Medical Devices Expert Witnesses

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
• Brain-computer interfaces and neurological sensing
• 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)
• Wearable computers and biomedical sensor networks 
• Ventilators and life support equipment
• Bedside and ambulatory infusion pumps
• Robotic surgical systems

Electronic health record and clinical informatics matters turn on the safety and usability of the health IT system itself rather than on the device, and are handled by a dedicated expert. See our electronic health record safety and clinical informatics expert witness.

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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Medical Device 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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Further Reading

• Medical Device Litigation and FDA 510(k)
• How to Secure Consumable Components of Medical Devices
• Usability Standards for Medical Devices