Develop five phase project plan utilizing the quality management system and mutual contract; research and design novel leads, cuffs, delivery tools, and sensor systems; build prototypes and test; create connections with suppliers and enable efficient manufacturability of product; manage multiple clients and projects; day-to-day operations.

Med-Ally designs, develops, and manufactures Active Implantable Medical Device (AIMD) systems and associated components focused on neuromodulation applications. We work closely with our partnered clients through the complete process of product development, via a Quality System based upon FDA 21CFR820, certified to ISO 13485: 2016. We address all aspects of the process with Risk Management as specified in ISO 14971 assuring all requirements are met for customer specified therapy applications.

Primary Project:• Development of an Autism Spectrum Disorder Screening Test based upon Metabolic Profiling of Fresh Blood SamplesTwo-year National Institute of Mental Health Phase 1 STTR partnered with Greenwood Genetic Centero Developed standard operating procedures (SOP) for assay plate production, whole blood processing, cell line processing, and assay performanceo Configured and programmed automated robotic liquid handling system for use in 384-well plate assay production and cell processingo Optimized and automated plate absorbance and fluorescence readings on robotic incubator/plate reader systemo Created complex substrate solutions for subsequent metabolic analysiso Extracted PBMCs from whole blood samples in a biosafety level 2 facilityo Established immortalized lymphoblastoid cell lineso Characterized metabolic profile of isolated cellso Miniaturized sample volumes required for assay to 384-well plate volumeso Performed statistical analysis on time dependent absorbance and fluorescence readings o Extracted features from acquired absorbance data, SOP information, and survey resultso Developed classifier using machine learning, data filtering, and data mining techniques Secondary Projects: Coauthored DoD, NIH, and NSF proposals for relevant funding opportunities, including concept generation, background research, preliminary design, and rendering of novel prototypes in SolidWorks for SBIR/STTR grant submissions• Development of Novel Bio-Adhesive Mesh System for Abdominal Hernia Repair• SBIR/STTR Phase I Proposal Addressing COVID-19• Wireless In-Ear Sensors for Warfighter Monitoring• Magnetic Field Peripheral Ring Nerve Blocks• At-Home Minimally Invasive Tacrolimus Plasma Level Monitoring Device• Development of POC Assays to Quantify anti-Tuberculosis Antibiotics in Blood• Development of an At-home Urine Test for Monitoring Blood Phenylalanine Levels for phenylketonuria

• Dialysis Training Simulator Project. Designed a training simulator and its components to improve arteriovenous fistula cannulation for dialysis care. Verified and validated synchronization of cameras, sensors and electromagnetic emitters. Utilized Northern Digital Aurora & Trak STAR for tracking needle tip position. Utilized Leap Motion Tracker & Xbox Kinect for palpation analysis. 3D printed AV fistulas from ultrasound images collected by research team.• Neurodevelopmental Disorder Motion Tracking and Machine Learning Analysis (primarily Rett Syndrome, Parkinson’s Disease, Essential Tremor). Designed a biometric wearable device to track episodic behavior in order to analyze efficacy of symptomatic treatment. Designed and performed verification and validation studies for each sensor used (e.g. inertial measurement unit, gyroscope, magnetometer, electromyography, galvanic skin response, various proximity sensors, triaxial load sensor) as well as on the final device. Founded a research development team to continue the Rett syndrome research.

• Participated in full-time summer program through Clemson University that pairs clinical collaborators from the Greenville Health System with bioengineering students to conduct comprehensive clinical needs-finding rotations. o Compiled and analyzed any difficulties, device limitations or needs the physicians identified during the procedureso Presented procedure and physician needs to teachers, classmates and a panel of engineers from the surrounding communityo Observed a variety of surgeries ranging from basic appendectomies to total shoulder and hip replacements to surgeries utilizing the Da Vinci robot.  (Over 300 hours of total surgery observation time between 2011-2016.)

• Removed the temporomandibular joint (TMJ) from pigs, removed the cartilage intact, cut five cartilage samples, shaved samples with microtome to a uniform thickness, designed circuit to measure ion diffusion across the sample and interpreted data to better understand the properties of the TMJ cartilage• Performed 300 3-point bend load tests on hydraulic axial loading machine for dental students