Medical Device Development Experience Portfolio

Tronics MedTech incorporates a cross section of technical expertise for external and implantable medical devices in such areas as: algorithm development and signal processing expertise, open and closed–loop sensing systems, programmability, flow rate dynamics, device valve design, remote communications and battery management and power consumption.

Product Development

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Therapeutic	Cardiology	Bifurcated Stent	Developed a design of a coronary bifurcated stent, which exceeds the capabilities of the competition without infringement on existing intellectual property
Therapeutic	Cardiology	Implantable Devices	Led "value engineering" projects for four implantable medical products managing the development effort to completion. Identifying inefficient business processes and provided corrective action
Therapeutic	Cardiology	Pacemaker	Managed size reduction of two pacemakers
Therapeutic	Cardiology	Device Monitor	Developed non–invasive cardiac output measurement device
Therapeutic	Cardiology	Smart Magnet	Managed development of Smart–Magnet for use during surgery on implantable defibrillator patients
Therapeutic	Cardiology	Heart Valve	Designed and developed heart valve related products
Therapeutic	Cardiology	Valve	Designed and optimized Nitinol venous valve
Therapeutic	Cardiology	Stent Graph	Optimized design of Abdominal Aoristic Aneurysm (AAA) stent graph
Therapeutic	Cardiology	Implantable Device	Optimized design of bypass fastener
Therapeutic	Cardiology	Stent	Optimized design of aortic fastener for perforated roll–up Nitinol frictional lock coronary stent
Therapeutic	Gastrointestinal	Implantable Device	Designed Class III MRI–safe, implantable control system for obesity
Therapeutic	Gastrointestinal	Device Electronics	Designed and implemented control circuitry for application of RF energy to RF ablation device aimed at treating Barrett's syndrome
Therapeutic	Gastrointestinal	Implantable Device	Optimize design of gastric tissue fastener
Therapeutic	General	Implantable Pump	Developed remotely powered and monitored implantable pump system allowing long term intermittent therapy control
Therapeutic	Hospital – IV Pump	Safety Detection	Developed low cost air detector for IV pump
Therapeutic	Neurology	Screening Device	Managed development of external neurological screener
Therapeutic	Neurology	Stent	Directed optimization and mechanical analysis of neurological stent
Therapeutic	Neurology	Neurostim Implantable	Development of implantable neural stimulation system to treat chronic disease and pain
Therapeutic	Patient Aids	Advanced Wheel Chair	Created and implemented product development strategy for revolutionary wheel chair design
Therapeutic	Urology	Software	Led software development for urinary incontinence product
Surgical	Cardiology	Fastener Device	Optimized design of aortic tissue fastening device
Surgical	Surgical	Device	Designed and implemented Nitinol tissue fastener and delivery system
Surgical	Urology	Device	Optimized design of biliary and urinary invasive surgical components
Surgical	Urology	Surgical Tool	Developed concept an design for delivery system for a urinary device
Diagnostic	Audiology	Screening Device	Developed brainstem evoked response system for newborn hearing screening
Diagnostic	Audiology	Patents	Developed IP for otoacoustic analysis of middle ear
Diagnostic	Cardiology	Software	Developed vascular diagnostic software system
Diagnostic	Cardiology	Hemodynamics Ultrasound	Developed ultrasonic blood flow analysis
Diagnostic	Cardiology	Communications	Designed and implemented high speed data acquisition board for intra–vascular ultra sound system
Diagnostic	Diabetes	Glucose Monitoring	Designed Intel Celeron 400 ultra low power based glucose monitoring control system
Diagnostic	Gastrointestinal	Device + Sensor	Developed breath analysis system for diagnosis of digestive disorder
Diagnostic	General	Breath Analyzer	Developed non–intrusive breath alcohol analyzer
Diagnostic	Hemoanalyis	Device + Sensor	Developed breath analysis system for determination of hemolysis
Diagnostic	Laboratory	Lab System	Developed clinic–based portable vascular laboratory
Diagnostic	Monitoring	Hospital Device + Communication	Developed hospital based vital signs telemetry system
Diagnostic	Monitoring	Remote Monitoring	Managed development of remote monitoring system for worldwide patient home monitoring
Diagnostic	Monitoring	Signal Processing	Developed patented signal processing techniques for medical signal analysis
Diagnostic	Neurology	Test Kit	Managed development of a peripheral nerve evaluation kit

Mechanical Simulation

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Therapeutic	Cardiology	Pacemaker	Developed cost reduction plan and managed reengineering of market released pacemaker
Regulatory	Cardiology	Stent	Performed analysis submittal for stainless steel coronary tubular, balloon expandable stent
Regulatory	Cardiology	Stent	Performed FDA analysis submittal for perforated roll–up Nitinol frictional and manual lock coronary stents
Quality Assurance	Cardiology	CHF Device	CHF device analysis and verification
Quality Assurance	Cardiology	Implantable Pump	Computational Fluid Dynamics (CFD) analyses of implantable medical devices for blood shear reduction
Quality Assurance	Gastrointestinal	Ablation Device	Developed mechanical analysis method for ablation simulation
Quality Assurance	General	Implantable Pump	Computational Fluid Dynamics (CFD) analyses of blood flow through plaque removal devices and arterial graphs

Management Consulting

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Organization	Corporate	Corporate Reorganization	Redirected a functional department restructuring by managing, reorganizing, recruiting and restaffing department
Quality Assurance	Corporate	Mechanical Test Protocol	Lead author of American Society for Testing and Materials F04 draft recommendations for mechanical analyses of metallic stents
Quality Assurance	Corporate	Standards Committee	Key member of ASTM F04 committee for implantable medical devices

Manufacturing

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Quality Assurance	Corporate	Test System	Led development of new automated test system for high volume manufacturing

IP Consulting

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Legal	Corporate	Expert Witness	For multiple projects provided expert witness and litigation technical support in patent infringement and product liability litigation

Intellectual Property

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Legal	Corporate	Patents	Holders of multiple issued and pending patents of medical devices

Documentation & QA

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Product Support	Corporate	Product Manuals	Managed redefinition and restructuring of instruction manual creation process for major device company

Product Development + Market Intro

CATEGORY	FIELD	PRODUCT	DESCRIPTION
Diagnostic	Diabetes	Comprehensive Telemedicine – Device + Software	Developed remote ambulatory diabetes management system incorporating blood glucose monitoring, life style assessment, home software, clinic software and telemed communication with web link