You will be hearing a lot more about systems thinking and the principles of systems engineering from AAMI in the coming years. Recognizing the importance of this skill for the AAMI membership, a systems advisory group was formed last year, and it involves closer collaboration with the International Council on Systems Engineering (INCOSE). AAMI’s new three-year strategic plan includes the following goal: “Advance a systems approach for healthcare technology and related data.”
There are three different terms in the above paragraph that are related, but have slightly different meanings:
“Systems engineering” is a specific discipline that lives at the interface between the system users (or stakeholders), the business functions (e.g., marketing), and the design engineering disciplines (mechanical, electrical, software, etc.). It involves rigorous management of the requirements, systems design, verification, and validation of the system as a whole, from concept to retirement. The “-ilities,” such as reliability and usability, and risk management activities, such as safety and security, are supporting disciplines managed by the systems engineering processes. Those wanting more details should see the INCOSE Systems Engineering Handbook or look at the international standard ISO/IEC 15288. There are many excellent texts and several universities offer systems engineering degree options.
Many device companies and some larger hospital systems have formal systems engineering organizations. However, even smaller organizations should use a “systems approach” when developing their devices or integrating a hospital network. AAMI was deeply involved in in the development of the 80001 international standards family titled “Application of risk management for IT-networks incorporating medical devices.” Identifying the stakeholders, documenting their needs, using risk-based decisions, verification and validation activities are all parts of taking a systems approach—whether or not formal systems engineering disciplines are applied.
“Systems thinking” is a closely related concept. A system thinker addresses a complex systems problem by examining the interactions between the components of the system, the users of the system and the broad environment that the system needs to operate within. Systems thinkers address how the system is installed, used, maintained and decommissioned—the entire life cycle. They think about how the users really do their day-to-day jobs, and how the novice will differ from the expert. As a systems thinker, I always want to understand one or two layers of hierarchy above the level that my system needs to operate.
One does not have to be a systems engineer to be a systems thinker, though I believe the best systems engineers are experienced systems thinkers. At a device company, a systems thinker is the one who wants to go to several hospitals and observe the various users and how their device will fit into the entire ecosystem. In a hospital, the system thinker may be the one who wants to understand the patient experience before patients arrive and after they go home, or how the patient’s external physicians and specialists exchange information with the hospital to ensure the best, consistent care in the transitions.
Those people who are always said to be “thinking outside the box” are the systems thinkers. We need to identify, nurture, and train those who challenge whether we are even trying to solve the right problem.
There are huge opportunities to improve the quality and the efficiency of patient care in this country. Systems engineering and systems thinking is needed so that both device manufacturers and hospital technologists can collaborate together to achieve the device interoperability promise.
Ken Hoyme is a distinguished scientist at Adventium Labs in Minneapolis, MN. He is active in several AAMI initiatives, including the Systems Advisory Group and the Medical Device Security Working Group.