I was recently invited by a client of ours to speak at two sessions during the INCOSE (International Council on Systems Engineering) Healthcare Conference.

“Developing Systems Engineering and Systems Thinking Skills” was a panel organized by Chris Unger from GE Healthcare. Joining me as panelists were Tom Fairlie of Medtronic and Juan Fernandez De Castro of Stryker. We discussed how organizations can identify SE candidates and provide them training and resources to develop their skills.

As an experienced SE consultant, I offered perspective on coming into an organization to help with the creation and/or expansion of an SE team. At Base2, our SE consulting practice has identified key elements that need to be understood by the entire development organization for a SE project to succeed:

  • Understanding the what, why, and how of the project
  • Developing an organizational approach to SE processes and standards
  • Building an infrastructure that defines the SE process and provides the SE team with the training and tools they need to be successful
  • Preparing the case for SE, including impact studies, SE processes, evaluation of upfront investment vs. rework costs and time delays, and development of system requirements and architecture

Successful SE projects are all about requirements. Without a good understanding of requirements and a good system architecture, design teams are likely to face time-consuming rework that leads to missed delivery dates.

In my second session, I presented “Getting Started with Tools and Requirements Management,” which was focused on companies just starting out in systems engineering and also for those in the process of assessing/selecting requirements management (RM) tools. This can be a challenge for organizations as they bring in a tool but don’t have a SE process in place.

In addition to covering the key elements for a successful SE project from my first session, I discussed the importance of RM and how having a SE on board can assist with selecting and using RM tools, including understanding the need for a tool, the anticipated benefits, planning, and setting expectations for implementation.

In addition, a SE brings systems thinking and drives architecture design that has no hardware or software bias. Experienced SEs also bring valuable regulatory and standards knowledge as well as security considerations.

The three primary takeaways from these two informative sessions were:

  1. Project success is driven by having requirements that are clear and verifiable, traced to user needs, linked to all sub-system requirements, with changes that are controlled and managed.
  2. Any tool that is used for requirements collection or management should be fully supported by leadership and the project team must be thoroughly trained on its use.
  3. Having a SE team is an invaluable investment in improving product development. The SE team, just like the project team, must be fully supported with leadership support, training, and well-defined standard operating procedures (SoPs).

Hot Topic: MSBE

One of the event’s most talked-about topics among the attendees was Model-Based Systems Engineering (MBSE). The common difficulties mentioned were figuring out how integrate MBSE into an existing organization, how to sell the MBSE concept to management, and then having to explain why the initial project didn’t show an improvement in results (performance and schedule).  

Attendees agreed that a major challenge is laying out for management that it may take several projects before an organization will see performance improvements. This has also been my experience with RM tools such as DOORS, where management expects an immediate payback for the investment in a tool, but in reality, there is a learning curve and changes to the organization’s processes are likely before performance improvements can be achieved. In discussing his work with MBSE, one manufacturer attendee said the he felt a key to success was training in SysML.

New Standard

Staying abreast of new standards is always an important part of attending INCOSE events. An interesting new standard mentioned by a speaker from the VA was the Fast Healthcare Interoperability Resources (FHIR) standard.  This new standard is for data formats and APIs for Electronic Health Records.  Check out this link.

About the Event and INCOSE

With more than 140 attendees from large to small medical device manufacturers, healthcare companies, academics, and tool suppliers, the conference was an educational forum covering tracks on SE Skills and Tools, Cyber Security, Healthcare Delivery, Agile methods, and MBSE.

There are a host of INCOSE Working Groups. More information can be found here.

Paul Kostek

Paul Kostek

Advisory Systems Engineer

Paul is an Advisory Systems Engineer defining system architecture, system requirements, and risk assessment. He has served as president of IEEE-USA, IEEE Aerospace & Electronics Systems Society, and chaired the American Association of Engineering Societies, IEEE Intelligent Transportation Systems Conference, IEEE/AIAA Digital Avionics Systems Conference, and the IEEE Global Humanitarian Technology Conference.