AAMI News January 2016

Spotlight on Standards: Committee Co-Chairs Get Lessons in Systems Thinking


The author, Wil Vargas, is a director of standards at AAMI. He focuses on interoperability, software and information technology, and device security.


What Is a System?

“A system is built from a group of parts, whose combined interactions produce a behavior that no one part alone can produce.”
—John Thomas, past president of the International Council of Systems Engineering

“A system does something different than its constituent parts taken individually. It exhibits some property that the individual subcomponents don’t. So, for instance, flight is a system property of an aircraft. It’s only when you assemble the constituent parts—an engine, the wings, and the pilot together into a system—that this emergent property, or system property, of flight takes place.”
—Lane Desborough, chief engineer at Bigfoot Biomedical, Inc.


“A system is variously defined as ‘a group of interacting, interrelated, or interdependent elements forming a complex whole.’ ”
—Raymond Zambuto, president of Clinical Engineering Concepts, LLC

During last month’s Standards Week in Newport Beach, CA, AAMI introduced a systems engineering training workshop. This course was intended to provide committee co-chairs with systems engineering concepts and tools they could use to improve the organization of their committee meetings and structure their approach to developing AAMI standards and technical reports.

For decades, many complex industries, such as the aerospace and automotive industries, have embraced systems engineering principles and systems thinking and have enjoyed well-documented benefits, including improved safety. The medical device industry has long understood the need to incorporate these concepts into its activities and processes but is unable to simply take what has worked in other sectors and apply it as is, due to certain realities within the medical device industry, such as home use, that other industries have not had to consider.

As the clinical environment becomes more complex and technology more sophisticated, particularly with the interaction of multiple medical devices used by a single patient, there is a need to consider the entire system rather than the individual components. The increasing application of a systems approach and consideration of other principles, such as risk, human factors, and usability, in medical device design and development become even more important.

During the past few years, the AAMI standards program has utilized different methods to adapt and incorporate a systems approach and systems thinking into standards development. The pilot workshop was the latest of these efforts. It was rolled out strategically to committee co-chairs because they are the leaders charged with the responsibility of guiding their expert colleagues to successfully complete their respective work programs.

The content of the four-hour course leveraged the expertise of Michael Robkin, president of Anakena Solutions, Inc. and a longtime member of AAMI’s Interoperability Work Group. Robkin has one foot in both worlds—having participated in the standards development process and having years of experience as a systems engineer.

During the workshop, attendees learned the purpose of systems engineering, its relationship to business and product development, and the “V-Diagram,” which shows steps such as system design, product realization, and technical management. This introductory content just began to scratch the surface, as systems engineering is a very broad technical subject. In  the next few months, the co-chairs who participated will be invited to attend a two-hour online question-and-answer session that will draw on their experiences utilizing these concepts and techniques following the initial in-person training.

AAMI intends to provide the introduction to systems engineering training as part of every upcoming Standards Week with the goal of having every AAMI co-chair completing the program by the end of 2016. Based on feedback gathered from these sessions, AAMI is looking to tailor the content to specifically address the unique conditions of the standards development life cycle.

In time, incorporating systems engineering principles into the standards development process is expected to improve the overall quality of our standards and technical reports, which would ultimately benefit patient safety worldwide.