Agile Systems in Health Care 2016
May 23-24 - Schaumburg, IL (Chicago area)
The Health Care Working Group of the International Council on Systems Engineering (INCOSE), with support from the INCOSE Agile Systems Working Group and System Patterns Working Group present “INCOSE Conference on Agile Systems in Health Care”
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. This two-day conference includes multiple session learning tracks as well as collaboration session opportunities to advance the state of the community. Watch this space for future posting of the detailed schedule of tracks, topics, and sessions.
WHY THIS IS IMPORTANT: 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.
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 Schaumburg, IL (Chicago region), easily reached by Midwestern driving or through Chicago O'Hare Airport. Lunch will be provided at the meeting facility on both days. 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. To obtain the block rate, either call 800-993-0367and provide conference identifier "Agile", else or use the on line direct reservation link Make reservations soon, before April 22 release of the reserved block of rooms. After April 22, call 866-974-9288 to see if the conference rate can still be available.
Thanks to the conference organizers and sponsors, the registration fee for this event is a modest $100, for the full two-day event, including lunches and refreshments. (Each speaker presenting at the conference will be granted a free registration ticket.) However, meeting size is limited and you must register in advance to attend.
QUESTIONS? Contact any of the following organizing committee members:
Day 1 Keynote Address: “Front Line Lessons in Agile Health Care Systems”, Donald A. Gagliano, MD, MHA, FACHE, CPE
Abstract:
Military theater medicine represents one of the most demanding environments for agility in systems of health care. Dynamic change in threats, shifting uncertainties, and advances in medical science and technologies all demand agility in responding systems. The good news is that, in recent years, learning and innovations have dramatically improved theater medicine outcomes. How can these experiences provide insights into underlying principles of agile health care systems, applicable in other domains?
Our speaker, a leader in improved theater medicine, will share his experiences and insights, and encourage group discussion of future challenges and needs seen by attendees.
Biography:
DONALD A. GAGLIANO, MD, MHA, FACHE, CPE
From 2002–2004, Dr. Gagliano served as the Commander of the US Army 30th Theater Medical Command (MEDCOM) and was the Coalition Command Surgeon during the initial occupation of Iraq and throughout the remainder of Operation Iraqi Freedom-1. In November 2008, he was recalled from military retirement by the Assistant Secretary of Defense for Health Affairs and appointed as the first Executive Director of the Joint Department of Defense (DoD) and Department of Veterans Affairs (VA) Vision Center of Excellence (VCE). Dr. Gagliano was responsible for establishing the Congressionally-mandated VCE and overseeing the clinical care, research, prevention, treatment and rehabilitation of military eye injuries in the DoD and VA healthcare systems.
In April 2013, Dr. Gagliano retired after 38 years of military service and joined Bausch + Lomb (B+L) as the Vice President for Global Development Operations. He served in this capacity until November 2013, departing when B+L had been fully acquired by Valeant Pharmaceuticals. In March 2014, he founded Global Medical Innovation (GMI), a company designed to inspire innovative solutions and provide consultative support for research and development, education and training, and healthcare integration. GMI currently supports The MITRE Corporation for development of the DoD Biotechnology Research Strategy and the VA Choice Act Assessment.
Dr. Gagliano is a graduate of the United States Military Academy at West, Point (BS), the Chicago Medical School (MD), Penn State University (MHA), the US Army War College and the US Air War College. He is the author of multiple publications and book chapters, a Fellow of the American Academy of Ophthalmology, and a longstanding member of the Retina Society and the American Society of Retinal Specialists. Don has served at the CEO level of leadership as the Commander of the US Army Ocular Hazards Research Laboratory, the US Army Clinical Investigations Research Office, the 5th MASH (Airborne), 28th CSH (Airborne), and the Fort Campbell MEDDAC (Air Assault).
Day 2 Plenary Session: “Agile Model-Based Systems Engineering”, Bruce Power Douglass, PhD
Abstract:
Traditionally systems engineering is a heavily document-based approach. The acceptance of the SysML modeling language changed the face of systems engineering from a process of creating and reviewing documents to the construction, analysis, and execution of high fidelity systems models. This evolution of systems engineering has resulted in improved requirements specification, better architectural definition, and better hand off to downstream engineering, including mechanical, electrical and software development. What is needed now is a process that takes advantage of the advances in model-based engineering (MBE) while at the same time reduces the time and effort required for systems engineering.
Agile methods have proven successful in the software domain, but how can these incremental, iterative, and agile methods be applied to systems engineering? Absolutely crucial to the application to agility in systems engineering is the use of high-fidelity modeling - a technique that results in computable (executable) models that can be incrementally verified for correctness. This allows the production of high quality, verified engineering data (requirements, architectures, and designs) that can be incrementally handed off to downstream engineering. Dr. Bruce Powel Douglass, author of Real-Time Agility and Agile Systems Engineering, talks about how to best gain the advantages of agile methods within the systems engineering domain.
Topics include:
- The Harmony aMBSE Lifecycle
- Creation and analysis of requirements based on use cases
- Architectural analysis using parametrics
- Incremental Architectural design
- Incremental hand off to downstream engineering
Takeaways: Attendees will learn how to create system engineering work products from high-fidelity verifiable models, and how this is absolutely crucial to doing agile for systems engineering. They will also learn the work flows for various system engineering activities that allow MBSE to be used in an incremental, iterative lifecycle.
Biography:
Systems engineer. Ironman triathlete. Embedded Software Methodologist. Ultramarathon cyclist. Contributor to UML and SysML specifications. Writer. Black Belt. Neuroscientist. Classical guitarist. Bruce Powel Douglass, who has a doctorate in neurocybernetics from the USD Medical School, has over 35 years of experience developing safety-critical real-time systems in a variety of hard real-time environments. He is the author of over 6000 book pages from a number of technical books including Agile Systems Engineering, Real-Time UML, Real-Time UML Workshop for Embedded Systems, Real-Time Design Patterns, Doing Hard Time, Real-Time Agility, and Design Patterns for Embedded Systems in C. He has contributed to a number of standards including the UML, SysML, UML Profile for Schedulability, Performance and Time, UML Fault Tree Analysis Profile, and the UML Security Analysis Profile. He is the Chief Evangelist at IBM Internet of Things (IoT), where he is a thought leader in the systems space. He can be followed on Twitter @IronmanBruce.
Conference Abstracts
Title: The answer is SooS
Abstract:
The usage of agile ways of working outside of software development is hardly a new thing at this point, but still somewhat of a novelty for many people. This presentation will share experiences from trying to implement agile ways of working in many different parts of GE Healthcare – a company that is undergoing a fundamental cultural change. I will share a number of examples on how I have supported hardware development teams, groups of chemists, professional services teams and department management teams in implementing agile ways of working using SooS – Scrum outside of Software – as a starting point. One example of a systems project from the GE Healthcare Life Sciences business will also be shared in more detail.
Bio:
Mikael Boman is one of the most experienced practitioners, coaches and trainers of agile software development methods in Sweden. He has worked with agile methods since the late 1990s and was certified as a Scrum Master by Ken Schwaber, one of the fathers of Scrum, in 2003. He has ever since worked with agile methods in different roles, as a team member, Scrum Master, Product Owner, coach, mentor, release manager and engineering manager. He has spoken at a number of international conferences, including JavaOne, the XP conference and multiple ScrumGatherings. He was the organizer of the Scrum Gathering in Stockholm in 2008, and chair of the Scrum User Group Sweden 2008-2012. He is a Certified Scrum Trainer (see scrumalliance.org/cst) since 2008 and have worked together with Ken Schwaber, Mike Cohn and Jurgen Appelo among others, in bringing more knowledge about different aspects of agile to Sweden.
In 1996 Mikael was one of the founders of the consulting company Citerus (www.citerus.se) and worked there as a consultant until 2013. He remains as a member of the board of Citerus and occasional trainer. He is working as an Agile Coach at GE Healthcare based in Uppsala, Sweden, trying to implement agile/lean ways of working at all levels of the organization, with a special focus on the Life Sciences sub-business and agile outside of software.
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Be Lean and Be Safe: Applying Agile to Design Medical Devices
Abstract:
Agile practitioners need to understand the Design Controls and Software Development Lifecycle tasks to perform during every Program Increment. An Agile Coach and Quality Manager share how regulatory activities integrate into Agile development, such as the Scaled Agile Framework®. Participants will learn which roles perform specific regulatory tasks during the pre-planning, plan, execute, and review cycle of Program Increments. Teams will participate in a simulation to learn how to plan and execute Program Increments that incorporate quality and safety.
Bio:
Ram Nanjundeswaran, Lean/Agile Coach, GE Healthcare
Ram is a Lean/Agile Coach at GE Healthcare with 23 years of experience in software development in a variety of roles across different development methodologies (Waterfall, Iterative and Agile). He started his Agile journey 5 years ago with NOKIA (formerly NAVTEQ) where he was part of the Agile Transformation and served in the capacity of an Agile Coach & Agile Program Manager. Ram has been with GE since August 2013, where he has helped roll out Scaled Agile Framework across many programs as part of their Agile transformation.
Ianne Howards Koritzinsky, Design Controls Manager, GE Healthcare
Ianne Howards Koritzinsky is a Design Controls Manager for GE Healthcare over 30 years of experience in Engineering and Quality in healthcare and financial processing. Ianne helps systems and software teams across GEHC improve reliability and safety, and to adopt Agile. Ianne has a Masters in Computer Science from the University of Wisconsin-Madison.
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Title: Agile – Tailor It To Work For You!
Abstract:
Agile has many benefits and advantages over traditional software development methods, but medical devices and the medical device industry present many unique challenges and constraints. The Agile methodology can be tailored to work within these constraints and still be effective. These constraints include the need for progress against plan metrics, fixed scope, and a target delivery date. A variety of lessons were learned during the Agile adoption process, including the importance of role clarity, strong emphasis on backlog grooming, and how to measure progress against plan. Our Agile adoption journey is far from complete and we continue to look both internally and externally for best practices. Agile has much to offer, tailor it to work within your business!
Bio:
Dave Duckert, P.E.
Program Manager, General Electric Healthcare
Dave has worked in the medical device industry for 20 years, including research and development, software and hardware development, licensing, and program management. In his current role, Dave is championing Agile adoption for a new medical device development program at GE Healthcare. Dave holds a BSEE and an MBA from the University of Wisconsin-Milwaukee and is a registered engineer in the State of Wisconsin. Dave holds 8 US patents related to medical device technology.
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Implementing AAMI:TIR45 in Medical Devices is a Capability Building Exercise
Abstract:
Medical Devices are governed by provisions of regulatory standards such as Title 21 CFR Part 820.30 (Quality System Regulation: Design Controls) and Software Lifecycle Processes for Medical Devices Software such as IEC 62304. With Agile Software Development methods becoming the primary Software Lifecycle Process for many organizations that want to leverage the advantages of agile practices such as improving time to market and quality, reducing costs etc., the Association for Advancement of Medical Instrumentation (AAMI) published a Technical Information Report 45 (TIR45) in 2012 to provide recommendations to manufacturers and regulators for complying with International Standards and U.S. Food and Drug Administration (FDA) guidance documents when using agile practices in development of Medical Devices Software. In this dissertation, we will retrospect the experiences and the learnings that reinforce the notion that adopting agile practices in Medical Devices Software in alignment with AAMI:TIR45 is not simply a change in the process but a capability building initiative and exercise for the entire organization.
Bio:
Madhu Expedith
Sergey Korabelnikov
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Title: “Using the Agile SE Life Cycle Pattern to Plan and Manage Progress Increments in Health Care”
Abstract:
Viewed at almost any level—individuals, products, enterprises, market segments, or society--Health Care appears as a vast and complex system. Since there are countless challenges and opportunities for progress, how can an enterprise, industry, society, or individual systematically plan and manage future progress and innovation? Where can we best apply the principles and lessons of Systems Engineering, deeper Agility, or Lean Methods to make optimal progress today, tomorrow, and in the future? Is there a systemic approach to map-making for this progress? This session will include both an introduction to the INCOSE ASELCM Pattern being developed by the INCOSE ASELCM Discovery Project, and an opportunity to “test drive” it in a break-out team, to map challenging “hot spots” and opportunities for progress across the landscape of health care systems.
Bio:
Bill Schindel is president of ICTT System Sciences. His engineering career began in mil/aero systems with IBM Federal Systems, included faculty service at Rose-Hulman Institute of Technology, and founding of three systems enterprises. Bill co-led a project on Systems of Innovation in the INCOSE System Science Working Group, co-leads the Patterns Working Group, and is a member of the lead team of the INCOSE Agile Systems Engineering Life Cycle Project. He is president of the Crossroads of America Chapter of INCOSE.
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Topic: "Applying System Development Activities Within An Agile Model”
Abstract:
Agile Software Development is not just for software, because software development is usually not only about software engineering. Embedded software teams have long had to work different engineering disciplines within the context of a system development model. Even large “software-only” applications like internal IT systems, banking systems, retail software, etc., are big systems that need more than software engineering, they also need concepts and methods of systems engineering. The Agile community recognizes this, and the recent update to “SAFe 4.0 for Lean Software and Systems Engineering” embraces systems engineering concepts. Long-established Systems Engineering process models, such as those developed by INCOSE and NASA, can be applied within the context of SAFe, getting the benefits from a robust process model and the benefits of Agility. This session will explore this combination.
Bio:
Kelly Weyrauch
Owner, Agile Quality Systems LLC
Kelly has more than 30 years of software and systems development experience, and 20 years of focus on software processes and quality systems for medical devices. As an independent consultant, he works with software and systems creators to apply Agile concepts and Quality Management System requirements to the unique context of their development environment. As a leader of the Agile movement at Medtronic, he has worked with project teams to evolve Agile Principles and Practices in the context of a robust Quality System. As one of the principal authors of AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software, Kelly has worked with the FDA and industry leaders on the application of Agile practices to the medical device world. As an experienced software and systems developer, and an ASQ Certified Quality Auditor, Kelly helps teams to align the requirements of medical device regulations and standards with the practical realities and constraints of complex system development.
Kelly has a BS degree in Mechanical Engineering from the University of Minnesota, and a MS degree in Software Design and Development from the University of St. Thomas (Minnesota).
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Title: Agile Hardware and Systems
Abstract:
This presentation provides a proposed outline for an Agile implementation of a medical device system, including hardware and firmware content. WBS/task lists, Burndown charts, and SPA chart tools are employed for monitoring of the development status during sprints. Included is a discussion of timing of hardware and firmware sprints with respect to the overall project plan.
Bio:
Will Bishop
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Synchronizing Sub-teams When Mixing Agile With Other Methodologies
Abstract:
Subteams can use different development methodologies including Agile Scrum, Incremental/Evolutionary, and Waterfall that integrate with one another. This allows organizations to phase in Agile or provide greater flexibility across disciplines or functions. Although subteams may follow different processes, subteam interfaces need to be well defined and milestones scheduled. This session provides guidelines for structuring subteam interactions. It focuses on the typical phase gate transitions. As a case study, an example is used that includes Requirements and Verification performed as a Waterfall, Electrical and Mechanical performed using an Incremental/Evolutionary lifecycle, and Software Implementation performed using an Agile Scrum lifecycle.
Bio:
Rainy Mumper
Principal Engineer
Battelle Commercial, Industrial & Medical Products
Rainy Mumper has 15 years of software development experience including both embedded and application software for medical products. She also has experience in software requirements management and software verification, as well as in other support processes including configuration management, risk and failure modes assessment, and defect tracking. As a software task lead she has experience in software development planning and establishing Agile development processes that are appropriate for regulated devices.
Clark Fortney
Senior Software Engineer
Battelle Commercial, Industrial & Medical Products
For over 20 years, Mr. Fortney has focused his career on software development for medical devices. He has a broad background in Electrical Engineering, with an emphasis on embedded system/software design. He has served in software leadership roles for a wide variety of medical devices, including several drug delivery devices, enteral feeding pumps, and a heater/humidifier. Mr. Fortney’s primary skills are in Software Engineering (especially hardware/software integration), System Engineering, and Task Management.
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Agile and Compliant Medical Product Development
Abstract:
Agile and lean methods of new product development have been used for over a decade in non-regulated industries such as consumer electronics, especially for software development but also more recently for systems with hardware and software. These methods significantly speed product development and the resulting products hit the market needs more accurately. However Medical Device and Systems companies have been slow to adopt them, partially because they believe that regulatory requirements dictate a slower and more structured “waterfall” approach to development.
We will show that agile and lean methods are not only possible in a regulated environment, but they are much preferable to waterfall methods and can enhance regulatory compliance. The secret is to start with a compliant agile development framework, within which the team has flexibility to speed development using such techniques as Scrum and KanBan.
Bio:
Scott S. Elliott is CEO and Founder of TechZecs LLC, a San Francisco based consulting firm specializing in high-tech products and product development. He holds a PhD in Electrical Engineering from the University of California and worked in various roles as an engineer and executive for Hewlett Packard Test & Measurement (now Keysight Technologies) for 24 years. Scott is a frequent speaker and writer about management systems for agile product development
Aaron W. Joseph is a Biomedical Engineer and Consultant with 20 years of experience in medical device development over a wide range of technologies, from surgical robotics to x-ray imaging systems to catheters to drug inhaler devices. He helps medical device companies minimize the cost of compliance for new product development. He holds a BSEE from Rice University and a MS Bioengineering from the University of Washington.
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Title: Deliver Value Faster in Regulated Industries with the Scaled Agile Framework (SAFe)
Abstract:
All companies struggle with the modernization of their product development processes. The struggles are exacerbated when developing complex and highly regulated systems. Agile brings great promise, at face value, for gaining efficiencies in the development process. Meeting regulatory compliance and other governance concerns, as well as applying agile to hardware components in systems development, is not always clear in traditional agile approaches.
The Scaled Agile Framework (SAFe) brings an opportunity to address concerns at each of the team, program, value stream, and portfolio levels in order to achieve value faster and with more reliability. This presentation will discuss the basics of SAFe with an added focus on techniques for meeting compliance of regulatory standards and hardware/software co-development methods for complex systems.
Bio:
Doug Stewart, Director of Services at 321 Gang, is a SAFe® Program Consultant (SPC), a Certified ScrumMaster®, and he is certified in Lean Six-Sigma. With over 30 years of experience in the area of Software Development, Doug has held and mastered a wide variety of positions including Business Analyst, System Analyst, Software Architect, Tester, Software Developer, Project Manager, Sales Representative, Technical Sales Support, Customer Support, Deployment Consultant, Training Instructor, and Course Developer. With a combined 21 years at Rational and IBM, Doug is ready for any challenge the Gang and their clients are apt to present to him.
Doug has a passion for Software Development and Software Development Process Improvement. Recently, Doug has been working as an Agile Coach working with industry thought-leaders to help organizations achieve business agility through better software processes and tools. With such a long history in software process improvement, he is also pleased to contribute to the evolution of the Scaled Agile Framework® (SAFe®) and to help businesses implement the Framework.
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Tales from the Field: Agile in the Regulatory Context
Abstract:
“Individuals and interactions over processes and tools” is a concept many medical device companies struggle with, given the regulated nature of developing their products. Often, the pendulum swings too far to the pure agile side, resulting in processes that are out of control. In this discussion, we will touch briefly on applicable regulatory guardrails that are in place, and dive into our real-world experiences with medical device companies starting out with agile. Our examples will focus on agile’s relationship with FDA (US) regulation, and will include common pitfalls we’ve seen in quality systems, records, and documentation. We will also share our direct experience with several FDA investigators on the subject.
Bio:
Chad Gibson is the co-founder of CMD MedTech, a contract medical device product development company focusing on systems and software engineering. Chad has fifteen years of experience exclusively in the medical device industry. He started his career as a software engineer, and moved into a diverse array of roles including systems engineer, quality manager, and regulatory project leader. Chad has recently implemented agile-centric processes and quality systems for several large and small medical device companies, and has led “front room” interactions during FDA inspections for companies employing agile. Chad is an INCOSE member, has the RAPS RAC certification, and is an inventor on thirteen US patents in the fields of medical devices and healthcare information systems.
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Panel Session: Do Agile Practices Support or Hinder Achieving Quality and Compliance
Abstract:
Both traditional and agile practice strive to create quality solutions that are readily deployable into their operational environment. While traditional methods apply phase gates, formal reviews, and sign-offs, agile counters with test-driven development, continuous integration and testing cycles, cadence-based demos, and self-managed teams. This panel session deliberates quality and compliance questions. Does a move to agile create quality and/or compliance risks? When adopting agile practices, are traditional practice necessary? Do traditional practices disappear, or are they altered to fit in an agile flow? When adopting agile, are Scrum and Agile “By The Book” sufficient to address our quality and compliance demands? Bring your skeptical and challenging agile concerns and be prepared for lively discussion.
Moderator – Harry Koehnemann, 321 Gang
Panelists
Kelly Weyrauch – Agile Quality Systems
Ianne Koritzinsky – GE Healthcare
TBD
TBD
Open Chair for Attendees to Fill
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Title: “Front Line Lessons in Agile Health Care Systems”
Abstract:
Military theater medicine represents one of the most demanding environments for agility in systems of health care. Dynamic change in threats, shifting uncertainties, and advances in medical science and technologies all demand agility in responding systems. The good news is that, in recent years, learning and innovations have dramatically improved theater medicine outcomes. How can these experiences provide insights into underlying principles of agile health care systems, applicable in other domains? Our speaker, a leader in improved theater medicine, will share his experiences and insights, and encourage group discussion of future challenges and needs seen by attendees.
Bio:
DONALD A. GAGLIANO, MD, MHA, FACHE, CPE
From 2002–2004, Dr. Gagliano served as the Commander of the US Army 30th Theater Medical Command (MEDCOM) and was the Coalition Command Surgeon during the initial occupation of Iraq and throughout the remainder of Operation Iraqi Freedom-1. In November 2008, he was recalled from military retirement by the Assistant Secretary of Defense for Health Affairs and appointed as the first Executive Director of the Joint Department of Defense (DoD) and Department of Veterans Affairs (VA) Vision Center of Excellence (VCE). Dr. Gagliano was responsible for establishing the Congressionally-mandated VCE and overseeing the clinical care, research, prevention, treatment and rehabilitation of military eye injuries in the DoD and VA healthcare systems.
In April 2013, Dr. Gagliano retired after 38 years of military service and joined Bausch + Lomb (B+L) as the Vice President for Global Development Operations. He served in this capacity until November 2013, departing when B+L had been fully acquired by Valeant Pharmaceuticals. In March 2014, he founded Global Medical Innovation (GMI), a company designed to inspire innovative solutions and provide consultative support for research and development, education and training, and healthcare integration. GMI currently supports The MITRE Corporation for development of the DoD Biotechnology Research Strategy and the VA Choice Act Assessment.
Dr. Gagliano is a graduate of the United States Military Academy at West, Point (BS), the Chicago Medical School (MD), Penn State University (MHA), the US Army War College and the US Air War College. He is the author of multiple publications and book chapters, a Fellow of the American Academy of Ophthalmology, and a longstanding member of the Retina Society and the American Society of Retinal Specialists. Don has served at the CEO level of leadership as the Commander of the US Army Ocular Hazards Research Laboratory, the US Army Clinical Investigations Research Office, the 5th MASH (Airborne), 28th CSH (Airborne), and the Fort Campbell MEDDAC (Air Assault).
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Title: Agility as a Win-Win Game, and the Rules of Play on Any Board
Abstract:
Agility in all aspects of Healthcare will share a common foundation of necessary agility-enabling and agility-operational principles. Agility as a system development and system operational capability is independent of the application domain, from medical device development, regulation, and manufacturing, to healthcare delivery by hospitals and practitioners. This presentation will review fundamental domain-independent concepts and principles for designing, implementing and operating agile systems and processes; provide a case example of an effective agile systems engineering process dealing with combined hardware, software, and people ware development; and interactively discuss this example’s applicability to Healthcare.
Bio:
Rick Dove is a leading researcher, practitioner, and educator of fundamental principles for agile enterprise, agile systems, and agile development processes. In 1991 he initiated the global interest in agility as co-PI on the seminal 21st Century Manufacturing Enterprise Strategy project at Lehigh University. Subsequently he organized and led collaborative research at the DARPA-funded Agility Forum, involving 250 organizations and 1000 participants in workshop discovery of fundamental enabling principles for agile systems and processes of any kind. He is CEO of Paradigm Shift International, specializing in agile systems research, engineering, and education; and is an adjunct professor at Stevens Institute of Technology teaching graduate courses in agile and self-organizing systems. He chairs the INCOSE working groups for Agile Systems and Systems Engineering, and for Systems Security Engineering, and is the leader of the current INCOSE Agile Systems Engineering Life Cycle Model Discovery Project. He is an INCOSE Fellow, and the author of Response Ability, the Language, Structure, and Culture of the Agile Enterprise.
Program
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