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Wednesday Morning Session Details

*Program subject to change

For Wednesday Full Day schedule click here
Download HWG2019 tentative program pdf.

Authors	Gary Strong, GE Healthcare (Retired)
Title	So You Wanna Be a Rock ‘n Roll Star; Maximizing Your Impact as a System Engineer
Session	Type: Keynote Theme: Keynote Time: Wednesday May 01, 2019, 08:30 AM Room: Ballroom
Abstract	This talk will describe what are the attributes of a truly effective systems engineer in a complex organization. While this has to build on basic technical competence, the "soft skills" are what truly differentiates the most impactful systems engineers. Key leadership attributes are: Accountability, Credibility, Discernment, Inclusiveness, Ability to Synthesize, Delegation and Communication, and Confidence. Examples of how these attributes are instantiated and their impact on the organization are given.

Authors	Michael Pafford, INCOSE
Title	Tutorial: Using Lean Startup Method (LSM) and Agile for Initial Project Planning (IPP)
Session	Type: Submitted Theme: Agile Methods Time: Wednesday May 01, 2019, 10:30 AM Room: Wright
Abstract	An interactive Tutorial sharing a hybrid approach to Initial Project Planning (IPP) that uses best practices from the Lean Startup Method (LSM) and Agile Systems and Software Engineering, as well as Agile Project Management. This hybrid IPP approach was used during three IPP workshops for an ongoing Model-Based Systems Engineering (MBSE) project to develop a "Resilient Hospital Reference Model (RHRM)". The RHRM MBSE project will deliver a Reference Architecture that any hospital can use as part of a Decision Support Tool Suite to plan for continuing hospital critical operations during an extended power outage. The three RHRM MBSE IPP workshops, held at the Johns Hopkins University Applied Physics Laboratory (JHU/APL) between April and September 2018, brought together engineers, managers, and other decision makers from INCOSE, IEEE, FBI/InfraGard, and the Medical Profession. The project was given an award for "Collaboration in 2018" at the INCOSE International Workshop 2019. This Tutorial will review all the LSM and Agile steps used in the three IPP workshops that has helped the RHRM MBSE project, and will help any other system solution development project, "Get It Right, Right From the Start".

Authors	Seth Carmody, US FDA
Title	US FDA: Working Toward More Secure Healthcare
Session	Type: Invited Theme: Cyber Security Time: Wednesday May 01, 2019, 10:30 AM Room: Ballroom 2
Abstract	Over the last several years FDA has been working with the healthcare industry to improve the level of security in patient care. The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, portable media, and the frequent electronic exchange of medical device-related health information. In addition, cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. To accelerate progress of security in healthcare FDA has collaborated with industry to produce guidance documents on addressing security both “pre-market” and “post-market” introduction. FDA is in the process of updating its Pre-Market guidance and is currently reviewing comments from industry as it prepares this revised guidance. The FDA approach emphasizes three key principles: Resilience, Trustworthiness, and Transparency Resilience refers to designing devices to sustain functionality and ability to provide safe patient care in an ever increasing threat environment. Trustworthiness is a concept that encompasses ensuring that devices provide known and appropriate security features and support commitment to establish a level of trust with users of devices. Transparency is integral to risk management by allowing users of devices to understand and manage risks. Transparency is an important element of establishing trust. This discussion will explore FDA’s approach toward working with industry to improve security within healthcare, and how this is reflected in the upcoming revision to their Pre-Market guidance document.

Authors	Jeff Horvath, Balanced Experience
Title	Human Factors Throughout the Product Design Lifecycle: Best Practices
Session	Type: Invited Theme: Healthcare Delivery Time: Wednesday May 01, 2019, 10:30 AM Room: Lindbergh
Abstract	In the health and medical domain, human factors is fundamentally about reducing the risk of harming a patient. Over the past few years, there has been a significant increase in regulatory oversight about proper human factors validation for manufacturers of medical devices and treatments. In this talk, we'll use a case study to walk through the product development lifecycle and explore human factors best practices along the way. We'll start at the end - with patient safety - and work our way back to the beginning with product ideation and user research to see how each step builds upon earlier work. In the case study that we'll explore, we'll talk about how what it looks like when things go well and what it looks like when they don't.

Authors	Chris Unger (GE Healthcare), Tom Fairlie (Medtronic), Paul Kostek (Base 2 Solutions) and Juan Fernandez De Castro (Beckman Coulter)
Title	Developing Systems Engineering and Systems Thinking Skills
Session	Type: Invited Theme: SE Skills and Tools Time: Wednesday May 01, 2019, 10:30 AM Room: Ballroom 1
Abstract	Effective systems engineering individuals and teams combine SE skill expertise, influencing and leadership skills, and critical thinking skills. What is the right balance of technical and leadership skills, and what is the best way to develop each? What is the right balance of technical breadth and depth? Developing good systems engineers takes patience, but there are simple tools which can help. Finally, we talk about approaches to developing the systems engineering organization as a whole.

Authors	Seth Carmody (US FDA), Jeffrey Brown (GE Healthcare), Bill Hagestad II (Medtronic), and Steven Abrahamson (GE Healthcare)
Title	Cyber Security Expert Panel - Exploring Risks and Solutions in Medical Device Cyber Security
Session	Type: Invited Theme: Cyber Security Time: Wednesday May 01, 2019, 11:30 AM Room: Ballroom 2
Abstract	Cyber security in medical devices is a primary concern of medical device manufacturers, health delivery organizations, and regulators. A variety of adverse effects can result from cyber security incidents, including patient safety risk, loss of patient data confidentiality, and loss of device availability. Threats can originate with trusted insiders, cyber criminals, and nation states. How do we establish a priority for cyber security within the healthcare ecosystem? How do we plan for long-term resilience? How has our perspective on risk changed over the last few years and how do we see it changing in the future? These questions do not have simple answers. This session will provide an opportunity to explore the challenges and opportunities within healthcare cyber security with a panel of experts with varying perspectives and experiences. Participants will be encouraged to join in the discussion and offer their own insights to these and other questions.

Authors	Nicole Werner, University of Wisconsin-Madison
Title	The Home as a Healthcare Environment: Implications for Medical Device Design and In-Home Care Delivery
Session	Type: Invited Theme: Healthcare Delivery Time: Wednesday May 01, 2019, 11:30 AM Room: Lindbergh
Abstract	Caring for medically complex patients in the home necessarily transforms the home environment. Assessing the home environment is critical because it contributes to individuals’ well-being and function and affects the care that families are able to provide, both positively and negatively. Bringing medical devices into the home alters the environment from one associated with safety and comfort to one resembling the healthcare environment, which can include impersonal relations and sickness. For example, the technical aspects of managing medical devices (e.g., feeding tubes and pumps, ventilators, nebulizer machines, etc.) requires operating the machinery, maintaining sterility, and troubleshooting technical problems. Although the direct influence of the home environment itself on the health of medially complex patients and their families is poorly described, emerging research from related populations suggests the impact is considerable. A series of studies will be presented aimed to explore the physical environment of the home using a sociotechnical system framework, and how the physical environment shapes and is shaped by medical devices, health information technologies, and professional and non profession healthcare providers.

Authors	Mark Ridgley, Radius Teknologies, LLC
Title	Analyzing Your Data for Maximum Insight With DIAdem
Session	Type: Submitted Theme: SE Skills and Tools Time: Wednesday May 01, 2019, 11:30 AM Room: Ballroom 1
Abstract	We can create and collect complex data at tremendous rates, but unless we can manage and analyze that data, it’s useless. In this presentation, Mark introduces you to data management and analysis software, discusses the importance of data management and analysis and introduces you to National Instruments DIAdem – a tool that enables you to quickly import, inspect and analyze your data so you can transform that data into valuable insights. This presentation also features a brief demonstration of DIAdem’s capabilities to illustrate how DIAdem can be applied to a broad range of industries and application areas. Don’t miss it!

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For questions and comments, please contact:
Healthcare Working Group Program
Kelly Weyrauch