiac Sonospectrographic Analyzer and Method of Using an Acoustic Coupling for Determining a Physiologic Signal.
EDUCATION Purdue University – West Lafayette, IN••••• 8/••••• – •••••/••••• · Bachelor of Science Physics · Minor Mathematics additional concentration in Atmospheric Science