Medical Device Applications

External and Implantable Medical Device Systems

• Neural Stimulation Systems — Development of external and implantable neural stimulation device systems that treat chronic diseases and acute pain management. Emphasis on safety, ease–of–use and low power consumption.
• Implantable Pump Systems — Developed remotely powered and monitored implantable pump system. Allows long terem intermittent therapy control. Established feasibility and prototype design.
• Diagnostic Device Systems — Designed telemedicine system for management of chronic diseases. System incorporated ambulatory patient device with diagnostic test, data acquisition capabilities, remote communications and clinic and patient management software.
• Wireless Power, Programming & Control Of Implantable Systems — Developed implantable devices and external controllers that power and communicate with the implantable device regulating the coupled power to optimize performance and battery life as well as transmitting critical control parameters and securely storing and retrieving patient and device data.
• RF (Distance Communication) — Designed communications systems for transmittal of information at significant distances from a monitored patient.
• Rfid Communication Protocol — Designed devices and systems using off–the–shelf and custom devices utilizing recognized RFID communication protocols.
• Implantable Materials — Identified and analyzed devices determining appropriate implantable materials for suitable strength, durability and biocompatibility. Devices included stents, orthopedic devices, catheters, reservoirs and delivery systems for such devices.
• Non–Linear Implantable Materials — Extensive experience in designing & modeling shape memory alloys, tissue & flow.
• Low Power Design — Designed highly efficient, low power devices utilizing primary and secondary batteries and devices capable of being powered by remote wireless power transmission such as bio–sensors and stimulators.
• Sensors — Developed and selected sensors and designed packaging for both in vivo and external use for both monitoring and therapeutic systems utilizing electrical, temperature, pressure, optics and ultrasound elements.
• Implantable Pumps — Developed implantable pumping systems including actuator optimization, control, power and communication systems.
• Implantable Device Locator — Developed a system to power, communicate and locate with an implanted device within a very tight window. The system intended to reduce patient discomfort during follow–up.
• Ergonomic User Interface For Intuitive Operation — Across broad spectrum of medical device hardware, screen displays and software design, incorporated ease–of–use features, GUI and safety parameters and alarms.

Diagnostic Systems

• Bioelectrical Diagnosis — neuro and myo–electrical amplification and analysis hardware and software
• Electro–chemical Systems — iontophoretic drug delivery, electrochemical analysis and body fluid analysis
• Spectro–photometry Systems — UV / VIS / NIR analyzers including specialized cuvette and biological cuvette implementations
• Photo–plethysmography — invasive & noninvasive Laser, LED based systems for fluid analysis, blood pressure, blood flow
• Critical and Consumer Vital Signs Monitoring
• EKG, core temperature, blood pressure, respiration
• Ultrasound: Doppler and B–scan
• Blood flow, arterial, and tissue imaging systems
• Optical intra–luminal sizing
• Length and diameter determination using optical imaging techniques
• Minute ventilation
• Non–intrusive monitoring of chest and abdominal volume changes
• EEG / EKG / EMG
• Auscultation (stethoscopy)
• Breath (gas) analyzers — spectrophotometric, electrochemical, paramagnetic
• Blood pressure — invasive, implantable, ambulatory
• X–Ray and electron radiation & dosimetry
• Semiconductor and gas discharge detectors and monitoring systems
• Visible, RF and gamma radiation
• Energy sources and detection systems
• Audiometry — auditory brainstem response systems, acoustic sources, hearing diagnostic systems

Engineering Development Capabilities

Electronic Design

• Analog design and filtering
• Digital design and high–speed logic
• Mixed–signal digital signal processing
• RF / microwave
• Data acquisition
• FPGA, CPLD (VHDL, Verilog)
• Display interface
• Power supply, battery power and advanced battery management
• PCB design
• Remote power of internal devices

Communications

• Advanced RF, microwave, cellular and direct digital radio
• Bluetooth, USB, Firewire, Infrared, IRD
• Medical telemetry, teleradiology

Software & Firmware

• Embedded systems
• Real–time Operating Systems (RTOS)
• User interface (Win Embedded, X–win)
• Embedded small flat panel user ergonomic design
• Device drivers (WinCE, etc.)
• High–speed, high–resolution data acquisition

Mechanical Design

• Finite Element Analysis (FEA)
• Design Failure Modes Effects Analysis (FMEA)
• Photomechanical testing
• Diffraction moire interferometry
• Failure analysis
• Industrial design and human factors
• Thermodynamics / thermal cycling
• Vibration analysis and testing
• Fluid Dynamics (CFD)
• Biocompatibility
• Drug delivery system design
• Environmental testing
• Magnetic, smartcard, biosensor mechanicals
• Advanced cabling, flex circuitry
• Specialized, custom connector design

Advanced Products Systems

Medical device development is multi–disciplinary requiring expertise in specific technologies and skills coupled with the ability to synergistically integrate multiple elements into a workingsystem. Examples of Tronics MedTech's experience include:

• Neural Stimulation Systems — Development of implantable and external neural stimulation device systems to treat chronicdiseases and acute pain management. Established concept, intellectual property, feasibility,prototype and preclinical data with emphasis on safety, ease–of–use and low power consumption.
• Implantable Pump Systems — Developed remotely powered and monitored implantable pump system. Allows long term intermittent therapy control. Conducted feasibility phase demonstrating proof–of–concept and design of prototype.
• Diagnostic Device System — Created and developed telemedicine device–software system for ambulatory management of chronic disease. System incorporated patient device and diagnostic test, data acquisition for related life–style parameters, individualized patient therapy plans and remote communications and Internet capabilities.
• Balloon Catheter — Developed concepts and design for delivery system for a tissue expander for treatment of urological disfunction.