Electronic Medical Device Software Expert Witnesses

Barr Group's experienced medical device software experts consult with attorneys in medical product liability and intellectual property cases. Our experts in medical device technology have hands-on experience designing electronic systems and software and the credentials and composure to testify successfully before judges and juries.

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Electronic Medical Devices

An electronic medical device is an embedded system, which is a combination of software and electronics. When an electronic medical device malfunctions the results can be deadly. Barr Group is in the business of designing reliable and secure embedded systems and our expert software engineers, electrical engineers, and mechanical engineers are well acquainted with the design of FDA-rated Class II and Class III electronic medical products such as:

  • Electronic medical records and medical billing software
  • Pacemakers and implanted defibrillators
  • Automated external defibrillators (AED)
  • Glucose monitors and insulin pumps
  • MRI machines and PET/CT scanners
  • Digital medical imaging algorithms for X-ray and ultrasound
  • Hearing aids and cochlear implants
  • Functional e-stimulators, including spinal cord stimulators
  • In-vitro diagnostic equipment for laboratory specimen testing
  • Point-of-care testing (POCT) including blood gas systems
  • Vital sign monitoring devices (e.g., EKG and ECG)
  • Ventilators and life support equipment
  • Bedside and ambulatory infusion pumps
  • Robotic surgical systems

Barr Group's software experts are familiar with all of the operating systems used in medical devices, including real-time operating systems like VxWorks and QNX as well as Windows, and all programming languages for embedded systems such as assembly, C, C++, and Matlab. And we are just as comfortable with electronic circuits and ASICs and the Verilog and VHDL languages.

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Expert Witness Services

Barr Group's medical device software experts support plaintiffs and defendants in litigation in U.S. District Courts, at the International Trade Commission (ITC), and before the Patent Trial and Appeal Board (PTAB). Our services include:

  • Technical assistance with drafting of discovery requests
  • Software source code review and analysis
  • Source code comparisons for copyright and trade secret theft
  • Analysis of electronics and related design documents
  • Prior art review for patent invalidity
  • Reverse engineering, including disassembly of binary code
  • Forensic analysis and malfunction reconstruction
  • Comparison to FDA 510(k) and medical-industry safety standards
  • Expert reports, declarations, and witness statements
  • Testimony at deposition, oral hearings, and trials

Barr Group has a demonstrated ability to quickly activate one or more code reviewers to match the size, scope, and complexity of any project.

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The following is a representative subset of Barr Group's experts who have experience designing and/or testifying about these technologies:

Medical Devices

Software Quality Assurance Expert Profile

Independent consultant and former vice president of engineering with significant experience leading development of enterprise software systems, including systems for electronic payments, information management, and e-commerce. More than two decades of work in software industries and a strong background in core natural sciences to the analysis of neural networks and other complex mission-critical information management systems.

High-Performance Computing Expert Profile

Professor of electrical and computer engineering and expert in architectural paradigms and technologies for high-performance computing and distributed computing. Research spans a range of areas from semiconductor design to compilers and database systems. Has organized workshops on graphics processors (GPUs) and computer security as well as binary translation and profiling.

Fault Tolerant Computing Expert Profile

Electrical and computer engineering professor with decades of experience in computer architecture and design who has been recognized as one of the top innovators in the first half century of the history of computing. Has specialized technical expertise in bio-robotics, medical devices, actuators, mechatronics, fault tolerant computing, processor cache and memory design, high speed networks, storage subsystems, and system performance evaluation.

Medical Device Software Safety Expert Profile

Consultant certified in regulatory requirements for medical with more than twenty-five years of experience in the field of medical device firmware and software design. Specialist in safety-critical product development who has developed software as well as technical and regulatory documentation for a range of medical products under all FDA levels of concern and IEC 62304 classes. Has participated in several software submissions and inspections before the FDA and EU notified bodies. Also an inventor of technologies in the field of electronic program guides for TV set-top boxes.

Smart Grid Electrical Power Expert Profile

Professor of electrical and computer engineering with significant industry experience in telecom, aerospace/defense, security, and healthcare application domains. Director of a university program that supports NASA’s Johnson Space Center and co-director of a connected infrastructure program that prototypes smart grid, smart energy, smart transportation, and other smart city projects. Research relates to those and other topics that touch on embedded computing systems and communication and networking protocols. Has held executive and senior engineering positions

Biotech and Pharma Database Expert Profile

Experienced computer engineer and corporate information technology leader with a successful track record in the biotech, pharmaceutical, medical device, and other industries. Specialized expertise in software development and testing in a variety of languages and with a range of database platforms and languages. Experienced trainer and engaging communicator.

Cybersecurity & CompSci Expert Profile

Consultant and former computer science instructor who has written more than two dozen books and numerous scientific papers on computer security, cyberwarfare, and digital forensics, as well as cryptography and other forms of applied mathematics. Has mastered and then written and taught a wide range of technical topics within and outside of computer science. After serving in the U.S. Army, earned his undergraduate degree while also doing hands-on work in technical support and design of websites in HTML and JavaScript.

Ultrasound Medical Imaging Expert Profile

Former assistant professor of electrical and computer engineering and Oxford-educated materials scientist whose areas of specialized technical expertise include design of semiconductors and other electronics and sensors and micro-electromechanical systems (MEMS) as well as signal and image processing. Industry experience includes working for and consulting with multinationals such as General Electric, Medtronic, Fujifilm, Samsung, and Siemens on projects relating to medical devices, consumer electronics, biometric security, clean-tech, and electrical power delivery.

Video Game Computer Graphics Expert Profile

Professor of computer science and consultant with more than thirty years of experience in the software industry in areas ranging from scientific computing and medical visualization to video gaming technologies. Significant experience in the field of computer graphics, including for military simulators, flight simulators, and video games. Also a specialist in web-based services that use Service-Oriented Architecture (SOA). Has researched and applied video gaming technologies to serious pursuits, including for improved health. Hands-on experience with video game design and development.

Electronics Source Code Review Expert Profile

<p>Computer engineer with over fifteen years of hands-on experience in all phases of product engineering including system architecture, electronics design, software design and code review, project management, testing, and manufacturing. Areas of specific technical expertise include FPGA and ASIC chip design involving hardware description languages, simulation, synthesis, and timing analysis; printed circuit board electronics design, verification, and debug; embedded software design; and system-level architecture and design.</p>


Expert S425N

Electrical engineer and expert in battery and power electronics technology with special...

Expert J525N

Experienced computer engineer and corporate information technology leader with a successful...

Expert J520S

Independent engineering consultant in the design of both electronics and software with a formal...

Expert S530O

Electrical engineer with extensive electronics and software product development experience...

Expert E235M

Consultant and former computer science instructor who has written more than two dozen books and...

Expert W550N

Engineer with over thirty-five years of experience designing electronics and software for...

Expert B620S

<p>Computer engineer with over fifteen years of hands-on experience in all phases of...

Expert B600R

Former adjunct professor of computer engineering with more than twenty-five years of experience...

Expert H623T

Electrical and computer engineering professor with decades of experience in computer...

Expert W635N

Consultant certified in regulatory requirements for medical with more than twenty-five years of...


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