Ken Hoyme: Systems Thinkers, Engineers, and a Systems Approach All Have a Role to Play

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.

One thought on “Ken Hoyme: Systems Thinkers, Engineers, and a Systems Approach All Have a Role to Play

  1. I have been in the business a long time now. It is my observation that thinking systematically and multi-dimensionally is very rare. It is not something most people do naturally. Certain individuals are born with the ability to do so. Many service calls result when an equipment user was taught to do A-B-C and expect X. Then, when there is an unexpected variant in the device’s performance, that device then becomes “broken.”
    Far too many people in the healthcare industry do their jobs by repeating sets of motions and/or steps, or by following a “formula.” Groups and departments in a hospital do these same things without regard for the bigger picture. Group behaviors know as “silos” and “fracturing” are common symptoms. An organization that wants to improve performance, should have a mechanism to discover, recognize, and utilize the “systems thinkers” in their employ. Leadership, should follow thru and encourage development of organization behaviors based on “systems thinking.”
    One horrible example of “not system thinking” in our core business is the CE manager who allows his biomed staff to issue “demo stickers” to sales reps without making sure the reps have first provided complete PDF factory service manuals and operators manuals before the device is allowed in for a demo. The result has a severe negative impact on our ability to service the device during its life cycle. Our industry’s current epidemic of biomeds who don’t have service manuals they need is a classic example of not thinking ahead. If you are faced with a salesman in need of a demo sticker, be sure to hold the line “no manuals, no sticker!” Good luck. Be a systems thinker today!

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