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INCOSE Systems Engineering in Healthcare Conference

HWG2021 Program








Authors Dr. Steven Dam
President, SPEC Innovations
Title Knowing When You Have Good Requirements
Session Type: LIVE
Theme: Requirements Tools to Meet FDA Design Control Requirements
Time: Friday, October 29, 2021 1:00 PM - 1:50 PM
Room: Virtual
Recording Video Recording: Knowing When You Have Good Requirements
Presentation Slides: Knowing When You Have Good Requirements
Abstract Requirements come from many sources: FDA, analysis of hospital processes, design of cutting edge diagnostic equipment, etc. But how do we know when we have good requirements? Two methods are commonly used for analyzing requirements to determine their quality: heuristics and functional analysis. Heuristics represent rules derived from experience: is the requirement clear?; is the requirement complete?; is the requirement verifiable; etc. Functional analysis usually requires complex modeling and simulation. The modeling provides the functional requirements, while the simulation verifies those requirements are feasible under constraints and can provide a source of performance requirements as well. Few “requirements tools” provide both these capabilities for analysis. This presentation will discuss an integrated tool, Innoslate® that provides both features using the cutting edge technologies of cloud computing and artificial intelligence.


Authors Laurence Sampson
Sr. Director Industry Strategy
Title Digital design control value and development frameworks
Session Type: LIVE
Theme: Requirements Tools to Meet FDA Design Control Requirements
Time: Friday, October 29, 2021 2:00 PM - 2:50 PM
Room: Virtual
Recording Video Recording: Digital design control value and development frameworks
Presentation Slides: not yet available
Abstract Learn how to frame development processes into functional traceability data models. In this session we will discuss the value of building comprehensive traceability, and how to build design perspectives into the traceability data model. Examples include how to define “good” product, integration of user risk, system modeling and functional chain development, integration of standards libraries, agile development methods, and traceability from product performance requirements to the product bill of material.


Authors Andrs Emmerich
CEO, Aligned AG
Title Reduce your Design Control documentation effort with Aligned Elements
Session Type: LIVE
Theme: Requirements Tools to Meet FDA Design Control Requirements
Time: Friday, October 29, 2021 3:00 PM - 3:50 PM
Room: Virtual
Recording Video Recording: Reduce your Design Control documentation effort with Aligned Elements
Presentation Slides: not yet available
Abstract Aligned Elements is a Medical Device ALM software written for Medical Device developers by Medical Device developers aiming to ensure compliant development documentation with as little effort as possible. We know from experience that the maintenance of Design Controls is a painstaking undertaking that very few people enthusiastically embrace. Aligned Elements applies automation when possible and reuse when sensible to minimize the administrative work associated with Design Control Management.


Authors David Cronin
Chief Research Officer, Cognition Corporation
Title A Structured Approach To Risk Management And Design Controls
Session Type: LIVE
Theme: Requirements Tools to Meet FDA Design Control Requirements
Time: Friday, October 29, 2021 4:00 PM - 4:50 PM
Room: Virtual
Recording Video Recording: A Structured Approach To Risk Management And Design Controls
Presentation Slides: not yet available
Abstract An unstructured approach to managing data results in tedious, manual data entry and verification as well as errors, project delays, and audit exposure. A structured data approach is a key infrastructure component of good systems engineering. Structured data enables a single source of truth, reduced resource burdens and error reduction. Structure ensures data integrity, chain of evidence, and increased credibility with health authorities. This session will explore some of the fundamentals of structured data and how it supports a holistic approach to risk management and design controls in medical device product development.


Authors Aaron Katz
Group Supervisor, JHU Applied Physics Lab
Title Foundations of the JHU Coronavirus Dashboard
Session Type: LIVE
Theme: Systems Responses to COVID-19 and Future Pandemics
Time: Friday, November 5, 2021 1:00 PM - 1:50 PM
Room: Virtual
Recording Video Recording: Foundations of the JHU Coronavirus Dashboard
Presentation Slides: not yet available
Abstract In January of 2020, Lauren Gardner of the Johns Hopkins University‘s Center for Systems Science and Engineering launched the JHU COVID-19 Dashboard. Since its launch, the dashboard has received broad acclaim, being described by Time magazine as the “go-to resource to track the global pandemic”. While the story of the dashboard as a compelling interactive resource for situational awareness has been told, the data infrastructure that is the foundation for the dashboard‘s operations is a story less covered. This brief will describe the design, engineering, and operation of the data pipeline that powers the dashboard, the JHU Coronavirus Resource Center, and the globally used public data sets.


Authors Brian Hasselfeld
Johns Hopkins Medicine- Medical Director, Digital Health and Telemedicine
Title The Rapid Rise of Telemedicine
Session Type: LIVE
Theme: Systems Responses to COVID-19 and Future Pandemics
Time: Friday, November 5, 2021 2:00 PM - 2:50 PM
Room: Virtual
Recording Video Recording: The Rapid Rise of Telemedicine
Presentation Slides: not yet available
Abstract Prior to the global pandemic, telemedicine accounted for just a small fraction of healthcare encounters. As the pandemic unfolded, that fraction escalated explosively challenging long standing approaches to provisioning care to millions. Suddenly, system changes were needed everywhere from technology, policy, workflow, and other aspects of healthcare. This presentation will describe the experiences an academic medical center related to scaling telemedicine services while highlighting the system-related challenges and opportunities the field is facing as these new services become an enduring feature of healthcare.


Authors Matthew Sawicki, MS - Health Systems Engineer
Donald Richardson MD, PhD- Operations Researcher
Title Systems approach to COVID-19 Response for Supply Chain Risk Management
Session Type: LIVE
Theme: Systems Responses to COVID-19 and Future Pandemics
Time: Friday, November 5, 2021 3:00 PM - 3:50 PM
Room: Virtual
Recording Video Recording: Systems approach to COVID-19 Response for Supply Chain Risk Management
Presentation Slides: not yet available
Abstract The Johns Hopkins University Applied Physics Lab (APL) supported the COVID-19 National Response by providing advanced analytic capabilities to enable situational awareness and decision support tools. A hybrid approach, balancing short-term needs and working towards strategic capabilities, was implemented to develop analytic tools and inform robust and resilient analytics driven by hospital-level data. In order to achieve this goal, the APL team worked with the National Response to elicit actionable insights from beneficiaries and stakeholders, developed data pipelines to build models highlighting potential system risks, and delivered data products to aid the response to current and prevent future critical supply shortfalls. In this overview, the team will discuss the modeling capabilities that were built out to provide scenario-driven resource demand estimates based on the state of the COVID-19 pandemic.


Authors Michael Grant MD
Associate Professor, JHU School of Medicine
Title Systems Challenges to In-Patient Care During the Pandemic
Session Type: RECORDED
Theme: Systems Responses to COVID-19 and Future Pandemics
Time: Friday, November 5, 2021 4:00 PM - 4:50 PM
Room: Virtual
Recording Video Recording: Systems Challenges to In-Patient Care During the Pandemic
Presentation Slides: not yet available
Abstract The COVID-19 Pandemic both introduced and highlighted existing systems-level challenges to in-patient healthcare. As teams work to address barriers, the Systems Engineering framework can provide some insights into how to prioritize resources, educate staff and realize durable long-term solutions


Authors Chris Unger (moderator) GEHC
Kerry Griffin, Stryker;, Diana Mac Kenzie, Werfen;, Mike Casper, Smith and Nephew;, Tom Fairlie, Medtronic
Title Roundtable on ‘Requirements/Systems ALM’ tools
Session Type: LIVE
Theme: User Views on Requirements Tools
Time: Friday, November 5, 2021 1:00 PM - 1:50 PM
Room: Virtual
Recording Video Recording: Roundtable on ‘Requirements/Systems ALM’ tools
Presentation Slides: Roundtable on ‘Requirements/Systems ALM’ tools
Abstract The new Systems Lifecycle Management tools cover a lot more than simply requirements. That makes them more powerful, but makes selecting and deploying a tool more complex. The roundtable will share thoughts on best practices in selecting and deploying such a tool.


Authors Kerry Griffin
Director, Test Engineering, Stryker
Title Requirements/Systems ALM Tool Selection Process Best Practice
Session Type: LIVE
Theme: User Views on Requirements Tools
Time: Friday, November 5, 2021 2:00 PM - 2:50 PM
Room: Virtual
Recording Video Recording: not released
Presentation Slides: not yet available
Abstract Selecting a new requirements or development tool and getting alignment across stakeholders can be daunting. We will present some best practices that ensure the selection has full company and stakeholder acceptance. The selection process Stryker followed was similar to a discovery and product development process.


Authors Diana Mac Kenzie
Werfen
Title What to Expect after Selecting a New ALM TOOL: A Strategy for Systems Tool Integration: Year One
Session Type: LIVE
Theme: User Views on Requirements Tools
Time: Friday, November 5, 2021 3:00 PM - 3:50 PM
Room: Virtual
Recording Video Recording: What to Expect after Selecting a New ALM TOOL: A Strategy for Systems Tool Integration: Year One
Presentation Slides: What to Expect after Selecting a New ALM TOOL: A Strategy for Systems Tool Integration: Year One
Abstract Selecting a new requirements and lifecycle development tool was a critical decision and a lot of work .... but what happens next? This session will discuss what to expect and how to plan for that first year after the tool selection process. From securing the NDA, setting the budget, initial deployment plans, to monitoring and addressing the emotional journey and challenges of integration to a new tool.


Authors Lou Wheatcraft
INCOSE Requirements Working Group Co-Chair
Title Needs, Requirements, Verification, and Validation Across the System Lifecycle
Session Type: LIVE
Theme: User Views on Requirements Tools
Time: Friday, November 5, 2021 4:00 PM - 4:50 PM
Room: Virtual
Recording Video Recording: Needs, Requirements, Verification, and Validation Across the System Lifecycle
Presentation Slides: Needs, Requirements, Verification, and Validation Across the System Lifecycle
Abstract Design input requirements and the integrated set of needs from which they were transformed, form the backbone of the project management (PM) and systems engineering (SE) data and information model of the system of interest (SOI) being developed. For final acceptance, certification, and qualification, the SOI is verified against design input requirements, and validated against the integrated set of needs. To successfully compete system verification and system validation with any degree of reliability or repeatability, the needs and requirements of the system as well as the system verification and system validation artifacts must be managed over the entire product lifecycle; this presentation provides guidance on what must be done to do this.


Authors Marc Horner
Senior Prinicpal Engineer, ANSYS
Title Bridging Systems Engineering and Multi-Fidelity Analytical Models using ModelCenter MBSE
Session Type: LIVE
Theme: Linking SE Models with Simulations for Device Development
Time: Friday, November 12, 2021 1:00 PM - 1:50 PM
Room: Virtual
Recording Video Recording: Bridging Systems Engineering and Multi-Fidelity Analytical Models using ModelCenter MBSE
Presentation Slides: not yet available
Abstract This tutorial will describe and demonstrate ModelCenter MBSE, an analysis integration framework for CAMEO Systems Modeler, Rhapsody, GENESYS, and PTC Windchill Modeler. ModelCenter MBSE allows engineers to integrate analysis tools with any SysML model element to validate system behavior, verify requirements satisfaction, and perform trade studies to optimize the system design, resulting in reduced cost, shortened development times, and higher quality product roll outs.
This tutorial will use the example of an auto-injector to demonstrate how engineers can use ModelCenter to automate the execution of multiple engineering analysis tools and to connect these tools together to create automated and repeatable engineering process workflows. This will include a description of how the analysis tools are executed in the required order, and how data is automatically linked from tool to tool as needed. Finally, we will show how engineers can use ModelCenter MBSE to connect the automated workflows to SysML models for requirements validation, behavioral analysis, and optimization.


Authors John Andersson- VP Product Development - Stille AB
Stephane LeCrampe, ObeoSoft/Arcadia-Capella
Title Using MBSE and Capella to improve regulatory certification
Session Type: LIVE
Theme: Linking SE Models with Simulations for Device Development
Time: Friday, November 12, 2021 2:00 PM - 2:50 PM
Room: Virtual
Recording Video Recording: Using MBSE and Capella to improve regulatory certification
Presentation Slides: not yet available
Abstract The regulatory certification for medical devices can be an extremely long and costly process. The certification process will look at things from a process point of view to user validation and everything in between. One of the big problems is to describe the product in an easy-to-understand way and to get the certifying institute to grasp how risks and requirements have flown down into the design and onto the product with crystal clear traceability. This is our journey to get there.


Authors Saulius Pavalkis
Catia NoMagic, Dessault Systems
Title Introduction to Model Simulation and Engineering Analysis with SysML in Context of Medical Device Sample
Session Type: LIVE
Theme: Linking SE Models with Simulations for Device Development
Time: Friday, November 12, 2021 3:00 PM - 3:50 PM
Room: Virtual
Recording Video Recording: Introduction to Model Simulation and Engineering Analysis with SysML in Context of Medical Device Sample
Presentation Slides: Introduction to Model Simulation and Engineering Analysis with SysML in Context of Medical Device Sample
Abstract The tutorial provides a reusable typical system modelling pattern on how to create and analyse models in OMG standard SysML that can be executed as a single system. Model execution is performed based on other standards such as OMG fUML, SC XML. The tutorial is very practical - it is driven by a sequence of hands-on assignments based on an educational case study model used in multiple workshops and trainings. Tutorial explains SysML by simulating system model. We will explain how to model system structure as independent interconnected communicating components, we will add behavior models (state machines, activities), parametric analysis, Instances representing configurations, sequence capturing execution scenarios. Attendees will learn easy to follow modelling pattern suitable for any system simulation.


Authors Kelly Hay, MPH
Principal Public Health Informaticist, The MITRE Corporation
Title Where Engineering Meets Epidemiology: Agile Development of a National Resource for Disease Containment and Mitigation
Session Type: LIVE
Theme: System Approaches to Tracking Pandemic Responses
Time: Friday, November 12, 2021 1:00 PM - 1:50 PM
Room: Virtual
Recording Video Recording: Where Engineering Meets Epidemiology: Agile Development of a National Resource for Disease Containment and Mitigation
Presentation Slides: not yet available
Abstract Since its initial deployment in April 2020, Sara Alert™ has helped jurisdictions across the United States, which span 8 states, 6 counties, 4 territories and freely associated states, and 1 city, monitor over 6 million individuals in response to the COVID-19 pandemic. Agile methodology and continuous stakeholder engagement ensure features, user interface design, and workflow are closely aligned with user needs and evolve with changes in public health response. Rapid development, deployment, and scaling of Sara Alert™ demonstrates the impact of close collaboration between public health users and engineers.


Authors Jason Walonoski
Senior Principal Engineer, The MITRE Corporation
Title Simulation of COVID-19 Disease Progression, Personal Protective Equipment (PPE), Durable Medical Equipment (DME), and Patient Outcomes
Session Type: LIVE
Theme: System Approaches to Tracking Pandemic Responses
Time: Friday, November 12, 2021 2:00 PM - 2:50 PM
Room: Virtual
Recording Video Recording: Simulation of COVID-19 Disease Progression, Personal Protective Equipment (PPE), Durable Medical Equipment (DME), and Patient Outcomes
Presentation Slides: Simulation of COVID-19 Disease Progression, Personal Protective Equipment (PPE), Durable Medical Equipment (DME), and Patient Outcomes
Abstract The open-source patient simulator Synthea was modified to model the disease progression of COVID-19, including the use of Personal Protective Equipment (PPE) and Durable Medical Equipment (DME). Additionally, the model produced patient morbidity and mortality outcomes. The data has been used in several online challenges, including a challenge cohosted by the FDA and VHA. Recent updates to the model reflect historical infection rates and vaccinations.


Authors James T. O’Neal, MBA, Principal MITRE Biomedical Innovation Division,
Joan M. Grand, RN MS, Principal, MITRE Health Innovation Center
Title Effective Systems Engineering Applications in Community Activation for COVID-19 Therapeutics
Session Type: LIVE
Theme: System Approaches to Tracking Pandemic Responses
Time: Friday, November 12, 2021 3:00 PM - 3:50 PM
Room: Virtual
Recording Video Recording: Effective Systems Engineering Applications in Community Activation for COVID-19 Therapeutics
Presentation Slides: Effective Systems Engineering Applications in Community Activation for COVID-19 Therapeutics
Abstract COVID-19’s impact on the health, economy, and the security of the nation has been swift and devastating. Near and long-term solutions for improving the clinical health of those afflicted with COVID-19 must be addressed with a commitment to rapidly adapt upon the receipt of additional information.
Using an end-to-end systems approach, a Community Activation Model was developed to reach, educate, and activate various stakeholders on the benefits of COVID-19 therapeutics. Adapted from the Lean Startup “Build, Measure, and Learn” model, the Community Activation Model ensured that data insights were systemically identified, collected, and incorporated to inform refinements to program activities in the respective service areas. The combination of clinical and communication science with advanced analytics supported large scale stakeholder engagement and multi- channel communications which resulted in:
1) increased exposure to and awareness of COVID-19 therapeutics
2) community activation and behavior change (increased acceptance of monoclonal antibodies and Convalescent Plasma donations) and
3) enhanced data driven decision making


Authors Dr. Linda Desens, Principal Scientist, Health Communication, The MITRE Corporation
Gary Bundy, The MITRE Corporation-, Mike Fulk, The MITRE Corporation
Title Countering Disinformation and Misinformation to Develop Messaging that Builds Confidence in Public Health
Session Type: LIVE
Theme: System Approaches to Tracking Pandemic Responses
Time: Friday, November 12, 2021 4:00 PM - 4:50 PM
Room: Virtual
Recording Video Recording: Countering Disinformation and Misinformation to Develop Messaging that Builds Confidence in Public Health
Presentation Slides: Countering Disinformation and Misinformation to Develop Messaging that Builds Confidence in Public Health
Abstract Social media has been a vital communication channel for governments and other public-interest organizations to disseminate accurate and timely information about COVID-19. Conversely, social media channels have also been used to disseminate misinformation and disinformation COVID-19 and the SARS-CoV-2 vaccine. False and inaccurate information may have a disproportionate impact on specific groups that have been historically marginalized, and it may increase SARS-CoV-2 vaccine hesitancy. As we enter the next era of the COVID-19 pandemic-with broad availability of vaccines for the general population-we know many in public health will be working even harder to promote vaccination in their communities and workplaces. Moreover, some are juggling this responsibility on top of their usual duties. health communication scientists and public health engagement experts at the MITRE Corporation applied their expertise and research to create the COVID-19 Health Communication Playbook, structured as a series of easy-to-follow steps that will guide public health communicators to formulate and execute a strategy. Our health communication scientists have also worked with multiple to city and county public health departments to help execute effective, evidence-based strategies within their communities. With applied research, a persuasion annotation tool was also created using machine-learning to understand critical behavior and inform public health response.


Authors Prof. Bo Oppenheim
Loyola Marymount University
Title Overview of the Lean Healthcare Systems Engineering Process at Loyola Marymount University
Session Type: LIVE
Theme: Lean Healthcare Systems Engineering Applications
Time: Friday, November 19, 2021 1:00 PM - 1:20 PM
Room: Virtual
Recording Video Recording: Overview of the Lean Healthcare Systems Engineering Process at Loyola Marymount University
Presentation Slides: Overview of the Lean Healthcare Systems Engineering Process at Loyola Marymount University
Abstract This overview will serve as framework for the projects subsequent to be described in the subsequent presentations.


Authors Dr. Gabrielle Johnson
Title Using Lean Healthcare Systems Engineering to Streamline Patient Flow Through the Post Anesthesia Care Unit
Session Type: LIVE
Theme: Lean Healthcare Systems Engineering Applications
Time: Friday, November 19, 2021 1:25 PM - 2:15 PM
Room: Virtual
Recording Video Recording: Using Lean Healthcare Systems Engineering to Streamline Patient Flow Through the Post Anesthesia Care Unit
Presentation Slides: not yet available
Abstract The post anesthesia care unit (PACU) is a monitoring and treating location for patients recovering from surgery. The average length of stay in the PACU at Keck Hospital of USC is prolonged at 133 minutes. Studies show that 98% of delays in PACU are caused by “avoidable, non-clinical reasons”. LHSE was used to analyze the process and provide recommendations for improvement. The objective of this project was to decrease the average length of stay for patients in the PACU while maintaining patient safety and clinical excellence.


Authors Dr. David Hassel
Kaiser Permanente Population Health
Title Improving Peritoneal Dialysis Care Procedures at Kaiser Permanente - Anaheim Medical Center
Session Type: LIVE
Theme: Lean Healthcare Systems Engineering Applications
Time: Friday, November 19, 2021 2:20 PM - 3:10 PM
Room: Virtual
Recording Video Recording: Improving Peritoneal Dialysis Care Procedures at Kaiser Permanente - Anaheim Medical Center
Presentation Slides: not yet available
Abstract The presentation focuses on proposing methodology that has been successfully previously implemented in other competing healthcare companies and high-ranking countries in the space of peritoneal dialysis care. In proposing these solutions, the goal is to address the disconnects that exist in patient/provider education, patient safety culture, and patient/provider accessibility. These solutions will result in a net-positive gain in patient confidence, financial standing, and time management for patients and providers. The project used the LHSE process.


Authors Lily Bautista
Kaiser WLA Population Care
Title Improving Timely Access for Hernia Consults in The LAC+USC MIS Clinic
Session Type: RECORDED
Theme: Lean Healthcare Systems Engineering Applications
Time: Friday, November 19, 2021 3:15 PM - 4:05 PM
Room: Virtual
Recording Video Recording: Improving Timely Access for Hernia Consults in The LAC+USC MIS Clinic
Presentation Slides: Improving Timely Access for Hernia Consults in The LAC+USC MIS Clinic
Abstract Over 40% of general surgery clinic visits at the LAC+USC large safety-net hospital are for abdominal wall hernias; most of which are deferred surgery due to poor surgical candidacy, for reasons including high body mass index, uncontrolled comorbidities, and tobacco use. This high deferral rate results in poor clinic resource utilization and suggests an ineffective referral review process. The objective of this study was to use the LHSE process to analyze our referral review process to improve referral appropriateness and decrease the proportion of patients deferred surgery.


Authors Alyna Velasquez
Loyola Marymount University
Title Home-Use Devices for Telehealth Visits
Session Type: RECORDED
Theme: Lean Healthcare Systems Engineering Applications
Time: Friday, November 19, 2021 4:10 PM - 4:50 PM
Room: Wright
Recording Video Recording: Home-Use Devices for Telehealth Visits
Presentation Slides: not yet available
Abstract AltaMed is one of the largest federally qualified health centers (FQHCs) that provides health services and care to predominantly Latin, multi-ethnic, and underserved communities. AltaMed greatly expanded their telehealth services as a result of the Covid-19 pandemic, however, a lack of access to a patient‘s vital measurements, reduced the quality of these virtual visits. The objective of this project was to review potential vital measurement devices for patients to use at home; that would be both easy to use and low in cost. The LHSE process was used for the project.



For questions and comments, please contact:
Technical Program Lead
Kelly Weyrauch