Expert Details
Medical Device Software, Safety Critical Systems, Embedded Systems Design
ID: 728502
Massachusetts, USA
Expert has experience in software, hardware design, and FPGA development that gives him the unique ability to analyze a design from all perspectives. This allows him to optimize a design for cost, speed, or power efficiency. He has experience analyzing systems that are not working to determine if the problem is caused by hardware, software or a combination of the two.
Expert has training in FDA QSR, ISO 13485, and the IEC 60601 regulatory process.
Expert has over 25 years of consulting experience developing products that have embedded systems. He has written software and firmware in C, C++, and BASIC, for a variety of products, including medical devices, underwater robots, microfluidic drug testing, alarm systems, automotive sensors, gas chromatography, superconductor magnetic quench detector, image recognition, consumer products, industrial control systems and electric power control systems.
Expert has worked with many different microprocessors including MSP430, ARM, 8051, 68HC11, PIC, dsPIC, 8086, 8088, Pentium, 6800 family, 68000, 68332, TMS320, 8085, Z80, and 8080.
Expert has experience in software, hardware design, and FPGA development that gives him the unique ability to analyze a design from all perspectives. This allows him to optimize a design for cost, speed, or power efficiency. He has experience analyzing systems that are not working to determine if the problem is caused by hardware, software or a combination of the two.
Expert has published articles in Embedded Systems Programming magazine.
Expert has over 25 years of consulting experience designing real time control systems. He understands the timing, reliability and process issues that are specific to real time systems. Many of the real time systems he has designed are safety critical systems that have stringent requirements for reliability.
Expert has written software and firmware in C, C++, BASIC, for a variety of products including medical devices, underwater robots, microfluidic drug testing, alarm systems, automotive sensors, gas chromatography, superconductor magnetic quench detector, image recognition, consumer products, industrial control systems and electric power control systems.
Expert has worked with many different microprocessors including MSP430, ARM, 8051, 68HC11, PIC, dsPIC, 8086, 8088, Pentium, 6800 family, 68000, 68332, TMS320, 8085, Z80, and 8080.
Expert has experience in software, hardware design, and FPGA development that gives him the unique ability to analyze a design from all perspectives. This allows him to optimize a design for cost, speed, or power efficiency. He has experience analyzing systems that are not working to determine if the problem is caused by hardware, software or a combination of the two.
Expert has designed the electronics for many different products. His specialty is digital design of embedded systems. He has designed products for medical devices, robotics systems, image processing systems, consumer products and industrial control systems.
Expert has worked with many different microprocessors including MSP430, ARM, 8051, 68HC11, PIC, dsPIC, 8086, 8088, Pentium, 6800 family, 68000, 68332, TMS320, 8085, Z80, and 8080.
Expert has designed systems using Field Programmable Gate Arrays (FPGA) and custom chips.
Expert has experience in software, hardware design, and FPGA development that gives him the unique ability to analyze a design from all perspectives. This allows him to optimize a design for cost, speed, or power efficiency. He has experience analyzing systems that are not working to determine if the problem is caused by hardware, software or a combination of the two.
Superconducting Magnet Quench Detection - Expert was called in to evaluate client’s subcontractor work on designing a magnetic quench detection system for a super conducting magnet used in a Medical treatment system. The system monitors the magnet in real time and has to decide within 100 milliseconds if excessive heating due to loss of superconductivity might damage the magnet. It can dump the energy out of the coil to protect the million dollar magnet. Expert was selected for his expertise in evaluating the software, hardware and the FPGA design of the system. The project also required an expert who could evaluate the real time responsiveness and reliability of the system. He visited the subcontractor a number of times and examined their designs and progress. Expert advised the client that it was unlikely the current approach would be robust enough or completed on schedule. Expert worked out a new approach with a member of the client’s engineering staff and implemented the system in time to meet the client’s milestone for its investors. Expert wrote the software and FPGA code for the new system. It worked flawlessly, client met its milestones and project was back on schedule.Proton Radiation Therapy – Expert designed embedded software and Verilog FPGA code for real time control of the RF subsystem in a cyclotron that controls the acceleration of high-energy protons for a Medical device. The system focuses proton beams on cancerous tumors to destroy the tumors without damaging surrounding tissue. The embedded computer implements control and safety functions and uses TCPIP to communicate with other subsystems. Expert assisted in failure mode analysis and verification and validation for FDA compliance.Marine GPS System - A client had developed a new marine GPS navigation system to replace a product with discontinued parts. When the first 10 units were built none of them worked. Client had orders for units and could not ship products. Client’s hardware group thought the problem was in the software. The software group said it was a hardware issue. Expert was called in because of his experience in both hardware and software. Expert spent time with each group going through the design and the failure mode symptoms. He found that the printed circuit board layout was flawed and had serious noise issues. It would have to be respun. He also found a flaw in the FPGA code that was preventing proper initialization. These fixes solved the problem and client was able to ship the product.Robot Guidance System – Expert designed a guidance system that allows Autonomous Underwater Vehicles (UAV) to navigate underwater vehicles in strong cross currents. This real time embedded system controls a group of steerable fins on the front of the vehicle in coordination with the rear propulsion system. It has to be extremely power efficient since the system operates for hours off an internal battery system before surfacing. It also has to be extremely reliable since the system operates at depth in the ocean far from the vehicles users.Medical Blood Infusion Pump - Expert developed the firmware for a battery powered, DSP based, infusion pump for use in hospitals. He wrote signal processing algorithms to process the sensor data in real time. The system has many advanced features for precise measuring and monitoring infusion parameters. Expert worked with client’s hardware and software engineers to integrate his work with the other processors in the system.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1980 | Degree: BS | Subject: Computer Engineering | Institution: Boston University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1985 to Present | Employer: Undisclosed | Title: President | Department: |
Responsibilities:He runs a consulting company that designs electronic products for the medical, consumer and industrial market. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2006 | Employer: Cambridge Consultants Inc | Title: Project Manager | Department: US Medical Products |
Responsibilities:He managed project teams, brought in new clients and wrote and presented client proposals. He designed electronics and firmware for medical instruments. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: Bluefin Robotics | Title: Senior Electrical Engineer | Department: |
Responsibilities:He designed the electronic propulsion system for a family of Autonomous Underwater Vehicles. The system operates at ambient pressures under the ocean. It has to be extremely power efficient since the system operates for hours off an internal battery system before surfacing. The system uses three microprocessors and an FPGA to do real time control of the vehicle position using high torque brushless DC motors. He designed the hardware for the digital sections and the analog circuitry to drive the motors. He wrote the firmware to control the microprocessors. He wrote the FPGA code to control motor phase timing.He designed hardware and software for other vehicle systems from specification, hardware and software design, prototyping, to production units. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1992 | Employer: Woods Hole Oceanographic Institution | Title: Research Engineer | Department: Deep Submergence Lab |
Responsibilities:He was in charge of hardware and software development of the on board computer systems for robotic vehicles. He developed remote control system to operate robotic vehicles from distant sites via satellite links. He designed telemetry interfaces for Ethernet and fiber optic systems. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1985 | Employer: Logical Services | Title: Project Manager | Department: |
Responsibilities:He designed digital hardware and microprocessor based products. He wrote software for embedded products. He managed project teams, including scheduling and budget. |
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| Years | Employer | Title | Department |
| Years: 1980 to 1981 | Employer: SRI International | Title: Research Engineer | Department: Systems Techniques Lab |
Responsibilities:He developed Fault Tolerant computer networks. He designed computer architectures for satellite control. He wrote computer simulations to test security of Army communications system. |
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| Years | Employer | Title | Department |
| Years: 1979 to 1979 | Employer: Boston University | Title: Teaching Assistant | Department: Computer Engineering |
Responsibilities:He taught the lab portion of class in Assembly language programming for the Computer Engineering department. He helped them with problems and questions about the course work. He assisted students working on their course projects. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1990 to 1990 | Country / Region: Canada | Summary: Expert was part of a televised National Geographic Expedition with Dr. Ballard and the Woods Hole Oceanographic Institution to Lake Ontario in Canada to find two shipwrecks from the War of 1812. He was developing and running the computer systems for the Jason robot that provided live television pictures of the shipwrecks, Hamilton and Scourge on the lake bottom. |
| Years: 1989 to 1990 | Country / Region: Mid Pacific | Summary: Expert spent months at a time at sea in international waters developing and operating deep sea robots exploring the volcanic vents at the Mid Pacific Ridge, exploring underwater archaeological sites, deep ocean fault lines, and environmental sites with Woods Hole Oceanographic Institution. |
Career Accomplishments
| Associations / Societies |
|---|
| IEEE |
| Publications and Patents Summary |
|---|
| He has published 5 papers in conference journals and industry trade publications in real time control systems. |
Additional Experience
| Expert Witness Experience |
|---|
| 1) Analyzed medical device source code for plaintiff, wrote Expert Report, deposed by defendant’s counsel, testifying as expert witness for plaintiff 2) Consulting expert for defendant, analyzed medical software for radiation treatment 3) Consulting expert for defendant, evaluated medical device hardware 4) Consulting expert for respondent, patent infringement 5) Consulting expert for defendant, Workman’s Compensation claim, wrote expert report 6) Expert for respondent, patent infringement, Testfied at trial. |
| Training / Seminars |
|---|
| Expert has presented seminar on real time control of Windows based systems for clients. Expert presented paper on real time multiprocessor system design at SPIE conference |
Fields of Expertise
biomedical device engineering, electronic medical device, electronic medical device design, medical computer system, medical device, medical device design, medical software, computer hardware interfacing, medical device software, biomedical device, biomedical product development, microprocessor-based biomedical instrument, medical device product development, embedded computer system, embedded processing, embedded software, embedded system software development, software engineering, microcontroller application, C++ programming, computer programming, microcontroller, microcomputer system, firmware, assembly language, assembly language programming, real-time embedded system software development, real-time programming, real-time software, real-time software engineering, real-time system, microprocessor, microprocessor application, microprocessor-controlled, digital circuit, electrical engineering, electronics engineering, digital circuit design, digital data, digital data acquisition, programmable gate array, programmable logic array, programmable logic device design, computer system, field-programmable gate array, microprocessor circuit, IBM pc hardware, computer hardware design, personal computer architecture, software porting, remotely operated vehicle, MS-DOS 6.0, software system development, IBM-compatible personal computer, biomedical imaging, imaging, computer-aided robotic design, microcomputer, ocean engineering, hardware engineering, IBM personal computer, computer hardware, real-time operating system, operating system, computer software