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Director: Alford R. Taylor Jr.

The mission of the Division is to apply the electronics, software engineering, and systems engineering body of knowledge to the regulation of medical devices and electronic products that emit radiation. We fulfill our mission by providing highly specialized technical support to Center and Agency regulatory activities in the form of:

• Engineering reviews and analyses
• Laboratory investigations of product performance
• Forensic reviews and investigations
• Training (for both FDA and industry)
• Development of custom electronic instrumentation and software
• Basic and applied research

The underlying theme of much of our work is product realization, a term used by engineers to describe the process of converting a design concept into a viable product. While we recognize that cutting edge technologies are the focus of much regulatory attention in FDA, and properly so, our interest is in how these new technologies are reduced to practice. Product realization encompasses all phases of the product life cycle and all aspects of the product manufacturer’s business, from research and development through procurement, production, and ongoing customer support.

Our research program reflects our abiding interest in product realization, and focuses on improving the engineering practices and processes of regulated industry. Particular emphasis is placed on improving capabilities in measurement and analysis of medical device performance. The technologies and methods we explore may be cutting edge or tried and true and may be found in academia, industry (medical device or other industry sectors), military, or clinical research programs.

Our highly focused stakeholder focus permits us to provide a timely and balanced consulting review function within the CDRH and to other parts of the agency (both CBER and CDER) for software, electronic and systems engineering issues.

Electronics Laboratory

The Electronics Laboratory embraces three key aspects of medical electronics having immediate applicability to the mission of the Center.

Electronic Instrumentation. We provide custom instrumentation—i.e., measurement and control systems—for use by internal FDA customers and regulatory partners. Our capabilities include analog and digital circuit design, data acquisition and display, embedded microprocessor and PC-based systems, and software-based virtual instruments. This work provides two benefits to the Center. First, we provide an in-house R&D capability which is easy to access and attuned to the unique needs of our customers. Second, the engineers in this laboratory gain insight into the problems (and solutions) confronting medical device manufacturers as well as maintaining institutional knowledge of the latest developments in electronic technologies.

• Electrical Safety. This activity focuses on the design of medical devices to assure that the risk of harm due to electrical shock is adequately mitigated in the design. The laboratory also addresses other hazards arising from the use of electrical and electronic technology in medical products, including thermal burns and fires.

• Power Electronics. This activity focuses on an aspect of electronic design that poses continuing challenges to designers of medical devices. It deals with components, circuits, and analytical techniques for controlling high voltages and/or currents. Historically, power electronics has been a factor in many medical device recalls. Our strategy is to stay abreast of the evolving body of knowledge in the power electronics area so that we are prepared to probe for design weaknesses in the premarket review, thus heading off potential problems. We also maintain a suite of analytical tools and measuring equipment that can be brought to bear on emergent problems.

Software Laboratory

The work of this laboratory is focused on developing analytical methods and tools for assuring the safety and security of software used for medical purposes. This work is highly collaborative, drawing heavily on research in academia and industry practices in the area of high confidence software and embedded systems. Such methods include modeling techniques that can be used to assess and certify the safety and security of medical software. Areas of focus include: Formal methods – mathematically based requirements and design Safety – safety architectures and coding patterns Security – security architectures and coding patterns Certification – provable performance criteria Forensic analysis – reconstruction & analysis of failures Algorithmic assurance

This program is important to public health because more and more medical devices rely on software as a means of providing robust patient care in terms of diagnosis, monitoring, or therapy. Software development methods simply haven't kept pace with the complexities of today’s or future devices. Only by focusing on new software development methods, with an emphasis on safety and security, can this challenge be addressed. A byproduct of this program is the cross-pollination of academia and industry personnel which can result in the industry adopting more effective design methods, which in turn can result in faster regulatory reviews and reduced recalls and associated expenses. Clearly, device safety and patient information security is essential to quality patient care and public confidence in the health care systems.

Systems Engineering Laboratory

This laboratory applies a systems engineering perspective to medical device regulatory issues. The laboratory is currently focusing in two distinct areas.

Quality Systems and Risk Management. This program aims to improve industry practices in the area of quality management and risk management, principally those practices which are applicable to electronics and software. The conceptual framework that we have been developing to accomplish this is finding its way into relevant consensus standards, industry guidance, professional engineering publications, and education and training for both FDA and personnel and the regulated industry.

• Intelligent Medical Devices. This program is directed at the development of methods and tools that can be used by device manufacturers, users, and regulators to objectively assess the monitoring and diagnostic performance of intelligent medical devices. Intelligent medical devices operate by acquiring and analyzing physiological waveforms to monitor and diagnose clinical conditions. The program seeks to develop methods to assess specific aspects of the safety and performance of these devices, such as detection ability in the presence of physiological and environmental noise and artifact, and to understand and quantify the effects of these conditions. Our research is intended to stimulate the development of more effective diagnostic and monitoring products, thus improving the public health.

Research Program Areas:

• Electrical, Electronics, and Software Engineering

Science and Engineering Staff Matrix

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