News & Events


Agile Methods for the Development of Healthcare Systems 2017

May 16-17th   -  Chicago, IL 

Key Deadlines

Online Registration Deadline May 1st
Deadline for Abstracts February 28th
Acceptance Notification Final Notification March 3rd
Deadline for Final Presentations April 12th

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Register for the Conference Here

Conference Theme / Description

Agile Software Development has been delivering value to software development teams for many years, but Agile is not just for software development - Agile Product Development principles apply to the creation of any system. This conference focuses on the application of Agile principles in practices in the development of medical systems – systems built by large teams and/or systems that include more than software.


Mr John F. Murray Jr., Expert Regulatory Review Scientist, United States Food and Drug Administration 

FDA logo

Title: FDA Perspective: Software Guidance and Common Concerns
John will describe current topics and recent initiatives at the FDA related to software products, and address common concerns from the industry and the FDA related to agile software development practices and regulatory expectations.

Mr. Murray provides FDA Management and staff with expert advice; opinion and guidance for FDA “regulated” software and computer systems. He plays a primary role in the preparation and publishing of software & computer related regulations, guidance, standards and training.

Prior to joining the FDA in 1994, John’s professional experience includes the United States Navy Nuclear Submarine Service, Telex Computer Products, General Dynamics Corporation, and Technology Management & Analysis.

John is a graduate of the United States Navy Electronics Technician School Great Lakes, and Naval Nuclear Power School Bainbridge. Mr. Murray received his B.S. degree in Electronics Engineering from George Mason University and his M.S. degree in Computer Science from Rensselaer Polytechnic Institute (RPI).

The audience for this conference is Systems Engineers, Software/Mechanical/Electrical Developers and Testers, Program Managers, Architects, Certifiers, and leaders of organizations developing complex healthcare products, from large Healthcare IT systems to medical devices that include software and hardware components.  Attendees from other domains with Agile Systems experiences are welcome as well.

Call for Presentations, Panels, and Workshops
To form the program for this conference, we are looking for ideas to share, a story to tell, a workshop to build skills, or questions to pose to an inquisitive audience. This is an interactive conference, so we want sessions that are a mixture of presentation and discussion. We are looking for topics in the following categories:
- Aligning Agile concepts and practices with System Engineering principles, such as those described by ISO/IEC/IEEE 15288:2015
- Agile team structures and Agile transformation models – how the architecture of the system affects the architecture of the development system that creates it
- Experiences with applying Agile practices to the development of hardware and systems
- Application of Agile Scaling models such as SAFe, Scrum Nexus, Scrum-Of-Scrums, etc.
- Cultural barriers to Agile adoption, and ways to overcome them
- Sharing Agile Systems experiences from other domains 
We are looking for either 45-minute or 90-minute presentations for the main conference 17-18 May 2017, or half-day or full-day tutorials for 16 May 2017. Do you have a presentation in mind? Do you have a question you want to explore in a workshop?

Speakers get a discounted registration fee!

The Conference

The overall system and system components of Health Care (including its delivery processes, pharmaceuticals and other therapies and preventive measures, medical devices, and its regulatory and economic framework) are challenged to be "agile systems". Agility challenges arise from shifting threats, expectations, and competition, advances in technology and medical science, and evolving economic and regulatory aspects. 

Although the software development community has advanced the practice of agile development of software, the system-level opportunities and challenges of agility are much broader than software alone. This conference is about the current landscape, examples of progress in agility for more general systems, and the road ahead. It builds on an earlier conference held in 2015 and 2016.  This three-day conference includes multiple session learning tracks as well as collaboration session opportunities and tutorials to advance the state of the community. Watch this space for future posting of the detailed schedule of tracks, topics, and sessions.

LEARN, CONTRIBUTE, COLLABORATE:  This two-day conference includes multiple session learning tracks as well as collaboration session opportunities to advance the state of the community. See below for the detailed schedule of tracks, topics, and sessions.

EASILY REACHED LOCATION, PRODUCTIVE FACILITIES:  The meeting site is in Chicago, IL, easily reached by Midwestern driving or through Chicago O'Hare Airport. Lunch will be provided at the meeting facility each day. The venue is the excellent conference center provided by the American Society of Anesthesiologists, 1061 American Lane, Schaumburg, IL.


CONFERENCE HOTEL: A block of rooms has been reserved at the nearby Hyatt House Chicago/Schaumburg, at 1251 American Lane, Schaumburg, IL 60173.  Use this link to book your rooms . Or call the Reservations center at 1-800-993-0367 and ask for the Agile Rate. This is based on the availability of room types and overall inventory.


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Thanks to our Sponsors


INCOSE Conference Abstracts

  1. Advancing Agility in Health Care Systems--Applying the INCOSE ASELCM Pattern

    William D. (Bill) Schindel, ICTT System Sciences

    The most widely-familiar paradigm associated with “agile” approaches refers to (1) the development process, for systems or sub-systems that are (2) software-oriented. INCOSE in general, and the INCOSE Agile Health Care Systems Conference in particular, have already examined the notion that agility in development is not a practice limited to software technology. In this talk, we will pursue this further, looking beyond system development to the rest of the system life cycle, and how agility applies there as well, in the context of the health care domain. During the 2016 Agile Heath Care Systems Conference, participants in a break-out session identified a set of “bigger picture” targets for agility in the overall Health Care domain, which we’ll also look into further in this session. If your agility comfort zone is limited to daily scrums for software development, this session is meant to stimulate discomfort and expanded horizons.

  2. Transitioning from Waterfall to AGILE

    Kenneth Mosteller, PD Mentors

    Several healthcare and medical device manufacturers are trying to implement AGILE development for their software staff without figuring out how to integrate the AGILE philosophy with their hardware staff.

    Waterfall, a requirements based methodology and AGILE, a solutions based methodology seem to be mutually exclusive. This tutorial will show you how to bridge that gap.

    The problem for the INCOSE community is that as a general rule the healthcare community does not understand the systems engineering Vee model. One healthcare provider believed the Vee was a software only development model with the sole purpose of addressing verification, and they had the u-tube video to prove it.

    The tutorial is based one vendors packaging of Waterfall development with an AGILE wrapper which has caused AGILE to have a "bad name", one healthcare providers struggles in applying AGILE to everything including hardware upgrades, and one medical device manufacturers success in integrating Rapid Prototype design for hardware development with AGILE software development.

  3. Facilitating the Agile Systems Engineering (SE) Workshop

    Harry Koehnemann, 321 Gang

    Specification Workshops provide a lean-agile approach to creating and evolving engineering specifications. Workshops are face-to-face meetings that create a shared understanding across customers, users, domain experts, product owners and teams. They record system structure, behavior, and information decisions in SysML using a Model-Based Systems Engineering (MBSE) approach. Workshops align everyone on a common approach to building a solution as well as discover and drive work in the agile backlog.

    This tutorial teaches future workshop coaches and participants how to incrementally build system specifications that define system context, behavioral response to stimulus, structural design and interfaces. It teaches the mechanics of running a workshop through a simulation and how to perform workshops as part of the regular agile development flow.

  4. How do you make the case for “Agile” to stakeholders who don’t speak the language?: Putting it into terms everyone can get behind.

    Beth Kent Principle Software Project Engineer Medtronic, Inc.

    Have you ever been trying to drive a change toward Agile in your organization and you feel like you are speaking “lingo” that no one understands? Whether it is because you have implemented Agile or Scaled Agile techniques before in your career or you have just gone to training or a conference, you believe implementing Agile is the right thing for your organization. You try to share your vision but you are talking the “lingo”. You know the terms: scrum, backlog, retrospective, SAFe, iteration, program increment, and on and on. For people who have never been trained in Agile, they are really left wondering what in the world you are talking about.

    There is a real communication gap and to really implement any of this, you are fundamentally asking the leadership to uproot how they organize their teams and their work. It usually it takes starting with one team, showing the results and then the momentum grows. It takes a lot of trust and buy-in to set up even that first cross-functional team since it usually requires approval across multiple organizations.

    How do you get that buy-in? Where do you start? Maybe if you can talk to them in terms that are universal and not the “lingo”, they could more easily get behind the idea. After all, the reasons behind “why do Agile?” are universal Lean principles and workflow truths. Reduce handoffs. Reduce interfaces. Drive ownership and accountability. Integrate quality into your workflow. Maybe your leadership comes from a manufacturing background. Talk about the Agile teams as production lines. The Lean principles this is based on do have their roots in manufacturing. Once you have the teams up and running, they are a well-oiled machine and you don’t want to re-tool or change their configuration any more than necessary. Put it in whatever terms they can understand and get behind.

  5. Agile Approach for Agile Healthcare Delivery: The Virtual ER

    Randall Russell, Ex Nihilo Systems

    From Hospital Emergency Departments to Pre-Admissions Testing clinic to small office healthcare providers, personnel and resource availability and utilization is a critical factor delivering effective and cost efficient healthcare services. These healthcare providers face the challenges of on-demand services in a dynamic and vital context. We propose that a model of the actual clinic or ER will assist in making short term staffing decisions. We further propose that an agile development process will enable the development of a pattern-based virtual model which can execute time dilation simulations based on probability algorithms. A virtual ER can project probable near-term workloads based on actual workloads, and signal areas of personnel and resources allocation adjustments.

    This presentation will explore the alignment of a dynamic healthcare situation with a dynamic solution with a dynamic solution development process, leveraging DSDM methodologies, Systems Engineering processes, and evolving life science knowledge.

  6. Challenges in Implementing AGILE in a large Healthcare Environment

    Kenneth Mosteller, PD Mentors

    For the past several years The Veteran's Administration, the worlds largest healthcare organization, has been trying to move away from a waterfall environment to an AGILE environment. This transition started due to several highly publicized system failures, documented in GAO reports. The first attempt at moving away from Waterfall was to implement a "time box" strategy PMAS (Project Management Accountability System). This strategy required projects to be fully staffed before they could start and required all projects to have production deliverable's at a maximum of 90 days. Per GAO the result was fewer failed projects, however it also resulted in fewer project deliverables.

    At the beginning of 2016, the VA piloted a transition to AGILE development for all IT projects. This transition was rolled out throughout 2016 and in January 2017, all aspects of PMAS were eliminated. The paper will show the new process models and talk about the challenges the VA is still facing in its implementation. The two greatest challenges still being faced by the VA are getting their users "trained" on writing a request (EPIC) and getting IT Operations on board with the process.

  7. Systems Engineers Using Lean Methods for Initial Planning of Agile Projects

    Michael Pafford,

    A growing number of system solutions are being designed and developed around large software applications, or sets of integrated software applications. These solutions are often referred to as Application Lifecycle Management (ALM) or Application Development Lifecycle Management (ADLM) projects. With the increase of these ALM/ADLM projects, we’re seeing more use of current and modern project engineering and management techniques such as Agile. The purpose of this Educational Workshop (Tutorial) is to provide Systems Engineers (SEs), Software Engineers (SWEs), and Project Managers (PjMs) with experiential-based information, lessons learned, and tools and techniques to enable successful collaboration in characterizing stakeholders, needs, requirements, functions, and features, and in developing initial work items for Agile ALM/ADLM system solution projects. The main objective of the Tutorial is to help SEs, SWEs, and PjMs, “Get It Right, Right From the Start”, when collaborating in Agile ALM/ADLM project planning. Attendees will learn about and practice using specific Lean Method process steps, tools, and techniques to collaboratively develop solution-ready Product Backlog Item (PBI) sets of initial work products for Agile Scrum ALM/ADLM projects.


  8. Leadership: Beating the Odds of OCM Failure in Agile and DevOps Transformations

    Stephen Mayner,  Scaled Agile Inc.

    Adopting Agile and DevOps principles and practices frequently leads enterprises down a path to significant cultural and organizational change. This creates a real barrier for coaches and change agents to overcome. Leading researchers sparked by John Kotter’s claim of a 70% failure rate for organizational change have confirmed through scientific study that these types of transformative efforts are more likely to fail than to succeed. Fortunately, all is not lost! Scholar practitioners have also uncovered a powerful tool that consistently increases the success rate of transformational change. The secret weapon is leadership… but not just any style of leadership…

    In this session, Dr. Steve Mayner will share the potential power of transformational leadership behaviors to drive successful organizational change. His primary research was the first to explore the correlation between this specific leadership style and positive response to change in Agile/DevOps implementations. How enterprise leaders cast vision, encourage individual growth, demonstrate authenticity, and challenge followers to maximize their creative potential can have a greater influence on the success of an Agile/DevOps implementation than any change management method, methodology, or toolset. Steve will also share examples from his own experiences observing transformational leadership in action, and the results that followed.

  9. When World’s Collide: Regulatory Compliance meets Lean-Agile Development using SAFe

    Harry Koehnemann, 321 Gang & Stephen Mayner,  Scaled Agile Inc.

    Achieving Regulatory and Industry Standards Compliance with the Lean-Agile at Scale.

    Many of the big, complex systems in medical, aerospace, defense, automotive, banking, and other industries have an unacceptable social or economic cost of failure. These systems are also subject to extensive regulatory oversight and rigorous compliance standards. Historically, organizations building these systems have relied on comprehensive quality management systems and stage-gate based waterfall life-cycle models to reduce risk and ensure compliance. These same organizations are now beginning to adopt lean-agile methods, and are struggling to understand how their existing stage-gate compliance activities participate in a lean-agile flow of value.

    In this presentation, we will discuss current trends in lean-agile adoption in these high assurance markets, and will show how SAFe is being used by many of these organizations to guide their transformation initiatives. We show how several lean-agile principles produce better compliance outcomes by:

    - Taking an incremental approach to creating and assessing compliance information

    - Including compliance teams and their concerns in the product development ecosystem to collaborate on planning, executing, assessing, and adapting.

    - Incorporating compliance into agile quality practices – automating, adapting, & continuously improving

    - Integrating V&V and compliance activities into iterative development flow

  10. Agile Health Care Systems and Comfort Zones: Are We Thinking Broadly Enough?

    William D. (Bill) Schindel, ICTT System Sciences

    The most widely-familiar paradigm associated with “agile” approaches refers to (1) the development process, for systems or sub-systems that are (2) software-oriented. INCOSE in general, and the INCOSE Agile Health Care Systems Conference in particular, have already examined the notion that agility in development is not a practice limited to software technology. In this talk, we will pursue this further, looking beyond system development to the rest of the system life cycle, and how agility applies there as well, in the context of the health care domain. During the 2016 Agile Heath Care Systems Conference, participants in a break-out session identified a set of “bigger picture” targets for agility in the overall Health Care domain, which we’ll also look into further in this session. If your agility comfort zone is limited to daily scrums for software development, this session is meant to stimulate discomfort and expanded horizons.

  11. FMEA to inform an agile sprint approach for health IT workflow and systems improvements

    Kendra Kreutz, Kendra Kreutz Consulting, LLC & Rick Shepardson, Nordic Consulting Partners, LLC

    The implementation of end user software can often be done hastily and without a fully integrated effort across operations and IT designed to positively affect workflow improvement. A root cause of this may be that implementations happen for the sake of software or technology and that they lack the effort needed to proactively update operational processes with supporting change management. Also, software workflow best practices can sometimes be at odds with existing organizational process workflows and each side can be reluctant to change. Further, once in place, the software customizations and resulting end user workflows tend to stay in place rather than undergo continuous QI efforts for either or both workflow and systems improvements. One of the reasons for this is that it is difficult to make swift, relatively easy optimization adjustments. Large healthcare systems are very good at making large changes and are better equipped for those large organizational changes by assigning a comprehensive team (PMO, training, operational go-live support, communication, executive leadership engagement, etc) to the change.

    In an effort to fill these gaps, we developed an Agile methodology using sprints to implement rapid changes for user and system improvements. While this methodology solves for many of the existing challenges with smaller optimization efforts, many healthcare systems currently are not organized to successfully work and operate quickly, let alone agily. In order to understand the methodology within the context of the systems of healthcare, we subsequently performed an FMEA to understand the process bottlenecks and potential errors that we may encounter. In this presentation, we will cover historical software implementation and optimization approaches, the development of our agile methodology and the FMEA.

  12. Getting Serious About a Systems Approach to Healthcare

    Kevin Nortup, Sugar Creek Solutions

    Everyone “knows” that healthcare is a complex, sociotechnical system of systems. Yet invariably, attempts to approach it as such – even among systems engineers – encounter entrenched assumptions, concessions and traditions that seek to exclude critical elements of healthcare from a systems approach. With fundamental dysfunctional elements out of scope of the defined problem, the efficacy of any developmental approach – agile or otherwise – will be severely limited.

    This session explores how a systems approach to healthcare might progress when we “get serious” about analyzing, designing, implementing, operating and remediating it as a system. It proposes a simple yet powerful model of institutions (such as hospitals) as sociotechnical systems. It examines key areas where healthcare, as implemented today, flagrantly disregards fundamental principles of systems and of software. Balancing naïveté and skepticism with humor, it proposes “simple and obvious” alternatives to traditional assumptions, entrenched practices and protected interests – particularly with respect to aligning architecture of the system with the architecture of the development system that creates it. Finally, it challenges attendees to be agile yet systemic in their meta-approach as well as in their developmental approach.

  13. Applying Agile Practices to Integrated Product Development

Carissa Black

At first glance, "traditional" product development methods do not appear compatible with "modern" Agile-based approaches. The traditionalists are concerned about the unstructured nature of Agile - the lack of a clear plan, a clear end, and the emphasis on software. Agile proponents rally against the strict, top-down, and over-structured nature of traditional product development that does not take into account the realities of changing product requirements. Having worked in both methods, we have found that it is possible, and in fact desired, to blend these approaches to product development. Integrated product development, which combines both hardware and software elements, benefits from the overall structure provided by classic approaches, and the accountability and flexibility that comes from Agile methods. In this presentation we will describe how we have combined these methods to create a product development process that has improved predictability, speed, and customer satisfaction. We will discuss examples and lessons learned from applying this combined method on integrated consumer, dental, and medical projects.