Greater Houston
I am an experienced biomedical engineer with over 10 years of science research background and over 15 years of regulatory experience. I have extensive knowledge of FDA, EU, and Health Canada regulations. My expertise are in cardiovascular diseases and neuroscience, and medical devices that support these functions. I enjoy working in a team environment both as a leader and team player. I thrive on learning about new technologies and applications that will help protect and promote public health, and look for such opportunities to apply my research and regulatory experience to achieve that mission. Specialties: Cardiovascular Devices, Neurological Devices, FDA Regulations, Biomedical Engineering, First-in-Human and Early-Feasibility Clinical Trials, De Novo Classification Process, Project Management, Spinal Cord Injury, EUMDR Class II/Class III medical device, AIMD, Notice of Change submissions Technical Skills: Fluorescence Microscopy, Confocal Microscopy, Histology, Cell culture techniques, Cardiac Perfusions, Animal Models, Immunohistochemistry, Electrical Safety
My FDA experience includes reviewing medical devices pre-market submissions (i.e. 510(k)’s, PMA’s, IDE's, de novo’ s, pre-submissions, 513g's, and HDE's) for the Division of Cardiovascular Devices (DCD) and the Neurodiagnostic and Neurosurgical Devices Branch (NNDB). Specifically, I examine devices used in the diagnosis and treatment of cardiac arrhythmias, diagnosis and treatment of various neurovascular conditions, robotic-assisted surgical procedures, and therapeutic hypothermia during surgical procedures. Percutaneous electrophysiological mapping and ablation catheters of various modalities (RF/Cryo/3D mapping etc.), cardiac and neurovascular guide catheters, blood pressure monitors, ECG monitors, robotic systems used in cardiac surgical procedures, esophageal cooling systems, and body temperature management systems are just a few of the devices that I am responsible for reviewing.
Thesis Title: Motor Neuron Axon-Schwann Cell Interactions in Organotypic Cultures of the Murine Spinal Cord Advisor: Dr. Lawrence P. Schramm • Identified cells responsible for axon regeneration and guidance in slice cultures of spinal-motoneurons. • Designed the first platform to integrate organotypic cultures and microfluidic technology for focal myelination studies. • Characterized the roles of laminin2/8 in axon guidance and Schwann cell-axonal interactions. • Studied the spinal pathways involved in the recovery of baroreflex control after spinal lesion in the rat using pseudorabies virus (publication below). Laboratory Techniques: immunohistochemistry, fluorescent and confocal microscopy, organotypic cultures, dissociated cell cultures, vibratome/microtome sections, histology, spinal laminectomy, cardiac perfusions.
• Spring 2007: Physiological Foundations II. Junior level undergraduate course. • Fall 2006: Models and Design. Freshman level undergraduate course.
• Co-founded student run strategy consulting firm committed to providing graduate students with consulting experience. • Estimated market size ($50M) and assessed competitive environment for a Class II medical device. • Evaluated the market potential ($14M) for an oncology therapy through estimating its addressable patient population (~2.8K) and its potential pricing ($5K annually). • Identified key drivers for the refurbished-mobile market in Central America.